Pfizer Says Covid-19 Vaccine Safe for Kids Ages 5 to 11

Photo Courtesy Pfizer 

Hope may finally be on the horizon for America’s kids. 

Monday, the same day data compiled by Johns Hopkins University confirmed Covid-19 as the deadliest pandemic in the country’s modern history with 675,000 U. S. fatalities reported, Pfizer announced a trial studying the effectiveness and safety of the Pfizer and BioNTech COVID-19 vaccine for children ages 5 to 11 generated a "robust" antibody response.

Today with @BioNTech_Group, we are proud to announce positive topline results from the pivotal trial of our #COVID19 vaccine in children 5-11 years of age. https://t.co/a1mSEgxNHQ pic.twitter.com/9xGfYEzFuy

— Pfizer Inc. (@pfizer) September 20, 2021

“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,” Albert Bourla, the chairman and CEO for Pfizer, said in a statement touting the early victory. “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.”

The study was conducted on a group of 2,628 children 5 to 11 years of age using 10-microgram dosages —as opposed to the 30-microgram ones used for those 12 and older — of the vaccine administered three weeks apart. According to Pfizer and BioNTech the vaccine “was safe, well tolerated and showed robust neutralizing antibody responses.” The companies said side effects were generally comparable to those observed in participants 16 to 25 years of age.

The strong results are a reason for optimism at a time when a surge of pediatric infections has swept the nation, but it could be some time before a rollout of the vaccine. 

The companies expect to include the data in a “near-term submission” for Emergency Use Authorization while they continue to accumulate the data needed to file for FDA approval for those in the age group. Trial results for children 2-5 years of age and children 6 months to 2 years of age are expected as soon as the fourth quarter of this year.