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The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appear to be effective in preventing Covid disease in children under the age of 5, given the level of virus-blocking antibodies the vaccines cause.
Agency’s assessment It was posted online ahead of Wednesday’s meeting of vaccine experts called to recommend how the FDA should decide on applications from both Pfizer and Moderna to vaccinate the nation’s youngest children.
Some public health experts expect the FDA to authorize both Moderna’s and Pfizer’s vaccines, giving parents a choice between the two. The Centers for Disease Control and Prevention should also weigh in on their recommendations after the FDA takes action. Americans not yet eligible for the vaccine are nearly 18 million children under the age of 5.
In a staff analysis, the FDA said data presented by Pfizer and its German partner BioNTech suggest that three doses are more effective than two. However, the agency said it was difficult to draw firm conclusions as there were very few cases of Covid-19 among the 1,415 children who received three doses of the vaccine during the clinical trial.
Pfizer said only eight children in the placebo group and two in the vaccine group fell ill. The trial protocol said 21 cases were required to make a decision on efficacy.
So far, the FDA has welcomed pediatric vaccine requests from both Pfizer and Moderna. Parents are so eager to have a coronavirus vaccine for their youngest child that some have said they will accept even low impact rates as long as the vaccines are safe.
In the analysis of Pfizer’s data, the agency stated that hospitalization and death rates due to Kovid among children under the age of 5 are higher than those aged 5-17, “emphasizing the benefit of an effective Covid-19 vaccine in this age group.”
The agency also noted that among children 5 or older currently eligible for the Pfizer vaccine, the vaccines helped prevent hospitalizations and other serious consequences, including the current year when the highly contagious Omicron variant and its rapidly evolving sub-variants became dominant. forms of the virus.
“Given the uncertainty of the Covid-19 pandemic and the continued possibility of SARS-CoV-2 transmission in the months that follow, the use of the vaccine among children aged 6 months to 4 years will have a positive impact on Covid-19. “Associated morbidity and mortality in this age group,” said the FDA. The agency identified minimal side effects.
On Friday, the FDA said Moderna’s coronavirus vaccine for children under 6 was also effective in preventing symptomatic infection without causing alarming side effects. Both vaccines are based on the same type of technology, but the dosages and regimens are different. Moderna recommends two doses, one quarter of the adult dose. Pfizer recommends three doses, one-tenth the strength of adult vaccines.
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