UK drugs regulator reassures public allergic reactions after vaccines are ‘very rare’

GPs have been told they need to monitor patients given Pfizer’s coronavirus vaccine for side effects for at least 15 minutes after injection – in a move which could scupper Government plans to inoculate a million Brits a week by next year.

Britain’s medical watchdog issued the new advice to vaccination centres and doctors’ surgeries today after three people vaccinated on V-Day suffered allergic reactions to the jabs.

Practices were told last month a 15-minute observation period would not be necessary and that banning patients from driving within that time period would be sufficient.

The new rule is significant because logistical and regulatory problems in storing and distributing Pfizer’s jab mean time is of the essence when it comes to the rolling the vaccine out en masse.

Each vaccination site is expected to deploy 975 doses of the vaccine within three-and-a-half days of taking it out special freezers which keep it at -70C.

This is because medics are not allowed to split up the near-1,000 dose batches and the vaccine risks ‘spoiling’ if it’s left out longer than that time.

Now vaccination hubs will have to make sure they have the physical space to allow patients to remain on-site for 15 minutes while socially distanced, further slowing down the process.

There will be questions raised about whether Matt Hancock’s plan to vaccinate one million people a week by early next year is feasible.

The Royal College of GPs says with most vaccines patients only need to be monitored for two minutes after being injected because ‘the majority of reactions will occur within’ that time.

If the NHS was to spend two minutes administering every Covid-19 vaccine, it would take about 33,000 man-hours to vaccinate one million Brits. By comparison, it could now take a mammoth 250,000 hours with the new quarter-hour rule. 

The UK Medicines and Healthcare products Regulatory Agency updated its guidance today after two NHS workers given the jab on V-Day suffered an ‘anaphylactoid reaction’.

The reaction is similar to, but milder than, anaphylactic shock and tends to involve a rash, shortness of breath, swelling of the face and tongue or a drop in blood pressure.

Both, who have not been named, are said to be recovering well. A third patient is suspected of suffering ‘a possible allergic reaction following immunisation,’ according to MHRA chief, Dr June Rain.

The MHRA initially responded by saying anyone with a history of a significant allergic reaction to a vaccine, medicine or food should not take the shot.

An adviser to the group later said it was “tweaking” advice in part to say a food allergy was not a risk.

Commenting on the updated guidance, Dr Raine told GP Online: ‘We convened an expert group of the Commission on Human Medicines (CHM), attended by experts in allergy and clinical immunology, to robustly review these reports to consider any possible mitigation on the rare risk of anaphylaxis.

‘Any person with a history of anaphylaxis to a vaccine, medicine or food should not receive the Pfizer/BioNTech vaccine. A second dose should not be given to anyone who has experienced anaphylaxis following administration of the first dose of this vaccine.’

All vaccination sites are being told an anaphylaxis pack and EpiPen ‘must always be available whenever the Pfizer/BioNTech vaccine is given’. 

The allergic reactions prompted the MHRA to stop offering the jab to people with a history of severe allergies, thought to include up to 250,000 people. 

Dr Raine reassured Brits that reactions are ‘very rare’ and the vaccine wouldn’t have been approved unless it met rigorous safety standards. No vaccine would be approved unless it meets these stringent standards – on that you can be sure,’ she said.   

‘We have in place a robust and proactive safety monitoring strategy for Covid-19 vaccines which allows for rapid, real-time safety monitoring at population level. The fact that these incidents were picked up and reviewed shows that to be the case.’ 

Pfizer found a ‘very small number’ of allergic reactions to the vaccine during its trials, after 137 out of 19,000 people who got the vaccine experienced ‘potential’ allergic reactions – it was not clear how severe they were.

But British scientists called for calm amid the news, saying side effects are rarely serious and noting that the two people affected had a medical history of reactions like this.

Professor Ian Jones, a virologist from the University of Reading, told MailOnline he was ‘surprised’ that the vaccine had triggered an allergic reaction as it is ‘cleaner’ than many vaccines already recommended for Britons including the flu jab. 

‘The big allergic reaction to vaccines normally is an egg allergy, because historically influenza vaccines and several others have been grown in hens eggs and you inevitably get a bit of egg protein coming through with the final product,’ he said.

‘But there’s nothing like that in the mRNA vaccine. The only addition is the lipid coating that they put on the mRNA before it goes into cells – but there’s no history of allergic reactions to that.’ 

Dr Penny Ward of King’s College London added: ‘As these two events occurred in people with a history of severe allergy, it is sensible of the MHRA to draw attention to these reports and to suggest that individuals with a history of severe allergy not receive the vaccine at this time. 

‘MHRA is actively monitoring the safety of the vaccine during clinical use and can be expected to provide updates to practitioners as more information is gathered. The prompt reporting of these events using the yellow card scheme and the rapid issuing of additional information to guide practice shows that the safety monitoring system is working well.’ 

The number of people who suffer from allergies severe enough to exclude them from getting the vaccine is not known, although up to seven million people in the country have allergies severe enough to require medical care, according to the NHS – while around 250,000 people need to carry an EpiPen or similar gadget at all times.  

Despite the two allergy cases the Government is continuing to vaccinate between 5,000 and 7,000 people per day across the UK with 800,000 Pfizer doses already in hospitals and millions more on the way. 

Yesterday the MHRA – which authorised emergency use of the vaccine faster than any other country in the world – gave precautionary advice to all 50 NHS trusts now vaccinating the population that anyone who has a history of ‘significant’ allergic reactions to medicines or food should not receive the vaccine.

The allergy scare came hours after Britain’s drug regulator dismissed safety fears over the Pfizer/BioNTech coronavirus vaccine after a report revealed four people in a trial in the US got Bell’s palsy. The condition, which is usually temporary, causes muscles on one side of the face to droop because of nerves not working properly.

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, the company said.

Professor Graham Ogg of Oxford University urged calm yesterday, saying: ‘It will be important to now understand the specific nature of the reactions and the background medical history of the individuals affected so that any risks of reactions can be more closely defined. 

‘Staff are always prepared for the possibility of reactions and as with all medications, will continue to submit reports of any further episodes. In the meantime, reasonable precautions have been advised by the MHRA.’ 

Dr Andrew Garrett, executive vice president of Scientific Operations at ICON, pointed out: ‘The large clinical trial used to support vaccine approval by the MHRA excluded those with a “History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s)”.

‘The resulting UK patient leaflet stated that the vaccine should not be given to individuals who are allergic to the active substance or any of the other listed ingredients. In this respect the patient information was similar to the clinical trial exclusion criterion, and the approved vaccine labelling will have reflected the data received and reviewed by the MHRA to date.

‘As more data accumulate from both clinical trials and clinical practice then one naturally expects the safety profile to be updated and refined, as with any medicine. 

‘The MHRA has moved quickly today to strengthen their direction on the basis of two allergic reactions in individuals with a history of allergic reactions – that is, to exclude individuals with a significant history of allergic reactions moving forward.’

He added: ‘Tuesday was a welcome cause for celebration, and there was an enthusiastic response from those vaccinated. Labelling may well expand in the future, but it would be wise to be cautious in these early days to avoid undermining public confidence – particularly given the vaccine is in limited supply. Careful questioning of those about to receive the vaccine is in order.’ 

And Professor Peter Openshaw, past president of the British Society for Immunology and professor of experimental medicine at Imperial College London, said: ‘As with all food and medications, there is a very small chance of an allergic reaction to any vaccine. However, it is important that we put this risk in perspective. 

‘The occurrence of any allergic reaction was one of the factors monitored in the phase 3 clinical trial of this Pfizer/BioNTech COVID-19 vaccine, the detailed data from which was released yesterday. In this, they reported a very small number of allergic reactions in both the vaccine and placebo groups (0.63 per cent and 0.51 per cent).

‘Similar to the rollout of all new vaccines and medications, this new COVID-19 vaccine is being monitored closely by the Medicines and Healthcare products Regulatory Agency (MHRA). They will now investigate these cases in more detail to understand if the allergic reactions were linked to the vaccine or were incidental. The fact that we know so soon about these two allergic reactions and that the regulator has acted on this to issue precautionary advice shows that this monitoring system is working well.’

NHS England national medical director Professor Stephen Powis said yesterday: ‘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 yesterday: ‘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’.  

The allergy scare came hours after Britain’s drug regulator dismissed safety fears over the Pfizer/BioNTech coronavirus vaccine after a report revealed four people in a trial in the US got Bell’s palsy. The condition, which is usually temporary, causes muscles on one side of the face to droop because of nerves not working properly.

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, statistics show. 

An initial 800,000 doses of Pfizer’s vaccine are being rolled out across the UK over the coming days and Health Secretary Matt Hancock has promised millions more before Christmas. 

The NHS yesterday embarked on its plan to vaccinate the entire population against coronavirus by rolling out the UK’s new weapon in the war on Covid at 50 hospital sites to the over-80s, the vulnerable and at-risk frontline hospital and care home staff.

Dr June Raine, the chief executive of the MHRA, told the Science Committee yesterday there had been two allergic reactions to the Pfizer vaccine on Tuesday.

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.’

The yellow card scheme is the UK system for collecting and monitoring information on suspected safety concerns or incidents involving medicines and medical devices.  

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.’

At least 5,000 people were inoculated on the first day  – 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’.

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.’ 

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.’ 

NHS bosses were told on Tuesday 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.

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 Stevens 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.