UK prepares for decision on AZ/Oxford vaccine as COVID cases soar

The UK’s COVID-19 vaccination programme could get a speed boost, with the country’s drugs regulator expected to make a decision on a shot from Oxford University/AstraZeneca in the next few days.

If the vaccine becomes available the UK will be able to step up its vaccination programme as large swathes of the country face draconian “Tier 4” restrictions due to the emergence of as more infectious variant.

Latest figures show that there were nearly 40,000 cases recorded yesterday, the highest since mass testing began, although it’s thought infection rates were higher during the first wave of the virus in spring when tests were not readily available.

The Medicines and Healthcare products Regulatory Agency (MHRA) began a fast-track rolling review of the vaccine in November and reports point towards a decision between Christmas and New Year.

The UK has ordered 100 million doses of the vaccine, which is based on an adenovirus vector and is easy to handle than rivals from Pfizer/BioNTech and Moderna.

AZ’s vaccine, dubbed AZD1222, is stored at normal refrigerator temperatures while the Pfizer/BioNTech and Moderna shots need to be kept at around -70C and -20C respectively to maintain the integrity of their RNA structure.

According to health secretary Matt Hancock, the full dossier of trial evidence is now with the regulator, which is poised to make a decision in the coming days.

AZ’s vaccine is safe and effective, according to the data publicly available so far, although it seems that giving a half-dose shot first following a second full dose is more effective.

Just how this will be viewed by regulators is unclear, as are the plans to distribute the vaccine.

With two full doses, efficacy is around 62%, according to findings released towards the end of last month based on data from nearly 9,000 patients in the UK and Brazil.

Efficacy rose to around 90% in just over 2,700 patients given the low dose-high dose formulation, which was stumbled on by mistake because of a manufacturing error.

Quite what the MHRA will make of this is not clear, nor is it known whether the regulator has more up-to-date figures than those announced at the end of November.

Professor Sir John Bell, the government’s life sciences tsar and Regius Chair of Medicine at the University of Oxford, told BBC Radio 4’s Today programme yesterday:  “We are getting to be about prime time now.

“I would expect some news pretty shortly, I doubt we will make Christmas now but just after Christmas I would expect.

“And I have no concerns whatsoever, the data looks better than ever.”

Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.