Advisers to US FDA set stage for Moderna vax’s approval – Times of India

The coronavirus vaccine by Moderna moved closer to authorisation on Thursday, a significant step that would expand the reach of the US’ vaccination campaign to many more hospitals.
As the US buckled from uncontrolled spread of Covid-19, with over 3,000 deaths for third straight day, a panel of independent experts recommended — by a vote of 20 in favour and one abstention — that the Food and Drug Administration authorise the Moderna vaccine for emergency use. It would provide more hope to a nation that has seen the coronavirus spreading at a consistently rapid rate, with each day bringing an average of more than 2,00,000 new reported cases.
The total number of confirmed infections surpassed 17 million on Thursday, five days after eclipsing the 16-million mark. After the country’s first case was confirmed on January 21, it took more than three months to reach a million cases. Even at the previous peak in July, when testing had become more readily available, it took 16 days to go from three million cases to four million.
The FDA will “rapidly” work towards granting emergency approval of Moderna’s vaccine candidate, FDA commissioner Stephen Hahn said on Thursday. The formal decision, likely late on Friday, would clear the way for some 5.9 million doses to be shipped around the US starting this weekend. Moderna would be the second company allowed to begin inoculating the public, giving millions more Americans access to desperately needed vaccine. The first, made by Pfizer and BioNTech, received authorisation last week.
President Donald Trump sparked some confusion when he tweeted that the Moderna vaccine was “overwhelmingly approved” and that distribution of it would “start immediately.” An FDA spokesperson later clarified that the shot hasn’t yet been granted an emergency authorisation.
The Moderna vaccine can be distributed more widely because it can be stored at normal freezer temperatures and, unlike the Pfizer-BioNTech vaccine, does not require ultracold storage. It also comes in smaller batches, making it easier for hospitals in less populated areas to use quickly.
The two vaccines, and an ambitious rollout by the federal government, states and businesses, are the first signs of hope for an end to the pandemic that has killed more than 3,00,000 Americans. The vaccines are in short supply, and the initial batches are being given to people at high risk: frontline health workers and residents of nursing homes.
The subcommittee proposed putting people 65 and older, as well as people with conditions that put them at high risk for Covid-19, like diabetes or obesity, after essential workers. But it will be up to the larger group to make a final decision on Sunday. The one abstention came from Dr. Michael Kurilla, who works at the National Institutes of Health and felt blanket authorisation for those 18 and older was too broad.
US officials have said they expect to have 40 million doses of the Pfizer and Moderna vaccines by the end of the year — enough to inoculate 20 million people. Both vaccines were about 95% effective at preventing illness in pivotal clinical trials with no serious safety issues.

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