Pfizer and BioNTech announced the results of a new study that showed their Covid-19 vaccine was safe and effective in children aged five to 11 years old.
The pharmaceutical companies announced their findings Monday, September 20th, saying that two doses of the vaccine for children of the appropriate age “compare well (was non-inferior)” to the results from a similar study involving 16-to-25-year-olds. Pfizer and BioNTech’s study is not peer-reviewed and the results still need to be submitted to the Food and Drug Administration and other regulatory agencies around the world for final approval.
As The New York Times reports, the Pfizer/BioNTech study comes as Covid-19 case numbers and hospitalizations tick up among young children. Generally, Covid remains more of a threat to adults, even the highly contagious Delta variant, but a recent study from the American Academy of Pediatrics reported that more than one in five new cases are children.
Delta has also sent more kids to hospitals and intensive care units in the past few weeks than at any other time during the pandemic, with 30,000 children hospitalized alone in August (that number does include children over 12, who are eligible for the vaccine). Some children who catch Covid have also developed a dangerous condition called multi-system inflammatory syndrome, or MIS-C, while others have had symptoms stick around for months.
Pfizer’s CEO, Albert Bourla, said in a statement, “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 five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”
Pfizer and BioNTech are still conducting studies on the vaccine’s safety and efficacy among children under five. Results are not expected until the fourth quarter of this year.