Posted by Roger Mallett Posted on 7 November 2020

What COVID Vaccine Policymakers Can Learn From Botched Military Anthrax Vaccine Program

It’s time to re-evaluate recommendations related to the approval, mandating and monitoring of vaccines.

In 2002, the U.S. Government Accountability Office (GAO) issued a report to Congress on the Anthrax Vaccine Immunization Program (AVIP), a mandatory program created by the military in the late 1990s.

The 55-page report detailed a litany of adverse reactions to the anthrax vaccine, and the subsequent mass exodus of military pilots and other highly valuable military personnel who refused the mandated vaccine.

Why revisit a report, written nearly two decades ago, on how the military handled the anthrax vaccine?

First, the report validates many of the concerns parents have voiced for decades about childhood vaccine schedules. It should serve as a warning to parents, especially in light of the rush to develop a COVID-19 vaccine. After all, the Centers for Disease Control and Prevention is directing the Childhood Immunization Program under the same dysfunctional decision-making paradigm as the one used by the military.

Second, the report’s insights into the military’s poor handling of the anthrax program are valuable today — when the threat of a SARS-CoV-2 vaccine mandate looms large — for their potential to reshape our current approach to vaccines and mandates.

We’ve seen recently how a corrupt pharmaceutical industry, just by putting a few letters in the mail and incentivizing the media to broadcast panic, can manipulate officials at the highest level of the federal government into endorsing the need for fast-tracking a vaccine.

It’s time to re-evaluate how the U.S. Food & Drug Administration (FDA), the Department of Defense (DOD) and the Department of Health and Human Services (HHS) make recommendations related to the approval, mandating and monitoring of vaccines.

If government officials do undertake this re-evaluation process, they would do well to consider the GAO’s critique of the military’s handling of the anthrax vaccine — including the GAO’s assessment of how one man’s actions needlessly put an entire military population at risk of experiencing a dangerous reaction to an unproven vaccine.

1. Did the risk of anthrax justify mandating the vaccine for all military members?

The anthrax vaccine had been in development and limited use in the military since 1970. As of 1997, there was talk of making the vaccine compulsory for all 2.4 million military service members, including active duty and reserve personnel and civilian contractors.

2. Anthrax manufacturer fraudulently reported mild adverse reactions with low rates 

The GAO report documented that overall injuries, both localized and systemic, from the anthrax vaccine were double the reported rate from the manufacturer. The data also revealed that more serious and long-lasting adverse events were 100 times more frequent than the manufacturer reported.

“According to our survey results, the reported rate and severity of adverse events experienced by personnel who had received the anthrax shots were considerably higher than those published in the vaccine manufacturer’s product insert in use at the time of the survey or reported by DOD. For example, an estimated 84 percent of the personnel who had had anthrax vaccine shots between September 1998 and September 2000 reported having side effects or reactions. This rate is more than double the level cited in the vaccine product insert. Further, about 24 percent of all events were classified as systemic—a level more than a hundred times higher than that estimated in the product insert. The reaction rates from our survey were also consistent with the results of two earlier DOD studies of the anthrax vaccine. In addition, we found that most events were not being reported to either official or informal DOD channels, partly because most individuals were unaware of the reporting process for documenting any such occurrences.”

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