Pfizer, BioNTech To Seek Emergency Use Authorization for COVID-19 Vaccine in Children Under Five

Kimberly Redmond  |

Video source: YouTube, The Hill

Pfizer Inc (NYSE:  PFE) and BioNTech SE (Nasdaq:  BNTX) expect to seek emergency use authorization from the US Food and Drug Administration by November for their COVID-19 vaccine to be administered to children younger than five years old.

During the Morgan Stanley Global Healthcare Conference on Tuesday, Pfizer’s chief financial officer Frank D’Amelio said the drugmaker is awaiting results of pediatric trials of the vaccine, which should be available over the next month.

As long as the data is positive, D’Amelio expects Pfizer to submit the results from the 5 to 11-year-old age group by early October and from children between 6 months and 5 years “in the weeks shortly thereafter.”

After the applications are submitted, it is expected that the FDA will rule quickly on whether or not the shot is safe and effective in younger children. 

Former FDA commissioner Scott Gottlieb believes parents may have access to vaccines by Halloween.

Gottlieb, a board member at Pfizer, told CBS’s “Face the Nation” on Sunday, “The FDA says it will be a matter of weeks, not months, to make a determination if they're going to authorize vaccines for kids between 5 to 11. I interpret that to be perhaps four weeks, maybe six weeks.”

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and President Joe Biden's top medical advisor, has also estimated younger children will be eligible for the jab in October or early November. 

The FDA approved the Pfizer-BioNTech vaccine in late August, making it the first COVID-19 vaccine to be fully licensed for use in the US for people over 16. It was also authorized in May by the FDA for emergency use in children aged 12 to 15.

The agency is facing mounting pressure to grant emergency use authorization of coronavirus vaccines for children younger than 12, especially with schools reopened and the highly contagious delta variant continuing to spread. 

In the past two weeks, the number of pediatric COVID-19 cases has grown “exponentially” to almost 500,000, according to the American Academy of Pediatrics (AAP).  

According to the AAP, nearly 5.3 million children total have tested positive, and youngsters currently account for 29% of all cases reported nationwide.

The latest uptick in pediatric infections comes as schools across the US are in full swing and public health experts continue to urge adults to get vaccinated as a way to protect kids under 12 who are not eligible for the jab.

As of Thursday, only 180 million Americans — 54.2% of the population eligible for the shot — are fully vaccinated, according to the US Centers for Disease Control and Prevention (CDC). 

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