New Delhi, Nov 18: Pharmaceutical giant 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, adding it had the required two-months of safety data and would apply for emergency US authorization within days.
The drugmaker said the 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.
The final analysis from Pfizer comes just one week after initial results from the trial showed the vaccine was more than 90 per cent effective. Moderna Inc on Monday released preliminary data for its vaccine, showing similar effectiveness.
The better-than-expected data from the two vaccines, both developed with a new technology known as messenger RNA (mRNA), have raised hopes for an end to a resurgent pandemic that has killed more than 13 lakh people globally and upended economies and daily life.
Worldwide, there are dozens of vaccine candidates at various stages of trials involving tens of thousands of volunteers. The next data release will likely be in November or December from AstraZeneca and the University of Oxford which has partnered the Serum Institute of India for large-scale production.