Pfizer's COVID-19 vaccine 94% effective for people above 65, no safety concerns reported

On November 18, US pharmaceutical company Pfizer announced that its mRNA-based COVID-19 vaccine has proven to be 94 percent effective in preventing SARS-CoV-2 infection in people over 65-years-old. “No serious safety concerns” were reported in the 43,000 volunteers that were administered with the trial doses, the firm informed, adding, that it has met the safety criteria needed for emergency authorization. Furthermore, Pfizer and BioNTech said that they planned to submit the efficacy report to the US regulator for emergency use approval "within days." 

According to Pfizer’s first interim efficacy analysis report, at least 42 percent of the participants enrolled were having diverse backgrounds, and despite that, no serious safety concerns related to the vaccine were observed. The company said that it achieved the safety milestone with reps t to its mRNA-based vaccine candidate, BNT162b2, against SARS-CoV-2 with the demonstrated efficacy evidence studied by the independent Data Monitoring Committee (DMC) from the clinical trials.

“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,” said Dr. Albert Bourla, Pfizer Chairman and CEO.

“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.”

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Overall 95 percent effective

In its primary efficacy analysis, Pfizer’s vaccine candidate BNT162b2  proved to be overall 95 percent effective just merely 28 days after the first dose. At least 170 confirmed cases of COVID-19 were evaluated, with 162 observed in the placebo group versus 8 in the vaccine group, the firm informed. Efficacy was consistent across age, gender, race, and ethnicity demographics, it added. Of the total 43,000 participants enrolled, only 2 percent reported fatigue at 3.8 percent and headache at 2.0 percent as only Grade 3 adverse event. M.D., CEO and Co-founder of BioNTech, Ugur Sahin said, “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.”

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(image Credit: AP)