Pfizer plans to apply for emergency authorization from the Food and Drug Administration, as they continue clinical trials on children as young as 6 months

By Glenn Garner
May 05, 2021 04:29 PM
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As President Joe Biden seeks to have the United States reach herd immunity by July 4, pharmaceutical companies are developing COVID vaccines for younger age groups.

Pfizer is planning to apply for emergency authorization from the Food and Drug Administration to use their vaccine on children aged 2 to 11 by September, according to The New York Times.

The news comes as Pfizer and Moderna continue their vaccine trials on children as young as 6 months old. "Together with our partner BioNTech, we have dosed the first healthy children in a global Phase study to further evaluate the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 vaccine (BNT162b2) in preventing COVID-19 in healthy children 6 months to 11 years old," a spokesperson for Pfizer recently told PEOPLE in a statement.

"We are proud to start this much needed study for children and families eagerly awaiting a possible vaccine option," they added. "We anticipate early safety results from this study could be available in the second half of 2021."

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The FDA is expected to issue emergency authorization next week for use of the vaccine in children ages 12 to 15, as they make up 22% of all U.S. COVID cases. It comes after Pfizer announced that their Phase 3 trials with the age group "demonstrated 100% efficacy and robust antibody responses."

The Pfizer-BioNTech vaccine was the first in the United States to receive emergency authorization in December, which is meant to be temporary, and can be revoked when the public health emergency is over. Full FDA approval would mean they can market the vaccine directly to consumers, but the approval process would likely take months.

Full approval could make it easier for companies, government agencies, schools and other entities to require vaccination. It could also help boost the public's confidence in the COVID vaccine.

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President Biden has recently refocused his administration's vaccination efforts on the vaccine "doubters," among other groups, as he aims to have 70% of adults get at least one dose of the vaccine by Independence Day. "I'd like to get it 100%, but I think realistically we can get to that place between now and July Fourth," he said Tuesday, according to the Associated Press.

The president also acknowledged that "the pace of vaccination is slowing," as the Centers for Disease Control and Prevention reports that 32% of the population has been fully vaccinated, and 44.5% have received at least one dose.

"You do need to get vaccinated," Biden added from the White House. "Even if your chance of getting seriously ill is low, why take the risk? It could save your life or the lives of somebody you love."