A study of the Pfizer-BioNTech COVID-19 vaccine in children ages 5 to 11 indicates it is safe and effective for children, the pharmaceutical companies announced on Monday. Local doctors said it’s an exciting step towards getting more kids vaccinated.
“My initial reaction was one of joy,” said Dr. David Dausey, the executive vice president, provost, and professor of medicine and health sciences at Duquesne University.
The vaccine was “safe, well tolerated and showed robust neutralizing antibody responses,” in study participants, whose ages ranged from 5 to 11, Pfizer said in a statement. The results are the first from any trial of the COVID-19 vaccine in kids younger than 12.
“I was happy that the antibody response in kids was robust,” said Dr. Brian W. Donnelly, a general pediatrician at Allegheny Health Network. He also noted that some parents and teachers have been anxious to get their young children vaccinated, and that the announcement could help them “feel better about things.”
Currently, COVID-19 vaccines are only approved for people ages 12 and older.
Some trial participants received two doses of 10 micrograms of the vaccine. People 12 and older receive 30 microgram doses. Pfizer said the smaller dosage was “selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age.”
According to Dausey, the reduced dosage will still offer kids the same protections adults get from the vaccine.
“Whenever you’re taking any medication your size obviously matters. But also, in the example of vaccines, the development of your immune system matters as well,” he said. “You have to always assume that you have to make adjustments for, not only their size and development, but also the capacity of their immune system.”
COVID-19 cases in children have surged in Allegheny County and across the country in recent months. According to the Allegheny County Health Department, there were 67 cases among children 12 and younger in June. In July there were 157 cases in children in that age group, and in August there were 773 cases. UMPC’s Children’s Hospital of Pittsburgh reported a “huge” increase in patient volumes over the last several weeks.
“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,” Pfizer chairman and CEO Albert Bourla said in a statement.
As cold and flu season begins, Dausey and Donnelly said vaccinating more children against COVID-19 could help reduce the strain on local hospitals and health care facilities.
“As kids get together and things open up and adults can mix germs more, there’s going to be more illnesses, and that’s been the case around the country," Donnelly said. The hospitals are saying ‘we’re getting full here,’ and there’s a lot of people getting sick. If the vaccine can help with the COVID part and we can start to give influenza vaccines, then hopefully that will lessen the blow.”
Though local health experts say the initial study results are promising, the data has not yet been published or peer-reviewed. It could take some time for health care officials to review the data and give the vaccine full approval. Pfizer and BioNTech said they will submit their findings to the U.S. Food and Drug Administration and other regulators “as soon as possible.” The FDA must approve the vaccine for emergency use authorization, and eventually give it full FDA approval, before kids can get it.
Donnelly said, if the authorization process moves quickly, younger kids could be vaccinated as early as October.
Pfizer and BioNTech are also conducting COVID-19 vaccine trials for both children aged 2 to 5 years old and infants and toddlers aged 6 months to 2 years. Initial results for those studies are expected later this year.
In the meantime, health officials advise unvaccinated children to wear masks, social distance when necessary, and monitor for signs of the virus.
