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Product Development

CHMP review date sets up Pfizer-BioNTech COVID-19 vaccine to earn first EMA approval

Dec 2, 2020 | 1:24 AM GMT

The first European approval of a COVID-19 vaccine could come before year-end as EMA sets its deadlines for review of the mRNA vaccines from Moderna and partners Pfizer and BioNTech.

The European Commission has agreed to procure up to 460 million doses of the two vaccines, together comprising more than 20% of its commitments to COVID-19 vaccines.

EMA said Moderna (NASDAQ:MRNA) and partners Pfizer Inc. (NYSE:PFE) and BioNTech SE (NASDAQ:BNTX) had completed rolling submissions for conditional approval of their mRNA-1273 and BNT162b2, respectively.

BNT162b2 will be first under EMA’s microscope with the agency’s CHMP expected to complete its review at an extraordinary meeting of the committee on Dec. 29. The review for mRNA-1273 is expected to conclude two weeks later at an extraordinary CHMP meeting on Jan. 12.

An EMA spokesperson said the agency has had longer to review manufacturing, preclinical and initial clinical data for the Pfizer-BioNTech program than that of Moderna, leading to BNT162b2’s faster timeline. Pfizer and BioNTech started their rolling review for BNT162b2 on Oct. 6, while Moderna submitted the first data for its rolling review on Nov. 16.

Both programs have reported strong efficacy data from Phase III trials, with Pfizer and BioNTech showing 95% efficacy in a final analysis, while yesterday Moderna reported 94.1% efficacy in its final analysis of the Phase III COVE trial of mRNA-1273.

Should CHMP recommend approval for each vaccine, the EC has committed to accelerating its process to approve the vaccines within a matter of days.

The EC has procured up to 300 million doses of BNT162b2, and up to 160 million doses of mRNA-1273. In total Europe has secured access to nearly 2 billion doses across six different programs, with 860 million doses for the three programs that have reported late-stage data, including up to 400 million doses for AZD1222, which reported Phase III data last month.

AstraZeneca plc (LSE:AZN; NASDAQ:AZN) started a rolling review of AZD1222 with EMA on Oct. 1, while Johnson & Johnson (NYSE:JNJ) started on Tuesday its rolling submission with EMA for its adenoviral vector vaccine Ad26.COV2.S. Phase III data from the single-dose trial of Ad26.COV2.S is expected by year-end or early January.

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