The US health regulator is delaying its decision on licensing Moderna’s COVID-19 vaccine for teens to check whether the shot could increase the risk of a rare inflammatory heart disease, the Wall Street Journal reported Friday.

Moderna shares were down about 4% to $319.50 in the afternoon.

Quoting people familiar, the report said the US Food and Drug Administration (FDA) is examining the risk of developing the condition myocarditis among younger men vaccinated with the Moderna vaccine, especially versus the Pfizer vaccine, after some Nordic countries limited use of the vaccine. with this issue.

The report said the agency has not yet determined whether there are increased risks, and the delay could take several weeks, although the timing is unclear.

The Food and Drug Administration and Moderna did not immediately respond to requests for comment.

In June, Moderna applied for a US license for a vaccine among 12- to 17-year-olds. The U.S. Food and Drug Administration allowed Pfizer’s competing vaccine to be used in children as young as 12 in May.

Europe’s drug regulator found in July that such inflammatory conditions can occur very rarely after vaccination with Moderna or Pfizer and partner BioNTech’s vaccine, 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 halted use of the Moderna vaccine for younger males due to reports of myocarditis, although the Danish Health Agency later said the vaccine is available for those under 18 years old.

Moderna’s two-ply vaccine is permitted for adolescents in Canada, the United Kingdom and Europe. It has a US permit for emergency use for people 18 years of age and older.

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

(This story has not been edited by Business Standard employees and is automatically generated from a shared feed.)

Dear Reader,

Business Standard has always strived to provide the latest information and commentary on developments that matter to you and that have broader political and economic implications for the country and the world. Your continued encouragement and feedback on how we can improve our offerings has made our resolve and commitment to these ideals even stronger. Even during these challenging times brought about by Covid-19, we continue our commitment to keeping you updated with trusted news, authoritative opinions and insightful commentary on relevant topical issues.
However, we have a request.

As we fight the economic impact of the pandemic, we need your support even more, so we can continue to bring you more quality content. Our subscription form has seen an encouraging response from many of you, who have subscribed to our content online. More subscribing to our online content can only help us achieve our goals of providing better and more relevant content. We believe in free, fair and credible journalism. Your support with more subscriptions can help us practice the journalism we are committed to.

Support quality press and Subscribe to Business Standard.

digital editor

Source link

By admin

Leave a Reply

Your email address will not be published.