Published 17:32 IST, November 19th 2020
Pfizer's COVID-19 vaccine 94% effective for people above 65, no safety concerns reported
At least 42 percent of the participants were enrolled from diverse backgrounds in Pfizer’s first interim efficacy analysis and 2 percent reported fatigue.
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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.”
BREAKING: We are proud to announce, along with @BioNTech_Group, that the Phase 3 study of our #COVID19 vaccine candidate has met all primary efficacy endpoints.
— Pfizer Inc. (@pfizer) November 18, 2020
Read: Storage Of Pfizer's COVID Vaccine Challenge For Most Nations; India Examining Possibilities: Govt
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.”
Ongoing coordination is critical to help ensure efficient vaccine distribution as soon as possible if our vaccine candidate receives authorization or approval. Thank you @GregAbbott_Tx for helping as we prepare to create effective immunization programs.
— AlbertBourla (@AlbertBourla) November 18, 2020
(image Credit: AP)
17:33 IST, November 19th 2020