Pfizer Inc said Friday that it could request emergency use of its coronavirus vaccine as soon as a safety milestone is reached in November. The drugmaker should have enough data from its late-stage trial to know if its coronavirus vaccine works for this month, CEO Albert Bourla wrote in an open letter. “In the case of the US Emergency Use Authorization for a possible COVID-19 vaccine, the FDA requires companies to provide two months of safety data on half of the trial participants after the dose end of vaccine. Based on our current trial enrollment and dosing rate, we estimate that we will reach this milestone in the third week of November, “Bourla said.
Pfizer is developing a COVID-19 vaccine with German partner BioNTech. The experimental vaccine contains genetic material called messenger RNA or mRNA that makes the immune system fight the virus, scientists believe.
Illustrating the three key areas in which the Pfizer COVID-19 vaccine demonstrates success in gaining approval for public use, Bourla said: “First, the vaccine must demonstrate efficacy, which means that it can help prevent COVID-disease. 19 in at least a majority of vaccinated patients. Second, and equally important, the vaccine must demonstrate its safety, with robust safety data generated from thousands of patients. And finally, we must demonstrate that the vaccine is can consistently manufacture to the highest quality standards. “
“Safety is, and will continue to be, our number one priority, and we will continue to monitor and report safety data for all trial participants for two years,” Bourla wrote.
The drugmaker should have key data from its late-stage trial for the Food and Drug Administration by the end of October. “As I said before, we are operating at the speed of science. This means that we can know if our vaccine is effective or not by the end of October,” Bourla added.
“Since Pfizer does not know who received the vaccine compared to placebo, a committee of independent scientists will review the complete data and inform us whether the vaccine is effective or not based on predetermined criteria at key interim analysis points throughout the trial.” added.
“The second requirement is to demonstrate that the vaccine is safe. Our internal vaccine safety standards and those required by regulators are high,” he said.
“All the data contained in our US application would be reviewed not only by the FDA’s own scientists but also by an external panel of independent experts in a public meeting called by the agency,” he said.
The “final requirement will be the submission of manufacturing data demonstrating the quality and consistency of the vaccine to be produced.”
“Pfizer has been investing in risk since the early days of the pandemic to refine our manufacturing processes and rapidly increase capacity. We look forward to having our manufacturing data ready to ship before the safety milestone is reached,” he added.
Pfizer’s coronavirus vaccine could be distributed to Americans before the end of the year if it is found to be safe and effective, believed CEO Albert Bourla. If the FDA approves the vaccine, the company is prepared to distribute “hundreds of thousands of doses,” he said. “The above timelines reflect our best estimates of when these important milestones could be achieved,” concluded the CEO.
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