Serum Institute expects EU regulatory nod for Covishield in a month

Serum has fallen short on its delivery promise made to a WHO-backed initiative aimed at securing an equitable global roll out of Covid vaccines.

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 few weeks, paving 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 Chief Executive Office Adar Poonawalla said at the India Global Forum 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 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 the same vaccine -- as 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 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.”

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

— Adar Poonawalla (@adarpoonawalla) June 28, 2021

Closely-held Serum was last 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 Keep 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 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.