WASHINGTON — The Trump administration on Wednesday announced a nearly $2 billion contract with Pfizer and a smaller German biotechnology company for as many as 600 million doses of a coronavirus vaccine, one of the largest investments yet in the global race to lock up vaccines even before they are ready.
The contract is part of what the White House calls the “Warp Speed” project, an effort to drastically shorten the time it would take to manufacture and distribute a working vaccine. So far the U.S. has put money into more than a half-dozen efforts, hoping to build a manufacturing capability for an eventual breakthrough.
Europe has a parallel effort underway. Germany recently took a 23 percent stake in a German firm, CureVac, that President Trump once tried to lure to American shores, in hopes its vaccine, if successful, would be distributed in the United States first. A European-led fund-raising effort in May brought $8 billion in pledges from the world’s governments, philanthropists and leaders for coronavirus vaccine research, even with the United States sitting out the conference.
China, meantime, has militarized the effort: Researchers associated with the Academy of Military Medical Sciences have developed one of China’s leading candidates, and another Chinese firm, Sinopharm Group, announced in June that it was beginning Phase 3 trials in the United Arab Emirates.
The Pfizer contract, an agreement to purchase the first 100 million doses and ensure the pharmaceutical giant a market for its work, is the biggest splash yet by the Americans. If the vaccine being produced by Pfizer and BioNTech, the German firm, proves to be safe and effective in clinical trials, the companies say they could manufacture those first doses by December.
Under the arrangement, the federal government would obtain the first 100 million doses for $1.95 billion, or about $20 a dose, with the rights to acquire up to 500 million more. Americans would receive the vaccine for free. Before it could be distributed, it would need emergency approval by the Food and Drug Administration. But the U.S. government does not pay the nearly $2 billion until the drug is approved and the first 100 million doses are delivered.
Pfizer said that 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.
On Monday, Pfizer and AstraZeneca, a British drug company developing a potential vaccine with Oxford University, released data suggesting that their vaccines could stimulate strong immune responses with only minor side effects.
But unlike AstraZeneca, which has also obtained funding from the U.S. government, Pfizer did not receive a contract for its earlier research and development efforts — only for the doses and their distribution.
By refusing funding up until now, Pfizer was able to avoid drawn-out contractual negotiations and get its vaccine to trials, company officials say.
“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 a congressional hearing on Tuesday with executives from five vaccine manufacturers.
Pfizer and BioNTech, a German pharmaceutical company, are developing a vaccine candidate that uses genetic material from the virus, known as messenger RNA, to stimulate the immune system without making the recipient sick. The technology can create a vaccine quickly, but has not yet produced one that has been approved and marketed.
Moderna, a Massachusetts biotech company, received $483 million from the U.S. government for its vaccine development and is also using mRNA technology. By putting the might of an industry giant behind it, Pfizer is making the technology mainstream.
The lack of a track record has sparked some skepticism about the mRNA approach, but Kathrin Jansen, Pfizer’s senior vice president and head of vaccine research and development, dismissed the criticism.
“That’s not a scientific mind-set — that just because it’s new, it will fail,” she said in an interview.
Earlier in her career Dr. Jansen worked for Merck, where she led its development of a vaccine to prevent cervical cancer, which is caused by a virus. The vaccine, Gardasil, has been successful. It, too, used a technology that was new at the time and faced considerable skepticism.
Pfizer calls its coronavirus project “Lightspeed,” a name that Dr. Jansen said the company picked before the administration coined “Warp Speed.”
Dr. Jansen said Pfizer had placed its bet on mRNA not just because the technology can produce a vaccine quickly, but also because its review of previous work by BioNTech on experimental cancer vaccines suggested the approach could spark a powerful immune response. Before the Covid-19 pandemic, the two companies had been collaborating on flu vaccines.
Vaccines using mRNA consist of genetic material from part of the virus, encased in tiny particles made of fat that help it get into human cells. The mRNA then prompts the cells to churn out a tiny piece of the virus, triggering the immune system to attack the real virus if the person is exposed. In essence, the patient’s cells become factories for a harmless fragment of the virus.
These mRNA vaccines set off several different kinds of immune responses, Dr. Jansen said, which is important because scientists don’t yet know which type will be most potent against the coronavirus.
The Coronavirus Outbreak ›
Frequently Asked Questions
Updated July 21, 2020
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I have antibodies. Am I now immune?
- Not very long, a study published in Nature Medicine suggests. Antibodies — protective proteins made in response to an infection — may last only two to three months, especially in people who never showed symptoms while they were infected. That does not necessarily mean that people can be infected a second time, several experts cautioned. Even low levels of powerful neutralizing antibodies may be protective, as are the immune system’s T cells and B cells. But nothing is certain. Experts caution against the idea of “immunity certificates” for people who have recovered from the illness. Also, the tests aren’t entirely accurate. Having antibodies just means you had the virus. It doesn’t mean you won’t again.
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Why do masks work?
- The coronavirus clings to wetness and enters and exits the body through any wet tissue (your mouth, your eyes, the inside of your nose). That’s why people are wearing masks and eyeshields: they’re like an umbrella for your body: They keep your droplets in and other people’s droplets out. But masks only work if you are wearing them properly. The mask should cover your face from the bridge of your nose to under your chin, and should stretch almost to your ears. Be sure there are no gaps — that sort of defeats the purpose, no?
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Is the coronavirus airborne?
- The coronavirus can stay aloft for hours in tiny droplets in stagnant air, infecting people as they inhale, mounting scientific evidence suggests. This risk is highest in crowded indoor spaces with poor ventilation, and may help explain super-spreading events reported in meatpacking plants, churches and restaurants. It’s unclear how often the virus is spread via these tiny droplets, or aerosols, compared with larger droplets that are expelled when a sick person coughs or sneezes, or transmitted through contact with contaminated surfaces, said Linsey Marr, an aerosol expert at Virginia Tech. Aerosols are released even when a person without symptoms exhales, talks or sings, according to Dr. Marr and more than 200 other experts, who have outlined the evidence in an open letter to the World Health Organization.
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What are the symptoms of coronavirus?
- Common symptoms include fever, a dry cough, fatigue and difficulty breathing or shortness of breath. Some of these symptoms overlap with those of the flu, making detection difficult, but runny noses and stuffy sinuses are less common. The C.D.C. has also added chills, muscle pain, sore throat, headache and a new loss of the sense of taste or smell as symptoms to look out for. Most people fall ill five to seven days after exposure, but symptoms may appear in as few as two days or as many as 14 days.
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What’s the best material for a mask?
- Scientists around the country have tried to identify everyday materials that do a good job of filtering microscopic particles. In recent tests, HEPA furnace filters scored high, as did vacuum cleaner bags, fabric similar to flannel pajamas and those of 600-count pillowcases. Other materials tested included layered coffee filters and scarves and bandannas. These scored lower, but still captured a small percentage of particles.
Dr. Jansen described making mRNA vaccine as a clean, fast process that requires a relatively small footprint to produce many doses.
“mRNA has the potential to be fast to produce a product that is very well defined and very pure,” she said.
Several other companies are also making mRNA vaccines, and each has its own formulation of the genetic material and types of fat used to encase it.
The large vaccine studies set to begin this month will each include 30,000 people, with some getting placebo shots. The Food and Drug Administration has said that to be considered effective, a coronavirus vaccine should protect 50 percent of the people who receive it.
Companies hope to show proof of effectiveness by the fall, but that will depend on enrolling enough volunteers in areas where the infection rate is high enough to see a significant difference between the vaccinated people and the placebo group.
“We think we will see the endpoints, given that the infection rates are going up, up, up,” Dr. Jansen said. “If the stars are aligned, it could be next fall. But everything has to be right.”
Dr. Amesh Adalja, an infectious disease physician and senior scholar at the Johns Hopkins University Center for Health Security, said that Pfizer, unlike some smaller pharmaceutical companies the government has contracted with, did not need research money because it likely had the infrastructure and early data it needed to speed its vaccine to trials without federal help.
“Pfizer is a company that has a lot of expertise in making vaccines,” he said. “They knew that any negotiation with the government could have delayed the start” of trials, which he said the company knows how to set up rapidly.
He added that the $1.95 billion agreement was a way to guarantee a market for the vaccine at the end of production, since prominent drugmakers have historically been hesitant to spend on infectious disease outbreaks.
“Advance purchase agreements have been one way we’ve been able to acquire vaccines and countermeasures against certain threats that pharmaceutical companies have traditionally stayed away from,” he said.
The agreement with Pfizer, which the company and the Department of Health and Human Services announced Wednesday morning, is the largest one 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.
