Right prescription

Fast-tracking of vaccine approvals is a welcome policy change

The government on Tuesday announced it had accepted a recommendation by the National Expert Group that vaccines approved by health regulators in the European Union, the United States, Japan, and the United Kingdom should be granted emergency-use approval in India. Those approved by the World Health Organization (WHO) would also be eligible. Till now, the authorities had insisted even vaccines that had passed large Phase-III trials elsewhere in the world must conduct additional “bridging” trials in India. This caused major delays. It is also costly, and so pharmaceutical companies that were not expecting to make great margins on their vaccines in India did not attempt to get regulatory authorisation. This was a short-sighted approach, as the need was to get as many vaccines available to the Indian public as possible in order to head off another wave of the pandemic. It may be too late to control the spread of the current wave, which has been brought on by the poor vaccination roll-out over the first three months of this year. But, even so, many lives could be saved if current supply constraints on vaccines are alleviated.

This emergency-use approval opens the door to at least three more vaccines immediately. The Russian-made Sputnik-V vaccine has already been granted emergency-use authorisation. Of the three additional candidates, the Pfizer-BioNTech vaccine, which uses novel messenger RNA technology, had originally submitted an application for approval last year but withdrew it weeks later when it failed to have the requirement for a bridging trial waived. Moderna, which also uses mRNA technology, did not apply. Pfizer may be encouraged to apply again under the new rules, and could be used to fill supply gaps in the metropolitan cities in particular. But because of the special storage requirements for mRNA vaccines, achieving sufficient scale would be difficult. The last current candidate, Johnson & Johnson/Janssen Pharmaceutical’s vaccine, is perhaps the best shot for scale on short notice. J&J has existing tie-ups for manufacturing in India — Biological E has promised 600 million doses a year — and it is also a one-shot vaccine that would make planning the administration easier.

There are several other vaccines in the pipeline elsewhere in the world which now become of interest to India, given this decision. Novavax, which has an agreement for hundreds of millions of shots with the Serum Institute of India, may be approved in Britain in a few weeks, making it eligible in India as well. The German company CureVac, which is working with Elon Musk’s Tesla on a “vaccine printer”, has said that its vaccine might be approved by the European Union in May. None of the national regulators is close to approving any of the Chinese vaccines, though WHO is expected to announce its decision on the SinoVac candidate and one Sinopharm candidate at the end of this month. Finally, there’s India’s own Zydus Cadila, whose ZyCov-D vaccine is in Phase-III trials that the company assumes will be completed in June. Having eased these onerous requirements, the government’s next step must be to ensure that India’s spare vaccine capacity — it could be producing enough two-shot vaccines a year to inoculate half the world — is pressed into service. Public distribution must be augmented by the private sector, especially for expensive vaccines like Pfizer’s. There is still time to repair the vaccination programme’s roll-out.