Last month, Astra Zeneca conceded in a UK court that its Covid-19 vaccine, called Vaxzevria in the UK and Covishield in India, could trigger a rare side-effect called TTS (or thrombosis with thrombocytopenia syndrome). This admission has come up amidst a class action suit that seeks to link the vaccine with death and serious injury in over 80 cases. Serum Institute of India (SII), the franchisee producer for Astra Zeneca, has said that this is contraindicated in the Covishield vaccine package insert and the FAQs released by the company. But the UK legal storm has galvanised those in India who lost their near and dear ones after they took the vaccine.
It is perhaps beyond dispute that given the health emergency at that time, Covid vaccines were very effective in mitigating the severity of the illness. Besides, hindsight is always 20:20. Yet, there remains a niggling doubt over whether the vaccination roll-out could have been managed a bit differently, in view of information on adverse effects that was available even in March 2021. Many Western countries in March 2021 had either stopped administering Vaxzevria or restricted its use to the elderly. On April 16, 2021, the WHO issued a statement that TTS has been reported “after vaccination” with Astra Zeneca vaccines in particular. Yet, barely three weeks before this statement, a top functionary of NITI Aayog had said, “there is no risk of blood clotting related complications...and our own scientific community has told us that it is safe”.
No doubt, India was faced with the prospect of containing Covid fatalities in a billion-plus population, and the rapid rollout of vaccines that were being developed at ‘warp speed’ was the only way out. But in trying to speed up first dose coverage, with Covishield being the first available vaccine, it remains an open question as to whether some sections could have been shielded from this vaccine. This is not to cast blame from the comfort of hindsight but to merely take stock. Covishield accounted for 170 crore out of 220 crore doses given in India. The adverse events ratio of 1:100,000 gives rise to doubts on whether a number of episodes went unreported. This is very likely, as the Adverse Events Following Immunisation (AEFI) information system is not in active use.
According to a March 2023 paper by the National Centre for Biotechnology Information, “the Covid-19 vaccine-related deaths reported in India were 946,” a figure stated in Parliament. It also says: “As of November 30, 2021, 1.23 billion vaccine doses had been administered with AEFIs amounting to 4/100,000 doses. Among these AEFIs, 1,965 cases were reported to be serious AEFIs, translating to 1.6/million doses administered.” Most of these were Covishield-related, it says. The Health Ministry did well in managing the Covid crisis. Now it should consider a no-fault compensation protocol, as outlined by the WHO. Adverse events reporting must be strengthened. Mistakes could occur in handling emergencies, but the right lessons must be learnt.