Next on the FDA’s agenda: Booster shots from Moderna, Johnson & Johnson’s vaccines

WASHINGTON — With so many Americans who have already received Pfizer vaccines rolling up their sleeves for a booster shot, millions of those who have received the Moderna or Johnson & Johnson vaccine are anxiously waiting to see when it is their turn.

Federal regulators begin to address that question this week.

The Food and Drug Administration is meeting Thursday and Friday with its independent Phase 1 advisors in the process of deciding whether additional doses of the two vaccines should be dispensed and, if so, who should get them and when. Final approval is not expected for at least another week.

After FDA advisors give their recommendation, the agency itself will make a formal decision on whether or not to allow the use of boosters. Then next week, a panel convened by the Centers for Disease Control and Prevention will offer more details about who should get them. Its decision is subject to approval by the director of the CDC.

This process aims to enhance public confidence in the safety and efficacy of vaccines. But it has already led to conflicts and disagreements between various experts and agencies.

For example, last month the CDC’s advisory committee supported Pfizer’s boosters at the six-month point for older Americans, nursing home residents and people with underlying health problems. But the director of the CDC, Dr. Rochelle Wallensky, overturned her advisors and decided that the boosters should also be offered to those with high-risk jobs such as teachers and health care workers, adding tens of millions of Americans to the list.

Some health experts fear back-to-back deliberations could overwhelm public efforts to persuade the unvaccinated to get their first vaccinations. They worry that talking about boosters will lead people to falsely suspect the effectiveness of vaccines in the first place.

As the FDA committee meets to review the Moderna and J&J vaccine, its decisions this time will likely be more complex, with experts debating whether a third dose of Moderna should contain only half the original dose and what is the best timing for a second shot of a single dose of the vaccine. J&J.

Moderna’s first two shots contain 100 mcg of vaccine each. But the drug’s manufacturer says 50 micrograms should be enough to fortify healthy people.

A study in 344 people gave them a 50-mcg dose six months after the second dose, and their anti-viral antibody levels jumped. Moderna said the booster even caused a 42-fold spike in antibodies capable of targeting the highly infectious delta variant.

The company said the side effects were similar to the fever and aches that Moderna recipients typically experience after their second regular shot.

For people who got the J&J vaccine, the company has submitted data to the Food and Drug Administration for different options: a booster dose in two months or six months. The company did not indicate its preference.

J&J released data in September showing that a booster dose given in two months provides 94% protection against moderate to severe COVID-19 infection. The company has yet to disclose patient data for the six-month booster, but early measures of anti-virus antibodies suggest it offers higher protection.

J&J says that even without a booster, its vaccine is still about 80% effective in preventing COVID-19 from entering hospitals in the United States.

Scientists confirm that all three vaccines used in the United States still provide strong protection against severe illness and death from COVID-19. The problem is how quickly and how well the protection against moderate infection diminishes.

In one recent study, researchers compared about 14,000 people who got their first dose of Moderna a year ago with 11,000 people who were vaccinated eight months earlier. Due to the high delta variant in July and August, the most recently vaccinated group had a 36% lower rate of ‘breakthrough’ infections than those vaccinated longer ago.

However, medical experts continue to debate the science and rationale for giving extra shots to those who already have significant protection.

The White House and its top medical advisers announced sweeping plans in August to offer the boosters to nearly all adults, citing signs of waning protections and a variable delta that was escalating afterward. But they were rejected by many experts who said there was little data showing whether such widespread use would halt the spread of infection or limit the general course of cases.

While the US Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) eventually reduced the use of Pfizer’s boosters, Biden administration officials, including Dr. Anthony Fauci, suggested that additional doses would eventually be recommended for most Americans.

They point to data from Israel showing lower rates of infection and serious illness among people who received a third dose of Pfizer.

The FDA meetings come as US vaccines are once again soaring above one million per day on average, an increase of more than 50% over the past two weeks. The main driver behind the rally was Pfizer’s boosters and employer vaccine mandates.

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