Moderna Asks FDA To Authorize Covid Vaccine For Children Under 6
The FDA has pledged to "move with all expediency" to review the company's data on a lower-dose kids' vaccine.
Shares of Moderna Inc. gained 2.1% in premarket trading on Thursday after the company said it filed for authorization of its COVID-19 vaccine in children between the ages of 6 months and 6 years old. The submission is set to be completed next week, and is broken out into two categories: 6 month olds to 2 year olds, for which the vaccine has a 51% efficacy rate, and children between the ages of 2 and 6 years old, for which the efficacy rate was 37%. The series has two shots. Moderna said these...
Dr Peter Marks, who heads up evaluation and research at the FDA, said: 'We are not going to delay things unnecessarily here. We would anticipate June authorizations for one or more pediatric jabs.'
The submission will kick off the review process that could finally deliver a vaccine for kids under 5, who are the only remaining group ineligible for vaccination.
The company says a low-dose version of its vaccine triggers an immune response in children ages 6 months to less than 6 years equivalent to what has protected older children and adults.
BioNTech SE and Pfizer Inc. said Tuesday that they asked the Food and Drug Administration to authorize a COVID-19 booster dose for children between the ages of 5 and 11 years old. Boosters are already authorized for teens and adults. The companies said data from a Phase 2/3 clinical trial yielded no new safety concerns when children in this age group received a booster six months after completing the primary series of shots. So far this year, BioNTech's stock has tumbled 43.6% and Pfizer...
Moderna has asked the FDA for authorization to give its vaccine to kids under 6.
If authorized, it will be the first COVID vaccine available for very young children.
Moderna on Thursday asked U.S. regulators to authorize low doses of its COVID-19 vaccine for children younger than 6.
Moderna asked the FDA to authorize its Covid vaccine for kids under 6. Young children are the only ones who can't be vaccinated yet.
Moderna announced Thursday that the company has asked the Food and Drug Administration to authorize a low-dose version of its COVID-19 vaccine as the first vaccine for children younger than age 5.