Keeping tabs on Covid-19: A watershed moment for Pfizer and BioNTech as they announce Covid-19 vaccine is 90 per cent efficient

In a special edition Keeping tabs round-up, Pharma IQ features the ever-anticipated news of a possible Covid-19 cure.

Pfizer and BioNTech announce Covid-19 vaccine candidate success

Pfizer and BioNTech have announced their mRNA-based vaccine candidate, BNT162b2, is more than 90 per cent effective in preventing Covid-19 in cases where participants have shown no evidence of being infected with coronavirus.

After completing the first interim efficacy analysis on 63 cases on November 8, 2020, subsequent results have proved BNT162b2 has lasting effects for up to 28 days after the initiation of the vaccination, which consists of a two-dose schedule. As the Phase 3 study continues, Pfizer and BioNTech claimed the final vaccine efficacy percentage may vary.

Pfizer has submitted the vaccine for emergency-use authorization to the US Food and Drug Administration (FDA) and plans to release the vaccine for use as early as the third week of November if it achieves the required safety milestone.

In the last stage of the interim efficacy analysis, the Data Monitoring Committee (DMC) performed its own analysis on vaccinated individuals and on those who received the placebo to prove its efficiency. The DMC claimed the “savior drug” indicates a vaccine efficiency rate above 90 per cent and no serious safety concerns were highlighted during its examination.

Recommendations that the study continues have been suggested in order to collect additional safety and efficacy data. Pfizer claimed the data of the trial's progress would continue to be discussed with regulatory authorities worldwide.  

The Phase 3 trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed Covid-19 cases have been accrued. The study will also evaluate the potential for the vaccine candidate to provide protection against Covid-19 in those who have had prior exposure to coronavirus, as well as vaccine prevention against severe Covid-19 symptoms.

Dr. Albert Bourla, chairman and CEO of Pfizer, 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.

“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.”

Professor Ugur Sahin, co-founder and CEO of BioNTech, said: “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.

“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 toward ending this pandemic and for all of us to regain a sense of normality,” Sahin added. 

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