How much will Indian pharma pay for the ‘virus of vaccine nationalism’ ?
The credibility of Indian regulatory framework and capacity to develop vaccines and vaccinate large populations have received a beating in the wake of the controversy surrounding the approval by DCGI
India’s handling of the coronavirus vaccines made in India has been amateurish, if not unprofessional and unethical. As the world’s largest producer of vaccines India was well placed to come up with an effective vaccine sooner or later. But the political desire to be one-up appears to have led to the hurried approval given to the indigenous ‘Covaxin’ developed by Bharat Biotech. The reluctant approval was also given to ‘Covishield’, a vaccine developed by Oxford University and Astrazeneca and produced in India by the private sector Serum Institute of India. The Drugs Controller General of India’s emergency approval added to the confusion by declaring that the approval was granted “for restricted use in emergency situation, in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains”. The convoluted statement made no sense to people or experts. Poor use of the English language was not the only problem with it. The statement carried far too many caveats and gave the impression that the regulator gave approval under duress. The suspicion that the DCGI had acted under pressure of political bosses was strengthened when both Serum Institute of India and Bharat Biotech engaged in a slanging match over the efficacy of the vaccine produced and the processes followed by the other.
Bharat Biotech founder Krishna Ella claimed that ‘Covishield’ had reported more adverse side effects while Adar Poonawalla of SII made the snide comment that ‘Covaxin’ was as safe as water. Between the DCGI and the two companies, the credibility of India’s regulatory regime and efficacy of the two vaccines took a beating. It is no secret either that Indian Council of Medical Research (ICMR) had tried to arm-twist Bharat Biotech to come up with a vaccine by August 15, the Independence Day. The attempt was abandoned only after a public uproar by experts. The refusal of the DCGI to answer questions, the lack of transparency and absence of data related to trials reinforced this perception. The remaining doubts were removed by politicians, union ministers and TV channels, the latter falsely claiming that India’s indigenous vaccine had been pre-booked by 190 countries.
The virus of ‘vaccine nationalism’ promoted by politicians had earlier been visible in China, Russia and even in the United States. The outgoing US President Donald Trump claimed ‘victory’ for his administration when Pfizer and Moderna developed vaccines in record time. The outgoing President also proceeded to issue an order that no other country would receive the vaccines until all Americans were vaccinated. The order gave the President an alibi to defend the shortage of vaccines for Americans but did not stop the US companies from selling their vaccine to other countries. Both China and Russia had claimed to have developed coronavirus vaccines several months ago.
But by the end of the year both these countries had vaccinated barely one percent of their population. Vaccines developed by the two countries are also struggling to gain international acceptance. Their experience should have alerted the Indian establishment to the perils and pitfalls of promoting untested vaccines and difficulties in vaccinating the population. With doubts raised about the efficacy of Indian vaccines and regulatory laxity, the damage to the Indian pharmaceutical industry could be serious and take a long time to overcome. In this game of one-upmanship, people have sadly been left in the lurch.