Pfizer asks FDA to approve Covid-19 vaccine for children under 5 years old

Pfizer and partner BioNTech are expected to request the Food and Drug Administration soon to authorize a coronavirus vaccine for children 6 months to 4 years of age as a two-dose regimen while they continue to study whether the three how the dose works.

According to multiple people familiar with the discussions, federal regulators are eagerly reviewing the data in the hope that they could allow emergency vaccinations for young children as early as late February. If Pfizer waits for data on the three-dose regimen, the data won’t be sent out until the end of March and the vaccine may not be available for that age group until late spring, according to multiple people familiar with the situation. .

Federal officials and Pfizer executives have suggested for days that an emergency application for a vaccine for the youngest children is being worked on. Scott Gottlieb, a Pfizer board member and former commissioner of the Food and Drug Administration, told CBS News on Sunday that the vaccine could be licensed as early as March. The development is the first Washington Post newspaper.

As the Omicron variant has swept across the country, there has been a dramatic increase in cases of the virus in children, based on The American Academy of Pediatrics, which collects state-level data. Although young children tend to fight off viruses well, some children can get very sick. Federal officials have been anxious to start a vaccination program for the youngest children, as studies show two doses provide a significant level of protection against Covid disease without safety concerns.

Pfizer and BioNTech in mid-December announced that two doses of the vaccine, given as one-tenth of the adult dose, produced no more immune response in children 2 to 5 years of age than in young adults 16 to 25. Children 6 years of age months to 2 years old can do it. showed a comparable immune response.

The failure prompted the companies to test the third lowest dose of the injection in children 6 months to under 5 years old. While federal regulators expect that the third dose will eventually be licensed, they have taken the unusual approach of encouraging Pfizer to apply for a license before that study is completed in the hope of preserving protect more children from the Omicron variant and other mutations that may follow, according to four people familiar with the strategy.

The FDA and the Centers for Disease Control and Prevention are both expected to convene committees of outside vaccine advisors before deciding whether to delete the shot. That will give the company and independent experts the opportunity to review and discuss the data the companies have collected. Most senior federal health officials strongly support the strategy, but want outside experts to consider it, some said.

How federal regulators look at childhood immunizations can be of great importance for vaccine uptake. Vaccination rate for America’s 28 million children 5 to 11 years old is still even lower than health experts had feared. Just over a quarter of children in that age group received at least one dose, according to CDC data.

Kathrin Jansen, Pfizer’s head of vaccine research, said in December that the company would seek FDA approval for three doses for young children, a strategy she said would allow ” a consistent three-dose vaccine approach for all ages”. The two said the company switched its plans because the FDA was pressing for more urgent action. If allowed, young children will receive a second dose three weeks after the first dose and a third dose two months later.

CDC now considers three doses of the vaccine an “updated” regimen for people who are eligible for additional doses, including those 12 years of age and older who are eligible for booster doses. again. Regulators have allowed booster doses to be given 5 months after the second injection. Children under 5 years of age with weakened immune systems are also eligible for additional shots. Pfizer asks FDA to approve Covid-19 vaccine for children under 5 years old

Fry Electronics Team

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