The COVID-19 vaccine candidate being developed by Pfizer and BioNTech has shown strong efficacy in a Phase 3 late-stage study. Pfizer on Monday said that the vaccine candidate has shown more than 90% efficacy in preventing COVID-19 among participants who had not previously been infected with SARS-CoV-2 in the first interim efficacy analysis.
“The results demonstrate that our mRNA-based vaccine can help prevent COVID-19 in the majority of people who receive it,” Pfizer CEO Dr. Albert Bourla said in a letter on Pfizer’s website. “This means we are one step closer to potentially providing people around the world with a much-needed breakthrough to help bring an end to this global pandemic.”
Bourla noted that the results he shared were not sufficient grounds for FDA Emergency Use authorization, and that the company was continuing to gather safety data via its ongoing clinical study.
“We estimate that a median of two months of safety data following the second and final dose of the vaccine candidate — required by FDA’s guidance for potential Emergency Use Authorization — will be available by the third week of November,” he said.
He said the company was focusing on efficacy, safety and consistent manufacturing of the two-dose vaccine before Pfizer files for authorization.
“When we embarked on this journey 10 months ago this is what we aspired to achieve,” said Ugur Sahin, BioNTech co-founder and CEO. “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.”
Scott Gottlieb, former FDA commissioner and a member of Pfizer’s board, told CNBC that the vaccine likely would be available as early as late December for early, limited use and widely available by Q3 of next year.