Pfizer on Wednesday announced that final data on its coronavirus vaccine candidate showed it to be 95 percent effective, adding that the company would be applying for Federal Drug Administration (FDA) emergency authorization “within days.”
Pfizer said that the vaccine candidate, developed with German company BioNTech, is 95 percent effective “against COVID-19 beginning 28 days after the first dose.”
The company last week said that interim data revealed its vaccine to be 90 percent effective.
It also said on Wednesday that it had the two months of safety data necessary to apply for an emergency use authorization from the FDA.
“The study results mark an important step in this historic eight-month journey to bring forward a vaccine capable of helping to end this devastating pandemic,” Albert Bourla, Pfizer chairman and CEO, said in the company’s statement. “With hundreds of thousands of people around the globe infected every day, we urgently need to get a safe and effective vaccine to the world.”
Pfizer said that 170 people in its trial tested positive for COVID-19, with 162 of them receiving a placebo and 8 in the vaccine group.
The company added that the efficacy rate was consistent across age, gender, race and ethnicity groups, and that the effectiveness for adults older than 65, who are at higher risk of complications from COVID-19, was more than 95 percent.
Pfizer reported no major side effects or safety concerns connected with the vaccine candidate, although fatigue and headaches were reported in some test subjects following the second dose.
The company also said on Wednesday that it and BioNTech expect to produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021.
On Monday, Pfizer announced that it was starting a pilot program to deliver its experimental vaccine to four U.S. states: Rhode Island, Texas, New Mexico and Tennessee.
The program launched the same day Moderna said that interim data revealed its coronavirus vaccine candidate to be 94.5 percent effective. The drug developer also said that it would be applying for FDA approval “in the coming weeks,” once it has the final safety and efficacy data.
Health care workers and other higher risk populations will be prioritized in the distribution of a federally approved vaccine beginning in December, with experts saying that a vaccine will likely not be distributed to the general public until well into 2021.
While Pfizer did not receive development funds from the Trump administration through its Operation Warp Speed, Moderna was given $955 million for the development of its vaccine.
–Updated at 7:48 a.m.