Pfizer CEO says company will seek FDA approval for COVID-19 vaccine in children aged 5-11 ‘within days’
Pfizer’s CEO says the company plans to ask the U.S. Food and Drug Administration (FDA) to authorize its COVID-19 vaccine in younger children within days.
On Sunday, in an appearance on ABC’s This Week, Albert Bourla was asked when the country can expect to approve the injections in children between the ages of five and 11.
The New York-based company, along with its German partner BioNTech, recently released data showing the vaccine was safe and effective at smaller doses in elementary school students.
“I think we’re going to be submitting this data pretty soon,” Bourla told host George Stephanopoulos.
“It’s a matter of days, not weeks, and then it’s up to the FDA to review the data and come to their conclusions and approve it or not.”
Pfizer Inc CEO Albert Bourla told ABC’s This Week on Sunday (above) that the company will submit its application for FDA approval of its Covid vaccine in children ages 5-11 “within days.”
Recently released data showed that the vaccine induced a “robust” immune response in younger children, Pfizer said. Pictured: Dr. Erin Biro holds her son as he receives an injection in Pfizer’s clinical trial in younger children
According to clinicaltrials.gov, Pfizer’s study worked the same way in younger children as it did in older children and adults.
A total of 4,500 younger children between the ages of six months and 11 years were enrolled at nearly 100 clinical trial sites in 26 US states, Finland, Poland and Spain.
About half of the group aged five to 11 received two doses 21 days apart and the other half received placebo injections.
The team then tested the safety, tolerability and immune response generated by the vaccine by measuring antibody levels in the young subjects.
Pfizer said it had chosen lower doses for COVID-19 vaccine trials in children than for teens and adults.
Individuals 12 years of age and older will receive two 30 micrograms (μg) doses of the vaccine.
However, children between the ages of five and 11 received doses of 10 g and children aged six months to four years received three g doses.
Bourla assured that Pfizer would be ready to ship these smaller doses across the country if the FDA approves the injection in younger children.
“If they approve, we will finish our production to deliver this new formulation of the vaccine,” he told This Week.
“Because the vaccine the children will receive…is a different formulation. It’s a third of the dose we give to the rest of the population.’
Unlike the larger adult clinical trial, the pediatric trial did not measure efficacy by comparing the number of COVID-19 cases in the vaccine group with the number in the placebo group.
Instead, scientists looked at levels of neutralizing antibodies in young vaccine recipients and compared the levels to those in adults.
The companies expect data on how well the vaccine works in children between the ages of two and five and between six months and two years by the end of the year.
Recently, pediatric cases also increased from 71,726 per week in early August to more than 243,000 earlier this month, fueled by the Delta variant.
However, according to the American Academy of Pediatrics, they now appear to be on a downward trend with 225,000 reported last week.
There have also been 480 pediatric deaths since the start of the pandemic, indicating that children account for less than 0.1 percent of all deaths.
Currently, there is no evidence that the Delta variant is more dangerous in children than previous virus strains.
Because of this low risk of serious illness, polls have shown that many parents are not inclined to vaccinate their children.
A poll conducted by the Kaiser Family Foundation found that among parents of children ages five to 11, 19% said they only plan to vaccinate their children if their school requires it and another 19% said their child will definitely not be vaccinated
In an April 2021 poll conducted by the Kaiser Family Foundation, parents were asked whether they would have their child vaccinated once a COVID-19 vaccine is approved and available for their child’s age group.
Of parents aged five to 11, 27 percent said they would have their child vaccinated ‘immediately’ and 32 percent said they would wait and see how it works.
Nineteen percent said they only plan to vaccinate their children if their school requires it, and another 19 percent said their child certainly will not be vaccinated.
A July 2021 survey conducted by CS Mott Children’s Hospital National Poll on Children’s Health at Michigan Medicine found similar results.
Of the parents of children ages three to 11, 49 percent said it was likely their children would receive a vaccine and 51 percent said it was unlikely.