Biden’s advisers warn that the timing of Trump’s mass vaccine may be too optimistic

WASHINGTON – Millions of Americans are looking forward to delivering the first coronavirus vaccines, but doctors advising President-elect Joe Biden are raising concerns that the timeline for widespread distribution could be longer than expected.

The team of medical professionals advising Biden internally warns that the program he will inherit from outgoing President Donald Trump may not live up to expectations of rapid and widespread relief. Instead of mass distribution to the general population in the coming months, pandemic-fatigued Americans may experience delays in approval, disruptions in distribution, and insufficient quantities.

Getting the vaccine for every American who wants to be vaccinated could take six months or more, Dr. David Kessler, a former FDA commissioner who advised Biden, said 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 transition, who was not licensed to discuss the matter and spoke in background.

This is in contrast to the timelines set by Trump administration officials, who said the general public could start receiving the vaccine in late February.

Dr Brett Giroir, who led the testing efforts for the Trump administration, said on Wednesday that most of the U.S. population could be vaccinated by late spring or early summer. Dr Anthony Fauci, the country’s leading infectious disease doctor, who is planning to stay in the Biden administration, said he expects that by the end of March or early April, the general public will be able to get vaccinated, with life potentially starting to return to normal in the late fall.

Diverging views on how quickly the vaccine will become widely available hinges, in part, on several assumptions about how the next crucial steps will go smoothly, which include vaccine testing, manufacturing and distribution, the doctors said.

Advocates for the transition warn that it is difficult to understand the variables and the difficulty of potentially giving a vaccine 600 million times in a matter of months – the number of doses that would be needed if the majority of the American population were given Pfizer or Moderna. vaccines that require injections three to four weeks apart. A vaccine being developed by Johnson & Johnson will only require one dose, while the one tested by AstraZeneca will likely require two injections, but neither vaccine has completed Phase 3 clinical trials nor received FDA clearance.

Biden has promised 100 million “gunshots” in its first 100 days, but has not outlined a plan or publicly voiced concerns about the timing of the Trump administration.

Biden’s team has held multiple meetings with the Trump administration team, but members warn they won’t have a full understanding of the vaccination plan until after the unveiling, an official who briefed Biden’s transition said.

“We are continuing 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 more details to share in the coming weeks and months,” an official said. of the transition. in a statement.

The conflicting timelines could have political implications for Biden. Should the distribution take longer than members of Trump’s Operation Warp Speed, or OWS, predicted, Biden’s detractors could try to blame the management of a program he inherited from his administration.

“You have to wonder if the Trump team is intentionally laying the groundwork for the new Biden administration to blow past expectations that could not be met due to the current incompetence of the White House,” said Zac Petkanas, a Democratic strategist who has formed a group. dedicated to criticizing Trump’s response to Covid-19.

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 before the end of the summer, additional vaccines will have to be authorized or the federal government will have to sign an agreement to purchase more doses of existing licensed vaccines. According to estimates by public health officials, to get to the point where there is enough immunity in the population for the virus to start disappearing, about 250 million people would need to be vaccinated.

“The planned supply of vaccines in the spring depends on the authorization of further vaccines. It’s not certain, “said Topher Spiro, vice president of health policy and senior fellow for economic policy at the liberally-oriented Center for American Progress. public. And we’ve already seen OWS having to tweak their promises a couple of times. “

Pfizer said it will not be able to provide the United States with additional doses of its vaccine until at least July, after Washington gave up the option to purchase additional doses several months ago.

The Trump administration and Pfizer are currently in talks to order 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 produce the vaccine. The company wants the United States to invoke the Defense Production Act to help them obtain additional resources to accelerate production.

It is also unclear when additional vaccines might be authorized. As for the next two vaccines in the pipeline, the U.S. has contracts to purchase 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 those vaccines isn’t guaranteed. There were questions about the effectiveness of the AstraZeneca vaccine after the company presented confusing results from a study. Johnson & Johnson has not released the results of its large-scale study, and the first that could get US clearance is late January or early February.

“People are getting pretty nervous that the AstraZeneca vaccine will be viable,” said a doctor working with the transition. “Communications and analysis have been such a mess that we have to wait for the US trial to be read in January.”

Beyond that, doctors say they are concerned about how smooth the mass vaccination schedule will go. While hospitals are relatively well equipped for employee health units to administer vaccines to staff, they lack the resources to administer the entire nation, a Biden Covid-19 consultant said.

This will likely leave much of the task of getting the general public vaccinated to retail pharmacies like CVS and Walgreens that have facilities in place for over a decade of delivering flu shots, but have never had to vaccinate on such a large scale at such a large scale. short period of time.

“It would take everything to function well, which is unlikely,” said Leslie Dach, a former senior adviser in the Department of Health and Human Services under President Barack Obama. “Look at all the unanswered questions, starting with the number of doses, no clear guidelines stating by state about who gets vaccinated and when, rural distribution issues, and open questions about how people get their shots across the wide range of nodes. urban distribution. And this assumes that people want to get vaccinated. “