Subscribe to our Newsletters !!
Out there, in the fossil beds of Illinois, imposin
An emerging technology is sweeping under the radar
This doesn't feel like another one of my English e
New Delhi, India – April 27, 2025 - An Indian co
Alembic Pharmaceuticals Limited (Alembic) announce
For some time now,
Dear Readers, Welcome to the latest issue of The Magazine
Britain’s drug regulator is auditing manufacturing procedures in Serum Institute of India (SII) which could pave the way for AstraZeneca’s COVID-19 vaccine to be shipped from there to the UK and other countries, according to two sources close to the matter.
SII, the world’s largest vaccine manufacturer, is now mass producing the AstraZeneca vaccine, developed in conjunction with Oxford University, for dozens of poor and middle-income countries but not the UK, which was getting its supply of the shooter primarily from national facilities.
Reuters couldn’t determine what was the rationale for the audit. The MHRA confirmed that an inspection was occurring but declined further comment.
“Due to commercial confidentiality we do not comment on inspections that are still continuing,” the regulator’s chief executive Dr June Raine said in a statement to Reuters.
Both sources, who asked not to be named as the thing is private, said the audit should be somewhat routine for SII, as its website already supplies other vaccines to the UK.
The inspection comes as nations around the world scramble to secure vaccine supplies amid supply disruptions and delivery reductions from leading drugmakers like Pfizer Inc, Moderna and AstraZeneca.
It was not immediately clear whether an MHRA approval would enable the UK or AstraZeneca to route SII volumes of COVISHIELD – the brand name under which SII markets the AstraZeneca shot – to the EU, which has been pressuring the UK for distribution from AstraZeneca’s facilities in the UK, amid shortages in Europe.
The EU’s drug regulator, the European Medicines Agency (EMA), audits sites where it intends to supply medicines but throughout the global pandemic, with multiple COVID-19 vaccines being developed, it is also partly leaning on inspections carried out by some other international regulators.
“Inspection results for Covid-19 vaccines performed by the MHRA will be considered by EMA,” said the regulator. Any such approved sites would also require an EMA sign off before they can export to the EU, the regulator told Reuters.
MHRA declined to comment on specifics, but Raine said it was cooperating”with international partners in response to the outbreak and on topics of mutual interest.”
AstraZeneca, which has tapped SII to help meet some of its vaccine orders from Brazil, South Africa and Saudi Arabia, didn’t respond to a request for comment on whether it requires SII to help meet obligations in the UK, or in any other countries that would recognise an MHRA certification.
The second source, along with a government official in New Delhi, said the UK has expressed an interest in purchasing vaccines from SII. Both sources said the volumes or timelines for any such purchases were unclear.
A UK government spokeswoman said:”Any discussions that have taken place between the UK Government and India on vaccines aren’t related to securing extra vaccine distribution to the UK.”
The UK has so far ordered 100 million doses of AstraZeneca’s vaccine.
“Most nations have approached us and India’s government,” SII told Reuters, but it didn’t comment on any UK outreach. “We are trying our best to fulfill demand, and supply the vaccine to as many nations as possible, maintaining India as the priority.”
SII’s chief executive, Adar Poonawalla, told Reuters in late January, his family-owned firm was eager to encourage AstraZeneca’s supply needs but its main focus was on India and other poorer nations in Asia and Africa.
