Tuesday, June 7, 2022

BCG beats novavax

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Novavax Covid-19 Vaccine Faces FDA Advisers’ Scrutiny

Outside panel to recommend whether the shot should be authorized, after the agency found it effective but flagged a heart-safety concern

The company’s Covid-19 vaccine would be the first authorized in the U.S. with a traditional protein-based platform.PHOTO: MARKUS HIBBELER/ZUMA PRESS

Vaccine experts advising the Food and Drug Administration are set to scrutinize NovavaxInc.’s Covid-19 shot, after months of manufacturing-related delays and an agency review that found the shots effective but raised a safety concern.

The outside panel’s consideration of the two-shot vaccine, scheduled for Tuesday, would move the shot one step closer to becoming available in the U.S. The FDA is expected to make a decision on authorizing the vaccine shortly, after considering the vote of its advisers.

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