EU Audits SII, Likely To Buy Its COVID-19 Vaccine

  • 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.

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