The World Health Organization’s (WHO) decision to recommend a pause in the supply of Covaxin for export is worrying. This follows an inspection of the company’s production facilities between March 14 and 22 that found “deficiencies” in the process to ensure that the vaccine produced is consistently suitable for use. Bharat Biotech, the makers of Covaxin, has said it is committed to addressing these ‘Good Manufacturing Process deficiencies’ and developing a “corrective and preventive” action plan that it will submit to the Drugs Controller General of India (DCGI). WHO has told countries that for now they should “consider” alternative vaccines but it has also said that the data available with it suggest that Covaxin is safe and effective. The details of these lacunae are not public but Bharat Biotech has said that sophisticated equipment needed to “enhance the process stringency” were unavailable during the COVID-19 pandemic. This is not the first time that Bharat Biotech has tangled with WHO. The global body sought information at least nine times from the Hyderabad company before approving it to be a global supplier of Covaxin. In March 2021, the Brazilian health regulator, Anvisa, pointed to several problems with Bharat Biotech’s manufacturing plant ahead of an agreement by the company to sell 20 million doses of the vaccine to Brazil. This deal was ultimately terminated, but there has never been clear communication either by Bharat Biotech or the DCGI on the concerns raised by the Brazilian health body.
While India is no stranger to making and supplying billions of vaccine doses, it has historically done so with the benefit of time. The pandemic saw pulling out all the stops and the balance between safety and speed tilting towards the latter by both drug regulators, under pressure from their governments, and vaccine manufacturers, for whom gargantuan demand promised a financial windfall. Other companies, internationally too, have made mistakes in supply. AstraZeneca mistakenly supplied some volunteers who were being tested with the Oxford vaccine with half the required dose that led to surprising results. This was not disclosed until much after the trial results were made public and experts openly questioned the efficacy results. The defining characteristic of a vaccine is its safety profile and its acceptability is premised on its makers and the regulators being transparent about it at all times. Both the Government and Bharat Biotech should strive for better public communication on these fronts.
