I don't pretend to know what the repercussions of such testing would be for children. But I do know that for me, regardless of the chances of a possible threat from Anthrax spores in the future; I draw the line at ANY children being treated as guinea pigs in ANY test for ANY vaccine without full knowledge beyond the shadow of a doubt of ANY possible side effects whether they're short-or-long-term. There's got to be another way of testing this product.
Children are off limits for me. Full stop. End of freakin' story.
The National Vaccine Information Center has the deeply disturbing story:
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.Description of the ["strongly worded, evidence-based"] letter sent to the commission is here:
The report released by the Presidential Commission for the Study of Bioethical Issues (created by Executive Order #13521 (PDF) on November 24, 2009) says the program would still have hurdles to surmount before the initiation of any vaccine testing on children. In fact, now that the report has been released, the next step is that any final decision to go forward with the program and take the steps recommended by the commission lies with Secretary of Health and Human Services Kathleen Sebelius
Here's more from the National Vaccine Information Center:
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.
Reuters is reporting a sales report of the vaccine by Emergent BioSolutions:
The company reported $215.9 million in sales of BioThrax, its only licensed product, in 2012.The following description of the product in question is from the blog @ Scientific American: (written in May 2012)
... the package insert on Biothrax (AVA) says:And here's a webpage describing the program, "Dark Zephyr" which led us to where we are now. The report's from the Global Security Newswire. The program ensures distribution of vaccines for first responders in various cities. Participants in the program would follow specific regiments in dosing at "pilot sites":
Serious allergic reactions, including anaphylaxis, have been observed, and notes that birth defects were slightly more common in first trimester-exposed infants (odds ratio = 1.18). There was a >10 % incidence of significant arm pain after injection, with limited range of motion. All adverse events were more common in women.
In 2011, a bioterrorism preparedness exercise, “Dark Zephyr,” was conducted. (This was a coy symbolic name, as Zephyr means “A soft gentle breeze,” and reminded me of spies and intrigue.) The Dark Zephyr exercise found a notable lack of data about the safety or immunogenicity of AVA in those <18 or >65 years old.
A standard vaccination regimen would involve five shots over 18 months and yearly boosters to confer and sustain immunity. The trial is expected to hew roughly to the duration of the initial 18-month "priming series."It's unclear if any testing on children or infants would follow regiments different from
the ones prescribed for adults.
Here's more from Scientific American:
Historically, dosing for children has been extrapolated from that for adults. The NBSB argues that, during an emergency, the planned dosage of vaccine would have to be the same as in adults and that they would not be able to do sequential studies. So the question is whether the limited likelihood and risk of an attack warrants testing a vaccine with significant side effects on healthy children—especially since it is not known whether any antibodies formed would actually be protective, and boosters have to be given annually. (Note: for example, the dose of diptheria and tetanus proteins in vaccines are higher for infants than for adults.) And it is known that antibiotics and post-exposure vaccination are effective for preventing anthrax infection if necessary.Here's a very informative article on the history of Anthrax vaccines in the DoD from the Homeland Security Affairs Blog @ The Journal of the Naval Postgraduate School Center for Homeland Defense and Security written shorty before the 2009 Executive Order was issued:
Past problems with the Department of Defense anthrax vaccine currently impact national emergency response plans approved by the Department of Homeland Security and Department of Health and Human Services. Following the 2001 anthrax letter attacks, those departments diverged from long established protocols advocating limited use of the old anthrax vaccine, also known as BioThrax®. The Executive departments procured mass quantities of the product for the Strategic National Stockpile as a prophylaxis for citizens under emergency contingencies. The departments share oversight responsibilities for the emergency stockpile’s composition of vaccines and drugs based on Presidential Directives. 1 Yet a review of past oversight efforts reveals regulatory problems, ethical controversies and dubious threat assessments underlying use of the vaccine. Based on the historic controversy, and studies suggesting the majority of U.S. service members continue to object to the vaccine’s use, 2 the government should resurvey the vaccine’s suitability for American citizens. A thorough review may find that widespread use of a known antiquated product of disputed safety and efficacy in treating a non-communicable threat provides an imprudent illusion of protection for our citizens.Corporate profit margins for products deemed compulsory for American citizens gives me an uneasy feeling in my gut. I know it takes money to test and produce these products but corporations have been known to take shortcuts in the past as far as testing goes, and I don't want to see any children harmed while being subjected to these tests whether it's by side effects in the present or by side effects... unexpectedly discovered in the future.
I'll end this with another disturbing little detail reported by Reuters:
Under a 2005 law, children in an anthrax-vaccine study would be prohibited from seeking damages through the legal system. The presidential commission, said Gutmann, "strongly recommended that a plan be in place to compensate any children" who are harmed.Carte Blanche?
Call me paranoid... but not my grandchildren.
Not now. Not ever. No way. No how.