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 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, it was “just a matter of time” since the vaccine was approved by the World Health Organization the U.K.’s health care regulator.

Leaving Serum-made Covishield off the so-called ‘Green Pass’ list while including Vaxzevria — European brname 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 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 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 hope to resolve this matter soon, both with regulators 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 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 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.

Dear Reader,

Business Standard has always strived hard to provide up-to-date information commentary on developments that are of interest to you have wider political economic implications for the country the world. Your encouragement constant feedback on how to improve our offering have only made our resolve commitment to these ideals stronger. Even during these difficult times arising out of Covid-19, we continue to remain committed to keeping you informed updated with credible news, authoritative views incisive commentary on topical issues of relevance.

We, however, have a request.

As we battle the economic impact of the pandemic, we need your support even more, so that we can continue to offer you more quality content. Our subscription model has seen an encouraging response from many of you, who have subscribed to our online content. More subscription to our online content can only help us achieve the goals of offering you even better more relevant content. We believe in free, fair credible journalism. Your support through more subscriptions can help us practise the journalism to which we are committed.

Support quality journalism subscribe to Business Standard.

Digital Editor

Source link