After a months-long trial and much public anticipation, the Pfizer/BioNTech COVID-19 vaccine trial on children aged 12-15 has concluded, and the results seem promising. On March 31, Pfizer announced the results of the trial to the public in a news release.
The vaccine was found to be 100% effective in preventing COVID-19 infection. They also found that it was “well tolerated,” meaning side effects were limited. Pfizer and BioNTech plan to release their data to the FDA for expansion of their emergency use authorization. This means that 12-15 year olds have not yet been cleared by the government to get the vaccine, but they likely will soon. The Pfizer vaccine, it seems, will be the first vaccine to be approved in the United States for this age group, as Moderna has not yet finished its trial for ages 12-17, and Johnson and Johnson has not yet begun its trial for children (Moderna and J&J are the only other vaccines approved by the FDA thus far).
The vaccine trial enrolled 2,260 children aged 12-15, all of whom had shown no prior evidence of COVID-19 infection. About half of the participants were given a placebo, while about half received the real vaccine. Among the placebo group, 18 COVID cases were recorded, compared to zero cases in the vaccine group, hence the efficacy rating of 100%. The efficacy rating means that the risk of getting COVID seems to be completely eliminated by the vaccine, at least among the sample size it was tested on.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Albert Bourla, Chairman and CEO of Pfizer.
Pfizer’s data has not yet been released to scientific publications, but they will soon do so. This will provide additional details about how the trial was conducted. Additionally, Pfizer just began their vaccine trial for individuals aged 6 months to 11 years old.
In the news release, BioNTech Co-founder and CEO Ugur Sahin said, “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.”