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Observed efficacy of the Pfizer/BioNTech mRNA-based Covid-19 vaccine candidate in adults over 65 years of age was over 94% and results show older adults tended to report fewer and milder solicited adverse events following vaccination.
The primary efficacy analysis indicates a vaccine efficacy rate of 95% (p<0.0001) in participants without prior SARS-CoV-2 infection (first primary objective) and also in participants with and without prior SARS-CoV-2 infection (second primary objective), in each case measured from seven days after the second dose.
Data demonstrate that the vaccine was well tolerated across all populations with over 43,000 participants enrolled. No serious safety concerns were observed and the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%.
The safety data milestone required by US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been achieved by the companies.
Analysis of the data on Covid-19 vaccine
The first primary objective analysis is based on 170 cases of Covid-19, as specified in the study protocol, of which 162 cases of Covid-19 were observed in the placebo group versus eight cases in the BNT162b2 group. Efficacy was consistent across age, gender, race and ethnicity demographics.
There were 10 severe cases of Covid-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.
Ugur Sahin, CEO and Co-founder of BioNTech, said: “We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against Covid-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection.
“These achievements highlight the potential of mRNA as a new drug class. Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against Covid-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities.”
The Phase 3 clinical trial of BNT162b2 began on July 27 and has enrolled 43,661 participants to date, 41,135 of whom have received a second dose of the vaccine candidate as of November 13, 2020. Approximately 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds, and 41% of global and 45% of U.S. participants are 56-85 years of age.
A breakdown of the diversity of clinical trial participants can be found here from approximately 150 clinical trials sites in United States, Germany, Turkey, South Africa, Brazil and Argentina. The trial will continue to collect efficacy and safety data in participants for an additional two years.
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 by the end of 2021.
The companies have developed specially designed, temperature-controlled thermal shippers utilising dry ice to maintain temperature conditions of -70°C±10°C. They can be used be as temporary storage units for 15 days by refilling with dry ice. Each shipper contains a GPS-enabled thermal sensor to track the location and temperature of each vaccine shipment across their pre-set routes leveraging Pfizer’s broad distribution network.
Pfizer and BioNTech plan to submit the efficacy and safety data from the study for peer-review in a scientific journal once analysis of the data is completed.