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UK auditing Indian vaccine web site amid scramble for shots-sources By Reuters

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© Reuters. FILE PHOTO: Health officials prepare AstraZeneca’s COVID-19 vaccines manufactured by the Serum Institute of India at Army Hospital in Colombo

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By Neha Arora, Krishna N. Das, and Euan Rocha

NEW DELHI (Reuters) – The UK Medicines Agency is currently reviewing manufacturing processes at the Serum Institute of India (SII) paving the way for AstraZeneca’s (NASDAQ 🙂 COVID-19 vaccine to be shipped from there to the UK and other countries could. according to two sources close to the matter.

SII, the world’s largest vaccine maker, is currently mass-producing the AstraZeneca vaccine, which has been developed in partnership with Oxford University for dozens of low- and middle-income countries, but not for the UK, which gets the shot mostly from domestic facilities.

If the UK Medicines and Health Products Regulator (MHRA) gives the green light to the SII manufacturing process for Oxford / AstraZeneca, the drug could be exported to the UK and other countries that recognize MHRA’s approvals, one of the sources said.

Reuters was unable to determine the reasons for the audit. SII did not respond to a request for comment. The MHRA confirmed that an inspection had taken place but declined to comment.

“Due to the trade secret, we do not comment on ongoing inspections,” said the managing director of the regulatory authority, Dr. June Raine, in a statement to Reuters.

The two sources, who asked not to be named as the matter is private, said testing for SII should be relatively routine as the site is already supplying other vaccines to the UK.

The inspection comes as countries around the world strive to improve vaccine supplies in the face of supply disruptions and cutbacks from leading drug manufacturers such as: Pfizer Inc (NYSE :), Modern (NASDAQ 🙂 and AstraZeneca.

It was not immediately clear whether MHRA approval would allow the UK or AstraZeneca to transfer SII volumes from COVISHIELD – the brand name under which SII markets the AstraZeneca shot – to the EU, which the UK has been pressuring to from AstraZeneca’s facilities in the US to deliver to the UK, amid shortages in Europe.

AstraZeneca executives told EU officials last week that they could supply some cans made outside of Europe to expedite supplies to the block, two EU sources told Reuters. One said the SII could be a supplier.

AstraZeneca, which previously tapped SII to fulfill some of its vaccine orders from Brazil, South Africa and Saudi Arabia, didn’t respond to a request for comment on whether SII is needed to meet obligations in the UK or other countries that would make an MHRA- Recognize certification.

It was not immediately available to comment on the reported offer to provide the EU with recordings of the SII.

INSPECTIONS

The EU medicines regulator, the European Medicines Agency (EMA), reviews locations where it wants to source medicines. However, during the global pandemic where several COVID-19 vaccines are being developed, it also relies in part on inspections carried out by several other international regulators.

“The inspection results for Covid-19 vaccines carried out by the MHRA are taken into account by the EMA,” said the supervisory authority. Such approved locations would also need to be approved by the EMA before they can be exported to the EU, the regulator told Reuters.

MHRA declined to comment on the details, but Raine said it is cooperating “with international partners in response to the global pandemic and on matters of mutual concern”.

The UK, along with a government official in New Delhi, has expressed an interest in purchasing vaccines from SII, according to the second source. The two sources said the quantities or deadlines for such purchases were unclear.

A UK government spokeswoman said: “All talks between the UK government and India about vaccines have nothing to do with ensuring an additional supply of vaccines for the UK.”

The UK has so far ordered 100 million doses of the vaccine from AstraZeneca.

“Most countries have turned to us and the Indian government,” SII told Reuters, but did not comment on coverage in the UK. “We are trying our best to meet the demand and get the vaccine to as many countries as possible, with India as a priority.”

SII chief executive Adar Poonawalla told Reuters in late January that his family business is keen to meet AstraZeneca’s utility needs, but its primary focus is on India and other poorer countries in Asia and Africa. He said at the time SII has no plans to reroute supplies to Europe.

(Neha Arora and Krishna N. This reported from New Delhi and Euan Rocha from Mumbai; additional reporting by Paul Sandle, Kate Kelland and Alistair Smout in London, Francesco Guarascio in Brussels and Ludwig Burger in Frankfurt; editing by Carmel Crimmins)

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