Trump administration officials denied there would be availability issues in the second quarter, citing other vaccines in the pipeline -- most immediately, Moderna’s, also expected to be approved in coming weeks. Both vaccines are two-dose regimens, so the 100 million doses purchased of each would cover 50 million people each.
“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.”
But several officials knowledgeable about the contracts said that supplies from other companies may be insufficient to fill the gap.
Last summer, Pfizer officials had urged Operation Warp Speed to purchase 200 million doses, or enough of the two-shot regimen for 100 million people, according to people knowledgeable about the issue who spoke on the condition of anonymity because they weren’t authorized to discuss the situation. But the Warp Speed officials declined, opting instead for 100 million doses, they said. The New York Times first reported that federal officials passed on the opportunity when Pfizer offered to sell more doses.
“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.
It was only last weekend, with a Food and Drug Administration clearance expected any day, that federal officials reached back out to the company asking to buy another 100 million doses. By then, Pfizer said it had committed the supply elsewhere and suggested elevating the conversation to “a high level discussion,” said a person familiar with the talks.
Pfizer said the company might be able to provide 50 million doses at the end of the second quarter, and another 50 million doses in the third quarter, the individuals said.
The government had a different type of contract with Pfizer than with other companies involved with Operation Warp Speed. Pfizer was the only company that did not take government money for research and development, which meant U.S. officials have had less insight into its decisions than it does with the other companies, said a senior administration official familiar with the matter who spoke on the condition of anonymity.
The contract between the government and Pfizer stipulated that if Pfizer’s vaccine was successful and received authorization from the FDA, the U.S. government would purchase 100 million doses at a set price.
Pfizer spokeswoman Amy Rose declined to confirm any information about the company’s discussions with the government, and said that beyond the first 100 million doses the U.S. has already secured, a separate agreement would have to be negotiated.
President Trump is expected to sign an executive order Tuesday that would prioritize vaccinating Americans before providing doses to other countries, according to a senior administration official who requested anonymity because he was not authorized to speak about the plans. Fox News first reported the executive order. 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.
“The executive order reaffirms to the American people that we are going to put America first,” said a senior administration official, who spoke on the condition of anonymity because he was not authorized to discuss the issue publicly.
The order will be announced as part of a White House “vaccine summit” designed to highlight the administration’s accomplishments on vaccines.
The vaccine by Pfizer and German biotech firm BioNTech is expected to receive emergency authorization from the FDA in the next several days, and Moderna is lined up for likely clearance shortly after that. Shipments of the vaccines will begin within 24 hours of the approvals, federal officials have said.
Warp Speed officials hope that other companies with promising vaccine candidates will supplement the supply in the near future, but some are still conducting late-stage clinical trials, while others haven’t begun them.
That means it could be several weeks to months before they are ready to apply to the FDA for clearance. One of the companies, AztraZeneca recently reported encouraging vaccine data, but experts raised questions about it 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 different types of vaccines from different manufacturers. He declined to comment on negotiations with any company, but said he did not believe there would be any kind of vaccine “cliff,” where the available doses would fall off sharply.
Slaoui said that 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 later that month.
“We could have all of them," Slaoui said. "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 vaccine doses, and contained an option to contract to buy an additional 500 million doses.
“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 around-the-clock so we can bring the vaccine to the world as quickly, efficiently and equitably as possible,” Rose said.
Additional doses would be “subject to a separate and mutually acceptable agreement” she said.
No agreements with Moderna beyond its initial contract for 100 million have been announced, but the U.S. has the option to purchase 400 million additional doses. Moderna is expected to deliver 20 million doses by year’s end and another tranche in the first quarter of 2021.