Pfizer
"Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S.--underscoring the public health need for vaccination," Pfizer CEO Albert Bourla said in a press statement Monday. "These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the [Food and Drug Administration (FDA)] and other regulators with urgency."
Pfizer's and BioNTech's joint COVID vaccine has been authorized for emergency for people as young as 12, with the shot being fully approved for Americans aged 16 years and older. If the FDA spends as much time reviewing the trial's data as it did for the young adolescent age range, then the children's vaccine doses could be authorized for emergency use by the end of October.
The trial, which included more than 2,200 children, tested a two-dose regimen of 10 micrograms given three weeks apart; that dosage size is about a third of the amount used for adolescents and adults. The data showed that the shots were well tolerated in younger participants and produced an immune system response similar to those seen in participants ages 16 to 25 years old.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine," Bourla added. "We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children."
The two companies plan to release clinical trial data on the effectiveness of their COVID vaccine in children between the ages of 6 months to 5 years old as early as the end of October.
Moving forward, the FDA is expected to issue a decision this week on which populations will be eligible for a third dose, better known as booster shot, of the Pfizer-BioNTech vaccine to increase the shot's effectiveness against infection. Last week, an FDA independent advisory panel only recommended booster shots for people aged 65 years and older, with the group determining that there is not enough data to support broad distribution of booster shots to the general population.
