Pfizer Submits Data For COVID Vaccine In Kids To FDA

Pfizer Submits Data For COVID Vaccine In Kids To FDA

Pfizer Makes $1.95 Billion Deal With U.S. For Future COVID-19 Vaccine
Jeenah Moon/Getty

Pfizer brings us a step closer to vaccine authorization in kids ages 5-11

Exciting development today, parents. Pfizer just announced this morning, September 28th, that it’s submitted the initial data to the FDA from the trial in its COVID-19 vaccine in kids ages 5 to 11. Parents have long awaited this news and there’s been info floating around for months about the possible timeline and it looks like a vaccine authorized for use in this age group just got a lot closer to fruition.

It’s important to note that this step isn’t an actual bid for emergency authorization, but that would follow, according to Pfizer, “in the coming weeks.” That tracks with what former FDA Commissioner Scott Gottlieb was quoted as saying just days ago — “if everything goes well” the Pfizer vaccine could be authorized for ages 5 to 11 by the end of October.

The news comes on the heels of Pfizer announcing the encouraging results from their trial of the COVID vaccine in kids ages 5-11 with the company saying it had a “favorable safety profile and robust neutralizing antibody responses.” The doses in the trial for this age group contained a third of the size of that used for adults.

On September 10th, FDA officials Janet Woodcock and Peter Marks released a statement concerning the COVID vaccine for kids. “Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible,” they said. “We have to let the science and data guide us.”

The pair assured the public that things are moving along as quickly as possible without compromising safety. “The FDA is working around the clock to support the process for making COVID-19 vaccines available for children. As outlined above, this process is complex and relies on robust manufacturer trials and data, and while we cannot offer a specific date or timeline for when it may be completed for the various manufacturers’ vaccine candidates, we can assure the public we are working as expeditiously as possible to meet this critical public health need and we very much hope to have pediatric COVID-19 vaccines available in the coming months.”

In the statement, they emphasized that once the full emergency use authorization application is submitted, the FDA will move along as quickly and safely as possible. “When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months. However, the agency’s ability to review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.

Pfizer states that the next age group, kids under 5, will have trial results “as soon as the fourth quarter of this year.”