Oxford/AstraZeneca Covid vaccine approved by UK regulator


The Oxford University/AstraZeneca vaccine has been approved by the UK medicines regulator, opening up the possibility of rapidly scaling up vaccination against Covid-19, especially for the thousands of elderly people in care homes, who need it most.

The Medicines and Healthcare products Regulatory Authority (MHRA) has approved the vaccine for use in the UK. Because it needs only normal refrigeration at 2-8C and is easily transported, the rollout to GP practices and care homes will be swift.

The first batches of vaccine are already in the UK and more will be made in UK factories, ensuring a good supply. The UK has ordered 100m doses, of which 4m are expected to be available within the next few days.

Appraisal has taken longer than it did for the Pfizer/BioNTech vaccine, which the UK approved faster than any other regulator in the world on 2 December. The dossier of testing and trial results for the Oxford vaccine is more complicated.

Pfizer/BioNTech, whose vaccine is based on novel mRNA technology, had very positive and straightforward results, with 95% efficacy from an international trial involving 43,000 people.

Oxford/AstraZeneca had 62% efficacy in their largest trial, of 11,636 people, but 90% efficacy in a small additional sub-group in the UK numbering 2,741 who were given a half dose of the vaccine, followed by a whole dose four weeks later.

The researchers have pointed out that none of the volunteers in the trials who had the vaccine became seriously ill or were admitted to hospital.

“It’s really important to note that within 21 days of the first vaccination, nobody was admitted to hospital with Covid or had severe Covid and that’s just after one dose – that’s after any one dose in these trials – no admissions to hospital, and that’s a really major result for public health benefits,” Prof Sarah Gilbert, who led the research at Oxford University, said at the time of publication of their full results.

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The Oxford/AstraZeneca vaccine is vital to hopes of immunising the most vulnerable people all over the world. The researchers and manufacturers have undertaken to do all they can to make it globally accessible, with a low price as well as no need for storage in sub-zero conditions. They have committed to making 3bn doses in 2021.

Trials of the vaccine are still taking place to gather more data. AstraZeneca is running a large trial in the US and it is not thought the US regulator, the Food and Drug Administration, will approve the vaccine until that is complete. The FDA has also sought more data on the protection the vaccine gives to older people and black and ethnic minority groups.



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