Trump administration officials denied there would be availability issues 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.”
But several officials knowledgeable about the contracts said that supplies from other companies may be insufficient to fill the gap, depending on what other vaccines have been authorized by then.
Pfizer officials had urged Operation Warp Speed 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 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, 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.
But last weekend, when federal officials reached out to the company asking to buy another 100 million doses, Pfizer said it didn’t have it and asked that the conversation be elevated to “a higher level discussion,” said a person familiar with the talks who spoke on the condition of anonymity because they were not authorized to speak.
The government struck a different type of contract with Pfizer than with other companies it worked with through Operation Warp Speed. Pfizer was the only company that did not take government money for its research and development process, which means U.S. officials have less insight into its manufacturing process than it does with the other companies, said a senior administration official familiar with the matter who spoke on the condition of anonymity.
The government purchased 100 million doses of Pfizer’s vaccine with an option to purchase another 500 million. Government officials believed at least some of those additional doses would be available when they went to purchase them, the official added.
But when federal officials recently approached Pfizer to buy another 100 million doses for the second quarter of next year, Pfizer said the company would be able to provide only 50 million doses at the end of that quarter, and another 50 million doses in the third quarter, the individuals said. That’s because other countries have ordered the vaccines, they said.
Pfizer spokeswoman Amy Rose declined to confirm or deny the information and said that beyond the first 100 million doses the U.S. has secured, a separate agreement would have to be reached. “The company is not able to comment on any confidential discussions that may be taking place with the U.S. government,” Rose said.
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 order will be announced as part of a White House “vaccine summit” designed to highlight the administration’s accomplishments on vaccines.
“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 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 is lined up for 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 — including Johnson & Johnson — will provide what’s needed but some of those companies are still conducting late-stage clinical trials, while others haven’t 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 different 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,” 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.
“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 a vaccine, and contained an option to request up to an additional 500 million doses. Those doses will begin being shipped to communities across the country within 24 hours of FDA approval, which could come as early as this week.
“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” and the company could not comment on confidential negotiations that might be taking place with the U.S. government, she said.
No agreements with Moderna beyond its initial contract have been announced, but the U.S. has the option to purchase 400 million additional doses, at a cost of $16.50 per dose.
View original article here Source