Wednesday, September 22, 2021

Serum Institute of India To Supply ‘Made-in-India’ Vaccines To Europe – Reports

The Made-in-India AstraZeneca vaccines could soon be exported to Europe if things go as planned. Serum Institute of India’s (SII) manufacturing plant in Pune is currently being audited by Europe’s drug regulator.

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News agency Reuters quoted sources as saying that the audit is a necessary step before AstraZeneca’s Covid-19 vaccine can be exported to the European Union (EU) countries. SII being the largest vaccine manufacturer in the world is producing the AstraZeneca vaccine, developed with Oxford University, for poor and middle-income countries.

While the exact reason for the audit cannot be confirmed, the Reuters report claims that “a green light would mean the drug could be exported to the European Union”.

The audit comes a month after the British drug watchdog carried out an inspection at the factory. The work-processes at the SII plant have been scrutinized by the European drug regulator for the past week.

“You have to look at all the steps of production. The process right now is in a phase of virtual contacts and data requests. No need for an in-person visit if the data are convincing,” a source was quoted by Reuters as saying.

The Indian drug regulator had formally approved the emergency use of Oxford/AstraZeneca and Covaxin in January. On Monday, Prime Minister Narendra Modi also took his first dose of the Covid-19 vaccine.

India has begun the second phase of the inoculation drive aimed at 300 million people. The Covid-19 vaccine is being administered free of cost at government hospitals, while it can be purchased for INR 250 ($3.40) at private facilities.

Meanwhile, India has supplied the vaccine to many other countries in South Asia and Africa. Both the EU and Britain were receiving supplies for the vaccine from local facilities but production problems have cut deliveries by the British-Swedish drugmaker to the EU.

The European Medicines Agency (EMA) and the European Commission are overseeing the bloc’s supply contract with AstraZeneca. Both told Reuters that EMA has to approve the manufacturing site and change marketing authorization for the shot to be exported to the bloc.

Since the first three months of the year have seen a drop in deliveries of the vaccine, AstraZeneca chief executive Pascal Soriot told EU lawmakers last week that he hoped to boost shipments to the 27-nation bloc in the second quarter.

The company was expected to deliver to the 27 EU countries about 80 million doses by the end of March but informed the EU of the reduction to 31 million doses in January due to production problems.

Till January, EU countries had administered more than five million doses to citizens, and they aim to inoculate 70% of adults by the end of August.

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