Pfizer-BioNTech COVID vaccine candidate succeeds in first interim analysis from phase 3 trial

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 per cent, at seven days after the second dose, indicating protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule

Pfizer and BioNTech’s mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 has demonstrated evidence of efficacy against COVID-19 in participants without prior evidence of SARS-CoV-2 infection, based on the first interim efficacy analysis conducted on November 8, 2020 by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.

Calling it a great day for science and humanity, Dr Albert Bourla, Chairman and CEO, Pfizer said, “We look forward to sharing additional efficacy and safety data generated from thousands of participants in the coming weeks.”

After discussion with the US FDA, the companies recently elected to drop the 32-case interim analysis and conduct the first interim analysis at a minimum of 62 cases. Upon the conclusion of those discussions, the evaluable case count reached 94 and the DMC performed its first analysis on all cases.

The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 per cent, at seven days after the second dose, indicating protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.

The Pfizer release cautions that as the study continues, the final vaccine efficacy percentage may vary. The DMC has not reported any serious safety concerns and recommends that the study continue to collect additional safety and efficacy data as planned. The data will be discussed with regulatory authorities worldwide.

Prof Ugur Sahin, co-founder and CEO, BioNTech  said, “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.”

The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,538 participants to date, 38,955 of whom have received a second dose of the vaccine candidate as of November 8, 2020. Approximately 42 per cent of global participants and 30 per cent of U.S. participants have racially and ethnically diverse backgrounds.

The trial is continuing to enroll and is expected to continue through the final analysis when a total of 164 confirmed COVID-19 cases have accrued. The study also will evaluate the potential for the vaccine candidate to provide protection against COVID-19 in those who have had prior exposure to SARS-CoV-2, as well as vaccine prevention against severe COVID-19 disease.

In addition to the primary efficacy endpoints evaluating confirmed COVID-19 cases accruing from seven days after the second dose, the final analysis now will include, with the approval of the FDA, new secondary endpoints evaluating efficacy based on cases accruing 14 days after the second dose as well.

The companies believe that the addition of these secondary endpoints will help align data across all COVID-19 vaccine studies and allow for cross-trial learnings and comparisons between these novel vaccine platforms.

The companies are continuing to accumulate safety data and currently estimate that a median of two months of safety data following the second (and final) dose of the vaccine candidate – the amount of safety data specified by the FDA in its guidance for potential Emergency Use Authorization – will be available by the third week of November. Additionally, participants will continue to be monitored for long-term protection and safety for an additional two years after their second dose.

Along with the efficacy data generated from the clinical trial, Pfizer and BioNTech are working to prepare the necessary safety and manufacturing data to submit to the FDA to demonstrate the safety and quality of the vaccine product produced.

Based on current projections the companies expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021.

Pfizer and BioNTech plan to submit data from the full Phase 3 trial for scientific peer-review publication.