If you felt FOMO while watching British seniors receive coronavirus vaccinations on Tuesday, you’re not alone. Host Jeremy Siegel talks with POLITICO’s Sarah Owermohle about why Britain beat the U.S. to those first doses — and when we can expect FDA authorization.
The United States has reserved roughly 800 million doses from six manufacturers — including 100 million each from Pfizer and Moderna — but it’s not yet clear whether all of their vaccines will prove safe and effective enough to use. And the two frontrunners have inked deals with multiple countries that are stretching thin their early supplies.
The Trump administration is not alone in assuming that all of its big vaccine bets will pay off. Several other countries’ estimates “are based on a best-case scenario,” said Krishna Udayakumar, founding director of the Duke Global Health Innovation Center, whose team has tracked global vaccine purchases.
Those best-case scenarios generally involve manufacturers proving their vaccines are safe and effective, and then quickly scaling up production to make hundreds of millions of doses. They also make assumptions about which countries or organizations — such as the United States, or the COVAX Facility, an international public-private partnership aimed at providing vaccines to low-income countries — actually get the supplies early on.
Reports this week that the U.S. government turned down opportunities to buy up to 400 million more Pfizer shots have raised fresh questions about how the country will secure its supply. Senior administration officials denied those reports at a Monday Operation Warp Speed briefing and said negotiations are ongoing. But former FDA Commissioner Scott Gottlieb, now on Pfizer’s board, said Tuesday the firm offered more supply multiple times and the government rejection was recent.
A Pfizer spokesperson said “any additional [U.S.] doses beyond the 100 million are subject to a separate and mutually acceptable agreement,” and that the country had signed deals with more than 30 countries.
Moderna, the other vaccine frontrunner, said it expects to distribute 100 million to 150 million doses globally in the first quarter of 2021, of which 85 million to 100 million will go to the United States.
Roughly 650 million of the 1.3 billion doses Pfizer says it can make in 2021 are already spoken for, according to Udayakumar. Moderna says it can make anywhere from 500 million to 1 billion doses next year, and has already promised 380 million shots to various countries, he said.
Just delivering the doses governments have already ordered could take six months or more, Udayakumar added.
An HHS spokesperson said all the companies “have negotiated the terms of their own legal agreements. including different conditions and delivery schedules.”
And a senior administration official dismissed the idea of a vaccine cliff during a call Monday with reporters. “We are absolutely confident we’ll have enough doses to vaccinate the American people by the end of second quarter 2021,” the official said.
Still, the complexity of vaccine purchasing and distribution means Trump’s executive order, released Thursday afternoon, could be mere “America First” symbolism, rather than a tool to help the government fulfill its promise to immunize 100 million people by the end of February. The order aims to prevent doses from being delivered to other countries until all Americans are vaccinated — but is short on practical details of how to meet that goal.
“We are assessing the EO to determine its potential impact,” the Pfizer spokesperson said. Pfizer and the German company that developed its coronavirus vaccine, BioNTech, “continue to work in collaboration with governments and Ministries of Health around the world to ensure that our potential vaccine can reach those most in need as quickly as possible.”
Moncef Slaoui, head of the government’s initiative to speed vaccine delivery, Operation Warp Speed, was optimistic the United States would be able to get enough vaccine to reach its goals.
“With the mRNA vaccines [from Moderna and Pfizer], we haven’t had a significant glitch,” he told POLITICO this month. “In January or February, we’ll reach the levels where we’re immunizing 50 or 60 million people, so 100 million doses.”
But Slaoui has acknowledged that his optimism relies on a continued stream of positive news — including the success of other companies’ shots.
Those firms include Johnson & Johnson and AstraZeneca, both of which have shots in sweeping late-stage trials and could be authorized for use in early 2021 if they prove safe and effective.
Johnson & Johnson’s shot is tantalizing for other reasons — including the fact that it is given as a single dose, and its reliance on proven technology that makes it relatively easy to manufacture.
But the outlook for the AstraZeneca vaccine is mixed. The company’s late-stage trials have been slowed by surprises, from a long pause this fall to assess safety risks to a dosing mistake that proved more effective in early data than the intended dosing regimen. It’s unclear when the British drugmaker could seek emergency authorization in the U.S.
Meanwhile, the AstraZeneca vaccine remains the U.S. government’s biggest bet — with an advance purchase of 300 million doses. The company is also the biggest donor by far to the COVAX Facility, although the international group has purchased only about 700 million shots total from various manufacturers, according to Médecins Sans Frontières.
The U.S. government’s projections for how fast it can vaccinate the public do not lay out which manufacturers it’s depending on for doses or whether delays — in authorization, or manufacturing — could throw a hitch in the goal to inoculate America this spring.
Part of the problem is that Operation Warp Speed is not being transparent about how it is compiling its projections, said Hotez. Much like the hyperspace-traveling ships in “Star Wars” or “Star Trek,” “Operation Warp Speed came with its own cloaking device.”