In a major breakthrough in the COVID-19 vaccine race, Pfizer and BioNtech have announced that their COVID-19 vaccine candidate BNT162b2 has performed exceedingly well in Phase 3 clinical trial as determined by an external, independent Data Monitoring Committee (DMC) that conducted a first interim efficacy analysis. In response to this news, Pfizer’s shares have touched $41.87 from its closing price of $36.40 last week. Similarly, shares of BioNTech also rose from $92 to $114.46 when last checked at 9.30 am ET.
“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,” said Dr. Albert Bourla, Chairman and CEO of Pfizer.
“We are reaching this critical milestone in our vaccine development program at a time when the world needs it most with infection rates setting new records, hospitals nearing over-capacity, and economies struggling to reopen. 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. We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.” said Dr. Bourla in a statement.
The interim analysis has revealed that the vaccine candidate was more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection. The press release stated that when compared to the placebo, the vaccine registered an efficacy rate above 90%, 7 days after the second dose. However, as the study continues, this percentage could vary.
The Phase 3 trial enrolled 43,538 participants, with 42% of them belonging to diverse backgrounds. Currently, vaccine candidates of four companies are in Phase 3 evaluations in the US. Among them, Pfizer and BioNtech are the first to report these positive results, albeit using an interim analysis of just 94 cases. While the company did not disclose how many of the 94 received the vaccine, the 90% effectiveness implies that no more than 8 of the 94 people received two vaccine shots administered about three weeks apart. At present, no serious adverse effects have been observed, but the study will continue to monitor safety and efficacy.
“The first interim analysis of our global Phase 3 study provides evidence that a vaccine may effectively prevent COVID-19. This is a victory for innovation, science, and a global collaborative effort,” said Prof. Ugur Sahin, Co-Founder and CEO of BioNTech. “When we embarked on this journey 10 months ago, this is what we aspired to achieve. 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. We will continue to collect further data as the trial continues to enroll for a final analysis planned when a total of 164 confirmed COVID-19 cases have accrued. I would like to thank everyone who has contributed to make this important achievement possible.”
Even if authorized, the initial supplies of the vaccine will be limited. Only 50 million doses will be rolled out globally by the end of the year. Topping that, the vaccine will face distribution challenges, as it requires super-cold temperatures for storage. Nevertheless, Pfizer is confident that these issues can be tackled.
Take it With a Pinch of Salt
While the vaccine shows effectiveness in a small population, experts are worried that these short analyses do not provide enough data when a vaccine could be given to billions of people. Moreover, the vaccine’s effectiveness in elderly patients and patients with severe cases of COVID-19-those who need hospitalization has not been tested.
Despite the caveats, Pfizer will, however, continue accumulating data from the trial to strengthen the confidence in the vaccine. The inclusion of different racial and ethnic backgrounds is a plus point for the trial and it could help understand the vaccine efficacy in different genetic backgrounds. Besides, the company is also testing if the vaccine is capable of protecting against COVID-19 in those who had contracted the virus previously and had developed severe disease. It will also continue monitoring the participants for up to 2 years to understand the long-term protective effects of the vaccine.
By Ruchi Jhonsa. Ph.D. & Rajaneesh K. Gopinath, Ph.D.
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