Pfizer said no serious safety concerns related to the vaccine candidate have been reported.
Pharmaceutical major Pfizer on Wednesday said that its COVID-19 vaccine candidate was found to be 95 per cent effective in the final analysis of the Phase 3 trial and the company plans to seek regulatory approval within days.
The drugmaker said efficacy of the vaccine developed with German partner BioNTech SE was consistent across age and ethnicity demographics, and that there were no major side effects, a sign that the immunization could be employed broadly around the world.
The study reached 170 confirmed cases of COVID-19, with the vaccine candidate BNT162b2 demonstrating 95 per cent efficacy beginning 28 days after the first dose, Pfizer said.
"Additionally, the safety milestone required by the US FDA (Food and Drug Administration) for Emergency Use Authorization (EUA) has been achieved. To date, no serious safety concerns related to the vaccine candidate have been reported," it said.
"Within days, we plan to submit a request to the US FDA for an EUA based on the totality of safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the vaccine candidate," it added.
The Pfizer vaccine, however, has been all but ruled out for use in India because it needs to be stored and transported at a temperature of minus 70 degrees celsius which is a huge challenge. The government on Tuesday said it is examining the possibilities if at all the vaccine has to be obtained.
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 for the Indian population, will not be available, but the government is looking at the possibilities and will work out a strategy for its procurement and distribution in case it gets the regulatory approvals.
"The arrangement of cold-chains for storing the vaccine developed by Pfizer at a low temperature of minus 70 degrees Celsius is a big challenge and it will not be easy for any nation. But then, if at all it has to be obtained, we are examining what we need to do...and will work out a strategy," he said.
