Saturday, October 23, 2021

Next on FDA’s agenda: Booster shots of Moderna, J&J vaccines

WASHINGTON (AP) – While many Americans who have received the Pfizer vaccination are already rolling up their sleeves for a booster shot, millions of others who have received either Moderna or Johnson & Johnson vaccines wait anxiously to find out what their When is it your turn?

Federal regulators begin tackling that question this week.

On Thursday and Friday, the Food and Drug Administration convenes its independent advisers for the first step in the process of deciding whether additional doses of the two vaccines should be given and if so, who should receive them and when. Final approval is not expected for at least another week.

After FDA advisors make their recommendation, the agency will decide for itself whether to authorize the booster. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics about who should get them. Its decision is subject to approval by the CDC director.

This process is to increase public confidence in vaccines. But it has already sparked conflict among experts and agencies — and FDA documents released on Tuesday suggest this week’s decisions will be equally difficult.

In an earlier vaccine controversy, the CDC’s advisory panel last month endorsed a Pfizer booster at the six-month point for older Americans, nursing home residents, and people with underlying health problems. But CDC Director Dr. Rochelle Valensky dismissed her advisors and decided that boosters should also be offered to people with high-risk jobs such as teachers and health care workers, adding millions more Americans to the list.

Some health experts fear that back-and-forth discussions are spoiling a public effort to persuade non-vaccinated people to get their first shot. He worries that talk of boosters will lead people to falsely doubt the effectiveness of vaccines in the first place.

More on the COVID-19 Pandemic

When the FDA’s panel meets to review Moderna and J&J vaccines, experts will discuss whether the third Moderna shot should contain just half of the original dose and the best timing for a second shot of the single-dose J&J vaccine. What.

The panel will also look into the safety and effectiveness of mixing-and-matching different brands of vaccine, something regulators have so far not endorsed.

According to the CDC, an estimated 103 million Americans have been fully vaccinated with Pfizer’s formula, 69 million with Moderna and 15 million with J&J. Regulators first raised the question of Pfizer Booster because the company submitted its data before other vaccine makers.

Tim Anderson, a US history teacher at a high school outside Louisville, Kentucky, had two of his Moderna shots just months before he came down with COVID-19 in August. While his symptoms hit him “like a hammer”, he is convinced that the vaccination saved him and his girlfriend from the more severe effects of the disease.

Both are now awaiting approval for a modern booster shot.

“As long as we don’t build enough immunity within ourselves and, you know, as a group of humans, I’m willing to do what I need to do,” Anderson, 58, said.

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The FDA meetings come as the US vaccination average has climbed above 1 million per day, a more than 50% increase in the past two weeks. Growth has been primarily driven by the Pfizer booster and employer vaccine mandates.

While the FDA and CDC have so far only endorsed Pfizer boosters for specific groups, Biden administration officials, including Dr. Anthony Fauci, have suggested additional shots will eventually be recommended for most Americans.

In a new review of Moderna’s data, the FDA on Tuesday did not indicate whether it was leaning toward cleaning up the company’s boosters. It said vaccines used in the US still provide protection, and it questioned some of Moderna’s data.

The two initial Moderna shots each contain 100 micrograms of the vaccine. But the drugmaker says 50 micrograms should be enough for a booster for healthy people.

One company study of 344 people given them a 50-microgram shot six months after their second dose found a jump in the levels of virus-fighting antibodies. Moderna said the booster triggered a 42-fold increase in antibodies capable of targeting the extra-infectious delta variant.

Side effects were similar to the fever and pain that Moderna recipients typically experience after their second regular shot, the company said.

For people who received the J&J vaccine, the company submitted data to the FDA for different options: a booster shot in two months or six months. The company said in its FDA submission that a six-month booster is recommended but in some situations a second dose may be given in two months.

J&J released data in September showing that boosters given over two months provided 94% protection against moderate to severe COVID-19 infections. The company hasn’t disclosed patient data on the six-month booster, but early measures of virus-fighting antibodies suggest it offers even greater protection.

Even without the booster, J&J says, its vaccine is about 80% effective in preventing COVID-19 hospitalizations in the US

Scientists emphasize that all three vaccines used in the US still offer strong protection against serious illness and deaths from COVID-19. The issue is how quickly and how little protection against minor infections can be.

In a recent study, researchers compared nearly 14,000 people who received their first Moderna dose a year ago to 11,000 who had received the vaccine eight months earlier. As the delta variant increased in July and August, the “success” infection rate in the recently vaccinated group was 36% lower, compared to the previously vaccinated group.

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AP writer Bobby Cana Calvan contributed to this story from New York.

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The Associated Press Department of Health and Science receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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