October 14, 2020 -- Pfizer will expand its coronavirus vaccine clinical trial to include children as young as 12, the company has announced.
It will become the first major vaccine developer to begin testing a COVID-19 vaccine in children that young. Pfizer CEO Albert Bourla told Business Insider that he expects to have data from this study before the end of October. The drugmaker also said it received permission to expand the study to include as many as 48,400 participants, 10% larger than a cap previously stated.
In September, the trial was expanded to include volunteers ages 16 and 17, along with participants who have hepatitis C, B, or HIV. On its website, Pfizer says it expanded its Phase III trial to about 44,000 to include enrollment of those newer populations.
Then, in October, Pfizer got FDA permission to enroll teens as young as 12.
Pfizer, in collaboration with BioNtech and Fosun Pharma, is testing four vaccines, each using messenger RNA in different combinations to produce antibodies. Phase II/III trials of the vaccine, BNT162b2, launched July 27 in the U.S. Early results from the ongoing phase I/II study of the BNT162b1 form of the vaccine showed that it produced a ''robust'' immune response in adults who got the immunization.
Other vaccine developers, including Moderna and Johnson & Johnson, told Business Insider they, too, are committed to starting pediatric trials. Trials began with adult subjects because experts believed that younger people can recover better than adults. However, experts also agree that a vaccine for kids will be crucial to reopen school safely.