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Pfizer and BioNTech to ask FDA to authorize COVID-19 recall for children as young as 5 years old


Pfizer and BioNTech plan to ask the Food and Drug Administration to eliminate a third dose of their COVID-19[feminine] vaccine for children as young as 5 years old, the companies said on Wednesday, citing trial results showing a “robust response” of antibodies in this age group after the booster.

In the trial, 140 children aged 5 to 11 received a third dose of the Pfizer-BioNTech COVID-19 vaccine six months after receiving their second injection. Blood taken from the children showed a six-fold increase in antibodies compared to the amount seen one month after the second dose, indicating “a strong immune response in this age group”, the companies said.

A subset of antibodies from the children in the trial were also tested against the Omicron variant. These 30 samples had an antibody response strong enough to neutralize the variant, with a “robust response” whether or not the children had already survived a case of COVID-19, the companies said.

“Pfizer and BioNTech plan to submit an Emergency Use Authorization (EUA) request for a booster dose for children ages 5-11 in the United States in the coming days,” the companies said. in a press release.

While vaccine effectiveness against hospitalization remained relatively high during the Omicron wave, the risk of breakthrough infections among Americans who had received only two doses of a COVID-19 vaccine soared across the board. age groups, including children.

According to data presented last week by an official at the Centers for Disease Control and Prevention, two doses were only 24% effective in curbing infection in children from 5 to 11 years old during the Omicron wave.

If Pfizer and BioNTech’s application is approved by the FDA and approved by the CDC, only a small handful of children would likely initially be eligible for the recall. According to the CDC, only 28% of Americans ages 5 to 11 have been fully immunized since the agency officially recommended vaccines for that age group in early November.

Federal officials have openly expressed frustration with the slow pace of vaccinations. The CDC found in March that about 4 in 10 parents of children ages 5 to 11 are unlikely to get their children vaccinated.

However, the announcement also comes as concerns grow among some health experts and officials over a new wave of cases in the coming months. by sub-variant BA.2 of Omicron. The national pace of COVID-19 cases and hospitalizations has begun to pick up in recent weeks, with the biggest increases in northeastern regions, where the subvariant first became dominant.

“All you hear about, don’t worry about the kids, let them get infected, that’s a bunch of nonsense. There’s been about 12 million cases in children, there’s been more than 120,000 hospitalizations,” Dr. Anthony Fauci said Monday. , in a lecture at the Uniformed Services University.

“We really need to put an end to this myth that we don’t need to protect children now,” Fauci added.

No data for children under 5 years old

The publication does not include widely expected data on the immune response in children under 5 years of age. .

“We at the FDA really understand the urgency people feel to want to get the youngest children vaccinated. We also understand that this is the age group where people are most concerned about potential side effects and the potential safety of vaccines,” said Dr Peter Marks. , the FDA’s top vaccine official, told reporters last month.

Data on three doses in children under 5 are expected in the “coming weeks”, according to a Pfizer spokesperson.

“The FDA is very familiar with these datasets and therefore can act quickly. Assuming the data comes out in April, as planned, I think the agency could potentially act in May,” the former FDA commissioner said. , Dr. Scott Gottlieb. , who sits on Pfizer’s board of directors, told “Face the Nation” on Sunday.

Moderna also released “positive interim data” from trials of just two doses of its vaccine in children as young as 6 months old, with plans to seek FDA clearance in the coming weeks.

“My hunch is that it’s going to slide a bit because that sense of urgency will have dissipated as infection levels will be relatively low as we get into spring,” Gottlieb added.


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