Pfizer asks FDA for authorization of its COVID-19 vaccine for kids ages 5 to 11

Key Points

• Pfizer has asked the FDA to authorize its COVID-19 vaccine for kids ages 5 to 11

• The clinical data for the kids showed “robust” immune response

• Thursday’s request may mean the shots won’t be available until around November

Pfizer Inc and BioNTech SE on Thursday have asked the U.S. Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for kids ages 5 to 11, an age group for whom there is no available vaccine in the market.

The FDA has already announced a panel meet with outside advisers for October 26 to discuss amending its Emergency Use Authorization (EUA) to make the two-dose Pfizer/BioNTech vaccine available for about 28 million children in this age group.

“With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against #COVID19,” Pfizer wrote on Twitter.

Pfizer’s two-dose regime has already won EUA for teens between the age of 12 to 15 and is fully approved by the FDA for people ages 16 and up.

Two-dose regimen for kids

The news comes when delta variant surges across the nation, and parents are getting anxious to get their children vaccinated as kids start the new school year.

Last month, Pfizer published new data from its clinical trial conducted on 2268 children aged between 5 to 11, showed a smaller dose of 10 micrograms, which is one-third of the dosage used for teens and adults, is safe and generates a “robust” immune response.

The drugmaker said the shots were well tolerated and produced an immune response and side effects like fatigue, headache, muscle pain, chills, fever, and nausea comparable with those seen in adults and teens.

Pfizer’s request on Thursday means the vaccine for the kids won’t be available until around November if the FDA takes as much time reviewing the data as it did for 12 to 15 year-olds. 

Dr. Scott Gottlieb, a former FDA commissioner and one of Pfizer’s board of directors, told CNBC last week that the shots for young kids could come by Halloween.

The White House COVID-19 response coordinator Jeffrey Zients told CNN that the administration has the supply and is currently gearing up with states to set up convenient locations for parents and kids to get vaccinated, including pediatricians’ offices and community sites.

Picture Credit: CBS 17