Dubai, United Arab Emirates (CNN) – Moderna is seeking emergency use authorization from the US Food and Drug Administration for its vaccine once morest “Covid-19” for children aged 6 months to 5 years, according to a statement. company Thursday.
“We believe mRNA-1273 will be able to secure these children’s safe protection from SARS-CoV-2, which is very important in our ongoing fight once morest COVID-19,” said Stefan Bansell, CEO of Moderna, in the statement. and caregivers in particular.
None of the COVID-19 vaccines have been approved for use in children under the age of 5 in the United States, which number regarding 18 million, and the timeline for a possible licensing is not yet clear. Moderna officials expect the agency to move quickly, and a Pfizer official said its vaccine for younger children might be available in June, if authorized.
This week, Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biological Evaluation and Research, called vaccines for younger children “one of our highest priorities,” but acknowledged that the agency needed full applications from vaccine manufacturers to be able to finish its review.
The Food and Drug Administration will ask its independent vaccine advisors to give their opinion of vaccines for younger children as well, and Marks said the agency will release a schedule for advisory committee meetings next week.
Moderna vaccine results
In late March, Moderna announced the results of a clinical trial involving 2,500 children aged 6–24 months, and 4,200 children aged 2–5 years. The company said two doses of the 25-microgram vaccine resulted in an immune response in young children similar to two doses of 100 micrograms for adults aged 18 to 25 years. She said this expected protection from “Covid-19” and the severe disease it caused up to the age of 6 months.
In a press release issued Thursday, the company said the data showed a “strong antibody response” and “appropriate safety data.”
“We’d like to see anything over 1,000 units, and what we’ve seen here are levels between 1,400 and 1,800,” Moderna chief medical officer Dr. Paul Burton said Wednesday. “So it’s very reassuring.”
Burton also noted that vaccines were very safe for this age group. The most common reactions were pain at the injection site and heat. No cases of inflammation of the heart or myocarditis were reported in the study.
Most of the results announced in March during the “Omicron” wave, and included a home test for “Covid-19”. In conclusion, the company found that the vaccines appeared to be less effective for children than they were in the older age groups.
The data provided by “Moderna” on Thursday was limited to analyzing cases that were confirmed to be positive following conducting a sensitive PCR test. In the revised analysis, vaccines were 51% effective in preventing symptoms in children aged 6 months to less than 2 years, and 37% effective in preventing symptoms in children aged 2-5 years. These efficacy estimates are similar to those for adults once morest Omicron following two doses, the company said.
Boosters for young children?
On Tuesday, Pfizer asked the US Food and Drug Administration to give the green light for a third dose or a booster dose for children aged 5 to 11 years. Studies have shown that vaccine efficacy has diminished significantly in this age group during the Omicron outbreak.
Burton said Wednesday that Moderna was also testing booster doses, including formulations for mutants.
“Our lead candidate is now an anti-Omicron native strain,” he said, predicting the fall-winter booster formula.
“And I think for these young children, we have to continue to follow the natural historical path and see, what is mutating? What is going on with younger children as we approach fall? Then the Food and Drug Administration, the US Centers for Disease Control and Control, and regulators around the world can Make recommendations on if they need another booster later in the year.”
What’s next for vaccinations for younger children
The US Food and Drug Administration will evaluate Moderna’s report, and indicated that it will convene the Vaccines and Related Biological Products Advisory Committee meeting to express an opinion on licensing the vaccine for younger children. And if the FDA allows it, the vaccine advisors at the US Centers for Disease Control and Control will vote on whether it should be recommended. The agency director will then need to sign the vaccine recommendation before the vaccines are given.
Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, said that the Food and Drug Administration is considering whether to consider emergency use authorization for both the “Covid-19” vaccines for “Moderna” and “Pfizer/BioN Tech” for young children at the same time. Instead of looking at them separately.
