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: What to expect from Tuesday’s CDC meeting about BioNTech and Pfizer’s COVID-19 shots for young children

The U.S. is preparing to roll out BioNTech SE
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and Pfizer Inc.’s
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COVID-19 vaccine to children between the ages of 5 and 11 years old later this week.

There are about 28 million children in the U.S. in this age group who have not yet qualified for a COVID-19 shot. The U.S. has secured enough doses of the vaccine developed by these companies to cover this group of children, the White House said Monday.

The BioNTech/Pfizer vaccine received regulatory authorization for its COVID-19 shot in children between the ages of 5 and 11 last week. The Centers for Disease Control and Prevention is expected to make a final recommendation within days that will open the door to widespread availability of this shot for elementary school-aged children.

“Parents should feel comforted not just that their children will be protected, but that this vaccine has gone through the necessary and rigorous evaluation that ensures the vaccine is safe and highly effective,” CDC director Rochelle Walensky said Monday during a White House briefing.

The federal process to distribute COVID-19 vaccines for this age group is slightly different than how adult and teen doses were dispersed, in that the doses are one-third of what is administered to teens and adults and aren’t currently in pharmacies and doctors’ offices. About 15 million doses of the BioNTech/Pfizer vaccine for young children are currently being shipped to sites around country.

“The whole distribution plan that we’ve been talking about—20,000 sites, millions of doses being shipped as we speak—is all Pfizer vaccine,” Jeff Zients, the White House’s COVID-19 response coordinator, said at the briefing.

BioNTech and Pfizer have long been the leaders in getting their vaccine authorized first in different age categories in the U.S.

But now Moderna Inc.
MRNA,
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is also facing a slowdown in getting its shot authorized in teens while the Food and Drug Administration conducts a safety review related to the risk of myocarditis.

Moderna said Sunday it will wait for the FDA’s safety review to conclude, which may not wrap up until January, to move forward with its application for authorization in young children.

That likely means that the BioNTech/Pfizer vaccine will be the only COVID-19 shot available in the U.S. for teens and children in the U.S. this year.

Getting Pfizer’s shot to elementary school-aged children is inching closer

The FDA last Friday authorized BioNTech and Pfizer’s COVID-19 vaccine in children between the ages of 5 and 11 years old, making it the first shot to receive emergency-use authorization for elementary school-aged children in the U.S. 

There are two more steps in the regulatory process before children can start getting vaccinated, both of which are expected to happen this week. The CDC’s Advisory Committee on Immunization Practices is set to meet Tuesday to discuss how the vaccine should be rolled out to 5- to 11-year-olds. Dr. Walensky, the CDC director, then has to sign off on the committee’s recommendation.

The authorization requires two doses but it is administered at one-third of the dose that adults and teens get. The vaccine had an efficacy rate of 90.7% when it comes to preventing symptomatic cases of COVID-19 in the roughly 2,000 children who participated in the clinical trial, according to the FDA.

BioNTech/Pfizer’s COVID-19 vaccine is currently authorized for children between the ages of 5 and 11 years old and teens between the ages of 12 and 15, and it is fully approved for individuals who are at least 16 years old. 

The FDA wants additional information about the myocarditis risk in teens from Moderna’s vaccine

Moderna said Sunday that the FDA may need until January to assess the myocarditis risk in teens between 12 and 17 who have received its COVID-19 shot before it can authorize the company’s vaccine in this age group.

The regulator told the company it plans to study international data about the risk of myocarditis, a type of rare heart inflammation that can occur in some people after getting the vaccine. Moderna said it did not have access to this data.

Teen boys and young men are thought to be at the highest risk for this rare condition after they get their second shot. 

Moderna’s stock was down 5.0% in trading on Monday, the day after announcing the delay. Its shot is currently authorized for adults. 

About 13 million teens are fully vaccinated with any one of the three COVID-19 shots available in the U.S., according to CDC data. About 1.5 million teens have received Moderna’s vaccine, the company said. 

As a result of the extended safety review at the FDA, Moderna said it would delay its application for authorization of its vaccine in children between the ages of 6 and 11 years old. 

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