WASHINGTON - Sept. 7, 2020 - Despite a planned pledge by vaccine manufacturers, a promise by FDA Commissioner Stephen Hahn, and assurances by an FDA advisory committee of a thorough review of the safety and effectiveness of any COVID-19 vaccine before widespread immunization is authorized, Democratic vice presidential candidate Kamala Harris said she wouldn't trust any vaccine released before the election.

Thus she appears to join 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.

Of great 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.

But 50% reliability is 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 only if they conclude there is "substantial evidence of safety and efficacy" from apparently interim results.

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 safety 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.

So Prof. Banzhaf suggests that it would be appropriate for major medical organizations, large hospital chains, and big medical insurance companies to consider what their role should be regarding the distribution and administration of any vaccine without the satisfactory completion and unbiased evaluation of clinical trials.

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

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