September 20, 2021-With record numbers of COVID-19 cases reported in children, Pfizer and its partner BioNTech announced that their mRNA vaccine is safe for COVID-19 and appears to generate a protective immune response in children as young as 5 years old.
The companies tested a lower dose of the vaccine — only 10 milligrams — in children between the ages of 5 and 11. This is a third of the dose given to adults.
In a clinical trial involving more than 2,200 children, Pfizer says that two doses of vaccine given 3 weeks apart generated a high level of neutralizing antibodies, similar to the level seen in older children who had a higher dose of vaccine.
On the advice of its vaccine advisory committee, the FDA asked vaccine makers to include more children in these studies earlier this year.
Instead of testing whether the vaccines COVID-19 disease occurs in children, as in adults, the pharmaceutical companies that manufacture the COVID-19 vaccines look instead at the antibodies generated by the vaccines. The FDA has approved the approach in hopes of speeding up vaccinations for children, who are now in full-time school in most parts of the US
With that in mind, Evan Anderson, MD, a physician at Children’s Healthcare of Atlanta, an investigator for the trial – and therefore kept in the dark about the results – said it was important to keep in mind that the company does not share any efficiency data today.
“We do not know if there were cases of COVID-19 among children enrolled in the study and how it compared to those who received placebo compared to those who received vaccine,” he said.
The company says side effects seen in the trial are similar to those found in older children. The company said no cases of myocarditis called myocarditis were observed. Pfizer says they plan to send their data to the FDA as soon as possible.
The company says side effects seen in the trial are similar to those found 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 provide data to the regulatory authorities for this group of school-going children before the start of the winter season,” Ugur Sahin, managing director, CEO and co-founder of BioNTech, said in a news release. “The safety profile and immunogenicity data in children aged 5 to 11 years who were vaccinated at a lower dose are consistent with those we observed with our vaccine at a higher dose in other older populations.”
Asked how quickly the FDA could respond to Pfizer’s application, Anderson said others had speculated on timings of 4 to 6 weeks, but he also noted that the FDA could still exercise its authority on the company for more information. to ask, which can slow down the process mode.
As a parent myself, I would like to see the timeline take place quickly. However, I want the FDA to review the data completely and ask the necessary questions, ‘he said. “It’s a bit speculative to get too definite with timelines.”