Pharmaceutical company Pfizer announced on Wednesday that its COVID-19 vaccine candidate was 95 percent effective in the final analysis of the Phase 3 study. He had the required security information for two months and would apply for an emergency permit within the US days.
The drug manufacturer said the effectiveness of the vaccine developed with German partner BioNTech SE was consistent in terms of age and ethnicity and that there were no major side effects, a sign that the vaccine could be used worldwide.
The study reached 170 confirmed cases of COVID-19, with vaccine candidate BNT162b2 showing 95 percent effectiveness from 28 days after the first dose, Pfizer said.
“In addition, the US Food and Drug Administration (FDA) has reached the safety milestone required for approval for emergency use (EUA). To date, no serious safety concerns have been reported with the vaccine candidate,” it said.
“In a matter of days, we plan to submit an application to the US FDA for an EUA based on all of the safety and efficacy data collected, as well as manufacturing data on the quality and consistency of the vaccine candidate,” he added.
However, the Pfizer vaccine is all but ruled out for use in India as it has to be stored and transported at a temperature of minus 70 degrees Celsius, which is a major challenge. The government said Tuesday it is examining the possibility of receiving the vaccine at all.
NITI Aayog Member (Health) Dr. VK Paul, who also heads the National Task Force on COVID-19, said sufficient doses of the Pfizer vaccine as required by the Indian population will not be available, but the government is reviewing the options and a strategy will be drawn up for it work out its procurement and distribution if it receives regulatory approvals.
“Arranging cold chains to store the vaccine developed by Pfizer at a low temperature of minus 70 degrees Celsius is a major challenge and will not be easy for any nation. But if anything, we need to get them and see what we need to do … and will work out a strategy, “he said.
Pfizer’s final analysis comes just a week after initial study results showed the vaccine was more than 90 percent effective. Moderna Inc released preliminary data for its vaccine on Monday showing similar effectiveness.
Better-than-expected data from the two vaccines, both developed using a new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that kills more than 13 lakh people worldwide came and the economy and daily life were shaken.
Globally, there are dozens of vaccine candidates in various stages of trials that involve tens of thousands of volunteers. The next data release is expected to be in November or December by AstraZeneca and the University of Oxford, who have partnered with the Serum Institute of India for large-scale production.
(With contributions from agencies)