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(CNN) – A final analysis of the phase 3 trial of Pfizer’s coronavirus vaccine shows that it was 95% effective in preventing infections, even in older adults, and did not cause serious safety concerns, the company said Wednesday.
The company counted 170 cases of coronavirus infection among the volunteers who participated in the trial. He said 162 infections occurred in people who received placebo or saline injections, while eight cases were in participants who received two doses of the actual vaccine. That results in a 95% efficiency, Pfizer said.
“Efficacy was consistent across demographics of age, race, and ethnicity. The observed efficacy in adults over 65 years was greater than 94%, “said Pfizer and its German partner BioNTech in a joint statement.
“There were 10 severe cases of COVID-19 seen in the trial, nine of which occurred in the placebo group and one in the BNT162b2 vaccinated group.” BNT162b2 is the experimental name for the vaccine.
An independent group has been monitoring the results and side effects. “To date, the Data Monitoring Committee for the study has not reported any serious safety issues related to the vaccine,” the companies said. The U.S. Food and Drug Administration said it wanted to see two months of safety data after half of the volunteers in any coronavirus vaccine trial had received injections.
“The only requested Grade 3 (severe) adverse event greater than or equal to 2% in frequency after the first or second dose was fatigue at 3.7% after dose 2.” Older adults tended to have fewer adverse events and those who did were milder.
Pfizer said it will seek the FDA’s Emergency Use Authorization “in a few days.”
“This data will also be sent to other regulatory agencies around the world,” said Pfizer. He also plans to publish the data in a peer-reviewed scientific journal.
“The rapid protection this vaccine provides, combined with its tolerance profile across all age groups studied so far, should help make this vaccine an important tool in addressing the current pandemic,” said Dr. Ugur Sahin, Director. executive and co-founder of BioNTech.
