The Food and Drug Administration said on Sunday that three doses of the Pfizer-BioNTech coronavirus vaccine appeared to be effective in preventing Covid disease in children under 5, judging by the level of antibodies blocking the virus caused by the injections.
The agency’s assessment was published online ahead of a meeting of external vaccine experts on Wednesday, urging it to recommend how the FDA should respond to applications from both Pfizer and Moderna to vaccinate the world’s youngest children.
Some public health experts expect the FDA to approve both Moderna and Pfizer vaccines, offering parents a choice between the two. Centers for Disease Control and Prevention should also evaluate their recommendations after the FDA acts. Approximately 18 million children under the age of 5 are the only Americans not yet eligible for vaccination.
In an analysis of staff, the FDA said the data provided by Pfizer and its German partner BioNTech suggest that three doses are more effective than two. But the agency said it was difficult to draw definitive conclusions because there were so few cases of Covid among 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 vaccinated group became ill. The test report says 21 cases are needed to judge the effectiveness.
For now, the FDA appears to be favoring Pfizer and Moderna’s demands for pediatric vaccines. Parents are so eager to have a coronavirus vaccine for their youngest children that some say they would accept even low levels of effectiveness if the vaccines were safe.
In its analysis of Pfizer data, the agency said that the rate of hospitalization and death due to Covid among children under 5 years of age is higher than among those aged 5 to 17 years, “emphasizing the benefits of an effective vaccine against Covid-19 in this age group. “
The agency also noted that among children 5 years of age or older who are already eligible for the Pfizer vaccine, the vaccines have helped prevent hospitalization and other serious outcomes, including this year, when the highly contagious version of Omicron and its rapidly developing subvariants became the dominant forms of the virus.
“Given the uncertainty of the Covid-19 pandemic and the likelihood of continued transmission of SARS-CoV-2 in the coming months, the introduction of the vaccine for use in children aged 6 months to 4 years is likely to have a beneficial effect on Covid-19. 19 -related morbidity and mortality in this age group, “the FDA said. The agency found 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 technology, but the dosage and regimens differ. Moderna offers two doses at a quarter of the strength of adult doses. Pfizer offers three doses at one-tenth the strength of adult injections.
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