Pfizer and BioNTech’s mRNA-based vaccine candidate for Covid-19 has been found to be 90% effective against the virus, the companies have announced.
Covid-19
The companies’ BNT162b2 vaccine candidate has been involved in a Phase 3 clinical trial since 27 July, involving 43,538 participants, 38,955 of whom have received a second dose of the vaccine candidate.
After discussions with the FDA, Pfzier and BioNTech decided to conduct their first interim efficacy analysis. Conducted by an independent Data Monitoring Committee (DMC), the analysis included 94 cases of volunteers from the Phase 3 clinical trial. Split between a vaccinated group and those who received a placebo, data from the analysis indicates an efficacy rate over 90%, at seven days after the second dose. Pfizer and BioNTech have warned that the final vaccine efficacy percentage may vary. The DMC did not report any serious safety concerns and the study will continue to collect additional safety and efficacy data.
Dr Albert Bourla, Pfizer Chairman and CEO described the news as 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. 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.”
“I want to thank the thousands of people who volunteered to participate in the clinical trial, our academic collaborators and investigators at the study sites, and our colleagues and collaborators around the world who are dedicating their time to this crucial endeavour,” added Dr Bourla. “We could not have come this far without the tremendous commitment of everyone involved.”
“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 professor Ugur Sahin, BioNTech co-founder and CEO. “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 enrol 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.”
Pfizer and BioNTech estimate that the amount of safety data required by the FDA for a potential Emergency Use Authorisation will be available in the third week of November. Participants of the trial will continue to be monitored for long-term protection and safety for an additional two years after their second dose.
The companies are also working to prepare the necessary safety and manufacturing data to submit to the FDA so that they can demonstrate the safety and quality of the vaccine product that is produced. The companies expect to supply up to 50 million vaccine doses this year, and aim to manufacture up to 1.3 billion doses in 2021.
In response to the new, a UK government spokesperson said: “The results from Pfizer/BioNTech are very promising and we have procured 40 million doses of their vaccine. While we are optimistic of a breakthrough, we must remember that there are no guarantees.
"We will know whether the vaccine meets robust standards of safety and effectiveness once the safety data have been published, and only then can the medicines regulator consider whether it can be made available to the public."
"Once approved, the NHS stands ready to begin a vaccination programme for those most at risk, as currently recommended by the independent Joint Committee on Vaccination and Immunisation (JCVI), before being rolled.”