Pfizer and Moderna Boosters are Authorized by FDA for All Adults

The Food and Drug Administration (FDA) has authorized booster doses of the Pfizer-BioNTech and Moderna COVID-19 vaccine for all adults 18 years of age and older, the companies and agency announced Friday, expanding eligibility just before the winter and holiday season. .

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

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

The 50 microgram dose in Moderna booster is half the 100 microgram used for the first two adult injections. The Pfizer booster is the full 30 microgram dose.

Officials in the Biden administration have been encouraging anyone eligible to receive a booster as soon as possible, and the authorization of wide availability of both vaccines before Thanksgiving reflects the administration’s concern over the growing number of COVID-19 infections.

ÔÇťAuthorizing the use of a single booster dose of Modern COVID-19 or Pfizer-BioNTech vaccine for people 18 years of age and older helps provide ongoing 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 usually meets and makes a formal recommendation after FDA clearance. If the panel recommends authorization, the CDC Director Rochelle WalenskyRochelle Walensky Conflicts Increase to Ease COVID-19 Restrictions Amid Fall Case Peaks Overnight Care – Presented by Emergent Biosolutions – 2.6 Million Children Vaccinated in First Two Weeks Moderna Requests Emergency Dose Authorization booster for all adults PLUS It is expected to pass, although it is unclear how the panel will react at the rate at which the FDA cleared Moderna’s boost. The CDC does not need to follow the panel’s recommendation, although it normally does.

Friday’s action represents the culmination of a lengthy debate among experts about who should be eligible for booster injections and is belatedly compliant. President BidenJoe BidenHouse Democrats push vote on social spending plan through Friday Fauci says all adults should ‘go get a boost’ Senate confirms Park Service director after years of sitting bosses MOREpromise of widespread reinforcements for all adults by September.

An FDA advisory panel voted against Pfizer’s request that all adults receive a booster in September because members felt the evidence was not strong enough and instead recommended them for a smaller group. Moderna followed up and only requested authorization for the same group.

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

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

The federal guidance for boosters is already broad enough: the people who should get a booster are people over the age of 65, anyone at high risk due to work or where they live, or those with an underlying medical condition, as long as It has been at least six months from the second Pfizer or Moderna vaccine, or two months from a Johnson & Johnson vaccine.

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

But eligibility has been gradually expanding as health officials point to concerns that the efficacy of vaccines against symptomatic infection declines over time. Cases are on the rise, and while 70 percent of the eligible population in the US is fully vaccinated, there is concern that another wave of infections is on the horizon if we don’t act.

A growing number of states and jurisdictions are also ignoring federal limitations and are already offering booster injections to anyone over the age of 18. Officials have argued that the federal guidelines are confusing and prevent some of the most vulnerable people from getting boosted.

Less than 40 percent of people 65 and older have received a booster dose, according to CDC data. Overall, only about 18 percent of all adults have received a booster dose.

“Simplifying the eligibility criteria and making booster doses available to everyone over the age of 18 will also help eliminate confusion about who can get a booster dose and ensure that booster doses are available to all who they may need them, “said Peter Marks. the head of the FDA’s vaccine division.

But there has also been a pushback from some infectious disease experts who argue that boosters for younger and relatively healthy people will not end the pandemic. They argue that the Biden administration’s focus on drivers reflects an unrealistic goal of making sure no one gets sick from COVID-19.

Updated at 8:53 am



Reference-thehill.com

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