WHAT ARE THE KNOWN SIDE EFFECTS FROM THE PFIZER VACCINE?
The UK medicines regulator advised today that anyone who has a history of ‘significant’ allergic reactions to medicines, food or vaccines should not get the Pfizer coronavirus jab.
Dr June Raine, the chief executive of the MHRA, told Parliament’s Science and Technology Committee that this was not identified in the trials.
‘We know from very extensive clinical trials that this wasn’t a feature,’ she said.
Studies identified 12 possible side-effects from the vaccine, with seven identified as ‘very common’ meaning they are likely to affect more than one in ten people. Below are the known side effects.
Very common (Likely to affect more than one in ten people)
- Pain at injection site
- Muscle pain
- Joint pain
Common (Likely to affect up to one in ten people)
- Injection site swelling
- Redness at injection site
Uncommon (May affect one in 100 people)
- Enlarged lymph nodes
- Feeling unwell
The UK’s world-first vaccine rollout has hit problems within 24 hours after anyone with a serious allergy was warned not to have the Pfizer jab because two NHS staff fell ill because they suffered a bad reaction on V-Day.
Both the unnamed healthcare workers, who carried EpiPens due to their medical histories, are recovering from anaphylactoid reactions shortly after the injections on the first day of Britain’s biggest ever mass vaccination programme.
This morning the Medicines and Healthcare products Regulatory Agency (MHRA) gave precautionary advice to NHS trusts that anyone who has a history of ‘significant’ allergic reactions to medicines, food or vaccines should not receive the vaccine.
The number of people set to be barred from having the Pfizer jab is not known, but up to 7million people in Britain have have allergies severe enough to require specialist allergy care, according to the NHS. Around 250,000 people need to carry an EpiPen.
The NHS has said the two workers are ‘recovering well’ and has said a small number of allergy cases like this are ‘common’ when rolling out new vaccines.
Professor Stephen Powis, national medical director for the NHS in England, said: ‘The MHRA have advised on a precautionary basis that people with a significant history of allergic reactions do not receive this vaccination after two people with a history of significant allergic reactions responded adversely yesterday. Both are recovering well.’
A Pfizer spokesman said: ‘We have been advised by MHRA of two yellow card reports that may be associated with allergic reaction due to administration of the COVID-19 BNT162b2 vaccine.
‘As a precautionary measure, the MHRA has issued temporary guidance to the NHS while it conducts an investigation in order to fully understand each case and its causes. Pfizer and BioNTech are supporting the MHRA in the investigation.
‘In the pivotal phase 3 clinical trial, this vaccine was generally well tolerated with no serious safety concerns reported by the independent Data Monitoring Committee. The trial has enrolled over 44,000 participants to date, over 42,000 of whom have received a second vaccination’.
Last night thousands of elderly British patients urged vaccine sceptics to have the jab for the good of the country as health bosses prepared for a delivery of more than a million doses of the Pfizer vaccine next week.
The national vaccination drive was launched at 70 UK hospitals, with most doses given to the over-80s. Margaret Keenan, a Coventry grandmother, was first in line, declaring: ‘If I can have it at 90, then you can have it too.’
Lyn Wheeler, 81, who was given the Pfizer jab in front of Boris Johnson at Guy’s in London, called for everyone to do their duty so normal life can resume. ‘It’s all for Britain,’ she added. ‘I’m going for it because I feel there’s no other way forward. We can’t keep sitting in our houses.’
An initial 800,000 doses are being rolled out in the coming days and Health Secretary Matt Hancock has promised millions more before Christmas.
In other coronavirus news:
- Holidays abroad were given the green light for next summer by officials;
- Care homes were told to expect doses of the vaccine by Christmas;
- Mr Hancock appeared to well up on live TV as he described his pride at the rollout;
- The Oxford University/AstraZeneca vaccine was found to be ‘safe and effective’ in a major study in the Lancet;
- However regulators face a decision over whether to approve the vaccine with a low-dose initial injection;
- US regulators inched closer to approving the Pfizer jab for the most vulnerable;
- Mr Johnson appeared to issue a warning about London following a rise in infection rates, sparking fears it could be plunged into Tier Three next week;
- Chief scientific adviser Patrick Vallance warned the public may still be wearing face masks a year from now;
- Schools may be allowed to take an inset day on the last Friday of term so stressed teachers can have a ‘proper break’;
- A further 616 people died of coronavirus, taking the total to 62,033. Another 12,282 cases were confirmed.
Both are recovering following the first day of the mass vaccination programme, it is understood (pictured, the vaccine being administered in Glasgow yesterday)
Dr June Raine, the chief executive of the MHRA, told the Science Committee today there had been two allergic reactions to the Pfizer vaccine yesterday.
She said: ‘I may share with the committees that even last evening we were looking at two case reports of allergic reactions.
‘We know from the very extensive clinical trials that this wasn’t a feature, but if we need to strengthen our advice now that we’ve had this experience in the vulnerable populations – the groups who’ve been selected as a priority – we get that advice to the field immediately.’
Dr Raine said careful plans had been made for ‘real-time vigilance’ when monitoring side effects from vaccinations and that any updates to advice for patients would be communicated ‘immediately’.
She told the Committee regulators had been aware since last night of the two people who had experienced the reactions.
She said: ‘The role is before, during and after, and there is a true end-to-end looking from the scientific laboratory bench through to the patient who yesterday first received the vaccine.
‘As an illustration to this, I may share with the committee that even last evening we were looking at two case reports of allergic reaction.
‘We know from the very extensive clinical trials that this wasn’t a feature but if we need to strengthen our advice now that we have had this experience in the vulnerable populations… we will get that advice to the field immediately.’
The MHRA advice states: ‘Any person with a history of a significant allergic reaction to a vaccine, medicine or food (such as previous history of anaphylactoid reaction or those who have been advised to carry an adrenaline autoinjector) should not receive the Pfizer/BioNtech vaccine.
‘Resuscitation facilities should be available at all times for all vaccinations. Vaccination should only be carried out in facilities where resuscitation measures are available.’
At least 5,000 people were inoculated – around 100 people in each centre – with 800,000 doses of the Pfizer /BioNtech vaccine already in the country as the UK’s vaccine chief Kate Bingham predicted that in 2021 ‘we will all be going on summer holidays’.
UK regulator dismisses Bell’s palsy fears over Pfizer vaccine
Britain’s drug regulator today dismissed safety fears over the
Four cases of it were found in a group of 21,720 people who had the Pfizer vaccine in a trial in the US, compared to none among 21,728 people given a placebo vaccine. But this rate of occurrence is no different to how often it would be expected to happen in a random population – in the UK there are around 20 to 30 cases per 100,000 people per year.
The Food and Drug Administration in the US said in its report: ‘The four cases in the vaccine group do not represent a frequency above that expected in the general population.’ This means that it was almost certainly random that all the people who developed the condition happened to be in the vaccine group, and the same number of people would likely have got it in any group that size, regardless of a vaccine.
And the British counterpart, the MHRA, said today: ‘The general safety profile of this vaccine is similar to other types of routinely used vaccine..
‘No vaccine would be authorised for supply in the UK unless the expected standards of safety, quality and efficacy are met.’ The Pfizer/BioNTech vaccine, proven to be safe in clinical trials, is now being given to members of the public in Britain, which is the first country to give a jab to its citizens.
The next to get the jab was William Shakespeare, 81, from near Stratford-upon-Avon – the Bard’s home town – who appeared so relaxed many joked that to him, being the second person in the world to be vaccinated was ‘much ado about nothing’.
Health Secretary Matt Hancock said he was emotional as he watched Mrs Keenan getting the jab after a grim 2020, and cried on Good Morning Britain as Mr Shakespeare hailed the ‘ground-breaking’ jab that will ‘start changing our lives’.
Mr Hancock wiped away tears as he told Piers Morgan and Susanna Reid: ‘It’s been such a tough year for so many people and there’s William Shakespeare putting it simply for everybody that we can get on with our lives’.
But in a gloomy warning for Britain he added: ‘There’s still a few months to go, I’ve still got this worry that we can’t blow it now Piers, we’ve still got to get the vaccine to millions of people so we’ve got to keep sticking to the rules, there’s so much work gone into this – it makes me proud to be British’.
Later in the Commons a more composed Mr Hancock gave a statement to MPs on the vaccine’s rollout and joined in on the Shakespeare puns, declaring: ‘If you prick us, do we not bleed?’
Boris Johnson, who watched people getting vaccinated at Guy’s Hospital yesterday, said: ‘It’s a shot in the arm for the entire nation, but we can’t afford to relax now’.
At 6.30am, wearing a bright blue ‘Merry Christmas’ T-shirt, Mrs Keenan, known as ‘Maggie’ to friends and family, could be seen smiling under her mask as the nurse May Parsons at University Hospital Coventry & Warwickshire injected her with the life-saving medicine.
Mrs Keenan, a former jewellery shop assistant who only retired four years ago, has a daughter, a son and four grandchildren.
She said: ‘I feel so privileged to be the first person vaccinated against Covid-19, it’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the New Year after being on my own for most of the year.
‘I can’t thank May and the NHS staff enough who have looked after me tremendously, and my advice to anyone offered the vaccine is to take it – if I can have it at 90 then you can have it too.’
Boris Johnson with patient Lyn Wheeler before she received her vaccine at Guy’s in south London
Henry Vokes, 98, celebrates after receiving his jab at Southmead Hospital in Bristol
Belfast: Sister Joanna Sloan (left) becomes the first person in Northern Ireland to receive the first of two Pfizer/BioNTech Covid-19 vaccine jabs, at the Royal Victoria Hospital, in Belfast
Cardiff: David Farrell, 51, from Llandow, a care home worker, became one of the first people in Wales to get the vaccine
Staff at Southmead Hospital take delivery of the Pfizer-BioNTech COVID-19 vaccine
The vaccine (pictured) has to be stored at minus 70C and can only be transported at elevated temperatures a limited number of times
Oxford confirms its Covid vaccine is 70% effective and safe
The UK’s regulator now faces a ‘dilemma’ over whether to approve a one-and-a-half dose regimen that researchers accidentally discovered makes the experimental jab 90 per cent effective.
The MHRA has been considering whether to approve the vaccine since November 27 and is expected to reach a decision before the end of the year.
And Oxford’s own scientists suggest they expect approval for the original two-dose regimen before the end of this year, which could later be adapted to the more effective combination if data proves it is better.
It came as V-Day heroes last night urged vaccine sceptics to have the Covid jab for the good of the country ahead of the arrival of more than a million more doses of the Pfizer vaccine next week.
Thousands of elderly British patients made history yesterday by being the first in the world to get the injection outside of medical trials.
The national vaccination drive was launched at 70 UK hospitals, with most doses given to the over-80s. Margaret Keenan, a Coventry grandmother, was first in line, declaring: ‘If I can have it at 90, then you can have it too.’
Lyn Wheeler, 81, who was given the Pfizer jab in front of Boris Johnson at Guy’s in London, called for everyone to do their duty so normal life can resume.
‘It’s all for Britain,’ she added. ‘I’m going for it because I feel there’s no other way forward. We can’t keep sitting in our houses.’
The PM said: ‘You have seen Lyn take it, you have seen people take the vaccine in large numbers. There’s nothing to be nervous about. To all those who are scared – don’t be.’
Day one saw around 5,000 people vaccinated, including the elderly, care home staff and NHS workers. An initial 800,000 doses are being rolled out in the coming days and Health Secretary Matt Hancock has promised millions more before Christmas.
NHS bosses were last night told that they would received either 1.2 million or 1.6 million doses of the breakthrough Pfizer/BioNTech vaccine next week, with the remainder of an initial four million arriving the week after.
Writing in the Times Red Box, NHS England medical director Stephen Powis said GP surgeries would ‘join up’ across the country to support hospitals in the delivery of the jab, followed by larger vaccine hubs in key locations.
Hospitals have been told they will be expected to use a minimum of one box of vaccine – 975 doses – during the first week, suggesting a total of almost 70,000.
London ‘heading for TIER THREE before Christmas’: Pubs and restaurants could shut AGAIN in new rules shake up on December 16
London’s Covid-19 infection rate is now higher than more than two dozen areas currently stuck under Tier Three restrictions, official data revealed after Matt Hancock warned it is on the verge of being plunged into the toughest measures before Christmas. Department of Health statistics show the city recorded 169.2 cases per 100,000 people during the seven-day spell ending December 2.
For comparison, the city’s Covid infection rate stood at 151.6 in the last seven days before Downing St’s blanket intervention was imposed on November 2. MailOnline’s analysis of Government figures show London is now recording more cases per day, for its size, than 27 of 61 authorities currently living under Tier Three curbs, including Nottingham, Leeds, Leicestershire, Bristol, Newcastle and Derby.
And 21 out of the capital’s 32 boroughs saw a rise in coronavirus infections in the last week of the shutdown, with the biggest surges in Haringey, Bromley and Kingston. Asked whether the capital is in danger of being upgraded to Tier Three next week, the Health Secretary pointed to rising cases as he pleaded with people to keep obeying the rules.
Designated family doctors have been asked to operate from 8am to 8pm, seven days a week, calling patients in for appointments by phone, message and letter.
Further stocks are due to arrive next week, before being checked and distributed to hospitals and surgeries across the UK from a secret storage facility.
Mr Hancock said he hoped ‘several million’ vulnerable people will have been given the jab by Christmas, paving the way for the easing of coronavirus restrictions by spring. Professor Stephen Powis, medical director of NHS England, hailed yesterday as a turning point for the pandemic.
‘This is the way out of it, the beginning of the end,’ he added. ‘It’s not going to happen tomorrow, it’s not going to happen next week or next month. We still need to socially distance, we need to follow all those restrictions in place.
‘But, in 2021, vaccination programmes will mean we can get back to normality.’
NHS England’s chief executive Simon Stevens said: ‘Less than a year after the first case of this new disease was diagnosed, the NHS has now delivered the first clinically approved Covid-19 vaccination – that is a remarkable achievement.’
Sir Simon also thanked all the scientists, health workers and volunteers who helped with the breakthrough.
US regulators last night confirmed that the Pfizer and BioNTech vaccine was strongly protective against Covid-19.
The Food and Drug Administration is expected to give the jab the green light within days, paving the way for thousands of Americans to join Britain’s vaccination efforts.
Coronavirus was involved in a quarter of deaths recorded in the final week of November, according to the Office for National Statistics.
The number of fatalities in England and Wales fell for the first time in more than two months as the lockdown drew toward an end.
Despite the fall in overall deaths, Covid fatalities rose and more people died than has been typical for the same time of the year.
There were 12,456 deaths in the week that ended on November 27 – 79 fewer than in the previous week.
Sir Simon Stevens, chief executive of the NHS, watches as a nurse administers the first of two Pfizer/BioNTech Covid-19 vaccine jabs to Frank Naderer, 82, at Guy’s Hospital in London
A member of staff takes a tray containing phials of the Pfizer-BioNTech COVID-19 vaccine out of a fridge as 100 hospitals and NHS sites begin the rollout of the vaccine
Michael Tibbs, 99, receiving COVID vaccine from Liz Rix, Chief Nurse at Queen Alexandra Hospital in Portsmouth
A huge team of Doctors and Nurses are ready to start vaccinating the Gwent population in South Wales. 300 people will receive the vaccine at a sports centre in Cwmbran
Covid-19 vaccination record card and ‘I’ve had my covid vaccination’ stickers at the Royal Victoria Infirmary. Some are concerned about being told to carry the card at all times
EVERYTHING YOU NEED TO KNOW ABOUT PFIZER’S COVID VACCINE
Britain yesterday began mass vaccination of the public with Pfizer/BioNTech’s Covid vaccine, bringing the ‘end in sight’ to pandemic lockdown rules.
Here, MailOnline answers all the questions about the jab, including who will get it first, how much it costs and where people will be vaccinated.
What could the logistical challenges of delivering it be?
Both the Prime Minister
The problems stem from the fact the vaccine must be kept in long-term storage at -70C.
To keep doses at this ultra-low temperature, they need to be packaged with dry ice and placed in a special transport box the size of a suitcase which hold 5,000 doses.
These containers can prevent the vaccines from spoiling for 10 days if they remain unopened.
Once the batches arrive at vaccination hubs, they can be stored in standard medical fridges at between 2°C and 8°C for up to five days.
Or they can be kept in their shipping boxes for up to 30 days if the containers are topped up with dry ice at least once a week.
Welsh Health Minister Vaughan Gething said the logistical issues meant ‘in practical terms at this stage that we cannot deliver this vaccine to care homes’
The sticking point for delivering the jab to places like care homes may be that BioNTech says that the vaccine can only be kept at between 2°C and 8°C for six hours in transit without going off.
Because the Pfizer suitcases hold 5,000 vaccine doses, smaller quantities would have to be removed from the dry ice suitcases for transport to care homes.
But once they are in transit the doses could perish after six hours. It’s unclear exactly why this is the case.
Who is top of the list to get a coronavirus vaccine?
The Joint Committee on Vaccination and Immunisation (JCVI) has examined data on who suffers the worst outcomes from coronavirus and who is at highest risk of death.
The JCVI’s guidance says the order of priority should be the below.
1. Residents in a care home for older adults and their carers
2. All those who are 80 years of age and over and frontline 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. Adults aged 18 to 65 years in an at-risk group, such as the morbidly obese
7. All those aged 60 and over
8. All those aged 55 and over
9. All those aged 50 and over
However, because of the aforementioned logistical problems, care homes cannot receive the vaccines straight away, so elderly NHS patients, care workers and NHS staff are receiving the first doses.
Where will people get the vaccine, and who will be administering it?
Work was going on behind the scenes to ensure that NHS staff were ready to start delivering vaccines to the most vulnerable from the start of December.
Vaccinations yesterday started in 70 NHS hospitals and the operation will be scaled up in the coming days and weeks.
Nightingale Hospitals and sports stadiums have been prepared as sites for mass vaccination clinics, while GPs and pharmacists will also be involved in the mammoth Army-backed operation to deliver the jab.
New regulations allowing more healthcare workers — and NHS volunteers — to administer flu and potential Covid-19 vaccines have also been introduced by the Government. They will be supervised by a healthcare professional.
NHS England stated that GP practices offering vaccines must be able to operate from 8am to 8pm, seven days a week including bank holidays when required for reasons such as needing to use up supplies of a vaccine without wasting any.
A letter sent to all practices suggests that it may be necessary for some staff to vaccinate patients on Christmas Day. Vaccination sites are expected to be able to deliver at least around 1,000 jabs per week. The contract to vaccinate begins next Tuesday and GPs will be paid £25.16 for every two jabs they administer.
Volunteers without medical training can put themselves forward through the GoodSAM app to give injections working with St John Ambulance. The role description states: ‘Volunteer vaccinators will be trained to deliver a vaccination to a patient. They will also be ready to act if a patient has an adverse reaction.’
People are also being sought to act as vaccination care volunteers. They will help patients get to the right place for their jab and be on hand to provide first aid if anyone becomes unwell.
Volunteer patient advocates, the third type of helper, will ‘concentrate on the welfare of patients through their experience’.
How many doses of the Pfizer vaccine has the UK bought?
The UK has secured 40million doses of the Pfizer/BioNTech vaccine, with 10million due in the UK by the end of the year. 800,000 doses are already in the country and ready to be used.
Patients need two doses, meaning Number 10 has only secured enough doses for around a third of Britain.
However, it is likely other vaccines, including one from Oxford University that the UK has bought 100million doses of, will be approved in the coming weeks and months.
How long does it protect you for?
Regulators yesterday said there was evidence of ‘partial immunity’ just seven days after the first dose, offering a glimmer of hope that the roll-out beginning next week may have an effect before Christmas.
But they insisted the best immunity comes seven days after the second dose, which is given three weeks after the first.
It remains a mystery as to how long immunity against Covid lasts for, with top scientists warning that people may need to be vaccinated against the disease every winter, like the flu.
What type of vaccine is this?
The jab is known as a messenger RNA (mRNA) vaccine.
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.
What are the advantages of this type of vaccine?
No actual virus is needed to create an mRNA vaccine. This means the rate at which it can be produced is dramatically accelerated. As a result, mRNA vaccines have been hailed as potentially offering a rapid solution to new outbreaks of infectious diseases.
In theory, they can also be modified reasonably quickly if, for example, a virus develops mutations and begins to change. mRNA vaccines are also cheaper to produce than traditional vaccines, although both will play an important role in tackling Covid-19.
Where is the vaccine made?
Pfizer’s jab is being manufactured at the firm’s plant in Belgium, as well as separate sites in the US.
BioNTech — the other drug company involved in the vaccine — has two production facilities in Germany that are expected to start churning out doses in the New Year.
Can the vaccine be transported in a fridge?
Yes, although the vaccine should be kept at -70°C to ensure its long-term preservation, it can be transported by car or van if refrigerated between 2°C and 8°C.
According to the latest data from BioNTech, the company that owns the vaccine, it is only safe to use within six hours of being defrosted if transported in a fridge.
Researchers say this would allow administration of the vaccine to high-risk populations who may be unable to visit vaccination centres, such as care home residents. However, it also says that the vaccine remains stable and viable for up to five days if kept in a stationary fridge — like in a GP surgery – at 2-8°C.
The only difference between the two scenarios is that one involves being chilled and transported, while the other is not moved while being cooled.
Why this difference shortens the vaccine’s shelf-life is currently unexplained.
Speaking at a virtual press conference, the vaccine’s developers hinted the restrictions would be eased as more data was gathered, indicating the limits are currently overly-cautious to ensure the vaccine reaches society’s most vulnerable people with no drop-off in its efficacy.
Are they safe?
All vaccines undergo rigorous testing and have oversight from experienced regulators.
Some believe mRNA vaccines are safer for the patient as they do not rely on any element of the virus being injected into the body. mRNA vaccines have been tried and tested in the lab and on animals before moving to human studies.
The human trials of mRNA vaccines – involving tens of thousands of people worldwide – have been going on since early 2020 to show whether they are safe and effective.
Pfizer will continue to collect safety and long-term outcomes data from participants for two years.
Can you get the Covid vaccine privately?
The Queen and the rest of the Royal Family will not be able to jump the queue for a Covid-19 vaccine and even Boris Johnson will have to wait his turn, it was revealed last month.
No one will be given ‘special treatment’ when the country launches its mass-immunisation drive, according to Government sources.
Even rich companies won’t be able to skip the line, despite fears wealthy corporations would snap up vaccines directly to get their staff back to work and make up for the money haemorrhaged during lockdown.
Could employers force staff to get a vaccine?
It is ‘highly unlikely’ private employers could force staff to get a Covid jab when one finally becomes available, according to lawyers.
Although most of Britain will need to get vaccinated to achieve herd immunity and stop the disease spreading, a jab can’t be given without people’s consent.
Lawyers at the global firm Morgan Lewis said it was not likely that firms in the UK could start enforcing vaccination.
They said: ‘A vaccine could only be lawfully administered provided that the individual consented to such treatment. It is highly doubtful an employee could be described as consenting to treatment under any degree of compulsion by their employer.’
Will I get a vaccine passport if I get the jab?
Immunity passports have been touted as the key for getting swathes of society back to normal life, and allowing millions to evade restrictions. This is because they would indicate someone is protected against the virus, and is able to fight it off without getting severely ill or dying.
Bars, cinemas and football stadiums could turn away Britons who have not been vaccinated against coronavirus, the UK’s vaccine minister Nadhim Zahawi suggested.
But ministers have since denied Britons will need ‘immunity certificates’ to go to the pub. Michael Gove was asked yesterday during a round of interviews whether people could need to prove they had been given coronavirus vaccines to enter bars and restaurants. He replied flatly: ‘No.’
Pressed on whether they could be required at theatres or sports centres, he said: ‘No I don’t think so, no.’
Mr Hancock said that a vaccine passport ‘isn’t part of our plan’. He told Sky News: ‘While we know that this vaccine protects you from getting ill with Covid – we don’t yet know how much it stops you transmitting Covid until we roll it out broadly.’
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.
Aren’t there other vaccines?
Yes, recent data from the Oxford/AstraZeneca, and Moderna vaccine trials suggests their candidates also have high efficacy.
Oxford data indicates the vaccine has 62 per cent 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 per cent, according to data. But the breakthrough results from trials of Oxford University’s vaccine were based on ‘shaky science’, experts have warned.
The combined analysis from both dosing regimes resulted in an average efficacy of 70.4 per cent.
Final results from the trials of Moderna’s vaccine suggest it has 94.1 per cent efficacy, and 100 per cent efficacy against severe Covid-19.
Nobody who was vaccinated with the vaccine known as mRNA-1273 developed severe coronavirus.
A graph showing vaccine orders made by the EU, US, Canada, UK, Japan and Australia
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.
Analysis shows the Pfizer vaccine can prevent 95 per cent of people from getting Covid-19, including 94 per cent in older age groups.
A technician inspects vials of coronavirus disease (COVID-19) vaccine candidate BNT162b2 at a Pfizer manufacturing site in manufacturing site in St. Louis, Missouri
The vaccine has been tested on 43,500 people in six countries and no safety concerns were raised. Approval means the UK can begin rolling out the vaccine to those most in need, including frontline NHS workers.
How many doses of other jabs has the UK secured?
The UK has secured access to 100million doses of the AstraZeneca/Oxford University vaccine, which is almost enough for most of the population.
It also belatedly struck a deals for seven million doses of the jab on offer from Moderna in the US.
The deals for 357million doses of seven different vaccines cover four different classes: adenoviral vaccines, mRNA vaccines, inactivated whole virus vaccines and protein adjuvant vaccines.
How much does Pfizer’s vaccine 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.
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 front-runners.
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 would the regulator have looked 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.
Husband and wife Ugur Sahin and Oezlem Tuereci are behind the Pfizer Covid-19 vaccine that could change the world
Regulators look at stacks of data before approving any vaccines (stock)
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.
‘If I can do it, so can you’: Stirring message from ‘Super Gran’ aged 90 who’s first to receive vaccine
By Andy Dolan and Claire Duffin for the Daily Mail
The grandmother aged 90 who became the first person to receive the covid vaccine jumped at the chance, her grandson said yesterday.
Conor Maton said despite being just 4ft 10in, Margaret Keenan was a ‘larger than life’ character who wanted to do what she could to help get the country back on track.
And after she had the jab, Mrs Keenan declared: ‘If I can have it at 90 then you can have it too.’
Grandmother Margaret Keenan, aged 90, who became the first person to receive the covid vaccine jumped at the chance, her grandson said yesterday
Forsooth! William Shakespeare is second in the queue
William Shakespeare became the second person to receive the covid vaccine yesterday.
The 81-year-old former Rolls-Royce worker from Coventry – believed to be a descendant of the Bard – said he was pleased to be given the ‘groundbreaking’ jab.
He was filmed receiving it at University Hospital in Coventry yesterday morning – prompting a deluge on social media of Shakespeare puns.
William Shakespeare, 81, from Coventry, became the second person to receive the covid vaccine yesterday
His niece Emily Shakespeare said her ‘lovely uncle’ was a ‘worthy recipient’ of the vaccine.
She said the family were ’86 per cent sure’ he was a descendant of England’s greatest playwright, who was born in nearby Stratford-upon-Avon.
Mr Shakespeare had been admitted to the hospital’s frailty ward after falling ill at home.
The father of two and grandfather praised his ‘wonderful’ wife Joy, who he hoped to be reunited with soon.
He appeared relaxed as he received the vaccine in front of the media. Asked if it hurt he replied simply: ‘No.’
He added: ‘It’s groundbreaking I think. It could make the difference to our lives from now on couldn’t it? I’m not nervous at all.
‘A bit apprehensive about what the side-effects could be but there is a small chance of that so I am just pleased there is an advancement for the future of everyone else.’
Asked if he knew when his wife might be receiving the vaccine, he said: ‘No news on that, hopefully soon.
‘My wife is absolutely wonderful – she’s so caring, she’s so generous. She is the best partner I could ever have.’
Mr Maton, 29, said Strictly Come Dancing fan Mrs Keenan was much younger than her years and was working in a jewellers until six years ago before falling ill – not with Covid – and being admitted to hospital a few days ago.
After recovering well, Mrs Keenan, who is due to celebrate her 91st birthday next week, received the vaccine from nurse May Parsons at University Hospital in Coventry at 6.31am yesterday.
Mail volunteer’s shot in the arm
A pensioner who answered the Daily Mail’s call for volunteers as part of our Hospital Helpforce campaign received the vaccine at the same hospital.
Doreen McKeown, 81, from Hutton in Lancashire, signed up to help at the Royal Preston Hospital, last year and has worked at the hospital trust’s endoscopy unit.
The former civil servant and police civilian worker was in line at 7.20am yeterday and said: ‘It was marvellous and a momentous occasion.
Doreen McKeown, 81, received the vaccine at the Royal Preston Hospital
‘Everything went according to plan so far as I can tell.
‘It is a miracle that things have happened really quickly. We never thought it would happen until next year.’
Known to family and friends as Maggie, Mrs Keenan said: ‘I feel so privileged to be the first person vaccinated against Covid-19.
‘It’s the best early birthday present I could wish for because it means I can finally look forward to spending time with my family and friends in the new year after being on my own for most of the year.’
She added: ‘I can’t thank May and the NHS staff enough, and my advice to anyone offered the vaccine is to take it.’
Mrs Keenan had been isolating since March. Mr Maton said having the jab means she can now celebrate her birthday with those in her bubble and see her family at Christmas.
Mr Maton, who lives around the corner from his grandmother in Coventry, said: ‘We’re really proud of her.
The fact that she’s 90 years old – 91 next week – will hopefully give other people confidence to have the jab.
‘It sums her up because she’s a wonderful woman. She’s always been Super Gran to us.’
Her proud son Philip Keenan, an electronics expert at Cambridge University, described her as a ‘little person with a heart of gold’.
Mr Keenan, 61, said: ‘She is determined to live beyond 100 and has done everything possible to protect herself.
‘She’s a very sociable person and it has been hard for her to lose that contact with people during the pandemic.
She has bubbled with my sister and her family in Coventry, but otherwise mum has not left her house since March, up until her admission to hospital.’
Mrs Keenan, who was widowed in 2007, will receive a booster jab in 21 days’ time to ensure she has the best chance of being protected against the virus.
NHS nurse Mrs Parsons said it was a ‘huge honour’ to be the first person in the country to deliver a Covid-19 jab to a patient.
‘The last few months have been tough for all of us working in the NHS, but now it feels like there is light at the end of the tunnel,’ she added.
Ex-doctor’s praise for NHS heroes
An 87-year-old grandfather had the jab and said it was his duty to ‘do whatever I can to help’.
Dr Hari Shukla, a former GP and race relations campaigner, heaped praise on the NHS as he and his wife Ranjan, 84, were given the jab at the Royal Victoria Infirmary in Newcastle.
The couple, who have four children and nine grandchildren, thanked those who have worked on the vaccine.
Dr Shukla said: ‘I don’t take this for granted because hundreds of people have worked for this vaccine day and night to make sure we got the vaccines in good time, so the lives of people can be saved.’
Dr Hari Shukla, a former GP and race relations campaigner, heaped praise on the NHS as he and his wife Ranjan, 84, were given the jab
… and Boris is there to see it done
Lyn Wheeler, 81, had her jab at Guy’s Hospital in London – and was applauded by the Prime Minister.
Boris Johnson asked her how it had been, and the pensioner from Bromley, south-east London, replied: ‘It’s all for Britain.’
She also told him : ‘I’m going for it because I feel there’s no other way forward, we can’t keep sitting in our houses.’
The FIRST to roll up their sleeves on V-Day: From 99-year-old WWII hero to nurse, 28, whose wedding was postponed by the pandemic… the brave Britons who beat the rest of the world to getting Pfizer Covid jab
A Second World War submarine lieutenant, a young Northern Irish nurse whose wedding was cancelled due to Covid-19 and a Welsh care home worker with diabetes were among the first people to get vaccinated in Britain.
Shortly after Margaret Keenan, 90, became the first person in the world to get the approved Pfizer/BioNtech vaccine, Royal Navy veteran Michael Tibbs, 99, from Portsmouth, became the oldest.
While in Wales care home worker Craig Atkins, 48, from Ebbw Vale, became the first person to get the jab at the nation’s Cwmbran mass vaccination centre.
In Scotland, Clinical Lead of Outpatient Theatres, Andrew Mencnarowski, was first in line at Edinburgh’s Western General Hospital.
Michael Tibbs, 99, being administered the COVID vaccine by Liz Rix, Chief Nurse.Michael Tibbs is the first person in the South West to receive the Covid-19 vaccination at Queen Alexandra Hospital in Portsmouth
Sister Joanna Sloan is congratulated by her colleague Conor McDowell, as she becomes the first person in Northern Ireland to receive the first jab
Margaret Keenan, 90, returns to her ward after becoming the first person in the world to get the approved jab in Coventry
The Royal Navy hero who fought on D-Day and was the oldest person to get a jab on V-Day
A Royal Navy veteran who was on the front line in WWII has joined the ‘V-Day’ battle against Covid-19 by becoming one of the first people in the world to receive the vaccine against the virus.
Royal Navy veteran Michael Tibbs, 99 smiled and joked with nurses as he walked into the Queen Alexandra Hospital, Portsmouth as the NHS mass vaccination programme across 70 hospitals in Britain swung into action.
Dressed in a tweed suit and cardigan, he made his way into the hospital’s vaccination centre using a walking frame and accompanied by his son Philip, a retired GP.
Mr Tibbs, believed to be the oldest person vaccinated today, said: ‘I didn’t know what to expect but it’s absolutely wonderful and feel really fortunate to have the vaccination.
‘During lockdown I have been confined to the garden, however when things get back to normal, I’m really looking forward to seeing my grandchildren and great grandchildren. The vaccine will make a difference to everybody and we are so fortunate to have the NHS.’
Michael Tibbs, 99, rolling up his sleeve in preparation in receiving the COVID vaccine
Mr Tibbs pictured with his wife Anne, who died last year
A little bemused by the media attention, Mr Tibbs blinked in the flashlights, but smiled when he saw a nurse, and shook her hand as he entered the building.
Mr Tibbs, the son of a Royal Navy chaplain, served aboard submarine HMS Tantalus in the Far East, and recalled surfacing in Port Said, Egypt when news came to the crew that the Germans had surrendered on VE Day, but ‘V-Day’ as today was dubbed, was also a proud a moment for the veteran.
The vessel completed the longest patrol of any British submarine in WW2 of 55 days’ duration.
Mr Tibbs was among the first of millions of Britons who will receive the Pfizer vaccine as Britain was the first country in the world to give approval for the drug’s use.
After the war, Mr Tibbs went to Oxford then joined the Sudan Political Service which administered the Sudan as a joint protectorate with Egypt.
Michael Tibbs, 99, and his son Philip enjoyed a nice cup of tea together afterwards
At independence in 1954 he was a district commissioner. He gave a Sudanese TV crew a 4 hour interview to mark the 65th anniversary of independence. He is one of only two members of the service still alive.
In 1955, they returned to England, settling in Lynchmere, West Sussex. He worked for the AA for 10 years and was secretary of the Royal College of Physicians until he retired in 1986.
Since retirement he was Chairman of the Lynchmere Parish Council and continued to produce and direct the local pantomime
His wife Anne died last year after 67 years of marriage. He still lives in Lynchmere with his younger son Christopher and daughter in law (Sylvia).
During COVID he has found his confinement at home frustrating particularly as he would have liked to see more of his two great-grandchildren and spend time with his large circle of friends. Most frustratingly there is no pantomime this year, only the second time since 1947 that the village has not put on this traditional Christmas event.
Mr Tibbs told a Royal British Legion podcast about some of his remarkable wartime memories for the VE Day commemorations.
‘On our way home we learned in Port Said, there was a buzz going on about peace in Europe. ‘So sure enough, we discovered that was the day after we left there.’
‘On the way home, he and the crew held a service on board HMS Tantalus.
‘We dived to 60 feet, quite alone, and had our service down there. The captain made a little speech, and had our service.
‘He said that we were very grateful to be going home. And that our families would be very grateful that they were no longer threatened by these V1 and V2 bombs, and that we would remember our friends out in the Far East, still fighting.
‘By the time VJ Day came along. I was actually 1st Lieutenant of a small submarine up in the western isles of Scotland.’
Frontline Belfast nurse whose wedding was cancelled because of Covid
Sister Sloan gives a thumbs up after becoming the first person in Northern Ireland to get the jab
Joanna Sloan, 28, is sister in charge of the team of vaccinators for the Belfast Health and Social Care Trust, Northern Ireland’s largest.
She received the jab at the Royal Victoria Hospital in West Belfast shortly after 8am on Tuesday morning, and said it felt like she had cleared the final hurdle.
The nurse, from Dundrum in Co Down, said: ‘I feel privileged and honoured and a little bit emotional that we have got here – very, very grateful.’
She felt ‘apprehensive and nervous’ beforehand.
As the vaccine was administered, she said she was thinking: ‘At last – we are here.’
Ms Sloan added: ‘Through everything that healthcare workers (went through), either in hospital or (the) community – people themselves losing family members, us losing colleagues – it felt like it was a huge moment and that this was and could possibly be the final hurdle in the fight against Covid.’
She is a former emergency department nurse and has been in her job for six years.
The nurse is engaged, but her wedding was postponed due to the pandemic.
Ms Sloan has a daughter aged five.
Afterwards, she said of the jab: ‘It did not feel any different than any other immunisation that I have had, I did not feel any pain.’
She said it had been stressful and hard work preparing for the moment.
‘We worked tirelessly to make sure that people are safe.’
Northern Ireland’s chief medical officer, Dr Michael McBride, said it was a remarkable day.
‘We can begin to look to the future with a degree of optimism, with this vaccine and other vaccines and more effective treatments,’ he said.
‘Hopefully in the future Covid-19 will become a more manageable disease and we will begin the pathway to a more normal life.’
Dr McBride added that he did not think this day would come so soon, 10 months after Covid-19 was discovered, as opposed to the more normal 10 years taken to develop vaccines.
He recalled the sacrifices and harm caused by the virus as well as the number of lives lost, and warned there will be more challenging months ahead.
Wales’ first was a care home caretaker with diabetes
This is the moment a scared and shaking Craig Atkins, 48, from Ebbw Vale, was vaccinated
Craig Atkins, 48, from Ebbw Vale, was the first Welshman to get the jab today, describing it as ‘scary’.
The care home worker described getting the vaccine as a ‘leap into the unknown’.
Mr Atkins, a care home maintenance worker, was vaccinated at the Cwmbran mass vaccination centre at around 8am.
Wales has the highest average Covid-19 infection rate in the UK, and recorded 2,000 cases yesterday for the first time.
He told the BBC that he was shaking as he waited for the jab.
He said: ‘It was scary’ – but admitting he smiled with relief when it was done. Mr Atkins is a diabetic and gets the flu jab each year.
He added: ‘I was the first to have this here today and it’s a bit of a leap into the unknown’.
Scottish NHS boss was all smiles as he beat countrymen to first jab
A smiling Andrew Mencnarowski, a clinical lead for Outpatient Theatres at NHS Lothian, received the Pfizer-BioNTech jab this morning at the Western General Hospital in Edinburgh
An NHS boss has become the first person in Scotland to receive the new Covid-19 jab – as the ‘milestone’ vaccine begins its rollout in the UK.
Andrew Mencnarowski, a clinical lead for Outpatient Theatres at NHS Lothian, received the Pfizer-BioNTech jab this morning at the Western General Hospital in Edinburgh.
The hospital is one of 23 sites around Scotland which will carry out vaccinations against Covid-19 for priority groups.
Nicola Steedman, Scotland’s deputy chief medical officer, was at the Western General to see the first vaccines being administered.
She said: ‘I felt genuinely privileged to see this long hoped for and clinically crucial vaccination programme begin at NHS Lothian’s Western General Hospital in Edinburgh and I would like to sincerely thank all those involved in the vast amount of work which has allowed us to reach this absolute milestone in our Covid-19 response.
‘The arrival of these first Covid-19 vaccines is a huge turning point for us all and will protect those most at risk from the serious effects of the virus, but we can’t relax yet.
‘Even after the first people are vaccinated it will be important for now that everyone continues to follow the Scottish Government’s guidance for their area and, above all, to follow FACTS.
‘These will continue to be the most important things we can do to protect ourselves and others from the virus, as we continue to roll out the vaccination to all of those who need it.’