Covid-19 vaccine from Oxford University and AstraZeneca approved in UK - and mass rollout to begin

The Covid-19 vaccine from Oxford University and AstraZeneca has been approved for use in the UK - and could prove a game changer in the fight against the virus.

Mass rollout of the vaccine will begin on January 4 after it was announced today (Wednesday) that it has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) for the immunisation of those aged 18 and over.

Two vaccinations will be given to recipients, with an interval of four to 12 weeks in between.

Vulnerable people and care home residents will be the first to get the jabs, before it is rolled out to other adults.

AstraZeneca chief executive Pascal Soriot told Radio 4’s Today programme: “We will start delivering this week – maybe today or tomorrow we will be shipping our first doses.

“The vaccination will start next week and we will get to one million a week and beyond that very rapidly.

“We can go to two million. In January we will already possibly be vaccinating several million people and by the end of the first quarter we are going to be in the tens of millions already.”

Asked whether two million vaccinations per week is possible, Mr Hancock told Times Radio: “That’s absolutely deliverable by the NHS.”

The UK has ordered 100 million doses of the vaccine – enough to vaccinate 50 million people.

This is in addition to the 10 million doses of the Pfizer/BioNTech vaccine which is already being administered following its approval on December 2, meaning the UK has enough to vaccinate its entire adult population.

Unlike the Pfizer/BioNTech jab, which needs cold storage of around minus 70C, the Oxford/AstraZeneca vaccine can be stored in a standard fridge, meaning it is much easier to roll out to places such as care homes and GP surgeries, which is why it has been described by some as a “game changer”.

Its approval comes the day after the UK recorded 53,135 new cases - the highest number in a single day since mass testing began. There were 414 further deaths recorded within 28 days of a positive test.

With a new, more easily transmissible variant of the virus spreading rapidly, there are now more people in hospital with Covid-19 than in the first wave of the pandemic.

Both vaccines are expected to be as effective against variants of the virus.

Announcing the new approval, Mr Hancock said: “This is a moment to celebrate British innovation - not only are we responsible for discovering the first treatment to reduce mortality for Covid-19, this vaccine will be made available to some of the poorest regions of the world at a low cost, helping protect countless people from this awful disease.

“It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world. I want to thank every single person who has been part of this British success story. While it is a time to be hopeful, it is so vital everyone continues to play their part to drive down infections.”

And 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.”

Mr Hancock is due to announce any changes to tier areas in a statement to the Commons on Wednesday.

And he warned “We are going to have to take further action.”

The Joint Committee on Vaccination and Immunisation (JCVI), which advises ministers, will publish its latest guidance on who should receive the vaccine and in which order later.

England’s chief medical officer, Professor Chris Whitty, said the jab is “safe and effective”.

Data published in The Lancet medical journal in early December showed the vaccine was 62 per cent effective in preventing Covid-19 among a group of 4,440 people given two standard doses of the vaccine when compared with 4,455 people given a placebo drug.

Trials involving 1,367 people aged 55 and under who were given a half first dose of the vaccine followed by a full second dose, there was 90 per cent protection against Covid-19 when compared with a control group of 1,374 people. The initial half dose was an accident, but the MHRA was made aware of what happened and clinical trials for the vaccine were allowed to continue.

However, the regulator has authorised two full doses of the vaccine to be given to people as there was not enough clear data to approve the half-dose, full-dose regimen.

The pooled analysis from the trials suggests the vaccine was 70.4 per cent effective.

In the vaccine trial, 10 people given the placebo dummy drug were admitted to hospital with coronavirus, including two with severe Covid which resulted in one death.

But among those receiving the vaccine, there were no hospital admissions or severe cases.

Unpublished data has suggested that a longer gap between the first and second doses increases the overall effectiveness of the jab.

The aim is to administer the first dose of a Covid-19 vaccine to as many as possible, as quickly as possible.

Mr Hancock said: “This is important because it means that we can get the first dose into more people more quickly and they can get the protection the first dose gives you.

“The scientists and the regulators have looked at the data and found that you get what they call ‘very effective protection’ from the first dose.

“The second dose is still important – especially for the long-term protection – but it does mean that we will be able to vaccinate more people more quickly than we previously could.”

Professor Andrew Pollard, director of the Oxford Vaccine Group, who led the clinical trial, said this was “a landmark moment” and the focus now would be “getting them into people’s arms” and “stopping the virus from causing severe disease and hospitalisation, which we know that all of the vaccines can do very efficiently”.

He added: “There’s good protection with the first dose, up until the time of the second dose.

“And then the second dose is really important because we think that will be critical for the durability of the immune response that continues after that and hopefully will help us prevent further waves of disease once we have a large segment of the population vaccinated.”

Mr Soriot added: “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. We would like to thank our many colleagues at AstraZeneca, Oxford University, the UK government and the tens of thousands of clinical trial participants.”

Prime Minister Boris Johnson tweeted: “It is truly fantastic news – and a triumph for British science – that the @UniofOxford/@AstraZeneca vaccine has been approved for use.

“We will now move to vaccinate as many people as quickly as possible.”

AstraZeneca is building its new R&D centre on Cambridge Biomedical Campus, which is due to open in 2021.

It is working with global partners to building manufacturing capacity of the new vaccine of up to three billion doses globally in 2021 on a rolling basis, pending regulatory approvals elsewhere.

The company says the vaccine can be stored, transported and handled at normal refrigerated conditions - of 2-8 degrees Celsius/36-46 degrees Fahrenheit) - for at least six months.

Co-invented by the University of Oxford and its spin-out company, Vaccitech, the vaccine - originally known as ChAdOx1 nCoV-19 - is made from a weakened version of a common cold virus, or adenovirus, that has been genetically changed so that it is safe and impossible for it to grow in humans. It contains the genetic material of the SARS-CoV-2 virus spike protein. After vaccination, the surface spike protein is produced, priming the immune system to attack the SARS-CoV-2 virus if it later infects the body.

Prof Sarah Gilbert, professor of vaccinology at the University of Oxford, said: “This is a day for the team developing the vaccine to celebrate, after a year of extremely hard work under difficult circumstances. Now that the first authorisation or use of the vaccine outside of clinical trials has been granted, we still have more to do and will continue to provide more data to multiple regulatory authorities, until we are able to see the vaccine being used to save lives around the world.

Professor Adrian Hill, director of the Jenner Institute, said: “For the past 25 years, staff at the Jenner Institute have worked to develop vaccines using novel technologies to protect people around the world from diseases that claim many lives each year. The work on ChAdOx1 nCoV-19 builds on many years of research by a dedicated team of vaccinologists, and we are delighted to see the first emergency use licensure.”

How safe is the Oxford University / AstraZeneca vaccine?

Safety data published so far involves more than 20,000 participants enrolled across four clinical trials in the UK and Brazil and South Africa.

The study published in The Lancet publication showed the vaccine - now known as AZD1222 - was well tolerated and that there were no serious safety events confirmed related to it.

Those involved in the trials were diverse racial and geographic groups who are healthy or have stable underlying medical conditions.

As well as the programme led by Oxford University, AstraZeneca is also conducting a large trial in the US and globally. Overall, Oxford University and AstraZeneca expect to enrol up to 60,000 participants globally.