EU gives nod to India’s Covishield vaccine

Mumbai — The Serum Institute of India expects European drug regulators will approve Covishield — the Covid-19 shot it manufactures in partnership with AstraZeneca — in a few weeks, paving the way for it to be added to the region’s “Green Pass” list.

The world’s biggest vaccine maker is “quite confident” that the European Medicines Agency will approve the shot in a month, Serum’s CEO Adar Poonawalla said at the India Global Forum on Wednesday. Serum has applied through AstraZeneca, he said, and it was “just a matter of time”, since the vaccine was approved by the World Health Organization (WHO) and the UK’s health-care regulator.

Leaving Serum-made Covishield off the so-called “Green Pass” list while including Vaxzevria — the European brand name for the same vaccine — as part of the EU’s vaccine passport initiative triggered a furore in India because it risked barring entry for Indian travellers despite receiving their shots. Nations are racing to inoculate their populations, fully reopen their economies and ward off newer virus variants.

“It’s not a controversy at all,” Poonawalla said. “The reason why it was flagged is if we don’t address it now, when India gets off the red list and citizens want to travel, they should not be refused in a given country just because they have a Covishield certificate.”

India has so far administered 336-million Covid-19 doses, according to the latest health ministry data. Only 4.3% of the country’s population has been fully inoculated against the virus, Bloomberg’s Vaccine Tracker shows.

Closely held Serum was in 2020 named a top supplier of Covid-19 shots to Covax, the WHO-backed initiative aimed at securing an equitable global roll out. But the company has fallen short on its delivery promise, dogged by setbacks that hampered its ability to fill orders.

The company has been ramping up its vaccine manufacturing capacities and had already gone from producing 50-million doses in January to about 90-million in June, according to Poonawalla. The Pune-based firm intends to raise it by another 10% in August.

To prepare better for future pandemics, Poonawalla suggested setting up “four or five” vaccine manufacturing hubs in different countries to quickly meet any surge in demand. Long-term contracts — 10 to 15 year pacts — between countries and vaccine makers will also help governments quickly access shots, he said.

Such long-term vaccine pacts “could supply an entire region on priority with the push of a button”, Poonawalla said.

Bloomberg. More stories like this are available on bloomberg.com