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"For the millions who have received COVAXIN, the vaccine certificates issued still stand valid as there is no impact on efficacy and safety of the vaccine," read the statement issued by Bharat Biotech on suspension from WHO.
Gennova had last month submitted interim data on India's first indigenously developed mRNA Covid vaccine to the drug regulator. The Central Drug Standard Control Organisation (CDSCO) has sent some queries to the company on the data, the people said.
The company said the decision has been taken as it has completed its supply obligations to procurement agencies and is foreseeing decrease in demand. The company will now focus on pending facility maintenance, process and facility optimization activities, it said.
Nearly 30% of those vaccinated against Covid in India may not be as safe as they think. Multiple studies show protection offered by two doses tends to weaken or wane in six to eight months.
The EMA's Committee for Medicinal Products for Human Use (CHMP) opinion will be considered by the European Commission. "The European Commission decision on the approval is expected later this year," Biocon Biologics said. Once approved by EMA, the company said it commercialise Inpremzia in the EU by a leading global medical products company.
