Pfizer-BioNTech Expects to Seek Approval for Vaccine for Younger Pediatric Population

The co-founders of BioNTech said they expect to present US and European regulators with data soon for children 5-11 years old.

BioNTech CEO Ugur Sahin and CMO Ozlem Türeci, MD told a German news site they expect to seek approval for the Pfizer-BioNTech COVID-19 vaccine, BNT162b2 (Comirnaty) for the 5 to 11 year old population soon, and potentially could see the first doses of the vaccine become available in Europe by mid-October.

"In the coming weeks we will present the results of our study on the 5 to 11 year olds worldwide to the authorities and apply for approval of the vaccine for this age group, including here in Europe," Türeci told SPIEGEL.

The co-founders and husband and wife said the data just needs to be processed by the US and European authorities.

"It looks good, everything is going according to plan," Şahin said in the interview.

In addition, they expect study results for children 6 months and over to be complete by the end of the year.

"As a society, we still have around 60 days to avoid a harsh winter," Şahin, said. "We should do what we can to mobilize as many people as possible in these two months."

The Pfizer-BioNTech vaccine received full Food and Drug Administration (FDA) approval in August, and they submitted their application for the booster dose to the American federal agency. The 2 companies are seeking marketing and prescribing of a third booster dose of the vaccine for fully vaccinated individuals aged 16 years and older.

The FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss the booster dose in an upcoming meeting on September 17.