"Great Day for Science and Humanity" as Pfizer INC. and BioNTech Announce First Successful COVID Vaccination Trials

Pfizer Inc. and BioNTech SE announced the first effective coronavirus vaccine on November 9, 2020. In the official press release shared by the companies, it was revealed that they arrived at the historical discovery based on their analysis conducted on November 8, 2020, by an independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

In the test that was conducted between vaccinated individuals and the ones who received a placebo, it was found that the efficacy of the vaccine was "above 90%, at 7 days after the second dose." The statement read, "This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule." But they added that the final vaccine efficacy percentage might vary in the future.

"The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned," stated the press release.

Pfizer Chairman and CEO, Dr. Albert Bourla said, “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.”

Pointing out the world's condition with "infection rates setting new records, hospitals nearing over-capacity and economies struggling to reopen," he said, "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."

The Phase 3 clinical trials of the vaccine BNT162b2 began in July this year with 43,538 participants. Dr. Bourla, expressing his gratitude to his colleagues and collaborations said, “I want to thank the thousands of people who volunteered to participate in the clinical trial... we could not have come this far without the tremendous commitment of everyone involved.”

Prof. Ugur Sahin, BioNTech co-founder and CEO, said that the efficacy of the global Phase 3 in preventing COVID-19 is "a victory for innovation, science, and a global collaborative effort.”

He added, “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."

Pfizer and BioNTech said that they would be submitting for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) by the third week of November once the safety data is achieved. Until then, neither can the vaccines be taken to regulators nor can countries begin with their vaccination campaigns.

They also pointed out that "clinical trial" would "continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints."

As far as the question of when the vaccine would be available globally goes, it was stated by the two companies that, "They will be able to supply 50 million doses by the end of this year and around 1.3 billion by the end of 2021. Each person needs two doses."

Professor Peter Horby of the University of Oxford said, “This news made me smile from ear to ear. It is a relief to see such positive results on this vaccine and bodes well for COVID-19 vaccines in general,” according to Reuters.

References:

https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-announce-vaccine-candidate-against

https://www.businesswire.com/news/home/20201109005539/en/

https://www.reuters.com/article/health-coronavirus-vaccines-pfizer-int-idUSKBN27P1E5