Tribune News Service
New Delhi, November 18
US pharma major Pfizer and its German collaborator BioNTech today announced successful completion of phase 3 Covid vaccine trials, claiming 95 per cent efficacy in the final analysis.
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The companies said primary efficacy analysis demonstrated the vaccine candidate to be 95 per cent effective against Covid-19, beginning 28 days after the first dose and 170 confirmed cases of Covid-19 were evaluated with 162 observed in the placebo group versus eight in the vaccine group.
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Efficacy was consistent across age, gender, race and ethnicity demographics and efficacy in adults over 65 years of age was over 94 per cent, the firms said. India has already expressed apprehensions about the procurement of the Pfizer vaccine with VK Paul, chairperson of the national Covid vaccine administration task force, saying minus 70 degree cold chain storage requirement for the Pfizer vaccine would prove challenging for any country.“Cold chain storage requirements for the Pfizer vaccine will surely hamper its scale up,” Paul today said, adding that Pfizer had approached India for procurement and talks were underway.
Meanwhile, Pfizer and BioNTech today said the two-month safety data milestone required by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA) has been achieved.
Companies plan to submit within days to the FDA for Emergency Use Authorisation and will share data with other regulatory agencies around the globe.
“Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; the only Grade 3 adverse event greater than 2 per cent in frequency was fatigue at 3.8 per cent and headache at 2.0 per cent,” Pfizer said.
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