U.S. moves closer to clearing Moderna and J&J Covid booster shots this week

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  • Millions of Americans will be closer to getting a COVID booster shot when a major FDA panel meets this week to debate additional doses of Moderna and J&J vaccines.
  • The Biden administration hopes that increasing the US population will ensure long-term and sustainable protection from serious disease.
  • “Even with Delta, current vaccines are holding up fairly well to hospitalizations and serious illness,” said Norman Baylor, former director of the FDA’s Office of Vaccines.

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Millions of Americans will be one step closer to getting a Covid-19 booster shot this week, when a major Food and Drug Administration advisory panel meets on Thursday and Friday to debate additional doses of Moderna and Johnson & Johnson vaccines.

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The meetings of the FDA’s Vaccines and Related Biological Products Advisory Committee come less than a month after US regulators authorized Pfizer and BioNTech’s vaccine Covid booster shots for a wide range of Americans, including the elderly, with underlying medical conditions. adults and people who work or live. High-risk settings such as healthcare and grocery workers.

As of Saturday, more than 7 million Americans have received a booster dose in the US, according to the latest data available from the CDC.

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Members of independent committees by the FDA and the Centers for Disease Control and Prevention said at the time they were disappointed that only Pfizer recipients would be eligible to receive the additional shots, excluding the millions of Americans who received shots from Moderna or J&J.

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The FDA advisory group is scheduled to discuss data on the safety and effectiveness of the Moderna booster shot in adults on Thursday. On Friday, the committee is expected to debate the J&J booster shots for adults. The FDA can make a final decision within days of the meetings, handing it over to the CDC and its Vaccine Advisory Committee to make their decision.

CDC’s next vaccine advisory meeting is scheduled from October 20 to October 21, where the booster is expected to be discussed.

The FDA meeting came after the average daily Covid cases in the US fell below 100,000 last week, with more than 56% of the population fully immunized against the virus and showing signs of pandemic easing. Health experts say getting vaccinated, booster shots and avoiding large gatherings are important ways to reduce the potential increase in cases during the holidays.

The Biden administration hopes that boosting the US population will also continue to ensure long-term and sustainable protection against serious illness, hospitalization and death as the rapidly growing delta variant spreads.

The stress caused an increase in the number of hospitalizations in the US, mainly among non-vaccinated people. Still, few vaccinated Americans have suffered so-called breakthrough infections, and just over 19,000 of them – less than 1% – were hospitalized or died with COVID as of September 20, according to data compiled by the CDC. Went.

“Even with Delta, current vaccines are holding up fairly well to hospitalizations and serious illness,” said Norman Baylor, former director of the FDA’s Office of Vaccines. “It is the infection that appears to be a concern.”

Last month, Moderna said the third shot at half the dose used for the first two jabs was safe and produced a stronger immune response than was seen after the second dose in its Phase III clinical trial.

J&J said last month that the second dose of its single-shot vaccine was safe and increased protection against symptomatic infection from about 70% to 94% in the United States when administered two months after the first dose.

Baylor said in a phone interview that the FDA could authorize Moderna and J&J booster shots under the same criteria as Pfizer or perhaps change course and increase the number of Americans eligible to receive the additional shots.

“The question is: does everyone need a booster right now?” Baylor, now president of Biologics Consulting Group.

Baylor said committee members will have to debate whether it is safe and effective for J&K recipients to receive a second dose. He said he doesn’t expect any trouble authorizing the third dose of Moderna’s vaccine because it uses mRNA technology, which was also used to develop Pfizer’s vaccine.

“If I were at the FDA in my old position, I probably wouldn’t have taken Moderna on the advisory committee because it’s in the same class as Pfizer,” he said.

The administration’s communication on Pfizer booster shots was already confusing and “very harmful” in terms of public perception, said Dr. Isaac Bogoch said.

“Looking at the outside, it seems a little free-for-all,” Bogoch said. “Like, yeah, there’s some lax guidance in the United States. But it basically looks like anybody can go to any pharmacy and get a booster shot and say you know what I smoke or I am obese or I am a health care worker.”


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