The Union government saying that the states/priority-group beneficiaries will have no decision more than no matter whether they obtain Bharat Biotech’s Covaxin or the Oxford/AstraZeneca-created vaccine (manufactured in India by Serum Institute of India and marketed as Covishield) is however a further indicator of how haste is trumping sense when it comes to the government’s vaccine technique. Covaxin received accelerated approval for roll-out in “clinical trial mode”, but the government hasn’t accomplished substantially on clearing the air on what this mode entails to be confident, this cannot be treated as the common clinical trial as there is no manage group, even if vaccine recipients are monitored cautiously more than a period (which is what the government has stated about “clinical trial mode”).
Against such a backdrop, as this newspaper has argued when Covaxin received the approval, the government should assure that every person becoming vaccinated will obtain the Covishield vaccine, and if Covaxin is supplied, prospective recipients need to be permitted to reject it.
The lack of clarity more than Covaxin has been exacerbated by many statements from the authorities in the light of the accelerated approval. ICMR chief Balaram Bhargava had justified the clearance for Covaxin, citing immunogenicity and security information from phase 2 clinical trials as surrogates for eventual efficacy in such a case, why ask for phase 3 data—which can take months—from any vaccine candidate? Jurisdictions such as the US and the UK have only granted approval soon after candidates submitted information from phase 3 trials, as has been pointed out by this newspaper. Indeed, the gold common is to have lengthy observation periods, across recipient groups—something that the government has followed for a clutch of other vaccine candidates, like Cadilla’s DNA-vaccine against Covid-19.
The government, soon after examining security and immunogenicity information from its phase 1 and 2 trials, gave it permission to start out phase 3 trial and stated the efficacy of the vaccine ‘should be assessed on the data generated after day 84 from the first dose’. Add to this, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation speaking about Covaxin “having potential to target mutated coronavirus strains” such as the UK strain although recommending grant of permission “for restricted use in emergency situation”.
Bear in thoughts, 102 circumstances of the UK strain have been reported in India so far, and it was only final week that the National Institute of Virology was reported to be moving to commence trials of vaccines against the UK strain isolated in India—results on no matter whether the immune response from a certain vaccine is helpful against the strain are, hence, nevertheless awaited. And, a clinical trial needs enlisting of volunteers, whereas what the government is suggesting in the present instance is that folks will be presented with a Hobson’s decision.
With neither the emergency to justify the roll-out of Covaxin—as envisaged by the SEC—nor efficacy established from phase 3 information, the government forcing it on folks appears to be not only poor policy but also a damaging prospect for the reputation of Bharat Biotech, that has been a frontrunner in the vaccines (not just against Covid-19) landscape in the nation.
What tends to make this worse, is that it would have been a wait of just a couple of months ahead of phase 3 information would have began to emerge for the vaccine. Against such a backdrop, the government’s repeated missteps on vaccine strategy—after designing a reasonably great roll-out plan—and its failure to communicate with clarity could expense the fight against Covid-19 large, if it begins to erode people’s trust in vaccines.