HomeAmericaFDA advisory group recommends Moderna Booster for emergency use

FDA advisory group recommends Moderna Booster for emergency use

A Food and Drug Administration advisory panel voted Thursday to recommend The Moderna Booster Shots for Emergency Use Authorization brings millions of Americans one step closer to being eligible for an additional dose.

The panel, called the Vaccines and Related Biological Products Advisory Committee, voted unanimously in favor of authorizing the shots. The decision will now go to the FDA, which is expected to make a final decision in the coming days.

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The panel’s recommendations for Moderna’s boosters followed Pfizer-BioNtech’s blueprint established last month for vaccine booster shots: For people who were initially vaccinated with Moderna, the boosters are intended for adults 65 years of age and older. will be authorized; people in long-term care facilities; people aged 18-64 with underlying medical conditions and who are There is a high risk of exposure to the coronavirus because of your job. These individuals would be eligible for at least six months after their second shot.

Moderna’s Booster Dose The initial vaccination will be given as a half dose of 50 micrograms, compared to the original 100 micrograms given in the series. (In contrast, Pfizer’s booster is the same 30 microgram dosage as its initial series.)

Jacqueline Miller, the head of the medical field for infectious diseases at Moderna, said in her presentation to the committee that the company chose half the dose because it wanted to use the minimum dose needed to induce an immune response.

Miller notes that using a low-dose booster has worked well for other vaccines, including the DTaP vaccine, which protects against tetanus, diphtheria, and whooping cough.

The meeting was less controversial than last month’s group discussion on Pfizer, when Consultants refuse to authorize Pfizer boosters for all adults Early vaccination at 18 and six months after that and instead opted to limit eligibility.

In a discussion after the vote, the panel largely agreed that the booster was not yet needed for the wider population, which would include all adults 18 and up.

The younger population appears to be responding quite well to vaccines, and Dr. Michael Kurilla, an infectious disease specialist at the National Institutes of Health, said protection is ongoing. “I don’t necessarily need a ‘Let It Rip’ campaign for boosters for everyone who has ever been vaccinated.”

case for modern

Data shows that Moderna’s vaccine has reduced protection: People who were vaccinated earlier in the year were more likely to have a breakthrough transition Compared to people who received the vaccination several months later, Miller said. Almost all of these breakthrough transitions were due to the delta variant.

Several of the breakthrough cases were considered serious, and there were two deaths.

“We are concerned about the breakthrough disease we are seeing in participants” [original clinical trial], and especially the success cases that we are starting to see in older adults with severe disease,” Miller said.

The booster dose led to higher antibody levels, including antibodies against the delta variant.

Still, a handful of breakthrough infections — 20 cases — were reported in people who received the booster.

Dr. Doran Fink, deputy director of the FDA’s Department of Vaccines, said it is still unknown what level of antibody is needed for protection.

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Moderna’s presentation and the FDA’s analysis both found the booster to be safe, although several committee members noted that they would like to see more safety data from the company.

booster side effects were similar to those observed after the second dose. These include arm pain, fatigue, headache and muscle aches.

However, the booster trial did not include enough participants to evaluate whether the additional dose posed a risk. myocarditis, Fink said.

Myocarditis, or inflammation of the heart muscle, has been linked to both Moderna and Pfizer’s Covid-19 vaccines. This condition is rare and is most commonly seen in men under the age of 30.

Hui-Lee Wong, associate director of innovation in the FDA’s Office of Biostatistics and Epidemiology, notes that myocarditis occurred at similar rates after the second dose of both Pfizer and Moderna.

In figures from Israel, where 3.7 million people have received the Pfizer booster shot, 17 cases of myocarditis were recorded, said Dr. Sharon Alroy-Press, who presented Thursday.

“Its rate is really, really lower than you’d expect if it were the same rate after the second dose,” she said. “Maybe it’s because we’re giving this dose five months or so later” as opposed to giving two doses three weeks apart.

The same group of advisers will convene on Friday to discuss a booster shot for Johnson & Johnson’s Covid vaccine. It will also review the results of the National Institutes of Health study. “Mixing and Matching” Covid Vaccines. That study found that giving a booster dose of Pfizer or Moderna to people who initially received the Johnson & Johnson vaccination resulted in a stronger immune response than a second dose from Johnson & Johnson.

Next week, a group of advisers from the Centers for Disease Control and Prevention will raise the question of who should get the Moderna and Johnson & Johnson booster shots. If a booster is recommended, CDC Director Dr. Rochelle Valensky will sign off, and shots can go into the arms.

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