Oxford/AstraZeneca Covid vaccine approved by UK regulator

The University of Oxford / AstraZeneca vaccine was approved by the UK drug regulatory agency, highlighting the possibility that vaccination against Covid-19 would rapidly increase within days.

The Medicines and Healthcare Products Regulatory Authority (MHRA) has approved the vaccine for use in the UK. Since it only needs normal refrigeration at 2-8C and is easily transported, the transition to GP practices and nursing homes will be quick.

The first batches of vaccines will already be produced in the UK and more in UK factories, with good supply. The UK has ordered 100 million doses, of which 4 million are expected to be ready in the next few days.

Announcing the approval, the Ministry of Health and Social Care (DHSC) said Wednesday that the vaccine will be available to those at the highest risk of Covid-19.

The government’s joint committee on vaccination and immunization (JCVI) recommended that many people in at-risk groups should be given the first dose of the Oxford or Pfizer vaccine, rather than providing the two required doses quickly. as you can.

“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.”

Evaluation of the Oxford vaccine took longer than it was for the Pfizer / BioNTech vaccine, which the UK approved on December 2 faster than other regulators in the world. The test and trial results file for the Oxford vaccine is more complex.

Pfizer / BioNTech, whose vaccine is based on the new mRNA technology, achieved very positive and understandable results with 95% effectiveness from an international trial involving 43,000 people.

While Oxford / AstraZeneca had 62% efficacy in its largest trial of 11,636 people, a small additional subgroup of 2,741 in the UK showed 90% efficacy, given a half dose of the vaccine followed by a full dose four weeks later. .

The researchers noted in the trials that none of the volunteers who had the vaccine got seriously ill or hospitalized.

AstraZeneca said its vaccine will be offered to some of the poorest areas in the world at a low cost and not 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.”

Vaccine trials are still ongoing to gather more data. AstraZeneca is conducting a major trial in the US, and the US regulator, the Food and Drug Administration, is not expected to approve the vaccine until this is complete. The FDA also requested more data on the protection the vaccine provides to older people and black and ethnic minority groups.

Professor Andrew Pollard, director of the Oxford Vaccine Group and principal investigator of the Oxford study, said: “The editor’s assessment of this as a safe and effective vaccine is a landmark moment and a team of researchers and private trial participants of the great effort of a committed international organization.

“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.” -theguardian-

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