It was updated on April 28, 2022.
Moderna asked the FDA to allow the use of the Covid-19 vaccine in children under six years old, paving the way for the first coronaviruses shot to be available to infants and young children.
Emergency use authorization is needed for the Covid-19 vaccine.
Moderna has asked the FDA to approve emergency use of its vaccine for children ages 6 months through five years.
The vaccine was found to be one quarter the strength used for adults in its mid- to late-stage clinical trial.
The submission will be complete next week.
Similar requests are made with international regulators.
The company was proud to have started the application, which will be especially welcomed by parents and caregivers.
Moderna's shot will be the first coronaviruses vaccine available to children under five.
Moderna lags behind its main competitors in the vaccine market for teens and children, but it could be in a position to jump ahead of them in the vaccine market for young people. Pfizer's shot is only authorized for use in children five and up, and trials for younger groups are still ongoing after disappointing early results. Pfizer is testing a three-dose regimen in younger children to see if it will generate a stronger immune response.
Boosters for children. Moderna is studying booster doses for children six months and up. The original shot and a new booster containing the original formula and an omicron-specific component were to be tested to address slipping efficacy against the now-dominant variant. Pfizer asked the FDA to approve a booster dose for kids aged 5-11 after evidence of waning immunity emerged during the omicron surge.
Pfizer is asking the FDA to let it sell Covid Booster for kids.
Moderna will seek emergency use approval for low-Dose Covid vaccine.
Live updates on the coronaviruses.
All Rights Reserved © 2024
