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FDA Panel Approves Low Dose Moderna COVID Shots for Boosters | National News

A US health adviser said Thursday that some Americans vaccinated with Moderna’s COVID-19 vaccine need to get half the boost to strengthen their defenses against the virus.

The Food and Drug Administration’s Advisory Board unanimously voted to recommend booster shots to older people and adults with other health problems, work, or living conditions that increase the risk of COVID-19.

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.

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 on Thursday and Friday 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 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.

This is the latest news update. The previous story of AP is as follows.

US health advisers are discussing whether millions of Moderna-vaccinated Americans need to get booster shots-this time using half the original dose.

Millions of people who took their first Pfizer shot at least six months ago have already got a booster for that brand. On Thursday, a Food and Drug Administration adviser evaluated evidence that Moderna boosters should also be provided-and on Friday, they address the same question for Johnson & Johnson vaccinated people.

U.S. officials have identified 66 million unvaccinated Americans to be immunized, the ones most at risk due to the burning of highly contagious delta variants of the coronavirus nationwide. It emphasizes that shooting is a priority.

“It’s important to remember that vaccines provide strong protection against serious consequences, such as hospitalization and death from COVID-19,” said Dr. Peter Marks, FDA’s Head of Vaccines.

However, Marks also said that all three coronavirus vaccines used in the United States have been shown to have weakened protection against mild infections. It will “minimize confusion” for the general public.

Moderna seeks FDA approval for boosters that are used in the same way as Pfizer: people over the age of 65, or have other health problems, work, or living conditions and are at high risk of serious coronavirus. For adults-final dose after at least 6 months.

The FDA will use the advisor’s recommendations when deciding whether to approve the Moderna booster. If so, there is yet another hurdle: next week, a panel convened by the Centers for Disease Control and Prevention will provide more details on who should get it.

What is the evidence that the protection of the Moderna vaccine is weakened? Moderna’s Dr. Jacqueline Miller said that recently vaccinated individuals had a 36% lower “breakthrough” infection rate than previously vaccinated individuals due to the surge in delta variants in July and August. Told an FDA adviser.

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. According to the company, this will reduce unpleasant firing reactions such as fever and pain, while increasing the number of vaccines available for global supply.

A study of 344 people found that booster shots were taken 6 months after the first vaccination and that the virus-fighting antibodies were restored to the levels seen after the recipient’s last dose. This includes a significant increase in antibodies that target the delta mutant.

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 conducted a thorough investigation into heart inflammation, but after 3.7 million boosts, there are no signs that additional injections are dangerous. I told the FDA panel.

In the United States, scientists are divided on who needs a booster and its purpose, whether it is needed primarily by people at risk of severe illness or whether it should be used to reduce mild infections. 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.

When the deliberations began on Thursday, FDA advisors highlighted one confusing issue: people with a severely weakened immune system could already get a third full Moderna vaccine shortly after the first vaccination. Masu-So the question is whether they too should be eligible for boosters. This will be their fourth dose.

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The Associated Press’s Department of Health Sciences is supported by the Department of Science Education at the Howard Hughes Medical Institute. AP is solely responsible for all content.



FDA Panel Approves Low Dose Moderna COVID Shots for Boosters | National News

Source link FDA Panel Approves Low Dose Moderna COVID Shots for Boosters | National News

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