The FDA has moved to expand vaccine eligibility to include children at least 5 years old.
Earlier this week, the agency’s Vaccines and Related Biological Products Advisory Committee concluded that the benefits of the Pfizer-BioNTech (NYSE:PFE/NASDAQ:BNTX) for children 5 to 11 outweigh the risks. The recommendation pertained to two 10-µg doses of the vaccine, which is one-third of the dose used in individuals 12 and up.
A total of 17 out of 18 of the VRBPAC’s members voted in favor of expanding the vaccine eligibility.
FDA noted that it based its decision on a range of data, including a study that enrolled roughly 3,100 children in the relevant age group. The study found that the vaccine was 90.7% effective at preventing symptomatic COVID-19.
“Our comprehensive and rigorous evaluation of the data pertaining to the vaccine’s safety and effectiveness should help assure parents and guardians that this vaccine meets our high standards,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
The agency is committed to sharing data used in its decision-making process publicly, according to Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
While the risk of heart inflammation tied to mRNA vaccinations — namely myocarditis and pericarditis — appears to be lower in younger children, Pfizer plans on monitoring such vaccine recipients for those conditions.
In related news, FDA has authorized a manufacturing change related to the Pfizer-BioNTech vaccine to allow a different buffer. The resulting change makes the vaccine more stable at refrigerated temperatures for an extended period. The agency doesn’t expect the change to lead to safety or effectiveness issues.
Filed Under: clinical trials, Drug Discovery, Infectious Disease