More time will be needed to evaluate a COVID vaccine for kids under age 5. The FDA is postponing a meeting about the COVID-19 vaccine for children younger than 5. The meeting, scheduled for February 15, will be pushed back since new data has emerged regarding Pfizer and BioNTech’s emergency authorization request, CNN reported on Friday.
“This will give the agency time to consider the additional data, allowing for a transparent public discussion as part of our usual scientific and regulatory processes for COVID-19 vaccines,” FDA Commissioner Dr. Janet Woodcock and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in a statement. “We will provide an update on timing for the advisory committee meeting once we receive additional data on a third dose in this age group from the company’s ongoing clinical trial and have an opportunity to complete an updated evaluation.”
In November 2021, the CDC gave the okay for the vaccine to be used for kids ages 5-11. The findings from the clinical trials for the vaccine for babies and children ages 6 months old to 4 years of age will be further evaluated, the agency said. They went on to say that they have been careful to “follow the science in this ever-changing situation” and that more time is needed to evaluate a third dose of the vaccine for the youngest children.
“The agency will ensure the data support effectiveness and safety before authorizing a COVID-19 vaccine for use in our youngest children,” said the statement.
In the meantime, the FDA advised them to continue to practice social distancing and masking at schools or daycares in accordance with public health recommendations, and for their family members of kids and caregivers to get vaccinated or receive a booster dose when eligible.