Based on data from ongoing clinical trials, the US Food and Drug Administration has granted permission to Pfizer boosters be administered to children between five and eleven years old. The agency disregarded an advisory board meeting that is usually held prior to such decisions because the issue had already been discussed during past discussions.
FDA acknowledged Wednesday that the FDA had extended booster eligibility. “Covid-19 tends to be less severe in children than adults,” the virus’ Omicron variant has led to “more kids getting sick with the disease and being hospitalized”Hence, the demand for boosters in younger Americans.
“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech Covid-19 Vaccine for children 5 through 11 years of age to provide continued protection,” FDA Commissioner Robert Califf said, adding that “Vaccination continues to be the most effective way to prevent Covid-19 and its severe consequences, and it is safe.”
According to the regulator, the emergency use authorization had been based on it. “analysis of immune response data in a subset of children from the ongoing randomized placebo-controlled trial,”This indicated that boosters conferred stronger immunity. The same trial also provided the basis for the FDA’s decision in October 2021 to approve initial two-dose vaccinations for the 5-11 age group.
While the FDA’s independent Vaccines and Related Biological Products Advisory Committee usually meets to evaluate new authorizations, the agency said that was not needed due to “extensive discussions regarding the use of booster doses”in the past. Pfizer’s request to expand eligibility “did not raise questions that would benefit from additional discussion by committee members,”It was added.
CNBC reported that the Centers for Disease Control and Prevention is likely to make its own recommendation after a meeting later in this week. Pfizer and Moderna along with other pharma giants will also meet next month with FDA officials, to discuss vaccinations for children below 5 years old.
The vaccine jointly developed by Pfizer and its partner BioNTech was the first in the US to receive emergency authorization in December 2020, followed by Moderna and Johnson & Johnson. The FDA has since scaled back approval for the latter company’s vaccine, however, limiting it to adults only earlier this month, pointing to potentially dangerous side effects for children.
Share this story via social media
[ad_2]
