According to Gottlieb, if the vaccine is produced before next year, it would be distributed through a “phased introduction” that prioritizes high-risk groups, such as nursing home residents and health workers. health.
“You can almost think that the vaccine is used in a therapeutic sense, to try to protect populations at very high risk,” he explained. “… Not in the way we traditionally think of vaccines, in terms of trying to provide broad-based immunity in a population. ”
The same methodology was used in 2009 when the H1N1 flu, also known as swine flu, took hold. According to Gottlieb, this vaccine was also distributed first to doctors and frontline health workers. “We were able to do it very effectively with the swine flu,” he said.
Three of the six vaccine candidates supported by the White House’s Operation Warp Speed initiative are currently in phase 3 trials. The Trump administration has set a goal of delivering 300 million doses of a coronavirus vaccine by January.
The expedited process has left some worried that vaccine production oversight agencies, including the FDA, face increased political pressure from the White House. Gottlieb said on Sunday that despite the fast pace, he had “absolute confidence in the scientific staff” responsible for approving any vaccine.
“I don’t think politics should get in the way at all, and I don’t think it will,” Gottlieb said. “There is a very rigorous process around the development and approval of a vaccine. ”
“There are many levels of scrutiny among people who are experts in these areas. So I don’t think these people are going to be pushed to make a decision in which they are not absolutely confident, ”he said.
The first line of defense is the independent Data and Safety Oversight Committee, which is made up of research experts who review clinical trial data and has the power to end trials early.
In an interview with Kaiser Health News this week,, director of the National Institute of Allergy and Infectious Diseases, said he was “not worried about the political pressure” influencing the council either.
According to Gottlieb, the test data reviewed by the board is not “exposed” to the drug developer and the FDA until the board is “comfortable with the conduct of the trial.” The company is then required to file the data with the FDA, requesting permission, either for an authorization or for an approval, followed by a “very rigorous process within the FDA,” said Gottlieb.
Until the vaccine arrives, however, Americans are being asked to continue to distance themselves socially, to wear masks and to avoid gatherings. Despite calls for precaution, national COVID-19 infections have increased since the start of the summer.
“If you look at where we are heading towards Memorial Day, compared to where we are heading towards Labor Day, we have an equal amount, if not more infection before Labor Day,” Gottlieb said. By the end of May, the United States was diagnosing about 21,000 new cases of coronavirus per day, now that rate has risen to about 40,000 infections per day, with “about 150 tragic deaths per day,” according to Gottlieb.
“And we’re heading into a more difficult season, we’re heading into fall and winter, where we would expect a respiratory pathogen like coronavirus to start spreading more aggressively than it would in been, ”he said.
As the virus persists, America’s stamina has declined. “People are exhausted,” Gottlieb said. “People are socially distancing themselves and wearing masks and staying at home for a long time right now, small businesses are suffering. ”
“I think people’s willingness to stick to the simple things that we know can reduce the spread is going to start to unravel as we head into fall and winter,” he said. declared. “And that’s another challenge, trying to stay vigilant at a time when we know it can spread more aggressively. ”
“It could run its course in 2020, and as 2021 approaches, start to slow down,” he said. “I think the tragic consequence of this is that there will be a lot of deaths and illnesses along the way. “