Pfizer and Moderna urged to expand COVID vaccine studies of children 5 to 11
|Toronto Star 26 Jul 2021 at 14:53|
The Food and Drug Administration told the companies that the initial size and scope of their pediatric studies were inadequate to detect rare side effects.
The side effects include myocarditis, an inflammation of the heart muscle, and pericarditis, inflammation of the lining around the heart, The New York Times reported.
The FDA has asked the companies to include 3,000 children in the 5-to-11 year old age group.
A Moderna spokesman said the company intends to expand its trial “to enrol a larger safety database which increases the likelihood of detecting rarer events” and expects to seek emergency authorization in “winter 2021/early 2022.”
Pfizer may be able to meet the FDA’s expectations on a bigger trial size and still file a request to expand emergency authorization of its vaccine by the end of September, the Times reported.
Pfizer has said it expects to have results for the 5-to-11-year old group in September, with results for children aged 2 to 5 shortly after. Results for the youngest children between the ages of six months and 2 are expected in October or November.
The Centers for Disease Control and Prevention published data showing that the two vaccines may have caused myocarditis and pericarditis in more than 1,200 Americans, including about 500 who were younger than 30.
In June, Dr. Juan C. Alejos, medical director of the pediatric heart transplant and cardiomyopathy program at UCLA Health, told The street that “the incidents of this are tiny compared to the number of people who are getting vaccinated.”
Last week, Pfizer and its partner, BioNTech (BNTX) said they had submitted a biologics license application to the FDA to gain full clearance for their COVID-19 vaccine.