Pharmaceutical giant Pfizer on Wednesday (November 18) that its COVID-19 vaccine was found to be 95 per cent effective in the final analysis of the Phase 3 trial and it would soon apply for US authorisation for emergency use.
The company said the efficacy of the vaccine candidate BNT162b2 was consistent across age and ethnicity demographics and had no major side effects. The trials covered 170 confirmed COVID-19 cases and the vaccine worked in 95 per cent of the cases within 28 days of the first dose.
Pfizer is developing the vaccine in collaboration with German company BioNTech SE.
“Efficacy was consistent across age, gender, race and ethnicity demographics; observed efficacy in adults over 65 years of age was over 94%,” Pfizer said in a press release.
“Data demonstrate vaccine was well tolerated across all populations with over 43,000 participants enrolled; no serious safety concerns observed; the only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%,” it added.
“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 Centre, however, has said that the vaccine may not be available in India soon due to apparent roadblocks in storing and transporting it.
The vaccine needs to be stored at a temperature of minus 70 degrees Celsius and the government on Tuesday said it was a huge challenge to arrange a cold chain for the same. The government, has, however, assured that all possibilities to obtain the vaccine are being examined.
Pfizer has said it hopes to produce 50 million vaccine doses by the end of the current calendar year. At two doses per person, this would help protect protect 25 million people. It said in 2021, it will produce 1.3 billion doses.