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FDA staff doesn’t take stance, says two doses protect against severe disease

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James Truong (Maryland National Guard Specialist) gives a Moderna Coronavirus vaccine to a Wheaton Welcome Center patient on May 21, 20,21 in Wheaton.

Chip Somodevilla | Getty Images

Scientists from the Food and Drug Administration declined Tuesday to decide whether they would back moderna’s Covid-19 booster shot. Data shows that two doses of vaccine are sufficient to prevent severe illness and death in America.

In a document of 45 pages, they stated that “Some real-world effectiveness studies have suggested decreasing efficacy for Moderna COVID-19 Vaccine against symptomatic infections or against the Delta variant,” while other documents have not. Overall, however, the data show that US-licensed and authorized COVID-19 vaccinations provide protection against serious COVID-19 diseases, death, and other complications in the United States.

FDA staff did not take the same position as Pfizer on Pfizer Covid booster shots. The agency’s Vaccines and Related Biological Products Advisory Committee didn’t hesitate to recommend third shots. Pfizer’s initial plan to distribute boosters to anyone 16 years old or older was rejected by the committee. Instead, the committee divided that distribution to the most at-risk people, such as the elderly, and those with chronic health problems. FDA officials extended the eligibility to people who were exposed in a variety of settings, including grocery and health-care workers.

FDA scientists have prepared the report to inform the committee. The panel meets on Thursday to discuss Moderna’s request for Covid booster doses to be cleared for adults. The agency offers a glimpse into its third shot view in the documents that were published.

This meeting is less than one month after U.S. regulators. authorized Covid booster shots of Pfizer and BioNTech’s vaccine to a wide array of Americans, including the elderly, adults with underlying medical conditionsAnd those who work or live in high-risk settings like health and grocery workers.

The FDA advisory group is scheduled to discuss data on the safety and effectiveness of Moderna’s booster shot in adults on Thursday and J&J’s on Friday. It is possible that the agency will make a decision in the midst of these meetings. If not, it could hand the matter off to the CDC or its vaccine advisory panel to decide. This decision would likely be made next week.

Moderna filed a request for FDA authorization to increase the dose on September 1. The FDA approved Moderna’s application for a booster dose on Sept. 1.

Biden hopes that the administration will give additional doses of the U.S. vaccine to continue long-term protection from severe illness, hospitalization, and death. The fast-moving Delta variant is still spreading rapidly.

This strain caused an increase in U.S. hospitalizations, mostly among unvaccinated. Still, some vaccinated Americans have suffered so-called breakthrough infections and just over 19,000 of them — less than 1% — have been hospitalized or died with Covid as of Sept. 20, according to data compiled by the CDC.

This is an ongoing story. Stay tuned for new updates.

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