WASHINGTON — Millions of Americans are watching with anticipation as the first coronavirus vaccines are administered, but doctors advising President-elect Joe Biden are raising concerns that the timeline for widespread distribution may be longer than anticipated.
The team of medical professionals advising Biden are warning internally that the program he will inherit from outgoing President Donald Trump may not live up to expectations of fast and widespread relief. Instead of mass distribution to the general population in the coming months, pandemic-fatigued Americans may find approval delays, distribution disruptions and insufficient quantities.
Getting the vaccine to every American who wants to be vaccinated could take six months or longer, Dr. David Kessler, a former FDA commissioner who has been advising Biden, said in an interview Wednesday on MSNBC.
It might not be until late summer or early fall before the vaccine begins to be widely available to the general public, said another physician close to the transition, who was not authorized to discuss the matter and spoke on background.
That is in contrast to the timelines being laid out by Trump administration officials, who have said the general public could start getting the vaccine in late February.
Dr. Brett Giroir, who has been leading testing efforts for the Trump administration, said Wednesday that the majority of the U.S. population could be vaccinated by late spring or early summer. Dr. Anthony Fauci, the country’s top infectious disease doctor, who is planning to stay on into the Biden administration, said he expects that by the end of March or the beginning of April, the general public will be able to get vaccinated, with life potentially starting to return to normal by late fall.
The diverging views for how quickly the vaccine will become widely available come down, in part, to different assumptions about how smoothly the next crucial stages will go, which include vaccine testing, manufacturing and distribution, the doctors said.
Those advising the transition warn it is difficult to comprehend the variables and the difficulty of potentially administering a vaccine 600 million times in a matter of months — the number of doses that would be required if most of the American population were given the Pfizer or the Moderna vaccines that require injections spaced three to four weeks apart. A vaccine in development by Johnson & Johnson will require only one dose, while the one being tested by AstraZeneca will likely require two injections, but neither vaccine has completed Phase 3 clinical trials nor received FDA authorization.
Biden has pledged 100 million “shots in arms” in his first 100 days, but has not outlined a plan nor has he publicly raised concerns about the Trump administration's timeline.
The Biden team has held multiple meetings with the Trump administration’s team, but members caution they won't have a complete understanding of the vaccine plan until after the inauguration, an official advising the Biden transition said.
"We are continuing to work with the Operation Warp Speed team and our focus will be ensuring safe and effective vaccines are available to all Americans, and we'll likely have additional detail to share in the coming weeks and months," a transition official said in a statement.
The contrasting timelines could have political implications for Biden. Should distribution take longer than members of Trump’s Operation Warp Speed, or OWS, have projected, Biden’s detractors could try to place the blame on his administration's handling of a program he inherited.
“You have to wonder whether the Trump team is intentionally laying the groundwork for the incoming Biden administration to blow past expectations that couldn’t possibly be met because of the current White House’s incompetence,” said Zac Petkanas, a Democratic strategist who formed a group dedicated to criticizing Trump’s Covid-19 response.
The U.S. ordered enough of the Pfizer and the Moderna vaccine doses to inoculate 150 million people. That would cover most of the high-priority populations identified by the Centers for Disease Control and Prevention, including critical infrastructure workers, the elderly and those with certain underlying conditions.
But for the U.S. to inoculate the wider population before late summer, additional vaccines will need to be authorized or the federal government will have to sign a deal to buy more doses of existing authorized vaccines. In order to reach the point where there is enough immunity in the population for the virus to begin to go away, about 250 million people would need to be vaccinated, public health officials estimate.
“The projected vaccine supply in the spring depends on authorization of additional vaccines. That is uncertain,” said Topher Spiro, vice president for health policy and a senior fellow for economic policy at the liberal-leaning Center for American Progress. “It’s unwise to overpromise and underdeliver — it erodes public trust. And we have already seen OWS have to dial back their promises a couple times.”
Pfizer has said it won’t be able to provide the U.S. with additional doses of its vaccine until at least July after Washington passed up on an option to buy additional doses several months ago.
The Trump administration and Pfizer are currently in talks about ordering another 100 million doses before then, but Pfizer CEO Albert Bourla said earlier this week that the company has a “critical supply” of some components used to make the vaccine. The company wants the U.S. to invoke the Defense Production Act to help them secure additional resources to speed production.
It is also unclear when additional vaccines could be authorized. With respect to the next two vaccines in the pipeline, the U.S. has contracts to buy 100 million doses from Johnson & Johnson and 150 million from AstraZeneca, both of which are expected to have results from trials in early 2021.
But getting FDA authorization for those vaccines isn't guaranteed. There have been questions about the effectiveness of the AstraZeneca vaccine after the company presented confusing results from one trial. Johnson & Johnson hasn't released results from its large-scale study and the earliest it could get U.S. authorization is late January or early February.
“People are getting pretty skittish about whether the AstraZeneca vaccine is going to be viable,” a doctor working with the transition said. “Communications and analysis has been such a mess we have to wait for the U.S. trial to read out in January.”
Beyond that, the doctors say they are concerned about how smoothly the mass vaccination program will go. While hospitals are relatively well-equipped for employee health units to administer vaccines to staff, they lack the resources to administer to the entire nation, a Biden Covid-19 adviser said.
That will likely leave much of the task of getting the general public vaccinated to retail pharmacies such as CVS and Walgreens that have frameworks in place from over a decade of giving flu vaccines, but have never had to vaccinate on such a large scale in such a short time period.
“It would take everything to work right, which is unlikely," said Leslie Dach, a former senior counselor at the Department of Health and Human Services under President Barack Obama. "Look at all the unanswered questions, starting with number of doses, no clear guidelines state by state on who gets vaccinated when, rural distribution issues, and open questions for how people get their shots at the large array of urban distribution nodes. And that’s assuming people want to get vaccinated."