Moderna said the FDA needs more time to complete its review of its Covid-19 vaccine for 12-to-17-year-olds before granting emergency use authorization.
said the Food and Drug Administration will need more time to complete its assessment of the biotech company's Covid-19 vaccine for children ages 12 to 17.
The agency is looking specifically at the risk of myocarditis in kids, Moderna said in a statement Sunday, and the review may not be completed before January 2022. Myocarditis is the inflammation of the heart muscle. "The company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," Moderna said.
Moderna also said it will delay filing a request for emergency use authorization for a smaller dose of the vaccine for younger kids ages 6 to 11 while the FDA completes its review.
Canada Latest News, Canada Headlines
Similar News:You can also read news stories similar to this one that we have collected from other news sources.
FDA Authorizes Pfizer's COVID-19 Vaccine For Children Ages 5 to 11More than 28 million children in the US are now eligible to get the vaccine.
Read more »
FDA authorizes Pfizer's Covid-19 vaccine for kids 5 to 11The US Food and Drug Administration issued emergency use authorization on Friday for Pfizer's Covid-19 vaccine for children 5 to 11. This is the first Covid-19 vaccine authorized in the United States for younger children.
Read more »
Pfizer-BioNTech Covid-19 Vaccine Authorized for Young Children by FDABreaking: Pfizer-BioNTech's Covid vaccine was cleared for use in children ages 5 to 11 by the FDA. Kids could get a first dose within days, once the CDC gives its sign-off.
Read more »
FDA Authorizes Pfizer's COVID-19 Vaccine for KidsFriday’s FDA authorization of the shots triggers the shipment of millions of doses to pediatricians, family practice doctors, children’s hospitals, community health centers, and pharmacies.
Read more »
The FDA Just Authorized Pfizer's COVID-19 Vaccine for Kids Under 12This is a major milestone.
Read more »