In Review, F.D.A. Stays Neutral on the Need for a Moderna Booster

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An advisory panel is to vote later this week whether to recommend emergency authorization of boosters for the Moderna and Johnson & Johnson vaccines.

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The Food and Drug Administration set the stage for a new round of decisions Tuesday on which Americans should get a coronavirus booster shot, releasing data review This suggests that an additional half-dose of Moderna’s vaccine produces increased antibody levels at least six months after the second dose. But the agency did not take a stand on whether additional shots were needed.


An independent advisory panel of experts will examine available data on both Moderna and Johnson & Johnson Booster in a two-day meeting later this week. Votes are set to recommend emergency authorization of boosters for both vaccines. While the panel’s votes are not binding, the FDA usually follows them.

In documents released Tuesday, Moderna argued that a third injection is needed because the potency of its vaccine decreases over time, with the level of neutralizing antibodies falling six to eight months after the second dose. The company also cited “real world evidence of reduced effectiveness against the delta variant”, although the FDA noted that studies depend on whether Moderna’s protection against symptomatic infections or against the delta variant weakens over time. happened.

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The company did not argue that the booster was necessary to prevent serious illness or hospitalization, but focused its arguments to prevent infection and mild to moderate illness.

Moderna said the average antibody level of participants in its study was 1.8 times higher after the booster than after the second shot. In another measurement, the booster increased antibodies by at least four times in 87.9 percent of people compared to after the second dose, thus narrowly failing to meet the agency’s requirement of 88.4 percent.

one in document Johnson & Johnson submitted to the FDA ahead of this week’s meeting, the company argued, that booster shots of its vaccine increased protection against COVID-19, including against severe forms of the disease, and increased protection against the virus. There is an increase in the strength of the body’s immune response against forms. . Johnson & Johnson said a booster shot could be given two months after the first dose, but recommended doing so at least six months later, when it said recipients showed a more robust immune response.

Only 14.9 million Americans have Received Totally compared with 103 million with Johnson & Johnson Vaccines, Pfizer-BioNtech’s Vaccines and 69 million with Moderna.

The advisory panel will decide whether to recommend booster shots for Moderna on Thursday and for Johnson & Johnson on Friday after hearing from companies, FDA scientists and the public.

A researcher will also present preliminary results from an ongoing National Institutes of Health study on how each of the three vaccines works as a booster shot, including whether using a different vaccine as a booster would help. Produces a better immune response against COVID-19.

In its data review from Moderna, the FDA noted that overall, vaccines used in the United States “still provide protection against serious COVID-19 illness and death”. The FDA summarized the evidence for the Moderna booster without a post, as it did last month ahead of a committee meeting to discuss whether to recommend a booster shot for the Pfizer-BioEntech vaccine .

The FDA and the Centers for Disease Control and Prevention decided to authorize boosters for multiple Pfizer-BioNTech vaccine recipients. Eligible people include people 65 years of age or older, those living in long-term care facilities, those with underlying medical conditions, or those at higher risk of exposure to the virus because of their jobs or institutional settings. The last group includes health care workers, teachers and prisoners.

In a review released Tuesday, the FDA proposed that outside experts consider essentially the same eligibility groups for Moderna recipients. People familiar with the deliberations said federal officials may also ask the committee to consider broadening booster eligibility to include more middle-aged people.

Moderna said this compared using a full dose and a half dose as a booster, and found that a half dose raised antibody levels well, with little risk of adverse side effects. It also said the half-dose would “substantially increase the worldwide supply” of its vaccine.

Several independent studies have tried to measure whether the potency of Moderna degrades over time. A federally-backed review in July and August looked at COVID cases among more than 15,000 volunteers in Moderna’s clinical trial. One group was fully vaccinated between July and October 2020; The other was vaccinated between December 2020 and March 2021.

Those who later got vaccinated had a 36 percent lower rate of infection. But Professor of Molecular Virology at Baylor College of Medicine and one of the lead researchers, Dr. Hana M. El Sahli said mild cases varied greatly among young volunteers.

The study did not find a statistically significant difference in rates of severe COVID-19 – and there were only 19 such cases. Overall, Dr. L. Sahli said, “the findings do not indicate that a booster is needed.”

one more Recent CDC Study From about 3,700 patients in 21 different hospitals from March to August, Moderna’s vaccine was found to outperformed the three vaccines.

Researchers said Moderna was 93 percent effective against hospitalization from COVID-19, compared to 88 percent for Pfizer and 71 percent for Johnson & Johnson. Pfizer’s efficacy dropped to 77 percent after four months, while Moderna basically remained stable, he said.

Given the paucity of data that MODERN boosters are needed to prevent severe disease, the Committee may debate other potential targets, including making the country’s booster strategy more consistent, providing MODERN recipients better against mild and moderate disease. Protecting and trying to intercept its transmission. Virus.

What to know about COVID-19 booster shots

The FDA authorized booster shots for a select group of people who received a second dose of the Pfizer-BioNTech vaccine at least six months ago. That group includes: Pfizer recipients who are 65 years of age or older or who live in long-term care facilities; Adults who are at high risk of severe COVID-19 due to an underlying medical condition; Health care workers and others whose jobs put them at risk. People with a weakened immune system are eligible for a third dose of Pfizer or Moderna four weeks after the second shot.

Regulators have yet to authorize booster shots for recipients of Moderna and Johnson & Johnson vaccines, but an FDA panel is about to meet to weigh booster shots for adult recipients of Moderna and Johnson & Johnson vaccines.

The CDC states that conditions that qualify a person for a booster shot include: high blood pressure and heart disease; diabetes or obesity; cancer or blood disorder; weakened immune system; chronic lung, kidney or liver disease; Dementia and some disabilities. Pregnant women and current and former smokers are also eligible.

The FDA authorized boosters for workers whose jobs put them at high risk of coming into contact with potentially infectious people. The CDC says the group includes: emergency medical workers; education worker; food and agricultural workers; construction workers; improvement worker; US Postal Service employees; public transport workers; Grocery store workers.

It is not recommended. For now, Pfizer vaccine recipients are advised to get the Pfizer booster shot, and Moderna and Johnson & Johnson recipients should wait until a booster dose is approved from those manufacturers.

Yes. The CDC says the COVID vaccine can be administered regardless of the timing of other vaccines, and many pharmacy sites are allowing people to schedule the flu shot at the same time as a booster dose.

The FDA’s lead vaccine regulator, Dr. Peter Marks, argued for a similar approach to boosters. Town hall earlier this month. He said the goal was to reach “a harmonized approach” for all three vaccines and to simplify booster recommendations for the general population.

At least 1.5 million Americans have already received an additional dose of Moderna, even though third shots are currently authorized only for recipients with immune deficiencies. Some people are looking for friendly pharmacists who are ready to give an extra shot, while…

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