Oxford/AstraZeneca Covid vaccine approved by UK regulator

The Oxford University/AstraZeneca vaccine has been approved by the UK medicines regulator, raising hopes of a rapid scale-up of vaccination against Covid-19 within days, using just a single jab in order to get as many vulnerable people protected as possible.

The approval of the vaccine by the Medicines and Healthcare products Regulatory Authority (MHRA) after weeks of examining trial data was greeted with excitement and relief by experts. The Pfizer/BioNTech vaccine already in use needs storage at -70C and is hard to deploy. Because the Oxford vaccine needs only normal refrigeration at 2-8C and is easily transported from UK factories, it will not have to be kept in central hospital and community hubs, making the rollout to GP practices and care homes swift.

The vaccination programme will start on Monday 4 January and will aim to reach millions of people in at-risk categories as quickly as possible. The emergence of a new variant of the virus causing high rates of infection has made vaccination much more urgent. The ease of use of the Oxford vaccine means that pharmacists will be able to give the jab in high street chemist shops, as they do flu jabs.

The Joint Committee on Vaccination and Immunisation (JCVI) has advised that the priority should be to give as many people in at-risk groups their first dose of either the Oxford or Pfizer vaccine, rather than providing two doses in four weeks in line with the protocol in the trials.

“Everyone will still receive their second dose and this will be within 12 weeks of their first. The second dose completes the course and is important for longer-term protection,” said a spokesperson for the Department of Health and Social Care (DHSC)..

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The decision to approve the vaccine followed “rigorous clinical trials and a thorough analysis of the data by experts at the MHRA, which has concluded that the vaccine has met its strict standards of safety, quality and effectiveness”, the DHSC said.

AstraZeneca said its vaccine would be made available to some of the poorest regions of the world at a low cost and was not being manufactured for profit.

Talking to BBC Radio 4’s Today programme, its chief executive, Pascal Soriot, said AstraZeneca could provide the UK with up to 2m doses a week and would start shipping the first doses “today or tomorrow”.

He said: “Vaccination will start next week and we will get to 1m a week and beyond that a week very rapidly.The good news with this is we are going to be able to inject a lot of people with one dose very quickly, provide them with a reasonably good dose of protection until they get their second dose two to three months later. That will enable us to protect many more people because we can wait two to three months for the second dose.”

The UK has ordered 100m doses of the jab, and eventually all adults will be offered the vaccine, according to Matt Hancock, the UK health secretary.

Speaking to BBC Breakfast, he said: “Because we’ve got enough of this vaccine on order to vaccinate the whole population – we’ve got 100m doses on order – add that to the 30m doses of Pfizer and that’s enough for two doses for the entire population.

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“So I can now say with confidence that we can vaccinate everyone, except of course for children because this vaccine has not been trialled on children, and anyway children are much, much less likely to have symptoms from the disease.”

Boris Johnson celebrated the vaccine’s approval as “truly fantastic news – and a triumph for British science”. He tweeted: “We will now move to vaccinate as many people as quickly as possible.”

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

Pfizer/BioNTech, whose vaccine is based on novel mRNA technology, had clear results, with 95% efficacy from a single 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 half a dose of the vaccine followed by a whole dose four weeks later.

It is understood that people will be given a single standard dose, and not the half-dose that appeared to give better protection in a small sub-set of people in the clinical trials.

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.

Trials of the vaccine are still taking place to gather more data. AstraZeneca is running a large trial in the US and it is thought that the US regulator, the Food and Drug Administration, will not 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 minority ethnic groups.

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Prof Andrew Pollard, the director of the Oxford Vaccine Group and the chief investigator of the Oxford trial, said: “The regulator’s assessment that this is a safe and effective vaccine is a landmark moment, and an endorsement of the huge effort from a devoted international team of researchers and our dedicated trial participants.

“Though this is just the beginning, we will start to get ahead of the pandemic, protect health and economies when the vulnerable are vaccinated everywhere, as many as possible as soon possible.”

The Labour leader, Keir Starmer, tweeted: “We now need a national effort to get vaccinations delivered across the country.”

Jonathan Ashworth, the shadow health secretary, welcomed the news, tweeting: “Now let’s go hell for leather to get jabs rolled out. We’ve seen how more virus circulating means opportunities for variants to emerge. This is now a race against time. We need vaccination ramped up especially for NHS staff urgently.”

Johnson said the UK had already vaccinated more than 800,000 people with the Pfizer/BioNTech jab.


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