Pfizer Now Says COVID Vaccine Is 95 Percent Effective with 'No Serious Safety Concerns Observed'
Pfizer Inc. is updating the public about a promising step in reaching a safe COVID-19 vaccine.
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 after its phase three study, the vaccine has proven to be 95 percent effective with "no serious safety concerns observed" in the trial participants.
Pfizer will, in the next few days, submit a request to the U.S. Food and Drug Administration for Emergency Use Authorization approval.
"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.
In a press release, 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."
According to Pfizer and BioNTech's projections, they expect to "produce globally up to 50 million vaccine doses in 2020 and up to 1.3 billion doses by the end of 2021." Pfizer also said it is "confident in its vast experience, expertise and existing cold-chain infrastructure to distribute the vaccine around the world."
"Our objective from the very beginning was to design and develop a vaccine that would generate rapid and potent protection against COVID-19 with a benign tolerability profile across all ages. We believe we have achieved this with our vaccine candidate BNT162b2 in all age groups studied so far and look forward to sharing further details with the regulatory authorities," Ugur Sahin, CEO and co-founder of BioNTech, said in a recent statement.
"I want to thank all the devoted women and men who contributed to this historically unprecedented achievement," continued Sahin. "We will continue to work with our partners and governments around the world to prepare for global distribution in 2020 and beyond."
On Monday, 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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