American pharma company Pfizer said on Monday that in the primary interim analysis from phase 3 clinical trials, its vaccine candidate had been found to be quite 90 per cent effective in preventing Covid-19 in participants without evidence of prior SARS-CoV-2 infection.
Pfizer and its partner, the German biotech company BioNTech, said the analysis of phase 3 trial data of the m-RNA vaccine candidate by an external independent Data Monitoring Committee (DMC) “has not reported any serious safety concerns”.
However, the independent expert committee has recommended that the study “continue to gather additional safety and efficacy data as planned”, the corporate underlined. “The data are going to be discussed with regulatory authorities worldwide,” Pfizer said during a release on Monday.
The release didn’t provide details on the specifics of the immune reaction , adverse reactions, and age-specific efficacy of the vaccine candidate. “Pfizer and BioNTech decide to submit data from the complete phase 3 trial for scientific referee publication,” the discharge said.
While Monday’s announcement isn’t scientifically conclusive evidence on the security and efficacy of the vaccine candidate, Pfizer has become the primary firm to release promising late-stage trial data of a possible vaccine for Covid-19.
“This may be a first but critical step in our work to deliver a secure and effective vaccine,” chairman and CEO Dr Albert Bourla said. As of Monday, over 50 million people had been infected by the novel coronavirus worldwide, and 1.25 million had died.
The phase 3 clinical test of the Pfizer-BioNTech candidate, BNT162b2, began on July 27 and enrolled 43,538 participants, 38,955 of whom had received a second dose by November 8. The candidate may be a single nucleoside-modified messenger RNA (modRNA) vaccine, which is formed of a brief segment of genetic material — the messenger RNA — which provides instructions for a person’s cell to form a harmless version of a target protein, during this case the spike protein of SARS-CoV-2, so as to activate an immune reaction .
Pfizer’s announcement on the primary interim analysis comes days before the corporate plans to submit safety and efficacy data from the trial to the American regulator, the us Food and Drug Administration (FDA) seeking emergency use authorisation “soon after the specified safety milestone is achieved, which is currently expected to occur within the third week of November”.
Pfizer said on Monday that following “discussion” with USFDA, the corporate had “recently elected to drop the 32-case interim analysis and conduct the primary interim analysis at a minimum of 62 cases”.
“Upon the conclusion of these discussions, the evaluable case count reached 94 and therefore the DMC performed its first analysis on all cases. The case split between vaccinated individuals and people who received the placebo indicates a vaccine efficacy rate above 90%, at 7 days after the second dose.
“This means protection is achieved 28 days after the initiation of the vaccination, which consists of a 2-dose schedule,” the corporate said.
The clinical test will continue through to “final analysis at 164 confirmed cases so as to gather further data and characterise the vaccine candidate’s performance against other study endpoints”, the corporate said.
Bourla hailed the trial data as representing “a great day for science and humanity”.
“With today’s news, we are a big step closer to providing people round the world with a much-needed breakthrough to assist bring an end to the present global health crisis. we glance forward to sharing additional efficacy and safety data generated from thousands of participants within the coming weeks,” he said.
Last month, Bourla had said in an letter that Pfizer was likely to submit the two-month safety data on half the trial participants to the regulator for emergency use authorisation within the third week of November.