Lab to people

Amid a surge in Omicron-driven infections, India’s Drugs Controller General has granted emergency use approval to Molnupiravir, the world’s first Covid-19 pill. The regulator also gave an EUA to two vaccines, Hyderabad-based Biological E’s Corbevax and Covovax manufactured by the Serum Institute of India, under licence from the US vaccine company, Novavax. The pharmacological interventions are potential game-changers in the battle against the scourge that has tormented the world for two years now. If it can replicate the clinical trial results in an actual outbreak scenario, Molnupiravir can reduce hospitalisation amongst patients with severe Covid infection by 50 per cent. Corbevax and Covovax have demonstrated close to 90 per cent efficacy in clinical trials. Though these protein-based vaccines take longer to develop compared to the jabs that use the viral vector or mRNA platforms, they tutor the recipient’s immune system to react faster to a viral attack.

India now has at least five homegrown or indigenously manufactured vaccines. However, the country’s inoculation drive continues to rely predominantly on the two first generation vaccines, Covishield and Covaxin. In August, the drug regulator cleared the use of Zydus Cadila’s Zycov-D for children and adults. Eight months later, the DNA-based vaccine will reportedly be used in a limited manner in seven states for adult inoculation. The inoculation programme for 15-18-year-olds, that will take off from next week, will draw on Covaxin, despite its Hyderabad-based manufacturer, Bharat Biotech, pleading production constraints several times during the inoculation drive for adults. Similarly, the protein-based vaccines are not amongst the initial options for the “precautionary doses” announced recently for healthcare professionals, frontline workers, and elderly citizens. According to the government’s estimates, released in June, about 300 million shots of Corbevax were to be available between September and December. Biological E’s latest statements indicate that it is aiming at a monthly manufacturing target of 100 million shots by February. Production must be ramped up and timelines scrupulously adhered to for the vaccine to justify its potential.

India’s experience with Covid vaccination shows that the country’s scientific bodies and its vaccine manufacturers and developers are adept at generating technological knowhow — this includes institutions other than the world-renowned SII. However, Bharat Biotech’s performance indicates that these firms struggle to produce at the scale necessary to make their presence felt in the inoculation drive. There are early and worrying indications that Biological E and Zydus Cadila could go the Covaxin manufacturer’s way. The government should ascertain if these firms are facing production-related difficulties and create an enabling milieu for them.