New York: US-based pharmaceutical major Pfizer and German biotech firm BioNTech said their vaccine candidate was found to be more than 90 per cent effective in preventing Covid-19 in first interim analysis of data from late-stage Phase 3 trial.
Pfizer Chairman and CEO Albert Bourla called the development “a great day for science and humanity.”
“Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis,” Pfizer said in a statement.
Pfizer and German partner BioNTech SE are the first drugmakers to show successful data from a large-scale clinical trial of a coronavirus vaccine. The companies said they have found no serious safety concerns so far, and expect to seek US emergency use authorization later this month.
While the pandemic has killed over 1.2 million people worldwide, the announcement by Pfizer and BioNTech raises hope that effective Covid-19 vaccine dose could be on its way, and if approved, before the end of this year itself.
The two companies said that their mRNA-based vaccine candidate, BNT162b2, has demonstrated evidence of efficacy against Covid-19 in participants without prior evidence of SARS-CoV-2 infection. SARS-CoV-2 is the virus responsible for Covid-19.
The analysis was conducted by an external, independent Data Monitoring Committee (DMC) from the Phase 3 clinical study.
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, the two companies said.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.
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.
“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,” Albert Bourla, Pfizer Chairman and CEO, said in a statement.
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 on November 8.
Based on current projections, Pfizer and BioNTech expect to produce globally up to 50 million vaccine doses this year and up to 1.3 billion doses in 2021.