Pfizer said no serious safety concerns with the vaccine candidate have been reported.
New Delhi:
Pharmaceutical giant Pfizer said on Wednesday that its COVID-19 vaccine candidate was found to be 95% effective in the final analysis of the Phase 3 trial, adding that it had the required two months of safety data and would request an American emergency 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 vaccination could be widely used around the world.
The study reached 170 confirmed cases of COVID-19, with the BNT162b2 vaccine candidate demonstrating 95% effectiveness as of 28 days after the first dose, Pfizer said.
In addition, the safety milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) has been met. To date, no serious safety concerns related to the vaccine candidate n ‘has been reported, “he said.
“Within a few days, we plan to submit a request to the US FDA for an EUA based on all of the safety and efficacy data collected, as well as manufacturing data relating to the quality and consistency of the product. vaccine candidate, “he added.
The Pfizer vaccine, however, has been all but ruled out for use in India because it has to be stored and transported at minus 70 degrees Celsius, which is a huge challenge. The government said on Tuesday it was examining the possibilities of obtaining the vaccine.
Dr VK Paul, member of NITI Aayog (Health), who also heads the National COVID-19 Working Group, 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 develop a strategy for its supply and distribution in the event that it obtains 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 it will not be easy for any country. But then, if it is to be obtained, we look at what we need to do … and develop a strategy, “he said.
Pfizer’s final analysis comes just a week after initial trial results showed the vaccine to be over 90% effective. Moderna Inc released preliminary data for its vaccine on Monday, showing similar efficacy.
Better-than-expected data from the two vaccines, both developed with new technology known as messenger RNA (mRNA), has raised hopes of ending a resurgent pandemic that has killed more than 13 lakh worldwide and upset the savings and everyday. life.
Around the world, there are dozens of vaccine candidates at different stages of trials involving tens of thousands of volunteers. The next data release will likely be in November or December by AstraZeneca and the University of Oxford, which has partnered with the Serum Institute of India for large-scale production.
(With contributions from agencies)
