Live Updates of FDA Meeting on Pfizer’s Covid Vaccines for Kids Ages 5 to 11

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Live Updates of FDA Meeting on Pfizer’s Covid Vaccines for Kids Ages 5 to 11

Shawn Rocco | Duke University | via Reuters

This is CNBC’s live blog covering updates out of the FDA’s Vaccines and Related Biological Products Advisory Committee all-day meeting and vote on Pfizer and BioNTech’s Covid-19 vaccine for kids ages 5 to 11.

The FDA’s Vaccines and Related Biological Products Advisory Committee meets Tuesday for an all-day meeting on Pfizer and BioNTech‘s Covid-19 vaccine for kids ages 5 to 11.

Many parents are anxiously awaiting the approval with schools now open across the U.S. and the delta variant driving a surge in children’s cases.

The White House outlined its plan last week to distribute the doses as soon as it’s authorized by the Food and Drug Administration and Centers for Disease Control and Prevention, which is expected to come early next month. The Biden administration said it’s procured enough vaccine to inoculate all 28 million 5- to 11-year-olds in the U.S., and will distribute it in smaller dosing and with smaller needles to make it easier for pediatricians and pharmacists to administer to kids.

The meeting starts at 8:30 a.m. ET and is scheduled to wrap up around 5 p.m. with a vote on whether to recommend the shots at the end of the day. The FDA is expected to quickly grant emergency approval for the shots before passing the matter on to the CDC for review next week.

School closures impacted more than 1 million kids, CDC says

There have been more than 2,000 Covid-19 related school closures nationwide since August, affecting more than 1 million children and 68,000 teachers, said CDC official Dr. Fiona Havers, citing Google News data.

School closures can impact a child’s social, emotional and physical well-being, Havers said.

“Lost in-person learning is another potential adverse outcome of Covid-19 illness and exposure among children,” she said, adding there’s been a “disproportionate impact” on communities of color.

—Berkeley Lovelace Jr.

Correction: This post was updated to reflect that there have been more than 2,000 Covid related school closures since August.

CDC identifies risk factors for severe Covid in kids

The Centers for Disease Control and Prevention presented data at the FDA’s meeting on 562 children ages 5 to 11 who were hospitalized with Covid-19 from March 2020 through August.

The CDC’s analysis identified underlying medical conditions – such as obesity, chronic lung disease and neurological disorders – as risk factors for severe disease. Of the 562 children hospitalized, 68% had at least one underlying condition, said CDC official Dr. Fiona Havers.

The most common underlying medical condition was lung disease, primarily asthma, she said.

—Berkeley Lovelace Jr.

FDA proposes voting question for committee


FDA

Dr. Ramachandra Naik of the FDA’s Office of Vaccines Research and Review for the Center of Biologics Evaluation and Research presented the voting question before the committee.

The plan is to vote on a smaller dosage for kids at a third of the amount of an adult dose, which is what Pfizer and BioNTech tested on kids, saying Friday that it was more than 90% effective.

–Berkeley Lovelace Jr.

‘Small army’ of FDA staff worked around the clock on kids’ data

Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, said a “small army” of FDA staff worked around the clock over the last month to ensure the data on kids they were presenting today was as accurate as possible.

He said they “worked tirelessly, working nights, weekends and holidays for longer than I can remember.”

Over the past month, in particular, he said they were “literally working around the clock at times to ensure that the information that we present, we are as certain as possible about its accuracy and that we are as transparent as possible in the areas that we have uncertainty.”

—Dawn Kopecki

Kids ages 5 to 11 account for 9% of U.S. Covid cases, FDA official says

Children ages 5 to 11 account for roughly 9% of all reported Covid-19 cases in the U.S., Dr. Doran Fink, a deputy director of the FDA’s division of vaccines, said during an overview of Pfizer’s clinical trial data.

The age group also accounts for approximately 40% of all pediatric Covid-19 cases, near the highest of any other age group, he said.

“As we head toward the winter months, where people will be forced to go more inside and as we continue to adhere to a national priority of getting life back to normal as much as possible, which includes keeping children in school and involved in their activities, it is likely because we have not reached herd immunity that transmission of the virus will continue,” he said.

—Berkeley Lovelace Jr.

FDA officials Dr. Marks asks panel members to keep debate ‘civil’

The FDA’s Dr. Peter Marks, who is the agency’s de facto top vaccine regulator as director of the Center for Biologics Evaluation and Research, asked committee members to keep today’s debate “civil,” saying there were strong feelings on both sides.

“To be clear, today’s discussion is going to be about the scientific data that are presented, and it’s not about vaccine mandates which are left to other entities outside of FDA,” Marks said at the top of the meeting. “I ask that we keep our discourse today civil and focus on the science related to this issues so that we can get through a productive discussion.”

—Dawn Kopecki

 

Committee Chairman Monto says they will ‘review the science’

Dr. Arnold Monto, who is the committee’s acting chairman, opened the meeting at about 8:30 a.m. Monto is a leading epidemiologist at the University of Michigan’s School of Public Health.

“There’s been a lot of interest in this subject,” he said in his opening remarks. The meeting is being conducted entirely online. “We are going to review the science here and make a decision that I know affects a lot of people.”

–Berkeley Lovelace Jr.

FDA staff says the benefits generally outweigh the risks

Pfizer/BioNTech's new pediatric COVID-19 vaccine vials are seen in this undated handout photo.

Pfizer | Reuters

Pfizer/BioNTech’s new pediatric COVID-19 vaccine vials are seen in this undated handout photo.

The staff of the Food and Drug Administration published an analysis late Friday, saying a smaller dosage of Pfizer and BioNTech‘s Covid-19 vaccine appears to be safe and highly effective in kids ages 5 to 11.

FDA scientists noted the increased risk of myocarditis and pericarditis but said the benefits of the shots, including preventing severe disease, hospitalization and death, would generally outweigh the risk of the rare inflammatory heart conditions.

“If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable,” they wrote.

–Berkeley Lovelace Jr.

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