Pfizer and BioNTech Seek FDA Emergency Use Authorization for COVID-19 Vaccine in Children Under 5 with 80.3% Efficacy

Intelligent Finance APP learned that Pfizer (PFE.US) and its partner BioNTech (BNTX.US) have applied to the U.S. Food and Drug Administration (FDA) for emergency use authorization of their COVID-19 vaccine in children under 5 years old.

Pfizer and BioNTech announced in late May that three doses of the vaccine were 80.3% effective in preventing coronavirus infection in children under 5, based on early results from a trial, and generated a strong immune response in these young children.

In February this year, the two companies conducted a rolling review of trial data from 1,678 children under the age of 5. The results showed that their three-dose vaccine was well-tolerated and safe in children, with most side effects being mild or moderate.

It is reported that the FDA will hold a meeting of the Vaccines and Related Biological Products Advisory Committee on June 15. The expert panel will discuss the risks and effects of the vaccine jointly developed by Pfizer and BioNTech on young children and whether the vaccine can be used in young children on an emergency basis.

Pfizer stated that the company and BioNTech also plan to submit data to the European Medicines Agency as well as regulatory authorities in other countries and regions.