- A clinical trial showed that the Pfizer-BioNTech COVID-19 vaccine is safe and effective for younger adolescents.
- The Pfizer-BioNTech COVID-19 vaccine has been approved for people over the age of 16.
- The pharmaceutical companies are now asking the FDA to allow vaccinations in children as young as 12.
Drugmaker Pfizer Inc. and German partner BioNTech asked the Food and Drug Administration (FDA) on April 9 to expand the emergency approval of their COVID-19 vaccine to include its use in adolescents ages 12 to 15.
This comes a week after the drugmakers said in a news release that a phase 3 clinical trial found that the vaccine is safe and effective and produced robust antibody responses in this age group.
The Pfizer-BioNTech vaccine is currently approved in the United States for use in people 16 years or older. This is the age range included in initial clinical trials of the vaccine.
If the FDA expands the emergency use authorization (EUA) to include younger adolescents, it will move the United States closer to achieving herd immunity, according to experts.
Dr. Christina Johns, senior medical advisor for PM Pediatrics, says this is a very exciting development, both for protecting children and for ending the pandemic.
“This means we are one step closer to vaccinating the rest of the population that we need to vaccinate in order to get closer to herd immunity,” she said, “so that we can really defeat this virus.”
The companies plan to request similar authorizations in other countries in the coming weeks, reports Reuters, including in Canada, where the vaccine is approved for use in people 16 years or older.
Source: healthline