The first results from the highly anticipated trial studying the effectiveness and safety of the Pfizer-BioNTech COVID-19 vaccine for children younger than 12 showed promising results.
The pharmaceutical companies said early results of trials indicate the shots are safe for children and establish a strong antibody response against the virus.
In its trial, Pfizer studied a lower dose in more than 2,200 kindergartners and elementary school-aged kids. The kids developed coronavirus-fighting antibody levels just as strong as teenagers and young adults.
Giving a two-dose regimen of 10 micrograms administered 21 days apart for children ages 5 to 11 was well tolerated, according to Pfizer and BioNTech. Side effects of the shots were also generally comparable to those of people age 16 to 25 who received the vaccine.
A dosage of 30 micrograms is used for people 12 and older. The dosage was selected as the preferred dose for safety and effectiveness in younger children.
News of the results comes 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.
"Over the past nine months, hundreds of millions of people ages 12 and older from around the world have received our COVID-19 vaccine. 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," Bourla said in a statement.
It will be some time before the general public can see an official rollout of vaccines for children under 12. Once trials are completed, Pfizer and BioNTech will submit the results to the Food and Drug Administration for review and possible approval.
That is likely several months away. Parents and caregivers will likely have to wait until the end of 2021 before a COVID-19 vaccine is fully approved for ages 5 to 11, Dr. Francis Collins, director of the National Institutes of Health, recently told NPR.
Trial results for children under 5 could come later this year, the pharmaceutical companies said.
Pfizer and BioNtech are hoping to get the trial's data submitted to regulatory authorities soon.
"Already in March 2021, we have started the study to evaluate the immunization of younger children. Our objective was to generate and submit the data for school kids to regulatory authorities around the world before the winter season begins," Ugur Sahin, CEO and co-founder of BioNTech, said.
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