Britain’s regulators today approved the Oxford/AstraZeneca Covid-19 vaccine, offering renewed hope the end of the pandemic could just be months away.
Officials said the jab will be made available ‘from next week’, while Health Secretary Matt Hancock claimed the approval now offers ‘high confidence’ the UK could ‘get out of this by spring’.
It comes after Britain yesterday recorded more than 53,000 infections in record daily high amid fears hospitals may be overwhelmed by spiralling admissions within days.
Here, MailOnline answers all the questions about the jab including how it works, when it will be rolled out, and how many Britons could be able to get it every day.
Top experts, including members of SAGE, have warned ministers they need to ramp up weekly vaccination rates seven-fold to 2million by mid-January to prevent the NHS from being overwhelmed this winter. Currently about 280,000 Brits are being inoculated each week
More than 24,000 volunteers were involved in Oxford’s phase three trials in the UK and Brazil, half of which were given the vaccine and the rest were given a fake jab. There were only 30 cases of Covid-19 in people given the vaccine compared to 101 in the placebo group. None of the participants who took the vaccine fell seriously ill
The Oxford vaccine is a genetically engineered common cold virus that used to infect chimpanzees. It has been modified to make it weak so it does not cause illness in people and loaded up with the gene for the coronavirus spike protein, which Covid-19 uses to invade human cells
A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia
Data from Pfizer’s trial showed that rates of coronavirus started to drop around 10 days after people received the first dose of the vaccine (blue line), while they continued to rise among people who had been given a fake jab instead (red line)
What happened to the half-dose, full-dose regimen that was supposed to be more effective?
When Oxford University scientists presented their landmark trial results to the world, the academics suggested the vaccine was more effective when given as a half dose followed by a full one.
Results of the research found two full doses was up to 62 per cent effective against the virus, making it better than most winter flu jabs.
But an analysis of the data also appeared to show that giving volunteers a half dose followed by a full dose was actually 90 per cent effective.
However, questions were immediately asked about how the researchers came to that conclusion.
It was revealed that the 90 per cent efficacy figure was based on a tiny sample size and none of the volunteers were over the age of 55 — the group who is most at risk from the virus.
Britain’s regulators today shelved the half dose regimen, with its chief executive Dr June Raine saying it was not ‘borne out’ in further analysis.
There was no mention of further studies to determine whether it was more effective at preventing infection.
What has been approved?
The UK’s regulator the Medicines and Healthcare products Regulatory Agency (MHRA) has approved the Oxford/AstraZeneca vaccine for over-18s.
It has recommended that two doses be administered, but said there can be an up to 12 week gap between them – sparking hopes that millions could receive their first dose quickly.
They added that two full doses should be given, which trials show are 62 per cent effective against the virus.
There were suggestions a half dose and full dose regimen could get the green light, after trial data suggested it was up to 90 per cent effective against the virus. But the ‘higher efficacy’ was based on a much smaller sample which included no one over 50 – who are most at risk from the virus.
It is thought the MHRA took the view there was insufficient data to approve a half dose and full dose regimen.
How does the AstraZeneca/Oxford vaccine work?
The vaccine – called ChAdOx1 nCoV-19 – uses a harmless, weakened version of a common cold virus to trigger immunity to Covid-19.
Scientists have already used this technology to make vaccines against flu, Zika, Middle East Respiratory Syndrome (MERS) and a number of other diseases.
To make the vaccine, the common cold virus is genetically modified to trigger it to make the Covid-19 spike protein – which the virus uses to invade cells.
When the vaccine is administered the patient’s immune system attacks the spike protein by building antibodies, priming it to fight off Covid-19 before it leads to an infection.
The common cold virus used is also modified to ensure it cannot grow in humans.
When will the vaccine be available?
Doses of the vaccine are already being delivered, with millions more expected to arrive this week.
And the Health Secretary Matt Hancock said the first shots will be administered from the start of January.
First in line are over 80s and those who work in care homes or the NHS, meaning all of these people will need to be vaccinated before the jab can be offered to other priority groups.
How many Britons will be able to get the jab every day?
Ministers aim to get two million Britons vaccinated every week by the middle of January, as they turbo-charge the roll out of the Oxford jab.
AstraZeneca’s chief executive Pascal Soriot has said they will ramp up deliveries ‘very rapidly’ in the first and second weeks of January – and could even start delivering two million every week.
‘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,’ he told BBC Radio 4’s Today programme.
The Joint Committee on Vaccination and Immunisation (JCVI) said today a gap of up to 12 weeks between doses was possible, meaning millions more could receive their first shot of the vaccine.
AstraZeneca said it aimed to supply millions of doses in the first quarter of next year as part of an agreement with the Government. The UK has secured 100million doses – enough to vaccinate 50million people.
Will the vaccine work on the mutant strain of the virus?
Scientists have said the vaccine will work against the mutant Kent strain of coronavirus, which is spreading rapidly and is thought to be at least 50 per cent more infectious.
The strain is now thought to account for up to two thirds of positive tests in the South East and East of England – triggering the decision to plunge most of the South into Tier 4 restrictions.It has also prompted more than 50 countries to impose travel restrictions.
Professor Liam Smeeth, a clinical epidemiologist at the London School of Hygiene and Tropical Medicine, said that there is ‘nothing to suggest the existing vaccines will be any less effective against hte new variant’.
The chief medical and science officers for the UK have also said it is highly unlikely that the mutation will impact on the effectiveness of the vaccine.
A volunteer is administered the coronavirus vaccine developed by AstraZeneca and Oxford University, which has been approved for use today
Does it differ from Pfizer and Moderna’s vaccine?
Yes. The jabs from Pfizer and Moderna use messenger RNA (mRNA) to trigger immunity to Covid-19.
Conventional vaccines are produced using weakened forms of the virus, but mRNAs use only the virus’s genetic code.
An mRNA vaccine is injected into the body where it enters cells and tells them to create antigens.
These antigens are recognised by the immune system and prepare it to fight coronavirus.
No actual virus is needed to create an mRNA vaccine. This means the rate at which the vaccine can be produced is accelerated.
What about antibodies and T-cells?
The Pfizer, AstraZeneca and Moderna vaccines have been shown to provoke both an antibody and T-cell response.
Antibodies are proteins that bind to the body’s foreign invaders and tell the immune system it needs to take action.
T-cells are a type of white blood cell which hunt down infected cells in the body and destroy them.
Nearly all effective vaccines induce both an antibody and a T-cell response.
A study on the AstraZeneca vaccine found that levels of T-cells peaked 14 days after vaccination, while antibody levels peaked after 28 days.
Can this vaccine help the elderly?
There have been concerns that a Covid-19 vaccine will not work as well on elderly people, much like the annual flu jab.
Earlier data from the Oxford University and AstraZeneca vaccine trial suggests that there has been ‘similar’ immune responses among younger and older adults, with Moderna reporting the same.
In a statement earlier this year on its phase two data, Oxford University said its data marked a ‘key milestone’, with the vaccine inducing strong immune responses in all adult groups.
How do we know the vaccines are safe?
Researchers report that their trials have not suggested any significant safety concerns.
The MHRA is considered a leading regulator in its field, and would not approve any vaccine that posed a concern for people’s health and well-being.
What other vaccines has the UK secured access to?
The Government has pre-ordered a total of 100 million doses of Oxford’s vaccine, which is almost enough for most of the population.
It also belatedly struck deals for seven million doses of the Moderna jab from 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:
- 100million doses of the Oxford vaccine
- 60million doses of the Novavax vaccine
- 60million doses of the Valneva jab
- 60million doses of protein adjuvant vaccine from GlaxoSmithKline and Sanofi
- 40million doses of the Pfizer/BioNTech vaccine
- 30million doses of the Janssen vaccine
- 7million doses of Moderna’s jab
How does the Oxford vaccine compare with the Pfizer/BioNTech and Moderna vaccines?
Data published in The Lancet medical journal in early December showed the vaccine was 62 per cent effective in preventing Covid-19 in people given two standard doses of the vaccine and, following a dosing error, 90 per cent in people given a half first dose of the vaccine followed by a full second dose.
The Pfizer/BioNTech and Moderna vaccines have efficacies of 95 per cent and 94.5 per cent respectively.
However, the Pfizer vaccine needs to be stored initially at very low temperatures, and can travel for no more than six hours after it leaves cold storage. It can then be kept in a normal fridge at 2C to 8C (35.6-46.4F) for a maximum of five days.
The Oxford vaccine only needs to be stored at 2C to 8C (35.6-46.4F).
Both jabs require two doses.
Aren’t other countries working on vaccines?
Yes. Russia’s coronavirus vaccine is up to 91.4 per cent effective at stopping people developing Covid-19 symptoms, according to its developers.
Interim phase three results of the Sputnik V vaccine trial were based on data from volunteers who received both the first and second doses of the Sputnik V vaccine or placebo at the third and final control point.
The Russian Direct Investment Fund, said it would create a report to submit for accelerated registration in various countries.
Health Secretary Matt Hancock heralded the approval of the vaccine today
Elsewhere, preliminary studies suggest a Chinese coronavirus vaccine candidate appears to be safe and induces an immune response in healthy volunteers.
Phase one/two trials of an inactivated Sars-CoV-2 vaccine candidate – CoronaVac – involved more than 700 healthy volunteers aged between 18 and 59 recruited in China between April 16 and May 5.
According to preliminary results, the vaccine appeared to be safe and well tolerated at all tested doses.
Phase three trials of the vaccine are continuing.
When might we return to normal life?
While it is not known exactly how long it might take for the population to be vaccinated, Health Secretary Matt Hancock has said it is looking as though things may start returning to normal after Easter.
But until then, and until there is some kind of herd immunity in the population – achieved through vaccination – people will need to continue to wear face masks, socially distance and wash their hands.
Prime Minister Boris Johnson previously said there might be a potential crossover point before Easter when enough vulnerable and elderly people have been vaccinated – which could lead to the implementation of new social distancing measures.
And Mr Hancock said he hopes the approval provides a ‘route out’.
He told Sky News the decision by regulators to recommend that the second dose of the Oxford vaccine can be administered up to 12 weeks after the first would speed up the rollout.
Can the Oxford vaccine be manufactured to scale?
Yes. The UK Government has secured 100 million doses of the Oxford University and AstraZeneca vaccine as part of its contract, enough for most of the population.
The head of the UK Vaccine Taskforce, Kate Bingham, has said she is confident it can be produced at scale and AstraZeneca said it aims to provide millions of doses to the UK in the first quarter of 2021.
Health Secretary Matt Hancock said rollout would begin on January 4.
How has this come about so quickly?
The timetable for developing and approving a Covid vaccine has been condensed due to the coronavirus crisis.
What is the usual process for developing a vaccine?
Traditionally vaccine development takes several years and includes various processes, including design and development stages followed by clinical trials – which in themselves need approval before they even begin.
The trials take place in three sequential stages – also known as phases. The research will show whether a vaccine generates antibodies but also protects people from disease. They will also identify any safety issues.
Once the trials are complete, the information gathered by researchers is sent to regulators for review.
This is thoroughly analysed by clinicians and scientists before being approved for widespread use.
Then, after approval from regulators, people can start to receive the vaccine.
Is this different because of the pandemic?
The process looks slightly different in the trials for a Covid vaccine.
While the early design and development stages look similar, the clinical trial phases have overlapped – instead of taking place sequentially.
But won’t that mean that safety is compromised?
Even though some phases of the clinical trial process have run in parallel rather than one after another, the safety checks have still been the same as they would for any new medicine.
The Medicines and Healthcare products Regulatory Agency (MHRA) has adopted the phrase ‘safety is our watchword’.
Regulators have said they will ‘rigorously assess’ the data and evidence submitted on the vaccine’s safety, quality and effectiveness.
And, in most clinical trials, any safety issues are usually identified in the first two to three months – a period which has already lapsed for most vaccine frontrunners.
How are regulators acting so quickly?
Regulators have been carrying out ‘rolling reviews’, which means that instead of going through reams of information at the conclusion of the trials, they have been given access to the data as the scientists work.
A rolling review of the vaccine data started several months ago.
This means regulators can start to look at scientific data earlier than they traditionally would do, which in turn means the approval process can be sped up.
Regulators sometimes have thousands of pages of information to go over with a fine-tooth comb – which understandably takes time.
Once all the data available on the vaccine is submitted, MHRA experts will carefully and scientifically review the safety, quality and effectiveness data – how it protects people from Covid-19 and the level of protection it provides.
After this has been done, advice is sought from the Government’s independent advisory body, the Commission on Human Medicines (CHM).
What does ‘approved for use’ mean?
For a medicine to be used in the UK it has to be granted a licence. This means that it has been through all the rigorous safety and efficacy checks and regulators are confident in the findings of the clinical trials.
By reviewing the data as they become available, the MHRA can reach its opinion sooner on whether or not the medicine or vaccine should be licensed without compromising the thoroughness of their review.
So what data will the regulator look at?
The information provided to the MHRA will have included what the vaccine contains, how it works in the body, how well it works and its side-effects, and who it is meant to be used for.
This data must include the results of all animal studies and clinical trials in humans, manufacturing and quality controls, consistency in batch production, and testing of the final product specification.
The factories where the vaccines are made are also inspected before a licence can be granted to make sure that the product supplied will be of the same consistent high standard.
What is the difference between the MHRA and the CHM?
The MHRA is the British regulator of medicines and medical devices, ensuring their safety, quality and effectiveness.
The CHM advises ministers on medicinal products. It is made up of an independent group of advisers responsible for advising on the need for, and content of, risk management plans for new medicines.
It also advises officials on the impact of new safety issues on the balance of risks and benefits of licensed medicines.
The CHM also offer advice on ‘applications for both national and European marketing authorisations’.
Haven’t pharmaceutical companies already started making vaccines?
Yes. Usually large-scale production and distribution begins only after regulatory approval. But in the case of Covid-19 vaccines, pharmaceutical firms have begun manufacturing before final approval had been granted – taking on the risk that they may be forced to scrap their work.
According to the Prime Minister, the UK has already vaccinated more than 800,000 people with the first jab to be approved by the MHRA – made by Pfizer/BioNTech.
The people behind the Oxford-AstraZeneca vaccine
Leading the team is Sarah Gilbert, a British vaccinologist who is Professor of Vaccinology at Oxford University
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 is the director of the vaccine group. He is also a Professor of paediatric infection and immunity at the University of Oxford
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 and cheif executive of AstraZeneca
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.’
Others
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.