FDA may authorize Moderna Booster for all adults as early as this week

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FDA may authorize Moderna Booster for all adults as early as this week

Moderna has asked federal regulators to authorize booster shots of its coronavirus vaccine for all adults, a request the Food and Drug Administration said earlier this week, with a similar request from Pfizer, according to people familiar with the plan. grant may be given accordingly.

If the Centers for Disease Control and Prevention also signs off every adult who was fully vaccinated with the Pfizer-BioNTech or Moderna shot at least six months ago, not only would be eligible for a booster, but which vaccine to choose. could. The agency’s committee of independent experts is due to meet on Friday to discuss booster shots.

It would allow President Biden to fulfill his August pledge to offer booster shots to every adult — nearly two months later than the administration originally planned, and amid ongoing debate among experts whether young, healthy adults Requires additional shots.

As it stands now, only people 65 or older or those at particular risk because of their medical conditions, job or living environment are eligible for a two-dose Pfizer-BioNTech or Moderna vaccine booster. Anyone taking a single dose of Johnson & Johnson can already receive a booster from one of three vaccines for at least two months after their first injection.

By some estimates, existing eligibility categories, which are broad but complex, cover up to 70 percent of adults. More than 30 million Americans, or about 16 percent of those who are fully vaccinated, have already received additional shots. But under federal rules, tens of millions are still ineligible.

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Even if federal regulators don’t act on Moderna’s request this week, the FDA and CDC are expected to allow fully vaccinated adults access to Pfizer’s boosters.

An increasing number of states and localities have gone on their own to offer booster shots to all of their adult residents, by liberally interpreting or ignoring federal guidelines, including Arkansas, California, Colorado and New Mexico. New York City health officials on Monday encouraged all adults who want boosters to seek them out.

Moderna announced Wednesday that it had requested the FDA to broaden its booster authorization to include all adults, as regulators in Canada and the European Union have done recently.

Moderna’s vaccine is considered more protective than Pfizer-BioNtech’s; Its dosage is 100 micrograms for the first two shots, while Pfizer’s is 30. Regulators authorized half the dose of Moderna as a booster for older people and other vulnerable groups to reduce concerns about side effects; Moderna is calling for similar half-dose boosters for the wider adult population.

State and local health officials have criticized the current federal eligibility categories for Moderna and Pfizer booster shots as too complicated for the public to figure out. In addition to those 65 or older, eligible people include medical conditions ranging from heart conditions to obesity to depression.

Also eligible, the CDC has said, are people “at risk for COVID-19 exposure and transmission due to occupational or institutional settings” — a category covering health care workers, residents of homeless shelters and inmates.

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