Developmental Milestones/Developments to Date:
Current Assessment/State of the Field:
Department of Health and Human Services, “Local Pandemic Influenza Preparedness: Vaccine and Antiviral Drug Distribution and Dispensing” September, 2009. https://www.hsdl.org/homesec/docs/oig/nps36-092109-02.pdf&code=9eab8e33f5e3cb46bec3f2325982fba2
- In a 2008 review of State pandemic influenza operating plans the Assistant Secretary for Preparedness and Response (ASPR) stated that states were “doing well” with vaccination plans.
- The Department of Health and Human Services (HHS) provided states with guidelines for planning vaccine distributions
- “The 8 planning areas outlined are: Receiving & Staging, Dispensing, Tracking, Vulnerable Populations, Priority Groups, Security, Storage, and Transportation. Selected localities had not addressed in their planning documents most of the vaccine and antiviral drug distribution and dispensing components and preparedness items identified in HHS pandemic influenza guidance.”
- “All selected localities conducted exercises related to vaccine and antiviral drug distribution and dispensing; however most did not create After Action Reports and Improvement Plans for these exercises.”
- “All selected localities collaborated with community partners to develop and exercise their plans to distribute and dispense vaccines and antiviral drugs during an influenza pandemic.” The HHS provided several recommendations in this article.
Henderson, D., A., “Bioterrorism as a Public Health Threat,” Emerging Infectious Diseases, vol. 4, No. 3, July-sept 1998.
- Admonition & historical accounts.
Benjamin, Georges C. “Chemical and Biological Terrorism: Planning for the Worst” Physician Executive Volume 26 Issue 1. 80. January/February 2000.
- Chemical or biological terrorism is the use of pathogenic microbes or toxins derived from plants, animals, microbes, or chemical agents to achieve terror.” – page 80
- ”Chemical and biological weapons, like nuclear weapons, are categorized as weapons of mass destruction (WMD) because of the high number of potential victims that can result from their use.” – page 80 *
- ”While any chemical can be weaponized, the chemical agents traditionally of concern fall into four categories: nerve agents like sarin, which create an anticholinergic-like syndrome; vesicants like mustard gas, that cause a blistering or burn-like syndrome; cyanide, which interrupts aerobic metabolism; and riot control agents such as mace, which generally cause incapacitation.” – page 80
- ”Biological agents act like chemical agents but have a slower onset of action. Agents of concern include Ricin.” – page 81
- ”The ideal bioweapon is hard to detect from the usual microbial flora, has person-to-person spread, and is easy to aerosolize. There are two groups of organisms of public health concern: those that cause a high morbidity or a high mortality.” – page 81
- ”Examples of high morbidity organisms include salmonella, cholera, or E. coli. The number of highly toxic organisms is fortunately quite low and includes anthrax, smallpox, and the viruses that cause hemorrhagic fevers, plague, brucellosis, and tularemia.” – page 81
- “Clues that biological terrorist events have occurred include an unexplained increase in respiratory cases or deaths, or dead and dying animals. Epidemiological clues include diseases with the wrong mode of transmission, which occur in an inappropriate geographic distribution or infect a new or novel population.” – page 81
- “Components of a biological/chemical terrorism disaster plan: plan how to identify the threat; develop an effective public health disease surveillance system; link the public health system and the traditional medical care delivery system; develop command and control systems; determine hospital bed availability; define disease containment, isolation, and quarantine procedures; plan how to obtain extra life support equipment such as respirators; plan how to train clinical staff to identify high-risk unusual diseases; ensure non-clinical staff are trained on the management of suspicious packages and mail; identify experts; plan simple handling and transport; plan how to communicate high risk information; manage medical examiner cases; and maintain a crime scene.” – page 81
- ”Effective disease control strategies such as case finding, decontamination, prophylaxis and vaccination, and quarantine must be defined.” – page 82
Chemical, WMD, Bioterrorism, Public Health, Military, Sarin, Japan, Ricin, E. coli, Cholera, Salmonella, Anthrax, Smallpox, Hemorrhagic fever, Plague, Brucellosis, Tularemia, Prophylaxis, Vaccination, Quarantine
Inglesby, Thomas, V. et al., “Plague as a biological weapon: Medical and public health management” JAMA, ma3, 2000, vol. 283, No. 17, 2281
- consensus statement 1995 microbiologist in ohio acquired plague y pestis by fraudulent means, antiterrorism drawn in response.
- Vaccination info/treatment.
Stolberg, Sheryl, “A NATION CHALLENGED: THE HEALTH SYSTEM; Struggling to Reach a Consensus On Preparations for Bioterrorism”. The New York Times; November 5, 2001.
- “This year, Johns Hopkins will buy extra medicines, masks, ventilators and radios for its security force. It will retrofit a building with new air filters, to keep infectious germs from spreading. The price: $7 million. The question is, who will pay for it?”
- “”The federal government is going to have to give us some assistance,” Mr. Peterson said. Last week, the American Hospital Association estimated that the nation would have to spend $11.3 billion to get hospitals ready to handle a serious bioweapon attack.”
- “The system they have tested — the public health system — has been strained to its breaking point.”
- “”We have spent, in the last three years, one dollar per year per American on bioterrorism preparedness,” said Dr. Tara O’Toole, director of the Center for Civilian Biodefense Studies at Johns Hopkins University. “We are basically getting what we paid for.””
- “”We can achieve much better preparedness very quickly,” Mr. Kennedy said, “but it will require a major national effort and a major commitment of new resources.””
- “Having the will does not just mean having the money. It means training doctors and nurses and public health professionals. It will also mean a sea change in the way hospitals do business.”
- “To prepare for bioterrorism, hospitals must build surge capacity back in. Yet because they are reimbursed by health insurers only for patient care, hospital executives say they have no way to pay for bioterrorism preparedness. And because hospitals compete for patients, most have not engaged in regional planning for a bioterrorist attack — designating one city hospital as the burn unit, for instance, and another the infectious disease ward.”
- “Some bioterrorism experts, among them Dr. Frank E. Young, the former director of the Office of Emergency Preparedness at the Department of Health and Human Services, have suggested that military field hospitals could be used to help cope with an attack. Others say that is not practical.”
Inglesby, Thomas, V., et. al., “Anthrax as a Biological Weapon, 2002: Updated Recommendations for Management,” JAMA, May 1, 2002. vol. 287, No. 17, p. 2236.
Campion, Edward, W., “Suspicions about the Safety of Vaccines,” N Engl J Med, Vol. 347, No. 19 , November 7, 2002.
- Perspective. “the overall safety record of vaccines is extraordinarily good.” ‘
Barry, John et. al, “Assessing the Threat“, Newsweek, Vol. 140 Issue 16, p52, 14 October 2002.
- “Labs in the United States and Russia keep samples under lock and key; whether anyone else has it is the crucial question.”
- “No longer found in nature, smallpox can’t be made in a lab and would probably require a suicidal carrier to deliver it.”
- “The notion of a black market in smallpox keeps the Bush administration up at night. Homeland Security czar Tom Ridge points to “credible information within the international community at large that some of our enemies have smallpox. ‘Vice President Dick Cheney thinks so, too.’”
- “When bioweapons inspectors visited Iraq in the mid-1990s they found no smoking gun, but they did find a disturbing sliver of evidence. They saw the word “smallpox” written in Arabic on a freeze-dryer that could have been used to weaponize the virus; Iraq claimed the dryer was used to make vaccines.”
- “When Hussein Kamel, Saddam’s son-in-law and his bioweapons director, defected temporarily to Jordan in 1995, he disclosed much about Iraq’s bioweapons, but he denied any effort to weaponize smallpox.”
- “The simplest delivery vehicle would be an infected soldier or terrorist with a hacking cough riding the crowded subways or buses of an American city. Whereas that might initially infect dozens of people, an aerosol bomb that sprayed a virus-laden mist would reach hundreds.
- “Iraq and several other countries have the capability of making aerosols.”
- “…last month started vaccinating frontline health-care workers. Some Israeli bioweapons experts are convinced that Iraq poses a smallpox threat and advocate vaccinating the entire population. Britain and Australia have been buying vaccines.”
Vellozi, Claudia, et.al, “Generalized Vaccinia, Progressive Vaccinia, and Eczema Vaccinatum Are Rare following Smallpox (Vaccinia) Vaccination: United States Surveillance,” INVITED ARTICLE: CONFRONTING BIOLOGICAL WEAPONS, 2003.
- “military began vaccinating against smallpox in Decemeber 2002 for bioterrorism preparedness.”
- dermatological manifestations
- “adverse reactions” to the smallpox vaccine
Goldstein, Avram, “Progress Cited on Health Threat; ‘We’re Worlds Better Prepared,’ City Official Says” The Washington Post, April 17, 2003
- “They are buying protective gear; expanding drug, food and water stockpiles; adding or enhancing decontamination facilities outside emergency rooms; and creating patient isolation rooms to help control a smallpox outbreak.”
- “The city has set up an elaborate incident command center that is so new it hasn’t been seen by Mayor Anthony A. Williams (D), said Feseha Woldu, acting administrator of the D.C. Emergency Health and Medical Services Administration.” *“The District has expanded its epidemiology staff to eight and assigned nearly 60 city workers to bioterrorism preparedness. Meanwhile, hundreds of private doctors and nurses have volunteered to deliver health care services or to provide information to the public by phone or computer if called upon by the city.”
- “”We live in the No. 1 terrorist target in the world,” said Jeffrey A. Elting, medical director for bioterrorism response coordination at the D.C. Hospital Association. That stark reality has spurred much of the cooperation, he said.”
- “The best example is a radio system that enables all hospitals to communicate if telephone service is interrupted, allowing them to rapidly exchange information on their capacity to accept new patients and lend each other equipment and supplies. It also would let public health officials broadcast messages to hospitals regarding the dimensions and type of event. The system is tested a few times a day, when roll is called.”
- “The survey found that, on average, hospitals can generate their own electric power for 5.8 days. Without outside help, surveyed hospitals said, they had enough food to last 4.7 days, water for 2.5 days, and medical supplies for 7.1 days.”
- “At Providence Hospital, officials are buying 20 protective full-body suits, including respirators, so doctors and nurses can safely and rapidly care for people contaminated by dangerous chemicals or pathogens. They also are buying a mobile decontamination unit where patients exposed to hazardous substances can shower.”
- “If a smallpox outbreak occurred, Providence has 12 patient rooms and a 16-bed unit that can be isolated to keep a virus from spreading to unprotected patients and staff. The hospital also has eight portable HEPA (High Efficiency Particulate Air) filtration units that can convert a room or even a plastic tent to a temporary isolation unit.”
- “He said the hospital does not want to use the inflatable decontamination units they already have because they take too long to set up — 18 minutes.” *“Wuerker said 12 people have been vaccinated for smallpox, including himself, and another 12 are scheduled. With that many first-line responders, he said, all 5,000 hospital workers could be vaccinated quickly to prepare for an outbreak.”
- “Exactly which surge facilities might be needed and when is unpredictable and depends on the exact location and nature of and attack, officials say. Instructions and guidance would be offered by public health officials through electronic and print media, they say.”
Editors & Staff, “Preparedness: US government releases Weill Cornell computer model for bioterror response,” Bioterrorism Week, p. 12, July 12, 2003.
- Program will, “help health officials better plan large-scale antibiotic dispensing and vaccination responses to bioterrorism and large-scale epidemics.”
Mair, Julie Samia; Mair, Michael, “Vaccine Liability in the Era of Bioterrorism,” Biosecurity and Bioterrorism. Volume 1, Number 3. Sept. 15, 2003.
- Concerns the “Liability Protection Under Section 304 of the Homeland Security Act for Participants in the National Smallpox Vaccination Program”
- “Approaches to Vaccine Liability… …There are four important historical precedents to handling vaccine liability, which are not always mutually exclusive: (1) the government can substitute itself as defendant and accept liability on behalf of the participants in the vaccination program; (2) the government can decide that no one needs to be held liable and establish a no-fault compensation program; (3) the government can indemnify (i.e., reimburse) vaccine manufacturers and distributors, providers, and other participants after they have been sued and a judgment issued against them; or (4) the government can alter the normal rules of litigation and/or compensation.”
- “Biodefense and Vaccine Liability: Principles to Consider… …Liability cannot be separated from compensation… …Ongoing communication with the various stakeholders is critical… …The extent of liability protection and compensation should be clear prior to the desired implementation date… …Liability laws that protect participants in vaccination programs should have flexibility to address new circumstances that may arise”
Bozzette., Samuel, A., et. al., “A Model for a Smallpox-Vaccination Policy,” n engl j med 348;5, January 30, 2003.
- “The new reality of biologic terrorism and warfare has ignited a debate about whether to reintroduce smallpox vaccination.”
- “We developed scenarios of smallpox attacks and built a stochastic model of outcomes under various control policies. We conducted a systematic literature review and estimated model parameters on the basis of European and North American outbreaks since World War II. We assessed the trade-offs between vaccine-related harms and benefits.”
Hearne, Shelly, “Health departments remain ill-prepared to respond to public health emergencies” H&HN: Hospitals & Health Networks. February 2004.
- *“The report, “Ready or Not? Protecting the Public’s Health in the Age of Bioterrorism,” examines 10 key indicators to assess areas of improvement and areas of ongoing vulnerability in the nation’s efforts to prepare against bioterrorism and other large scale health emergencies” (Pg. 1-2)
- “California, Florida, Maryland and Tennessee scored the highest, meeting seven of the 10 indicators.” (Pg. 2)
- “”Are we ready or not? The answer is not,” says Shelley A. Heame, executive director of TFAH.”Now is the time to get serious about developing an all-hazards approach to public health to ensure we are ready for the range of possible threats we face” (Pg. 2)
- “Among the major concerns raised in the report are: cuts to public health programs in nearly two-thirds of states; an impending shortage of trained professionals in the public health workforce; disagreements between state and local health agencies over resource” (Pg. 2)
- “The report also found that only Florida and Illinois are prepared to distribute and administer emergency vaccinations or antidotes from the national stockpile.” (Pg. 2)
Edward Despott, Mario J. Cachia, “A Case of Accidental Ricin Poisoning“, Malta Medical Journal 2004;16(4):39-41
- “Ricin is one of the most potent naturally occurring toxins known to man.”
- “With a LD50 of 3 g/kg body weight (aerosol and parenteral) and 30 g/kg body weight (ingestion)”
- “Ricin belongs to a class of proteins known as ribosomal inactivating proteins (RIPs). As their name suggests, these proteins interfere with the function of ribosomes, halt protein synthesis and thus induce cellular death.”
- “These worries have led to intensive awareness campaigns and research into the development of vaccines of antiricin and methods of rapid serological diagnosis by EIA.”
- “In this case the diagnosis was made using the clear evidence provided but in other scenarios where suspicion is strong but other corroborative evidence is lacking, the toxin can be detected by Enzyme Immuno Assay (EIA), as ricin is very immunogenic.”
Brookmeyer, Ron, “Editorial: Biosecurity And The Role Of Statisticians,” J.R. Statistical Society, 168, Part 2, pgs. 263-266, 2005.
- “Statisticians who work in Public Health are most familiar with designing and analyzing large clinical trials and epidemiological studies to answer questions.”
- “We must use modern statistical tools to estimate model parameters together with sensible mechanistic models for the spread of infectious diseases.”
- “One way to shorten the silent period is to improve disease surveillance for new outbreaks. Statisticians have been actively engaged in developing and assessing methodological approaches for rapid detection of emerging outbreaks.”
- “One example of an approach to speed the detection of an outbreak is Syndromic Surveillance, which refers to the collection and statistical analysis of vast quantities of public health data to detect early symptoms of a new disease.”
- “Syndromic surveillance offers that tantalizing possibility of an early warning of an emerging outbreak from data mining rather than waiting until public health officials have been notified of confirmed cases of disease from traditional medical care settings.”
- “Another approach to speed recognition of a bioterrorist attack is air monitoring systems for contaminants and pathogens in the environment.”
- “Biomedical research is under way to improve diagnostic test, vaccines and therapeutics for the most worrisome pathogens.”
- “Statisticians should be at the forefront in assisting policy makers to determine how to apportion limited resources to increase public health preparedness whether the debates involve syndromic surveillance, air monitoring systems, or vaccination programs.”
KAREN T. MORR, [the Acting Assistant Secretary for Office of Information Analysis in DHS] Statement, ”HEARING BEFORE THE SUBCOMMITTEE ON EMERGENCY PREPAREDNESS, SCIENCE, AND TECHNOLOGY OF THE COMMITTEE ON HOMELAND SECURITY HOUSE OF REPRESENTATIVES, ONE HUNDRED NINTH CONGRESS”, FIRST SESSION JULY 12, 2005. “PROJECT BIOSHIELD: LINKING BIOTERRORISM THREATS AND COUNTERMEASURE PROCUREMENT TO ENHANCE TERRORISM PREPAREDNESS.”
- “Al-Qa’ida documents recovered from a training camp in Afghanistan show interest in a variety of biological agents and mentioned plague, anthrax, cholera and tularemia.”
- “To determine threat, we examine an actor’s capability and intent. We assess capability based on factors such as the actor’s level of skill or knowledge, their ability to acquire a biological agent, the materials necessary to grow the agent and their capacity to effectively disseminate a biological agent. For intent, in addition to the actor’s desire to simply use biological weapons, we discern which agents they are more likely to pursue, their preferred method of deployment and which targets they intend to attack.”
- “Last month one of our analysts provided some of the Committee members with a classified briefing on the specifics of the current bioterrorist threat to the Homeland. I will not be able to revisit this classified threat assessment in this open forum but we would be happy to provide this information to additional members in a closed session.”
- “On occasion, we require quick access to information that does not reside within IA. In these cases, our analysts are supported to the Biodefense Knowledge Center (BKC)—a 24×7 support cell based at Lawrence Livermore National Laboratory and sponsored by the S&T Directorate. The BKC possesses vast repositories of biological technical information and is able to access SMEs from around the country, such as the U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), the U.S. Army Medical Research Institute for Chemical Defense (USAMRICD), and the Armed Forces Medical Intelligence Center (AFMIC), in support of a tasking from IA. The BKC compiles the appropriate information and relays it to our analysts who integrate the information into their finished intelligence analysis.”
- “Our analysts regularly collaborate with other intelligence agencies, particularly NCTC, DIA, FBI, and CIA. We also work with experts from government, academic, and private institutions and partner with scientists who keep us abreast of their potential areas of concern and the trends they see. Interaction with outside public and private sector institutions keeps us well-informed of new and emerging technology that may be exploited or misused by malicious actors. For example, IA recently hosted a workshop on emerging biotechnologies and the future biological threat. This provided a forum for non-governmental experts to provide IA with information of which they believe we should monitor.”
- “Our analysts are broadly focused and access a wide array of information in gathering source material for our assessments. They use all-source intelligence, scientific and technical information, terrorist profiles, historical trends, and open source information such as media reports and scientific journal articles.”</div>
- “We keep current on foreign State biological weapons program developments as these activities may have implications for future terrorist events. We look at the intent of the enemy, their capabilities, potential scenarios, and attack vectors. Working with counterterrorist experts in the Community, we develop link charts on potential associates here in the United States of operatives abroad who may have received training in WMD capabilities or have knowledge of WMD programs.”
- “we assessed the implications of the H2N2 influenza shipment in which a U.S. contractor sent a highly virulent strain of influenza to hundreds of laboratories worldwide. We also recently published an Information Bulletin advising State and local Law Enforcement officials of
indicators of covert anthrax production. Generally, our products fall into two categories: threat assessments and feasibility assessments.”
- “Threat Assessments. Threat assessments are written on known actors and are based on specific intelligence. To determine threat, we examine an actor’s capability and intent. We calculate capability based on factors such as a particular actor’s level of skill or knowledge; their ability to acquire a biological agent and the materials necessary to grow the agent; and their capacity to effectively disseminate a biological agent. For intent, we consider more than just an actor’s desire to use biological weapons. We attempt to discern which agents they are more likely to pursue, their preferred method of deployment, and which targets they intend to attack.”
- “Feasibility Assessments. Intelligence is never complete or all-knowing and we cannot wait until intelligence is received in order to consider plausible scenarios or the impact of a particular technique or technology on a bioterrorist’s capability. To move beyond this limitation, IA, in partnership with S&T, conducts assessments of biological processes, emerging technologies, and techniques and determines their feasibility for use in a bioterrorism event. These assessments include indicators that will help to identify if a particular scenario begins to unfold so we can prevent or disrupt events before they occur. In conjunction with the feasibility assessment, we are producing unclassified excerpts with the indicators which are distributed widely to local, State, Federal officials as well as the private sector to enhance awareness in the field and to increase suspicious activity reporting and trigger investigations where necessary.”
- “IA also has produced several bioterrorism-specific ‘‘red team’’ products, which explore issues from a terrorist’s perspective using nongovernmental experts and creative thinkers. These topics have included terrorist use of genetically modified food and recombinant DNA technologies to damage the U.S. food supply; possible terrorist exploitation of a U.S. flu vaccine shortage; and the safety and security impacts of a pandemic influenza outbreak.”
- “Under the BioShield legislation, DHS is charged with assessing current and emerging threats of chemical, biological, radiological, and nuclear agents; and determining which of such agents present a material threat against the United States population. S&T, supported by IA, has been conducting Material Threat Assessments (MTAs) and Material Threat Determinations (MTDs) in order to guide near term BioShield requirements and acquisitions.”
- “MTAs … are speculative and represent a best estimate of how an adversary may create a high-consequence event using the agent/weapon in question. Currently, MTAs are drafted by the S&T and IA provides comments on the assessment before it is provided to HHS. In our review, we ensure that the assessment reflects what IA assesses is the general capability of terrorist groups that are pursuing biological weapons.”
- “MTAs result in an estimate of the number of exposed individuals, the geographical extent of the exposure, and other collateral effects. If these consequences are of such a magnitude to be of significant concern to our national security, the Secretary of DHS then issues a formal Material Threat Determination to the Secretary of HHS, which initiates the BioShield process. To date, one MTA has been completed for anthrax and MTAs for plague, botulinum toxin, tularemia, radiological devices and chemical nerve agents are underway and an MTA for viral hemorrhagic fevers will be initiated next month. MTDs have been approved for four agents: smallpox, anthrax, botulinum toxin, and radiological/nuclear devices.”
- “IA, in cooperation with NCTC and the FBI, is providing WMD outreach briefings around the country. These briefings outline the terrorist WMD threat, including descriptions of the types of weapons used and indicators and warnings aimed at increase awareness and reporting. In the near future, we hope to expand these briefings to other audiences such as academia and the private sector to further increase awareness and reporting.”
- “IA will be playing a key role in supplying current intelligence to the National Biosurveillance Integration System (NBIS) operations center once it begins operation later this summer. NBIS will fuse information on human, plant, and animal health with environmental monitoring of air, food, and water systems. This information will be integrated with threat and intelligence information to provide real-time situational awareness and identify anomalies or trends of concern to the Homeland Security Operations Center.”
Berger, Matthew, E., “Lawmakers Uneasy About White House Plan for Combatting Pandemic Flu,” CQ Homeland Security, May 16, 2006.
- Jursidiction for HHS & DHS.
- “DHS in charge of law and order.”
- supplies and distribution: masks, vaccination, response.
Olmsted, Stuart, “Patient experience with, and use of, an electronic monitoring system to assess vaccination responses.” Health Expectations. June 2006.
- “National Research Council (NRC) report, Networking Health: Prescriptions for the Internet, highlights the potential for information technology (IT) and the Internet to revolutionize health-care delivery in the near future” (Pg. 1)
- “When applied to populations, electronic monitoring of many individual patients with chronic or infectious diseases can improve surveillance and management of chronic diseases, as well as reducing health-resource utilization.” (Pg. 1-2)
- “In public health practice, a mass vaccination program, whether for pandemic influenza or smallpox, may be strengthened and easier to administer if an electronic system were used to monitor vaccine reactions and side effects.” (Pg. 2)
- “Such a system can reduce the need for clinical assessments of vaccine responses, cutting travel time, work absenteeism and clinician time to assess vaccine sites. In addition, a system such as this can act as an early warning device for adverse events.” (Pg. 2)
- “Users also reported that the picture on the web or pocket card closely matched the appearance of their vaccine site (143/169; 85%) and that they were confident that what they reported matched their true reaction to the vaccine (147/171; 86%).” (Pg. 3)
- “While survey responders in this study were comfortable with a physician tracking their vaccination status via their electronic reports, and many were comfortable with having their take check determined electronically, half of the respondents were not comfortable eliminating the follow-up visit with a health-care provider.” (Pg. 6)
- “a similar reporting system may prove useful in public health settings in which large numbers of people will need treatment and follow-up in a short period of time, such as a mass vaccination or prophylaxis during a bioterrorism event, an influenza pandemic or another public health emergency.” (Pg. 6)
Zimmerman, Richard, “Rationing of influenza vaccine during a pandemic: Ethical analyses“, Vaccine, 25, 2007, pg. 2019–2026.
- “Rationing of scarce vaccine supplies will likely be required when the next pandemic occurs, raising the questions about how to ration and upon what principles.”
- “Since influenza pandemics have differing mortality patterns, such as the 1918 pandemic’s “W” shaped curve that effected healthy young adults, the particular pattern should inform rationing.”
- “ethical principles for vaccine rationing can be utilitarianism and egalitarianism.”
- “A framework that uses multiple principles to address influenza vaccine rationing in light of a shortage is recommended.”
Forden, Geoffrey, “How the World’s Most Underdeveloped Nations Get the World’s Most Dangerous Weapons,” Technology and Culture, 2007, pp. 92-103.
- “Iraqi biological weapons administrative infrastructure relied on its own mytoxin experts, who encouraged first research and then production.”
- “According to the Iraq Survey Group’s ”Comprehensive Report”, the Iraqis began research on the powerful nerve agent VX in 1985 with a literature search for published work on its synthesis and production.”
- “In 1975, the Sunday Times of London revealed that the British patent office had, a number of years earlier, approved and published the formula and method of synthesis for a whole family of organophosphate chemicals, including VX.”
- “A machinist can just as easily learn to operate a flow-forming machine by making a tuba horn as a rocket nuzzle; a technician can learn to control a fermenter to brew a vaccine as well as a pathogen; producing a nerve agent is not so different from producing a pesticide. As such beneficial knowledge spreads–and no one would deny a developing country the right to produce vaccines or refine its own agricultural chemicals–it will become that much easier for proliferators to find the necessary population of skilled workers already within the country.”
- “We still need our supply-side-oriented nonproliferation regimes to try to prevent crucial technologies from being shipped to countries that might abuse them.”
Vawter, Dorothy, et. al., “Allocating pandemic influenza vaccines in Minnesota:Recommendations of the Pandemic Influenza Ethics Work Group,” Vaccine 25, 2007, 6522–6536.
- “A public–private, multidisciplinary work group developed recommendations for rationing vaccines in Minnesota during a worst-case influenza pandemic. The recommendations encompass an ethical framework of principles, goals, and strategies. The primary goal is to maximize Minnesotans’ chances of surviving both the pandemic and the years immediately thereafter and to limit two major causes of death.”
McNeil Jr., Donald, G., “Polio in Nigeria Traced to Mutating Vaccine.” NYT, A15, October 11, 2007,
Capua, Ilaria, Marangon, Stefano, “Control and prevention of avian influenza in an evolving scenario,” Vaccine 25 (2007) 5645–5652.
- Continuing outbreaks of highly pathogenic avian influenza (HPAI) across Eurasia and in Africa, caused by a type A influenza virus of the H5N1 subtype appear out of control and represent a serious risk for animal and public health worldwide. It is known that biosecurity represents the first line of defence against AI, although in certain circumstances strict hygienic measures appear to be inapplicable for social and economic conditions. The option of using vaccination against AI viruses of the H5 and H7 subtypes, has made its way in recent times—primarily as a tool to maximise the outcome of a series of control measures in countries that are currently infected, but also as a means of reducing the risk of introduction in areas at high risk of infection
Capuzzo, Jill P. “New Jersey considers Preschool Vaccines.” New York Times, Dec 9, 2007, A35,
- would be first state to mandate flu and meningitis vaccines
- preschool flu
- sixth grade meningitis
- CDC rec flu shot
- 100 kids per year die from flu
- Dr. Bresnitz wants to inoculate kids for flu to protect population as a whole
- 13 states require pneumonia vaccines.
Collett Marc S. “Impact of Synthetic Genomics on the Threat of Bioterrorism with Viral Agents. In: Working Papers for Synthetic Genomics: Risks and Benefits for Science and Society,” pp. 83-103. Garfinkel MS, Endy D, Epstein GL, Friedman RM, editors. 2007.
- “From a bioterrorism perspective, viruses isolated from nature are a sure bet. Their virulence and transmissibility are known. Their effect and impact can be predicted or calculated. Viruses isolated directly from diseased hosts (called “primary isolates”) demonstrate clearly the consequences of their infection. Additionally, the virus’s ability to survive, persist and spread in the environment and among susceptible hosts is generally known. Finally, pathogenic viruses isolated from diseased hosts are typically “hot” viruses; that is, primary isolates of pathogenic viruses tend to cause severe disease in their host.” P87
- “Most viral genome sequences deposited in databases are derived from laboratory-passaged viruses. While many sequences may be derived from low-passage viruses, and are therefore more likely to be close to their primary isolates, in some cases the passage history of the virus from which the sequence was derived is unclear, as are the biological attributes associated with that virus. Thus, there can in some cases be uncertainty regarding the biological attributes of a synthetic replica of a gene bank virus sequence.” P88
- “[S]ynthetic genomics technology could provide the means for the re-creation of variola virus, and therefore could affect the availability of this agent for malevolent use. Due to the large size of the poxvirus genome, however, it would be anticipated that well-established poxvirus recombination techniques would play a significant supportive or alternative role in producing an entire poxvirus genome.” p 91
- “Smaller genome segments of a sequence derived from variola virus may be readily incorporated into a “base” monkeypox virus, resulting in chimeric orthopoxviruses with unknown and unpredictable biological characteristics.” p 91
- “Because of their virulence, filoviruses are handled in high containment laboratory facilities to prevent virus release into the environment, and also to protect those working with these highly pathogenic viruses. Consequently, the number of labs in possession of these viruses is limited, as is access to these labs. However, during outbreaks, unsecured local hospitals and medical field teams collect, hold and transport numerous infectious patient specimens. Additionally, there may be covert stores of virus outside known containment laboratories. Hemorrhagic fever viruses were the subject of biowarfare research in the former Soviet Union, where weaponized Marburg virus was produced and research on Ebola was conducted. Upon the dissolution of the Soviet Union and these programs, the disposition of laboratory biological materials was not tracked.” pp 92-93
- “While [Australian workers] trying to improve their experimental mouse contraceptive vaccine, they engineered the expression of cytokine IL-4 from ectromelia virus, hoping that infection with this recombinant poxvirus would enhance antibody production by their vaccine. It instead resulted in severe suppression of cellular immune responses in the mice, uncontrolled virus replication, and animal death. Even mice previously immunized against normal ectromelia virus 16 or treated with the antiviral drug cidofovir17 were unable to survive ectromelia-IL-4 virus challenge.” p 95
McNeill Jr., Donald, G. “A Pandemic That Wasn’t but Might Be,” NYT, January 22, 2008, D1 (continued D8)
- preparations/better vaccine/European Center for Disease Prevention and Control, Stockholm/poor countries/faster lab tests/international/recommend vaccinating millions.
Associated Press, “Preschoolers’ parents protest required flu shots: N.J. policy is first in the nation to require the vaccine for small children,” Oct. 16, 2008, http://www.msnbc.msn.com/id/27225500/
Oshitani, Hitoshi, Kamigaki, Taro, Suzuki, Akira, “Major Issues and Challenges of Influenza Pandemic Preparedness in Developing Countries.” Emerg Infect Dis. 2008 June; 14(6): 875–880. http://www.pubmedcentral.nih.gov/articlerender.fcgi?tool=pubmed&pubmedid=18507896
- ”Deaths attributable to an influenza pandemic could be substantially higher in developing countries than in industrialized countries. Pharmaceutical interventions such as vaccines and antiviral agents are less likely to be available in developing countries.”
- ” The most critical limiting factor for stockpiling of neuraminidase inhibitors in developing countries is their high cost. One treatment course of oseltamivir (i.e., 10 tablets) costs US $15, even at a discount rate (16), which is far too expensive for developing countries. Some industrialized countries have set a target to stockpile oseltamivir to treat 25% of the general population. To purchase adequate oseltamivir for 25% of the total population, only 0.11% of the total annual health expenditure is required in high-income countries. In low-income countries, however, the expense would be 12.9% of the annual expenditure (Table 1). Therefore, it is not feasible for low-income countries to allocate scarce resources to stockpile sufficient quantities of oseltamivir for an unpredictable influenza pandemic.”
Poltzer, Patrice, “Tuberculosis: A New Pandemic?“, CNN, November 17, 2008. http://www.cnn.com/2008/HEALTH/11/17/tb.pandemic/index.html
- “TB mutating into dangerous new strains for which there is no known cure”
- XDR-TB = a drug-resistant TB, incurable, could lead to a pandemic, airborne disease,
- 40,000 new cases of XDR-TB each year – WHO
- disease primarily affects developing nations
- TB is curable but if drugs not administered or used, disease can mutate into strands like XDR
- strong link between TB and poverty
Zukas, Walter, Cabrera, Catherine, Harper, James, Kunz, et al. “Assessment of Nanotechnology for Chemical Biological Defense,” in Nanoscience and Nanotechnology for Chemical and Biological Defense, Chapter 9, American Chemical Society, Washington DC, 2009.
- ”The term nanotechnology generally refers to the evolving body of tools and knowledge that allow manipulation of material structures at the scale of approximately 10-100 nanometers and to understand the relationship between nanometer scale features and the macroscopic properties of materials. Rapid progress in the development of analytical tools to probe the nanometer scale and to manipulate materials at this scale has led to a dramatic increase in the number and diversity of research programs on nanoscience and technology.” P. 10
- ”…the deeply scaled dimensions of nanoparticles enhance the surface-area-to-volume ratio, and suitable surface chemistry can then lead to highly efficient sensing schemes or catalytic reactions.” P. 10
- ”…sorption-based detection is the one most suited for application of nanotechnology. ….on the nanoscale of living systems, all sensing and molecular recognition functions are based on sorption of some sort, suggesting that man-made sensing systems aimed at mimicking biological systems will most likely use this mechanism. When a molecule adsorbs [SIC] to a surface it not only changes the mass at the surface, but it can also impart changes in the electrical, optical, and/or luminescent properties, all of which have been explored as mechanisms for chemical sensing. High surface-area-to-volume ratio nanostructures generally exhibit amplified responses to these properties, leading to sensor demonstrations with unprecedented sensitivity.” P. 10
- ”Nanotechnology may also play a role in development of non-caustic decontamination treatments. Most non-caustic decontamination chemicals exhibit slower reaction rates with agents than caustic chemicals such as bleach or sodium hydroxide.” P. 10
- ”CB agents pose extreme challenges for detection, protection, and decontamination. Their characteristic feature is their high lethality, so that even minute amounts (micrograms to milligrams) can constitute a lethal dose. Therefore, the fundamental challenge of CBD is to develop products which are highly sensitive, selective, and efficient. Sensors must detect agents at levels well below LD50, and still having extremely low levels of false alarms.” P. 12
- ”Calometric means to detect this heat would obviate the need for engineering fluorescent centers into the receptor, and could result for a whole new class of sensors, but other detection methods may also be feasible.” P. 14
- ”The vast majority of nanotechnology-based CB sensor research has focused on ultra-sensitive transducers such as nanowires, nanotubes, and cantilevers (14-16). However, sensing elements are only useful if particles of interest are present in the sample volume being interrogated; as the volume decreases, the effective concentration in the sample must increase (17).” P. 14
- ”Nano-permeable membranes (NPMs), especially those based on carbon nanontubes, have been the focus of extensive research. Recently, several groups have reported that the transport of water through nanotube pores is [SIC] orders of magnitude higher than predicted by classical hydrodynamic theories (87-89). … The field appears to have excellent potential to yield substantial valuable results from an investment focused on projects specifically tailored to address chem/bio protection, and the long-standing need for permselective membranes with improved water transport and high selectivity.” P. 18
- ”The recommendation is to focus on projects that seek to extend these results to applications of direct relevance to CBD (e.g. chemical and biological agent prophylaxis, vaccines, diagnostics, and treatments) and that seek to demonstrate that the nanoscale features of these methods to offer revolutionary capability improvements when compared to traditional approaches.” P. 18
Verweij, Marcel, “Health Inequities In Times Of A Pandemic“, PUBLIC HEALTH ETHICS, Volume 2, Issue 3, pgs 207-209, 2009. http://phe.oxfordjournals.org/content/2/3/207.extract
- people in low-income countries may have no access to vaccination despite being more vulnerable to the significant negative effects of H1N1
- “Australia, Canada, and the Netherlands expect to have sufficient vaccines to immunise the whole population”
Editors, “Local Pandemic Influenza Preparedness: Vaccine and Antiviral Drug Distribution and Dispensing” Department of Health and Human Services, September, 2009. https://www.hsdl.org/homesec/docs/oig/nps36-092109-02.pdf&code=9eab8e33f5e3cb46bec3f2325982fba2
- In a 2008 review of State pandemic influenza operating plans the Assistant Secretary for Preparedness and Response (ASPR) stated that states were “doing well” with vaccination plans.
- The Department of Health and Human Services (HHS) provided states with guidelines for planning vaccine distributions
- The 8 planning areas outlined are: Receiving & Staging, Dispensing, Tracking, Vulnerable Populations, Priority Groups, Security, Storage, and Transportation.
- “Selected localities had not addressed in their planning documents most of the vaccine and antiviral drug distribution and dispensing components and preparedness items identified in HHS pandemic influenza guidance.”
- “All selected localities conducted exercises related to vaccine and antiviral drug distribution and dispensing; however most did not create After Action Reports and Improvement Plans for these exercises.”
- “All selected localities collaborated with community partners to develop and exercise their plans to distribute and dispense vaccines and antiviral drugs during an influenza pandemic.”
- The HHS provided several recommendations in this article.
Somerville, Margaret, “A world of competing sorrows; There’s a flu pandemic and health-care resources are scarce. How do we decide who lives and who dies?” The Globe and Mail (Canada), Pg. A17, July 16, 2009.
- “H1N1 flu presents us with what we call in ethics “a world of competing sorrows” – that is, one in which there is no response that does only good and not also harm.”
- “How do we decide who gets a chance to live and who dies, when those outcomes depend on who gets access to or is denied scarce health-care resources? Who should decide? On what basis? Using which processes? The H1N1 influenza pandemic raises a large cluster of such ethical issues.”
Kevin Anderson, “ Vaccines for Biodefense and Emerging and Neglected Diseases,” chap. 3, Pages 33-42, 2009., Viral Biothreat Agents, (Available online 16 January 2009).
- The risk posed by viruses as biological threat agents is discussed primarily from a public health perspective, with the potential occurrence of significant morbidity and mortality as a result of infection via natural or intentional exposure. Parameters of risk associated with the spectrum of viruses considered as biological threat agents are discussed, to include examples of intentional use. In consideration of the threat posed by viruses, mitigating illness and preventing death are the principal goals of medical countermeasure development efforts. The existence of safe and efficacious vaccines is critical to establishing a robust posture of preparedness to address the spectrum of viral threat agents.”
Associated Press, “Polio vaccine blamed for outbreaks in Nigeria
Mutation of live virus in oral doses linked to 124 cases this year, experts say,” MSN, Aug. 14, 2009, http://www.msnbc.msn.com/id/32418446/ns/health-infectious_diseases
Yamada, Tadataka, “Poverty, Wealth, and Access to Pandemic Influenza Vaccines“, THE NEW ENGLAND JOURNAL OF MEDICINE. September 17, 2009. Volume 361, Number 12, pgs. 1129-1131., http://content.nejm.org/cgi/content/full/NEJMp0906972?query=TOC
- do developing countries have the manufacturing capacity, cost, and delivery systems and resources available to get vaccines?
- only a few countries in the world have plants for manufacturing influenza vaccine and 3 companies account for most of the world’s manufacturing capacity: GlaxoKlineSmith, Sanofi-Aventis, and Novartis.
- problem- “much if not most of the manufacturing capacity is already spoken for through purchasing contracts held by many of the world’s wealthy countries.”
- steps to ensure global community has vaccinations: identify strategies and mechanisms to make vaccines more accessible
Editors, “Swine Flu Pandemic Will Reveal 21st Century’s Poverty Pandemic“, GLOBAL HEALTH POLICY AT NYU-WAGNER, Sept 27, 2009. http://globalhealthpolicynyu.wordpress.com/2009/09/27/swine-flu-pandemic-will-reveal-21st-century%E2%80%99s-poverty-pandemic/
- historically influenza not an “equal opportunity” disease
- “people with coexisting conditions are more susceptible to poor health outcomes” and “most developng countries have high incidence of malnourished children and adults with many coexisting medical conditions.”
- socioeconomic factors- “poor resources for clean water and sanitation, no health care system or inadequate resources to seek medical attention”
Collin, Nicolas, de Radiguès, Xavier, “Vaccine production capacity for seasonal and Pandemic (H1N1) 2009 influenza,” Vaccine 27 (2009) 5184–5186.
- the World Health Organization H1N1 Vaccine Task Force
- “WHO carried out a survey in May 2009 among influenza vaccine manufacturers on their planned seasonal and pandemic production with a view to developing recommendations on the distribution and use of pandemic influenza vaccine.”
- “The potential output of 4.9 B doses of pandemic vaccine per year reported in the present survey is a best-case scenario.”
- “the WHO Director-General, Dr. Margaret Chan, and the United Nations Secretary-General, Mr Ban Ki-moon, met with senior officials of vaccine manufacturers on 19 May to ask them to reserve part of their production capacity for poor countries with no or little access to pandemic vaccine”
Franco-Paredes, Carlos, Carrasco, Peter, Preciado, Jose Ignacio Santos, “The first influenza pandemic in the new millennium: lessons earned hitherto for current control efforts and overall pandemic preparedness,” Journal of Immune Based Therapies and Vaccines, 2009, 7:2, http://www.jibtherapies.com/content/pdf/1476-8518-7-2.pdf,
- “it has become clear that responding to the current pandemic or preparing for future ones, nation states need to develop or strengthen their laboratory capability for influenza diagnosis as well as begin preparing their vaccine/antiviral deployment plans. Vaccine deployment plans are the critical missing link in pandemic preparedness and response. Rapid containment efforts are not effective and instead mitigation efforts should lead pandemic control efforts.”
McNeil, Donald, G., “One Shot Seen as Protective For Swine Flu: Vaccine Should cover High-Risk Groups,” NYT, A1, September 11, 2009.
- “…clinical trials are showing that the new H1N1 swine flu vaccine protects with one dose instead of two, so the vaccine supplies now being made will go twice as far as had been predicted.”
- “…the government hopes to have 195 million doses by year’s end.”
- “The H1N1 swine flu pandemic has now reached 168 countries. It arrived in the United States late in the spring and infected more than one million people.”
- “Cases are surging again, especially in the Southeast where many schools and universities reopen earlier than the rest of the country.”
- “There were no deaths or dangerous side-effects [from the trials]. Almost half of the participants reported sore arms or headaches, but that is normal with flu shots.”
- “The authors from the Australian study said the robust respose implied that there was some previously unsuspected crossover protection from having had previous strains of H1N1 seasonal flus or from teh H1N1 components of seasonal flu shots.”
Associated Press, “Vaccine is Approved,” NYT September 16, 2009, A23.
- “The Food and Drug Administration approved the new swine flu vaccine. … Limited supplied should start trickling out the first week of October.”
Associated Press, “U.S. to Share Vaccine, Obama Says,” NYT, September 18, 2009, A22.
- “President Obama said the united States will share 10 percent of its swine flu vaccine with other nations. The White House said the vaccine to counter the virus known as H1N1 would be available through the World Health Organization to nations taht otherwise would not have access to the vaccine.”
McNeil, Donald, G. & Zraick, Karen, “New York Health Care Workers Resist Flu Vaccine Rule” NYT, September 21, 2009. A17.
- “emergency health regulation adopted this summer by State Health Department making all hospital home health and hospice workers get seasonal and swine flu vaccinations was a stratling and radical step.”
- “federal officals say, only about 42 percent of all health care workers get an annual flu shot.”
- “Dr. Julie Gerberding, the former director of the Centers for Disease Control and Prevention …pushed for years for mandatory vaccinations — not just to protect health care workers, she explained, but to protect their patients, who are often aged, have weakened immune systems or are bedridden after surgery, which increases pneumonia risks.”
- “unions do not oppose vaccination ‘but we oppose a mandatory program.'” saaid Joel Shufro, executive director of a coalition of 200 local unions.
- Dr. Thomas R. Frieden, Director of the CDC said, “he would not push to make vaccinations mandatory.”
- “Every state already requires health workers to be immunized against measles, mumps and polio, and the unions do not object.”
- “Immunologists generally agree that real protection against any disease requires vaccination rates over 90 percent.”
- “only two hospital groups in the country, Virginiaa Mason in Seattle and BJC HealthCare in St. Louis, now make all their employees get flu shots or face dismissal.”
- “With volunteers ‘the best you get is usually between 50 to 60 percent,’ said Dr. William Schaffner.”
- “Surveys of 8,500 Hong Kong health care workers published last month in BMJ, formerly the British Medical Journal, found that more than half planned to refuse the new vaccine if they could.”
- “Overall, virologists say, of every 100 people who fatihfully get flu shots, only about 70 are fully protected every year.”
McNeil, Donald, Jr., “China: Swine Flu Campaign, First in world, Begins in Beijing,” NYT, A11, September 22, 2009.
- “The Health Ministry said it hoped to vaccinate 65 million people, about 5 percent of the population, by year’s end. Besides students, other groups with top priority include border and customs guards, transit workers, the military and the police, and people with heart and lung diseases. The Health Ministry has reported over 13,000 confirmed cases of the flu across the nation.”
Pollack, Andrew, “In Vaccine Additive, Benefit and Doubt, NYT, D1, Sept. 22, 2009.
- “Are Americans obliged to use an unproven vaccine to help protect people in other countries from the flu pandemic? That is the crux of a debate over adjuvants”
- “Early studies suggest that adjuvants (pronounced AD-joo-vants) could allow four times as many people to be immunized against H1N1 pandemic influenza with a given amount of vaccine.”
- “But while Canada and some European nations will use vaccines containing adjuvants, American officials have decided against it for now.”
- “Officials also fear that using an adjuvant would raise public fears about vaccine safety at a time when their challenge might be about to shift from producing enough vaccine to persuading people to use it.”
- “…There’s a concern that people would be reluctant to get vaccinated,’ said Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases.”
- “Officials say, one reason to use adjuvants is that they can increase a vaccines’s potency against a virus to which it is poorly matched. But the swine flu vaccine is well matched to the virus, which has not mutated.”
McNeil, Donald, G., “Swine Flu Officials Message: Don’t Blame Shots for All Ills,” NYT, A1, Septmeber 28, 2009.
- Preemptive public relations strategy by CDC targeting media for reporting coincidental maladies and powerful antivaccine activists. Due in part from lessons learned from 1976 flu vaccination campaign which was suspended due to questions over relationship with Guillain_Barre syndrome.
- “Every year there are 1.1 million heart attacks in the United States, 795,000 strokes and 876,000 miscariages, and 200,000 Americans have their first seizure.”
- “Some antivaccine groups are raising fears of thimerosal, a preservative used in some brands of vaccines. Others issue dire warnings about squalene, an immune-booster used in military vaccines but not in any American ones.”
Fitzsimmons, Emma, Graves, “Researcher Had Bacteria For Plague At His Death,” NYT, A 13, Sept. 22, 2009.
- “researcher, Malcom Casadaban, 60 had a weakened strain of the bacteria Yersinia pestis in his blood when he died from an infection on Sept. 13, university officials said.”
- [He was] studying the bacteria to create a better vaccine for plague.”
- “As a precaution, though, the University of Chicago medical Center offered antibiotics to about 100 people who knew the researcher, including his family members, friends and colleagues.”
- “Plague is rare in the United States, with fewer than 15 cases reported annually, mostly in rural areas in the Southwest, according to the C.D.C. About 1,000 to 3,000 cases of plague are reported globally each year, many in Africa.”
- “Dr. Casadaban had hoped to create a better vaccine for plague in part because of concerns about its possible use in bioterrorism.”
- “Officials are investigating whether Dr. Casadaban may have become infected through breathing, through a cut in his skin, or through his eyes or mouth.”
- “… required to follow safety guidelines, including wearing gloves, a lab coat and goggles and using a biosafety cabinet, a device that has a filter to clean the air in a laboratory, according to the C.D.C.”
Medina, Jennifer, “In New York, Opting Out of Schools’ H1N1 Vaccine,” NYT, A4, Oct. 29, 2009.
- “Fewer than half of new York City parents with children in elementary school have given permission for their children to receive the vaccine at school.”
- “5 to 50 percent of parents had given consent for their children to receive the vaccine at schools that had begun to offer it.”
- “Health officials had estimated a 30 percent to 50 percent participation rate.”
- “But in Charleston, W.Va., which is seeing high levels of swine flu infection, demand in schools has exceeded supply, with 50 percent of parents already consenting.”
- “a computer model developed several years ago by epidemiologists at Emory University based on expereinces with mandatory flu shots for Japanese schoolchildren suggested that, when 50 percent of children are vaccinated, the community’s risk of seasonal flu falls by two thirds, and when 70 percent are vaccinated, the risk drops to 4 percent.”
McNeil, Donald G. “New Advice on Swine Flu Doses for Pregnant Women,” NYT, A16, Nov. 3, 2009.
- “One dose of swine flu vaccine protects pregnant women against the flu, but children under 10 still need two doses, federal officials said Monday announcing further results of clinical trials of the vaccine.”
- “The officials also announced the formation of a panel of experts from outside the government to watch for any rare or unexpected side effects as millions of Americans get vaccinated.”
- “The World Health Organization last week recommended one dose of vaccine for all children, but the United States is ignoring that advice. The organization’s primary goal is to make sure that the world’s vaccine supplies stretch as far as possible among the world’s children. It endorses vaccine-stretching adjuvants and favors one dose per child so more children can get one.”
- “[Federal officials in the US] decided not to use adjuvants, even though they think they are safe, because anti-vaccine lobbyists have campaigned against them, calling them dangerous, and some officials feared that some Americans would be scared away from being vaccinated.”
- “Most European countries and Canada use vaccines with adjuvants, which are usually mixtures of water and oil that, for unknown reasons, increase the immune response and make smaller doses of vaccine work better.”
McNeil, Donald, G., “Nation Is Facing Vaccine Shortage For Seasonal Flu: An Increase in Demand,” NYT, A1, Nov. 5, 2009.
- “The current problems began years ago, experts said, when vaccine companies started abandoning the American market. Vaccines, which involve living viruses, are much harder to make than most drugs. Profits are lower and unused flu vaccine expires after a few months. Also, vaccines are primarily intended for children, and Americans frequently sue when a child is injured.”
- “Little was done to lure companies back until bioterrorism fears emerged after the anthrax attacks of 2001 and H5N1 avian flu virus, which kills about 60 percent of humans infected with it, emerged in 2003, Dr. Fauci said.”
- “The drawback of relying on foreign plants was made clear recently when the Australian government pressured CSL to keep its vaccine at home instead of fulfilling its contract for 36 million doses of swine flu vaccine for the United States.”
- “Although the government itself ordered and paid for all this year’s swine flu vaccine, about 90 percent of each year’s seasonal vaccine is made for the private sector.”
- “They [vaccine makers] are under pressure to make more to donate or sell to the World health Organization. Even optimistic predictions say the world’s poorest countries will get only 10 percent of the vaccine they need by winter’s end.”
Editors, “University of Pittsburgh Schools of the Health Sciences; Immune system quirk could lead to effective tularemia vaccine” Life Science Weekly, NewsRx.com, November 10, 2009.
- “Immunologists…have found a unique quirk in the way the immune system fends off bacteria called Francisella tularensis, which could lead to vaccines that are better able to prevent tularemia infection of the lungs.”
- “…if we want to make an effective vaccine against tularemia, we must target ways to boost IL-17.”
Belluck, Pam, “Nations Hit by Swine Flu Getting Emergency Drugs,” NYT A11, Nov. 13, 2009.
- “Emergency supplies of antiviral drugs are being sent to Ukraine, Afganistan and other countries in Eastern Europe and Cental Asia, where hospitals report that they are being overwhelmed by patients with swine flu, the World Health Organization said Thursday.”
- “The agancy [WHO] said it was revising its guidelines and urging more people to take antiviral medication even before they are sure they have the flu.”
- “the agency was not yet confident, as it is now, about the safety and efficacy of the antivirals, Tamiflu and Relenza. Doctors there were also worried about shortages.”
- “The agency said the countries most affected were Afganistan, Mongolia, Belarus, Ukraine, Azerbaijan and Kyrgyzstan.”
- “When the authorities in Lviv, in western Ukraine, officially connected the deaths to swine flu and called for quarantine measures, frightened residents began buying up masks, prices of home remedies like garlic and lemon shot up and ambulance calls increased fivefold.”
Associated Press, “Vaccine Requirement to be Ended,” NYT, A23, Nov. 17, 2009.
- “Starting Dec. 14, the human papillomavirus vaccine will no longer be on the list of immunizations female immigrants ages 11 to 26 must receive before becoming legal permanent residents.”
McNeill, Donald G. Jr. “Shifting Vaccine For Flu To Elderly,” D1, NYT, Nov. 24, 2009.
- “reports of price gouging have grown more frequent. That also happened in 2004, when sterility problems at a British plant cut the American flu vaccine supply in half; prices shot up as high as $90 a dose, from the normal level of $8 to $9.”
- “Gouging is illegal in about half the satets, but each state varies in how big a price increase constitutes gouging and as to whether an emergency must have been declared for the law to kick in.”
- “‘To pursue a case, we need to show it’s not just a couple of dolars but is very significant,’ said Attorney General Richard Blumenthal of Connecticut, who has opened an investigation.”
- “‘if distributors were ‘masquerading or fraudulently claiming to have vaccine,’ that could end in criminal charge.”
Davis, Sara, “BALANCING PUBLIC HEALTH AND INDIVIDUAL CHOICE: A PROPOSAL FOR A FEDERAL EMERGENCY VACCINATION LAW”. Health Matrix: Journal of Law Medicine, January 1, 2010.
- “Since 2001, the U.S. government has devoted considerable time and effort identifying potential vulnerabilities to biological attacks, promoting prevention strategies, and anticipating how best to respond should a large-scale biological attack ever occur.” (Pg. 2)
- ““The more that sophisticated capabilities, including genetic engineering and gene synthesis, spread around the globe, the greater the potential that terrorists will use them to develop biological weapons . . . . Prevention alone is not sufficient, and a robust system for public health preparedness and response is vital to the nation’s security.’” (Pg. 3)
- “The changes generally grant broad sweeping powers to state governors and health officials, including the power to order forced treatment and vaccination without specifying which exemptions….Such changes could increase the chances for state abuse of power and lead to confusion during a mass vaccination campaign.” (Pg. 3)
- “Currently, the federal government lacks authority to exert control over a state’s emergency vaccination plans, regardless of whether the plans are too lenient and severely risk the public’s health or too rigid and unnecessarily restrict individual liberty” (Pg. 4)
- “Maryland, the state’s attorney summoned parents of more than 1,600 children to court, giving them a choice between vaccinating their children and facing penalties of up to ten days in jail and fifty dollars a day in fines.” (Pg. 7)
- “Three key factors determine the percentage of the population that must be immunized in order to reach the herd immunity threshold: (1) the degree of the disease’s infectiousness; (2) the population’s vulnerability; and (3) the environmental conditions.” (Pg. 8)
- “The Court explained that the state had a duty to protect the welfare of the many and to refrain from subordinating their interests to those of the few.”(Pg. 12)
- “The Court determined that an individual’s belief qualified as a religious belief, if it was “sincere and meaningful” and it “occupied in the life of its possessor a place parallel to that filled by the God of those admittedly qualifying for the exemption.”” (Pg. 20)
- “The district court warned that while an individual may possess sincerely held beliefs, instead of being rooted in religious convictions, those beliefs may merely be framed in religious terms to feign compliance with the law.” (Pg. 21)
- “The Sherr case raises two issues. First, how much proof an individual must provide to demonstrate to the government the sincerity of the individual’s religious beliefs. Second, how public health officials in an emergency will determine quickly and fairly whether an individual meets the requisite burden of proof.” (Pg. 22)
- “Current state public health emergency laws inadequately address mass vaccination situations and leave wide-open the potential for the abrogation of individuals’ rights” (Pg. 29)
- “The model law, drafted by The Center for Law and the Public’s Health, at Georgetown and John Hopkins Universities, seeks to “grant public health powers to state and local public health authorities to ensure strong, effective, and timely planning, prevention, and response mechanisms to public health emergencies (including bioterrorism) while also respecting individual rights.” (Pg. 31)
- “Additionally, MSEHPA fails to address the need for a consistent and coordinated nationwide approach to mass vaccination in a multi-state emergency…..”To prevent the spread of contagious or possibly contagious disease the public health authority may isolate or quarantine . . . persons who are unable or unwilling for reasons of health, religion, or conscience to undergo vaccination.”‘ (Pg. 31)
- “The Public Health Emergency Medical Countermeasures Enterprise (“PHEMCE”)” is likely the most appropriate government body to be in charge of implementing the new informed consent requirements, the medical and religious exemptions, and the right of refusal conditioned on a discretionary requirement of isolation or quarantine” (Pg. 35)
McNeill, Donald, G., “Transfers of Surplus Flu Vaccine Are Going Slowly to Countries That Need It,” NYT, A15, February 2, 2010.
- “There is now so much unused swine flu vaccine in the world that rich nations, including the United States, are trying to get rid of their surpluses.”
- “…95 countries that told the World Health Organization last year that tehy had no means of getting flu vaccine…”
- “… countries that can afford vaccines save themselves first and, when the worst has passed, transfer their leftovers to the poor, using the W.H.O. as a clearinghouse. …’it’s a very complex operation.’”
- “Each country must submit a plan proving it can store and refrigerate vaccine, give it to those who need it most, inject it safely and do medical follow-up. It must also sign letters exempting donors from legal liability, and the W.H.O. has to certify the vaccine as safe if the country has no regulatory agency.”
- “Bill Gates … dismissed flu vaccine shipments a ‘a pipe dream.’ ‘It’s not practical; they have no infrastructure to deliver it.’
- “At first , there was deep skepticism; 80 percent of French residents polled said they would refuse. But after a few deaths were reported, such huge lines formed that, in Lyon, the riot police were called.”
- “The chairman of the Swiss pharmaceutical company Novartis, Daniel Vasella, recently warned governments breaking their contracts might not be be first in line in the next pandemic. ‘Reliable partners will be treated preferentially,’ Mr. Vasella said.”
- “Canada recently lent Mexico five million doses because Mexico’s first shipments were not due to arrive until this month. Similar bilateral deals took place between Western and Eastern Europe, a W.H.O. spokesman said.”
- “The [U.S.] cancellation of 22 million doses out of 36 million ordered from CSL Ltd., an Australian manufacturer that fell behind on orders anyway…”
- “The [US] country also promised 25 million doses to the W.H.O. [and the rest will be stockpiled in bulk antigen form, i.e. a portion of which will not placed in viles.] an extra step that involves a separate payment.”
PharmAthene, Inc. “Data Show Valortim(R) Anthrax Anti-Toxin May Augment Immune System’s Ability to Destroy Anthrax Bacteria,” http://www.prnewswire.com/news-releases/data-show-valortimr-anthrax-anti-toxin-may-augment-immune-systems-ability-to-destroy-anthrax-bacteria-85189772.html, PR Newswire, February 24, 2010.
- “Valortim® is a fully human anti-toxin monoclonal antibody being developed for the prevention and treatment of inhalational anthrax. Preclinical studies suggest that Valortim® has the potential to provide protection against anthrax infection when administered prophylactically (prior to the emergence of symptoms of anthrax infection) and also may increase survival when administered therapeutically (once symptoms become evident).”
- “Valortim® appears to augment the immune system’s ability to kill anthrax bacilli by enhancing the human dendritic cell response to a challenge with anthrax spores.”
- “Studies indicate that it may also assist in enhancing the adaptive immune response to anthrax, which may lead to a reduction and clearance of the bacteria in the host organism.”
McNeill, Donald, G., “Flu Shots in Children Can Help All Ages, Study Says,” NYT p. A16, March 10, 2010.
- “Although previous studies have demonstrated what scientists call ‘herd immunity,’ none have been so incontrovertable, because they were done in less isolated places with more sources of flu passing through.”
- “Dr. Anthony Fauci … added that its results validated the American government’s decision to vaccinate children first during the recent swine flu epidemic.”
- “In 25 of the colonies that joined, all children ages 3 to 15 received flu shots in late 2008; in 24 others, they received hepatitus A vaccine instead.”
- “There was a 60 percent ‘protective effect’ for the whole community, the study concluded.”
- “It implies, Dr. Bridges said, that giving flu shots only to school children would protect the elderly just as well as giving flu shots to the elderly themselves.”
Bradsher, Keith, “Report Says China Sold Bad Vaccines to Hospitals,” NYT, March 18, 2010 http://www.nytimes.com/2010/03/19/world/asia/19china.html
- ”A newspaper article by one of China’s best-known investigative reporters has reawakened a controversy over whether provincial authorities improperly stored vaccines in rooms without air-conditioning, rendering them ineffective, and then let them be administered to children.”
- ” a senior official there was relieved of all responsibilities at the end of last year because of improprieties related to the vaccines.”
- ”To monitor compliance by the hospitals, the center put a sticker on each package of vaccine to show that it had been approved. But the stickers would not adhere to the packages in air-conditioned rooms, Mr. Chen said, so through 2006 and 2007 the center routinely had the vaccines transferred to a warm room where the stickers were attached.”
- ”The center stopped exposing them to heat in 2008 but did not issue a recall for those that might have already been damaged, he said.”
- ”The press office of the Shanxi Health Department declined to comment, saying that it had already made a statement to the official Xinhua news agency. Xinhua reported that Li Shukai, the deputy director of the department, had said that the China Economic Times article was “basically not true.”
- ”The article said the parents of 4 children who died and 74 children who developed severe health problems were blaming the vaccines. Mr. Li told Xinhua that provincial health experts had examined some of the children and concluded that their problems were not caused by vaccines.”
- ”World Health Organization data shows that 99 percent of Chinese children receive all three doses of polio vaccine and that 97 percent receive all three doses of a vaccine against diphtheria, tetanus and pertussis. The data also shows that the percentage of Chinese infants receiving vaccinations for hepatitis B, one of China’s leading health problems, rose to 91 percent in 2008 from 76 percent in 2004, the earliest year the figures were reported.”
Baccini, Michela, et al., “Multiple Imputation in the Anthrax Vaccine Research Program,” http://www.springerlink.com/content/1q54165h36533m48/, CHANCE, Number 1, Volume 23, March, 2010.
- “Since 2000, the CDC has been planning and conducting a clinical trial, the Anthrax Vaccine Research Program (AVRP), to evaluate a reduced AVA schedule and a change in the route of administration in humans.”
- “The AVA trial is a 43-month prospective, randomized, double-blind, placebo-controlled trial for the comparison of immunogenicity (i.e., immunity) and reactogenicity (i.e., side effect) elicited by AVA given by different routes of administration and dosing regimens.”
- “Administration is subcutaneous (SQ) versus intramuscular(IM).”
- “The AVA study has been significant because, as a result of the interim analysis, the FDA approved the change in the routeof AVA administration from SQ to IM. However, as with other complex experimental and observational data, the AVRP data creates various challenges for statistical evaluation.”
- “During the last two decades, multiple imputation (MI) has become a standard statistical technique for dealing with missing
- “A practically more important task is to address missing measurements not intended to be obtained in this study— these values are the survival status of the human subjects if, after the vaccination, they had been exposed to anthrax.”
- “For predicting this survival, there is little information from the human study alone because exposing humans to lethal anthrax doses is not ethical, given the risks of such exposure. For this reason, in parallel to the study with humans, CDC has been conducting a study with macaques.”
Charney, Dennis S., and Davis, Kenneth, L. “Fulfilling the Promise of Biomedical Research,” NYT Paid commentary, A23, April 6, 2010.
- “We also need a drug development infrastructure that can handle the acceleration in biomedicala research. the pace of approval for new drugs by the U.S. Food and Drug Administration remains unacceptably low.”
- “From 1950 to 2008, the agency has approved 1,222 new drugs–with the per annum number remaining flat.”
- “Given the promise that biomedical research holds, it is a tragedy that in 2008 only 21 drugs of novel mechanism were approved for use in the United States.”
- “If the United States does not increase its investment in biomedical research, the worlds center for medical innovation and discovery will shift.”
Ramasamy, S., et al., “Principles of antidote pharmacology: an update on prophylaxis, post-exposure treatment recommendations and research initiatives for biological agents,” Review, British Journal of Pharmacology, Defence Science & Technology Organisation, Human Protection and Performance Division, Fishermans Bend, Vic., Australia; April 20, 2010.
- “Antibiotics are still recommended as the mainstay treatment following exposure to anthrax, plague, Q fever and melioidosis.”
- “There are two licensed anthrax vaccines available (Little, 2005; Wang and Roehrl, 2005). The US anthrax vaccine adsorbed is extracted from a cell-free culture filtrate of an unencapsulated, toxin-producing strain of Bacillus anthracis (V770-NP1R). The UK vaccine (Health Protection Agency) is prepared from a similar strain called Sterne 34F2. Both vaccines contain the protective antigen (PA) adsorbed to aluminium hydroxide and contain small amounts of lethal factor (LF) and oedema factor (EF). The vaccines are both effective against anthrax infection when administered prophylactically, although the vaccination protocols differ.”
- “Although current human anthrax vaccines are effective against anthrax, they still suffer from batch-to-batch variation in composition, require multiple doses and yearly booster injections and have been associated with occasional adverse reactions.”
- “Protection against anthrax via current anthrax vaccines is mediated largely by antibody (humoral) responses to the protective antigen (PA); however, cellular immunity has been shown to also play an important role.”
- “Previous studies have shown that whole spore-based vaccines are more effective against virulent strains of B. anthracis than the current PA-based vaccines.”
- “The FDA recommends that ciprofloxacin, doxycycline or amoxicillin be used for a period of 60 days post exposure to B. anthracis (http://www.fda.gov/).”
- “The most significant novel therapy has been the development of antibody-based passive immuno-therapy against anthrax toxin components, primarily PA and to a lesser extent LF. This has been made possible through significant funding from the US government to support the development and commercialization of antibody-based therapy.”
Reuters, “More than 1,000 exposed to dengue in Florida: Experts say the deadly infection is heading north in the U.S.” MSN. July 13, 2010. http://www.msnbc.msn.com/id/38232667/ns/health-infectious_diseases
- “Five percent of the population of Key West, Florida — more than 1,000 people — have been infected at some point with the dengue virus, government researchers reported on Tuesday.”
- “After 27 cases of dengue were reported in Florida in 2009, scientists from the CDC and the Florida Department of Health took blood samples from 240 randomly chosen Key West residents.”
- “‘These cases represent the reemergence of dengue fever in Florida and elsewhere in the United States after 75 years,’ Margolis said in a statement.”
- “Dengue is the most common virus transmitted by mosquitoes, infecting 50 million to 100 million people every year and killing 25,000 of them.”
- “It can cause classic flu-like symptoms but can also take on a hemorrhagic form that causes internal and external bleeding and sudden death. Companies are working on a vaccine but there is not any effective drug to treat it.”
Editors, “First Smallpox Vaccine for Special Populations Delivered Under Project BioShield” 14 July 2010, HHS http://www.hhs.gov/news/press/2010pres/07/20100714c.html Last Checked 3 May 2011.
- “Delivery to the Strategic National Stockpile of the first 1 million doses of the nation’s first smallpox vaccine for certain immune-compromised populations is now complete, the result of a Project BioShield contract.”
- “Danish company Bavarian Nordic is manufacturing and delivering 20 million doses of its next generation smallpox vaccine known as modified vaccinia Ankara (MVA) or Imvamune.”
- “Project BioShield gives BARDA the contracting authority to develop and procure medical countermeasures against chemical, biological, nuclear and radiological threat agents.”
- “In 2007, Bavarian Nordic was awarded a $505 million contract to develop and deliver the MVA smallpox vaccine. This contract was the first to use advance and milestone payments under Project BioShield.”
- “‘This product began with a basic research and development program initiated by the National Institute of Allergy and Infectious Disease at the National Institutes of Health in 2003, and progressed to the point that Project BioShield could be used for further development and procurement.’”
Fox News, “U.S. Flu Shots on Hold After Probe Into Australian Ban on Vaccine for Children,” http://www.foxnews.com/story/0,2933,596767,00.html July 15, 2010, checked July 19, 2010.
- “U.S. health authorities are holding off approval of this year’s seasonal flu shot as they probe Australia’s ban on the vaccine, which has been found to induce fever in young children, The Australian reported Thursday.”
- “The U.S. Food and Drug Administration (FDA) is collaborating with Australia’s Therapeutic Goods Administration (TGA) to ‘assess any potential implications for the U.S. flu season.’”
- “The FDA has also written to Australian pharmaceutical giant CSL — which manufactures the controversial Fluvax vaccine — detailing its ‘number of significant objectionable conditions’ relating to CSL’s compliance with American ‘good manufacturing practice.’”
- “FDA investigators observed “deviations” from U.S. manufacturing standards in CSL’s production of both seasonal flu and swine flu vaccines for the U.S. market.”
- “The audit was carried out the week Australian authorities suspended use of the Fluvax vaccine after it triggered febrile fits in nearly one percent of children younger than five.”
- “The FDA’s complaints relate to the presence of black particles in multi-dose vials of Afluria, the brand name for CSL’s seasonal flu vaccine in the U.S.”
- “It remains suspended for under-fives as researchers struggle to work out why it triggers febrile fits at nine times the usual rate.”
Bita, Natasha, “Checks by the TGA reveal 98 per cent of drug labs have problems,” The Australian, http://www.theaustralian.com.au/news/nation/checks-by-the-tga-reveal-98-per-cent-of-drug-labs-have-problems/story-e6frg6nf-1225893662606 July 19, 2010.
- “Deficiencies have been uncovered at 98 per cent of the pharmaceutical laboratories audited by the drugs regulator in the past year.”
- “The federal government’s Therapeutic Goods Administration yesterday revealed that only three of the 139 labs it audited last financial year were problem-free.”
- “But the TGA is now investigating the cause of discolouration affecting some multi-dose vials of Panvax — a problem it became aware of only after the FDA blew the whistle during its own audit of CSL in April. The TGA has proclaimed Panvax to be safe, even though it still does not know the cause of the discolouration.”
- “The TGA is conducting a separate inquiry into CSL’s seasonal flu shot — a world-first combination of swine and seasonal flu strains in a single vaccine.”
Editors, “Senators Oppose Looming Bioshield Funding Cuts” 23 July 2010, Global Security Newswire http://gsn.nti.org/gsn/nw_20100723_7284.php Last Checked 20 February 2011.
- “Three U.S. senators this week led the charge against a move to cut as much as $2 billion from the coffers of a program intended to promote development of countermeasures to biological agents and other WMD materials.”
- “Legislation passed July 1 in the House of Representatives would reallocate money from the Project Bioshield Special Reserve Fund or separate pandemic flu preparedness funding to pay for education assistance to states.”
- “To date Project Bioshield has reportedly bought about $2 billion worth of countermeasures for the U.S. Strategic National Stockpile.”
- “It has also already been stripped of hundreds of millions of dollars and has experienced some high-profile failures, including the cancellation of a contract for a new anthrax vaccine.”
- “Furthermore, the casualty potential of a biological attack is far greater than any terrorist attack we have seen to date. Yet, we still have no modern vaccine for anthrax and no countermeasures for dozens of other potential bioterror pathogens.”
- “The Project Bioshield rescission included in the House amendment, or any similar future rescission, would devastate the Bioshield program by cutting a majority of the program’s remaining funding, which is intended for the procurement of new vaccines and countermeasures.”
- “The Obama administration is preparing a method to better promote private production of vaccines and other countermeasures.”
- “‘Bioshield has demonstrated limited success in providing incentives for private-sector developers and has not provided a robust pipeline of medical countermeasures.”
Editors, “The Public Health Emergency Medical Countermeasures Enterprise Review, Transforming the Enterprise to Meet Long-Range National Needs,” U.S. Department of Health and Human Services, August 2010.
- “The review highlights the need for the enter prise to incorporate a strategy that balances the ability to quickly produce MCMs for unknown threats as well as the current strategy of counter ing identified threats.”
- “This new strategy is articu lated through the following vision: ‘Our Nation must have the nimble, flexible capacity to pro duce MCMs rapidly in the face of any attack or threat, known or unknown, including a novel, previously unrecognized, naturally occurring emerging infectious disease.’”
- “Findings in several key areas led to the development of the new strategy, including: (1) enhancing regulatory innovation, science, and capacity; (2) improving domestic manufacturing capacity; (3) providing core advanced development and manufacturing services to development partners; (4) creating novel ways for the enterprise to work with partners; (5) developing financial incentives, (6) addressing roadblocks from concept develop ment to advanced development; and (7) improv ing management and administration within the enterprise.”
- “According to Health and Human Services Secretary Kathleen Sebelius, ‘The ultimate goal of this review is a modernized countermeasure production process where we have more promising discoveries, more advanced development, more robust manufacturing, better stockpiling, and more advanced distribution practices. In other words, we want to create a system that can respond to any threat at any time.’”
- “The Centers for Innovation in Advanced De velopment and Manufacturing will support the country’s advanced development activities for CBRN-related products, and HHS, with U.S. Government partners, including BARDA, will provide guidance and management oversight in terms of specific product objectives.”
- “Initial Planned Objectives of the Centers are to: (1) Provide surge vaccine production capacity for a response to any serious emerging dis ease threat for which a vaccine is available, including pandemic influenza; (2) Provide advanced development and pro duction of priority, selected CBRN MCMs; (3) Provide additional capacity to manufacture clinical investigational lots of candidate vac cines, as well as manufacturing capacity to respond rapidly to emerging infectious dis ease outbreaks, including those involving previously unidentified microbes; (4) Provide vaccine production capacity at pi lot and/or commercial scale to augment the existing manufacturing infrastructure (e.g., small-market vaccines utilized by DOD, such as for adenovirus vaccine).”
- “A key component of this initiative would be Early Development Teams that would work closely with partner agencies and programs (NIH, CDC, DOD TMTP, ASPR/ BARDA, and FDA) and with academic research ers, biotech companies, and large pharmaceuti cal companies to provide strategic guidance for researchers as well as provide appropriate con tacts who can assist in moving promising can-didates through the process.”
Jiao, Guan-Sheng, et. al, “Antidotes to anthrax lethal factor intoxication. Part 1: Discovery of potent lethal factor inhibitors with in vivo efficacy,” PanThera Biopharma, LLC, Aiea, HI & Laboratory of Bacterial Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Bethesda, MD, Bioorganic & Medicinal Chemistry Letters, Accepted 12 August 2010.
- “Three forms of the disease anthrax caused by Bacillus anthracis are characterized by the route of exposure. Infection of an open wound leads to cutaneous anthrax, and ingestion of contaminated food causes gastrointestinal anthrax.”
- “Sub-nanomolar small molecule inhibitors of anthrax lethal factor have been identified using SAR and Merck L915 (4) as a model compound. One of these compounds (16) provided 100% protection in a rat lethal toxin model of anthrax disease.”
- “Given the effec- tiveness of B. anthracis as a weapon of bioterrorism,5 the major role LF plays in the pathogenesis of anthrax, and validation of LF as a target for small molecule drug intervention,6 we began our search for an antidote to LF intoxication.”
- “The resulting SAR led to the identification of the 3,5-di- methyl-4-fluoroaniline analog as the most potent inhibitor pos- sessing sub-micromolar inhibitory activity.”
- “One compound, the aniline 16, was capable of providing 100% protec- tion at this dose. Repeating this experiment with lower doses of 16 indicated that this compound was fully protective at both 5.0 and 2.5 mg/kg, although at the lowest dose the animals became ill approximately 3 h after treatment with LT but appeared fully recovered by 24 h post exposure (data not shown).”
- “In summary, we have identified sub-nanomolar inhibitors of anthrax lethal factor with potent in vivo efficacy.”
ALPHONSO CAROLINE. “GSK Defends its Pandemic Performance.” The Globe and Mail. August 27, 2010. http://www.theglobeandmail.com/life/health/gsk-defends-its-pandemic-performance/article1687367/
- “With the recent H1N1 flu pandemic in mind, Canadian health officials have launched a review of the country’s vaccination strategy, with an eye on moving beyond a single supplier for pandemic vaccines. ”
- “Paul Lucas, GSK’s president and CEO, defended his company’s actions in an interview Wednesday. But he also indicated that the federal government would be wise in contracting a back-up manufacturing company in the event of another pandemic.”
- “The bottom line was there was a little bit of a misalignment between what was expected and what was realistic. It took us a while to clarify for people what’s the actual process of getting the vaccine out the door. It’s not like filling Coca-Cola. You just don’t fill the bottle, it comes out at the end of the line and you shoot it out the door. We have a very strict quality-assurance process once it comes off the line. We had a couple of glitches in the manufacturing process initially because we had never made this before. Initially, the number of doses that we could actually get off the line and get through quality-control weren’t what we had wanted to get. We resolved that in a couple of weeks, and then we started flowing through fairly efficiently.”
- “How confident are you of getting a new contract? We’re in the process now, and it’s hard to say where that’s going to go. We’ve shown that we did a pretty good job through all of this, and I continue to say that Canada was the first country to have enough doses for all of its population, and we had that by the end of the year. The strategy worked, but we can always do better. That’s the bottom line of the whole pandemic. The problem with a pandemic is you’re practicing in the situation.”
Thomas, Richard, et. al., “Influence of particle size on the pathology and efficacy of vaccination in a murine model of inhalational anthrax,” Journal of Medical Microbiology(2010), 59, 1415–1427, August 19, 2010.
- “Deposition of Bacillus anthracis endospores within either the lungs or nasal passages of A/J mice after aerosol exposure was influenced by different particle sized aerosols and resulted in different infection kinetics.”
- “Particle size-related deposition of B. anthracis endospores has previously been shown to increase MLD and mean time-to-death (MTD) in the guinea pig model (Druett et al., 1953). A murine model has not been reported for the investigation of particle size-dependent effects of inhalational anthrax and the subsequent assessment of therapeutics.”
- “Inhalation of greater numbers of endospores within 12 mm particles is required to induce infection.”
- “Immediately after aerosol deposition (0 h), endospores were primarily localized to either the lungs or nasal passages depending on the size of the inhaled particles (Fig. 2).”
- “Deposition in the nasal passages was significantly higher with the 12 mm particle aerosol and bacterial counts remained higher than those associated with the infection caused by the inhalation of 1 mm particle aerosols over the 96 h time-course.”
- “A subunit vaccine based on the rPA constituent of anthrax toxin has been developed. The rPA vaccine is efficacious against anthrax caused by the inhalation of endospores within a small-particle aerosol in murine and non-human primate models (Flick-Smith et al., 2005; Williamson et al., 2005).”
- “This study represents the first investigation of the effect of therapeutic intervention on respiratory anthrax infection caused by deposition of endospores within the URT.”
Brady, Rebecca, et al., “Analysis of Antibody Responses to Protective Antigen-Based Anthrax Vaccines through Use of Competitive Assays,” Clinical and Vaccine Immunology, vol. 17, no. 9, p. 1390-1397, September 2010.
- “In this study, we examined the antibody response in humans as well as nonhuman primates and rabbits, animal species that will be used to generate efficacy data to support the approval of new anthrax vaccines.”
- “We found that PA-based vaccines elicited IgC antibodies to each of the four PA domains in all three species.”
- “These findings provide information that will be useful when linking animal protection data to humans via an antibody bridge to establish efficacy of new anthrax vaccines.”
Merkel, Todd, et al., “Development of a highly efficacious vaccinia-based dual vaccine against smallpox and anthrax, two important bioterror entities,” PNAS Early Edition, Center for Biologics Evaluation and Research, Food and Drug Administration, Bethesda, MD, September 2, 2010.
- “A compelling need exists for a better vaccine against B. anthracis that can confer rapid immunity with an abbreviated immunization schedule that can be stored long term and deployed quickly in the event of a bioterror event.”
- “Having demonstrated the superiority in immunogenicity and attenuation of virulence of IL-15–integrated Wyeth vaccinia, we exploited our Wyeth/IL-15 platform to generate a dual vaccine effective against both smallpox and anthrax by integrating the PA gene of B. anthracis (Wyeth/IL- 15/PA) to overcome the problems of poor immunogenicity and apparent lack of immunological memory associated with the li- censed Biothrax/AVA vaccine.”
- “We believe our dual vaccine, Wyeth/IL-15/PA, which is effective against two of the most deadly pathogens, will help consolidate and simplify our national bio- terror counterefforts by streamlining the manufacture, stockpiling, and swift deployment of such vaccines should the need arise.”
- “In developing Wyeth/IL-15/PA, a dual vaccine that is effica- cious against two leading deadly pathogens with high bioterror potential, we integrated cytokine IL-15 into a licensed smallpox vaccine with the disruption of the single vaccinia gene hemag- glutinin—which does not play an appreciable role in viral path- ogenesis or replication (27)—primarily to attenuate the residual virulence of the Wyeth strain of vaccinia.”
- “It is important to emphasize that the vaccinia-based dual vac- cine with integrated IL-15 not only is superior in immunogenicity and efficacy in comparison with the currently licensed vaccines against smallpox and anthrax, but also remedies the inadequacies associated with such licensed vaccines.”
Pharmaceutical Research and Manufacturers of America, “Medicines in Development for Infectious Diseases,” Report, Biopharmaceutical Research Continues Against Infectious Diseases with 395 Medicines and Vaccines in Testing, www.pharma.org, September 10, 2010.
- “America’s biopharmaceutical research companies are developing 395 medicines and vaccines to combat the many threats posed by infectious diseases. Each of these medicines in development is either in clinical trials or under review by the Food and Drug Administration.”
- “Among the medicines now being tested are 88 antibiotics/antibacterials for treating bacterial infections such as pneumonia and tuberculosis; 96 antivirals for treating such viruses as hepatitis, herpes and influenza; and 145 vaccines to prevent or treat diseases such as staph infections and pneumococcal infections. Not included in this report are medicines in development for HIV infection.”
- “Two combined monoclonal antibodies that bind to, neutralize, and destroy toxins caused by Escherichia coli infections.”
- “A medicine for the most common and difficult-to-treat form of hepatitis C that inhibits the enzyme essential for viral replication.”
- “An anti-malarial drug that has shown activity against Plasmodium falciparum malaria that is resistant to current treatments.”
- “A potential new class of antibiotics to treat methicillin-resistant Staphylococcus aureus (MRSA).”
- “A novel treatment that works by blocking the ability of the smallpox virus to spread to other cells, thus preventing it from causing disease.”
- “‘Included are several developments for anthax vaccines.’”
Grossman, Elaine, “Pentagon Pulls $1B from WMD-Defense Efforts to Fund Flu Vaccine Initiative,” August 27, 2010, Global Security Newswire. http://gsn.nti.org/siteservices/print_friendly.php?ID=nw_20100827_5297 Last checked September 2, 2010.
- “The U.S. Defense Department has shifted more than $1 billion out of its nuclear, biological and chemical defense programs to underwrite a new White House priority on vaccine development and production to combat disease pandemics, according to government and industry officials.”
- “The planned funding reduction ‘terminates essential CBRN [chemical, biological, radiological and nuclear] defense programs … required to meet high priority service needs, prevent casualties and protect against CBRN incidents,’ according to a Pentagon budget document drafted in early August.”
- “Amoretta Hoeber, a defense consultant and chair emeritus of the NBC Industry Group, said in an interview this week, ‘that if the funding reductions result in shutting down production lines for any highly specialized WMD defense items, it is unclear how quickly the industry could reconstitute its manufacturing capability in the event that a new threat emerged.’”
- “President Barack Obama noted the initiative in his Jan. 27 State of the Union address, saying it would ‘give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease — a plan that will counter threats at home and strengthen public health abroad.’”
- “The new initiative includes both Health and Human Services (HHS) and Pentagon plans for constructing ‘Centers for Innovation in Advanced Development and Manufacturing,’ to help small biotechnology companies innovate new vaccines and field them more rapidly. The modern facilities would also be capable of large-scale production of vaccine stocks during a public health emergency involving ‘emerging infectious diseases or unknown threats, including pandemic influenza,’ the HHS report states.”
- “Meanwhile, the Pentagon is left with deep budget cuts in a number of its WMD-defense efforts, and it remains unclear whether funds to backfill those project accounts will be identified, even after the fiscal 2012 budget request is delivered to Congress.”
Emergent BioSolutions Inc. “Emergent BioSolutions Awarded NIAID Contract That Increases Potential Funding to Over $58 Million for Advanced Development of Third Generation Anthrax Vaccine,” http://www.marketwatch.com/story/emergent-biosolutions-awarded-niaid-contract-that-increases-potential-funding-to-over-58-million-for-advanced-development-of-third-generation-anthrax-vaccine-2010-09-01?reflink=MW_news_stmp, press release, BUSINESS WIRE, September 1, 2010.
- “Emergent BioSolutions Inc. announced today that it has signed a contract valued at up to $28.7 million with the National Institute of Allergy and Infectious Diseases (NIAID), an institute within the National Institutes of Health (NIH), for advanced development of the company’s third generation anthrax vaccine candidate.”
- “This product candidate, one of two third generation vaccines being developed as part of Emergent’s anthrax franchise, consists of BioThrax(R) (Anthrax Vaccine Adsorbed) in combination with a novel immunostimulatory compound, CPG 7909 (VaxImmune(TM)). “
- “Daniel J. Abdun-Nabi, president and chief operating officer of Emergent BioSolutions said ‘We believe our vaccine candidate addresses key criteria established by the government for a third generation anthrax vaccine. If successfully developed, we believe this product would strengthen the government’s portfolio of biodefense medical countermeasures.'”
- “The Phase II clinical trial is anticipated to begin in the first quarter of 2012, with preliminary data expected to be available in the second half of 2012.”
Editors, “Scientists closer to a safer anthrax vaccine” Homeland Security Newswire September 4, 2010 http://homelandsecuritynewswire.com/scientists-closer-safer-anthrax-vaccine Last accessed October 21, 2010.
- “Researchers at Albert Einstein College of Medicine of Yeshiva University have identified two small protein fragments that could be developed into an anthrax vaccine that may cause fewer side effects than the current vaccine.”
- “The current anthrax vaccine is intended mainly for members of the armed forces serving in areas considered high risk and for individuals involved in homeland biosecurity.”
- “While this 40-year-old vaccine can prevent disease, it has significant drawbacks. Immunity is temporary, and five injections over the course of eighteen months are needed to sustain it. One in five vaccine recipients develop redness, swelling or pain at the injection site, and a small number develop severe allergic reactions.”
- “The researchers injected the current vaccine into mice and recovered six different “pure” strains of antibodies known as monoclonal antibodies. They then mixed each type of antibody with the 145 peptides formed by chopping up the vaccine protein. The researchers looked for peptides that were “recognized by” (became bound to) an antibody – an indication that those particular peptides might themselves be able to stimulate the production of protective antibodies on their own.”
- “Ultimately, the researchers found that two of the 145 peptides fit the bill: Each peptide elicited antibodies when injected into mice, and these antibodies protected macrophages from death that would normally have occurred when the macrophages were exposed to anthrax toxin (macrophages are protective white blood cells involved in the body’s immune response to foreign invaders). The next step in the Einstein research will be to inject the peptides into an animal model to see if the peptides can protect against anthrax infection.”
Editors, “Planned Malaysian Biolab Raises Security Concerns,” Global Security Newswire http://gsn.nti.org/gsn/nw_20100908_8991.php September 8, 2010. Last checked September 10, 2010.
- “Plans to construct a high-security biological research laboratory in Malaysia have caused some worry over possible proliferation of highly lethal disease materials, ProPublica reported yesterday.”
- “Maryland-based Emergent BioSolutions and Ninebio Sdn Bhd., which is funded by the Malaysian Health Ministry, in 2008 announced a joint plan to construct a large complex at an industrial site not far from Kuala Lumpur for ‘vaccine development and manufacturing.’”
- “Emergent is the producer of the only U.S.-licensed anthrax vaccine. The Emergent-Ninebio venture intends to manufacture halal-compliant vaccines for the international Muslim market. The complex is currently slated to begin work in 2013, according to an Emergent release.”
- “The two firms intend to construct a ‘biocontainment R&D facility that includes BSL … 3 and 4 laboratories,’ According to online architectural plans for the 52,000-square-foot complex.”
- “Biosafety Level 4 laboratories perform countermeasure research on diseases for which there are no known cures, such as the Ebola and Marburg viruses. There are fewer than 40 such facilities in the world and none in Malaysia. The nation has three BSL-3 laboratories, which handle potentially deadly pathogens like anthrax and plague.”
- “U.S. Assistant Secretary of State Vann Van Diepen said during a House panel hearing in March that a critical aspect of today’s biological weapon fears is ‘the growing biotechnology capacity in areas of the world with a terrorist presence.’”
- “Malaysia’s history with terrorism includes the 2002 bomb attack by Malaysian-based extremists from Jemaah Islamiyah that killed 202 people at a popular nightclub in Bali, Indonesia. Kuala Lumpur served as the ‘primary operational launchpad’ for al-Qaeda senior operatives planning the Sept. 11 attacks, according to the FBI. The Malaysian capital was also a key hub in the nuclear technology smuggling ring operated by Pakistani nuclear scientist Abdul Qadeer Khan (see GSN, March 14, 2005).”
- “Security specialists argue that having a U.S. firm such as Emergent involved in Malaysia’s growing biotechnology industry would give Washington some degree of clout and authority over international biodefense work.”
- “Malaysian authorities want the high-tech laboratories to respond to local epidemics of diseases such as SARS and Japanese encephalitis in addition to advancing research on cures for biological materials that could be used in acts of terrorism.”
- “Kuala Lumpur has started to develop new biological security regulations that would meet U.S. standards. It has received assistance in the effort from the U.S. Energy Department’s Sandia National Laboratories, ProPublica reported.”
- “…and monitoring of biological manufacturing installations under the Biological Weapons Convention. The United States and Russia, however, are against site inspections and the likelihood of more effective oversight controls being put into effect is not known.”
- “‘We currently do not have [BSL-4] labs in Malaysia but we would be happy to collaborate with the government of Malaysia on biosurveillance, safety and security in the future,’ a Defense Department spokesman said (Coen/Nadler, ProPublica, Sept. 7).”
Bigongiari, Jeffrey, “Multiple bioagent vaccines in the pipeline,” Bioprepwatch, NEWS, September 13 2010, http://www.bioprepwatch.com/news/215388-multiple-bioagent-vaccines-in-the-pipeline Last Checked September 23 2010.
- “Scientists in the United States are working on a number of vaccines intended to lessen the threat posed by agents of bioterrorism.”
- “There are currently ten separate treatments in development by biopharmaceutical companies to treat the devastating disease anthrax, according to BusinessWire.”
- “Increasingly, attention is being paid to bioterror agents and “super bugs” that are resistant to known treatments. In the United States alone, 2 million drug-resistant infections are reported every year, costing a total of $34 billion annually, according to the Infectious Disease Society.”
AFP, “Bangladesh human anthrax infections cross 500,” AFP, DHAKA, September 14, 2010. Last checked Tuesday, September 14, 2010. http://www.google.com/hostednews/afp/article/ALeqM5i13ISrs35cZiSrGd3uAOupEHEWkA
- “Ten districts have confirmed outbreaks of anthrax in humans and cattle, with the total number of people infected rising to 508 across the country, health ministry director Mahmudur Rahman told AFP.”
- “No humans have died because the cases of human infection consist of cutaneous, or skin, anthrax — which causes wound-like lesions but is not fatal if treated properly.”
- “Thirteen new cases of human anthrax have been reported in the last 24 hours.”
- “According to health ministry director Mahmudur Rahman, ‘The vaccination programme for cattle is having an impact.’”
Editors, “BARDA awards $51 million contract for next generation anthrax vaccine,” U.S. Department of Health and Human Services, hhs.gov, Friday, September 17, 2010. http://www.hhs.gov/news/press/2010pres/09/20100917c.html.
- “The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) awarded a $51 million contract to Emergent BioSolutions, Inc., of Rockville, Md., for the development of a new anthrax vaccine using the protective antigen (rPA) to stimulate a protective immune response that neutralizes the anthrax toxins.”
- “This contract builds on HHS investments in antibiotics, antitoxins, and vaccine development for anthrax. It highlights the department’s commitment to develop a next-generation, recombinant anthrax vaccine.”
- “In the first two years of the contract, Emergent will develop the final vaccine formulation and test its stability.”
- “This advanced research and development contract was awarded using a flexible federal government contracting tool known as a Broad Agency Announcement. This Broad Agency Announcement (BAA-BARDA-09-34) provides a way to identify innovative and promising technologies for advanced development across the chemical, biological, radiological and nuclear research areas of interest.”
Julie Steenhuysen, “U.S. Invests in Drug to Protect Against Radiation” 17 September 2010, Reuters/Yahoo!News. http://news.yahoo.com/s/nm/20100917/hl_nm/us_radiation_drug_clevelandbiolabs Last checked 24 September 2010.
- “Tiny Biotech Cleveland BioLabs Inc has won a $45 million contract from the Department of Defense to conduct clinical trials of a drug to prevent cell damage in the event of a nuclear attack.”
- “The drug works by interfering with a process of programmed cell death called apoptosis — basically a form of cell suicide. ‘This helps the body rid itself of damaged cells’, Fonstein said, ‘interfering with this process appears to strengthen the body’s ability to recover from radiation exposure.’”
- “The compound is made from a salmonella protein that naturally makes cells resistant to cell suicide.”
- “’This is the first product that is close to completion of the scientific studies for protecting populations that might be exposed to (radiation fallout),’ Rear Admiral Craig Vanderwagen, a former official at the U.S. Department of Health and Human Services who has advised the company.”
- “The drug is intended to protect the public in the event of a dirty bomb or a Chernobyl-like accident.”
- “Fonstein said the drug, known as CBLB502, could be approved for use in humans by mid-2012.”
Danny Rose, “Australian trials of dengue vaccine” The Sydney Morning Herald, September 24, 2010. http://news.smh.com.au/breaking-news-national/australian-trials-of-dengue-vaccine-20100920-15jgg.html
- “Late-stage trials are underway for a vaccine that would protect against all four known strains of the disease and study participants are now sought in Perth, Adelaide and Brisbane.”
- “Over half of the world’s population live in areas at high risk of dengue fever which can be fatal, usually among children, and it causes fever and severe headache, vomiting, muscle and joint pain and skin rash.”
- “Australia also has sporadic outbreaks of the infection, usually associated with travellers returning from dengue-prone regions and confined to the northern Queensland range of its specific type of carrier mosquito.”
Matishak, Martin, “Biodefense System Overhaul Was Necessary, HHS Secretary Says” Global Security Newswire, 27 September 2010, http://gsn.nti.org/gsn/nw_20100927_8250.php Last Checked 28 September 2010
- “A planned $1.9 billion revamp of the nation’s medical countermeasure enterprise was overdue as government scientists were using decades old technology to confront new and emerging biological threats.”
- “Countermeasures are typically defined as drugs and vaccines that ward against chemical, biological, radiological and nuclear agents and emerging infectious diseases.”
- “Successful countermeasure development also has proven difficult because the private sector saw little financial benefit in producing biodefense medicines and vaccines for the government, according to Sebelius. The development process can be costly and there is little if any market for such products outside the public sector.”
- “Of the initial $1.9 billion investment, $822 million would be spent on initiatives designed to decrease the amount of time the government needed to make pandemic flu vaccines, while the Food and Drug Administration would receive roughly $170 to enhance its regulatory efforts.”
- “Another $678 million would go toward setting up one or more nonprofit organizations that could provide financial support to small firms working on new treatments, as well as provide the companies with new production systems and manufacturing of vaccines for times of high demand.”
- “Sebelius said the ultimate goal of the revamp was a ‘nimble, flexible capacity to produce medical countermeasures rapidly in the face of any attack or threat’ including a naturally occurring, yet previously unrecognized, infectious disease.”
Leung, Gabriel M. and Nicoll, Angus. “Reflections on Pandemic (H1N1) 2009 and the International Response” PLoS Medicine 7.10 October 2010. http://www.plosmedicine.org/article/info%3Adoi%2F10.1371%2Fjournal.pmed.1000346 Last checked Feb. 21, 2011
- “The pandemic virus was detected and isolated reasonably early, although too late for any attempt at containment.”
- “…late clinical presentation and delayed initiation of antiviral treatment have been implicated with more severe complications worldwide, indicating gaps in identifying and treating patients before disease severity increases.”
- “Clear communication of public health messages will remain a particular challenge and not confusing what could happen (and should be prepared for) with what is most likely to happen.”
- “One challenge faced initially in this pandemic was for timely collection and sharing of clinical data to inform optimal management of critically ill patients worldwide.”
- “Greater access to antiviral and influenza vaccines worldwide is an ongoing challenge.”
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