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Moderna, Johnson & Johnson next up to seek FDA approval for booster shots

The number of people who think the worst

The number of people who think the worst of the pandemic is over has dropped from 68% in June to 50% today, according to a Siena College Research Institute poll. Credit: AP / Steven Senne

Pfizer already has won approval for a booster shot against COVID-19. Moderna and Johnson & Johnson now are trying for the same.

Two days of public meetings of a Food and Drug Administration advisory committee on the requests start Thursday. It's unclear when a final decision on boosters — and who should get them and when — will come.

Dr. David Hirschwerk, an infectious-disease specialist at Northwell Health who practices in Manhasset, said Tuesday that booster shots could be in arms as soon as sometime next week, assuming the process stays on schedule, and federal drug regulators greenlight the shots’ additional use.

After FDA advisers make their recommendations, the agency itself will make a decision on whether to authorize boosters. Next week, a panel convened by the U.S. Centers for Disease Control and Prevention could offer more specifics on who should get them. That panel's recommendations then would be subject to approval by the CDC director.

In briefing documents released Tuesday by the FDA, Moderna said its booster is half the dose of the initial two shots. The company said its studies support the use of a booster in people ages 18 and older, six months or longer after initial immunization.

Moderna cited an increase in breakthrough infections seen from the delta variant as a justification for a booster.

The company is seeking approval similar to what Pfizer received. The booster would be for people 65 and older, and those ages 18 to 64 and at high risk for severe COVID-19. It also would include people 18 to 64 whose institutional or occupational exposure put them at risk for severe COVID-19, including health care workers, teachers and prisoners.

In August, the FDA authorized a third, full-strength Moderna dose for people with compromised immune systems, about 8 to 10 million nationwide. That includes solid-organ transplant recipients, active cancer patients, those using steroids or other immunosuppressant medications, those with HIV that isn’t under control, and several others.

"The reason for that recommendation was the recognition that people with those conditions often did not mount an appropriate response to two doses, and many, though not all, of those people would mount a good response after receiving a third dose," Hirschwerk said.

He said that he didn’t know how many people would be newly eligible upon the broader approval for Johnson & Johnson and Moderna boosters.

Even without a booster, J&J said, its vaccine remains about 80% effective at preventing COVID-19 hospitalizations in the United States.

Dr. Sharon Nachman, chief of the division of pediatric infectious diseases at Stony Brook Children’s Hospital, said research studies are underway to determine the immune response and efficacy of booster shots for the general population, including "when they get their booster, what their immune response was, how did they do before they got their booster, after their booster, so I think there’s a lot of data that is pending."

"Unfortunately, until you get all of those patients that were enrolled on the studies originally [to] come in and get their booster and see how they’re doing, that takes time, so I don’t know exactly how soon it will happen," she said.

The studies involve nasal swabs, as well as antibody tests done by blood before and after the booster, she said.

Nachman said she hopes that perhaps by January, there will be an answer as to a timeline going forward on whether boosters are advisable for the general population.

"I think there’s a lot of moving parts," she said, adding: "I think everyone needs to sort of sit back and say, ‘Well, what does the data show? How helpful is it?’ It’s not an easy thing to recommend boosters for everyone, because people may not want to go."

That’s particularly true if boosters are going to be subject to a mandate, she said.

Scientists emphasize that all three vaccines used in the United States still offer strong protection against severe disease and death from COVID-19. The issue is how quickly, and how much, protection against milder infection might wane.

An estimated 103 million Americans are fully vaccinated with Pfizer’s formula, 69 million with Moderna’s and 15 million with J&J’s, according to the CDC. Regulators took up the question of Pfizer boosters first because the company submitted its data ahead of the other vaccine makers.

The approval process is meant to bolster public confidence in the vaccines. But it already has led to conflicts among experts and agencies — and documents the FDA released Tuesday suggest that this week’s decisions will be equally difficult.

The companies and medical experts said the booster shots will provide greater protection against the virus, on top of what the original shots offer. But some experts also acknowledge that the need for a booster is adding to the skepticism of people who don’t want — and don’t trust — the shots.

Medical experts said the shots are safe, effective and the best way to end the pandemic.

In one earlier vaccine dispute, the CDC's advisory panel last month backed Pfizer boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems.

But CDC Director Dr. Rochelle Walensky overruled her advisers and decided boosters also should be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions more Americans to the list.

On Long Island, meanwhile, COVID-19 continued to spread, with 649 new cases reported in test results from Monday. Nassau County registered 234 cases, and Suffolk had 415, while New York City had 1,028.

The seven-day average for positivity in testing continued to hover under 3%, registering 2.77% for Nassau and Suffolk counties.

Across the state, 35 people died on Monday of causes linked to the virus, including two fatalities in Suffolk.

With AP

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