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.
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 asks U.S. to authorize its COVID-19 vaccine for children under 6, which may make shots available by summer
The U.S. has wasted millions of covid-19 vaccine doses since the pandemic began, with many more ready to be tossed
Moderna on Thursday submitted a request to the Food and Drug Administration for emergency authorization of its COVID-19 vaccine for children younger than 6, a welcome development for parents.
Moderna has asked the FDA for authorization to give its vaccine to kids 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...
Moderna submits data to FDA, in hopes low-dose shots to protect babies, toddlers and preschoolers will be available by summer
Moderna submitted data to the U.S. Food and Drug Administration that it hopes will prove two low-dose shots can protect babies, toddlers and preschoolers from COVID-19.
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.
In the coming year, most COVID-19 vaccinations will be booster shots, or first inoculations for children, which are still gaining regulatory approvals around the world, they said.