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The CEOs of all major Western COVID-19 vaccine developers have promised to apply for FDA approval only after demonstrating safety and efficacy in phase 3. The promise comes amid reports that the Trump Administration is pushing for that a vaccine be approved before November. choice.
In the weeks between now and the election, some companies may share data from fairly comprehensive evaluations of their COVID-19 vaccines, but not the full results of the phase 3 studies of 30,000 subjects they are conducting to gain approval. in the U.S. If this happens, a company could apply for, and potentially obtain, an emergency use authorization based on evidence that does not meet the level required by FDA guidance, leading to claims of political interference and damage to confidence in vaccines.
In that context, the CEOs of AstraZeneca, BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck, Moderna, Novavax, Pfizer and Sanofi have signed a joint commitment. One of the commitments is “to submit for approval or authorization for emergency use only after demonstrating safety and efficacy through a phase 3 clinical study that is designed and conducted to meet the requirements of expert regulatory authorities such as the FDA” .
The nine companies are collectively working on all of the major vaccines to be released to market in the U.S. over the next nine months, suggesting that a COVID-19 prophylactic will only be widely available in the country once one of They have completed phase 3. The BioNTech-Pfizer collaboration has set the most aggressive goal for completing phase 3, but could still fail to obtain pre-election approval.
Concerns about regulatory independence and the implications for COVID-19 vaccines in an election season intensified following the emergency clearance of convalescent plasma and, in particular, a press conference attended by President Donald Trump and the commissioner. of the FDA, Stephen Hahn. The event raised concerns that political considerations are influencing decision-making at the FDA.
A letter sent by BIO last week said that “the FDA should maintain its historic independence” and “political considerations should be set aside,” but the nine CEOs avoided explicitly linking their commitment to the events of recent weeks and the concerns Trump will drive. premature approval.
Rather, the CEOs pledged to “always make the safety and well-being of vaccinated individuals our highest priority” and to “continue to adhere to high scientific and ethical standards with regard to conducting clinical trials and rigorous testing processes. manufacturing”. Those statements, and the broader promise, could be construed as a response to the political situation, but CEOs opted for more explicit and potentially inflammatory comments.
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