Pamela Cruz. Peninsula 360 Press.
U.S. drugmaker Pfizer and German firm BioNTech reported that studies of their COVID-19 vaccine have shown superior efficacy to 90% in participants who showed no prior evidence of infection with the virus.
Thus, during the first analyses of the phase three study on this vaccine, a level of protection of 90% against the virus was achieved only 28 days after the first dose and seven days after the second application.
However, in a statement, both companies cautioned that the final efficacy may vary as the study progresses.
So far, they said, no safety problems have been reported, so the independent body in charge of overseeing the clinical trials has recommended collecting additional information, which will be analyzed with the U.S. regulatory authorities.
"I am pleased to share with you that Pfizer and our collaborator, BioNTech, announced positive efficacy results from our Phase 3, late-stage study of our candidate COVID-19 vaccine. The vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants with no evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis," Pfizer CEO Albert Bourla said in the document.
This, he said, "means we are one step closer to bringing people around the world a much-needed breakthrough to help end this global pandemic.
He added that it could be about two months after the safety data from the second and final dose of the candidate vaccine, required by Food and Drug Administration (FDA) guidance, that a possible emergency use authorization could be given.
He also noted that data is being generated to show that the vaccine can be manufactured consistently to meet quality standards.
It should be noted that efficacy, safety and consistent manufacture are the three requirements that are needed before authorisation can be applied for.
Phase three of the trial began on July 27 and to date has required 43,538 volunteers, of whom 38,955 received a second dose on November 8.
