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FDA authorizes Pfizer, Moderna boosters for all adults

The Food and Drug Administration (FDA) has authorized booster doses of both Pfizer-BioNTech's and Moderna's COVID-19 vaccines for all adults over the age of 18, the companies and the agency announced Friday, broadening eligibility just ahead of the winter and holiday season.

The move comes just days after Moderna officially asked the FDA to authorize the booster for all adults, and the same day a Centers for Disease Control and Prevention (CDC) advisory panel is meeting to discuss the vaccines.

The FDA had previously planned to authorize Pfizer’s booster shot this week, but Moderna filed a similar request on Wednesday. Pfizer filed its request for broad authorization on Nov. 9.

The 50 microgram dosage in Moderna’s booster is half of the 100 micrograms used for the first two shots for adults. Pfizer's booster is the full 30 microgram dose.

Biden administration officials have been encouraging anyone eligible to get a booster as soon as possible, and authorizing wide availability of both shots ahead of Thanksgiving reflects the administration's concern about the growing numbers of COVID-19 infections.

“Authorizing the use of a single booster dose of either the Moderna or Pfizer-BioNTech COVID-19 vaccine for individuals 18 years of age and older helps to provide continued protection against COVID-19, including the serious consequences that can occur, such as hospitalization and death,” acting FDA Commissioner Janet Woodcock said in a statement.

The CDC panel typically meets and makes a formal recommendation after FDA authorization. If the panel recommends authorization, CDC Director Rochelle Walensky is expected to sign off, though it's unclear how the panel will react to the speed at which the FDA authorized Moderna's booster. The CDC does not need to follow the panel's recommendation, though it typically does.

Friday's action represents the culmination of a long-running debate among experts over who should be eligible for booster shots and belatedly delivers on President Biden's promise of widespread boosters for all adults by September.

An FDA advisory panel voted against Pfizer's request for all adults to have a booster in September because members felt the evidence wasn't strong enough, and instead recommended them for a narrower group. Moderna followed up and only asked for authorization for the same group.

This time, the agency did not convene the panel, called the Vaccines and Related Biological Products Advisory Committee.

"The agency has previously convened the VRBPAC for extensive discussions regarding the use of boosters for COVID-19 vaccines and, after review of the request, we have concluded that it does not raise questions that would benefit from additional discussion by the members of the committee," agency spokeswoman Alison Hunt said.

The federal guidance for boosters is already fairly broad — the people who should get a booster are those over age 65, anyone at high risk because of work or where they live, or those with an underlying medical condition, as long as it's been at least six months from the second Pfizer or Moderna shot, or two months from a Johnson & Johnson shot.

Vaccine providers are not supposed to ask questions or turn anyone away, relying on self-attestation for eligibility.

But the eligibility has been gradually widening as health officials point to concerns that the vaccines' efficacy against symptomatic infection wanes over time. Cases are rising, and even though 70 percent of the eligible population in the U.S. is fully vaccinated, there's a worry that another surge of infections is on the horizon if the federal government doesn't act.

An increasing number of states and jurisdictions are also ignoring the federal limitations and already offering booster shots to anyone over the age of 18. Officials have argued the federal guidelines are confusing and preventing some of the most vulnerable people from getting a booster.

Less than 40 percent of people over the age of 65 have received a booster dose, according to CDC data. Broadly, only about 18 percent of all adults has received a booster.

“Streamlining the eligibility criteria and making booster doses available to all individuals 18 years of age and older will also help to eliminate confusion about who may receive a booster dose and ensure booster doses are available to all who may need one," said Peter Marks, the head of the FDA's vaccines division.

But there's also been pushback from some infectious diseases experts who argue that boosters for younger, relatively healthy people are not going to end the pandemic. They argue the Biden administration's focus on boosters reflects an unrealistic goal of making sure nobody gets sick from COVID-19.

[Source: By Nathaniel Weixel, The Hill, Washington, 19Nov21]

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