Pfizer and BioNTech’s mRNA-based COVID-19 vaccine has demonstrated 100% efficacy and safety in adolescents, including children as young as 12 years old.
The results come from a phase 3 trial of the vaccine – known as BNT162b2 – in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection.
In this population, the vaccine – in addition to demonstrating 100% efficacy – also produced robust antibody responses, which exceeded those recorded earlier in vaccinated participants aged 16 to 25 years old according to the companies.
Pfizer and BioNTech added that the vaccine was also well tolerated, with side effects ‘generally consistent’ with those seen in participants aged 16 to 25 years.
“Across the globe, we are longing for a normal life. This is especially true for our children,” said Ugur Sahin, chief executive officer and co-founder of BioNTech.
“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 companies are now planning to submit the data to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to request an amendment to both the emergency use authorisation for the vaccine in the US and the conditional marketing authorisation currently in place in the EU.
Pifzer and BioNTech also announced that the first children have received the vaccine as part of a global phase 1/2/3 study to further evaluate the vaccine in children aged six months to 11 years of age.
This study will evaluate the efficacy and safety of BNT162b2 as a two-dose schedule in three age groups – children aged five to 11 years, two to five years and six months to two years.
Vaccination was started in the five- to 11-year-old cohort last week, and the companies also plan to initiate vaccination in the two- to five-year-old cohort next week.