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October 7, 2021

Pfizer and BioNTech Say Their COVID Vaccine is Safe for Younger Kids

Pfizer and BioNTech Say Their COVID Vaccine is Safe for Younger Kids

Pfizer and BioNTech say their vaccine is safe, well-tolerated, and effective for children between 5 and 11-years old. On September 20, the companies announced results from a Phase 2/3 trial, which found their vaccine produced a "robust" antibody response in this younger age group. They plan to submit their findings to the U.S. Food and Drug Administration (FDA) for authorization as soon as possible.

“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,” said Pfizer Chairman and CEO, Albert Bourla in a news release.

“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S., underscoring the public health need for vaccination,” Bourla added. “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.”

Cases rising among kids
The number of people testing positive for the infection has increased dramatically since July amid the rise of the highly contagious Delta variant.

Unvaccinated people account for the vast majority of these cases—a growing number of them are kids.

As of September, roughly 5.3 million children tested positive for COVID-19 since the pandemic began, accounting for about 15.5 percent of all infections. But in just the first two weeks of September, nearly 500,000 new child cases were reported, according to the American Academy of Pediatrics (AAP).

The AAP also noted that between September 2 and September 9, a total of 243,373 child COVID-19 cases were reported, making up almost 30 percent of the weekly tally. This is the second highest number of child cases in any given week since the start of the pandemic.

Dosing is different for younger kids
Parents considering vaccinating children younger than 12 should wait until the vaccine is authorized for this younger age group. Why? Kids aren’t smaller adults and the dosage for younger kids is different than teens and adults.

The trial included 2,268 children between 5 and 11-years old. Like teens and adults, these younger kids were given two doses of the vaccine 21 days apart. But they received a lower dose of 10-micrograms. People ages 12 and older get two 30-microgram doses.

Pfizer and BioNTech point out this dose was chosen carefully to ensure its safety and tolerability among younger people, while ensuring its effectiveness.

The trial showed the vaccine triggered a similar antibody response in these younger children to the response reported in trials among teens and adults. The vaccine was also well-tolerated, resulting in side effects comparable to those experienced by those between 16 and 25-years old, with few mild to moderate temporary side effects, such as sore arms, fever or achiness.

What happens now
Pfizer and BioNTech said they plan to submit their data to the FDA as soon as possible for Emergency Use Authorization (EUA). Research, however, will be ongoing as the companies continue to compile the safety and efficacy data needed for full approval in the United States.

“The agency will carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” said acting FDA Commissioner, Janet Woodcock MD, and Peter Marks, MD, PhD, director of FDA's Center for Biologics Research and Evaluation in a September 10 statement.

U.S. health officials reportedly estimate that the Pfizer vaccine could be authorized for children as young as 5-years old by the end of October.

Pfizer and BioNTech also plan to submit their full Phase 3 trial findings for scientific peer-reviewed publication.

The Pfizer-BioNTech vaccine is the only FDA-approved COVID vaccine in the United States for people ages 16-years and older, and it’s the only COVID vaccine authorized use among younger teens between 12 and 17-years old.

The Moderna and Johnson & Johnson COVID vaccines are also authorized by the FDA for adults ages 18 and older under EUA.  

All teens included in the Pfizer trial will continue to be monitored for two years after receiving their second dose of the vaccine. Researchers will not only be analyzing the long-term safety of the shots but also tracking the teens’ immunity to COVID-19 over time.

Pfizer is also evaluating the safety and effectiveness of its two-dose COVID-19 vaccine among children between 2 and 5-years old as well as babies and toddlers between 6-months and 2-years old.

American Academy of Pediatrics. “Children and COVID-19: State-Level Data Report.” Sep 13, 2021.
U.S. Food and Drug Administration. “FDA Will Follow The Science On COVID-19 Vaccines For Young Children.” Sep 20, 2021.