The World Health Organisation (WHO) issued a statement on April 2 saying that it had done an on-site inspection of Bharat Biotech’s facility where Covaxin was being manufactured in March. It found several deficiencies on quality control standards, as far as production was concerned.
Replying to The Wire’s queries, the WHO said that the company had tinkered with the manufacturing processes that it had committed to while applying for the WHO licensure. And, those changes which were made after the grant of the license had not been communicated to the body.
Therefore, it suspended the supply of Covaxin to UN agencies in April.
The WHO has approved 11 COVID-19 vaccines so far, including Covishield and Covaxin. Of them, Covaxin is the only one to have faced this stricture.
The Wire asked the WHO, again, in August, if Bharat Biotech had removed those deficiencies in good manufacturing practices. The WHO replied in the negative.
Can this lead to WHO revoking the license given to Covaxin? How would this affect those who have taken Covaxin? And, why are the Indian government and the country’s drug regulator not only completely silent about this, but are also dodging efforts to make this information public.