Pfizer said no serious safety concerns related to the candidate vaccine have been reported.
New Delhi:
Major drugmaker Pfizer said Wednesday that its COVID-19 vaccine candidate was found to be 95 percent effective in the final analysis of the phase 3 trial, adding that it had the required two months of safety data and would request authorization. US emergency days.
The drug maker said the efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnic demographics, and there were no major side effects, a sign that immunization could be used widely across the world. world.
The study reached 170 confirmed COVID-19 cases, and the BNT162b2 vaccine candidate demonstrated 95 percent efficacy as of 28 days after the first dose, Pfizer said.
“In addition, the safety milestone required by the US FDA for Emergency Use Authorization (US) has been achieved. To date, no related serious safety issues have been reported. with the candidate vaccine, “he said.
“In a few days, we plan to submit an application to the US FDA for an EUA based on all of the collected safety and efficacy data, as well as manufacturing data related to the quality and consistency of the vaccine. candidate, “he added.
The Pfizer vaccine, however, has been practically discarded for use in India because it needs to be stored and transported at a temperature of minus 70 degrees Celsius, which is a great challenge. The government said Tuesday it is examining the possibilities, if it is necessary to obtain the vaccine.
NITI Aayog (Health) member Dr. VK Paul, who also heads the National Working Group on COVID-19, said that sufficient doses of the Pfizer vaccine will not be available, as required for the Indian population, but the government is considering the possibilities and will develop a strategy for its acquisition and distribution should it obtain regulatory approvals.
“Arranging cold chains to store the vaccine developed by Pfizer at a low temperature of minus 70 degrees Celsius is a huge challenge and will not be easy for any nation. But then, if it is to be sourced, we are examining what we have to do … and we will develop a strategy, “he said.
Pfizer’s final analysis comes just one week after initial trial results showed the vaccine was more than 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing similar effectiveness.
Better-than-expected data from the two vaccines, both developed with a new technology known as messenger RNA (mRNA), have raised hopes of ending a resurgent pandemic that has killed more than 13 lakhs of people worldwide and it has disrupted economies and daily life. .
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