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 within days.

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.

Announcing the approval, the Department of Health and Social Care (DHSC) said on Wednesday the vaccine would be available for those at the highest risk of Covid-19.

The government’s joint committee on vaccination and immunisation (JCVI) has advised that 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 the required two doses in as short a time as possible.

“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 DHSC spokesperson.

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.

The UK health secretary, Matt Hancock, has said the approval signals a “route out” of the coronavirus pandemic.

He told Sky News: “I am now, with this approval this morning, highly confident that we can get enough vulnerable people vaccinated by the spring that we can now see the route out of this pandemic.

“It is going to be a difficult few weeks ahead. We can see the pressures right now on the NHS and it is absolutely critical that people follow the rules and do everything they can to stop the spread, particularly of the new variant of this virus that transmits so much faster.

“But we also know that there is a route out of this. The vaccine provides that route out. We have all just got to hold our nerve over the weeks to come.”

Appraisal of the Oxford vaccine 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.

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

Its chief executive, Pascal Soriot, said: “Today is an important day for millions of people in the UK who will get access to this new vaccine. It has been shown to be effective, well-tolerated, simple to administer and is supplied by AstraZeneca at no profit.”

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.

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.”

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.”

SOURCE

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