The U.S. Department of Health and Human Services (DHHS) and the nation’s sole manufacturer of anthrax vaccine, Emergent BioSolutions, are making plans to go forward with an experimental clinical trial testing anthrax vaccine on American infants and children. Last month, the Alliance for Human Research Protection (AHRP) issued a strongly worded, evidence-based letter to the Presidential Commission for the Study of Bioethical Issues protesting pediatric trials using BioThrax anthrax vaccine for the purpose of proving the vaccine is safe and effective to give to infants and children.[1]
BioThrax Vaccine: A Military Mandate
Emergent BioSolutions, formerly known as BioPort Corp., is the sole source supplier of anthrax vaccine to the U.S. military. All U.S. military personnel are required to take a series of the company’s BioThrax anthrax shots. Despite continuing reports that the vaccine is causing a high number of reactions, injuries and deaths, the Department of Defense (DOD) maintains that all soldiers and civilian military personnel must get a series of anthrax vaccinations based on a theoretical threat of a future bioterrorism attack using weaponized inhalation (aerosol) anthrax.
Anthrax is a non-communicable infection usually occurring in cows, horses, sheep and goats and transmitted to humans through contaminated animal by-products and soil. Anthrax has never been used as a bioterrorism weapon by any nation.[2] There are between 10 and 29 million doses of anthrax vaccine in U.S. stockpiles, but every year the Centers for Disease Control (CDC) and Department of Homeland Security throw out about 2 million doses of anthrax vaccine (worth $48 million) that have passed the expiration date.[3]
BioThrax Vaccine: “A Dangerous Vaccine”
Along with AHRP, the National Vaccine Information Center (NVIC) is also on public record since 2011 as opposing proposed anthrax vaccine experiments on children. The 2013 letter to the Presidential Commission, written by AHRP President Vera Sharav and Board Member Meryl Nass, MD, states that the anthrax vaccine’s “effectiveness after exposure to inhalation anthrax is unknown, and the lack of a reliable animal model makes any calculation of effectiveness and dosing impossible. What is known is that BioThrax is a dangerous vaccine. The FDA-approved 2002 label states: 5% to 35% of adults who were vaccinated suffered adverse events.”
The AHRP letter comes after several years of meetings in which federal officials and consultants debated the risks and ethics of enrolling infants and children in experimental trials and injecting them with the controversial vaccine. BioThrax anthrax vaccine was first associated with hundreds of cases of chronic brain and immune system damage and death suffered by soldiers in the Gulf War, who received a series of anthrax shots along with many other vaccines.
BioThrax Vaccine: Subject of Lawsuits
In 2004, a U.S. District Court Judge issued an injunction ordering the Department of Defense (DOD) to stop giving BioThrax anthrax vaccine to U.S. troops because the FDA had not properly tested and licensed the vaccine as effective against weaponized inhalation anthrax.[4] However, the DOD eventually invoked an “Emergency Use Authorization” created under post 9-11 Bioshield legislation passed by Congress and circumvented the court injunction in order to continue forcing soldiers to get BioThrax vaccinations without voluntary, informed consent.
In March 2005, NVIC joined with AHRP and military veterans groups in an amicus brief filed in a U.S. District Court in John Doe #1, et al v. Donald Rumsfeld opposing forced use of experimental anthrax vaccine by U.S. troops in violation of the informed consent ethic. In December 2005, the FDA issued a “Final Order” declaring that BioThrax vaccine was effective against inhalation anthrax, without conducting additional appropriate tests, and the federal court injunction was lifted.
Creating Civilian Markets for Bioterrorism Vaccines
In October 2011, the National Biodefense Science Board (NBSB) voted to endorse pediatric anthrax vaccine trials in the U.S. with the justification that government officials need to know whether the vaccine is safe and effective in children in case there is ever a future bioterrorism attack involving weaponized inhalation anthrax.[5] At a July 2011 NBSB public meeting, NVIC’s director of research and patient safety, Vicky Debold, RN, PhD, stated NVIC’s opposition to the pediatric trial:
“NVIC is deeply concerned about the safety of pre-event testing of BioThrax anthrax vaccine in pediatric populations in light of the continuing adverse event reports in previously healthy adult men and women, who have taken the vaccine. Without a credible, substantiated threat of weaponized anthrax being used against the U.S. civilian population, NVIC finds it hard to justify this kind of experimentation on American children.”[6]
The National Biodefense Science Board, which is housed in the Department of Health and Human Services (DHHS), was created by Congress in 2006, under the “Pandemic & All-Hazards Preparedness Act.” The law fosters a public-private partnership between the federal government and the pharmaceutical industry to develop new “bioterrorism” vaccines.[7]
Highlights of AHRP Letter Focus on Ethical Violations
In their Feb. 18 letter, Vera Sharav and Dr. Meryl Nass appealed to Dr. Amy Gutman of the Presidential Commission for the Study of Bioethical Issues to help put a stop to the proposed anthrax vaccine trials on American children. Stating that they are making “the case that the proposed pediatric anthrax vaccine trial… involves greater than minimal risk and is unethical and unapprovable in the absence of a clear and present danger to children,” the letter outlines a number of basic flaws associated with the anthrax vaccine, such as:
- FACT: No bioterrorism events have happened since 2001, due to anthrax or any other biological agent. Anthrax is only one of dozens of possible agents that could be used as biological weapons by terrorists or foreign militaries—or only one of hundreds more that could be genetically engineered.
- FACT: of many thousands of people exposed to anthrax spores in 2001, antibiotics prevented illness in 100% of those treated after exposure. Five people died, their cases unrecognized until very late. There was no additional benefit from anthrax vaccine, which was accepted by less than 2% of those who used antibiotics.
- FACT: Due to lack of an animal bridging model for anthrax vaccines, there are only immunogenicity data in humans, not human efficacy data. Immunogenicity data cannot reliably predict efficacy for this vaccine, either in adults or children.
- FACT: Possibly 30,000 people were exposed to spores from the anthrax letters in 2001. Most took antibiotics alone; only 198 accepted vaccine. Indeed, according to the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control (CDC): “No cases of anthrax have been detected among persons recommended to take antimicrobial prophylaxis after the terrorist attacks of 2001.”[8]
- FACT: No other country in the world mandates that its troops be vaccinated with anthrax vaccine. Canada, Australia and the United Kingdom all began anthrax vaccination of their troops during the Gulf War, but all three vaccination programs were soon cancelled.
- FACT: The proposed anthrax vaccine experiment indisputably poses greater than minimal risks with no direct benefit for the specific children involved. This government-initiated experiment fails to meet the statutory standard in Federal regulations for exposing children to greater than a “minor increase over minimal risk” in research.FACT: The antibody data to be gained from a pediatric trial will thus be clinically and scientifically uninformative. The proposed experiment will be scientifically useless and unnecessary—thereby violating ethical principles of the Nuremberg Code and Federal regulations.
- FACT: The proposed trial cannot answer meaningful safety questions—which would require using thousands of children. The inescapable conclusion, therefore, is that data to be obtained from the proposed pediatric experiment will have no scientific or clinical value. Undertaking such trials is, therefore, unethical and unapprovable under US statute.
The letter closes with a challenge to the Commission: “Your decision will draw a moral line in the sand—either you uphold children’s statutory protected human rights—or you provide the Administration with a disingenuous rationale for circumventing statutory safeguards enacted to protect children from exploitation as human guinea pigs. Which legacy do you wish to leave?”
The Alliance for Human Research Protection (AHRP) is a national network of lay people and health professionals dedicated to advancing responsible and ethical medical research practices.
Read the entire AHRP Feb. 18, 2013 letter here.
References:
[1] Sharav V, Nass M. Letter to the Presidential Commission for the Study of Bioethical Issues. AHRP Feb. 18, 2013.
[3] Global Security Newswire. U.S. Eliminates up to 2M Anthrax Vaccine Doses Yearly: Homeland Security April 20, 2012.
[4] M. Kaufman. U.S. Barred From Forcing Troops to Get Anthrax Shots. Washington Post Oct. 28, 2004.
[5] R. Stein. Federal advisers endorse testing anthrax vaccine in children. Washington Post Oct. 28, 2011.
[6] Debold V. Public Comment on Behalf of NVIC Opposing Pediatric Anthrax Vaccine Trials. National Biodefense Science Board Public Engagement Workshop Meeting, Anthrax Vaccine Working Group July 7, 2011.[7] U.S. Department of Health *& Human Services. National Biodefense Science Board (NBSB). March 7, 2013.
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