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

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Pfizer says vaccine side effects for children are comparable to those for young adults

Young children experienced side effects from the vaccine at rates similar to those seen in a clinical trial in adolescents and adults aged 16 to 25, Dr William Gruber, senior vice president of research, told the committee. vaccine clinic at Pfizer.

The incidence and severity of fever and chills were actually lower in children aged 5 to 11 compared to the older age group, he said.

“Compared to the other parameters of systemic events, you can see that the responses were comparable or lower than those seen in 16-25 year olds, representing a satisfactory response profile,” he said.

–Berkeley Lovelace Jr.

CDC Did Not Find An Increase In Myocarditis In 12-17 Year Olds After Vaccination

17-year-old receives first dose of Pfizer Covid-19 vaccine at mobile vaccination clinic during back-to-school event offering school supplies, Covid-19 vaccines, face masks and more resources for children and their families at the Weingart East Los Angeles YMCA in Los Angeles, California on August 7, 2021.

Patrick T. Fallon | AFP | Getty Images

The CDC has not seen increases in vaccine-induced myocarditis rates in children ages 12 to 17, said agency official and pediatric cardiologist Dr Matthew Oster in a presentation to the FDA Vaccine Advisory Group.

Rare cardiac inflammatory syndrome can be triggered in children with multisystem inflammatory syndrome due to Covid, or MIS-C.

Although the CDC has been following more than 5,000 cases of MIS-C linked to Covid, Oster said the agency is not yet “really seeing a big signal” that links the disease to vaccines for pediatric patients over 12 years old. years. The CDC has identified 24 people who got vaccinated before undergoing MIS-C, 18 of whom had evidence of recent Covid infection, Oster said.

“I’m reassured that we haven’t seen, you know, elevated levels of MIS-C associated with vaccines in native and older children,” Oster said.

—Robert Towey

Pfizer begins advocating with FDA to erase children’s photos

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

Pfizer | Reuters

Dr. William Gruber, senior vice president of vaccine research and development at Pfizer, has started advocating with the FDA to clear the company’s vaccine for children.

He said Covid infections were unpredictable in children and could affect healthy children almost as easily as those with underlying health conditions. Nearly a third of children hospitalized with Covid were otherwise in good health, he said. He said the need for a safe and effective vaccine was clear.

“Vaccinating children has other important societal benefits,” he said, noting that children play an important role in the transmission of the virus and that their vaccination could help the United States achieve herd immunity. . “The vaccination will help ensure in-person learning, which is essential for childhood development by limiting the spread in the community and epidemics in the school.”

—Dawn Kopecki

CDC reports 1,640 cases of myocarditis in people under 30

As of October 6, 1,640 cases of myocarditis have been reported in people under the age of 30 who have received Covid vaccines from Pfizer or Moderna, CDC official Dr Mathew Oster told the Vaccines Committee. FDA.

Only 877 cases met the CDC’s case definition for myocarditis, and 637 of the reported cases are still under review, he said.

At least 829 of those with rare heart disease have been hospitalized, but the majority have recovered and been discharged. Nineteen remained hospitalized including five in intensive care, he said.

–Berkeley Lovelace Jr.

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

In this document image provided by UNICEF and released on September 17, 2021 at 12:01 am GMT, UNICEF unveiled “No Time to Waste” at the United Nations Headquarters in New York, to draw attention to the crisis. education brought on by the COVID-19 pandemic.

UNICEF | Getty Images

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

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

“Lost learning 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.

Correction: This post has been updated to reflect that there have been over 2,000 Covid-related school closures since August.

CDC identifies risk factors for severe Covid in children

Ambulances are seen at the entrance to the emergency room of Arnold Palmer Children’s Hospital. The number of children hospitalized with COVID-19 in the United States has hit a record high of just over 1,900, with Florida leading the country in hospitalized children as school classes began this week.

Paul Hennessey | LightRocket | Getty Images

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 illness, 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 Evaluation 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

Lydia Melo, 7, is inoculated with one of two reduced 10 ug doses of Pfizer BioNtech COVID-19 vaccine during a trial at Duke University in Durham, NC on September 28, 2021 in an image still of a video.

Shawn Rocco | Duke University | via Reuters

Dr Doran Fink, deputy director of the FDA’s vaccine division, said that a “small army” of FDA staff 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 account for 9% of Covid cases in US, FDA official says

Mark Barsoun is helping his son Jordan Barsous, 4, with the swab for a quick COVID-19 test at Palos Verdes High School in Palos Verdes Estates on Tuesday, August 24, 2021.

Brittany Murray | MediaNews Group | Getty Images

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”

Dr Peter Marks of the FDA, 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 lower 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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