WASHINGTON - Sept. 8, 2020 - Today's pledge by nine vaccine makers that they will hold back seeking FDA approval until their product is proven to be both safe and effective is unlikely to persuade either the public nor a growing number of spectacle experts, says public interest law professor John Banzhaf, who predicts that it will be seen like an assurance from the NRA that gun owners will use assault rifles responsibly, or from the Hell's Angles that its members will obey traffic regulations.

Indeed, says Banzhaf, since the standard to establish effectiveness is only 50% - in contrast, most routine childhood vaccines are effective for 85% to 95% of recipients - 50% reliability is like playing Russian roulette with a revolver loaded with 3 out of 6 bullets

Despite this new pledge, 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 Banzhaf, who has proposed an alternative.
Among the numerous reasons for many reasonable members of the public to distrust the FDA and its head regarding the pandemic, Prof. Banzhaf lists the following:

* the very name of the vaccine program - "Operation Warp Speed" - strongly suggests rushing to judgment at all costs, and possibly not insisting upon sufficient testing to fully establish safety and effectiveness

* the FDA bungled in initially getting COVID-19 tests on the market, and then allowing antibody tests which proved inaccurate to be made available

* it hastily approved hydroxychloroquine as a treatment after it was touted by the President but before it was fully tested, and then had to withdraw the authorization only shortly thereafter

* it authorized the use of convalescent plasma, likewise strongly recommended by the President, despite the strong and continuing reservations of many medical experts

* FDA Commissioner Hahn just made a clearly misleading public statement which greatly overstated the effectiveness of the convalescent plasma in treating COVID-19

* the agency recently changed its testing guidelines in ways which concerned many public health experts, and without even consulting infectious disease expert Dr. Anthony Fauci

* many observers have suggested that it appears that top governmental pandemic experts are being pressured to take scientifically unjustified positions because of pressures from the White House

jbanzhaf3ATgmail.com @profbanzhaf

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