Pfizer says its COVID-19 vaccine is safe in kids 5 to 11

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CHARLESTON, S.C. (WCBD) – Pfizer and BioNTech are one step closer to supplying more Americans with COVID-19 vaccines. An announcement Monday morning from the company says after thorough trials, a smaller dose of the Pfizer vaccine was found to be safe and effective for children ages five to eleven.

“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, Pfizer.

Now Pfizer and BioNTech are compiling data, results, and other information to send to the Food and Drug Administration (FDA) as they are applying for Emergency Use Authorization.

Dr. Alison Eckard, a pediatric infectious disease expert at the Medical University of South Carolina says this update is very welcome and something she and many others have been waiting to hear.

“We’ve been waiting for quite a few months to hear that they are in a position to submit their data to the FDA for, hopefully, approval in this younger age group,” said Dr. Eckard.

The main difference between the vaccines for this younger age group and those for adolescents and adults is the dosage. According to a release from Pfizer and BioNTech, children would receive one-third of the dose that an adult would receive. The process, though, remains the same with two shots administered a few weeks apart.

This development comes as the American Academy of Pediatrics reports a steep increase in the number of COVID-19 cases among children across the United States, according to a recent report.

Dr. Eckard says she has seen more children being hospitalized with the virus since the beginning of July.
“Since about July and particularly in August, we have seen a dramatic shift. We think it’s partly related to how infectious the delta variant is,” she said.

When the vaccine does become available for young children, it will be another tool to protect children from COVID-19. Currently, masking and social distancing are the two measures being taken.

MUSC has been working to research and gauge interest from parents in vaccinating their younger kids and Dr. Eckard says so far, interest is high. That’s based on clinical trials conducted by the hospital.

“People are coming from all parts of the state, sometimes even outside of the state, to ask us if they can enroll their younger children in our trial,” she said. “So, we’ve seen a great amount of interest in vaccinating this younger age group and I think that the main reason is that they recognize how vulnerable this age group is.”

It could still be at least a few months before the FDA decides whether or not to grant Emergency Use Authorization to Pfizer for this age group.

At one point, Pfizer said they were hopeful it would be by Halloween. Dr. Eckard says that could be a stretch, but she hopes it’s sooner rather than later.

“I’m hoping that because we have more data now in the older children, perhaps the process won’t take so long. That would be ideal for that approval to roll out prior to the Christmas holiday and the winter break for many of these schools.”

As for setting up vaccine clinics in schools, Dr. Eckard says MUSC has been in talks with districts, including the Charleston County School District, to figure out the best way to roll out the doses. More details will become available once the vaccine gains approval from the FDA and production begins.

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