New York-based Pfizer and Germany-based BioNTech said Wednesday their phase 3 study of the candidate concluded after meeting all primary endpoints.
Analysis of the first primary objective, based on 170 cases, showed the efficacy of 95 percent was consistent across age, gender, race, and ethnicity beginning 28 days after the first dose, the companies said. Of the cases, 162 were in the placebo group and eight were in the vaccine group.
Over 43,000 patients were enrolled in the trial. No serious safety concerns have been observed in the volunteers. The only grade 3 adverse event greater than 2 percent was fatigue at 3.8 percent.
Older adults tended to report fewer and milder adverse events following vaccination, according to the companies.
“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. We continue to move at the speed of science to compile all the data collected thus far and share with regulators around the world,” Dr. Albert Bourla, Pfizer chairman and CEO, said in a 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.”
“We are grateful that the first global trial to reach the final efficacy analysis mark indicates that a high rate of protection against COVID-19 can be achieved very fast after the first 30 µg dose, underscoring the power of BNT162 in providing early protection,” added Dr. Ugur Sahin, CEO and co-founder of BioNTech.
COVID-19 is the disease caused by the CCP (Chinese Communist Party) virus.
Pfizer and BioNTech plan on submitting a request this week to the Food and Drug Administration for an emergency use authorization.
The administration didn’t immediately respond to a request for comment.
Pfizer and BioNTech expect to produce up to 50 million vaccine doses this year and up to 1.3 billion doses by the end of next year. Pfizer said Monday it was launching a pilot program to deliver the vaccine to four states: Rhode Island, Texas, New Mexico, and Tennessee.
Massachusetts-based Moderna said this week that a vaccine candidate it developed with the National Institutes of Health (NIH) is 94.5 percent effective, according to an analysis of clinical trial data. Moderna plans on submitting an application for emergency use authorization in the coming weeks.
Dr. Anthony Fauci, director of the NIH’s National Institute of Allergy and Infectious Diseases, told a summit on Tuesday that Operation Warp Speed, an effort to speed vaccine development by President Donald Trump’s administration, is looking successful.
That less than a year has passed since the CCP virus was discovered and companies are reporting Phase 3 clinical trial data, he added, “is beyond historic.”
Pfizer and BioNTech did not receive funds from Operation Warp Speed but did reach a $1.95 billion agreement with the Trump administration through the program for 100 million doses, with an option to acquire up to an additional 500 million doses.
Moderna received $483 million through Operation Warp Speed. The Trump administration also made available up to $1.5 billion in addition to support the large-scale manufacturing and delivery of the vaccine candidate.
Fauci said he hoped both vaccines would be available by the end of the year.
“I take one step at a time,” Fauci said, adding: “I’ll take the 94.5 percent effective for now, and we’ll worry about the durability of the effect” next.
From The Epoch Times