WASHINGTON - Sept. 5, 2020 - A planned public pledge by vaccine manufactures that they will not seek government approval until their product is shown to be safe and effective isn't likely to quell the growing demands for some kind of independent commission - entirely free of political, economic, or other biases - to review the data if approval for widespread distribution is sought before normal and extensive phase three trials are completed, says public interest law professor John Banzhaf, who has proposed an alternative.

A fierce debate has erupted, reports the Washington Post, over whether the Food and Drug Administration [FDA] should use its emergency authority to authorize the distribution of a coronavirus vaccine before it is thoroughly tested and finally approved - a move which many warn could pose safety dangers (if the vaccine triggered adverse reactions in some recipients, or failed to provide adequate protection), and also inflame existing anti-vaccination sentiment and cause even fewer people to be willing to be vaccinated.

As a result, there is a growing caucus within the medical community - as reported by CNN, the Washington Post, CBS, WebMD, STAT, and others - 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.

Also of concern is a statement by the FDA that it would approve a COVID-19 vaccine found to be only 50% effective; in contrast, most routine childhood vaccines are effective for 85% to 95% of recipients.

Fifty percent is like flipping a coin, or like playing Russian roulette with a revolver loaded with 3 out of 6 bullets, suggests Banzhaf.

The companies' draft statement says the drug makers will submit applications for government emergency-use authorization or licensure of vaccines based on "substantial evidence of safety and efficacy" from apparently interim results from phase 3 clinical trials.

But "substantial evidence" is far short of the standard of proof often sought in medical and scientific studies, or even political polling, which is to a confidence level of 95%, notes Banzhaf, an expert in statistics and the creator of the "Banzhaf Index."

Also, he argues, because of their undeniable self interest, and hundreds of millions of dollars at stake, such pledges from vaccine companies are like assurances from the NRA that gun owners will use assault rifles responsibly, or from the Hell's Angles that its members will obey traffic regulations, argues Banzhaf.

http://banzhaf.net/ jbanzhaf3ATgmail.com @profbanzhaf

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