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COVID vaccines approved by U.S. FDA by June


As of 09 December, no COVID-19 vaccines have been approved by the U.S. Food and Drug Administration (FDA). The FDA is the national regulatory authority responsible for approving vaccines in the U.S.

So far, both Pfizer/BioNTech and Moderna have filed requests for emergency use authorization (EUA) of their respective vaccine candidates after meeting the primary end points requested by the FDA for their phase III trials. Pfizer/BioNTech [filed on 20 November] (…) and Moderna filed on 30 November. The FDA vaccine advisory committee is meeting on 10 December to consider whether to recommend an EUA for the Pfizer/BioNTech candidate and will meet on 17 December to consider whether to recommend an EUA for the Moderna vaccine candidate. If positive, EUAs by the FDA may occur shortly thereafter.

In a press briefing on 09 December, OWS provided the following updates on other vaccine candidates in development:

  • the Johnson & Johnson vaccine candidate’s phase III trial has enrolled ~38,000 subjects and plans on completing its total enrollment of ~40,000 subjects in the next few days. If the initial readout on safety and efficacy data, expected to occur in early January, is positive then it is anticipated they will file for a FDA EUA in late January or early February.

  • AstraZeneca/Oxford has a new phase III trial with ~18,000 subjects that is taking place in the U.S. and is intended to provide a clear outcome on safety and efficacy (this comes after a series of missteps with its first phase III trial. An initial readout is expected in late January and, if it is positive, an FDA EUA filing is expected in late February.

  • Novavax is actively preparing to begin its phase III trial

  • Sanofi/GSK is in discussion with OWS to begin its phase III trial

How many COVID-19 vaccines will be approved by the U.S. FDA as of 30 June 2021?

The FDA “Emergency Use Authorization,” page, which is regularly updated, will be consulted at the end of the day on 30 June 2021. If any COVID-19 vaccine candidates have received full FDA approval by then, they will of course also be considered.

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