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Pfizer Covid Vaccine for Younger Kids Wins FDA Panel’s Backing

Bloomberg logo Bloomberg 10/26/2021 Fiona Rutherford and Robert Langreth
New Vaccinations Are Rebounding in the U.S. Covid Hot Spots © Bloomberg New Vaccinations Are Rebounding in the U.S. Covid Hot Spots

(Bloomberg) -- The benefits of a Covid-19 vaccine for young children made by Pfizer Inc. and BioNTech SE exceed its risks, according to a panel of U.S. experts, putting a shot for the youngest school-age children on track for a likely clearance.

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The Food and Drug Administration’s vaccines advisory committee voted 17-0, with one abstention, to back the immunization, which is intended for children from 5 to 11 years old and is one-third the dose currently given to people age 12 and older. 

Making a vaccine available to children in elementary school would mark a major milestone in the pandemic. Though kids generally don’t get as sick from Covid-19 as adults, schools have been at the center of public debate over U.S. virus policy, and providing children with a shield against infection is likely to be welcomed by many parents.

If the FDA issues an emergency authorization, which is expected, it could pave the way for shots to start being administered at schools, pediatricians’ offices and pharmacies around the U.S. within weeks. The agency isn’t required to follow the panel’s recommendations, but it often does.

A clearance would also mark the climax of a rapid series of developments on the vaccine front. Last week, regulators signed off on booster shots for many recipients of the Moderna Inc. and Johnson & Johnson vaccines in the U.S. Moderna also said on Monday it planned to submit data on its own shot for younger children to regulators. 

Together, those moves could also give renewed life to the U.S. vaccination effort, which has run into problems convincing more people to get a first dose even as increasing numbers of employers, restaurants and events require proof of inoculation. Health officials in the U.S. have continued to say that vaccination offers the best protection against the coronavirus.

Some Reservations

A big factor in the panel’s decision was that some kids have pre-existing conditions that make getting vaccinated important, or may live in areas where masking in school is less common. Members said it would be difficult to narrow their recommendation of the shot to at-risk groups without taking the chance it might leave out kids who could benefit.

Overall it was the right decision, given the complexities of the public-health landscape and that kids have suffered enough from pandemic restrictions, said Lucy McBride, a practicing internist, health-care educator and mental-health advocate in Washington.

“It’s good that the panel had a robust discussion about the pros and cons. I wish we lived in a world where all eligible adults were vaccinated and we didn’t need to vaccinate healthy kids,” she said.

The committee also debated whether voting to back the vaccine could lead to mandates and other policy measures some members said the clinical-trial data were too thin to support.

Pfizer shares gained 0.4% in after-hours trading in New York following the vote. 

“Covid-19 is an ongoing threat for the more than 28 million young children in this age group in the U.S.,” Kathrin Jansen, Pfizer’s head of vaccine research & development, said in a statement. “Immunizing children will help to get us closer to herd immunity, with the potential to stem the pandemic sooner.”

Though the final vote tally was one-sided, some panelists took issue with what they said was a lack of data on side effects, the prevalence of previous Covid-19 infections in children and the shot’s ability to protect from variants. 

But Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said that the group’s role is to decide whether the known benefits outweigh potential risks. 

“It’s never when you know everything, it’s when you know enough,” he said during the discussion period.

Next Steps

The committee also focused on the ability to monitor for safety issues such as the heart condition myocarditis, which has been seen in some young males who have received messenger RNA vaccines.

Before the vote, James Hildreth, president of Meharry Medical College, said that it was a challenging decision to make. He expressed concerns that a recommendation would lead to “vaccinating children to protect the adults, when it should be the other way around.”

“If 30 million children already have some form of immunity, they’ve made their contribution to herd immunity already and our focus should be to get the adults vaccinated to protect the children,” he said.

The FDA itself will now decide whether to follow the committee’s advice and authorize the vaccine. A decision is likely within a few days.

Should regulators greenlight the shot, the Centers for Disease Control and Prevention’s immunization advisory committee will then meet and recommend further guidelines for who should get the vaccine and how to administer it. The panel is currently scheduled to meet on Nov. 2 and 3. The CDC director would then issue final guidance taking the panel’s views into account, opening the door for shots to begin.

Pfizer Chief Executive Officer Albert Bourla said in an interview with Bloomberg Television last week that if the FDA authorizes the shot for ages 5-11, the company would be able to provide it almost immediately. 

(Updates stock price and adds reaction beginning in 8th paragraph)

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