FDA panel approves Moderna Booster Shots for seniors, high-risk groups | MCUTimes

FDA panel approves Moderna Booster Shots for seniors, high-risk groups

U.S. health advisers said Thursday that some Americans who received Modern’s COVID-19 vaccine should receive a half-dose booster to strengthen protection against the virus.

The panel of advisers to the Food and Drug Administration voted unanimously to recommend a boost to the elderly, adults with other health problems, jobs or life situations that put them at increased risk for COVID-19.

The recommendation is non-binding, but it is an important step towards expanding the US booster campaign to millions more Americans. Many people who got their first Pfizer shot at least six months ago are already getting a booster after the FDA approved their use last month.

In terms of dose, the first Moderna vaccination consists of two 100-microgram shots. But Moderna says a single shot of 50 micrograms should be enough for a booster.

The agency convened its experts Thursday and Friday to weigh up who should get boosters and when for people who received the Moderna and Johnson & Johnson shots earlier in the year.

The FDA will use the recommendations of its advisors to make final decisions for boosters from both companies. If we make a positive decision, there is still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more details on who should get one.

THIS IS A NEW UPDATE. The AP’s past history follows below.

U.S. health advisers are discussing whether millions of Americans who received Moderna vaccinations should get a boost shot – this time using half the original dose.

Already millions who got their first Pfizer shot at least six months ago are getting a boost of that brand. On Thursday, advisers to the Food and Drug Administration assessed the evidence that Moderna boosters should also be offered – and on Friday, they will address the same issue for those who received the Johnson & Johnson vaccine.

U.S. officials stress that the priority is to get shots at the 66 million unvaccinated Americans who are eligible for immunization — those who are most at risk, as the extra contagious delta variant of coronavirus has been burned across the country.

“It is important to remember that vaccines still provide strong protection against serious outcomes” such as hospitalization and death of COVID-19, said FDA Vaccination Director Dr. Peter Marks.

But Marks said it has also become clear that there is some declining protection against milder infections with all three of the coronavirus vaccines used in the United States, and he urged the advisory panel to consider whether the evidence also supports similar boosters. recommendations to all of them, since it would “create the slightest confusion” for the public.

Modern seeks FDA approval for a booster used like Pfizers: For people 65 and older or adults with other health problems, jobs or life situations that put them at increased risk for severe coronavirus – when they are at least six months after their last dose.

The FDA will use the recommendations of its advisors to decide whether to approve Moderna boosters. If it does, there is still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more details on who should get one.

What is the evidence that protection against the Moderna vaccine is declining? When the delta variant increased in July and August, people who were recently vaccinated had a 36% lower rate of “breakthrough” infections compared to those who were vaccinated a long time ago, Modernas Dr. Jacqueline Miller to FDA advisors.

In terms of dose, the first Moderna vaccination consists of two 100-microgram shots. But Moderna says a single shot of 50 micrograms should be enough for a booster. The company said it would trigger fewer unpleasant shooting reactions such as fever and pain, while leaving more vaccine available for the global supply.

A study of 344 people found the booster shot six months after the first vaccinations restored antiviral antibodies to levels seen after the recipients’ last dose — and that included large jumps in antibodies that could target the delta variant, Miller said.

A very rare side effect of both Moderna and Pfizer vaccines is heart inflammation, especially among young men shortly after the second dose – and a persistent question is whether another dose could trigger more cases. The modern booster study was not large enough to detect such a rare risk.

But Israel began offering Pfizer boosters faster than the United States and to more of its population. On Thursday, Dr. Sharon Alroy-Preis of the Israeli Ministry of Health told the FDA panel that after 3.7 million booster doses administered, there is no evidence that the extra shot is more risky — despite an intense study of heart inflammation.

In the US, researchers are divided on exactly who needs boosters and their purpose – whether they are most needed for people at risk of serious illness, or whether they should also be used to reduce minor infections. While Pfizer’s boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stem the delta wave.

“There is no doubt that the break in the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers, noting that other countries have experienced a drop in delta cases without widespread booster use.

As Thursday’s discussions began, FDA advisers highlighted a confusing problem: People with severely weakened immune systems can already receive a third full dose of the Moderna vaccine shortly after the first vaccinations – so the question is whether they should also be eligible for a booster. which would be their fourth dose.

The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. AP is solely responsible for all content.

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