Another beginning: On vaccine vigilance

Pharmacovigilance is vital as more vaccines become available and new side-effects seen

As India grapples with a vaccine shortage, the Drug Controller General of India has formally approved another vaccine candidate — Sputnik V — under emergency use authorisation. Since January, India’s vaccination strategy has hinged almost entirely on Covishield — the AstraZeneca vaccine — and to a very limited extent, Covaxin. Another significant move by the government is in allowing foreign-made vaccines approved by regulatory agencies in the U.S., the U.K., Europe, Japan or those that find mention in the World Health Organization’s list of approved emergency use vaccines which can avoid conducting a local clinical trial but opt for a parallel bridging trial post-approval. Last year, Pfizer had approached Indian regulators for permission but a sticking point was over this question of the conduct of local trials. It is important to note that bridging trials are critical. A vaccine that is approved in a different country may have untoward effects in another population. Past learnings from the history of drug and vaccine effects across geographies were what necessitated such rules in the first place.

However, India is in a crisis. When it had the opportunity to conduct clinical trials in the right way, in the case of Covaxin and even Covishield, India rushed through its regulatory process. This contributed to the hesitancy surrounding these vaccines. It is still a mystery why India did not plan for enough stocks like the U.K. and the U.S. did. Now, it seems India is taking a cue from these countries by conceding that no country can be entirely ‘atmanirbhar’ in vaccinating its population. While there are several vaccine candidates at various stages of approval that India can choose from, it must not repeat the same mistake of assuming that choice translates into immediate availability. All of the Indian companies that have tied up with foreign vaccine companies are private players. That is, while they may promise vaccines in the millions, it will always be the case that priority will be accorded to the highest global bidders. India must compete to ensure that these doses are available to a large fraction of its adult population in quick time. The pandemic wave seems to have ebbed in the U.S., to some extent, because at least 30% of its adults have got one dose. For India, this job of scaling up was always going to be uphill. Scenes from last year — paucity of hospital beds, ventilators, black marketing of drugs — are now being replayed in worrying proportions. With more vaccines come inevitably more complications associated with adverse events and rare side-effects. This is where India’s pharmacovigilance programme must step up. The easing up on conditions for facilitating more vaccines must be seen as a new beginning.

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