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

Bigg Boss 15: Nishant Bhat Becomes New Captain, Asks Boys to do 10 Sit-ups to Apologise Bigg Boss

Bigg Boss 15: In tonight’s episode, when Bigg Boss asked the contestants Shamita Shetty, Nishant Bhat, Pratik Sehajpal, Vishal Kotian, Akasa Sing, Jay Bhanushali and Tejasswi Prakash to nominate two contestants for the captaincy task (Captainc ki race) with aapsi sehamati (mutual consent), they come to a conclusion and choose Nishant and Prateek. The rest of the contestants were asked to help whom they want to support as a captain. Tejasswi Prakash became the sanchalak of the task. The winner of the captaincy task was declared and Nishant Bhat became the new captain of the house. Bigg Boss has asked to take the rights to control the house. After the captaincy task, Nishant and Shamita discuss the decision taken and Bhat made Shetty understand to play the game by not trusting anyone, pointing out on Pratik. After a few minutes, Bigg Boss raised Kukdu Ku alarm back-to-back as most of the contestants were sleeping. Nishant took all the boys outside in the garden, near the camera and sa

Heavy Rains Lash Delhi-NCR, Waterlogging in Several Parts; More Rains Predicted

New Delhi: People of Delhi and NCR woke up to heavy rains and pleasant weather on Sunday. However, waterlogging was reported in several parts of Delhi-NCR in the morning. According to the India Meteorological Department (IMD), thunderstorms with moderate to heavy intensity rain would occur over and adjoining areas of entire Delhi-NCR today. The IMD tweeted, “Thunderstorm with moderate to heavy intensity rain would occur over and adjoining areas of entire Delhi, NCR ( Bahadurgarh, Gurugram, Manesar, Faridabad, Ballabhgarh, Loni Dehat, Hindon AF Station, Ghaziabad, Indirapuram, Chhapraula, Noida, Dadri, Greater Noida)” Greater Noida) Kaithal, Karnal, Rajaund, Assandh, Safidon, Panipat, Gohana, Gannaur, Sonipat, Narwana, Jind, Rohtak, Hissar, Hansi, Tosham, Bhiwani, Charkhi Dadri, Jhajjar, Loharu, Narnaul, Mahendargarh, Kosali, Farukhnagar, Bawal, Rewari, Nuh, Sohana, Hodal, Palwal (Haryana) — India Meteorological Department (@Indiametdept) August 1, 2021 Vehicles commuting from

‘No Lockdown, But…’, Karnataka CM Bommai Issues BIG Statement Amid Omicron Scare

New Delhi: Putting an end to speculations surrounding ‘lockdown’ across the state in the wake of new Omicron variant of coronavirus, Karnataka Chief Minister Basavaj Bommai asserted that his government had no plans to impose shutdown-like curbs. However, based on the number of cases and scenarios in the coming days certain stringent measures might be taken, said the chief minister. “There is no question of lockdown, as of now. Normal public life should continue”, he stated, adding that COVID norms should be followed at places where people gather. CM Bommai further assured that his government is taking utmost precautions and keeping strict vigil against the new Omicron variant of coronavirus. Curbs Tightened Across The State Meanwhile, with new clusters emerging in the state, the government has tightened curbs against the Delta variant too. The chief minister asserted that the government has to manage things at two levels to control the further spread of the pandemic. “The state g

Ek-Learn

Search This Blog