Pfizer/BioNTech say vaccine works in 90% of COVID-19 patients
As the death toll from COVID19 inexorably mounts, Pfizer and BioNTech have announced that their COVID-19 vaccine candidate is more than 90% effective at countering the disease in an interim analysis.
The companies said they will be ready to file the vaccine with the FDA in the third week of November once they have enough safety data to meet the regulator’s requirements.
Top-line results come from a phase 3 trial of the candidate known as BNT162b2 and an evaluation of 94 cases from the trial of 43,538 patients.
The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90%, at seven days after the second dose, the companies noted.
This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule.
The companies cautioned that as the study continues, the final vaccine efficacy percentage may vary.
The independent data monitoring committee that conducted the interim analysis said that there had been no serious safety concerns identified.
It recommended that the study continues to collect additional safety and efficacy data as planned.
Results will be discussed with regulators worldwide and the European Medicines Agency has already begun its rolling review of data to hasten a decision on the clinical trial dossier.
The phase 3 clinical trial of BNT162b2 began at the end of July 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.
Around 42% of global participants and 30% of U.S. participants have racially and ethnically diverse backgrounds.
The vaccine is based on a strand of messenger RNA – a short segment of genetical material that codes for the “Spike” protein found on the surface of the coronavirus.
These cause the body to produce antibodies that neutralise the SARS-CoV-2 virus in the event of an infection.
Last month the companies said that they are already producing hundreds of thousands of shots each day should the vaccine get approved.
However it remains to be seen whether countries such as the US and UK, which have ordered millions of shots, will be able to organise a mass vaccination programme after failing to implement track and trace measures that could also slow the spread of the disease.
Pfizer’s CEO Albert Bourla 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.”
The vaccine is one of 47 in clinical development, according to the World Health Organization, showing several shots developed in China and a rival from the UK’s AstraZeneca are also close to reading out late-stage clinical results.
The pharma industry has developed vaccines for COVID-19 in record-breaking time after scientists from China published details of the SARS-CoV-2 virus shortly after the outbreak began in January.
Feature image courtesy of Rocky Mountain Laboratories/NIH
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