Pfizer and German partner BioNTech today announced that preliminary analysis of the Phase 3 clinical trial of their jointly developed 2019 Coronavirus Disease (COVID-19) vaccine showed more than 90 percent efficacy against COVID-19.
Based on preliminary results, patient protection was achieved seven days after the second of two doses and 28 days after the first dose.
Pfizer said today that the experimental vaccine is more than 90 percent effective against COVID-19, a major victory in the fight against a new coronavirus epidemic that has killed more than 1 million people worldwide, devastated economies and disrupted the daily lives of people around the world.
Pfizer and German biotech partner BioNTech were the first pharmaceutical companies to publish successful data from large-scale clinical trials of a novel coronavirus vaccine. The companies said they have not identified any serious safety concerns to date and expect to apply to U.S. regulatory authorities for an emergency use authorization for the vaccine this month.
If an emergency use authorization is granted, the initial supply of the vaccine will be limited, and many questions remain, including how long the vaccine will provide protection. However, the news also raises hope that other COVID-19 vaccines in development may also prove effective.
Pfizer Chairman and CEO Albert Bourla said in a statement: “Today is a great day for science and for humanity. The first results from our Phase 3 clinical trial of our COVID-19 vaccine provide preliminary evidence that our vaccine prevents COVID-19.”
Bolla added, “We are taking an important step closer to providing the breakthrough that people around the world desperately need to help end this global health crisis. Hospitals are approaching over capacity, economies are having a hard time restarting, and our vaccine development program is reaching this important milestone at a time of greatest global need.”
BioNTech CEO Ugur Sahin told Reuters that he was optimistic that the vaccine’s immunity would last at least a year, although it was not yet certain.
William Schaffner, an infectious disease specialist at the Vanderbilt University School of Medicin in Tennessee, USA, said: “The vaccine efficacy data are certainly impressive and better than most of our expectations. This study is not yet complete, but nonetheless, those numbers look very solid.”
Pfizer expects to seek a broad emergency use authorization from U.S. regulators for the vaccine for people aged 16 to 85. To do so, it must provide two months of safety information on about half of the 44,000 people enrolled in the Phase 3 clinical trial.
Pfizer and BioNTech have signed a $1.95 billion contract with the U.S. government to supply 100 million doses of the vaccine starting this year. They also have agreements with the European Union, the United Kingdom, Canada and Japan to supply the vaccines.
To save time, the two companies have begun manufacturing the vaccine before they know if it works. They expect to produce up to 50 million doses this year, enough for 25 million people to be vaccinated. Pfizer says it expects to produce up to 1.3 billion doses of the vaccine by 2021.
The U.S. pharmaceutical giant noted that the interim analysis was conducted after 94 participants in the clinical trial were infected, looking at how many of them received either the vaccine or a placebo. Pfizer did not announce how many people were still infected after receiving the vaccine, but a protection effect of more than 90% suggests that no more than 8 of the 94 people who were infected were vaccinated. The vaccine was administered twice, about 3 weeks apart, to vaccinated individuals.
The efficacy of this vaccine far exceeds the 50% efficacy rate required by the US Food and Drug Administration (FDA) for coronavirus vaccines.
To confirm the vaccine’s protective efficacy, Pfizer said it will continue Phase 3 clinical trials until 164 of the participants become infected. Bolla told CNBC today that the clinical trial could be completed by the end of November due to rising infection rates.
The foregoing information has not yet been peer-reviewed or published in a medical journal. Pfizer says it will do so once the results of the entire clinical trial are available.
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