Moderna says FDA needs more time to complete review of Covid jab for adolescents

[ad_1]




The US Food and Drug Administration (FDA) will need more time to complete its assessment of the Moderna's Covid-19 vaccine for adolescents aged 12 to 17 years, the pharmaceutical major said in a statement on Sunday.









The FDA informed Moderna earlier this week that the review may not be completed before January 2022, the company said. This is a major setback to the timing of an emergency use authorization (EUA) for the Covid vaccine meant for younger age groups.







The US biotech company said it was told late on Friday that the FDA needed the additional time to evaluate recent international analyses of the risk of a type of heart inflammation called myocarditis after vaccination, a rare side effect that has primarily affected young males.






Moderna said it is conducting its own review of new external analyses on the increased myocarditis risk in those less than 18 years of age as they become available.






Moderna had applied for US authorisation of its Covid-19 shot for 12- to 17- year olds in June.






Americans of those ages are eligible for the similar Covid-19 vaccine from Pfizer Inc and partner BioNTech SE after it was cleared by the FDA and Centers for Disease Control and Prevention in May.






Moderna also said it will delay filing its request for an EUA for a half strength 50-microgram dose of the vaccine for children ages 6 to 11 while the FDA completes its review of the 12-17 filing.




Subscribe to Mint Newsletters

* Enter a valid email

* Thank you for subscribing to our newsletter.



Never miss a story! Stay connected and informed with Mint.
Download
our App Now!!





[ad_2]

Source link
https://asiannews.in/moderna-says-fda-needs-more-time-to-complete-review-of-covid-jab-for-adolescents/

Comments

Post a Comment

Popular posts from this blog

(Video) Anti-regime measures continue in Iran with various protests in numerous cities

Image
[ad_1] Iran’s uprising is marking its 132nd day on Wednesday following the variety of anti-regime measures reported from cities and towns checkered across Iran specifically targeting regime Leader Ali Khamenei, (IRGC), paramilitary Basij, and plainclothes agents. On Wednesday evening, brave MEK Resistance Units marched in Tehran and chanted slogans against the regime as protests continue across the country. In Tehran and the city of Bandar Abbas in southern Iran began chanting slogans targeting the crackdown apparatus. Pensioners and retirees are among the worst-hit segments of Iran’s society. They depend on government stipends to make ends meet, but the regime has refused to increase their pensions in correspondence with the depreciation of the national currency. This is the third such rally held recently as family members of various inmates traveled from across the country to hold a gathering on January 24 in the country’s capital where children were seen holding pl...
Read more

Tata Salt Encourages Kids of Ahmedabad to Ask Questions for the Nation – Primex News Network

[ad_1] As part of its latest ‘Har Sawaal Uthega’ initiative, Tata Salt is conducting a nation-wide campaign in more than 300 schools to encourage children to ask questions as they have the power to shape a better tomorrow Ahmedabad (Gujarat) [India], January 26 : Keeping the theme of ‘Desh Ki Sehat, Desh Ka Namak’ at its core, Tata Salt, a pioneer and market leader in India’s branded iodized salt segment, has launched a nationwide Republic Day campaign called Desh Ke Liye #HarSawaalUthega. With its 360-degree approach, the campaign aims to empower children by providing them with a one-of-a-kind platform to raise questions that could spark relevant conversations and nudge a societal change. As a run up to Republic Day, the campaign has gone on-ground and aims to engage with students across India covering states like Maharashtra, Punjab, Haryana, Gujarat, Chennai, Karnataka, U.P and Rajasthan among other states. The on-ground event was suc...
Read more

India’s biggest integrated Housewares & Home Appliances Trade Fair, VIBRANT INDIA 2023 will be organized in Mumbai from January 20 to 22 – Primex News Network

Image
[ad_1] Mr. Narendra Diwakar, Organizer and Managing Editor of Vibrant India and speakers address press conference in Mumbai More than 500+ exhibitors from India & Abroad are expected to participate in this expo at Nesco Centre, Goregaon (East), Mumbai  Highlights: – ·         Over 30,000 visitors are expected to visit the exhibition ·         9 th edition of Housewares & Home Appliances Trade Fair – 2023 by Vibrant India Event Solutions ·         Celebrity Chef Mr. Harpal Singh Sokhi will inaugurate the VIBRANT INDIA 2023 exhibition. ·         It is an International Exhibition on Houseware, Kitchenware, Tableware, Hotelware, Plasticware, Thermoware, Utensils, Kitchen Appliances, Crockery, Home Appliances & Stainless-Steel Industry. ·       ...
Read more