FDA’s independent vaccine committee meets to discuss Pfizer’s COVID-19 vaccine for young kids

By CNN

October 26, 2021 9:36 AM

Published October 26, 2021 9:48 AM

By Jen Christensen, CNN

The US Food and Drug Administration’s independent vaccine advisory committee meets Tuesday to discuss if the Pfizer/BioNTech COVID-19 vaccine should be authorized for children ages 5 to 11. Pfizer’s vaccine is already authorized under emergency use for children 12 to 15 and is approved for people 16 and older.

The committee will listen to and discuss presentations from the US Centers for Disease Control and Prevention about the impact COVID-19 has had on children and will also discuss any potential safety issues with the vaccine.

Pfizer/BioNTech will also discuss the study trials it has conducted with this age group.

Data Pfizer submitted in September from a Phase 2/3 trial showed its COVID-19 vaccines generated a “robust” antibody response in children ages 5 to 11. In a new document posted ahead of the FDA meeting on Friday, Pfizer said its vaccine is safe and 90.7% effective against symptomatic COVID-19 in children ages 5 to 11.

The researchers gave 1,305 children a vaccine, one-third the dose given to adults. Three of those children became sick with COVID-19. They gave 663 children a placebo, a shot that does nothing, and 16 of them became sick with COVID-19. So while far fewer children received the placebo, far more of them became sick with COVID-19.

In an assessment posted late Friday night, the FDA said the benefits of Pfizer/BioNTech’s COVID-19 vaccine outweigh the risks to children ages 5 to 11 under current pandemic conditions. The FDA said the vaccine carries a theoretical risk of myocarditis, an inflammation of the heart muscle, or pericarditis, an inflammation of the outer lining of the heart, that could require treatment and even hospitalization. But the risk of COVID-19 is higher if enough virus is circulating.

It’s still less likely for children to be hospitalized or to die from COVID-19 compared to adults, but 745 children have died from COVID-19 in the United States since the start of the pandemic, according to the US Centers for Disease Control and Prevention.

Nearly 118,000 children tested positive for COVID-19 this past week alone, according to a new report published Monday by the American Academy of Pediatrics. Nearly 6.3 million children have tested positive for COVID-19 since the pandemic began.

For the week ending October 21, children accounted for a disproportionate number of COVID-19 cases, making up more than a quarter of total US cases. Children account for 22% of the US population.

If the FDA committee votes in its favor of emergency use authorization for the vaccine, the FDA will then make the final decision about whether to authorize it. The committee will consider evidence submitted by Pfizer that shows the vaccine is safe and works to protect this age group.

Then, the US Centers for Disease Control and Prevention’s independent advisory committee meets November 2 and 3, and will vote on whether to recommend the vaccine for this age group. Finally, CDC Director Dr. Rochelle Walensky will decide whether to accept or modify the committee’s recommendation.

Once Walensky signs off, younger children could start getting COVID-19 shots immediately.

Some 28 million children would be eligible for the vaccine if authorized. If the green lights for the vaccine are given, Dr. Anthony Fauci, chief medical adviser to President Biden, said that he is optimistic that children ages 5 to 11 could be getting vaccinated sometime in the first two weeks of November.

Article Topic Follows: Coronavirus Coverage

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