Pfizer-BioNTech COVID vaccine candidate proves successful in first analysis of Phase 3 trials

• Pfizer and BioNTech’s vaccine candidate, BNT162b2 proven efficient in providing immunity against coronavirus
• The results indicated a vaccine efficacy rate of over 90% on the seventh day.
• Pharma companies predicted to manufacture 50 million vaccine doses by the end of 2020

THD NewsDesk, New York: Pfizer and BioNTech’s potential Covid vaccine, BNT162b2, has been proven efficient in combating coronavirus in participants without prior indication of infection. On November 8, an independent Data Monitoring Committee (DMC) conducted the first interim efficacy analysis. Fortunately, the Phase 3 clinical study’s first analysis demonstrates that this mRNA-based vaccine could save humankind from the pernicious virus. 

Delighted at the greatest accomplishment of medical science this year, Dr Albert Bourla, Chairman and CEO of Pfizer said,

“We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

The study aims to analyze the efficiency of the vaccine candidate in providing immunity against the COVID-19 in those infected by Covid before. 

After receiving USFDA’s approval, the pharmaceutical companies chose to perform the first interim analysis on 62 cases instead of 32. Ultimately after discussion, the DMC performed the first analysis on 94 cases. As a part of the study, the participants were divided into two groups – vaccinated individuals and those administered with placebo. The results indicated a vaccine efficacy rate of over 90% on the seventh day after the second dose. Research scientists inferred that immunity from the Covid-19 virus could be achieved after 28 days since the vaccination initiation. 

So far, DMC has not observed any grave safety concerns that might jeopardize the study. It suggests that the study should resume. The collected additional safety and efficacy data will be shared with regulatory authorities across the world.

Aware of the fact that latter results may vary, Professor Ugur Sahin, co-founder, and CEO of BioNTech, said, “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.”

On July 27, the Phase 3 clinical trial of Pfizer’s vaccine candidate commenced with the enrollment of 43,538 participants. Out of whom, 38,955 have received a second dose of the vaccine candidate as of now.

Additionally, the final analysis is expected to include new secondary endpoints that help evaluate the vaccine’s efficacy based on cases accruing 14 days as well. The pharma companies believe that these secondary endpoints would assist researchers in aligning data across all COVID-19 vaccine studies. Moreover, it will enable scientists to gain cross-trial learnings and make successful comparisons between these novel vaccine platforms.

In compliance with the USFDA’s requirements, the companies are proceeding to compile safety data. Specified by the USFDA’s guidelines on potential Emergency Use Authorization, the companies estimate a median of two months’ data. In all likelihood, the data will be available by the third week of November. Till the study gets completed, participants will be kept under supervision for long-term protection and safety for two years.

Besides, Pfizer and BioNTech are preparing the required safety data, which would ensure the vaccine’s safety and quality.

The companies expect to manufacture 50 million vaccine doses by the end of 2020. The number will shoot up to 1.3 billion doses in 2021. The results of the analysis are going to be published soon for scientific peer-review publications.

Source: Express Pharma