Novavax awaits FDA decision on whether its next COVID shot can be offered in US
Novavax will only be able to offer a COVID-19 vaccine in the United States this autumn if regulators accept the shot it has started manufacturing that targets a variant that was dominant earlier this year, the company said.
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Novavax's updated vaccine targets a variant called JN.1, which is in line with European recommendations. The European Union's regulator told vaccine makers last month to update their vaccines for that variant because they would likely be effective against its descendant lineages.
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The U.S. Food and Drug Administration has not yet made a decision on the makeup of the next round of COVID vaccines and a JN.1 subvariant known as KP.2 has become dominant in the United States over the past month.
Novavax's traditional, protein-based vaccine is developed in moth cells and takes months to manufacture. In 2023, for instance, Novavax said it needed six months to bring an adequate supply of vaccine to the market.
Vaccines based on messenger RNA (mRNA), like those from Moderna or Pfizer and partner BioNTech, can be developed more quickly. In the past, Pfizer has said it could make the shots in 100 days.
Moderna and Pfizer each told Reuters they are waiting for the FDA's advisers to discuss vaccine design at a June 5 meeting before settling on which variant their next vaccines will target.
Novavax disclosed on its earnings call earlier this month that it had already advanced a
