Novavax, Inc. Stock News

Federal regulators are asking Novavax to complete an additional clinical trial on its Covid-19 vaccine after previously delaying approval, the Wall Street Journal reported on Friday, citing people familiar with the matter.

A new randomized study could cost Novavax tens of millions of dollars, vaccine experts say.

Thousands of Americans campaigning for the Novavax COVID-19 booster got some good news this week: the FDA signaled it might still win approval after Health Secretary Robert F. Kennedy Jr cast doubt on its efficacy.

Novavax, Inc. (NASDAQ:NVAX) shares surged more than 16% after the company shared a positive update on its COVID-19 vaccine, which it believes is “approvable” based on its conversations with the US Food and Drug Administration (FDA). The company said the FDA has requested additional data on the vaccine as part of a post-marketing commitment (PMC).

Novavax said on Wednesday the U.S. Food and Drug Administration has sought a commitment from the COVID-19 vaccine maker for additional clinical data if it approves the shot.

Preliminary data showed Novavax's non-mRNA JN.1 COVID-19 vaccine induced lower frequency and severity of short-term side effects and impact on daily life compared with Pfizer-BioNTech mRNA vaccine Full results will be submitted for publication later this year GAITHERSBURG, Md. , April 15, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preliminary results from the SHIELD-Utah ...

Vaccine maker Novavax's shares plunged over 22% on Thursday after Health and Human Services Secretary Robert F. Kennedy Jr. raised concerns about the company's COVID-19 vaccine in an interview with CBS News.

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