The European Union's drug regulator body is auditing the manufacturing site of the Serum Institute of India (SII) before the COVID-19 vaccine manufactured at the site can be exported to the bloc.
SII, who is the world’s largest vaccine manufacturer, is producing the AstraZeneca vaccine that is developed with Oxford University for dozens of poor and middle-income countries.
The reason for the audit of SII’s manufacturing processes and facilities was not clear but a green light would mean the drug could be exported to the European Union.
Local facilities have mainly been supplying to the EU and Britain, but production problems have cut deliveries by the British-Swedish drug maker to the EU, forcing it to look elsewhere.
European Commission and the European Medicines Agency that has overseen the bloc’s supply contract with AstraZeneca declined to comment, specifically on the audit.
An EMA spokesperson said that a drug maker would have to submit an application to the EMA to approve the change.
Pascal Soriot, AstraZeneca chief executive, on Thursday, told the EU lawmakers he hoped to boost shipments to the 27-nation bloc in the second quarter, after the drop in the first three months of the year.