Oxford/AstraZeneca Covid-19 vaccine approved in UK for mass rollout
A Covid-19 vaccine from Oxford University and AstraZeneca has been approved for use in the UK, paving the way for mass rollout.
The jab, which has been described as a “game changer”, was given the green light by the Medicines and Healthcare products Regulatory Agency (MHRA).
Health Secretary Matt Hancock said the approval was “fantastic news” and confirmed the rollout would begin on January 4.
“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,” he said.
“It is a tribute to the incredible UK scientists at Oxford University and AstraZeneca whose breakthrough will help to save lives around the world.”
It comes amid increasing strain on hospitals in England, where the number of Covid-19 patients is at its highest ever level during the pandemic.
Mr Hancock is due to announce any changes to tier areas in a statement to the Commons on Wednesday.
With case rates rising in all regions of England, and record patient numbers, any changes are likely to involve areas moving up a tier rather than down.
The UK has ordered 100 million doses of the Oxford University vaccine – enough to vaccinate 50 million people.
A Department of Health and Social Care spokesman said: “The Government has today accepted the recommendation from the Medicines and Healthcare products Regulatory Agency (MHRA) to authorise Oxford University/AstraZeneca’s Covid-19 vaccine for use.
“This follows 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 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.
Data published in The Lancet medical journal in early December showed the vaccine was 62% 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.
Of 1,367 people given a half first dose of the vaccine followed by a full second dose, there was 90% protection against Covid-19 when compared with a control group of 1,374 people.
The overall Lancet data, which was peer-reviewed, set out full results from clinical trials of more than 20,000 people.
Among the people given the placebo drug, 10 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.
People receiving the Oxford vaccine or the one from Pfizer/BioNTech, which is also being rolled out, will now receive their first dose of the vaccine followed by a second dose up to 12 weeks later.
The aim is to give as many people as possible a first dose of a Covid-19 vaccine.
The Department of Health spokesman said: “Having studied evidence on both the Pfizer/BioNTech and Oxford University/AstraZeneca vaccines, the JCVI has advised the priority should be to give as many people in at-risk groups their first dose, 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.
“From today the NHS across the UK will prioritise giving the first dose of the vaccine to those in the most high-risk groups.
“With two vaccines now approved, we will be able to vaccinate a greater number of people who are at highest risk, protecting them from the disease and reducing mortality and hospitalisation.”
Pascal Soriot, chief executive of AstraZeneca, 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.”
Professor Andrew Pollard, director of the Oxford Vaccine Group who led the clinical 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.”
During the Oxford vaccine trial, the half-dose followed by a full-dose regime came about as a result of an accident.
However, the MHRA was made aware of what happened and clinical trials for the vaccine were allowed to continue.
In an interview with the Sunday Times, Mr Soriot suggested that further data submitted to the regulator showed the vaccine could match the 95% efficacy achieved by the Pfizer/BioNTech and Moderna vaccines.
“We think we have figured out the winning formula and how to get efficacy that, after two doses, is up there with everybody else,” he said.
Who will get it, when and how?
The Covid-19 vaccine developed by the University of Oxford and AstraZeneca has been approved for use in the UK.
With the Pfizer/BioNTech jab already being administered to the most vulnerable, what does this new development mean?
– What’s in the pipeline for the UK?
The Government has secured 100 million doses of the Oxford vaccine.
The initial doses of the Oxford jab are due to be dispatched from Germany, with a large proportion then manufactured in the UK.
Like the Pfizer/BioNTech vaccine, people will need two doses.
There will be four million doses available post authorisation and tens of millions of doses in the first quarter of next year.
A specific schedule is difficult to establish as batches need to be quality approved by the Medicines and Healthcare products Regulatory Agency (MHRA).
– How will a vaccine be rolled out?
There is considerably less uncertainty over the rollout of the Oxford vaccine, with the scene having largely been set earlier in December with the Pfizer/BioNtech jab.
The Oxford vaccine can be stored at fridge temperature for at least six months so it is hoped the logistics of administering it will be easier.
Health Secretary Matt Hancock said the approval was “fantastic news” and confirmed that the roll out would begin on January 4.
AstraZeneca said was building up a manufacturing capacity of up to 3 billion doses worldwide next year, and aims to supply the UK with millions of doses in the first quarter in 2021.
– Now there are more vaccines, does this mean a wider range of people can be vaccinated?
All of the people at the top of the priority list created by the Joint Committee on Vaccination and Immunisation (JCVI) have not yet been vaccinated.
Therefore vaccinators will continue to work their way through the list.
It is hoped more people in care homes will be reached with the rollout of the Oxford AstraZeneca vaccine.
The JCVI’s guidance says the order of priority should be:
1. Older adults in a care home and care home workers
2. All those who are 80 years of age and over and health and social care workers
3. All those who are 75 years of age and over
4. All those who are 70 years of age and over and clinically extremely vulnerable individuals, excluding pregnant women and those under 18 years of age
5. All those who are 65 years of age and over
6. Individuals aged 16 to 64 years with underlying health conditions
7. All those aged 60 and over
8. All those aged 55 and over
9. All those aged 50 and over
– Don’t vaccines take a long time to produce?
In the past it has taken years, sometimes decades, to produce a vaccine.
Traditionally, vaccine development includes various processes, including design and development stages followed by clinical trials – which in themselves need approval before they even begin.
But in the trials for a Covid-19 vaccine, things look slightly different. A process which usually takes years has been condensed to months.
While the early design and development stages look similar, the clinical trial phases overlap, instead of taking place sequentially.
And pharmaceutical firms have begun manufacturing before final approval has been granted – taking on the risk that they may be forced to scrap their work.
The new way of working means that regulators around the world can start to look at scientific data earlier than they traditionally would do.
Is the Oxford vaccine being manufactured in the UK?
While there are some doses coming from Europe in the very first instance, the majority will be provided from the UK supply chain.
– Aren’t there other vaccines?
Yes. As well as the Pfizer vaccine which has an efficacy of 95%, a number of other jabs the UK has secured doses of.
Oxford data indicates the vaccine has 62.1% efficacy when one full dose is given followed by another full dose, but when people were given a half dose followed by a full dose at least a month later, its efficacy rose to 90%.
The combined analysis from both dosing regimes resulted in an average efficacy of 70.4%.
Final results from the trials of Moderna’s vaccine suggest it has 94.1% efficacy, and 100% efficacy against severe Covid-19.
– Which jab is best?
The early contenders all have high efficacy rates, but researchers say it is difficult to make direct comparisons because it is not yet known exactly what everyone is measuring in the trials.
– How many doses has the UK secured?
The UK has secured access to 100 million doses of the AstraZeneca/Oxford University vaccine, which is almost enough for most of the population.
It also belatedly struck a deal for seven million doses of the jab on offer from Moderna in the US.
The deals cover four different classes: adenoviral vaccines, mRNA vaccines, inactivated whole virus vaccines and protein adjuvant vaccines.
The UK has secured access to:
– 100 million doses of the Oxford vaccine
– 60 million doses of the Novavax vaccine
– Some 30 million doses from Janssen
– 40 million doses of the Pfizer/BioNTech vaccine – the first agreement the firms signed with any government
– 60 million doses of a vaccine being developed by Valneva
– 60 million doses of protein adjuvant vaccine from GlaxoSmithKline (GSK) and Sanofi Pasteur
– Seven million doses of the jab on offer from Moderna in the US.
– What do they cost?
Pfizer/BioNTech is making its vaccine available not-for-profit.
According to reports, the Moderna vaccine could cost about 38 dollars (£28) per dose and the Pfizer candidate could cost around 20 dollars (£15).
Researchers suggest the Oxford vaccine could be relatively cheap to produce, with some reports indicating it could be about £3 per dose.
AstraZeneca said it will not sell it for a profit, so it can be available to all countries.
However, the details of the deals made by the UK Government have not been made public.
– How do we know the vaccines are safe?
Researchers reported their trials do not suggest any significant safety concerns.
– Will people get a choice about which vaccine they are given?
As things stand the vaccines will be rolled out as and when they become available.
No announcement has been made on whether one might be given priority over another as they become ready on a mass scale.
People are not expected to be able to choose which jab they want to receive.
The people behind the Oxford-AstraZeneca vaccine
Who are some of the people behind the Oxford-AstraZeneca coronavirus vaccine?
– Sarah Gilbert
A professor of vaccinology at the university, Sarah Gilbert was the lead researcher of the trial.
She began her work at the university looking at genetics and host-parasite interactions in malaria, before starting on vaccine development, which has included work on the flu vaccine.
She first read on New Year’s Day in 2020 about a new virus emerging in China, and spent much of the rest of the year working with her team to create a vaccine.
The mother of grown-up triplets said she knew she could work without much rest and endured some sleepless nights along the way this year.
But she said she never doubted what she and her team of researchers were doing – just that at times she worried about things they might have missed along the way.
She told BBC Radio 4’s Today programme: “At the start of the year I did have sleepless nights, wondering what it was that we haven’t thought about – what problem was going to trip us up, because nobody had realised that we needed to do it, but, actually, that never happened. Somebody had always thought of everything.”
Throughout the development process she was always positive, telling the Duke of Cambridge when he visited the Oxford Vaccine Group’s facility back in June that she was hopeful they would “see something”.
“The only question is how good it is and how long it will last,” she added.
Describing the team’s work on creating a vaccine, she told Today the final parts of the jab were designed in a weekend, given that they had a good basis in employing methods they had used previously.
After all their hard work – with the hopes of a nation and beyond on their shoulders – she said the team was “very happy” with the vaccine’s performance and told how they were all “really looking forward” to approval and rollout.
– Andrew Pollard
The director of the Oxford vaccine group, Andrew Pollard is a professor of paediatric infection and immunity.After the vaccine’s results from clinical trials were announced in November, Prof Pollard said it was “a very exciting day” and hailed it as a “vaccine for the world”.
He said: “I think this is an incredibly exciting moment for human health.”
He also chairs the Joint Committee on Vaccination and Immunisation (JCVI), which advises UK health departments on immunisation.
He has published more than 500 manuscripts and books on various topics in paediatrics and infectious diseases, according to the Oxford website.
– Pascal Soriot
A doctor of veterinary medicine, Pascal Soriot is executive director and chief executive officer of AstraZeneca.
He was previously chief operating officer of Roche’s pharmaceuticals division and chief executive officer of a biologics business, Genentech.
The Frenchman has a passion for science and medicine, according to his current organisation’s website.
It was announced in April that Oxford had partnered with AstraZeneca for the development, manufacture and large-scale distribution of the university’s vaccine candidate that is currently being trialled in the UK.
Back then, as countries were dealing with their first wave of coronavirus, Mr Soriot acknowledged that it was a risk to “launch into development” of the vaccine, but added: “now is the time to take those risks – this is a terrible crisis we’re facing, and we need solutions”.
He said the partnership would combine the university’s “world-class expertise in vaccinology” with the pharmaceutical company’s “global development, manufacturing and distribution capabilities”.
Both partners agreed to operate on a not-for-profit basis for the length of the outbreak.
Following November’s trial results, Mr Soriot said: “The vaccine’s simple supply chain and our no-profit pledge and commitment to broad, equitable and timely access means it will be affordable and globally available supplying hundreds of millions of doses on approval.”
When the findings of their vaccine trials were announced, some of the scientists involved were celebrated in the form of gifs.
The series of animated images on Twitter featured Federica Cappuccini and Sean Elias, both members of the Edward Jenner Institute for Vaccine Research at Oxford.
Research assistant Ekta Mukhopadhyay was also seen offering two thumbs-up in a gif response to the positive trial news.
Published: by Radio NewsHub