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Johnson & Johnson Covid Booster Backed by FDA Panel

Johnson & Johnson shares rose after an FDA advisory panel backed the authorization of boosters for the company's single-shot Covid-19 vaccine.
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Shares of Johnson & Johnson  (JNJ) - Get Johnson & Johnson Report were higher after a Food and Drug Administration advisory panel recommended the authorization of boosters for the company's single-shot Covid-19 vaccine. 

The FDA's Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend the booster for the single-shot vaccine from Johnson & Johnson. It's been administered to an estimated 15 million Americans. 

The panel recommended boosters for everyone 18 and over who already received the single-dose shot earlier.

The same committee on Thursday voted unanimously to recommend a Moderna  (MRNA) - Get Moderna, Inc. Report booster shot for seniors, adults with other health problems, jobs or living situations that put them at increased risk for Covid.

The 19-0 recommendation is not binding on the agency but is an important step toward expanding the U.S. booster campaign to millions more Americans. 

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Many people who got their initial Pfizer  (PFE) - Get Pfizer Inc. Report shots at least six months ago are already getting a booster after the FDA authorized their use last month.

The FDA has a track record of following the committee's recommendations and the agency could make an official decision on the boosters within the coming days. 

Earlier this week, FDA staff said that the data to support boosters was limited and that the agency hadn't verified all the information in Johnson & Johnson's application. 

“Although not independently confirmed by FDA from datasets, summaries of the data suggest there may be a benefit in a second dose administered approximately 2 months after the primary dose, when compared to the efficacy seen in the pivotal study COV3001,” the FDA had said in a 54-page document, according to CNBC. 

Separately, people familiar with the matter told The Wall Street Journal that the FDA was delaying a decision on authorizing Moderna’s  (MRNA) - Get Moderna, Inc. Report Covid-19 vaccine for adolescents to assess whether the shot may lead to heightened risk of a rare inflammatory heart condition.

At last check J&J shares were trading up 0.8% at $161.37.