U.S. health regulators have further expanded eligibility for additional shots
The US Food and Drug Administration (FDA) has given the green light to administer Pfizer vaccine boosters to children aged 5 to 11, citing data collected in ongoing trials. The agency avoided an advisory board meeting usually held before such a decision, saying the issue was covered during previous discussions.
The FDA on Wednesday announced increased booster eligibility, acknowledging at the time “Covid-19 can be less severe in children than in adults,” The virus’ omikron has led to alternatives “More and more children are being hospitalized for the disease.” And has created the need for booster among young Americans.
“The FDA approves the use of a single booster dose of the Pfizer-BioNTech Covid-19 vaccine for children ages 5 to 11 to provide continued protection.”FDA Commissioner Robert Calif said “Vaccination continues to be the most effective way to prevent Covid-19 and its deadly consequences, and it is safe.”
The health regulator said the approval of the new emergency use was based on that “Analysis of immune response data in a subset of children from ongoing randomized placebo-controlled trials,” Which indicates that those who received the booster had stronger immunity. The same trial also provided the basis for the FDA’s decision to approve the initial two-dose vaccine for ages 5-11 in October 2021.
Although the FDA’s Independent Vaccine and Related Organic Products Advisory Committee usually meets to evaluate new approvals, the agency says it was not required. “Extensive discussion of booster dose use” In the past. Pfizer’s request to extend the qualification “Didn’t raise any questions that would benefit from additional discussions by committee members,” he said. It has been added.
The Center for Disease Control and Prevention (CDC) is expected to issue its recommendations after a meeting later this week, when Pfizer and partner pharma giant Moderna will meet with FDA officials next month to discuss approving immunizations for children under one year of age. 5, according to CNBC.
The vaccine, jointly developed by Pfizer and its partner BioNTech, first received emergency approval in the United States in December 2020, followed by Moderna and Johnson & Johnson. The FDA later withheld approval of the company’s vaccine, but earlier this month restricted it to adults, pointing to potentially dangerous side effects for children.