NEW DELHI: US-based pharma major Pfizer on Wednesday announced that its Covid-19 vaccine candidate was found to be 95% effective in the final analysis of the late-stage clinical trials. The firm said it was planning to seek regulatory approval within days.
In a statement, the drugmaker also said that the efficacy of the vaccine, developed with German partner BioNTech, was consistent across age and ethnicity demographics and that there were no major side effects, which suggests that the vaccine can be used across the globe.
The study found 170 confirmed cases of Covid-19, with the vaccine candidate BNT162b2 developed using message RNA technology demonstrating 95% efficacy 28 days after the first dose, Pfizer said, adding that the vaccine was 94% effective in those above 65.
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The vaccine had been tried on 44,000 individuals in the USA who were given two doses - 28 days apart - and then followed for two months.
Of the 170 Covid-19 cases that emerged among the volunteers, 162 were found in the placebo group while only eight in the vaccinated group developed the disease. Ten individuals went on to develop severe disease, nine of whom were in the non-vaccinated group, as per the statement.
"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," Pfizer 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.
The announcement by Pfizer comes days after another biotech company Moderna said that the interim analysis of the phase 3 trial of its potential coronavirus vaccine had shown that it's 94.5% effective.