Pfizer Inc, a pharmaceutical giant has revealed plans to seek authorisation for its COVID-19 vaccine in mid-November.
In statement issued on Friday, the company’s CEO Albert Bourla said: “So let me be clear, assuming positive data, Pfizer will apply for Emergency Authorization Use in the U.S. soon after the safety milestone is achieved in the third week of November. All the data contained in our U.S. application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts at a publicly held meeting convened by the agency.”
He added: “Our purpose is to discover breakthroughs that change patients’ lives. I cannot think of a breakthrough that would be more meaningful to a greater number of people than an effective and safe COVID-19 vaccine.”
Bourla said the company was operating at the speed of science. “This means we may know whether or not our vaccine is effective by the end of October. To do so, we must accumulate a certain number of COVID-19 cases in our trial to compare the effectiveness of the vaccine in vaccinated individuals to those who received a placebo. Since we must wait for a certain number of cases to occur, this data may come earlier or later based on changes in the infection rates.”
Bourla explained that there were three stages to complete before the vaccine can be considered safe and approved for public use.
“First, the vaccine must be proven effective, meaning it can help prevent COVID-19 disease in at least a majority of vaccinated patients. Second and equally important, the vaccine must be proven safe, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine can be consistently manufactured at the highest quality standards,” Bourla said.
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By seeking authorisation in the third week of November, the Pfizer vaccine is likely to be the first for distribution since the fellow front-runner Moderna said it would seek the same a week later, by November 25. The Oxford vaccine is however not expected to confirm whether it is effective until the end of the year, Euronews reported.