Pfizer gets $1.95B to produce vaccine
Firm to give U.S. first 100 million doses if found safe and effective
WASHINGTON >> The Trump administration Wednesday announced a nearly $2 billion contract with 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, 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.
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 Azar, 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 indicating 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 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 trigger 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 mindset; that ‘just because it’s new, it will fail,’ “she said in an interview.
Earlier in her career, 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 Jansen said the company picked before the administration coined “Warp Speed.”
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, Jansen said, which is important because scientists don’t yet know which type will be most potent against the coronavirus.
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% 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.