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Regulation

J&J, Novavax vaccines begin regulatory review, the first with variant data 

Feb 5, 2021 | 2:01 AM GMT

Data submitted to regulators by J&J and Novavax mark the beginning of a new wave of COVID-19 vaccine reviews that will have to grapple with performance against emerging viral variants.

On Thursday, Johnson & Johnson (NYSE:JNJ) said it submitted an application to FDA for emergency use authorization (EUA) of its single-dose adenoviral vector vaccine Ad26.COV2.S. The submission is based on top-line efficacy and safety data from the company’s Phase III ENSEMBLE trial, which was conducted in eight countries including the U.S.

J&J said it is ready to immediately begin shipping the vaccine upon authorization, and expects it will supply 100 million doses to the U.S. this half.

The same day, Novavax Inc. (NASDAQ:NVAX) announced the start of rolling reviews by multiple regulatory agencies including FDA, MHRA, EMA and Health Canada. The agencies will review non-clinical and early clinical data for Novavax’s recombinant protein nanoparticle vaccine NVX-CoV2373 while the company completes its Phase III pivotal study in the U.S. and the U.K.

Last week, J&J and Novavax unveiled the first COVID-19 vaccine efficacy data against emerging SARS-CoV-2 escape variants. While both vaccines appeared to have weakened efficacy against the South African B.1.351 strain, they were effective at preventing severe disease, hospitalization and death across a range of viral variants.

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