US COVID vaccinations may begin by Monday: well being secretary
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The United States could begin injecting the first Americans with the Pfizer-BioNTech COVID-19 vaccine starting Monday, the country’s health secretary said Friday.
Alex Azar told news channels that the final details would be ironed after a committee of experts convened by regulators decided to issue emergency clearance for the two-dose regimen for anyone aged 16 and over.
The Food and Drug Administration issued a statement on Friday telling Pfizer that it would now “work swiftly towards finalization and emergency clearance.”
Azar told ABC News that authorities are working with Pfizer on logistics and “we could see people getting vaccinated on Monday, Tuesday of next week”.
“So, it’s very close. It’s really just the final puncturing of I’s and the crossing of Ts,” he added.
One of those open questions is preparing a medical fact sheet, Azar told Fox Business.
Once the vaccine has been granted an Emergency Use Authorization (EUA), the federal government’s Operation Warp Speed program will oversee its distribution to thousands of locations across the country.
Before this happens, a committee from the Centers for Disease Control and Prevention (CDC) must also recommend the vaccine, then the agency itself must accept this recommendation.
The first of these meetings will take place on Friday and the second on Sunday, but they are currently considered to be pro forma meetings.
Thursday’s panel of experts voted 17 against four with one abstention for approval of the Pfizer vaccine, which in a clinical study has been shown to be 95 percent effective.
Some of the experts who voted no were concerned about the reduced follow-up time set for COVID vaccine studies compared to other vaccines.
Most scientists accept, however, that while the data are not yet perfect, the growing pandemic – almost 300,000 people have died in the United States alone – means that the risk-benefit analysis has to be changed.
An FDA committee will meet next week to review a second vaccine developed by Moderna and the National Institutes of Health.
Both top of the range vaccines are based on the new messenger RNA technology, which has never been approved but could potentially revolutionize the field.
The US hopes to immunize 20 million people this month, 100 million by February, and the entire population by June.
Long-term care residents and health care workers are at the forefront.
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© 2020 AFP
Quote: US COVID vaccinations could start by Monday: Secretary of Health (2020, December 11), accessed December 11, 2020 from https://medicalxpress.com/news/2020-12-covid-vaccinations-monday-health-secretary .html
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