FDA panel approves lower-dose Moderna COVID vaccine for booster


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

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

The recommendation is not binding, but it is a key step towards extending the recall campaign in the United States to millions more Americans. Many people who received their initial Pfizer injections at least six months ago are already receiving a booster after the FDA cleared their use last month.

Regarding the dose, the initial vaccination with Moderna consists of two injections of 100 micrograms. But Moderna says a single shot of 50 micrograms should be enough for a booster.

The agency called its experts on Thursday and Friday to determine who should receive boosters and when for people who received the injections from Moderna and Johnson & Johnson earlier this year.

The FDA will use the recommendations of its advisers to make final decisions about boosters for both companies. Assuming a positive decision, there’s yet 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 CURRENT UPDATE. AP’s previous story follows below.

U.S. health advisers are debating whether millions of Americans who have received Moderna vaccines should be boosted, this time using half the initial dose.

Already millions of people who received their first Pfizer injections at least six months ago are receiving a booster from this brand. Food and Drug Administration advisers on Thursday assessed the evidence that Moderna boosts 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 vaccinate the 66 million unvaccinated Americans who are eligible for vaccination – most at risk as the extra-contagious delta variant of the coronavirus has burned across the country.

“It’s important to remember that vaccines always offer strong protection against serious consequences” such as hospitalization and death from COVID-19, said FDA chief vaccine officer Dr. Peter Marks.

But Marks said it has also become clear that there is some decrease in protection against milder infections with the three coronavirus vaccines used in the United States. this would “create as little confusion as possible” for the public.

Moderna seeks FDA clearance for a booster used like Pfizer’s: for people 65 years of age and older, or adults with other health issues, jobs, or life situations that put them at risk increase in severe coronavirus – once they are at least six months after their last dose.

The FDA will use the recommendations of its advisers to decide whether or not to authorize Moderna boosters. If so, there’s yet 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 the protection of the Moderna vaccine is decreasing? As the delta variant increased in July and August, people who had been vaccinated more recently had a 36% lower rate of “breakthrough” infections compared to those vaccinated longer ago, said Dr Jacqueline Miller of Moderna to FDA advisers.

Regarding the dose, the initial vaccination with Moderna consists of two injections of 100 micrograms. But Moderna says a single shot of 50 micrograms should be enough for a booster. The company said it would trigger fewer uncomfortable reactions such as fever and body aches, while leaving more vaccines available for global supply.

A study of 344 people found that the booster six months after the initial vaccinations restored anti-virus antibodies to levels seen after recipients’ last dose – and this included significant jumps in antibodies able to target the delta variant, Miller said.

A very rare side effect of Moderna and Pfizer vaccines is heart inflammation, especially in young men soon after the second dose – and a lingering question is whether another dose could trigger more cases. Moderna’s recall study was not large enough to detect such a rare risk.

But Israel started offering Pfizer boosters earlier than the United States and more of its population. Dr Sharon Alroy-Preis of the Israeli Ministry of Health told the FDA panel on Thursday that after 3.7 million booster doses administered, there is no sign that the extra hit is riskier – despite a thorough investigation of heart inflammation.

Scientists in the United States are divided over exactly who needs boosters and their purpose – whether they are mostly needed for people at risk of serious illness or whether they should also be used to try to reduce infections. more benign. While Pfizer’s boosters are only intended for certain high-risk groups of Americans, Israeli officials attribute wider use of boosters in their country to stemming the delta surge.

“There is no doubt in my mind that the break in the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a drop in cases. delta without widespread use of callback.

At the start of Thursday’s deliberations, FDA advisers highlighted a puzzling issue: People with severely weakened immune systems may already receive a third full dose of Moderna vaccine soon after the initial vaccinations. which would be their fourth dose.

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



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