Pfizer and its partner BioNTech confirmed they will apply Friday for emergency use authorization for their coronavirus vaccine, becoming the first to do so in the US as the pandemic rages around the world.
The announcement had been expected for several days after the companies said that a completed study of trials of the product showed it was 95 percent effective in protecting people from infection.
Regulatory applications will be submitted to other regulatory agencies worldwide in the coming days, the companies said.
The announcement also confirms what BioNTech’s CEO told AFP Thursday.
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“Filing in the US 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 CEO Albert Bourla said.
The vaccine has been under evaluation for weeks in the European Union, Australia, Canada, Japan and the United Kingdom, the companies said.
“The companies will be ready to distribute the vaccine candidate within hours after authorization,” their statement said.
The Food and Drug Administration has not said how long it will take to study the vaccine data, but the government expects to give the green light for the vaccine in the first two weeks of December.
The European Union could also move quickly on the Pfizer-BioNTech vaccine, perhaps as soon as the second half of December, according to European Commission president Ursula von der Leyen.
Hot on the heels of these companies is a vaccine developed by another biotech firm, Moderna, which says its product is also about 95 percent effective.
The speed with which these vaccines have been developed as the pandemic wreaks havoc around the world has no precedent. Over the past decade, the vaccines authorized in the US have taken an average of eight years to develop.
The US government says it plans to vaccinate more than 20 million people in December, and then another 25-30 million per month.