Pfizer Seeks Emergency Approval of Their COVID Vaccine After Finding It 95 Percent Effective
Pfizer said it will submit requests for emergency approval from the Food and Drug Administration for their experimental COVID-19 vaccine, after data showed that it is 95 percent effective.
Earlier this month, the pharmaceutical company and its collaborator, BioNTech, announced that preliminary results from trials showed its potential vaccine was at least 90 percent effective. On Wednesday, Pfizer said that they had concluded their phase three study, and the vaccine has proven to be 95 percent effective with "no serious safety concerns observed" in the trial participants.
Now, the company hopes to get their vaccine — which requires two shots, given three weeks apart — approved, and have initial doses available for distribution before the end of the year.
"Our work to deliver a safe and effective vaccine has never been more urgent, as we continue to see an alarming rise in the number of cases of COVID-19 globally," Dr. Albert Bourla, Pfizer chairman and CEO, said in a news release. "Filing in the U.S. 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, along with their German partner BioNTech, said they could have 50 million doses available this year, and 1.3 billion in 2021.
In their Wednesday press release announcing the success of their human trials, Pfizer noted that efficacy was "consistent across age, gender, race and ethnicity demographics" and "the observed efficacy in adults over 65 years of age was over 94 percent."
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The trials have observed more than 43,000 participants, and the "only Grade 3 adverse event greater than 2 percent in frequency was fatigue at 3.8 percent and headache at 2.0 percent." Pfizer added the vaccine was "well tolerated across all populations."
"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," added Bourla.
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On Monday, another pharmaceutical company, Moderna Inc., announced that preliminary phase three trial data shows that its coronavirus vaccine is 94.5 percent effective.
World Health Organization Director-General Tedros Adhanom Ghebreyesus emphasized earlier this month that while an effective vaccine is "needed urgently," it will take more than that to remedy the global health crisis.
"A vaccine is needed urgently to control the pandemic. But as you know, it will not fix the vulnerabilities at its roots," he said while addressing the World Health Assembly. "There is no vaccine for poverty, hunger, climate change or inequality."
"This will not be the last global health crisis. When the next one arrives, will the headlines be the same?" he asked. "Will they say that after the COVID-19 pandemic, the world wrung its hands, wrote reports and changed nothing? Or will they say that COVID-19 was a turning point for global health security, and for global health?"
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