Live updates of FDA meeting on Pfizer's Covid vaccines for kids ages 5 to 11 – CNBC

FDA advisory panel breaks for lunch

The FDA’s advisory committee on vaccines recessed for a 30-minute break for lunch after hearing a staff presentation that supported Pfizer’s vaccine application.

Panel Chairman Dr. Arnold Monto said the group would reconvene at 1 p.m. ET.

Before the break, Hong Yang, senior advisor at the FDA’s Office of Biostatistics and Epidemiology, said her group modeled several different scenarios of myocarditis cases stemming from the vaccine and Covid deaths projected in kids.

Even in the worst-case scenario where hospitalizations from side effects of the vaccine run on the high said, she said the benefits to the shots for kids may still outweigh the risks. Other models that predict fewer heart inflammation cases show a clear benefit to the vaccine, depending on the trajectory of the pandemic and real-world side effects, she said.

The group is scheduled to hear public comments from 1 p.m. to 2 p.m. and then final debate and questions about the shots for kids before voting on whether to recommend them to the agency for its approval. The meeting is scheduled to adjourn at 5 p.m.

—Dawn Kopecki

FDA notes no severe reactions or deaths in Pfizer’s kids study

There were no “significant adverse events” or deaths in Pfizer and BioNTech’s early trials testing their Covid-19 vaccine in young kids, Food and Drug Administration official Dr. Leslie Ball noted during a presentation to the committee.

The phase one portion of the trial enrolled 48 children in the United States who were not at high risk of Covid exposure or severe disease and did not have evidence of a prior infection, she said. No children withdrew from this phase of the trial, she said.

She said there were similar immune responses to the 10 microgram dose of the vaccine as there were for the 20 and 30 micrograms, leading researchers to discontinue the higher doses and proceed with 10 micrograms.

The most common side effects reported in the trials were injection site pain, fatigue and headache, usually after the second dose, Ball said.

–Berkeley Lovelace Jr.

Pfizer says kids’ doses will come in special packaging

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

Pfizer | Reuters

Pfizer’s vaccine for 5- to 11-year-olds will include different directions and packaging to help medical providers avoid confusing the shots with the company’s doses for individuals over 12.

Responding to concerns about accidentally giving too strong a dose to children under 11, Pfizer will issue new instructions and dilution warnings with its vaccines for younger age groups, Dr. Nicholas Warne, the company’s vice president for pharmaceutical research and development, told the FDA’s vaccine advisory committee.

The shots for 5- to 11-year-olds will also come with orange caps, labels and boxes to contrast with the purple packaging used on Pfizer’s doses for anyone 12 and older.

“We have tried to maximize as best we can the number of ways we can differentiate the pediatric dosage form from the current dosage form,” Warne said.

—Robert Towey

Pfizer says vaccine side effects for kids comparable to young adults

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

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

“Across the other systemic event parameters, you can see that responses were comparable or less to those seen in 16-to 25-year-olds, representing a satisfactory reaction profile,” he said.

–Berkeley Lovelace Jr.

CDC hasn’t seen increased myocarditis in 12- to 17-year-olds following vaccination

A 17-year-old receives a first dose of the Pfizer Covid-19 vaccine at a mobile vaccination clinic during a back to school event offering school supplies, Covid-19 vaccinations, face masks, and other 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 hasn’t seen increased rates of myocarditis caused by vaccines among children ages 12 to 17, Dr. Matthew Oster, an agency official and pediatric cardiologist, said during a presentation to the FDA’s vaccine advisory panel.

The rare heart inflammatory syndrome can be triggered in children with multi-system inflammatory syndrome due to Covid, or MIS-C.

Though the CDC has tracked over 5,000 Covid-related MIS-C cases, Oster said the agency isn’t “really seeing a big signal yet” that connects the condition to vaccines for pediatric patients over 12. The CDC has identified 24 individuals who got vaccinated before experiencing MIS-C, 18 of whom had evidence of recent Covid infection, Oster said.  

“I’m reassured that we haven’t seen, you know, high rates of MIS-C associated with vaccines in the natal and in the older kids,” Oster said.

—Robert Towey

Pfizer begins making pitch to FDA to clear kids’ shots

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

Pfizer | Reuters

Dr. William Gruber, a senior vice president of vaccine research and development at Pfizer, began making the pitch to the FDA to clear the company’s vaccine for kids.

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

“Vaccinating children has other large societal benefits,” he said, noting that kids play an important role in transmitting the virus and vaccinating them could help the U.S. reach herd immunity. “Vaccination will help ensure in person learning which is critical for childhood development by limiting community spread and school outbreaks.”

—Dawn Kopecki

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

There have been 1,640 cases of myocarditis reported in people under 30 who received Pfizer or Moderna’s Covid vaccines as of Oct. 6, Dr. Mathew Oster, a CDC official, told the FDA’s vaccine committee.

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

At least 829 of the people with the rare heart condition were hospitalized, but the majority of them recovered and were discharged. Nineteen remained hospitalized with five in the ICU, he said.

–Berkeley Lovelace Jr.

School closures impacted more than 1 million kids, CDC says

In this handout image provided by UNICEF and released on 00:01 GMT Sept. 17, 2021, UNICEF unveiled “No Time to Lose” at the UN Headquarters in New York, to call attention to the education crisis wrought by the COVID-19 pandemic.

UNICEF | Getty Images

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

Ambulances are seen at the emergency entrance at Arnold Palmer Hospital for Children. The number of children hospitalized with COVID-19 in the United States hit a record high of just over 1900, 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’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

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

A healthcare worker administers a dose of a Pfizer-BioNTech Covid-19 vaccine to a child at a pediatrician’s office in Bingham Farms, Michigan, U.S., on Wednesday, May 19, 2021.

Emily Elconin | Bloomberg | Getty Images

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

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

Brittany Murray | MediaNews Group | Getty Images

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

A nurse gives a boy a dose of the Pfizer vaccine at a COVID-19 vaccine clinic at Lyman High School in Longwood on the day before classes begin for the 2021-22 school year.

Paul Hennessy | LightRocket | Getty Images

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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