By Sharon LaFraniere, Katie Thomas and Noah Weiland, The New York Times
WASHINGTON — Before Pfizer’s coronavirus vaccine was proved highly successful in clinical trials last month, the company offered the Trump administration the chance to lock in supplies beyond the 100 million doses the pharmaceutical maker agreed to sell the government as part of a $1.95 billion deal over the summer.
But the administration, according to people familiar with the talks, never made the deal, a choice that now raises questions about whether the United States allowed other countries to take its place in line.
While two vaccines, including Pfizer’s, have proved to be highly effective against COVID-19, and a third also appears at least moderately effective, supplies are shaping up to be scarce in the coming months as infections, hospitalizations and deaths surge to new highs. And while Pfizer is now negotiating with the administration to provide more of its vaccine, people familiar with the talks say the company cannot guarantee that it will be able to deliver more than the initial 100 million doses — enough to inoculate 50 million people since its vaccine requires two shots — before perhaps next June.
After it signed its federal contract in late July, Pfizer went on to seal deals with other governments, including the European Union, which last month finalized an agreement to acquire 200 million doses from Pfizer and its German partner, BioNTech. On Tuesday, Britain will begin inoculating its population with the vaccine.
President Donald Trump has hailed the development of the vaccine as a victory for his administration, even though Pfizer, unlike the developer of the other most promising vaccine, Moderna, took no upfront money from the government’s Operation Warp Speed development program.
On Tuesday, Trump is holding a White House event to promote the program’s role and plans to issue an executive order that applies his “America First” philosophy to the pandemic by proclaiming that other nations will not get the U.S. supplies of its vaccine until Americans have been inoculated.
The executive order by itself appears to have no real teeth and does not expand the U.S. supply of doses, according to a description of the order on Monday by senior administration officials. But it provides Trump with a talking point to rebut any criticism about the limited initial supply of the vaccine.
The order is being issued “to ensure that the United States government prioritizes getting the vaccine to American citizens before sending it to other nations,” according to a draft statement. Since the beginning of the vaccine development efforts early this year, some experts have been concerned that nationalism could complicate efforts to distribute the vaccine equitably around the world. Until now the United States has declined to participate in international efforts to supply low-income countries with vaccines.
Asked if the Trump administration had missed a crucial chance to snap up more doses for Americans, a spokeswoman for the Department of Health and Human Services said, “We are confident that we will have 100 million doses of Pfizer’s vaccine as agreed to in our contract, and beyond that, we have five other vaccine candidates, including 100 million doses on the way from Moderna.”
The federal contract signed in July called for Pfizer to deliver 100 million doses by March at a cost of $19.50 a dose. It gave the government the option to request 100 million to 500 million additional doses. It was one of six contracts that the Trump administration signed with vaccine makers in a strategy intended to hedge its bets and maximize the chances of success.
Accounts differ over the nature of the discussions between Pfizer and federal officials about whether to lock in extra doses. Several people said that during late summer or early fall, Pfizer officials repeatedly warned the Trump administration that demand could vastly outstrip supply and urged it to pre-order more doses, but were turned down.
One senior administration official, who spoke to reporters on Monday on the condition of anonymity, said that any company offering hundreds of millions of doses before it had proof its vaccine worked “was just not going to get the government’s money.”
Another person familiar with the negotiations said talks about possible additional doses began in early October. Michael Pratt, a spokesman for the Department of Health and Human Services, declined to comment on the discussions, but said that “an important part of any negotiation is having established timelines for delivery and production amounts.”
In a statement, Pfizer, an American company with headquarters in New York, said that “any additional doses beyond the 100 million are subject to a separate and mutually acceptable agreement,” and that “the company is not able to comment on any confidential discussions that may be taking place with the U.S. government.”
The decision by the White House to issue the executive order was reported by Fox News.
So far, only Pfizer has won emergency approval from a Western government. British regulators authorized it less than a week ago, after late-stage clinical trial results showed the vaccine was about 95% effective. The Food and Drug Administration is expected to follow suit in the United States as early as this weekend.
The agency may also soon approve another vaccine developed by Moderna, a small firm based in Cambridge, Massachusetts. But doses supplied by Pfizer and Moderna will initially be extremely scarce — enough to vaccinate about 22.5 million people before the end of the year — and federal officials have said vaccines will not be widely available to Americans until well into next year, even as the daily death toll continues to climb with more than 280,000 lives lost to date.
Originally, the White House cast Tuesday’s vaccine event as a kind of a victory lap for Trump. The president has repeatedly noted that his administration threw the might of the federal government behind vaccine development, a farsighted move that contrasted with its now nearly yearlong failure to curb the pandemic’s spread.
But some high-profile players will not be there. Representatives for Moderna and Pfizer said the company executives did not plan to attend. A senior administration official said on Monday that the companies were not included because the event would also include a top regulator from the FDA, Dr. Peter Marks, who is reviewing their vaccine applications.
Despite its “America First” theme, a major component of the executive order directs federal agencies to develop a policy for eventually selling or donating any additional doses to other countries.
“Once we’ve ensured the ability to meet the needs of the American people, it would then be in the interest of the United States to facilitate international access to a COVID vaccine,” a senior administration official told reporters on Monday.
The bulk of the global supply of vaccines has been claimed by wealthy countries like the United States, Canada, Britain and countries in Europe, leading to criticism that people in low- and middle-income countries will be left behind. The United States, for example, has declined to participate in a global initiative, called Covax, that is meant to make a vaccine available globally.
The federal government settled on 100 million doses in part because it had its “portfolio” of other candidates it was supporting, and because it was uncertain how well the company’s vaccine would perform in late-stage clinical trials, federal officials said.
Pfizer has struggled to meet initial expectations. This summer, the company predicted that it would have 100 million doses by the end of the year, but in November, it said manufacturing challenges forced the company to scale that back to 50 million. Vaccine manufacturing is notoriously unpredictable, and any number of factors — from shortages of raw ingredients to contaminated batches — could cause further setbacks.
As negotiations continue for additional doses, Pfizer is in a strategically important position, given that it is one of only two companies with applications pending in the United States for emergency authorization. If other vaccines prove to be promising, Pfizer could lose its leverage to dictate the terms of its agreements with the federal government.
The United States could use the Defense Production Act to compel Pfizer to prioritize the federal government in its domestic factories. But Pfizer and BioNTech have a duplicate production line in Europe, limiting the United States’ ability to control Pfizer’s global supply. Forcing Pfizer to serve the United States first could also be diplomatically delicate, given the company’s deals with other governments.
Warp Speed officials and Pfizer are still in regular contact, and more commitments to Pfizer and Moderna could be made in the coming weeks and months, one official said. But by January, a new administration will most likely play a significant role in how much more to invest in Pfizer before it could receive a full license of its vaccine from the FDA, when investments may shift to the private market.
But while both Pfizer and Moderna appear to have achieved success beyond what researchers even hoped, some of the other vaccine makers fell behind. Top federal health officials and outside experts have questioned the clinical trial data presented by AstraZeneca, a British-based company that is working with University of Oxford researchers.
Novavax, another vaccine maker that received huge support from the Trump administration, has delayed the start of its Phase 3 clinical trial in the United States in part because of setbacks in manufacturing enough doses for its trial. It has now said that it plans to start this month.
Johnson & Johnson has said it could report early results of its vaccine trial by January, and another Operation Warp Speed participant, Sanofi, has said it plans to start its late-stage vaccine trial before the end of the year.
Unlike Moderna, Pfizer largely spurned the federal government’s help developing and manufacturing its vaccine. In a recent interview with The New York Times, the company’s chief executive, Dr. Albert Bourla, said he worried that government oversight would slow his firm’s work, not accelerate it. And he feared federal funding would come with strings attached. That has left Warp Speed officials with a less complete week-to-week understanding of the company’s manufacturing.
The decision to issue the executive order was reported earlier by Fox News.
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