WASHINGTON – Millions of Americans are watching with anticipation the administration of the first coronavirus vaccines, but medics briefing President-elect Joe Biden fear the large-scale distribution schedule may be longer than expected.
The team of medical professionals advising Biden are warning internally that the program he will inherit from outgoing President Donald Trump may fall short of expectations of rapid and widespread relief. Instead of mass distribution to the general population in the coming months, Americans tired by the pandemic could see approval delays, disruption in distribution, and insufficient quantities.
Getting the vaccine for all Americans who want to get vaccinated could take six months or more, said Dr. David Kessler, a former FDA commissioner who advised Biden, in an interview on MSNBC Wednesday.
It may not be until late summer or early fall before the vaccine begins to be widely available to the general public, said another doctor close to the transition, who no was not allowed to discuss the matter and comment on the background.
This contrasts with the timelines set by Trump administration officials, who have said the general public could start getting vaccinated in late February.
Dr Brett Giroir, who has led testing efforts for the Trump administration, said on Wednesday that the majority of the U.S. population could be vaccinated in late spring or early summer. Dr Anthony Fauci, the country’s leading infectious disease physician, who plans to stay in the Biden administration, said he expects by the end of March or early April the general public will be able to get vaccinated, with life. potentially start to return to normal in late fall.
Divergent views on how quickly the vaccine will become widely available stem, in part, from different assumptions about how well critical next steps will unfold, which include testing, manufacturing and distributing the vaccines, the doctors said. .
Those advising the transition warn that it’s difficult to understand 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 needed if most of the American population received Pfizer or Moderna vaccines that require injections three to four weeks apart. A vaccine in development by Johnson & Johnson will only require a single dose, while one tested by AstraZeneca will likely require two injections, but no vaccine has completed phase 3 clinical trials or received approval from the FDA.
Biden has promised 100 million “shots” in his first 100 days, but has not come up with a plan or publicly expressed concerns about the Trump administration’s timetable.
The Biden team has held several meetings with the Trump administration team, but members warn they will not have a full understanding of the vaccination plan before the inauguration, an official briefing the Biden transition said.
“We continue to work with the Operation Warp Speed team and our goal will be to ensure that safe and effective vaccines are available to all Americans, and we will likely have additional details to share in the weeks and months. months to come, ”said a transition official. in a report.
The contrasting timelines could have political implications for Biden. If the cast takes longer than members of Trump’s Operation Warp Speed, or OWS, have projected, Biden’s critics might try to blame his administration for handling a program whose he inherited.
“You have to ask yourself if the Trump team is intentionally laying the groundwork for the new Biden administration to blow up expectations that could not be met due to the current incompetence of the White House,” said Zac Petkanas, a strategist Democrat who formed a group. dedicated to criticizing Trump’s Covid-19 response.
The United States has ordered enough doses of Pfizer and Moderna vaccine to inoculate 150 million people. This 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 in order for the United States to inoculate the wider population by the end of the summer, additional vaccines will need to be authorized or the federal government will need to sign an agreement to purchase more doses of existing licensed vaccines. To reach the point where the immunity of the population is sufficient for the virus to begin to go away, around 250 million people would need to be vaccinated, public health officials say.
“The planned spring supply of vaccines depends on the authorization of additional vaccines. It’s uncertain, ”said Topher Spiro, vice president for health policy and senior researcher for economic policy at the liberal-leaning Center for American Progress. “It is unwise to over-promise and under-deliver – it erodes public trust. And we have already seen OWS having to reiterate its promises several times. “
Pfizer said it would not be able to supply the United States with additional doses of its vaccine until at least July, after Washington waived an option to purchase additional doses several months ago.
The Trump administration and Pfizer are currently in talks about ordering an additional 100 million doses before that date, but Pfizer CEO Albert Bourla said earlier this week that the company has a “critical supply” of certain components used to make the vaccine. The company wants the United States to invoke the Defense Production Act to help them get additional resources to speed up production.
It is also unclear when additional vaccines might be authorized. As for the next two vaccines in development, the United States has contracts to buy 100 million doses from Johnson & Johnson and 150 million from AstraZeneca, both of which are expected to have trial results in early 2021.
But getting FDA clearance for these vaccines is not guaranteed. There have been questions about the effectiveness of the AstraZeneca vaccine after the company presented confusing results from a trial. Johnson & Johnson has not released the results of its large-scale study and the earliest possible time to get US clearance is in late January or early February.
“People are getting pretty nervous about whether the AstraZeneca vaccine will be viable,” said a doctor working with the transition. “The communications and analysis have been such a mess that we have to wait for the reading of the US trial in January.”
Beyond that, doctors say they are concerned about the smooth running of the mass vaccination program. While hospitals are relatively well equipped for employee health units to administer vaccines to staff, they lack the resources to administer nationwide, a Biden Covid-19 adviser said.
This will likely leave much of the job of getting the general public vaccinated to retail pharmacies such as CVS and Walgreens that have frameworks in place for over a decade of flu shots, but have never had to. vaccinate on such a large scale in such a case. short period of time.
“Everything would have to work properly, which is unlikely,” said Leslie Dach, a former senior advisor at the Department of Health and Human Services under President Barack Obama. “Look at all the unanswered questions, starting with the number of doses, not clear state-by-state guidelines on who gets vaccinated when, rural distribution issues and open-ended questions about how people get vaccinated in the country. wide range of urban distribution nodes. And that assumes that people want to be vaccinated. ”