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Pfizer Says Its Vaccine Is Safe in Kids 5-11 — Here’s What Comes Next

A smaller dose of Pfizer’s COVID-19 vaccine saw a “robust” immune response in children ages five to 11, according to data from Pfizer and BioNTech’s latest trial announced early Monday. 

The companies said in a press release that the trials tested two-doses of 10 micrograms (a third of the adult/teen dosage of the Comirnaty vaccine) with three weeks between doses and found that the vaccines produced a “robust” immune response within a month after their second dose and saw minimal side effects similar to those experienced by individuals age 16-25.  

As SheKnows has previously reported, the Pfizer/Biotech vaccine is an mRNA vaccine (like the one from Moderna — both entirely different from the Johnson & Johnson vaccine) have so far been cleared for and recommended for adults (including elderly, pregnant and breastfeeding adults) and children as young as 12. According to the CDC, mRNA vaccines “teach our cells how to make a protein—or even just a piece of a protein—that triggers an immune response inside our bodies. That immune response, which produces antibodies, is what protects us from getting infected if the real virus enters our bodies” instead of other vaccines that put weakened or inactive germs into our bodies to trigger an immune response. 

“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, Chairman and Chief Executive Officer, Pfizer, said in a press 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. These trial results provide a strong foundation for seeking authorization of our vaccine for children five to 11 years old, and we plan to submit them to the FDA and other regulators with urgency.”

As this complicated mid-pandemic back-to-school season began, parents and health officials alike were eager for more information on vaccination availability and safety for kids under the age of 12. The urgency is palpable, per the American Academy of Pediatrics (AAP), which has noted an increase in COVID-19 cases in children since the start of the pandemic — finding that between August 26 and September 9 of this year there was a 10 percent increase in the cumulated number of cases. Anecdotally, there have also been cases of partially-vaccinated families being exposed to the virus due to unvaccinated kids navigating school environments.

So the numbers look good — what happens next? 

“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO and co-founder of BioNTech. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”

Following this data from Pfizer, however, the company says we’re a bit closer to getting a timeline for kids to be eligible for the shot — with the hope that data will be submitted to agencies and evaluated ASAP. Per Pfizer, the next steps include sending the data with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) while also submitting the data for Emergency Use Authorization (EUA) in the United States. They also say they anticipate the next rounds of data for younger children (aged two to five and six months to two years) to drop by the end of 2021.

Looking for child-friendly face masks? This kids face mask gallery is a good place to start shopping!

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