Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) on Sept. 20 announced that a trial phase of its COVID-19 vaccine has found positive results for children 5 to 11 years of age using a two-dose regimen.
Those ages received the doses that are ⅓ of of those administered for ages 12 and older. The antibody responses were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years old immunized with the larger doses, the companies said. The smaller dose was selected for safety, tolerability and immunogenicity in the younger children.
“Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine,” Albert Bourla, chairman and chief executive officer of Pfizer, said in a news release. “We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children. Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination. These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
The study is enrolling children 6 months to 11 years of age and had 2,268 participants who 5 to 11 years old. The companies plan to include the data in a submission for Emergency Use Authorization in a filing for full FDA approval in this age group.
According to the Centers for Disease Control and Prevention, “Cases of myocarditis and pericarditis in adolescents and young adults have been reported more often after getting the second dose than after the first dose of one of the two mRNA COVID-19 vaccines, Pfizer-BioNTech or Moderna.” However, those conditions are very rare, the CDC said.
With schools in session and the delta variant being twice as contagious as earlier strains of COVID-19, according to the CDC, a growing number of younger children are being hospitalized.
According to the Centers for Disease Control and Prevention, as of Sept. 20, at least 672,738 Americans had died from COVID-19, with over 9,000 deaths occurring in the 7-day period ending at noon Sept. 20. Of those deaths, 119 were Hoosiers. Over 15,000 people in Indiana have died of COVID-19. Over 386 million total vaccines have been administered in the U.S.