Sept. 20, 2021 -- With record numbers of COVID-19 cases being reported in kids, Pfizer and its partner BioNTech have announced that their mRNA vaccine for COVID-19 is safe and appears to generate a protective immune response in children as young as 5.
They have tested a 10 mg dose of vaccine on children aged between 5 and 11 years. That’s one-third the dose given to adults.
Pfizer claims that three doses of the vaccines were given to more than 2200 children in a clinical study. The results are comparable to those seen in older children who receive a larger dose.
According to its vaccine advisory committee the FDA requested vaccine companies include more children in this study earlier this year.
The vaccine companies making the COVID-19 vaccines now focus on the antibodies generated by vaccines, rather than testing whether vaccines prevent COVID-19 disease in children as they do in adults. The FDA has approved the approach in hopes of speeding vaccines to children, who are now back in school full time in most parts of the U.S.
With that in mind, Evan Anderson, MD, a doctor with Children’s Healthcare of Atlanta who is an investigator for the trial — and is therefore kept in the dark about its results — said it’s important to keep in mind that the company didn’t share any efficacy data today.
“We don’t know whether there were cases of COVID-19 among children that were enrolled in the study and how those compared in those who received placebo versus those that received vaccine,” he said.
Side effects reported in the trial are similar to what is seen in older kids, according to the company. According to the company, there was no evidence of myocarditis (heart inflammation) in any cases. Pfizer plans to submit their data to FDA as quickly as possible.
Side effects observed in the trial were similar to what is seen in older kids, according to Pfizer. Pfizer states that they will send the FDA their data as soon as possible.
“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,” Ugur Sahin, MD, CEO and co-founder of BioNTech, said in a news release. “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.”
When asked how soon the FDA might act on Pfizer’s application, Anderson said others had speculated about timelines of 4 to 6 weeks, but he also noted that the FDA could still exercise its authority to ask the company for more information, which could slow the process down.
“As a parent myself, I would love to see that timeline occurring quickly. However, I do want the FDA to fully review the data and ask the necessary questions,” he said. “It’s a little speculative to get too definitive with timelines.”