The FDA told Moderna it needs more time to review use of their COVID-19 vaccine for kids

moderna vaccine
A container of the Moderna COVID-19 vaccine is seen at the United Memorial Medical Center on December 21, 2020 in Houston, Texas.

Getty Images/Go Nakamura

  • Use of Moderna's vaccine in kids 12 to 17 years old will most likely be delayed to early next year.
  • The drug company said the FDA told them they needed more time to review.
  • The FDA is looking into the risk of myocarditis, a rare heart condition.

The Food and Drug Administration on Friday told Moderna it needed more time to review a rare heart risk from COVID-19 vaccines in youths before it could allow the emergency use of the vaccine in people between the ages of 12 and 17, the drug manufacturing company said on Sunday.

Moderna said the FDA told them they need more time to review the risk of possible myocarditis - a heart muscle inflammation - after vaccination, which could delay approval until after January 2022.

"The Company is fully committed to working closely with the FDA to support their review and is grateful to the FDA for their diligence," the company said in the statement.

The Wall Street Journal reported that myocarditis is usually caused by a viral infection and could lead to an abnormal heartbeat, heart failure, and in extreme cases, death.

The Centers for Disease Control and Prevention said there have been reports of the heart condition after mRNA vaccination, mostly in adolescent and young adult males, a few days after the second dose. The CDC added that in most cases, those who developed the condition responded well to medicine and felt better quickly.

The Journal added that the condition is much more common in children who get COVID-19 then developing it after vaccination.

Moderna also said it's committed to "conducting its own careful review of new external analyses as they become available."

Read the original article on Business Insider


from Business Insider https://ift.tt/2ZQftLU

Comments

Post a Comment

Popular posts from this blog

Zombie startups

Image
Welcome to Startups Weekly, a fresh human-first take on this week’s startup news and trends. To get this in your inbox, subscribe here. People leave jobs for all kinds of reasons, but when it’s a CFO departing a richly valued company as the company itself conducts layoffs, the exodus can be a sign of a larger issue. This was one of the takeaways I had when chatting with Continuum CEO and co-founder Nolan Church about a recent spree of CFO resignations, including but not limited to OpenSea, Noom and Brex. The founder reiterated that we don’t know the exact reasons that people are leaving, but he also noted that it’s a red flag from a recruitment perspective. He also introduced me to the idea of zombie companies, which I appreciated as it is officially spooky season and we love a festive framework. Zombie companies are basically companies that raised a ton of money over the boom cycle but aren’t producing nearly enough revenue to justify the valuation. The late-stage market is full o...
Read more

Guilherme Rambo, who has published scoops about unreleased Apple products by examining beta software, says Apple locked his dev account with no stated reason (Buster Hein/Cult of Mac)

Image
Buster Hein / Cult of Mac : Guilherme Rambo, who has published scoops about unreleased Apple products by examining beta software, says Apple locked his dev account with no stated reason   —  Guilherme Rambo, one of the top Apple secret-spillers, says Apple locked him out of his developer account, preventing … from Techmeme https://ift.tt/37pX6fR
Read more

Minneapolis Mayor Jacob Frey wins tough reelection fight over a slew of challengers

Image
In this Feb. 17, 2021 file photo, Minneapolis Mayor Jacob Frey addresses the media in Minneapolis. Richard Tsong-Taatarii/Star Tribune via AP, Pool File What's at stake: Minneapolis' first-term Mayor Jacob Frey won reelection against numerous challengers in the city's ranked-choice election, where all candidates ran on the same ballot. The main Democratic Farmer-Laborer challengers to Frey were former state lawmaker Kate Knuth, community organizer Sheila Nehzad, Cedar-Riverside Community Council leader AJ Awed, and attorney Clint Conner . A smattering of Republican, independent, and third-party candidates also ran. Frey has faced local and national scrutiny for his handling of crime and policing issues in the city following the murder of George Floyd at the hands of Minneapolis police officer Derek Chauvin and the ensuing months of protests and civil unrest that Floyd's murder sparked around the country. The spotlight on that shooting made police and publ...
Read more