Moderna says its vaccine for ages under 6 will be ready for U.S. review in June -Breaking
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© Reuters. FILE PHOTO – This illustration, taken on January 16, 2022, shows a vial labeled “Moderna COVID-19 Vaccine”. REUTERS/Dado Ruvic/Illustration/File PhotoBy Doina Chiacu
WASHINGTON (Reuters). Moderna (NASDAQ:) Inc’s chief Medical Officer stated that on Sunday, the company’s vaccines for children below 6 years will be available for review by a Food and Drug Administration panel at its June meeting.
Moderna applied for an FDA emergency use authorization on Thursday.
In June, an advisory panel consisting of representatives from the U.S. Drug regulator will review the request.
“I believe that the FDA now has the essential data necessary to allow them to review applications. According to Dr. Paul Burton (the company’s chief physician), “So yes, we feel very confident,” he said during an interview with CBS’ Face the Nation.
Moderna could become the first vaccine to be approved for U.S. children younger than 5. Pfizer Inc (NYSE: ) expects that its data on vaccines for children below 6 years old will be available by June’s review.
Burton stated that the safety profile of this vaccine for very young children is very encouraging – rates of safety events are lower than what we have seen from 6-year-olds through 12-year-olds, and that’s fantastic.
Moderna’s vaccination is now approved by FDA to be used in adults aged 18 or older. The FDA has yet to approve the vaccine for children aged 6-17 years in the United States, even though it was approved for such a age in Australia and Canada. The U.S. regulatory authorities have requested more safety data from the company.
Burton stated that the company will test a second booster shot, which he thinks is superior to the booster results announced by the company on April 19. These booster shots are for the Beta and original coronavirus variants.
Moderna believes that he will have large amounts this fall of a booster vaccine to help protect him against Omicron variants.
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