Pfizer and BioNTech have announced that they have submitted a request to the European Union (EU) to extend a previous indication that allows them to vaccinate adolescents between 12 and 15 years old.
If approved, the companies will be authorized to offer their vaccine in all 27 member states of the EU. The companies have already submitted a similar request to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and plan to request additional amendments with other regulatory authorities worldwide.
Europe is a big market for Pfizer and BioNTech. The COVID-19 vaccine made by the pair was the first one to be greenlighted by the European Medicines Agency last December. Earlier this month, the companies announced that they will supply an additional 100 million doses of its COVID-19 vaccine to EU countries, bringing the total number of doses to be delivered to the EU to 600 million.
Why the push for adolescents?
While the Centers for Disease Control and Prevention (CDC) reports that only 0.5% of the 18-and-under population in the U.S. has been vaccinated against COVID-19, young people who do eventually get vaccinated will likely be well-protected from COVID-19. A pivotal Phase 3 clinical trial of Pfizer’s vaccine demonstrated an efficacy rate of 100% in participants between the ages of 12 and 15.
Pfizer and BioNTech have a cheerleader in German Health Minister Jens Spahn, who reacted positively when he learned about the companies’ request. “This can make a further real difference to our vaccine campaign, if approval is granted,” he said upon hearing the news.
As part of its ongoing Interim Clinical Considerations, the CDC said that COVID-19 vaccinations are recommended for all people 16 years and older and that the virus can affect adolescents both directly and indirectly.
“Beyond getting sick, many adolescents’ social, emotional and mental well-being has been impacted by the pandemic. Trauma faced at this developmental stage may have long-term consequences across their lifespan,” the agency wrote.
The CDC has created a resource kit to help parents navigate the social, emotional, and mental impact that COVID-19 can have on their children. It can be found here.