New York, Sep 17 : A 57 page “playbook” just in from the US government outlines a comprehensive plan to make the COVID-19 vaccine available free to all Americans once it is proven safe and effective.
At a hearing before a Senate subcommittee on Capitol Hill, CDC Direct Robert Redfield said any vaccine is unlikely to be widely available to most Americans before the summer or early fall of 2021, given initial constraints on supplies if and when a vaccine wins approval from the Food and Drug Administration (FDA).
“I think there will be vaccine that will initially be available some time between November and December, but very limited supply, and it will have to be prioritized,” Redfield told lawmakers. “If you’re asking me when is it going to be generally available to the American public so we can begin to take advantage of vaccine to get back to our regular life, I think we’re probably looking at late second quarter, third quarter 2021.”
His comments came after the Trump administration unveiled its plan to distribute a coronavirus vaccine soon after the FDA approves its use.
Federal officials from Operation Warp Speed, the government’s vaccine development task force, said on a call with reporters that vaccine distribution will be set in motion “within 24 hours” of the FDA authorizing a vaccine, different versions of which are being developed by major drug manufacturers. The strategy released by the Department of Health and Human Services (HHS) details plans to provide enough doses so that everyone who wants to be vaccinated can be, said Redfield.
The government has spent billions of dollars to secure millions of doses of potential vaccines, and “no American will be charged for either the COVID-19 vaccine or its distribution,” the HHS document said. The department is also developing plans under recent legislation to ensure that “no one will be charged any out–of-pocket expenses for the administration of the vaccine either.”
There are currently nine companies with vaccines in phase three efficacy trials, and five approved for early or limited use. Two prominent U.S. companies, Pfizer and Moderna, are both in phase three trials.
Pfizer CEO Albert Bourla said in an interview with “Face the Nation” on Sunday that the company has already manufactured hundreds of thousands of doses of its vaccine, and has a “good chance” of knowing whether it works by the end of October. Bourla said Pfizer is preparing for approval from the federal government and initial distribution of a vaccine before the end of the year.
On Labor Day, President Trump asserted that a coronavirus vaccine could be ready “during the month of October” — just weeks before the presidential election on November 3. The president’s truncated timeline raised concerns about political pressure on the normal regulatory process of vetting a vaccine.
Dr. Scott Gottlieb, the former commissioner of the FDA and a member of Pfizer’s board of directors, said on “Face the Nation” last week that despite the rapid pace, he has “absolute confidence in the scientific staff” tasked with approving any vaccine. “I don’t think politics should get in the way at all, and I don’t think it will,” he said. “There’s a very rigorous process around the development and approval of a vaccine.”
Gottlieb has stressed he does not believe a vaccine will be widely available until 2021.
“This is likely to be a very staged market entry,” he said on “Face the Nation.” “I think that’s what people should expect. But for most people, they will not have access to a vaccine until 2021. I think maybe the first quarter of 2021, probably the first half of 2021. And that’s assuming that these vaccines are demonstrated to be safe and effective in these large trials.”
The strategy for eventual vaccine distribution released by HHS on Wednesday outlines a “phased structure” that relies on cooperation between public and private entities. The relationship hinges on a shared database of vaccination history for all Americans opting to receive the coronavirus vaccine.
Any vaccine will likely require two doses, administered about a month apart, in order to be effective. Officials noted that the time lapse will inevitably force some people to be vaccinated at two different locations, therefore requiring all vaccination centers to be in communication with each other through a shared database.
Combining existing vaccination databases from states and private pharmacies is the next hurdle, according to officials. “The databases exist. The hard part is getting the databases to talk to each other,” said Lieutenant General Paul Ostrowski, who oversees logistics for Operation Warp Speed.
The first phase of distribution — after FDA approval — has the goal of “maximizing vaccine acceptance and public health protection while minimizing waste and inefficiency.” The initial supply for the vaccine will be limited. “Final decisions about prioritization” have yet to be made, according to the strategy document, but federal officials have begun developing plans “specific to focused populations” most in need of a vaccine.
“As the volume of available vaccine increases, distribution will expand, increasing access to the larger population,” reads the phase two outline. “When larger quantities of vaccine become available, there will be two simultaneous objectives: 1) to provide widespread access to vaccination and achieve coverage across the United States population and 2) to ensure high uptake in target populations, particularly those who are at high risk for severe outcomes from COVID-19.”
Phase three acknowledges that initial vaccine distribution may not be widespread enough to stamp out the virus. According to HHS, “if the risk of COVID-19 persists such that there remains a public health need for an ongoing vaccination program,” the vaccine will ultimately be made “universally available and integrated into routine vaccination programs, run by both public and private partners.”
Redfield noted that the framework is not final, and will be updated as more information is known. He called planning for distribution a a “critical next step” in order to “restore our normal way of life.”
“CDC is drawing on its years of planning and cooperation with state and local public health partners to ensure a safe, effective, and life-saving COVID-19 vaccine is ready to be distributed following FDA approval,” Redfield said in a press release. “CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021.”
According to HHS, the process for distributing the vaccine “will be adjusted based on experience from COVID-19, real-time data on the virus and its impact on populations, performance of each vaccine, and the ongoing needs of the essential workforce.”