Pfizer delays its request to the FDA to expand its Covid vaccine to children under 5 until April

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Pfizer and BioNTech said on Friday they were delaying their application to the Food and Drug Administration to license their Covid-19 vaccine for children under 5 until early April, awaiting more data on the effectiveness of a third dose.

“As the study proceeds at a rapid pace, the companies will await data from all three doses, as Pfizer and BioNTech continue to believe it may provide a higher level of protection in this age group,” Pfizer said in a statement. Pfizer said it needed more data “because rates of infection and illness remain high in children this age” due to the omicron variant.

The FDA said it will postpone a meeting Tuesday that was scheduled to discuss the children’s data.

The delay is a disappointment to parents who are eagerly awaiting the opportunity to vaccinate their children against covid. Children under 5 years of age are the last remaining age group in the US not eligible for vaccination.

Brayden Burton, 3, plays with child life specialist Maggie Kail, CCLS while receiving treatment for the coronavirus disease (COVID-19) at the Children’s Hospital of Georgia in Augusta, Georgia, USA, on March 14. January 2022.

Hanna Beerer | Reuters

Dr. Peter Marks, head of the FDA division responsible for vaccine safety, said data had quickly come in from Pfizer and BioNTech indicating it was best to wait for data on a third dose. He said the sudden decision to delay authorization should reassure parents that the FDA is doing due diligence to make sure the vaccine is safe and effective for children.

“Instead of having the problem of having someone question the process, I hope this reassures people that the process has a standard, that the process is one that we follow, and we follow the science to make sure that anything we authorize has the safety and efficacy that people have come to expect from our regulatory review of medical products,” Marks told reporters during a news conference on Friday.

Marks said parents will have to rely on mitigation measures to protect their children as they wait for vaccine authorization in the coming months. Those steps include wearing face masks and making sure all eligible family members get vaccinated.

U.S. health regulators have faced mounting public pressure to authorize the injections as hospitalizations of children with COVID surge during the unprecedented wave of infection caused by omicron. The FDA had originally asked Pfizer and BioNTech to submit an authorization application for the first two doses of the vaccine, while they finish collecting data on the effectiveness of the third dose.

Pfizer and BioNTech, at the FDA’s request, filed an application last week for authorization of the first two doses, citing an “urgent public health need” for younger children during the wave of omicron. However, Pfizer CEO Albert Bourla said at the time that children under 5 years of age would ultimately need a third dose to have the highest level of protection against omicron and future variants.

Pfizer modified its clinical trial for younger children in December to study the third injection after the first two doses failed to produce an adequate immune response in children 2 to 4 years old. Younger children will receive a smaller 3-microgram dose, compared to the 30-microgram injections that are approved for adults.

White House chief medical adviser Dr. Anthony Fauci said last month that he expected the FDA to expand eligibility for the vaccine to younger children in February.

The Centers for Disease Control and Prevention had already begun laying the groundwork for distributing the vaccines this month, telling state and local health officials earlier this week that they could receive their first shipments by Feb. 21. . However, the CDC said shipping would begin only when the FDA licenses the vaccine, and administration of the injections could not begin until the CDC gave its approval.

The CDC plans to roll out 10 million doses in three phases as soon as the FDA clears the lower 3-microgram dose. Pfizer Y BioNTech vaccines for children ages 6 months to 4 years, according to a new planning document issued quietly on Sunday. State and local health officials could start booking the first doses as early as Monday.

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