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Covovax needs quick regulatory okay. And there should be official clarity on other vaccines, like J&J’s

In 150 days of vaccination in India, around 259 million doses have been administered, which is roughly 12% of the 2.1 billion doses that have been administered globally. This looks good in absolute terms. But it’s dispiriting when you consider that the biggest demography, 590 million Indians in the 18-44 age group, has received just 44.2 million doses.

So, as everyone and their unvaccinated uncle know, we need guaranteed vaccine supplies beyond Covishield and Covaxin. And here America’s quick pace of vaccination – 54.4% adults fully vaccinated – means good news for India. Comforted by quick coverage, America’s drug regulator is reluctant to offer an Emergency Use Authorisation (EUA) for new vaccines. An American vaccine that may have missed the EUA bus is the one developed by Novavax, which this week announced that its phase-3 clinical trial conducted across the US and Mexico has achieved 90.4% efficacy overall.

Novavax has a technology transfer and manufacturing agreement with Serum Institute to make 1.1 billion doses for the Covax facility. This vaccine is based on the protein subunit platform, the most popular technology platform among vaccines under clinical development. Its storage conditions are ideal for India’s supply chain. The challenge ahead is for Serum, which has initiated phase-3 clinical trials on this vaccine, calling it Covovax, to meet the Indian regulator’s requirements.  Serum must process data fast and submit it to the regulator. And if safety and efficacy tests pass muster, the regulator must grant EUA with the same dispatch it showed for India’s two other vaccines.

Serum has been working with Novavax since 2020 on developing its manufacturing capacity for this vaccine. If it clears the regulatory threshold here quickly, it will be possible to bring doses into the market at a fast pace, unlike some other vaccines under development. If, as reported, 200 million shots are available in September-December, Covovax will make an appreciable difference in vaccination coverage.

We should have also got a clear picture by now of what’s happening to J&J’s single dose vaccine. The company approached DGCI for regulatory clearance a couple of months ago. There seems to be no official word on it as yet. It’s the only single-dose vaccine that’s been approved by FDA, WHO and the European Medicines Agency. It has a shelf life of two years. All of this suits India. Regulatory uncertainty is not something the country can afford right now.



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This piece appeared as an editorial opinion in the print edition of The Times of India.



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