WASHINGTON — The Trump administration on Wednesday announced a nearly $2 billion contract with the pharmaceutical giant Pfizer and a smaller German biotechnology company for up to 600 million doses of a coronavirus vaccine.
If the vaccine proves to be safe and effective in clinical trials, the companies say they could manufacture the first 100 million doses by December.
Under the arrangement, the federal government would obtain the first 100 million doses for $1.95 billion, with the rights to acquire up to 500 million more. Americans would receive the vaccine for free. Before it could be distributed, it would first need at least emergency approval by the Food and Drug Administration.
Large-scale safety and efficacy trials are to begin this month, with regulatory review set for as early as October.
“Depending on success in clinical trials, today’s agreement will enable the delivery of approximately 100 million doses of vaccine being developed by Pfizer and BioNTech,” Alex M. Azar II, the health secretary, said in a statement announcing the deal.
The news on Wednesday came as something of a surprise. Unlike AstraZeneca, Johnson & Johnson and Moderna, which have also received funding from the U.S. government, Pfizer did not earn a contract for its initial research and development efforts — only for producing and distributing the doses.
At a congressional hearing on Tuesday with executives from five vaccine manufacturers, including Pfizer, some lawmakers raised concerns about the company’s decision to reject federal funds, suggesting it could lead to price-gouging and a lack of transparency.
“We didn’t accept the federal government funding solely for the reason that we wanted to be able to move as quickly as possible with our vaccine candidate into the clinic,” John Young, Pfizer’s chief business officer, said at the hearing.
Several of the executives, including Mr. Young, said that their companies would not sell a coronavirus vaccine at cost.
“We’ll price our potential vaccine consistent with the urgent global health emergency that we’re facing,” Mr. Young said, adding that “a vaccine is meaningless if people are unable to afford it.”
BioNTech is a German pharmaceutical company. The two firms are developing a vaccine candidate that uses genetic material from the virus, known as messenger RNA, to trigger the immune system without making someone sick. The technology is fast to produce, but has never been used in an approved vaccine.
Moderna, a Massachusetts biotech company receiving $483 million from the U.S. government for its vaccine development, is also using mRNA technology.
The agreement, which the Department of Health and Human Services announced Wednesday morning, is the largest contract yet for “Operation Warp Speed,” the government’s crash coronavirus vaccine program. The federal government announced earlier this month that it would pay the Maryland-based company Novavax $1.6 billion to expedite the development of a coronavirus vaccine.
“We’ve been committed to making the impossible possible by working tirelessly to develop and produce in record time a safe and effective vaccine to help bring an end to this global health crisis,” said Dr. Albert Bourla, Pfizer’s chairman and chief executive officer said in a news release.