The timing of such an authorization, however, depends on clinical trial results.
A scientist works in the Moderna lab in Cambridge, Mass., on Feb 28, 2020.David L. Ryan / Boston Globe via Getty Images file
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The federal government released broad plans Wednesday aimed at distributing free Covid-19 vaccines within a day after an emergency use authorization or full approval is granted.
A “playbook” developed by the Centers for Disease Control and Prevention instructs state agencies to create a vaccine planning committee made up of leaders from different community groups, such as centers, hospitals, long-term care facilities and pharmacies. The CDC playbook advises states to prepare for a limited supply of vaccine doses in the fall.
It’s unclear which vaccine will receive authorization first, as well as when data from the clinical trials will be available for officials to review. Still, the CDC previously told states to prepare for a rollout by Nov. 1.
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“Our goal in Operation Warp Speed is that 24 hours after” a vaccine receives either emergency authorization or full approval, vaccines will be moving to administration sites, Paul Ostrowski, who is handling logistics for Operation Warp Speed, said Wednesday during a call with reporters.
It is clear, however, that supply will not meet demand, at least at first. The plan calls for a vaccination campaign to begin gradually, either later this year or in January. The CDC’s Advisory Committee on Immunization Practices, the National Academy of Medicine and other organizations are working to determine who should be first on the list to receive the vaccine. care workers, other essential employees and people at high risk of severe illness will likely take top priority.
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Director of National Institutes of : ‘We are NOT going to take shortcuts on vaccine safety’
Sept. 12, 202006:31
The Trump administration faces a complex set of logistical problems to meet its vaccine goals. The first is figuring out how to track when people receive their vaccine and which vaccine they get.
Two of the Covid-19 vaccines currently in phase 3 trials — Pfizer and Moderna — require two doses either 21 or 28 days apart.
“We have to be able to tell the person when it’s time to come back in for the second shot,” Ostrowski said.
What’s more, the second dose must be from the same manufacturer as the first dose. They are not interchangeable.
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And while doctor’s offices, hospitals, departments of and pharmacies all have their own databases to track patients, “the hard part is to get the databases to talk with one another,” Ostrowski said.
States and local communities will need to devise precise plans for receiving and distributing vaccines, some of which will require special handling such as refrigeration or freezing. States and cities have a month to submit plans.
Such detailed coordination is like “air traffic control,” said Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota.
“It’s making sure that everything is coming together at one time,” Osterholm said. That includes getting the shots to the people who need them, and making sure they understand what’s known about safety and efficacy of the vaccine. officials will “absolutely be required to educate the public.”
The vaccine itself is expected to be free of charge. Patients will not be charged out of pocket for the administration of shots, thanks to billions of dollars in taxpayer funding approved by Congress and allocated by the Trump administration.
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