US Panel Endorses Second COVID-19 Vaccine

A U.S. panel endorsed emergency use of a second COVID-19 vaccine Thursday.A committee of independent expert advisers to the U.S. Food and Drug Administration (FDA) voted, after seven hours of discussion, to recommend the use of a vaccine developed by U.S. drug manufacturer Moderna, one week after federal regulators authorized the first vaccine for emergency use. “The evidence that has been studied in great detail on this vaccine highly outweighs any of the issues we’ve seen,” Dr. Hayley Gans, Stanford University Medical Center, said Thursday. FILE – Biotechnology company Moderna protocol files for COVID-19 vaccinations are kept at the Research Centers of America in Hollywood, Florida, Aug. 13, 2020.The news comes as the United States has recorded nearly 310,000 deaths from the virus, according to the Johns Hopkins Coronavirus Resource Center. There are more than 17 million confirmed cases of COVID-19, the disease caused by the coronavirus, in the U.S. FDA authorization of emergency use of the vaccine could come as soon as Friday. Once approved, Moderna would then begin shipping nearly 6 million doses, with the first planned for health workers and nursing home residents. Last week, after the advisers endorsed the use of the first vaccine, the FDA authorized it for emergency use a day later. That vaccine, developed by U.S. drugmaker Pfizer and German partner BioNTech, is being distributed throughout the U.S.  The Pfizer/BioNTech vaccine’s distribution was threatened Wednesday and Thursday in Northeastern U.S. states by the region’s first major snowstorm, which forecasters said might leave more than 30 centimeters (12 inches) of snow on parts of New England before heading out to sea later Thursday. A massive inoculation program with an initial round of 2.9 million doses began Monday at U.S. hospitals and in long-term care facilities, as cases continued to surge across the U.S.  Staff members receive the COVID-19 vaccine at Holy Name Medical Center in Teaneck, N.J., Dec. 17, 2020.Thousands of people are dying daily, while intensive medical care units across the country are approaching capacity, threatening to overwhelm health care systems. Both vaccines were about 95% effective in clinical trials, but Moderna’s requires less onerous cold storage requirements than the Pfizer/BioNTech vaccine, making it a better choice for rural and remote areas. Moderna, however, reported more frequent side effects from its 30,000-person trial than those reported by Pfizer. These were mainly short-term reactions, such as hives, rashes and itching, officials said. FDA staffers did not mention any significant safety concerns about the Moderna vaccine in documents released Tuesday in preparation for the meeting.  General Gustave Perna, chief operating officer of the federal government’s Operation Warp Speed vaccine project, told reporters Monday the U.S. plans to transport 6 million doses of Moderna’s vaccine if it is approved. Operation Warp Speed scientific leader Moncef Slaoui said Monday that 20 million people in the U.S. would be vaccinated with either vaccine this month. Slaoui estimated that 100 million people, about one-third of the U.S. population, could be inoculated by the end of the first quarter of 2021. 

         

leave a reply: