A potential coronavirus vaccine from US-based drug giant Pfizer and the German biotech company BioNTech was proven to be more than 90 percent effective in preventing infection by COVID-19, according to a preliminary analysis that the two firms announced on Monday.
The two companies said the first results from its Phase 3 trials indicate the vaccine is 90 percent effective in preventing COVID-19 among those without evidence of prior infection. Protection is achieved 28 days after the initial vaccination, which consists of a two-dose schedule. By comparison, an influenza vaccine reduces the risk of infection by 40 to 60 percent, according to the United States according to the Centers for Disease Control and Prevention.
The Pfizer/BioNTech vaccine has long been considered one of the frontrunners in the global race to develop a vaccine that could tame the global pandemic. The efficacy analysis results from their Phase 3 clinical study indicated that the vaccine is highly effective and that no safety concerns have been found.
The vaccine, which uses mRNA technology to get human cells to produce immunogenic proteins in the body rather than injecting them from outside, has been tested on over 43,000 people in six countries. The vaccine consists of two separate doses and the results released on Monday found that those who received both doses had a vaccine efficacy rate above 90 percent one week after their second dose.
That rate immediately created cautious excitement in the global scientific community, as many researchers had expected that a vaccine might only be 60 to 70 percent effective. Kathrin Jansen, the head of vaccine research and development at Pfizer, told The Washington Post that the results were “almost stunning to hear.”
Pfizer Chairman and CEO Albert Bourla said the results represented a “critical milestone in our vaccine development program at a time when the world needs it most.”
“Today is a great day for science and humanity. The first set of results from our Phase 3 COVID-19 vaccine trial provides the initial evidence of our vaccine’s ability to prevent COVID-19,” he said in a press release. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
BioNTech co-founder and CEO Ugur Sahin called Monday’s announcement “a victory for innovation, science and a global collaborative effort.”
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19,” he said in the joint press release. “Especially today, while we are all in the midst of a second wave and many of us in lockdown, we appreciate even more how important this milestone is on our path towards ending this pandemic and for all of us to regain a sense of normality.”
Pfizer and BioNTech said they were on track to produce 50 million vaccine doses by the end of December and up to 1.3 billion doses next year. An Emergency Use Authorization (EUA) is expected to be submitted to the U.S. Food and Drug Administration (FDA) by the end of this month.
The Pfizer/BioNTech mRNA approach is one of a handful of potential coronavirus vaccines that could be deployed by the end of 2020. The speed of vaccine development is considered unprecedented, as vaccines typically take years to fully test. Some have warned that this amazing scientific feat could paradoxically end up undermining the public’s trust in an eventual vaccine.
The companies’ announcement comes as the COVID-19 pandemic approaches 51 million worldwide cases. To date, more than 1.2 million people have died from the virus.