Pfizer Vaccine Safe and Effective in Children Ages 5 to 11, Announces Company

Pfizer Vaccine Safe and Effective in Children Ages 5 to 11, Announces Company

Pfizer's coronavirus vaccine is safe and effective in children ages 5 to 11, the company announced Monday following the latest trials. 

According to their release, children given two doses of the vaccine 21 days apart — at a lower dose than adults receive — had comparable antibody responses to people ages 16 to 25 who participated in an earlier trial.

The younger children received doses that were a third the size of those administered to people 12 and older; vaccine side effects were also comparable to trial participants who were 16- to 25-years-old.

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Pfizer on Record - and Next Steps

“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 Albert Bourla, Chairman and Chief Executive Officer at Pfizer. 

“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,” Bouria continued. 

Pfizer and BioNTech plan to share these data with the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA) and other regulators as soon as possible. 

For the United States, the companies expect to include the data in a near-term submission for Emergency Use Authorization (EUA) as they continue to accumulate the safety and efficacy data required to file for full FDA approval in this age group. 

 

Delta Variant Hitting Children Hard

The announcement by Pfizer is significant as the number of cases for children has skyrocketed with the spread of the Delta Variant across the United States.