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‘Stricter FDA standards make COVID-19 vaccine OK unlikely before election day’

September 22, 2020

The Washington Post reports that tougher FDA standards for emergency use authorization (EUA) of a COVID-19 vaccine will extend the review timeline and make it unlikely that a nod could happen by election day on November 3.

The agency is tightening the criteria to boost transparency and public trust amid perceptions that the review process is being politicized. President Trump has repeatedly stated that a vaccine will be approved by November 3, a tight timeline that may give Americans pause that the vaccine was fully vetted and is safe and effective. According to Pew Research Center, a bit more than 50% of people would get the vaccine if available today, down from 72% in May.

The new FDA guidance reportedly will require study participants to be followed for a median of two months after they receive the second dose. Reviewers will also be looking for at least five cases of severe COVID-19 cases in the control arm as well as some cases in older people, signals that the vaccine works. The 50% efficacy bar compared to control remains unchanged.

The two-month follow-up period makes it unlikely that Pfizer (PFE +0.7%) or Moderna (MRNA -0.8%) could prepare their respective applications in time for sufficient agency review before November 3. Pfizer has previously stated that it might have data by the end of next month but that was before the new guidance.

Selected tickers: Johnson & Johnson (JNJ -0.5%), Sanofi (SNY -1.8%), GlaxoSmithKline (GSK -0.6%), Dynavax (DVAX -3.4%), Novavax (NVAX +1.2%), Merck (MRK -0.1%)

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