Long road to global acceptance

The vaccine maker published these numbers on the back of the third phase of clinical trials that it had conducted. COVID vaccines manufactured in India are facing a few roadblocks, primarily on account of their efficacy, which has been highlighted by the emergence of the Delta variant. Last week, the results of a new study were made public, which said that neutralising antibodies against the Delta variant were not found in 16.1 per cent of samples from those who had been administered both the first and second doses of Covishield.

The study added that neutralising antibodies were not observed in 58.1% of samples from those who had taken one shot of Covishield. Epidemiologists believe that the latest reports might indicate the necessity for an additional i.e. third booster shot of Covishield, for those who may not have been infected yet, while those who may have been infected once, would require just one shot of Covishield.

The developments assume significance in the backdrop of the ongoing rift between India and European nations regarding the green signal for COVID vaccines manufactured in India. As many as seven EU member states and two non-member states had added Covishield to their list of approved vaccines. This allows those vaccinated to travel freely within these nations.

The clearance had come after India stood its ground on recognising the EU’s digital COVID certificate only in return for a quid pro quo recognition of Indian vaccines – Covishield and Covaxin. Covaxin has also been facing issues about emergency use authorisation in the US. Its application for the same was rejected by the FDA in June, as it sought more data on clinical trials.

Phase 3 trial is a prerequisite for validation from the WHO, which in turn will allow Bharat Biotech to export the vaccine, adding it to the global vaccine passport kitty. In the absence of authorisation from the health regulators in strictly regulated markets, such as the US, the EU, even students who have been vaccinated with Covaxin and are pursuing higher studies, are being considered unvaccinated. The WHO’s Chief Scientist Soumya Swaminathan had recently remarked that a decision concerning emergency approval for Covaxin should be made by the mid of August.

The clean chit from the WHO could make a world of difference to the fortunes of Bharat Biotech, which has been undergoing a trial by fire in Brazil. The vaccine maker’s name has now been dragged into a controversy involving the President of the country Jair Bolsonaro, whose government has been pulled up for irregularities that have emerged in a health ministry contract to buy 20 mn doses of the vaccine. The pricing of the vaccine which was considered to be high despite it not obtaining the necessary regulatory clearance had piqued the curiosity of Brazil’s Supreme Court, which has opened an investigation into the order.

While it is understandable in a country like India with a population of over 1.4 bn people, the need to roll out vaccines even in the absence of complete data about clinical trials might have been necessary, one cannot disregard the importance of peer reviews and transparency. If homegrown manufacturers desire to be ranked alongside international pharma behemoths in the war against COVID, they must bank on the fundamentals of compliance when it comes to their business practices. The results will be seen as proof of India’s prowess in the pharmaceutical space and will elevate the country’s status as a nation leading from the front in the war against the pandemic.