A Moderna COVID-19 vaccine for children six months to five years could be on the way. On Thursday, the vaccine manufacturer submitted a proposal to the U.S. Food and Drug Administration to authorize the emergency use of its vaccine.
Moderna guarantees the safety and efficacy of its vaccines for young children. Chief executive officer of Moderna, Stéphane Bancel, said in a news release:
We like to see anything above 1,000 units, and what we, in fact, saw here are levels somewhere between 1,400 and 1,800 units. So that’s extremely reassuring.
No COVID-19 vaccines for children in the U. S. were authorized, and the authorization timeline was unclear and left 18 million children over the age of five unprotected.
Moderna officials stated they expect the FDA to move fast as the Pfizer vaccine for younger children could be available in June.
Director Dr. Peter Marks of the FDA Center for Biologics Evaluation and Research said that vaccines for younger children are their highest priority. However, the agency needs a complete application from the vaccine manufacturers to finish its review.
The FDA will also invite independent vaccine advisers to consider vaccines for younger children. Marks said the agency would release a timeline for the advisory panel sessions.
Moderna Vaccine Results
In late March, Moderna declared the outcomes of a clinical trial including 2,500 children ages six months through 24 months and 4,200 children ages two through five. The drugmaker said that two 25-microgram doses of its vaccine have an identical immune reaction in young children as two 100-microgram doses for ages 18 through 25. And it confirmed that this could protect children to six months of age from Covid-19 and severe Covid-19.
In Thursday’s news release, the chief medical officer of Moderna, Dr. Paul Burton, said:
We like to see anything above 1,000 units,and what we, in fact, saw here are levels somewhere between 1,400 and 1,800 units. So that’s extremely reassuring.
Burton also stated that the vaccines are safe for this particular age level. The most common reactions were fever and pain at the injection site. In the study, there were reports of myocarditis or heart inflammation. Heart inflammation was a rare side effect of the mRNA vaccines, and myocarditis was more common after Covid-19 infection than after vaccination.
The data submitted by Moderna last Thursday was only limited to the analysis of confirmed positive cases by sensitive PCR tests. The Moderna vaccines were proven to be 51% effective at preventing symptoms in children six months to two years and about 37% effective in averting symptoms in kids ages two through five. The efficacy estimates are similar with grown-ups against Omicron after two doses.
Boosters for Younger Children
Burton said last Wednesday that Moderna was likewise testing boosters and variant-specific formulations. He said:
Our lead candidate now is something against the original strain and Omicron. And I think for these young kids, what we’ll have to do is to continue to follow the natural history and see, what is the variant? What’s going on with the little kids as we get into the fall? And then the FDA and CDC and regulators around the world can make recommendations on whether they need another booster later in the year.
Written by Janet Grace Ortigas
Edited by Cathy Milne-Ware
CNN Health: Moderna seeks emergency use authorization for Covid-19 vaccine for children ages 6 months through 5 years: by Brenda Goodman
MSN: Moderna Seeks Emergency Use Authorization For COVID-19 Vaccine For Children Ages 6 Months Through 5 Years
NBC News: Moderna asks FDA to authorize Covid vaccine for children under 6; by Berkeley Lovelace Jr.
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