Shares of BioNTech (BNTX 3.78%) had climbed 4.3% as of 11:54 a.m. ET on Tuesday. The gain came after multiple news organizations reported that BioNTech and its big partner, Pfizer (PFE 2.32%), are expected to soon file for U.S. Emergency Use Authorization (EUA) of their COVID-19 vaccine in children ages 6 months to 5 years.
National Public Radio, The New York Times, and The Washington Post reported that BioNTech and Pfizer could submit for EUA to the U.S. Food and Drug Administration (FDA) as early as today. All three news organizations said they based their reports on information obtained from individuals knowledgeable about the companies' plans.
It's not surprising that BioNTech and Pfizer could be about to file for U.S. EUA of their COVID vaccine for younger kids. The companies had hoped to have already submitted for authorization in this age group. However, clinical studies last year found that the low doses that were effective in children up to 2 years old weren't as effective in kids ages 2 through 5. BioNTech and Pfizer subsequently added a third dose to their clinical studies.
Neither is it a surprise that investors cheered the news for BioNTech and caused the vaccine stock to rise. There could be a significant market for BioNTech and Pfizer if the FDA grants EUA for this younger group. Around 6% of the U.S. population (close to 20 million children) are under 5 years old, according to the U.S. Census Bureau.
Assuming that BioNTech and Pfizer file for this authorization quickly as expected, it's possible that their COVID vaccine could be available for young children before the end of February.