Pfizer gets approval from FDA to enroll children as young as 12 in COVID-19 vaccine trials

Flu Vaccine
Posted at 12:06 PM, Oct 14, 2020

Pharmaceutical company Pfizer announced on its website that it had received permission from the Food and Drug Administration that they can enroll children as young as 12 in its COVID-19 vaccine trial.

According to CNN, this is the first coronavirus vaccine trial in the U.S. to include children." By doing so, we will be able to better understand the potential safety and efficacy of the vaccine in individuals from more ages and backgrounds," the company said on its website.

The Vaccine Research Center at Cincinnati Children's Hospital says teenagers aged 16 and 17 will get the vaccine this week, and children between 12 and 15 years old will be enrolled in the trial later, CNN reported.

The drugmaker, which is in Phase 2/3 of its trial, enrolled more than 37,000 participants, and over 31,000 of them have received a second dose of the vaccine.

In September, the company expanded its enrollment to 44,000 to begin trials on teenagers as young as 16 and anyone with chronic, stable HIV, Hepatitis C, or Hepatitis B.

Pfizer is one of four companies currently in the U.S. to have a vaccine trial deep into Phase 3: Moderna, AstraZeneca, and Johnson & Johnson.

Johnson & Johnson had to pause its trial on Monday due to a participant getting an "unexplained illness."

AstraZeneca paused its trial on Sept. 8 due to "potential unexplained illness," but the company said on its website that it resumed the trial on Sept. 12.