Skip to main content

FDA Delaying Decision on its COVID-19 Shot for Adolescents, Says Moderna

Cambridge: U.S. regulators are delaying their decision on Moderna’s COVID-19 vaccine for 12- to 17-year-olds while they study the rare risk of heart inflammation, the company said Sunday. The U.S. Food and Drug Administration told the company Friday evening that its review could last until January, Moderna said.

The company also said it will delay filing a request for emergency-use authorization of a lower dose of the vaccine for 6- to 11-year-olds. Heart inflammation is an exceedingly rare risk of both the Pfizer and Moderna vaccines, and it more commonly seen in young men or boys. It’s difficult for clinical trials to detect such a rare problem. And public health officials have repeatedly stressed that COVID-19 itself can cause heart inflammation at higher rates than the rare cases caused by the vaccine. In the U.S., the Moderna vaccine is authorized for people 18 and older.

Moderna said more than 1.5 million adolescents around the world have received its vaccine and that the number of heart inflammation reports “does not suggest an increased risk” for those under 18. U.S. children from 12 to 17 can get the vaccine produced by Pfizer and its partner BioNTech.

The FDA last week moved to allow use of the Pfizer shots in children between 5 and 11. The Centers for Disease Control and Prevention is debating that this week. Moderna also has been testing two shots, one month apart, for children 6 to 11, at half the dose given to adults.



source https://www.india.com/news/world/us-drug-regulator-fda-delaying-decision-on-its-covid-vaccine-shot-for-adolescents-5078542/

Comments

Post a Comment

Popular posts from this blog

Delhi-NCR Rains LIVE Updates: Thunderstorm With Moderate to Heavy Rains Likely in Delhi, Gurugram, Faridabad and Adjoining Areas

Delhi-NCR Rains: The national capital and its neighbouring areas are likely to witness thunderstorms with moderate to heavy intensity rains during the next two hours on Wednesday, as per the predictions notified by the Indian Meteorological Department (IMD). The downpour will occur over and adjoining areas of Delhi-NCR. Taking to Twitter, the Met department said, “Thunderstorm with moderate to heavy intensity rain would occur over and adjoining areas of isolated places of Delhi (Lodi road, IGI airport ), NCR (Gurugram, Manesar, Faridabad, Ballabhgarh) Tosham, Bhiwani, Charkhi Dadri, Mattanhail, Jhajjar, Narnaul, Mahendargarh, Kosali, Farukhnagar, Bawal, Nuh, Sohana, Hodal, Palwal (Haryana) Barsana, Nandgaon (UP) Viratnagar, Kotputli, Khairthal, Bhiwari, Laxmangarh, Nadbai, Nagar, Alwar, Tizara, Deeg (Rajasthan) during next 2 hours,” tweeted IMD. Earlier on Tuesday, heavy rains lashed several parts of Delhi causing waterlogging and affecting the vehicular movement in parts of the city ...
Post a Comment
Read more

PM Kisan Samman Nidhi Yojana: Farmers Likely To get Rs 4000 in 10th installment, Must Submit Documents by Oct 31

PM Kisan Samman Nidhi Yojana Latest News Today : Here comes a piece of wonderful news for the farmers across the country. They will soon get Rs 4000 in the 10th installment of Pradhan Mantri Kisan Samman Nidhi Yojana, media reports have claimed. However, the Central government has not made any announcement on this yet. To take advantage of this, you have to register (PM KISAN Registration) under PM Kisan Samman Nidhi. For this purpose, they need to submit all the necessary documents by 31 October. It must be noted that the Central government has recently made some changes in the process of registration for PM Kisan Samman Nidhi Yojana. Under this, now ration card has been made mandatory for registration in in PM Kisan Samman Nidhi Yojana. Farmers will have to mandatorily submit ration card number in new registration. At the same time, they have to upload the soft copies of documents (in PDF format) on the portal during registration. If the farmers register themselves before October ...
Post a Comment
Read more

MP: Woman Forced To Undergo ‘Purification’ For Marrying Dalit Man

Betul: A 24-year-old woman from Madhya Pradesh’s Betul district was allegedly forced to undergo a “purification” ritual by her father and other relatives wherein she was forced to take bath in the Narmada river, her hair trimmed and her clothes discarded for marrying a Dalit man, police said on Saturday. Police have registered a case against the woman’s father and three of his relatives on Saturday after the woman lodged a complaint, said Betul Kotwali police station in-charge Ratnakar Hingve. On Friday, the woman submitted a complaint to Superintendent of Police (SP) Simala Prasad. The complainant alleged that she had married a Dalit man in March 2020. She said her family members filed a missing person complaint in January 2021, though her father knew about her whereabouts and used to meet her. “I got married on March 11, 2020, and informed my father on January 4, 2021. My father continued to meet me but despite that, he filed a missing person complaint on January 10, 2021, at Chop...
Post a Comment
Read more