Coronavirus vaccine could be given to Americans as early as December second week, says top US official
FDA’s advisory panel to review Pfizer’s emergency use application for its vaccine candidate on December 10. Operation Warp Speed chief said if things go according to plan, enough Americans could be vaccinated by May
Two companies, Pfizer and Moderna, announced this month that their coronavirus vaccines are about 95% effective, and Pfizer has formally submitted an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA). The official in charge of the federal government’s coronavirus vaccine program has now said that the first Americans to get the Covid-19 vaccine, if things go according to plan, could be as early as the second week of December. Dr Moncef Slaoui, head of Operation Warp Speed, elaborated that doses will be shipped within 24 hours after the FDA gives authorization.
The FDA’s advisory committee will hold a key meeting on December 10 that will discuss emergency authorization for Pfizer’s vaccine candidate. “The FDA has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on December 10 to discuss the request for EUA of a Covid-19 vaccine from Pfizer, in partnership with BioNTech,” the agency announced.
“Our plan is to be able to ship vaccines to the immunization sites within 24 hours from the approval. So, I would expect maybe on day two after approval, on the 11th or on the 12th of December, hopefully, the first people will be immunized across the US, across all states, in all the areas where the state departments of health will have told us where to deliver the vaccine,” Slaoui told CNN’s ‘State of the Union.’
Slaoui also emphasized that if the vaccination distribution and immunization plan goes well, enough Americans should be vaccinated by May 2021 or so to enable life to go back to normal. “So, normally, with the level of efficacy we have, 95%, 70% or so of the population being immunized would allow for true herd immunity to take place. That is likely to happen somewhere in the month of May or something like that, based on our plans. I really hope and look forward to seeing that the level of negative perception of the vaccine decreases and people’s acceptance increases. That’s going to be critical to help us. Most people need to be immunized before we can go back to a normal life,” he added.
The statements come amid a surge in coronavirus cases across the country, even as millions of Americans are expected to travel for the upcoming Thanksgiving holiday this week ignoring warnings from the US Centers for Disease Control and Prevention (CDC) and other scientists.
A final analysis of the Phase 3 trial of Pfizer’s vaccine candidate shows it was 95% effective in preventing infections, even in older adults, and caused no serious safety concerns. Pfizer and its partner BioNTech subsequently applied for emergency approval to the US regulatory body. “Based on current projections, the companies expect to produce globally up to 50 million doses in 2020 and up to 1.3 billion doses by the end of 2021. The companies will be ready to distribute the vaccine within hours after authorization,” the companies announced on November 20. Moderna also plans to submit its application soon for EUA.
The advisory group will submit their recommendations to the FDA, which is expected to make a decision shortly after that. The final decisions on whether to authorize the vaccine for emergency use are made by the FDA. “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in Covid-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential Covid-19 vaccine will be as open and transparent as possible,” noted FDA Commissioner Dr Stephen M Hahn.
The agency chief stressed that the FDA has been preparing for the review of EUAs for coronavirus vaccines for several months and stands ready to do so as soon as an EUA request is submitted. “While we cannot predict how long the FDA’s review will take, the FDA will review the request as expeditiously as possible, while still doing so in a thorough and science-based manner, so that we can help make available a vaccine that the American people deserve as soon as possible,” Hahn said. He added, “A discussion about the safety and effectiveness of Pfizer and BioNTech’s vaccine with this committee, made up of outside scientific and public health experts from around the country, will help ensure clear public understanding of the scientific data and information that the FDA will evaluate to make a decision about whether to authorize a vaccine for emergency use for the prevention of Covid-19.”
Slaoui explained that soon after a vaccine receives FDA authorization, the CDC’s Advisory Committee on Immunization Practices (ACIP) will issue recommendations on who should receive the vaccine first. Public health authorities in each state will be responsible for administering the vaccine roll-out.
“And the plan is, within 24 hours or less from the emergency use authorization approval, the ACIP will meet and issue guidance. The CDC will issue guidance to all the states. But then the way things are planned is, we will distribute vaccines where each state department of health will have asked us to distribute it. And then it will be the state,” Slaoui noted. He added, Each state will independently decide, take into account the guidance, who to immunize. So, some states may make different decisions, depending on their population and their situation. But, clearly, the highest-risk people, the first-line workers, the health care workers will be among the first to be immunized in the next three months, after immunization -- after approval.”
Alex Azar, US Secretary of Health and Human Services, had previously stated that the most vulnerable populations, including nursing home residents, could get the vaccines first. Healthcare workers and first responders are expected to be next in line. As many as 20 million Americans could be immunized by the end of the year. “It’s all dependent on the FDA review process, and it’s going to be as it has been throughout, by the book. But we have contracted with Pfizer for 100 million doses and that will start rolling to us 20 million a month, starting the end of this month (November),” he explained.