Early results from the Pfizer-BioNTech Covid-19 vaccine trial suggest it could be 90pc effective among those with no prior coronavirus infection.
Initial results from a phase-three trial involving more than 43,000 people has returned what looks to be a promising step towards an effective Covid-19 vaccine. Jointly developed by Pfizer and BioNTech, the vaccine candidate – BNT162b2 – was found to be 90pc effective in preventing the disease among a small sample of study participants.
The data from the phase-three trial is still awaiting peer review, which Pfizer and BioNTech said they will now look to secure. The trial is also still ongoing.
An external, independent data monitoring committee analysing the trial did not report any serious safety concerns and recommended that the study continue to collect additional safety and efficacy data.
Pfizer and BioNTech are now looking to file an emergency use authorisation with the US Food and Drug Administration (FDA). Once the government agency has received and analysed two months’ worth of trial safety data on at least half of the study’s participants, the vaccine developers can apply for the authorisation.
This, Pfizer and BioNTech said, means the application process will likely start towards the end of this month. The FDA states that a coronavirus vaccine must have an effectiveness rate of at least 50pc.
Based on current projections and if the vaccine is deemed safe, the companies could expect to produce up to 50m vaccine doses globally in 2020 and up to 1.3bn doses in 2021.
A ‘critical milestone’
“Today is a great day for science and humanity,” said Pfizer chair and CEO Dr Albert Bourla.
“We are reaching this critical milestone in our vaccine development programme 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.”
Over the course of testing, 94 trial participants with no prior evidence of the coronavirus developed Covid-19. It was not revealed how many of them had received the vaccine candidate and how many had received a placebo.
The clinical trial will now continue until there have been 164 confirmed Covid-19 cases in vaccinated and placebo groups, in order to collect further data and characterise the vaccine candidate’s performance.
Development of this vaccine candidate was announced in March and set out to use RNA to accelerate the production of proteins similar in composition to SARS-CoV2, which could be used to trigger the body’s immune system to fight the actual virus.
A potential challenge to the vaccine’s future distribution – if deemed safe to the public – is its need to be kept in ultra-cold storage at minus 70 degrees Celsius. This would limit the vaccine to being distributed to hospitals and labs, as storing it at a GP’s office would be “very difficult”, according to SVB Leerink analysts.