Pfizer applies for emergency use of COVID-19 vaccine in the United States
Pfizer said it had submitted a request to the relevant health authorities in the United States on Friday to approve the emergency use of the Covid-19 vaccine, which is the first such request in a major step towards providing protection from the emerging Coronavirus.
The application to the US Food and Drug Administration comes days after Pfizer and its German partner Biontech announced the results of final trials that showed that the vaccine is 95 percent effective in preventing Covid-19 without any safety concerns.
Pfizer CEO Albert Burla confirmed the request in a video clip on the company’s website on Friday afternoon.
Shares of Pfizer rose by 1.3 percent and shares of Biontech rose by 9.3 percent after news of the possibility of a vaccine being available soon, which boosted hopes of ending a pandemic that has killed more than a quarter of a million people in the United States and more than 1.3 million in various parts of the world.
The application also includes safety data for 100 children between the ages of 12 and 15.
The company said that 45 percent of the participants in the US trials were between the ages of 56 and 85.
US Health Secretary Alex Azar told CBS News that if the data is strong, “we may have literally weeks before getting a license for a vaccine that is 95 percent effective”.
The companies expect the FDA to grant approval for emergency use by mid-December.
They said they would start charging the doses immediately.
Pfizer said it expects to have 50 million vaccine doses ready this year, enough to protect 25 million people.
