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The FDA authorizes the booster doses of the Pfizer and Moderna covid-19 vaccine updated for the omicron variant

2022-08-31T21:57:48.861Z


This is the first time updated COVID-19 vaccines have received emergency use authorization in the United States.


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(CNN) --

The US Food and Drug Administration (FDA) on Wednesday authorized updated booster doses of Moderna and Pfizer's Covid-19 vaccines.

This is the first time the updated vaccines have received emergency use authorization in the United States.

Both are bivalent vaccines that combine the companies' original vaccine with one that targets the BA.4 and BA.5 sublineages of the omicron variant.

Both companies submitted applications to the FDA for emergency use authorization of their updated vaccines last week.

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Pfizer's updated vaccine is a 30-microgram dose licensed for people 12 years and older.

Moderna's updated vaccine is a 50-microgram dose licensed for people 18 and older.

Vaccines may be given once recommended by the US Centers for Disease Control and Prevention (CDC).

The CDC's vaccine advisory group is scheduled to vote Thursday on whether to support the booster recommendation.

The CDC director must then approve the recommendation.

The CDC's go-ahead would mean the updated boosters could be given in a matter of days, both to older people who might have received a booster just a few months ago and to younger people who haven't been eligible for an additional booster during the wave. of most recent cases.

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Change of reinforcements

The updated vaccines do not replace the primary schedule vaccines, but they do replace the booster received by those over 12 years of age.

"With today's authorization, monovalent mRNA COVID-19 vaccines are not authorized as booster doses for persons 12 years of age and older," the FDA said.

People 12 years of age and older can receive the Pfizer bivalent booster dose if they have received the initial vaccination schedule and at least two months have passed since the last dose of the vaccine.

People 18 years of age and older can receive Moderna booster doses on the same schedule.

People too young to get a catch-up booster dose can continue to get the old vaccine.

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The FDA said it will "work quickly" to evaluate future authorization requests for bivalent boosters for younger people.

Pfizer said in a news release that it expects to submit an authorization application for its updated booster for children ages 5 to 11 in early October, and is working to prepare an application for children ages 6 months to 4 years.

"We want to ensure that adults and adolescents covered by this authorization can receive the most up-to-date version of a booster vaccine, which is why we are no longer authorizing the original monovalent booster for administration as a booster dose to those populations." said Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research, during a briefing.

About two-thirds of the total US population is vaccinated against Covid-19 with an initial series, according to data from the CDC.

But less than half of those on the initial regimen, and less than a third of the total population, have also received booster doses.

There is no plan yet to phase out the previous vaccines used in the primary series, Marks said, but this is a "transition year," where people need to make sure they have a "good foundation to build on ... that help us protect ourselves against the unknown.

"If you haven't had a booster dose yet, or it's been several months since your last booster dose, now is the time to consider getting one," Marks said.

Officials Defend Quick Authorization

On Wednesday, FDA officials defended their swift emergency use authorization of the updated Covid vaccine.

Pfizer and Moderna applied for the authorization just last week.

"The public can rest assured that the FDA has taken great care to ensure that these updated boosters meet our rigorous safety, efficacy, and manufacturing quality standards for emergency use authorization," Marks said.

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The agency authorized these boosters after studies in mice, but before the results of human clinical trials.

This is similar to how annual flu shots are tested, but it's a first for covid-19 vaccines.

The approach has generated some controversy among vaccine experts.

In making the authorization, the agency did not convene a new meeting of its independent vaccine advisers, who often weigh in on vaccine changes;

the advisory group had provided input on updating the original vaccine at meetings held over the summer.

“We have been planning and gathering information on our approach to the booster vaccine update since the beginning of this year,” FDA Commissioner Robert Califf, MD, said during the briefing.

"The FDA has extensive experience evaluating strain switching for influenza vaccines and is confident in the data supporting these latest booster authorizations."

In addition to the animal data, the FDA said it was basing its decision on more than a year of experience with hundreds of millions of doses of mRNA vaccines administered worldwide.

It also builds on human clinical trials of different bivalent vaccines targeting the original omicron variant.

That vaccine was licensed in the United Kingdom, but it will not be available in the United States.

More than 1,400 participants were enrolled in clinical trials of Pfizer and Moderna's bivalent vaccines against the BA.1 subvariant.

Human studies of bivalent booster vaccines, which combine the companies' original vaccine with one targeting omicron's BA.4 and BA.5 subvariants, have begun, Marks said Wednesday.

Data from these studies are expected in another month or two.

modern vs.

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Vaccine milestone

"The United States is the first country in the world to license a bivalent vaccine that targets currently circulating viruses," Dr. Ashish Jha, who is leading the White House response to COVID-19, said in a telephone interview with CNN this Wednesday.

"We try to do this every year for the flu. We almost never hit the nail on the head. This was a big job for the FDA. They've tried to lean on the science, lean on some very good models. And then require companies to to produce vaccines that fit reality".

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The BA.5 subvariant of omicron has dominated broadcasting in the United States for more than two months.

Last week, it caused 89%, nearly 9 out of 10, of new Covid infections in this country, according to the latest CDC estimates.

A recent branch of the BA.4 subvariant, BA.4.6, has slowly increased in prevalence to second place.

Nationwide, it caused about 8% of new infections last week, but it has taken off the most in the Midwest (Kansas, Iowa, Missouri and Nebraska), causing 17% of new infections there.

-- Deidre McPhillips contributed to this report.

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Source: cnnespanol

All news articles on 2022-08-31

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