Albert Bourla, Pfizer
Gian Ehrenzeller | Keystone | AP
Pfizer's coronavirus vaccine could be distributed to Americans before the end of the year if it proves safe and effective, CEO Albert Bourla said on Sunday.
The drug company should have key data from its late-stage study for the Food and Drug Administration by the end of October, Bourla said during an interview on CBS "Face the Nation." If the FDA approves the vaccine, the company will be ready to give out "hundreds of thousands of doses," he said.
Because of the pandemic, U.S. health officials and drug manufacturers have accelerated vaccine candidate development by investing in multiple phases of research, although it could be for free if the vaccine is ultimately not effective or safe.
The US pharmaceutical company works with the German drug manufacturer BioNTech. In July, the U.S. government announced that it would pay companies $ 1.95 billion to manufacture and supply 100 million doses of its vaccine if it proves safe and effective. The contract was signed as part of Operation Warp Speed, the Trump administration's efforts to accelerate the development and production of vaccines and treatments to fight the coronavirus.
Bourla said Sunday that the company had already invested $ 1.5 billion in developing the potential vaccine. He said that if the vaccine didn't work, it would be "financially painful" for the company.
"At the end of the day, it's just money. But that won't break the company, although it will be painful," he said.
Pfizer's experimental vaccine contains genetic material called messenger RNA, or mRNA, that scientists hope will stimulate the immune system to fight the virus.
Pfizer is one of three companies currently in late-stage vaccine testing. The other two are Moderna and AstraZeneca, who announced on Saturday they would restart the process after being temporarily suspended for security reasons.
On Saturday, Pfizer made a proposal to the FDA to expand the late-stage study to 44,000 participants. This is a significant increase over the previous target of 30,000.
The developments come because infectious disease experts and scientists have raised concerns over the past few weeks that President Donald Trump is pressuring the FDA to approve a vaccine before it's been adequately tested. FDA Commissioner Stephen Hahn, who insisted he wasn't pressured by Trump to expedite a vaccine, told the Financial Times last month the agency was poised to bypass the full federal approval process to get a Covid- 19 vaccine available as soon as possible.
On September 8, nine drug companies, including Pfizer, released a letter pledging to give safety a priority and to uphold the "integrity of the scientific process" in their efforts to develop coronavirus vaccines.
Even if a vaccine is approved for distribution before the end of the year, it is likely to be in short supply. The vaccine is likely to require two doses at different intervals, and states still face logistical challenges such as setting up distribution points and obtaining enough needles, syringes, and bottles needed for immunizations.
Earlier this month, the National Academies of Science, Engineering, and Medicine released a draft proposal for distribution of a vaccine in the United States, if one is approved for public use. The report was requested by the National Institutes of Health and the Centers for Disease Control and Prevention.
The vaccine would be distributed in four phases, with health workers, the elderly, and people with underlying health conditions being vaccinated first, according to the group. Next on the list are key workers, teachers and people in shelters for the homeless and people in prisons, followed by children and young adults.