U.S. Government Secures 100 Million More Pfizer-BioNTech COVID-19 Vaccine Doses

Pfizer BioNTech_STR/NurPhoto via Getty Images

STR/NurPhoto via Getty Images

Pfizer and BioNTech have reached an agreement with the Trump administration on supplying more of their COVID-19 vaccine. Yesterday it was reported that the two companies were working to make more of their vaccine than the 1.3 billion it promised to manufacture in 2021. Ugur Sahin, BioNTech’s co-founder and chief executive officer, said late Monday that they should know by January or February whether they can and by how much.

“I am confident that we will be able to increase our network capacity, but we don’t have numbers yet,” Sahin said.

Apparently they could, and have agreed to supply an additional 100 million to the U.S by July 31, 2021. The U.S. government is paying an additional $1.95 billion for the 100 million doses. They will produce at least 70 million by June 30, 2021. The U.S. government also has the option to buy up to another 400 million doses.

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” said Albert Bourla, Pfizer’s chairman and chief executive officer. “We look forward to continuing our work with the U.S. government and healthcare providers around the country.”

To scale up manufacturing even more, they will need more raw materials, more clean rooms and more cooperation partners, according to Sahin. It will also require additional space to formulate the shots, package and prepare them for transport. Pfizer is currently manufacturing the vaccine at three locations in the U.S. and one in Europe; BioNTech has two manufacturing locations in Germany.

By the end of this year, Pfizer-BioNTech expect to ship 12.5 million doses to the European Union and 20 million to the U.S. They have already begun transporting the vaccine to the UK and that about 500,000 people have already received their first shot.

To date, the Pfizer-BioNTech vaccine has been authorized for use in more than 45 countries.

For the U.S. and Europe, there are currently two vaccines that have received emergency authorization, Pfizer-BioNTech and Moderna. The majority of what they are able to manufacture for the next six months has already been allocated via contracts with the U.S. and other government.

According to earlier reports, the agreement would require the U.S. government invoke the Defense Production Act, which would give Pfizer and BioNTech more access to about nine specialized products needed to produce the vaccine. This includes lipids, which are used as vectors to contain the mRNA that codes for part of the virus’s spike protein. It is not clear if that is the case for the final agreement.

Pfizer began asking for the U.S. government’s help in September to obtain supplies, but according to documents reviewed by The New York Times, were unhappy about the lack of response on the part of the Trump administration. Pfizer and BioNTech did not accept development money from the U.S. government’s Operation Warp Speed, although Moderna did, as did other companies, including Sanofi and Novavax, neither of which have even launched large-scale clinical trials in the U.S. Pfizer documents suggest that they had a disadvantage in negotiating with the Trump administration because of this, although they still got their vaccine authorized and began distribution a full week ahead of the Moderna effort, and have larger manufacturing capabilities.

Reportedly, Pfizer and the Trump administration have been in negotiations for more than a month, but other countries moved faster than the U.S. to buy up vaccine supplies.

Both Pfizer and Moderna have a deal to each deliver 100 million doses of their vaccines by the end of March. Moderna has agreed to sell the U.S. government another 100 million doses in the second quarter.

Both of the vaccines require two doses, so in order to vaccinate everyone in the U.S., should they want to, would require about 660 million doses, although there are indications that about a third of the population may refuse the vaccine.

At the moment, only about 260 million people in the U.S. are eligible for the vaccine anyway, because Moderna’s is only for people 18 and older, while Pfizer’s is for people aged 16 and over. If Pfizer manufactures an additional 100 million doses, between the two companies that would leave about 60 million eligible Americans who would not be able to receive a full dose in the first half of 2021. It’s possible that the AstraZeneca-University of Oxford vaccine will receive authorization in January, although about 40% of their supply is already allocated to low- and middle-income countries, with much of the rest targeted for the UK and Europe. They have also not yet completed enrollment in the U.S. arms of their Phase III vaccine trials. Johnson & Johnson is probably the next vaccine likely to be authorized, with interim data expected mid-January, and if good, might receive authorization by March. The J&J vaccine only requires a single shot.

According to The New York Times review of documents, Pfizer started asking Gen. Gustave F. Perna, the chief operating officer of Operation Warp Speed, in September for assistance with supplies and continued bringing it up in weekly meetings. A senior Trump official indicated the government was not willing to intervene because Pfizer would not promise it would use the materials to produce the vaccine only for the U.S.

“It’s our obligation under that type of priority rating to make sure that assets are used only for U.S. sales or production,” the official said, “and they (Pfizer) weren’t willing to do that.”

Other people familiar with the discussions also said the U.S. government wanted to protect its investment in the other companies it had funded through Operation Warp Speed and didn’t want to give Pfizer the same priority.

Pfizer and the Trump administration have not had a particularly good relationship with each other during this. After losing the presidential election in November, President Trump accused Pfizer of deliberately delaying submitting for emergency use authorization to make him look bad politically.

There have also been some questions about pricing for the vaccine. Pfizer’s deal with the European Union for 200 million doses ran $14.50 for each dose. The deal with the Trump administration in July for the original 100 million doses put the price at $19.50 per dose.

On its part, Pfizer had indicated they had repeatedly urged the Trump administration this summer and fall to lock in more doses early because other countries had expressed interest and they expected to lock in their supply. The administration turned them down, later saying it was because Pfizer would not commit to specific delivery dates.

Alex Azar, Secretary of the U.S. Health and Human Services, has said that the federal government would help Pfizer manufacture more vaccines “if they are willing to take our help.” He added, “I do wish we would just stop talking about this Pfizer things.”

He also denied there was a likelihood of a vaccine shortage and that the government has commitments for three times as many doses as it has ordered for the first six months of 2021. However, that total seems to include doses of vaccines that haven’t demonstrated efficacy or safety yet or are only part of contracts that have not been finalized.

Featured Jobs on BioSpace

Back to news