WASHINGTON - Sept. 26, 2020 - Worried that the FDA is about to toughen the standards for emergency authorization of a COVID vaccine which likely would prevent its release before Election Day, White House Chief of Staff Mark Meadows told FDA Commissioner Stephen Hahn that his agency must provide very detailed justification for its proposed strengthening of the authorization standards.
But major national medical organizations could protect the public by conducting their own review of any new vaccine before its release, and the National Medical Association [NMA] has already announced the formation of a independent commission to do exactly that, says public interest law professor John Banzhaf, who originally proposed the idea to the NMA weeks earlier.
Banzhaf noted that the premature authorization and release of a vaccine, before large-scale trials can be properly conducted and evaluated, could harm public health in several ways:
* There might be dangerous vaccine-related side effects - such as blood clotting issues or transverse myelitis (spinal cord inflammation) which tend to occur only 40-60 days after the second vaccine dose - which probably would not be detected if the vaccine were prematurely rushed to approval.
* It may offer insufficient protection to early recipients, such as medical personnel and first responders - or at least to some smaller segments (e.g., Blacks with diabetes) - causing them to become infected and die, or become disabled, from the virus.
* A successful attempt to prevent the FDA from adopting standards for emergency authorization, which it believes are necessary to protect the public, would further weaken public trust in the FDA and any vaccine it might authorize, thereby causing even more people to refuse to be injected, and thus endangering the public health
Banzhaf notes that there is already a growing outcry within the medical community - as reported by CNN, the Washington Post, CBS, WebMD, STAT, and others, and recently joined by former Vice President Joe Biden - calling for an independent commission, free from bias, including pressure from the President, to review the safety and effectiveness of any vaccine before it is widely administered.
http://banzhaf.net/ jbanzhaf3ATgmail.com @profbanzhaf
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