Pfizer vaccine effective in children under 5, FDA says

The Food and Drug Administration on Sunday said three doses of the Pfizer-BioNTech coronavirus vaccine appear to be effective in preventing Covid disease in children under 5 years of age, based on levels of antibodies that block the virus. -withdrawal caused by the injection.

Agency reviews was posted online ahead of Wednesday’s meeting of outside vaccine experts, convened to recommend how the FDA should regulate adoption from both Pfizer and Moderna on immunizing the nation’s youngest children. .

Some public health experts are expecting the FDA to approve both Moderna and Pfizer’s vaccines, giving parents a choice between the two. The Centers for Disease Control and Prevention must also weigh in with its recommendations after the FDA takes action. About 18 million children under the age of 5 are the only Americans who are not yet eligible for the vaccine.

In a staff analysis, the FDA said data submitted by Pfizer and its partner BioNTech in Germany showed that three doses were more effective than two. But the agency said it is difficult to draw definitive conclusions because there were very few cases of Covid among 1,415 children who received three doses of the vaccine during the clinical trial.

Only eight children in the placebo group and two in the vaccinated group fell ill, Pfizer said. The trial protocol said 21 cases were required to make a judgment on effectiveness.

So far, the FDA seems to favor Pfizer and Moderna’s requests for children’s vaccines. Parents are so desperate to have a coronavirus vaccine for their youngest child that some have said they would accept even low effectiveness rates, as long as the vaccine is safe.

In its analysis of Pfizer data, the agency said Covid-19 hospitalizations and deaths were higher among children under the age of 5 compared with the age group 5 to 17, “emphasizing the benefits of a Covid-19 vaccine- 19 effective in this age group.”

The agency also noted that among children 5 years of age and older who were eligible for the Pfizer vaccine, the shots helped prevent hospitalization and other serious outcomes, including in current year, when the highly contagious Omicron variant and its rapidly growing sub-variants become dominant. types of viruses.

“Due to uncertainty regarding the Covid-19 pandemic and the potential for continued transmission of SARS-CoV-2 in the months to come, the rollout of a vaccine for use in children 6 months to 4 years of age could be difficult. would have an effect on Covid-19-related morbidity and mortality in this age group,” the FDA said. The agency has identified minimal side effects.

On Friday, the FDA said Moderna’s coronavirus vaccine is for children under 6 years of age also effective in preventing symptomatic infections without causing worrisome side effects. These two vaccines are manufactured using the same technology, but different doses and regimens. Moderna is recommending two doses at one-quarter of the adult dose. Pfizer is recommending three doses at one-tenth the dose of the adult shots.

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