Pfizer And BioNTech Say Vaccine Trial For Kids Shows Its Safe And Effective

A health worker administers a dose of a Pfizer COVID-19 vaccine during a vaccination clinic earlier this month at the Reading Area Community College in Reading, Pa.Matt Rourke/AP

The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children under 12 showed promising results.

The pharmaceutical companies said early results of their trial indicate the vaccine is safe for children and establishes a strong antibody response against the virus.

Giving a two-dose regimen of 10 μg (micrograms) administered 21 days apart for children between the ages of 5 and 11 years old was well tolerated, according to Pfizer and BioNTech. Side effects were also generally comparable to those of people between the ages of 16 and 25 years old who received the vaccine.

This trial used a smaller vaccine dosage, 10 micrograms, rather than the 30 microgram dose used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in young children.

News of the results come as pediatric cases of COVID-19 are increasing amid a nationwide surge of infections.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. — underscoring the public health need for vaccination. 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 FDA and other regulators with urgency,” said Albert Bourla, the chairman and CEO for Pfizer.