Covid-19 Live Updates: Case and Vaccine News

Credit…Paul Ratje for The New York Times

Pfizer and its partner BioNTech are expected on Tuesday to ask the Food and Drug Administration to authorize a coronavirus vaccine for children under 5 in the form of a two-dose schedule while continuing to research the effectiveness of three doses.

Federal regulators are eager to review the data in hopes of authorizing injections for young children on an emergency basis as early as late February, according to several people familiar with the discussions, who were not authorized to speak publicly. If Pfizer was expecting data on a three-dose schedule, the data would not be submitted until late March and the vaccine may not be licensed for this age group until late spring.

Federal officials and Pfizer executives had been suggesting for days that a request for emergency authorization of a vaccine for children as young as 6 months old was in the works. Every age group above this is eligible for injections, and the highly contagious variant of Omicron has seen a sharp rise in infections at all ages, including children. There are over 19 million Americans under the age of 5.

Pfizer board member and former Food and Drug Administration commissioner Scott Gottlieb told CBS News on Sunday that the vaccine could be authorized as early as March for the youngest age group. The development was first reported by The Washington Post.

Parents of young children are eager to see Pfizer and federal regulators act to make vaccines available. Many families said they were in limbo waiting for the Omicron wave and struggling with daycare closures and child care crises.

Federal authorities are eager to begin a vaccination program for young children because Pfizer-BioNTech studies have shown that two doses provide a notable level of protection against Covid-19 without any safety concerns, according to people who have been informed of the data. Officials expect the regimen to eventually include three doses.

Pfizer and BioNTech announced in mid-December that children 6 months to two years old who received two doses of the vaccine at one-tenth the strength of adult doses produced an immune response comparable to that of young people aged 16 to 25. But among children aged 2 to 4, the response was less robust.

The setback prompted companies to test a third low dose of the vaccine in young children. Rather than wait for those results, federal regulators took the unusual approach of encouraging Pfizer to seek approval for a two-dose regimen to begin protecting children against the Omicron variant and other later mutations. possible, according to four people familiar with the strategy.

Even though young children are largely successful in fighting off the virus, the American Academy of Pediatrics says the Omicron variant has heightened the threat of Covid-19 in children under 5.

“Unfortunately, we are seeing hospitalization rates increasing for children 0-4 years old, children who are not yet currently eligible for vaccination against Covid-19,” director Dr Rochelle Walensky told reporters. from the Centers for Disease Control and Prevention. month. She said the high transmission rate of the Omicron variant was likely to blame.

Both the FDA and CDC should convene committees of outside vaccine advisors before deciding whether to allow injections. This will give independent experts the opportunity to discuss the data the companies have collected. Most senior federal health officials strongly support the strategy, two officials said, but they want outside experts to step in.

Kathrin Jansen, head of vaccine research at Pfizer, said in December the company would seek FDA clearance for three doses for young children, a strategy she said would allow “a cohesive three-pronged vaccine approach.” doses for all ages”. The company changed its plan because the FDA was pushing for more urgent action, two people said. If authorized, young children will receive their second dose three weeks after the first, and a third dose two months later.

The CDC now considers three doses of the vaccine an “up-to-date” regimen for people eligible for additional shots, including those age 12 and older. Regulators allowed booster doses given five months after the second injection. Children as young as 5 years old who have weakened immune systems are also eligible for additional injections.

Deliberations in the coming weeks could affect how quickly parents get their youngest children vaccinated. The vaccination rate for the 28 million American children aged 5 to 11 remains even lower than feared by health experts. About 30% of children in this age group received at least one dose, according to CDC data.

The reasons why more young children have not been vaccinated vary. Some parents are discouraged by misinformation about the vaccine; others do not believe the virus poses a sufficient threat to vaccinate their children. Some simply haven’t found the time to take their children for vaccinations yet, health officials report.

The CDC released research in late December that showed very few reports of serious problems in children ages 5 to 11 who received Pfizer-BioNTech injections. Another study of hundreds of pediatric hospitalizations in six cities last summer, published by the agency, found that nearly all seriously ill children had not been fully immunized.

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