Pfizer expects to petition the Food and Drug Administration for authorization of its coronavirus vaccine by the third week of November after early clinical trial results showed its efficacy as high as 90%.
“Today is a great day for science and humanity,” Dr. Albert Bourla, Pfizer chairman and CEO, said on Monday. “With today’s news, we are a significant step closer to providing people around the world with a much-needed breakthrough to help bring an end to this global health crisis.”
Pfizer, which developed the vaccine with the German drug manufacturer BioNTech, plans to apply for emergency use authorization from the Food and Drug Administration by the third week of November after it has collected the recommended two months of safety data.
Monday’s announcement exceeded expectations, as public health experts had cautioned that a COVID-19 vaccine likely would not be much more effective than a seasonal flu vaccine, which is usually about 50% effective. Dr. Anthony Fauci, the government’s top infectious disease expert, called Pfizer’s early results “just extraordinary,” in a Monday press briefing, adding: “Not very many people expected it would be as high as that.”
Pfizer estimated that it could manufacture 50 million doses of its vaccine by the end of 2020, which could cover 25 million people, as the vaccine consists of two separate shots. The company also would make the shots free to patients. The company has not shared which sectors of the population will get access to the first doses, but the Trump administration’s vaccine distribution plan entails cooperation between states and federal agencies to allocate first doses to most at-risk populations, such as healthcare workers and elderly patients.
The announcement comes less than a week after an election that was seen partly as a referendum on President Trump’s handling of the pandemic that has killed more than 237,000 people in the United States and at least 1.2 million people globally.
To date, nearly 10 million infections have been confirmed in the U.S., and the coronavirus has continued to surge most acutely in the Midwest, a region that was spared early in the pandemic. In South Dakota, for instance, the test positive rate has hovered at about 54% every day for the past week. Similarly, the test positive rates in Wisconsin, Kansas, and Idaho have averaged 15.9%, 37.1%, and 39.3% over the past week, respectively.
Pfizer’s clinical trials have not been funded by the U.S. government, but the Trump administration struck a deal with the company in July for $1.95 billion to deliver 100 million doses of the vaccine when it has been proven safe and effective by the FDA.
