U.S., Pfizer reach deal expanding American vaccine supply

WASHINGTON — The Trump administration and Pfizer on Wednesday said they had reached an agreement supplying the United States with an additional 100 million doses of the coronavirus vaccine made by the pharmaceutical giant and the German company BioNTech by the end of July.

The deal doubles the total number of doses the government has on order from Pfizer – enough to immunize 100 million people with a two-dose regimen. The government will pay $1.95 billion for the additional doses and has agreed to help Pfizer obtain the ingredients needed to make the vaccine, part of an effort to boost manufacturing of a product that embodies hope for reviving the economy and ending the pandemic.

The additional doses are unlikely to mean an expansion of early access to the shots, which are being rationed for health-care workers and longterm care residents and staff, as the coronavirus strains the country’s medical system. But the added supply averts the possibility of a devastating shortfall in the spring and summer, right as the government was anticipating being able to make immunization available to wider segments of the public.

Though it does not accelerate when most Americans will be able to receive shots, Wednesday’s announcement increases by one-third the amount of vaccine available by mid-2021. Pfizer and the biotechnology company Moderna, which have received federal authorization to distribute coronavirus vaccines on an emergency basis, have

now promised, between them, to provide the government with 400 million doses. The shots will be free to anyone who receives them.

“With these 100 million additional doses, the United States will be able to protect more individuals and hopefully end this devastating pandemic more quickly,” Albert Bourla, Pfizer’s chief executive, said Wednesday.

According to data maintained by the Centers for Disease Control and Prevention, more than 1 millionvaccine doses had been administered in the United States by Wednesday. Nearly 10 million doses had been distributed, mainly to large hospital systems equipped to rapidly inoculate large numbers of ICU nurses, respiratory therapists, service workers and others battling an intensifying surge of covid-19 infections.

As of Wednesday afternoon, the virus has infected 18.3 million people in the United States and killed nearly 324,000.

Adding to the unease in the midst of a burst of Christmas-related travel was the spread in Britain of new variants of the coronavirus. Britain’s top health official announced Wednesday that two cases of a new coronavirus variant were found in the country. Health Secretary Matt Hancock said the new variant spreads more readily and was first detected last week by scientists in South Africa. The variant comes on top of a different permutation of the virus that has been triggering a rapid rise of cases in Britain and prompted travel restrictions, which have stymied the movement of cargo and passengers between that country and Europe.

Britain and France reached an agreement that would allow some passengers and all freight into France, as long as drivers provided negative test results for the virus. The military was managing testing sites where thousands of trucks have been stranded on the British side of the English Channel.

Britain, earlier this month, was the first country to begin administering doses of the Pfizer-BioNTech vaccine, while European drug authorities on Monday authorized its use.

In the United States, the first vaccines are being given as the country faces a rapid surge in infections and deaths and some hospitals are exceeding their capacities. Over the past week, an average of 2,666 Americans died each day of coronavirus – a record. Nearly 118,000 patients were hospitalized with covid-19, in another all-time high for the country.

Between the products from Pfizer and Moderna, federal officials say they anticipate being able to deliver at least a first shot of the two-dose regimens to 100 million Americans by the end of February. Pfizer and Moderna have both promised that half of their doses will be available to the government for distribution by April 1.

The leaders of Operation Warp Speed, the Trump administration’s initiative to speed the development of vaccines and therapeutics, have stressed that other promising vaccine candidates will soon supplement this supply. Some of those additional candidates, which include single-dose regimens easier to store and administer, are in late-stage clinical trials, while others have yet to begin them.

The agreement reached Wednesday with Pfizer also includes options for the government to purchase an additional 400 million doses of the vaccine.

As part of the agreement, the government has agreed to use the Defense Production Act, a Korean War-era law allowing the designation of certain supplies as essential in wartime or other national emergencies, to help the pharmaceutical giant accelerate production.

The Trump administration has used the law on occasion, including to increase production of masks and ventilators. But the administration has drawn criticism, including from public health experts, for not using the law more broadly or consistently for the production of personal protective equipment that has remained in short supply or to increase the availability of tests earlier this year.

President-elect Joe Biden has called on the Trump administration to purchase more vaccine and to make greater use of the Defense Production Act for the raw materials needed by pharmaceutical companies and other pandemic-fighting purposes.

Pfizer has been stressing for several months its eagerness for the administration to help it gain vaccine-making supplies through this law, said people familiar with the negotiations, because some of the materials it needed had been snapped up by companies given priority under Operation Warp Speed.

Pfizer was the only company that did not take government money for research and development of a vaccine, which meant U.S. officials have had less insight into aspects of its manufacturing process, federal officials have said, and less certainty about where the company’s doses would be sold. Pfizer, for its part, had indicated to the government that it would be able to provide 70 million doses in the second quarter and an additional 30 million in the third quarter – but that it might be able to get to 100 million doses more quickly if it received help gaining access to certain raw materials.

Under Wednesday’s agreement, Pfizer is adhering to its original time frame even with government help, pledging to provide 70 million additional doses by June 30 and the other 30 million by the end of July.

The administration had earlier turned down entreaties to lock down more of the supply, causing Pfizer to commit hundreds of millions of doses to other countries. When administration officials recently returned to the drugmaker seeking to buy another 100 million doses, the question of support under the Defense Product Act became central to negotiations.

For vaccine developers, priority under the Defense Production Act means assistance in obtaining raw materials and producing supplies such as glass vials and syringes, as well as “specialty tooling and staff” to enhance plants and production lines, said Michael Pratt, a spokesman for Operation Warp Speed. The law is only invoked for contracts delivering supplies domestically, said an administration official familiar with its usage. Members of the Trump administration have complained this fall of lacking “visibility” into Pfizer’s manufacturing process.

“It does make sense that with earlier Warp Speed contracts, the companies would have worked out with the government what raw materials they needed and how priority through the DPA could help,” said Jerry McGinn, executive director of George Mason University’s Center for Government Contracting. “It doesn’t sound unreasonable for Pfizer, when doing another contract with the government for delivery, to fold that issue in. It probably gave the government some leverage.”

With a sharply limited supp ply of shots for the next few months, states have been prioritizing health-care workers and the residents and staff of long-term care facilities, with other front-line workers and people aged 75 and older expected to gain access in the next phase. In one bright spot for hospitals receiving the initial shipments of the Pfizer-BioNTech vaccine last week, some health-care providers discovered they could get as many as seven doses out of vials they were told contained only five doses of the precious vaccine.

The Food and Drug Administration is planning to reissue the emergency use authorization soon for the vaccine to make clear that six doses can be extracted from a vial, according to people familiar with the matter who spoke on the condition of anonymity because they were not authorized to share details publicly. The extra dose can be acquired by using a kind of syringe, called a low dead space syringe, which cuts medication waste.

Even in parts of the country with the most dire need, however, gaps are already emerging in access to the shots. Because of the size of each batch, and the ultracold storage requirements in the case of the Pfizer-BioNTech vaccine, states are turning to large hospital systems to inoculate their own staff. Other providers, said Gustavo Friederichsen, chief executive of the Los Angeles County Medical Association, are asking: “Where do I fit in this plan?”