A US health official said on Friday that hundreds of thousands of doses of coronavirus vaccines have already been manufactured in the hope that at least one of the candidates will be successful in clinical trials.
The Trump administration’s “Operation Warp Speed” program has struck deals for eight coronavirus vaccine candidates that are in various stages of development, none of which have been approved or licensed for use.
Paul Mango, deputy chief of policy staff at the U.S. Department of Health and Human Services, said that three of those experimental injections have already been produced on a massive scale, with hundreds of thousands of doses ready to be implemented in the event that receive authorization from the Food and Drug Administration. Three other candidates will soon go into manufacturing, he said.
The last two candidate vaccines in Operation Warp Speed’s portfolio have yet to be named by the White House, though health officials recently said they will soon undergo human trials.
Operation Warp Speed brings together HHS, the Advanced Biomedical Research and Development Authority and the Department of Defense, as well as other agencies, to accelerate the development, manufacture and delivery of inoculations and treatments for Covid-19.
As a handful of vaccine manufacturers accelerate their candidates through late-stage clinical trials, Warp Speed is working with states, cities and distributors on how to bring hundreds of millions of doses of a vaccine to the American public by mid-2021. .
“At first there will probably be a limited supply of one or more of the Covid-19 vaccines because there will be limited doses available,” Robert Redfield, director of the Centers for Disease Control and Prevention, told reporters on Friday. Redfield said that the priority of groups in an initial vaccination campaign will depend on the vaccine that is ultimately approved by regulators.
Who goes first?
Covid-19 vaccines have the potential to work differently in various racial and ethnic groups, demographic ages, and populations with underlying health conditions. The clinical trial data that illuminates the safety and efficacy of each injection in these subgroups will inform who is first in line to receive them.
The various vaccines purchased with Warp Speed will also have different storage requirements, Mango said. The United States is adapting distribution plans to suit each company.
Pfizer Inc., for example, is developing containers to store and distribute a vaccine that it has developed in partnership with BioNTech SE. If you are successful at the clinic, the New York-based drugmaker will not distribute your injection through McKesson Corp. as the rest of the Operation Warp Speed contract will.
The contract with Pfizer includes the delivery of vaccines “to the places where we direct it,” Mango said.
Current distribution plans assume that any Covid-19 vaccine will only have an emergency use authorization, which does not provide as much flexibility as full approval, Redfield said.
“If it does indeed turn out to be licensed at the time it is distributed, the distribution plans will be re-evaluated to see if that provides more flexibility to the plan,” he said.
Even if a coronavirus vaccine gets full approval, Redfield said it could still be withdrawn from the market if patients who were once healthy later exhibit adverse side effects. The United States plans to monitor the long-term health of patients after inoculation, he said.
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