An early independent analysis of a COVID-19 vaccine being developed by pharmaceutical companies Pfizer and BioNTech has been found to be more than 90% effective.
If the vaccine is approved, vaccination shots for coronavirus could be available by the end of this year, the companies said.
The companies said an interim independent analysis of the results showed that participants in the study who were given two shots of the vaccine three weeks apart experienced more than 90% fewer cases of symptomatic COVID-19 than those who received a placebo.
The vaccine is currently in phase 3 trials – the last stage before it can be commercially licensed.
Out of the 43,538 trial participants, 94 positive cases of COVID-19 were confirmed, enabling the independent evaluators to calculate the vaccine’s effectiveness after the two doses.
“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,” said Dr. Albert Bourla, Pfizer chairman and CEO, in a press release Monday announcing the study findings. “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.”
BioNTech co-founder and CEO Professor Ugur Sahin said the companies would 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.
Phase 3 of the clinical trial began on 27 July and has included volunteers from Argentina, Brazil, Germany, South Africa, Turkey and the United States,.
Of the 43,538 enrolled participants, 38,955 had received a second dose of the vaccine candidate by 8 Nov.
The US-based Pfizer and German company BioNTech said participants would be monitored for long-term protection and safety for an additional two years after their second, and final, dose.
The companies plan to submit the vaccine for Emergency Use Authorisation to the US Food and Drug Administration soon after the required safety milestone is achieved – when half of the study participants have been observed for safety issues for at least two months following their second dose. This is currently expected to be in the third week of November, the release noted.
“Based on current projections we expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses in 2021,” the companies stated.
The results have not yet been peer reviewed, though Pfizer and BioNTech say they plan to submit data from the full Phase 3 trial for scientific peer-review publication.
According to the World Health Authority, as of 3 Nov., there were more than 200 vaccine trials and evaluations being untaken globally.