The Union government saying that the states/priority-group beneficiaries will have no choice over whether they receive Bharat Biotech’s Covaxin or the Oxford/AstraZeneca-developed vaccine (manufactured in India by Serum Institute of India and marketed as Covishield) is yet another indicator of how haste is trumping sense when it comes to the government’s vaccine strategy. Covaxin received accelerated approval for roll-out in “clinical trial mode”, but the government hasn’t done much on clearing the air on what this mode entails; to be sure, this can’t be treated as the standard clinical trial as there is no control group, even if vaccine recipients are monitored carefully over a period (which is what the government has said about “clinical trial mode”).
Against such a backdrop, as this newspaper has argued when Covaxin received the approval, the government must guarantee that everyone being vaccinated will receive the Covishield vaccine, and if Covaxin is offered, potential recipients should be allowed to reject it.
The lack of clarity over Covaxin has been exacerbated by multiple statements from the authorities in the light of the accelerated approval. ICMR chief Balaram Bhargava had justified the clearance for Covaxin, citing immunogenicity and safety data 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 after candidates submitted data from phase 3 trials, as has been pointed out by this newspaper. Indeed, the gold standard is to have long observation periods, across recipient groups—something that the government has followed for a clutch of other vaccine candidates, including Cadilla’s DNA-vaccine against Covid-19.
The government, after examining safety and immunogenicity data from its phase 1 and 2 trials, gave it permission to start phase 3 trial and said 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 talking about Covaxin “having potential to target mutated coronavirus strains” such as the UK strain while recommending grant of permission “for restricted use in emergency situation”.
Bear in mind, 102 cases of the UK strain have been reported in India so far, and it was only last week that the National Institute of Virology was reported to be moving to begin trials of vaccines against the UK strain isolated in India—results on whether the immune response from a particular vaccine is effective against the strain are, thus, still awaited. And, a clinical trial requires enlisting of volunteers, whereas what the government is suggesting in the present instance is that people will be presented with a Hobson’s choice.
With neither the emergency to justify the roll-out of Covaxin—as envisaged by the SEC—nor efficacy established from phase 3 data, the government forcing it on people seems 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 country.
What makes this worse, is that it would have been a wait of just a couple of months before phase 3 data would have started to emerge for the vaccine. Against such a backdrop, the government’s repeated missteps on vaccine strategy—after designing a reasonably good roll-out plan—and its failure to communicate with clarity could cost the fight against Covid-19 big, if it starts to erode people’s trust in vaccines.