A big boost

Covaxin gets the stamp of international legitimacy

The World Health Organization (WHO) has approved the Indian-manufactured vaccine Covaxin for emergency use. The long-delayed emergency use listing authorisation for Bharat Biotech’s vaccine comes after the manufacturers first applied in April. The approval ends considerable uncertainty and means that those vaccinated by using Covaxin will finally be able to travel abroad, since most countries limit arrivals to travellers who can demonstrate that they have completed a full course of one of the WHO’s approved vaccines. The other Indian-manufactured vaccine, Covishield, is already approved by the WHO and by several national regulators. Bharat Biotech had claimed to have concluded its Phase 3 trials in June, but the full data is not yet publicly available. Presumably, the long delay was so the WHO could satisfy itself about the data. The international legitimacy granted by this approval to Indian science, manufacturing, and to the Indian vaccination programme overall, cannot be denied.

Now that India has moved beyond this immediate question of approval, it is important to take stock of how swiftly the broader target of vaccinating the entire country is progressing. While the Serum Institute of India has successfully scaled up the manufacturing of Covishield to hoped-for levels, the production of Covaxin has been something of a disappointment. Being an inactivated virus vaccine, it is somewhat more complex to manufacture. Nevertheless, in spite of some government support, the company has not been able to scale up to the degree required to keep its end of the vaccination programme going. That must be corrected in the coming weeks, and it is critical that Bharat Biotech increases the scale of production.  Over time, the possibilities of restarting exports at scale, including of Covaxin, must also be considered when it comes to making investments in production facilities. While some exports have now been restarted, India has overall delayed large-scale shipments for too long as far as some other emerging economies are concerned. 

The government has other questions it must now consider about the vaccination programme. For example, ensuring the proper spread of second doses. There is anecdotal evidence that some of those willing to get the first shot are reluctant to follow it up as mandated. This must be addressed through focused outreach and targeted policy. Eventually, local governments must also ask themselves whether, as is the case elsewhere, limited vaccine mandates for some employees and for access to some spaces should be put into place. Given that the vaccines are free and now there are fewer supply constrictions in most urban areas, the conversation about mandates cannot be postponed much longer. 

 It is also important to now seek out scientific data and consensus on whether booster shots of the vaccines being used in India are required to ensure continued protection against the virus and especially against the Delta variant. Many countries elsewhere have started rolling out booster programmes — some of which involve mixing and matching vaccines. The best results are reported through the use of both traditional vaccines, like the AstraZeneca/ Covishield shot, and the new mRNA vaccines. Thus, the debate about whether the latter should be granted permission in India, alongside the appropriate indemnification, is far from closed.