Serum Institute expects EU regulatory nod for Covishield in a month


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

The world’s biggest vaccine maker is “fairly self-assured” that the European Medicines Agency will approve the shot in a month, Serum’s Chief Executive Office Adar Poonawalla said at the India Global Forum Wednesday. Serum has applied through AstraZeneca, he said, and it was once “just a matter of time” since the vaccine was once approved by the World Health Association and the U.K.’s health care regulator.

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

“It’s not a controversy at all,” Poonawalla said. “The explanation why it was once flagged is whether we don’t address it now, when India gets off the red list and citizens wish to commute, they will have to not be refused in a provided country just because they have got a Covishield certificate.”

I realise that a large number of Indians who have taken COVISHIELD are facing issues with commute to the E.U., I assure everyone, I have taken this up at the highest levels and hope to unravel this matter soon, both with regulators and at a diplomatic level with countries.

— Adar Poonawalla (@adarpoonawalla) June 28, 2021

Closely-held Serum was once final year named a top supplier of Covid 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, including a ban on exports by India to a factory fire, that hampered its ability to fill orders.

Read more: Biggest Vaccine Maker’s Problems Retain World Short of Covid Shots

The company has been ramping up its vaccine manufacturing capacities and had already gone from producing 50 million doses in January to approximately 90 million in June, according to Poonawalla. The Pune-based firm intends to bring 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 provide an entire region on precedence with the push of a button,” Poonawalla said.

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