New Delhi In a major setback to leading Indian vaccine maker Bharat Biotech, the World Health Organization (WHO) has further delayed the Emergency Use Authorization (EUA) for its COVID-19 vaccine Covaxin. Media reports quoted sources as saying that the global health watchdog has sent further technical questions to its manufacturer Bharat Biotech.
All this comes days after Bharat Biotech claimed it had submitted all the data required for the approval of Covaxin.
Though there is no official confirmation about it yet, the delay is likely to adversely affect Indians, especially students, who are planning to travel abroad.
Without the EUA, Bharat Biotech-manufactured Covaxin would not be considered a vaccine approved by most countries around the world.
Interestingly, the Union Health Ministry had recently indicated that the global body may soon give its approval to Covaxin.
According to news agency ANI, Dr Bharti Praveen Pawar, Union Minister of State in the Ministry of Health had said last Friday, “There is a process to submit documents for approval. WHO’s emergency use authorization for Covaxin is expected soon.”
Earlier, Dr VK Paul, chairman of the National Expert Group on Vaccine Administration, had also said that the WHO approval for Covaxin is likely to come before the end of this month.
According to Bharat Biotech, the Phase III clinical trials of Covaxin had demonstrated an efficacy rate of 77.8 percent.
Covaxin, along with Covishield, was the first authorized vaccine by India in its massive nationwide vaccination campaign against COVID-19, launched in January this year. Others, such as the Russian-made Sputnik, were added to the country’s arsenal only later.
Covishield is now the only India-made vaccine on the WHO list. It is manufactured by Serum Institute of India in Pune and was developed by researchers from Oxford University and pharmaceutical firm AstraZeneca.
The WHO has also approved vaccines so far manufactured by Pfizer-BioNtech, Johnson & Johnson, Moderna and Sinopharm.
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