Moderna said on Monday that it could expand the size of its COVID-19 vaccine trial for young children, as Pfizer and Moderna plan to seek approval from the Food and Drug Administration to vaccinate some of the youngest Americans later this year.
Both drugmakers based their COVID-19 vaccines on a new platform technology, mRNA, and rare cases of heart inflammation have been reported in people under the age of 30 who have been vaccinated with mRNA vaccines. So, health officials and FDA advisers are hoping that expanding the size of the trials might help detect this and other possible rare side effects in young children.
“We intend to expand the trial and are actively discussing a proposal with the FDA. The goal is to register a larger safety database that increases the likelihood of detecting rarer events.” , a Moderna spokesperson said in a statement.
The FDA said in the past it had researched as many as 3,000 trial participants before authorizing other vaccines for children, and due to the use of mRNA, the FDA suggested in June that “an appropriate global pediatric safety database would approach the upper end of this range.”
Moderna and Pfizer have both announced clinical trials of doses of their COVID-19 vaccines to be tested in children as young as 6 months old.
Moderna says she may be able to apply for emergency FDA clearance by winter for these groups, which could allow her doses to be administered to young American children as early as next year. The drugmaker announced last month that it had applied for an emergency use authorization to vaccinate adolescents as young as 12.
A spokesperson for Pfizer declined to say if it also plans to expand the size of its pediatric vaccine studies, which plan to enroll up to 4,500 participants from the United States and a handful of European countries. .
Pfizer, currently the only COVID-19 vaccine authorized in the United States for teens as young as 12, is awaiting “first results” from its trials in children 5 to 11 years old by September. Results for other groups as young as six months could arrive “in October or November”, possibly allowing Pfizer to obtain emergency clearance to immunize all school-aged children by the end. of the year.
“We anticipate that we will have enough data by the end of fall, into early winter, to know whether or not these vaccines – which we totally predict they will be – will be safe and should be. effective in children of all ages, “Dr. Anthony Fauci, chief medical adviser to President Biden, told the Arkansas Democrat-Gazette last month.
The expanded trial was first reported by The New York Times.
An FDA spokesperson declined to comment, adding that the regulator typically works with drug companies to ensure trials “are of sufficient size to detect safety signals.”
While young children typically suffer from less severe cases of COVID-19 than adults, the CDC has warned that studies suggest that the rates of the disease spreading among children “may be comparable, and in some cases higher, than in adults ”.
With federal and local health officials urging schools to fully reopen for in-person teaching this fall, some officials have warned that large swathes of unvaccinated adults could be susceptible to further flare-ups when school starts.
“At the best of times, it’s a tough summer and more and more people are getting vaccinated. And a more realistic case is that fall gets even worse, as more and more people will be indoors and the kids will hopefully be back in school. And we have pockets across the country where there are a lot of unvaccinated people, ”Dr. Anne Schuchat, outgoing CDC second-in-command, told INFORMS Healthcare 2021 last week.
“We really need to step up vaccination on a large scale,” Schuchat added later.