FDA panel recommends approval of Moderna’s Covid-19 vaccine for emergency use
Expert Panel Recommends FDA to Approve Moderna Emergency Vaccine
US COVID-19 Vaccine Deliveries May Start This Weekend
On Thursday afternoon, an expert group of external consultants recommended that the US Food and Drug Administration (FDA) issue an emergency authorization for the coronavirus vaccine manufactured by the American company Moderna. This was reported by the “Reuters” agency.
The decision on the recommendation was supported by 20 members of the expert commission, one of the meeting participants abstained from voting.
FDA approval for the second US vaccine against COVID-19 can be obtained as early as Friday, December 18. Health and Human Services Minister Alex Azar told CNBC on Thursday that the first batch of Moderna vaccines in the amount of 5.9 million doses is ready for shipment. This will be enough for 2.95 million people.
“We are ready to begin shipping [the Moderna vaccine] this weekend with delivery on Monday, Tuesday and Wednesday next week,” Azar said..
Last Thursday, a specialized committee at the FDA recommended that the agency issue an emergency authorization for the use of a coronavirus vaccine developed by US pharmaceutical company Pfizer in collaboration with Germany’s BioNTech. FDA clearance was obtained the very next day, Friday, December 11.
Moderna vaccine can be stored at a higher temperature than Pfizer’s product – no higher than minus 20 degrees Celsius. This makes it more accessible to people in remote and rural areas. Both drugs have shown high efficacy in the region of 95% in clinical trials..
Pfizer / BioNTech’s vaccine shipments began over the weekend to hospitals across the country, but the first major storm this winter could disrupt plans for the vaccine in the northeastern United States. General Gustav Perna, the vaccine distribution manager for the government’s Operation Supersonic Speed, told reporters that FedEx and UPS, which provide express delivery of vaccines, had contingency plans. This will ensure the safety of Pfizer / BioNTech vaccines that require storage at an ultra-low temperature – no higher than minus 70 degrees Celsius..
According to Reuters, the Moderna vaccine was the first to receive funding from the US administration under Operation Supersonic Speed in the amount of $ 1.53 billion. 200 million doses of this vaccine are expected to be shipped in the United States by the end of the second quarter of 2021 – 20 million by the end of December, 80 million in the first quarter and another 100 million in the second quarter..
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