Across the United States, millions of frontline health care workers and nursing home residents have already started to get vaccinated for COVID-19. But at the current pace, most Americans won’t receive their own shots until the middle of next year — or later.
The question that will define the next phase of the pandemic is whether that’s the best the U.S. can do.
In an interview with Yahoo News, Dr. Zeke Emanuel, a member of President-elect Joe Biden’s transition COVID-19 advisory board, said he believes the Trump administration could have done more to optimize the vaccine rollout. He also suggested there should have been a more robust communications effort to promote the safety and effectiveness of the vaccine.
“All of these things probably could have used more attention to detail,” Emanuel said.
Emanuel is a bioethicist, oncologist and author who previously served as a White House adviser during the Obama administration. He played a key role in crafting President Barack Obama’s signature health care law, the Affordable Care Act. Emanuel is part of a prominent family that includes brothers Ari Emanuel, a Hollywood superagent, and former Chicago Mayor Rahm Emanuel, who was Obama’s first White House chief of staff.
The criticism from the incoming administration comes as the vaccine rollout hit its first high-profile snag this week.
State officials were furious Wednesday after realizing they would be receiving 900,000 fewer doses next week than “initially anticipated”; Florida Gov. Ron DeSantis blamed his state’s shortfall on production issues at Pfizer, the drug’s manufacturer.
Federal officials, in turn, blamed a scheduling hiccup while criticizing Pfizer for keeping the government “at arm’s length” — and predicting the pharmaceutical giant would soon “need help from us on their manufacturing.”
Pfizer, for its part, denied any delays or problems with production. “We have millions more doses sitting in our warehouse,” the company said in a statement. “But, as of now, we have not received any shipment instructions for additional doses” from the Trump administration.
The White House did not respond to multiple requests for comment.
The stumble right out of the gate — and the juvenile finger-pointing that followed — underscored a growing concern with America’s high-stakes mass vaccination campaign, which is launching at a moment when U.S. COVID-19 cases, hospitalizations and deaths seem to be setting grim new records every day: Will federal officials be able to meet their goal of administering an initial shot of the two-dose Pfizer vaccine and its newly authorized Moderna counterpart to 20 million people by Jan. 1, just two weeks away? And beyond that, is the U.S. really doing everything it can to inoculate as many people as quickly as possible?
There are also questions about how the Trump administration handled purchases of Pfizer’s vaccine. In July, the U.S. government signed a contract for 100 million doses; later, the drug company twice offered the administration a chance to reserve hundreds of millions of additional doses before other countries claimed them. The administration reportedly passed. Around the same time, Pfizer slashed the number of doses it expected to ship worldwide by the end of 2020 from 100 million to 50 million, admitting it was having trouble “scaling up the raw material supply chain.” As a result, half as many Americans will be receiving the Pfizer vaccine this year — and about 180 million Americans will still be uncovered once the U.S.’s initial Pfizer and Moderna orders run out in mid-2021.
According to a New York Times report, the Trump administration is currently “negotiating a deal to use its power to free up supplies of raw materials to help Pfizer produce tens of millions of additional doses of its Covid-19 vaccine for Americans in the first half of next year.” But even that effort, which would order Pfizer’s suppliers to prioritize its purchase requests, is belated: Pfizer reportedly asked for favored status with suppliers months ago, only to see the administration prioritize similar requests from firms that (unlike Pfizer) accepted billions of dollars in federal subsidies under its Operation Warp Speed program.
While vaccine distribution has sparked concerns, the development process was nothing short of miraculous. Before 2020, the fastest vaccine ever concocted — the shot for mumps — took four years to reach the public. Now, less than a year after development began, America will soon have two safe and highly effective COVID-19 vaccines to choose from: one from Pfizer and another from Moderna.
Over the next six months, these astonishing drugs (and several others) will be shipped from factories in Michigan, New Hampshire and elsewhere. They will be boxed at arctic temperatures and travel by truck and plane to all corners of the country. And, finally, they will be injected into thousands, then millions, then hundreds of millions of arms.
It may be America’s most daunting logistical lift since World War II. And it hasn’t even really started yet. The Pfizer vaccine was the first to earn emergency approval from the Food and Drug Administration. It was developed outside of Operation Warp Speed, which has a distribution plan that will use the McKesson Corporation as a “centralized distributor.” McKesson’s distribution network has yet to be tested.
While Biden doesn’t take office until next month, Emanuel said the president-elect has “assembled as good and as smart of a team as I know” and they are in “discussions” with President Trump’s administration, local officials and the companies involved in vaccine distribution and development so they can take over the process. Biden’s advisory board is also exploring ways to accelerate the actual vaccination campaign — even as it acknowledges the immense manufacturing and distribution challenges ahead.
“We need to get to 250, 275 million Americans vaccinated to make the family Thanksgiving possible,” Emanuel said. “We want to make normal life possible — to bring the economy back, to bring social life back, to bring education back. And we are investigating every single possible angle — everything that could disrupt that going forward. That’s everything from production to vials to administration to communication strategy to overcoming people’s hesitancy. Every single bit of that is being discussed and investigated, and plans are being made to overcome potential barriers.”
This isn’t an academic debate. It’s a matter of life and death. More than 313,000 U.S. residents have already died from COVID-19. Another 113,000 are currently hospitalized. Every day, an average of 200,000 new U.S. infections are detected through testing. According to past patterns, about 1.8 percent of those people — 3,600 Americans — will die from the disease 22 days later. Another 3,600 will die the next day, and the day after and so on.
Because of this bleak math, the U.S. death toll is ordained to continue rising well into 2021. Unless America’s current trajectory of both infections and immunizations changes, models project that anywhere from 400,000 to 600,000 U.S. lives will ultimately be lost.
So speed is of the essence. Every additional person who is vaccinated today is one fewer person who might die tomorrow, and potentially one fewer person who can pass the virus to other, more vulnerable Americans.
Trump officials are banking on forthcoming vaccines from Johnson & Johnson and others to bolster federal stockpiles sometime next year. But either way, federal officials have estimated that they will have only enough doses to vaccinate about 30 million Americans in January and 50 million in February.
Publicly, Biden’s transition team hasn’t promised much beyond that. In fact, the president-elect vowed earlier this month to get “at least 100 million COVID vaccine shots into the arms of the American people” during his first 100 days in office — a schedule that would mean just 50 million people (or 15 percent of the U.S. population) fully vaccinated by April 30. That’s less than half what Trump officials are estimating. Elsewhere, Biden advisers have warned that Trump’s timeline may be too optimistic, and that approval delays, distribution disruptions and insufficient quantities could lengthen the process.
Internally, however, Biden’s experts are busy exploring ways to make the rollout more efficient. According to Emanuel, Biden’s administration hopes to work “more closely with the states to harmonize the approach and get everything coordinated.” That’s a stark contrast to the Trump administration, which has let states fend for themselves during the pandemic. Among other things, a uniform national strategy could have critical implications for who gets vaccinated and in what order — which could lower the trajectory of deaths (if seniors, by far the most vulnerable group, are prioritized) and speed kids back into classrooms (if teachers move to the front of the essential-worker line).
“The whole point is to anticipate potential problems and try to address them now or develop plans to address them when ... the Biden administration takes over,” said Emanuel.
One idea that has gained some traction among experts involves studying whether a single dose of the Pfizer and Moderna vaccines is effective enough to halt the pandemic. Both vaccines have been fully tested only as a two-dose program. Approving their use as a single dose — with the second dose to follow later, once production ramps up — could potentially double America’s initial number of inoculations and end the crisis sooner.
Neither the Pfizer nor the Moderna trial was designed to study the effectiveness of a single dose, so no one knows how long this immune protection will last, or at what level. But the early data looks promising. Moderna reported that the initial dose of its vaccine was 92.1 percent efficacious in preventing COVID-19 after two weeks — well before volunteers received their second “booster” injection on day 28. Pfizer’s results suggested similar protection after 10 to 12 days.
To put that in perspective, the U.S. this week sent 2.9 million Pfizer doses to the states — or half of the initial shipment — while setting aside the other half for booster shots to be sent out three weeks later. But what if instead of producing full immunity in 2.9 million Americans next month, the initial Pfizer shipment had been used to produce something like 85 percent immunity in 5.8 million Americans before the end of the year? Would that trade-off be worth it?
Dr. Scott Gottlieb, a Pfizer board member and former FDA commissioner, says yes. “We should get as many shots in our arms as possible right away,” he recently told the USA Today Editorial Board. “The idea that we need to cut [the doses] in half and give half of it now and hold onto it, so we have supply in January to get the second dose ... I just fundamentally disagree with that.”
Team Biden agrees that the idea is worth exploring. “The data from Pfizer — the amount of protection you got from a single dose — was pretty impressive,” Emanuel said. “It is something that has to be considered: how to stretch this absolutely scarce resource.”
While the adviser suggested there may not be much extra vaccine manufacturing capacity, Biden’s team is also looking into whether a company like Pfizer could team up with another drugmaker, such as Merck, to produce more doses — a process that could involve the Defense Production Act and that Trump officials have also asked about, with little so far to show for it.
“It’s not like there’s a lot of spare production lying around fallow,” Emanuel said. “But I can assure you that is something we are thinking through: what is the capacity of the system and where might there be some spare capacity that could go to producing the different vaccines. The transition team is investigating all the possible options.”
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