The Trump administration is negotiating a deal to use its power to free up supplies of raw materials to help Pfizer produce tens of millions of additional doses of its Covid-19 vaccine for Americans in the first half of next year, people familiar with the situation said.
Should an agreement be struck, it could at least partially remedy a looming shortage that the administration itself arguably helped create by not pre-ordering more doses of the vaccine Pfizer developed with its German partner, BioNTech. Pfizer agreed this summer to provide the United States with 100 million doses by the end of March, enough to inoculate 50 million people since its vaccine requires two shots.
The Pfizer vaccine is one of only two that so far have been proven to work. The administration has locked in only enough doses of the two vaccines — the other, produced by Moderna, is on track to receive emergency authorization from the F.D.A. this week — to cover 150 million people by the end of June, or less than half the nation.
The administration recently asked Pfizer to sell it enough doses to cover an additional 50 million Americans, but Pfizer said it had already found customers around the world for all the doses it can produce until around the middle of next year.
In recent days, however, Pfizer has indicated that it would be able to manufacture more doses if the administration orders the company’s suppliers to prioritize its purchase requests. The two sides are now negotiating a contract under which Pfizer would provide tens of millions more doses between April and the end of June.
According to one person familiar with the situation, Pfizer asked for that favored status with suppliers months ago. But before it was clear which vaccine trials would succeed, Trump administration officials were apparently worried about hindering other vaccine makers that had accepted billions of dollars in federal subsidies. Federal officials worked to prioritize orders for manufacturing supplies from those firms, including Moderna.
It is unclear whether the government’s concerns about squeezing the supply chain have now faded, or whether its interest in securing more of Pfizer’s vaccine has simply grown. Pfizer announced in November that clinical trials had shown that its vaccine was about 95 percent effective, and the firm was the first to win approval from the Food and Drug Administration for emergency use of its vaccine.
On Monday, Dr. Albert Bourla, Pfizer’s chief executive, told CNBC that the company had asked the federal government for priority status for some components of its vaccine manufacturing that he described as “critical.”
“We are asking them right now,” Dr. Bourla said, adding, “I hope they will do it very soon.”
As an American company with a huge domestic consumer base, Pfizer has reason to prioritize the federal government’s orders. Dr. Bourla told CNBC it was possible that the firm could provide “a lot” of the extra 100 million doses the federal government wants before the end of June.
After the company signed a contract last July pledging to sell the United States 100 million doses by the end of March, Pfizer officials suggested at least twice that the Trump administration reserve more doses, but were turned down, according to people familiar with the situation.
With distribution of a coronavirus vaccine beginning in the U.S., here are answers to some questions you may be wondering about:
- If I live in the U.S., when can I get the vaccine? While the exact order of vaccine recipients may vary by state, most will likely put medical workers and residents of long-term care facilities first. If you want to understand how this decision is getting made, this article will help.
- When can I return to normal life after being vaccinated? Life will return to normal only when society as a whole gains enough protection against the coronavirus. Once countries authorize a vaccine, they’ll only be able to vaccinate a few percent of their citizens at most in the first couple months. The unvaccinated majority will still remain vulnerable to getting infected. A growing number of coronavirus vaccines are showing robust protection against becoming sick. But it’s also possible for people to spread the virus without even knowing they’re infected because they experience only mild symptoms or none at all. Scientists don’t yet know if the vaccines also block the transmission of the coronavirus. So for the time being, even vaccinated people will need to wear masks, avoid indoor crowds, and so on. Once enough people get vaccinated, it will become very difficult for the coronavirus to find vulnerable people to infect. Depending on how quickly we as a society achieve that goal, life might start approaching something like normal by the fall 2021.
- If I’ve been vaccinated, do I still need to wear a mask? Yes, but not forever. Here’s why. The coronavirus vaccines are injected deep into the muscles and stimulate the immune system to produce antibodies. This appears to be enough protection to keep the vaccinated person from getting ill. But what’s not clear is whether it’s possible for the virus to bloom in the nose — and be sneezed or breathed out to infect others — even as antibodies elsewhere in the body have mobilized to prevent the vaccinated person from getting sick. The vaccine clinical trials were designed to determine whether vaccinated people are protected from illness — not to find out whether they could still spread the coronavirus. Based on studies of flu vaccine and even patients infected with Covid-19, researchers have reason to be hopeful that vaccinated people won’t spread the virus, but more research is needed. In the meantime, everyone — even vaccinated people — will need to think of themselves as possible silent spreaders and keep wearing a mask. Read more here.
- Will it hurt? What are the side effects? The Pfizer and BioNTech vaccine is delivered as a shot in the arm, like other typical vaccines. The injection into your arm won’t feel different than any other vaccine, but the rate of short-lived side effects does appear higher than a flu shot. Tens of thousands of people have already received the vaccines, and none of them have reported any serious health problems. The side effects, which can resemble the symptoms of Covid-19, last about a day and appear more likely after the second dose. Early reports from vaccine trials suggest some people might need to take a day off from work because they feel lousy after receiving the second dose. In the Pfizer study, about half developed fatigue. Other side effects occurred in at least 25 to 33 percent of patients, sometimes more, including headaches, chills and muscle pain. While these experiences aren’t pleasant, they are a good sign that your own immune system is mounting a potent response to the vaccine that will provide long-lasting immunity.
- Will mRNA vaccines change my genes? No. The vaccines from Moderna and Pfizer use a genetic molecule to prime the immune system. That molecule, known as mRNA, is eventually destroyed by the body. The mRNA is packaged in an oily bubble that can fuse to a cell, allowing the molecule to slip in. The cell uses the mRNA to make proteins from the coronavirus, which can stimulate the immune system. At any moment, each of our cells may contain hundreds of thousands of mRNA molecules, which they produce in order to make proteins of their own. Once those proteins are made, our cells then shred the mRNA with special enzymes. The mRNA molecules our cells make can only survive a matter of minutes. The mRNA in vaccines is engineered to withstand the cell’s enzymes a bit longer, so that the cells can make extra virus proteins and prompt a stronger immune response. But the mRNA can only last for a few days at most before they are destroyed.
In early November, Pfizer completed a deal to sell the European Union 200 million doses, though it is not clear when it will deliver them. A chief negotiator for the European Union has said that the timetable is fixed but that he was keeping it confidential. Deliveries are supposed to start by the end of the year.
Alex M. Azar II, the secretary of health and human services, told “PBS News Hour” on Monday that in early October, the government resumed negotiations with Pfizer about delivering more doses. But he said Pfizer “resisted giving us any date by which they would do it.”
Moderna, a small Massachusetts-based firm that developed a similar vaccine, agreed last summer to provide the United States with 100 million doses by the end of March. It has now pledged to sell another 100 million doses by the end of June.
Because both the Pfizer and Moderna vaccines require two doses, about 180 million Americans would still be uncovered. On Monday, Dr. Moncef Slaoui, the scientific leader for Operation Warp Speed, the administration’s vaccine-development program, said that “we feel confident, provided that the vaccines’ performance remains on the path that we are on, that we will be able to have enough vaccine doses to immunize the U.S. population.”
The federal government has invested nearly $2.5 billion in the development and manufacturing of Moderna’s vaccine, while Pfizer and BioNTech have largely opted to develop the vaccine on their own, without significant government assistance.
While Pfizer estimates it can manufacture 1.3 billion doses next year, Moderna said it had plans to manufacture about 500 million doses in 2021 and has set an “aspirational” goal of double that.
Besides the need to bolster Pfizer’s supply chain, federal officials have been asking whether the company could team up with another drug maker, such as Merck, to produce more.
An American company that is one of the world’s biggest vaccine makers, Merck has previously shown interest in the technology that was used to produce the Pfizer and Moderna vaccines. A spokeswoman for Merck declined to comment.
Operation Warp Speed made a choice early to spread its risk across six vaccine makers using three different techniques, and has based its supply estimates on the assumption that those companies would succeed. But three of the companies have experienced setbacks in recent months, and none are as far along as Pfizer and Moderna.
Johnson & Johnson is expected to reveal results from its clinical trials early next month. Its vaccine requires only one dose and can be stored at normal refrigeration temperatures, while Pfizer’s requires ultracold temperatures.
Early results from clinical trials run by the University of Oxford suggest its vaccine, which it is developing with AstraZeneca, could be only 62 percent effective for a full two-dose regime, compared with about 95 percent for Pfizer’s and Moderna’s. AstraZeneca has not completed its Phase 3 clinical trial in the United States, partly because it was delayed by safety concerns.
Another firm, Novavax Inc., based in Maryland, has delayed its Phase 3 clinical trial in the United States in part because it has not been able to produce enough doses to cover participants. But one federal official said Novavax appeared to be overcoming that obstacle, and the company has said it plans to begin the trial this month.
Last week, Sanofi and GlaxoSmithKline said they were delaying their vaccine plans after early trial results showed a poor immune response in older people, meaning that their vaccine may not be available until the end of 2021.
Apoorva Mandavilli and Sheila Kaplan contributed reporting, and Kitty Bennett contributed research.