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FDA Panel Approves Low Dose Moderna COVID Shot for Booster | Chicago News

The file photo on Wednesday, December 23, 2020 shows a vial of Moderna COVID-19 vaccine in the first round of staff vaccination at a hospital in Denver. (AP photo / David Zalubowski, file)

U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine at least six months ago need to get half the boost to strengthen their defenses against the coronavirus. I did.

A panel of external advisors from the Food and Drug Administration unanimously recommends booster shots to young adults as well as older people with other health problems, work, or living conditions that increase the risk of COVID-19. I voted in.

This recommendation is non-binding, but it is an important step in expanding the US booster campaign to millions of Americans. Many people who took their first Pfizer shot at least six months ago have already taken boosters after the FDA approved their use last month. These are the same high-risk groups that FDA advisors have stated that they need to get a Moderna booster.

However, there is no evidence that it is time to release booster doses of either the Moderna or Pfizer vaccines to everyone, even though the first Biden administration plans to do so in the end. The panel emphasized.

Coronavirus remains a threat to unvaccinated people, but vaccinated people have strong protection against serious illness and death from COVID-19.

Dr. Michael Krilla of the National Institutes of Health said:

In terms of dose, the first Moderna vaccination consists of two 100 microgram shots. However, Moderna states that one 50 microgram shot is sufficient for boosters.

The agency convened experts to consider who should get the booster and when to consider for those who received the shots of Moderna and Johnson & Johnson earlier this year. The panel will discuss J & J on Friday.

The FDA will use the advisor’s recommendations in making the final decision on both companies’ boosters. Given a positive decision, there are yet another hurdles. Next week, a panel convened by the Centers for Disease Control and Prevention will provide more detailed information on who should get it.

Many US scientists have asked who needs a booster and what its purpose is, primarily for people at risk of severe illness, or whether it should be used to reduce mild infections. Opinions are divided.

The FDA panel wrestled with whether Moderna provided sufficient evidence to support low-dose boosters.

Due to the surge in delta variants in July and August, Moderna studies show that recently vaccinated people have a 36% lower incidence of “breakthrough” infections than previously vaccinated people. I found out.

Another study of 344 people found that a 6-month booster shot restored the virus-fighting antibodies to seemingly defensive levels. This included a significant increase in antibodies that could target the delta mutant. However, it was a small study and only about half of those people obtained the exact series of doses offered under the Moderna booster campaign.

“The data itself isn’t strong, but it’s certainly moving in favor of this vote,” said Dr. Patrick Moore of the University of Pittsburgh.

And some advisers were worried that booster immunity at lower doses might sacrifice some of the potential benefits of a full-blown third shot to people.

“It can actually have a huge impact on durability,” said Krilla.

Moderna said he chose a low-dose booster to not only cause unpleasant shot reactions such as fever and pain, but also to increase the vaccine available for global supply.

One of the very rare side effects of both the Moderna and Pfizer vaccines is heart inflammation, especially in young men immediately after the second vaccination. Moderna’s booster study wasn’t big enough to find such a rare risk.

But Israel began offering Pfizer boosters to more people sooner than the United States. On Thursday, Dr. Sharon Alroy Price of the Israeli Ministry of Health told the FDA panel that after 3.7 million boosts, there are no signs that additional injections are more dangerous.

Because the Moderna vaccines are similar, FDA advisors have found the data to be reassuring.

Pfizer’s boosters are targeted only at certain high-risk American groups, but Israeli officials believe that the use of boosters in their own countries has expanded as they have stopped the delta surge.

“There is no doubt in my mind that the curve break was due to the booster dose,” Alroy-Preis said in other countries there was a reduction in delta cases without widespread use of boosters. Said in response to the FDA Advisor.

However, FDA advisers also emphasized one confusing issue. People with a significantly weakened immune system can already receive the full dose of the third modana vaccine immediately after the first vaccination. This will be their fourth dose.


FDA Panel Approves Low Dose Moderna COVID Shot for Booster | Chicago News

Source link FDA Panel Approves Low Dose Moderna COVID Shot for Booster | Chicago News

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