Surgeon General Reassures Parents that COVID Vaccine Will Be Rigorously Analyzed for Kids Under 5

"Please know that the FDA will not cut any corners in their review process," U.S. Surgeon General Dr. Vivek Murthy said

Vivek Murthy
Dr. Vivek Murthy. Photo: Samuel Corum/CNP/Bloomberg via Getty

The U.S. surgeon general is reassuring parents that the Food and Drug Administration will rigorously analyze data on Pfizer-BioNTech's COVID-19 vaccine before approving it for use in kids under 5 years old.

One day after Pfizer-BioNTech submitted data on how their vaccine worked in children 6 months to 4 years old to the FDA to start the approval process, Surgeon General Dr. Vivek Murthy said that it will be thoroughly researched.

"Please know that the FDA will not cut any corners in their review process. They know that they are the gold standard that all of us rely on," he said during a White House news briefing on Wednesday, The Washington Post reported.

An advisory panel to the FDA is set to discuss the data on Feb. 15, and it could be approved for use by the FDA and Centers for Disease Control by the end of the month.

Pfizer-BioNTech had decided to submit their clinical data on Tuesday at the request of the FDA — a surprise move, as typically companies make that decision on their own, and because that data showed that two doses of the vaccine did not create much of an immune response in the age group. But the FDA said that it is necessary with omicron "having a much greater toll on children," they told USA Today.

RELATED VIDEO: FDA Grants Full Approval to Pfizer's COVID Vaccine

Pfizer-BioNTech had reported in December that the two, small doses of their vaccine that they had tested on children 6 months to 4 years old in clinical trials did not create enough of an immune response, though there were no safety issues. Based on those results, the company began testing out giving a third dose of the vaccine, which they hope will offer more protection against COVID-19.

The FDA is hoping that they can approve the initial two-dose vaccine series now to begin the process of vaccinating this youngest age group as pediatric cases and hospitalizations reach record highs, and that by the time kids are ready for a third dose, Pfizer-BioNTech will have completed their clinical trials and it will prove to be effective.

"In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available, including the data that it has recently collected during the omicron surge," the FDA told USA Today.

As information about the coronavirus pandemic rapidly changes, PEOPLE is committed to providing the most recent data in our coverage. Some of the information in this story may have changed after publication. For the latest on COVID-19, readers are encouraged to use online resources from the CDC, WHO and local public health departments. PEOPLE has partnered with GoFundMe to raise money for the COVID-19 Relief Fund, a fundraiser to support everything from frontline responders to families in need, as well as organizations helping communities. For more information or to donate, click here.

Related Articles