The Food and Drug Administration said Sunday that three doses of the Pfizer-Biotech coronavirus vaccine have been shown to be effective in preventing covid disease in children under 5 years of age, judging by the levels of virus-blocking antibodies induced by the shots.
The agency’s assessment was posted online ahead of Wednesday’s meeting of outside vaccine experts, calling for recommendations on how the FDA should rule on the application of both Pfizer and Moderna to vaccinate the country’s youngest children.
Some public health experts hope that the FDA will approve Moderna’s and Pfizer’s vaccines, offering a preference between parents. Centers for Disease Control and Prevention will also have to weigh in with its recommendations following the FDA Act. About 18 million children under the age of 5 are the only Americans who are not yet eligible for the shot.
In a staff analysis, the FDA said data from Pfizer and its German partner, Bioentech, showed that three doses were more effective than two. But the agency said it was difficult to reach a definitive conclusion because there were very few cases of covid among 1,415 children who received three doses of the vaccine during clinical trials.
Pfizer said only eight children in the placebo group and two in the vaccinated group became ill. The trial protocol states that 21 cases were required to rule on the merits.
So far, the FDA seems to be optimistic about both Pfizer and Moderna’s request for a children’s vaccine. Parents are so eager to get a coronavirus vaccine for their young children that some say they will take even lower rates of efficacy, as long as the vaccines are safe.
In an analysis of Pfizer’s data, the agency stated that hospitalization and mortality due to covid among children under 5 years of age were higher than those between 5 and 17 years of age, “based on the benefits of an effective covid-19 vaccine at this age.”
The agency also noted that shots have helped prevent hospitalization and other serious consequences for children 5 years of age and older who are already eligible for the Pfizer vaccine, including this year, when highly contagious omikron variant and its rapidly evolving subverts are dominant. Has become. The form of the virus.
“Given the uncertainty of the Covid-19 epidemic and the likelihood of SARS-CoV-2 infection continuing in the following months, the deployment of the vaccine for use in children aged 6 months to 4 years will have a beneficial effect on Covid-19. Illness and mortality related to this age group, ”the FDA said. The company has identified minimal side effects.
On Friday, the FDA said the modern coronavirus vaccine for children under the age of 6 is effective in preventing significant infections without causing worrying side effects. The two vaccines are based on the same technology, but the dosage and method are different. Moderna is offering two doses in one-quarter strength of adult doses. Pfizer is offering three doses of one-tenth of the power of an adult shot.