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Thursday, December 2, 2021

J&J Vaccine: FDA panel says two doses are needed

The Johnson & Johnson vaccine is a two-dose vaccine – and a second dose should be given to anyone who got their first dose more than two months ago, according to a Friday poll by a US Food and Drug Administration panel.

But a potentially better strategy is on the horizon: “mixing and matching” vaccines, where J&J recipients are offered access to Pfizer and Moderna Vaccines. Preliminary data shows a stronger immune response than this approach.

This leaves J&J recipients in booster-shot limbo. The FDA panel did not vote on the mix-and-match proposal, citing insufficient time to review the new data — but will take it in the future.

When first introduced, J&J’s one-dose vaccine was touted as a game-changer: It was cheap, easy, and convenient for people who didn’t want to roll up their sleeves twice. It doesn’t demand fancy cold-chain storage.

But the effectiveness of the single-dose J&J vaccine has been consistently lower than the efficacy of the mRNA vaccines from Pfizer and Moderna.

This is worrying for the 14 million Americans who have received the J&J vaccine. Even as the others ran for the third shot, they felt left behind.

“This is a group that overall sees less efficacy than mRNA vaccines, so something is urgent in this case,” said University of Michigan epidemiologist Dr. Arnold Monto, who chaired the panel.

Safety is greatly improved with a second dose of J&J. A second shot increased the vaccine’s efficacy from an average of 74% to 94%, according to the company’s 30,000-patient study. This was two months of data; There is not yet enough data on shots given after six months.

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“I think it was, frankly, always a two-dose vaccine,” said Dr. Paul Offitt, an infectious disease specialist at Children’s Hospital of Philadelphia.

All will be eligible. In contrast, Pfizer and Moderna Booster are only recommended for people who have severe COVID-19 because of their age, underlying health conditions, or a high risk of viral exposure where they work or live. -19 is at highest risk of disease.

Immunologist at Harvard School of Public Health and editor-in-chief of The New England Journal of Medicine, Dr. “If the vaccine isn’t enough, it needs to be extended to everyone,” Eric Rubin said.

For reasons that are not well understood, the durability of the three vaccines appears to vary greatly. While the Moderna vaccine showed the most potent initial response, antibodies decreased over time. The Pfizer vaccine also showed a fairly strong response, then subsided. While the J&J vaccine was initially the least effective vaccine, its response persisted over time.

The next step is to get approval from the FDA’s Acting Commissioner Dr. Janet Woodcock and the US Centers for Disease Control.

Will the FDA consider a mix-and-match recommendation? The FDA Was Fearless, But Preliminary Data

“I would say it is possible,” said Marx.

World Nation News Deskhttps://www.worldnationnews.com
World Nation News is a digital news portal website. Which provides important and latest breaking news updates to our audience in an effective and efficient ways, like world’s top stories, entertainment, sports, technology and much more news.
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