Clinical trial results of the Pfizer/BioNTech’s COVID-19 vaccine show it’s 100% effective at preventing infection in adolescents between 12 and 15 years old, the companies announced Wednesday.
The companies say they plan to submit the data to the Food and Drug Administration in hopes of expanding the emergency use authorization for the two-dose vaccine for use in adolescents. The Pfizer/BioNTech vaccine is authorized for use in those 16 and older. The data hasn’t yet been peer reviewed.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year,” said Pfizer CEO Albert Bourla.
BioNTech CEO and co-founder Ugur Sahin said the news is especially encouraging given the spread of variants thought to be more contagious.
“Across the globe, we are longing for a normal life. This is especially true for our children. The initial results we have seen in the adolescent studies suggest that children are particularly well protected by vaccination, which is very encouraging given the trends we have seen in recent weeks regarding the spread of the B.1.1.7 UK variant. It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” said Sahin.
The trial enrolled 2,260 adolescents 12 to 15 years of age in the U.S.
In the trial, 18 cases of COVID-19 were observed in the placebo group versus none in the vaccinated group.
Last week, Pfizer and BioNTech also dosed the first healthy children in a global study to further evaluate the safety, tolerability, and immune response to the vaccine in children 6 months to 11 years of age.
The 5 to 11 year-old cohort started dosing last week and the companies plan to initiate the 2 to 5 year-old cohort next week.
In other news:
- Dallas County Wednesday reported 364 more COVID-19 cases — 166 confirmed cases and 198 probable — and 18 additional deaths. The county also reported an outbreak of over 70 cases associated with attendees at a high school dance and dinner on March 13, including subsequent spread into their household members.
- Dallas County also celebrated giving out the 250,000th dose of the COVID-19 vaccine at Fair Park, the Dallas Morning News reported.
- Johnson & Johnson Wednesday reported a batch of its COVID-19 vaccine was ruined at a plant in Baltimore, the New York Times reported. The mix-up has delayed future shipments of Johnson & Johnson doses in the United States while the FDA investigates, but doesn’t affect doses that are being delivered and used nationwide now, the paper reported. Federal officials still expect to have enough doses from the approved COVID-19 vaccine manufacturers to vaccinate every adult in the U.S. by the end of May.
- Dallas Mayor Eric Johnson and Uber partnered on a new initiative to provide free rides to COVID-19 vaccination sites, the city announced Wednesday. Uber will provide 2,000 promo codes for rides to Project Unity, a nonprofit that has been working on vaccination efforts. Project Unity, in partnership with Catalyst Health Network, is hosting a vaccination event tomorrow at St. Luke “Community” United Methodist Church.