The COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) appears to be on the cusp of winning regulatory authorization for use in adolescents between the ages of 12 and 15, according to several media reports. FDA has authorized the vaccine for people aged 16 and up.
In March, Pfizer submitted clinical trial results to FDA, suggesting the efficacy of the vaccine was 100% for adolescents aged 12 to 15 based on a trial involving more than 2,000 participants. The reactogenicity of the vaccine in younger adolescents was also favorable.
The European Medicines Agency is also considering making the vaccine available to younger adolescents.
The news comes as vaccination rates in the U.S. fall while Europe’s vaccination efforts are picking up pace after months of sputtering.
In the U.S., the availability of the vaccine to children 12 and older would enable widespread vaccination before the beginning of the next school year.
Pfizer and BioNTech also have launched a clinical trial to evaluate their vaccine in children between six months and 11 years old.
The importance of the Pfizer-BioNTech vaccine is also growing in Europe. Authorities there anticipate receiving 400 million doses of the vaccine this quarter — almost four times greater than the 107 million doses delivered in the first three months of 2020. Meanwhile, demand is down for the AstraZeneca vaccine, which had won early authorization in Europe. Denmark halted the rollout of the AstraZeneca vaccine over concerns about rare blood clots.
Moderna (NSDQ:MRNA) is also testing their COVID-19 vaccine in adolescents. The company expects results from that trial to be ready this summer.