On Wednesday, Pfizer and BioNTech announced that their vaccine has 100% efficacy in children ages 12-15.
The companies conducted a study on the topic that has not yet been published but involved 2,260 adolescents in the United States who varied in age from 12-15 years old. The study included participants who had been infected with SARS-CoV-2 beforehand and those who had not been infected prior to the study.
In the trial, the companies state that there were 18 cases of COVID-19 seen in the placebo group, but none in the group of people that were given the vaccine. It also says that the vaccine showed “robust antibody responses, exceeding those reported in a trial of vaccinated 16-25-year-old participants in an earlier analysis, and was well tolerated” by the participants aged 12 to 15 years old. The company also stated that the side effects were “generally consistent with those observed in participants 16 to 25 years of age.”
Pfizer and BioNTech plan to provide the information for scientific peer review and will also give it to the U.S. Food and Drug Administration and European Medicines Agency in order to expand the use of the vaccine in children 12-15 years of age “as quickly as possible.” All of the people who participated in the trial will be examined “for long-term protection and safety for an additional two years after their second dose.”
“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 Chief Executive Officer of Pfizer in a press release. “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.”
CEO and Co-founder of BioNTech, 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.”
The report on the findings included:
The Pfizer-BioNTech COVID-19 Vaccine is authorized for use under an Emergency Use Authorization (EUA) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
The FDA granted emergency use authorization to the Pfizer COVID-19 vaccine in December for individuals who are over the age of 16. The vaccine is part of a two-dose regimen, spaced three weeks apart, and has been shown to be 95% effective at preventing COVID-19. It was the first COVID-19 vaccine authorized by the FDA. It has not been licensed or approved by the FDA past the emergency use authorization.
The American Academy of Pediatrics released a report with the Children’s Hospital Association in early February that included the cumulative number of child COVID-19 cases. It stated, “3,033,370 total child COVID-19 cases reported, and children represented 13.0% (3,033,370/23,284,471) of all cases.”
The mortality rate was also included from reporting of 43 states, New York City, and Guam, saying, “0.00%-0.05% of all child COVID-19 cases resulted in death.” It also said, “Children were 0.00%-0.25% of all COVID-19 deaths, and 10 states reported zero child deaths.”
The full Pfizer-BioNTech press release can be found here.