COVID-19: Almost 3.5 million UK vaccine doses held up by regulator

The medicines regulator says it is working "as fast as possible" to approve millions of doses of the COVID-19 vaccine that cannot be delivered to the NHS until they have been declared safe to administer.

Almost 3.5 million doses of the Oxford-AstraZeneca vaccine are understood to be awaiting approval by the Medicines and Healthcare Products Regulatory Agency (MHRA).

They are part of an initial consignment of four million vaccine doses delivered by AstraZeneca for use in the UK, only 530,000 of which have been cleared for use following a process known as "batch testing".

Each individual batch of biological medicines, like vaccines, has to undergo independent testing to ensure it is safe, a process that can take up to three weeks.

With demand for vaccines heightened since Prime Minister Boris Johnson set a target of delivering almost 14 million doses in just six weeks, the MHRA is under pressure to complete the testing process as fast as possible.

In a statement the regulator told Sky News it was working in parallel with AstraZeneca's own batch testing process to speed up delivery.

"We are working closely with the manufacturer, AstraZeneca, to ensure that batches of the vaccine are released as quickly as possible," it said.

"Biological medicines such as vaccines are very complex in nature and independent testing, as done by the National Institute of Biological Standards and Control (NIBSC), is vital to ensure quality and safety.

"NIBSC has scaled up its capacity to ensure that multiple batches can be tested simultaneously, and that this can be done as quickly as possible, without compromising quality and safety."

The MHRA process has caused some frustration in a vaccination program that will have to administer 300,000 doses every day for the next six weeks if it is to meet the prime minister's target.

The scale of the challenge was underlined by the current pace of vaccination, which has seen 1.3 million doses of the Pfizer-BioNTech delivered in the UK since 8 December.

That is a rate of around 300,000 a week, a process that will have to become seven times faster if it is to meet Mr Johnson's aim of vaccinating everyone in the four highest-priority groups by Valentine's Day.

Vaccines minister Nahdim Zahawi said there are 13.9 million people in the top four groups, which covers everyone over 70, care home residents and staff, around six million NHS and care workers, and the clinically vulnerable.

The UK has ordered 100 million doses of the AstraZeneca vaccine, and anticipates receiving "tens of millions" more by the end of March. It has also secured a further 40 million of the Pfizer jab, the first to be approved by the MHRA for use in the UK, and has received 22 consignments so far.

Around 700 vaccination centres have been set up across the country, largely comprising GPs and primary care settings as well as hospitals. Around 300 more are expected to be in use by the end of the week.

From next week, Mr Johnson said the NHS will publish daily figures for the number of vaccinations administered so the public can see progress "jab by jab".