coronavirus update indiaas on : 25 November 2020 05:48 GMT+5:30
Pfizer Says Its Covid Vaccine Is 95% Effective In Final Analysis,To Seek Approval In Days
Pfizer Says Its Covid Vaccine Is 95% Effective In Final Analysis
Pfizer Says Its Covid Vaccine Is 95% Effective In Final Analysis, To Seek Approval In Days
New Delhi: On Wednesday Pharmaceutical major Pfizer said that its coronavirus vaccine candidate was found to be 95 percent effective in the final analysis of the phase 3 trial and the company plans to seek the regulatory approval within days. The vaccine prevented infections even in the older adults and has caused no serious safety concern, said the company.
The study reached 170 confirmed cases of coronavirus, with the vaccine candidate BNT162b2 demonstrating 95 percent 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 a 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.
However, Pfizer has been all but ruled out for use in India because it needs to be stored and transported at the temperature of minus 70 degrees Celcius which is a huge challenge. On Tuesday the government said that it is examining the possibilities if at all the vaccine has to be obtained.
NITI Aayog member Dr. VK Paul who also heads the National Task Force on coronavirus said that 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.
"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 the initial results from the trials showed the vaccine was more than 90 percent effective.