On Sunday, Indian authorities approved two covid vaccines for emergency use, raising hopes that the scourge can be brought under control once enough people have been granted a shield of immunity by these jabs. Unfortunately, the country’s vaccine approval process has kicked up a controversy. Critics have drawn parallels with China and Russia, which okayed immunization shots they had developed without bothering to place data on their efficacy and safety in the public domain for others to examine. Surely, India cannot be clubbed with nations that frown upon independent scrutiny of an exercise as vital as a vaccination programme. Yet, we have no information on the outcome of final-phase domestic trials that were reported to be underway for the two candidates given a go-ahead: Oxford-AstraZeneca’s vaccine, being made here under the brand Covishield by the Pune-based Serum Institute of India (SII), and Hyderabad-based Bharat Biotech’s Covaxin, which it developed indigenously in alliance with the Indian Council of Medical Research. This awkward opacity has caused some disquiet among experts, especially over the latter, which, unlike Oxford’s jab, does not have global data to support its efficacy claims.
ALSO READ: India’s hunt for the new Vision 2020
While hasty approvals could, at a pinch, be justified by the urgency of our need to secure the health of Indian citizens, the apparent haste has also put a spotlight on the question of legal risk-sharing, should a few jabs result in serious adverse events. This is not to suggest that these jabs are risky (political attacks on them are best ignored), but prudence demands that we have even unlikely occurrences fully covered. As plans gather pace to administer daily doses by the million, the government must not delay clarifying this aspect of its vaccination drive. The Drugs Controller General of India has reportedly given its nod on the condition that vaccine providers submit details of any adverse effects every fortnight. Also, jab recipients would be given a ‘factsheet’ on safety and other points. However, whether they will individually be asked to sign a consent form remains unclear. Even if they are, it need not suffice to shift responsibility onto them, as it could conceivably be argued that it was popularly seen as just another formality. Rather than proceed with hazy exposure to legal action in case something goes wrong, we need a well-defined liability framework.
Since maximizing vaccinations is plainly in our national interest, the government must offer to pick up the tab for any compensation claims that arise. It should indemnify vaccine providers against both specific-case and class action lawsuits. This will convey its confidence in the jabs and also help marginalize the early stirrings of an anti-vaxxer movement in India. Such an indemnity exists abroad. The UK and Australia have given Pfizer protection for the vaccine it developed with BioNTech, while the US and Canada have laws to protect companies that make and supply critical therapeutic products (these cover covid vaccines). In the case of nuclear reactors, India rightly chose to let suppliers bear the liability for a radiation spill. Vaccines are an entirely different proposition. We cannot do without them. And while large volumes have already been churned out without sufficient legal clarity on the matter, it would be less than fair of the government if it doesn’t declare that the buck stops with it.
