US FDA delays decision on Moderna's Covid vaccine for adolescents: Report

The FDA and Moderna did not immediately respond to requests for comment
The US health regulator is delaying its decision on authorizing Moderna Inc's COVID-19 vaccine for adolescents to check if the shot could increase the risk of a rare inflammatory heart condition, the Wall Street Journal reported on Friday.

Moderna shares fell nearly 4% to $319.50 in afternoon trading.

The U.S. Food and Drug Administration (FDA) has been inspecting the risk of the condition, myocarditis, among younger men vaccinated with Moderna's shot, especially versus Pfizer's vaccine, after certain Nordic countries limited use of the shot, the report said, citing people familiar with the matter.

The agency has not yet determined whether there is heightened risk, and the delay could be several weeks, though the timing was unclear, the report said.

The FDA and Moderna did not immediately respond to requests for comment.

In June, Moderna filed for U.S. authorization of its vaccine among adolescents aged 12 through 17. The FDA authorized rival Pfizer's vaccine for use in children as young as 12 in May.

Europe's drug regulator found in July that such inflammatory conditions could occur in very rare cases following vaccination with Moderna's vaccine or Pfizer and partner BioNTech's shot, more often in younger men after the second dose.

However, the regulator stressed that the benefits of the shots outweighed any risks.

Earlier this month, Finland, Sweden and Denmark paused the use of Moderna's shot for younger males due to reports of myocarditis, though the Danish Health Agency later said the vaccine was available to under-18s.

Moderna's two-shot vaccine is authorized in teens in Canada, UK and Europe. It has U.S. authorization for emergency use in people aged 18 and above.

The FDA in June added a warning to the literature accompanying Pfizer/BioNTech and Moderna COVID-19 shots to indicate the rare risk of heart inflammation.




(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)


Dear Reader,


Business Standard has always strived hard to provide up-to-date information and commentary on developments that are of interest to you and have wider political and economic implications for the country and the world. Your encouragement and constant feedback on how to improve our offering have only made our resolve and commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed and updated with credible news, authoritative views and incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better and more relevant content. We believe in free, fair and credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism and subscribe to Business Standard.

Digital Editor

Business Standard is now on Telegram.
For insightful reports and views on business, markets, politics and other issues, subscribe to our official Telegram channel