A pause to reflect: on the WHO’s decision to recommend a halt in the supply of Covaxin

The World Health Organization (WHO) has approved Covaxin. has decided to recommend stopping the supply of Exports are worrying. It follows an inspection of the company’s production facilities between March 14 and 22, which found “shortcomings” in the process to ensure that the vaccine produced is suitable for continued use. Bharat Biotech, Manufacturer of Covaxin, has said it is committed to address these “good manufacturing process deficiencies” and develop a “corrective and preventive” action plan that it will submit to the Drug Controller General of India (DCGI). The WHO has told countries that for now they should “consider” alternative vaccines, but added that the accompanying data suggest Covaxin is safe and effective. The details of these shortcomings are not public, but Bharat Biotech has said that the sophisticated equipment needed to “increase the rigor of the process” during the COVID-19 pandemic was not available. This is not the first time India’s biotech is at odds with the WHO. The global body has sought information from the Hyderabad-based company at least nine times before allowing it to be a global supplier of Covaxin. In March 2021, Brazil’s 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. The deal was eventually scrapped, but there has never been a clear communication by Bharat Biotech or DCGI on concerns raised by the Brazilian health body.

While India is no stranger to manufacturing and supplying billions of doses of vaccine, it has historically done so with the advantage of time. The pandemic saw all halts being pulled and the balance between safety and speed tilted by both drug regulators, under pressure from their governments and vaccine makers, for whom huge demand had promised financial gains. Other companies have made supply mistakes internationally as well. AstraZeneca accidentally supplied some volunteers with the Oxford vaccine with half the required dose, resulting in surprising results. It was not disclosed until long 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 based on being transparent about it at all times by its manufacturers and regulators. Both the government and Bharat Biotech should strive for better public communication on these fronts.