WASHINGTON -- Pfizer has told the Trump administration that it cannot provide additional doses of its coronavirus vaccine until late June or early July because other countries have rushed to buy up its supply, according to individuals familiar with the situation.
That means the U.S. government will have 100 million doses of the two-shot Pfizer vaccine purchased earlier this year -- far fewer than it initially planned -- raising questions about whether it can keep to its aggressive schedule to vaccinate most Americans by late spring or early summer.
The report by The Washington Post comes as President Donald Trump's administration announced plans for a White House "vaccine summit" today, featuring experts who will outline distribution plans.
Separately, California on Monday announced a voluntary smartphone tool to alert people of possible coronavirus exposure as more than 80% of the state's residents are under lockdown orders.
Trump administration officials denied that there would be vaccine availability problems in the second quarter, citing other vaccines in the pipeline, but others said problems are possible.
"I'm not concerned about our ability to buy vaccines to offer to all of the American public," Gen. Paul Ostrowski, who oversees logistics for Operation Warp Speed, the government's initiative to expedite vaccine development, said in an interview Monday. "It's clear that Pfizer made plans with other countries. Many have been announced. We understand those pieces."
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But several officials knowledgeable about the contracts said that if there is a Pfizer shortfall in the second quarter, supplies from other companies may be insufficient to fill the gap, depending on which other vaccines have been authorized by then.
Pfizer officials had urged the federal operation to initially purchase 200 million doses, or enough for the two-shot regimen for 100 million people, last summer, according to people knowledgeable about the issue who spoke on condition of anonymity because they were not authorized to discuss the situation. But the Warp Speed officials declined, opting instead for 100 million doses, or enough for 50 million people, they said.
"Anyone who wanted to sell us ... without an [FDA] approval, hundreds of millions of doses back in July and August, was just not going to get the government's money," said a senior administration official.
When federal officials recently approached Pfizer to buy another 100 million doses for the second quarter of next year -- after the company released data showing the shots to be remarkably effective -- Pfizer said the company would be able to provide only 50 million doses in the second quarter, and another 50 million in the third quarter, the individuals said. That's because other countries have ordered the vaccines, they said.
The vaccine by Pfizer and German biotech firm BioNTech is expected to receive emergency authorization from the Food and Drug Administration in the next several days, and Moderna's is lined up for clearance shortly after that. Shipments of the vaccines will begin within 24 hours of approval, federal officials have said.
SHOPPING FOR VARIETY
Warp Speed officials are looking to other companies with promising vaccine candidates -- including Johnson & Johnson -- to provide additional vaccines, but some of those companies are still conducting late-stage clinical trials, while others have not started them.
That means there are several weeks to months before the companies are ready to submit an application to the FDA for emergency authorization. One of the companies, AztraZeneca, recently reported vaccine data that was encouraging, but experts raised questions about the data and what it meant about the efficacy of the vaccine.
Moncef Slaoui, chief science adviser to Warp Speed, said in an interview Monday that the U.S. government strategy was to spread its risk widely over many types of vaccines from different manufacturers. He declined to comment on negotiations with any company, including Pfizer. But he said he did not believe there would be any kind of vaccine "cliff," from which the available doses would fall sharply.
Slaoui said Johnson & Johnson was likely to report trial results in early January and be ready to ship doses in February, if its vaccine is authorized. He predicted that AstraZeneca's trial would report results in late January or early February and potentially begin providing doses that month.
"Specifically this means we can have more Moderna vaccine doses, more Pfizer vaccine doses, more Johnson & Johnson vaccine doses and AstraZeneca doses for the foreseeable future," Slaoui said. "We could have all of them. And for this reason, we feel confident we could cover the needs without a specific cliff ... . We have planned things in such a way as we would indeed avoid a cliff."
The contract that Pfizer signed with the government in July was to deliver 100 million doses of vaccine, and it contained an option to request up to 500 million more.
"Pfizer shall inform the Government of appropriate lead times based on purchase of raw materials, capacity reservation and other factors, and Pfizer and the Government shall mutually agree on an appropriate estimated delivery schedule," the contract states.
"Recognizing the urgency of the need, our manufacturing teams have been working round-the-clock so we can bring the vaccine to the world as quickly, efficiently and equitably as possible," Pfizer spokeswoman Amy Rose said.
Additional doses would be "subject to a separate and mutually acceptable agreement," she said, and the company would not comment on confidential negotiations that might be taking place.
TRUMP PLANS CELEBRATION
The White House summit today will feature Trump, Vice President Mike Pence and a host of government experts, state leaders and business executives, as the White House looks to explain that the vaccine is safe and lay out the administration's plans to bring it to the American people.
Senior administration officials provided details on the summit Monday.
Officials from President-elect Joe Biden's transition team are not invited, even though they will oversee the continuation of the largest vaccination program in the nation's history once he takes office Jan. 20.
Officials from the pharmaceutical companies developing the vaccines also were not expected to attend despite receiving invitations, according to people familiar with the matter. Some expressed concerns about the event contributing to the politicization of the vaccine development process and potentially further inhibiting public confidence in the drugs.
Trump is set to kick off the event with remarks aiming to "celebrate" vaccine development, according to an official who previewed the event. Trump also will sign an executive order to prioritize Americans for coronavirus vaccines procured by the federal government. A second official said the order would restrict the government from donating doses to other nations until there is excess supply to meet domestic demand. Both officials spoke on condition of anonymity to discuss plans for the summit.
"The executive order reaffirms to the American people that we are going to put America first," said a senior administration official.
It is not clear whether the order is related to the Pfizer supply issue or whether the president can prevent an American company from fulfilling lawful contracts with other countries.
VIRUS PHONE APP PROMOTED
California Gov. Gavin Newsom on Monday announced a voluntary smartphone tool to alert people of possible coronavirus exposure a day after large areas of the state began a new round of stay-at-home orders.
The tool -- which has been used on a pilot basis on some state university campuses -- doesn't track people's identities or locations but uses Bluetooth wireless signals to detect when two phones are within 6 feet of each other for at least 15 minutes, officials said.
California's 40 million residents can opt in to the system starting Thursday. When someone who has activated the technology tests positive, that person will receive a verification code from state health officials that can be used to send an anonymous alert to other users who may have been exposed over the past 14 days.
The technology comes as coronavirus cases are exploding in California and more than 80% of the state's residents are under orders not to leave their homes for at least the next three weeks except for essential purposes.
Newsom's administration issued the stay-at-home rules closing restaurant dining, salons and playgrounds in Southern California and a large swath of the Central Valley agricultural region after more than 85% of intensive care units were occupied in those regions. Five San Francisco Bay Area counties voluntarily joined the rules over ICU capacity concerns, and restrictions there will last until Jan. 4, a week longer than the state's timeline. Retailers including supermarkets and shopping centers can operate with 20% capacity.
FAUCI WARNS ANEW
Meanwhile, Dr. Anthony Fauci, the government's top infectious-disease expert, said Monday that the Christmas holiday season could pose greater risks than Thanksgiving when it comes to spreading the virus.
Thanksgiving travel and gatherings typically take place for a shorter period of time, while Christmas events may continue through Hanukkah and New Year celebrations, he said, in remarks made at the Milken Institute's Future of Health summit.
Christmas "extends that vulnerable period by two to three times," Fauci said, and could pave the way for another surge.
Infections are emerging from "modest-sized gatherings of family and friends in a home," including gatherings of around 10 people, something the American public should be very careful about in the coming weeks, he said.
Fauci urged Americans to double down on measures such as wearing masks, avoiding crowds and social distancing. But he also warned that the country hasn't yet seen the full extent of new virus data related to Thanksgiving, saying those numbers usually take up to two and a half weeks to emerge.
"Which is the reason why I'm so concerned, because the blip of Thanksgiving isn't even here yet," he said. "We're getting those staggering numbers of new cases and hospitalizations before we even feel the full brunt of the Thanksgiving holiday."
Information for this article was contributed by Laurie McGinley, Yasmeen Abutaleb and Carolyn Y. Johnson of The Washington Post; by Zeke Miller, Jonathan Lemire, Linda Johnson, Amy Taxin, Adam Beam, Matt O'Briend, John Antczak and Olga R. Rodriguez of The Associated Press; and by Emma Court of Bloomberg News.