September 20, 2021 – With a record number of COVID-19 cases reported in children, 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 this young than 5.
The companies tested a lower dose of the vaccine – just 10 milligrams – in children aged 5 to 11. This is a third of the dose given to adults.
In a clinical trial involving more than 2,200 children, Pfizer claims that two doses of the vaccine given 3 weeks apart generated a high level of neutralizing antibodies, comparable to the level seen in older children who received a higher dose. high vaccine.
On the advice of its vaccine advisory committee, the FDA asked vaccine manufacturers to include more children in these studies earlier this year.
Rather than testing whether vaccines prevent COVID-19 disease in children, as they did in adults, the pharmaceutical companies that make COVID-19 vaccines are instead looking at the levels of antibodies generated by the vaccines. The FDA approved the approach in hopes of speeding up vaccines for children, who are now back in school full time in most parts of the United States.
With that in mind, Evan Anderson, MD, a physician with Children’s Healthcare in Atlanta who is an investigator for the trial – and is therefore being kept in the dark about its results – said it’s important to keep in mind mind that the company has not shared any efficiency data today.
“We don’t know if there were any cases of COVID-19 among the children who were enrolled in the study and how those who were compared to those who received a placebo versus those who received the vaccine, ”he said.
The company says the side effects seen in the trial are comparable to those seen in older children. The company said no cases of heart inflammation called myocarditis have been observed. Pfizer says they plan to send their data to the FDA as soon as possible.
The company says the side effects seen in the trial are comparable to those seen in older children. Pfizer says they plan to send their data to the FDA as soon as possible.
“We are delighted to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Ugur Sahin, MD, CEO and co-founder of BioNTech, in a Press 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 could act on Pfizer’s request, Anderson said others had speculated on a 4-6 week timeframe, but he also noted that the FDA could still exercise its authority. to request more information from the company, which could slow down the process. down.
“As a parent myself, I would like to see this timeline unfold quickly. However, I want the FDA to fully review the data and ask the necessary questions, ”he said. “It’s a bit speculative to be too definitive with the timelines.”