Pfizer and BioNTech say that their COVID-19 is safe and effective for children ages 5 to 11, according to a news release from the company.
The biopharmaceutical company now plans to submit data supporting the announcement to the U.S. Food and Drug Administration for emergency use authorization amid the coronavirus pandemic.
What are the details?
In a Monday news release, the company said that a trial including more than 2,000 children determined that the vaccine is "safe, well-tolerated, and showed robust neutralizing antibody responses" in the age group.
According to NBC News, children in the trial were given two smaller doses of the vaccine when compared with those doses given to Americans age 12 years and older. Both the antibody response and side effects seen in the young age group were said to be comparable to those seen in a similar study of people ages 16 to 25 years who received full doses of the COVID-19 vaccine.
Pfizer is now testing the vaccine in children younger than 5 years old and are said to expect trial results by the end of 2021.
WSTM-TV reported that Pfizer hopes to be able to offer vaccines to the 5-11 age group as early as Thanksgiving or Christmas.
Dr. Joseph Domachowske — lead investigator for Pfizer's pediatric COVID-19 vaccine trial — said that it's the "next step in progress" and that it's "happening at lightning speed."
"Even at the level of the federal agencies, they are literally dropping everything else and putting this at the top of their pile," he added. "That's why we're seeing this happening at lightning speed. It's not because we've changed the process or made it a riskier, less safe process at all."
In a statement on the news, Pfizer chairman and CEO Albert Bourla said, "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. 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."