Pfizer vaccine effective for use in 12- to 15-year-olds, clinical trial finds
Wednesday, 31 March 2021
The coronavirus vaccine developed by pharmaceutical companies Pfizer and BioNTech has proven to be 100% effective in phase three clinical trials, Pfizer announced on Wednesday.
The results from the trial, involving 2,260 children in the United States, exceeded those reported in the research on the vaccine in 16-25-year-old participants, a press release stated.
“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 British variant,” said Ugur Sahin, CEO, and Co-founder of BioNTech.
Today, with @BioNTech_Group, we announced positive topline results in adolescents 12-15 years of age from the Phase 3 Pfizer-BioNTech #COVID19 vaccine study.
In the trial, 18 cases of Covid-19 were observed in the placebo group, whilst none were identified in the vaccinated group, and side effects were found to be consistent with those observed in participants 16 to 25 years of age.
The company will now submit the data to the European Medicines Agency (EMA) to request the expansion of the EU Conditional Marketing Authorisation for the vaccine and hopes to start vaccinating this group before the start of the next school year.
“Across the globe, we are longing for a normal life. This is especially true for our children. 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,” Sahin said in a statement.
All participants in the trial will continue to be monitored for long-term protection and safety for an additional two years after receiving their second dose.