Updated: July 1, 2021 7:50:44 am
The national drug regulator’s Emergency Use Approval to Moderna for its Covid vaccine is a significant development. The two sides are not on the same page on the indemnity clause and there is no clarity on the number of shots to be imported by Moderna’s India partner, Cipla. Nevertheless, the Drugs Controller General’s waiver of bridge trials, required of foreign vaccine manufacturers, meets one of Moderna’s major demands and opens the possibility of reinforcing the country’s vaccine basket in the near future — according to the government’s affidavit in the Supreme Court last week, negotiations with the company “are at an advanced stage”. The country’s negotiators must now work towards removing the other stumbling blocks in the introduction of the mRNA technology-based vaccine without compromising on safety yardsticks.
An average of nearly 60 lakh jabs administered in the past 10 days indicates that India’s vaccination drive has picked up momentum. This, unfortunately, is still far short of the pace required to attain the Centre’s target of inoculating the country’s entire adult population by the end of the year. The government’s affidavit to the apex court notes that the vaccination drive will acquire further speed after August with the projected acquisition of 135 crore shots. Indigenous manufacturers, Serum Institute of India and Bharat Biotech, will continue to be the mainstay of the endeavour with the latter’s share estimated to go up three times. Both companies will need to ramp up production, introducing an element of uncertainty that the country can ill afford at a critical stage of its vaccination drive. Fallback options such as supplies from Moderna would place the project on a more assured footing. That’s why the outcome of negotiations with the company and other pharma giants such as Pfizer and Johnson & Johnson — as well as Indian companies such as Biological E and Zydus Cadila — will be crucial to the country’s battle against the pandemic.
The imperative of investing in multiple vaccine candidates was evident in the early stages of the pandemic. With epidemiologists now apprehending that the virus will still be around in 2022 — even in countries that have completed their primary inoculation drive — the drive to diversify vaccine baskets and develop boosters tailored to new strains has acquired urgency. Moderna, for instance, has begun work on vaccines that tweak the antigen — the molecule used by the immune system to target a pathogen — to target SARS-CoV-2 variants. Policymakers and regulators — as well as other vaccine manufacturers — should be tuned in to such developments and be ready to look for reinforcements beyond borders.
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