Pfizer announced on Friday that it has applied for the emergency use authorization of its COVID-19 vaccine from the U.S. regulators.
Pfizer announced on Friday that it has applied for the emergency use authorization (EUA) of its COVID-19 vaccine from the U.S. regulators.
The move came two days after the pharmaceutical giant announced that its coronavirus vaccine has proven to be 95% effective during the final analysis from its large clinical trial.
Once the company acquires approval from Food and Drug Administration (FDA), the vaccines could be used to treat severe COVID-19 cases in the United States as early as next month.
The length of FDA’s reviewing process for the vaccine Pfizer and BioNTech is still unknown, but the federal government is expecting to approve the vaccine in the first half of December.
The shots would likely be limited and rolled out in phases, giving the first batch of immunizations to health-care workers, the elderly and people with underlying health conditions. The next round of inoculations would be given to essential workers, teachers and individuals living in homeless shelters and prisons, followed by children and young adults.
“Filing in the U.S. represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential,” Pfizer Chief Executive Dr. Albert Bourla said in a statement.
Aside from the application it submitted to FDA, the pharmaceutical giant also started sending applications to several regulatory agencies worldwide, including the European Medicines Agency and the Medicines & Healthcare Products Regulatory Agency in Britain.
“Our work to deliver a safe and effective vaccine has never been more urgent,” said Bourla.
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