Live updates from the FDA meeting on Pfizer’s Covid vaccines for children ages 5-11

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School closures have affected more than 1 million children, CDC says

There have been more than 2,000 school closures linked to Covid-19 across the country since the start of the pandemic, affecting more than a million children and 68,000 teachers, said Dr. Fiona Havers, official. of the CDC, citing data from Google News.

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

“Learning lost in person is another potential negative outcome of Covid-19 disease and exposure in children,” she said, adding that there had been a “disproportionate impact” on communities of color.

—Berkeley Lovelace Jr.

CDC identifies risk factors for severe Covid in children

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

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

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

—Berkeley Lovelace Jr.

FDA Proposes Committee Vote Question

Dr. Ramachandra Naik of the FDA’s Office of Vaccine Research and Review for the Biologics Assessment and Research Center presented the voting question to the committee.

The plan is to vote on a smaller dose for children at one-third the amount of an adult dose, which Pfizer and BioNTech tested on children, saying Friday was over 90% effective.

–Berkeley Lovelace Jr.

A “small army” of FDA staff worked around the clock on children’s data

Dr Doran Fink, deputy director of the FDA’s vaccine division, said that a “small army” of FDA employees have worked tirelessly over the past month to ensure that data on children they presented today were as precise as possible.

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

In the past month, in particular, he said that they “literally work around the clock at times to make sure that the information we present we are as certain as possible of its accuracy and that we are as transparent as possible. possible in areas that we are uncertain about. “

—Dawn Kopecki

Children aged 5 to 11 make up 9% of Covid cases in US, FDA official says

Children aged 5 to 11 make up about 9% of all reported Covid-19 cases in the United States, said Dr Doran Fink, deputy director of the FDA’s vaccine division, during an overview of Pfizer clinical trial data.

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

“As we head into the winter months, where people will be forced to go more indoors and 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 participating in their activities. It is probably because we have not achieved collective immunity that transmission of the virus will continue, “he said.

—Berkeley Lovelace Jr.

FDA officials Dr Marks urge panel members to keep debate “civil”

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

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

—Dawn Kopecki

Committee chairman Monto said they would “examine the science”

Dr. Arnold Monto, who is the acting chair of the committee, opened the meeting at approximately 8:30 am Monto is a senior epidemiologist in the School of Public Health at the University of Michigan.

“This topic has generated a lot of interest,” he said in his opening remarks. The meeting takes place entirely online. “We’re going to look at the science here and make a decision that I know affects a lot of people.”

–Berkeley Lovelace Jr.

FDA staff say the benefits usually outweigh the risks

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

Pfizer | Reuters

Food and Drug Administration staff released an analysis on Friday evening, claiming that a smaller dose of Pfizer and BioNTech’s Covid-19 vaccine appears to be safe and highly effective in children aged 5 to 11.

FDA scientists noted the increased risk of myocarditis and pericarditis, but said the benefits of the injections, including prevention of serious illness, hospitalization, and death, would generally outweigh the risk of inflammatory heart disease. rare.

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

–Berkeley Lovelace Jr.

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