Moderna Seeks FDA Approval For Updated COVID-19 Shot For Kids, But Scrambles Supply Challenges

Moderna Seeks FDA Approval For Updated COVID-19 Shot For Kids, But Scrambles Supply Challenges
  • Last week, Moderna Inc MRNA said it asked the FDA to authorize the use of its updated booster shot in children ages 6 to 17. The company expects to complete a request for the use of the booster in children six months through 5 years later this year.
  • But federal officials have advised state officials that there is a limited supply of updated booster shots for Moderna.
  • Vaccine sites have either canceled or stopped scheduling new appointments for people seeking a Moderna booster shot. 
  • Hence, the vaccine providers are offering the new COVID-19 booster shot only from Pfizer Inc PFE and BioNTech SE BNTX.
  • A Moderna spokesman said the company anticipates resolving constraint issues in the coming days, WSJ reported.
  • "We are working closely with the U.S. government to deliver significant amounts of updated, bivalent booster doses as we continue to see high demand in certain areas of the country," the report quoted the spokesman.
  • A manufacturing-quality problem at a contract manufacturer caused a shortage of Moderna's new booster shot.
  • FDA inspection found several potential violations of drug-manufacturing standards at Catalent Inc's CTLT plant this August.
  • The inspectors said Catalent didn't properly investigate findings of visible particles in certain products.
  • Moderna said booster shot supply could improve within days after the FDA cleared the release of about 10 million doses that had been held up over the production issue.
  • The company still expects to deliver 70 million doses of its updated booster shot by the end of this year.
  • Price Action: MRNA shares are trading lower by 1.08% at $122.30 in the premarket on Monday.

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