EU Assessing Serum Institute of India’s AstraZeneca Vaccine Production

The European Medicines Agency (EMA) is reportedly conducting an audit that could conclude this month of the Serum Institute of India (SII), the largest vaccine manufacturer in the world, as the EU faces delays to AstraZeneca (AZ)/Oxford’s COVID-19 vaccine shipments.

Though it’s not known specifically why the regulator is auditing the company’s manufacturing processes and production sites, the step is reportedly necessary for acquiring supplies of AZ/Oxford vaccine doses made by SII, which could be exported to the EU if everything checks out. The EU’s advance purchase agreement with the drugmaker reportedly allows vaccine doses to be manufactured by other firms if the EMA gives its approval.

In mid-February, SII requested patience from countries and governments awaiting shipments of AZ vaccines, noting that it had been ordered to prioritize vaccine production for India for the time being.

AZ CEO Pascal Soriot said Monday that his company is currently supplying 100 million vaccine doses per month globally and is working to double that figure from April onward. The company is also working to boost vaccine shipments to the EU to meet its second-quarter target, following early production delays that caused a clash between AZ and European officials (DID, Jan. 28).

Currently, the company anticipates meeting its contractual obligations with the European Commission (EC) to deliver 180 million vaccine doses in the second quarter. Around half of the doses will come from its EU supply chain, while the remainder will come from its international supply network (DID, Feb. 26). AZ and the EC previously reached an agreement in August for up to 400 million doses (DID, Aug. 17, 2020).

Soriot said that the company is striving to deliver 40 million doses to the EU in the first quarter, half of the 80 million vaccines previously agreed upon.

“Of course, I’m disappointed that lower than expected output in our dedicated European supply chain has affected our ability to deliver, but I want to assure you that we are ramping up production and doing everything that we can to deliver 40 million doses in the first quarter of 2021, enabling the vaccination of over 10 percent of the EU population,” Soriot said.

SII previously agreed to a licensing deal with AZ to produce 1 billion doses for low- and middle-income nations, including India, and has said it will deliver 240 million doses to the World Health Organization’s COVAX program in the first half of the year. — James Miessler