WHAT ARE THE SYMPTOMS OF THE RARE BLOOD CLOTS LINKED TO ASTRAZENECA’S VACCINE?
MHRA chief executive Dr June Raine said anyone who has one or more of the below symptoms for longer than four days after vaccination should seek urgent medical advice.
- Shortness of breath
- Chest pain
- Swollen leg
- Persistent stomach pain
- Severe headache
- Blurred vision
- Skin bruising beyond the site of injection
Health Secretary Matt Hancock today launched a media blitz to reassure the public over the safety of the AstraZeneca vaccine as he insisted the nation’s vaccination drive remains on course to offer all adults a jab by the end of July.
Mr Hancock said a decision by UK health chiefs to rule the jab should not be given to Britons under the age of 30 as experts continue to investigate its link to rare blood clots showed ‘the safety system is working because the regulators can spot even this extremely rare event’.
He said that ‘people can take confidence that we have a system that we are extremely careful on the safety front’ but he insisted that ‘when you get the call, get the jab’.
The Government’s vaccine advisory group yesterday ruled that people aged between 18 and 29 should be offered an alternative to AstraZeneca’s vaccine.
Mr Hancock said the UK has ‘more than enough’ Pfizer and Moderna jabs to cover all of the people in that age group who are yet to receive a vaccination – approximately 8.5million.
He said ‘all three vaccines that are in use in the UK are safe and they are safe at all ages’ and that there is simply a ‘preference for the under-30s, if they want, to have the Pfizer of Moderna jab instead’.
Mr Hancock said ‘there is no need’ for a drop off in uptake of the jab.
The comments came after a series of Government figures, opposition politicians and medical experts rushed to shore up confidence in the vaccine programme amid fears the AstraZeneca decision could damage the public’s faith in the jab.
Boris Johnson tweeted that the British-made vaccine was ‘safe’ and that the benefits far outweighed the risks for the vast majority of adults, while Labour leader Keir Starmer said he was ‘looking forward’ to getting his second dose.
A review by the drugs watchdog the MHRA found that by the end of March, 79 out of 20million Britons vaccinated with the AstraZeneca vaccine had suffered blood clots in the brain or arteries, a rate of about one in 250,000. Nineteen of the cases died and three were under the age of 30.
Slides presented at a press conference announcing the change in guidance showed that younger people are more prone to blood clots after vaccination than older groups.
The MHRA said healthy people aged 19 to 29 should be offered either the Pfizer or Moderna jabs instead when the programme moves to younger groups in the coming months.
Anyone who has already had their first dose of the AstraZeneca vaccine, regardless of their age, is being advised to go for their second appointment as planned.
But former Tory leader Sir Ian Duncan Smith told Politico the move could be a ‘real blow’ to uptake of the vaccine, adding: ‘I’m concerned that this statement by the MHRA will lead to a lack of confidence in the jab.’
Matt Hancock said a decision by UK health chiefs to rule the jab should not be given to Britons under the age of 30 as experts continue to investigate its link to rare blood clots showed ‘the safety system is working because the regulators can spot even this extremely rare event’
Mr Hancock told Sky News this morning that the AstraZeneca decision will not impact the Government’s target of offering every UK adult a jab by the end of July.
He said: ‘The vaccine programme is proceeding well. The speed of the vaccine programme is not affected by the decisions yesterday.’
Asked how concerned he is about the potential for a drop off in uptake of vaccinations, the Health Secretary said: ‘Well, there is no need for that. We have seen this incredible level of uptake of the vaccine in this country and what we have learned in the last 24 hours is that the rollout of the vaccine is working.
‘We have seen that the safety system is working because the regulators can spot even this extremely rare event, four in a million, and take necessary action to ensure that the rollout is as safe as it possibly can be.
‘And we are seeing that the vaccine working, it is breaking the link between cases and deaths, thenumber of people dying from Covid halved again just in the last nine days since I last spoke to you and is down 98 per cent from the peak.
‘So we can have confidence, people can take confidence that we have a system that we are extremely careful on the safety front but that the rollout is progressing at pace so when you get the call, get the jab.’
Mr Hancock insisted the MHRA was correct to be ‘totally transparent’. He said: ‘I think people can be reassured that we have the high class safety system run by our world class regulator if you like at the MHRA and then we are totally transparent with all of the side effects, no matter how extremely rare they are like these ones.’
He added: ‘Well, it is absolutely right that we are completely transparent and that we have this highly sensitive safety system that can spot even these extremely rare events and it is important though that we are clear about the policy.
‘All three vaccines that are in use in the UK are safe and they are safe at all ages but there is a preference for the under-30s if they want to have the Pfizer of Moderna jab instead then they can.
‘But not only the British regulator but even the European regulator and indeed theworld health authority yesterday said that the Oxford AstraZeneca jab is safe and we know that it is highly, highly effective.’
Asked how the rollout of vaccinations will work for people under the age of 30, he said: ‘There are 10.16million people aged 18-29 in the UK, 1.6million of them have already had their first jab.
‘Anybody who has had the jab should continue with the second jab because there is no evidence of this effect after a second jab.
‘And we have enough, more than enough, Pfizer and Moderna vaccine to cover all of the remaining eight and a half million people aged between 18 and 29 if necessary.’
AstraZeneca’s jab is only being paused for under-30s in Britain because coronavirus levels are so low, said Deputy Chief Medical Officer Jonathan Van-Tam.
If Covid was still more prevalent, as it is in Europe, he suggested that the vaccine would still be recommended for all ages, including young people.
The MHRA insisted there was still no concrete proof that the British-made vaccine is causing the clots, but admitted the link was getting firmer. The review prompted the Government’s vaccine advisory group, the JCVI, to recommend that people aged 18 to 29 be given an alternative jab.
Professor Wei Shen Lim, coronavirus chairman for the vaccines committee: ‘The Covid-19 vaccines have already saved thousands of lives and the benefit for the majority of the population is clear – if you are offered a vaccine, you should take it.’
However European regulator the EMA took a bolder approach, saying that blood clots should be listed as a ‘very rare’ side effect of the AstraZeneca vaccine but stopping short of imposing any age restrictions on its use.
Britons over that age are still being advised to get the vaccine because the risk of Covid far outweighs the chance of developing the extremely rare conditions. But the JCVI said the benefit to risk ratio was ‘more finely balanced’ in younger people.
Professor Van-Tam said the new advice marked a ‘course correction’ for the UK’s rollout – and reiterated that for the vast majority of people the ‘benefits outweigh the risks’.
Displaying three slides that showed the relative risk of coronavirus versus blood clots after vaccination, Professor Van-Tam said that for older age groups the risk of the disease always outweighs the risk after having the AstraZeneca jab.
He said that when coronavirus is prevalent in society, 100,000 AstraZeneca vaccines prevent 127.7 Covid ICU admissions among 60 to 69-year-olds. For 20 to 29-year-olds, every 100,000 vaccine administered stops seven people in that age group from being admitted to intensive care with the disease.
The Government wheeled out a series of graphs comparing the risk of falling ill with Covid compared to the threat of developing blood clots after getting the AZ vaccine in various age groups. In low Covid levels, every 100,000 vaccines prevents 0.8 ICU admissions from coronavirus in people under 30 but 1.1 people will suffer blood clotting after having the jab, making the threat higher than the virus itself
When coronavirus is prevalent in society, 100,000 AstraZeneca vaccines prevent 127.7 Covid ICU admissions among 60 to 69-year-olds. For 20 to 29-year-olds, every 100,000 vaccine administered stops seven people in that age group from being admitted to intensive care with the disease
The EMA, which polices the safety of drugs used on the continent, spotted 169 cases of cerebral vein thrombosis (CVST) and 53 cases of splanchnic vein thrombosis (SVT), from 34million jabs. CVST occurs when a vein that drains blood from the brain is blocked by a clot. It can lead to a stroke. SVT is the same type of blood clot but it occurs in the digestive system
Prime Minister Boris Johnson said the Government believes the Oxford/AstraZeneca vaccine is ‘safe’
He threw his weight behind the British-made vaccine amid fears the latest move by regulators could dent public confidence
Jonathan Van-Tam, England’s deputy medical officer, led a press conference this afternoon, where it was announced the AZ vaccine is being restricted in under 30s
However, he justified the change in course on the AstraZeneca vaccine by pointing out that when Covid levels are low – as they currently are in the UK – the benefit per vaccine is lower.
In low Covid levels, every 100,000 vaccines prevents 0.8 ICU admissions from coronavirus in people under 30 but 1.1 people will suffer blood clotting after having the jab, making the threat higher than the virus itself.
What should I do if I’ve had the AZ jab? What are the alternatives for under-30s? And what are the tell-tale symptoms of blood clots?
WHAT HAS HAPPENED?
The Joint Committee on Vaccination and Immunisation (JCVI) has advised that healthy adults aged 18-29 are offered an alternative vaccine to the Oxford/AstraZeneca jab, if available.
The recommendation follows a review by the UK’s medicines regulator, the MHRA, which found there was a ‘strong possibility’ that very rare blood clots, known as cerebral venous sinus thrombosis (CVST), could be caused by the vaccine.
Dr June Raine, chief executive of the MHRA, yesterday said the possible side effect was ‘extremely rare’, while the balance of benefits from having the jab are ‘still very favourable for the majority of people’. However, for healthy younger adults, for which the risk from coronavirus is far lower, it is more ‘finely balanced’.
SHOULD I STILL GET MY SECOND AZ JAB?
Anyone who has already had their first dose of AstraZeneca’s jab, regardless of their age, was today urged to still attend their second appointment as planned.
Trials have shown the jabs work better after two doses, with the UK’s current campaign based on getting the top-up 12 weeks after the first.
The decision only applies to healthy under-30s — who should not yet have been invited for vaccines.
Regulators insisted the benefits of the jab — which has been repeatedly been proven to save lives and stop people falling severely ill with Covid — clearly outweigh the very small risk for everyone else.
Addressing the fears today, Boris Johnson said it was ‘very important for everybody to continue to get their top-up jab when you’re asked to come forward for your turn.’
CAN I CHANGE AND GET A DIFFERENT VACCINE?
Currently, you cannot switch jabs in between first and second doses. The JCVI is not currently recommending the mixing of vaccines because there is not yet the evidence to support its effectiveness. Trials mixing doses of Pfizer and AstraZeneca are ongoing with data expected soon.
At the moment, people will be offered a second dose in line with the first. Furthermore, there have so far been no recorded cases of serious clotting incidents in the UK after a second dose of the vaccine – all have been following the first.
People are advised to get their second dose of the jab, whatever their age.
IF I’M PREGNANT, SHOULD I GET THE VACCINE?
The advice on this has not changed, meaning it’s recommended that those who are pregnant should not be vaccinated, with some exceptions. This is because the vaccines have not yet been tested in pregnancy.
While there is no evidence to suggest that the vaccine would harm the baby, pregnancy is more likely to lead to thrombosis.
Therefore women should discuss with their healthcare professional whether the benefits of having the vaccine outweigh the risks for them.
WHAT ALTERNATIVE JABS COULD BE GIVEN TO UNDER-30S?
The MHRA ruled that Britons under 30 should not be given AstraZeneca’s coronavirus vaccine due to mounting evidence linking it to rare blood clots.
More than 20million doses of the AstraZeneca vaccine have now been given in the UK, with the jab used as the main weapon in the UK’s arsenal.
The roll-out is unlikely to move on to under-30s for several weeks, perhaps months, meaning that supplies of the other jabs could be saved for younger adults.
The chief scientist behind the US-developed Novavax vaccine, which Britain has secured 60million doses of, has said he expects it to be given the green light this month and rolled out in May.
A separate vaccine made by American pharmaceutical giant Johnson and Johnson, which uses the same type of technology as AstraZeneca’s but is administered via a single injection, is slated for a summer rollout.
But, given that AstraZeneca’s vaccine is the main driver of the campaign, the roll-out could be slowed if the change of heart on blood clots knocks public confidence in 30-50 year olds.
I’M 29. WHAT IF THEY ONLY OFFER THE OXFORD VACCINE?
Officials say this will not happen unless you have an underlying medical condition and are prioritised. In such instances, they say the benefit of having the vaccine far outweighs any issues as you have an equivalent risk from coronavirus as 65 to 70-year-olds. For healthy under-30s, officials are confident there are sufficient supplies of the Pfizer and Moderna vaccines coming on stream to vaccinate all 10million 18 to 29-year-olds in the UK.
WHAT ARE THE BLOOD CLOTS LINKED TO ASTRAZENECA’S JAB?
European health chiefs today ruled that AstraZeneca’s Covid jab should come with a warning that, in very rare cases, it may cause potentially deadly blood clots.
The EMA, which polices the safety of drugs used on the continent, spotted 169 cases of cerebral vein thrombosis (CVST) and 53 cases of splanchnic vein thrombosis (SVT), from 34million jabs.
CVST occurs when a vein that drains blood from the brain is blocked by a clot. It can lead to a stroke.
SVT is the same type of blood clot but it occurs in the digestive system.
WHAT SYMPTOMS DO THEY CAUSE?
The EMA said symptoms of the two blood clots included:
- Shortness of breath
- Chest pain
- Swelling of leg
- Persistent stomach pain
- Severe headache
- Blurred vision
- Skin bruising beyond the site of injection
IS THERE ANY PROOF THE JAB CAUSES THE BLOOD CLOTS?
Scientists have repeatedly insisted there is no proof yet that AstraZeneca’s coronavirus vaccine causes the blood clots.
But officials are still investigating the link and can’t rule it out completely.
Although there isn’t any evidence that the clots are developing because of vaccinations, some academics have a theory that it is the immune reaction making it happen.
Research teams in Germany and Norway claim the blood clotting issue may be caused by the jab, in very rare cases, making the body attack its own platelets.
Platelets are tiny chunks of cells inside blood that the body uses to build clots to stop bleeding when someone is injured. But they can also make unwanted clots.
Experts from Oslo and Greifswald University believe the jab could cause the body to produce antibodies – normally used to fight off viruses – which mistake platelets in the blood for foreign invaders and attack them.
To compensate, the body then overproduces platelets to replace those that are being attacked, causing the blood to thicken and raising the risk of clotting.
The researchers say the phenomenon is similar to one that can occur in heparin-induced thrombocytopenia (HIT), when sufferers take a drug called heparin.
HOW OFTEN ARE THE CLOTS OCCURRING?
Figures presented by the EMA today — which took into account data up until April 4 — suggested the clots were occurring once in every 150,000 jabs. They also said most of the cases had occurred in women under 60.
The MHRA, which plays the same role in the UK, found 79 cases of clots in 20million doses by the end of March.
Officials said the risk was around one in every 250,000 doses.
They also insisted the benefits of the vaccine outweigh the risks for the vast majority of people — but that the ratio was more ‘finely balanced’ in younger people.
EMA chiefs said that the clots were occurring more often than expected, prompting them to say the jabs need to come with the warning that it is a rare side effect.
But it said the committee investigating the link did not conclude that age and gender were clear risk factors for the very rare side effects.
WHICH COUNTRIES HAVE ALREADY RESTRICTED THE JAB TO OLDER PEOPLE?
Germany last week temporarily banned the AstraZeneca vaccine for under-60s, while France took the same controversial move for under-55s.
Iceland has restricted it to over-70s, while Finland, Sweden and Lithuania all say it can only be given to adults over the age of 65.
Denmark, Norway, the Netherlands and Latvia have all suspended the jab completely, while regulators probe the link further.
But the EMA refused to back any of the nations in their age-restricted roll-outs. Last week it publicly said there was no evidence to justify sweeping bans for younger people.
I’VE HEARD ASPIRIN CAN STOP BLOOD CLOTTING. SHOULD I TAKE IT BEFORE THE JAB?
No. The risks of an adverse clotting event are extremely low. Taking aspirin or anti-coagulants can increase the risk of bleeding and is not
The EU currently has much higher levels of coronavirus than the UK and is in the midst of a third wave, likely driving the EMA’s decision not to issue any age restrictions for the vaccine.
Professor Van-Tam insisted the under-30s ban would have no bearing on the UK’s ambition to vaccinate all adults against coronavirus by the end of July, so long as Pfizer and Moderna can meet their scheduled deliveries.
However, leaked figures have revealed that the AstraZeneca jab makes up 75 per cent of Britain’s jab roll out.
The country is set to start vaccinating under-50s next month but has only comparatively small numbers of Pfizer and approximately 100,000 Moderna jabs available every week.
Any stall of the vaccine roll-out would be a political body blow to Boris Johnson who has enjoyed a recovery in the polls thanks to his success deploying jabs after a series of missteps at the start of the pandemic.
The UK’s drive has already been thrown into crisis, with NHS bosses effectively blocking over-40s from getting jabs this month following India’s decision to block a shipment of 5million AstraZeneca doses that officials hoped would speed up the roll-out.
Former Health Secretary Jeremy Hunt said he doesn’t believe the announcement will slow vaccine uptake, saying that being ‘over-cautious’ will ‘cost lives’.
He said: ‘This is a fascinating issue for the very simple reason that the EMA … is also recommending that the Oxford AZ vaccine remains safe for all age groups.
‘That was another thing that was interesting. Individual EU countries have restricted its use, I think that there is a real danger that being over-cautious as is happening in France and Germany will cost more lives than it saves.’
‘Because what we can see in this country is that we have a death rate from Covid nine times lower than for example in France because we have this vaccine rolled out quickly.’
‘A lot of that is thanks to Oxford AstraZeneca so I think most people can see we are really benefiting from a rapid rollout from the vaccine.
Prime Minister Boris Johnson said the Government believes the Oxford/AstraZeneca vaccine is ‘safe’ and had already countless lives, insisting that Britons who have had a first dose of AstraZeneca should continue to get their second jabs.
The Prime Minister said: ‘But the crucial thing for everybody is to listen to what the scientists, the medical experts, have to say.’
He added: ‘You can really start to see some of the benefits of that – it’s pretty clear that the decline in the number of deaths, the decline in the number of hospitalisations is being fuelled, is being assisted, the steepness of that decline is being helped by the rollout of the vaccines so it’s very important for everybody to continue to get your second jab when you’re asked to come forward for your turn.’
‘You can really start to see some of the benefits of that – it’s pretty clear that the decline in the number of deaths, the decline in the number of hospitalisations is being fuelled, is being assisted, the steepness of that decline is being helped by the roll-out of the vaccines so it’s very important for everybody to continue to get your second jab when you’re asked to come forward for your turn.’
Announcing the updated guidance today, Dr June Raine, head of the MHRA, told a press conference: ‘Based on the current evidence, the benefits of the Covid-19 vaccine AstraZeneca against Covid-19 and its associated risks – hospitalisation and death – continues to outweigh the risks for the vast majority of people. Our review has reinforced that the risk of this rare suspected side effect remains extremely small.’
Professor Anthony Harnden, deputy chairman of the Joint Committee on Vaccination and Immunisation (JCVI), said there was a slight gradient of risk of blood clots in younger age groups with the AstraZeneca vaccine.
It comes after regulators the Medicines and Healthcare products Regulatory Agency (MHRA) and European Medicines Agency (EMA) said the vaccine can be used in all age groups, as the benefits of the vaccine still outweigh the risks overall.
Speaking at a briefing hosted by the Science Media Centre (SMC) on Wednesday, Prof Harnden said: ‘We on JCVI have decided that that risk-benefit ratio doesn’t really stack up when it comes to the very well under 30-year-olds.
‘We felt on JCVI having weighed up all the data that the benefits outweighed the risks in anybody over the age of 30.
‘But under the age of 30 it was not clear the benefits did outweigh the risks and they were more similar, and therefore we decided… as a precautionary approach we would advise an alternative vaccine for that particular age group.
‘We just thought there was enough doubt in our minds that the benefits did not completely outweigh the risks of the vaccine in the very young, well age group.’
In other coronavirus developments today:
- A 24-year-old carer today became the first person in Britain to get Moderna’s coronavirus vaccine as the roll-out was expanded in Wales – but England will have to wait another fortnight to use the jab;
- The SNP could save Boris Johnson from a growing Tory revolt over domestic vaccine passports as Labour hardened its opposition to the documents;
- No10 refuses to rule out needing proof of jabs to enter non-essential shops, leading to fears you’ll need vaccine passport to buy clothes;
- Boris promises to make it ‘as easy as possible’ for families to travel abroad this summer, with £5 on-the-spot Covid tests set to be allowed instead of gold-standard £100 PCR swabs;
- Lockdown easing could be sped up because vaccines are working, says the scientists who correctly forecast second wave – as SAGE doomsday predictions are criticised for being ‘too pessimistic’;
- Britain’s daily Covid deaths fall by two-thirds in a week with 20 new victims – while cases plunge by 40% to 2,379;
- One in three Covid survivors are diagnosed with anxiety, depression or other mental health issues within six months of recovering, major study finds;
- Generation of home-schooled children lacked ‘discipline and order’ in lockdown says Gavin Williamson as he backs mobile phone ban in schools.
Professor Van-Tam said it was not unusual for doctors to alter their preference on medicines and vaccines. He acknowledged the change in recommended use of the AstraZeneca vaccine might result in delays and longer journeys to receive the jab. He told the press conference: ‘The NHS has a message that we will get the right vaccine to you in the right time according to the new JCVI advice.
‘There might be a small delay sometimes, there might be a slightly greater distance that some people might be asked to travel. But the NHS is all over this and understands the challenge of making the advice from JCVI truly operational in a smooth way.’
Of the 79 people who suffered clots after getting the AstraZenca vaccine in the UK, a total of 19 people have died, although it has not been established what the cause was in every case. The 79 cases occurred in 51 women and 28 men, aged from 18 to 79. Of the 19 who died, three were under the age of 30, the MHRA said.
Some 14 cases of the 19 were cerebral venous sinus thrombosis (CVST), a specific type of clot that prevents blood from draining from the brain. The other five cases were thrombosis in the arteries.
Asked if the new MHRA advice would lead to falling confidence in the AstraZeneca vaccine, former health secretary Jeremy Hunt told Sky News: ‘This is a fascinating issue for the very simple reason that the EMA … is also recommending that the Oxford AZ vaccine remains safe for all age groups.
‘That was another thing that was interesting. Individual EU countries have restricted its use, I think that there is a real danger that being over-cautious as is happening in France and Germany will cost more lives than it saves.
‘Because what we can see in this country is that we have a death rate from Covid nine times lower than for example in France because we have this vaccine rolled out quickly.
‘A lot of that is thanks to Oxford AstraZeneca so I think most people can see we are really benefiting from a rapid rollout from the vaccine.
‘But they also understand that as scientific advice comes in, in a pandemic where you need to you tweak the advice.’
Vaccines minister Nadhim Zahawi tweeted that there was ‘reassurance’ that drug safety standards worked well ‘in both the United Kingdom & the EU’.
He added: ‘This is important in maintaining confidence in the largest vaccination program in history. As @BorisJohnson has said; We will follow the advice & are confident in meeting our programme targets.’
Reacting to the guidance change in the UK, independent experts said the link between the jab and clotting was becoming ‘increasingly plausible’, but they reiterated they were still ‘rare’.
Dr Michael Head, Senior Research Fellow in Global Health, University of Southampton, said: ‘We have seen an update from the UK and EU regulators, suggesting that these thrombotic events may have been a causal, but rare, adverse event from the Oxford AstraZeneca vaccine. This link is still not proven, but is now thought to be increasingly plausible.
‘It’s important to emphasise that adverse events happen with all medicines, and vaccines are no exceptions. Safety surveillance is vital in picking up and assessing signals that emerge from the data. There were some cases of severe anaphylaxis with the Pfizer vaccine early in the UK rollout.
‘These were openly investigated, guidance subsequently updated, and the rollout continued with high public confidence. Hopefully, we will see similar outcomes here in the UK with the Oxford AstraZeneca product, and also that European countries can get their vaccine administrations back on track.
‘The harm from withdrawing the vaccine altogether is almost certainly going to be much greater than the harm from rare adverse events.
‘The Oxford AstraZeneca vaccine is a vital tool in the global strategy to contain the pandemic. It is being manufactured in large numbers, is stored at refrigeration temperatures and thus easier to transport, cost per dose is cheap, and key to the COVAX distribution to low- and lower-middle income countries.
‘Maintaining public confidence is so important. An open transparent process to assessing safety concerns must be part of that.’
When there is medium prevalence, the threat of Covid still outweighs the chance of clots after AZ vaccine in every age group
Leaked delivery schedules reveal the Government is expecting AstraZeneca’s vaccine to make up 75 per cent of its Covid jab supplies over the next two months. The document, published on the Scottish Government’s website in January and quickly taken down, showed Britain was anticipating about 29.4m doses of AstraZeneca’s jab between April and the first week of June. By comparison, officials expected just 8.5m of Pfizer’s vaccine in the next two months and 1m of the new Moderna jab, which is being rolled out for the first time in Wales today
Elle Taylor, 24, today became the first person to receive the Moderna jab in the UK. She said it would help her care for her grandmother ‘properly and safely’
Clots are similar to condition linked to blood-thinning medicine, says Europe
The rare but potentially fatal blood clots associated with the AstraZeneca Covid-19 vaccine are similar to a condition suffered by patients treated with a blood-thinning medicine, the European Medicines Agency (EMA) has said.
Analysis of the jab, prompted by concerns about severe blood clots, concluded that most of the incidents occurred in women under 60 within two weeks of vaccination with the AstraZeneca product, but said no specific risk factors have been identified based on current evidence.
They said the body’s natural response, similar to conditions seen in patients treated with the anticoagulant heparin, might be a plausible explanation for the blood clotting side effect.
EMA safety committee chairwoman Dr Sabine Straus told a Brussels briefing on Wednesday: ‘Current available data did not allow us to identify a definite cause for these complications.
‘However possible plausible explanations have been put forward, including an immune response that leads to a condition that seems similar to atypical heparin-induced thrombocytopenia.’
The EMA said data showed the blood clots reported had been found in veins in the brain, the abdomen and arteries, combined with low levels of blood platelets and sometimes bleeding.
Symptoms associated with the blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin beyond the area where the injection was administered, and anyone who displayed them should seek medical attention.
The EMA’s Pharmacovigilance Risk Assessment Committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of March 22, with 18 of the combined cases proving fatal.
They came from reporting systems in the European Economic Area and the UK, from around 25 million people who had received the vaccine.
The committee has requested new studies and amendments to ongoing ones to provide more information.
Emer Cooke, executive director of the EMA, said its review ‘confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects’, adding: ‘Vaccination is extremely important in helping us in the fight against Covid-19.’
Meanwhile, the EU’s medical regulators have said that AstraZeneca’s vaccine should come with a clear warning that blood clots are a ‘very rare side effect’.
No specific risk factors had been identified based on current evidence, the regulator confirmed at a press briefing this afternoon.
But the agency refused to back Germany and other nations banning the jabs for under-60s, saying they could not prove that age or gender was a risk factor for the ‘very rare’ side effect.
Health chiefs said they had spotted 169 cases of CVST and 53 cases of a separate blood clot called splanchnic vein thrombosis out of 34million doses dished out by April 4 – the equivalent of one blood clot for every 150,000 doses. But many of these clots would have occurred naturally, meaning the true risk will be smaller.
Health ministers from EU countries will hold a virtual conference this evening to discuss their next steps with the AstraZeneca jab.
The EMA said the risk of deadly side effects from AstraZeneca’s vaccine is far lower than the risk of death from Covid.
It suggested the vaccine comes with a warning and individual countries decide who is vaccinated with what company’s jab.
Emer Cooke, executive director of the European Medicines Agency, sought to downplay any concerns about blood clots.
She said: ‘These are very rare side effects. The risk of mortality from Covid is much greater than risk of mortality from these side effects.’
Dr Sabine Straus, the regulator’s chairwoman, said the available data found a ‘very rare event that might occur’.
She told a press conference: ‘The frequency is difficult to assess, but we feel if you state the reporting rate is approximately one in 100,000 or even a little bit higher, that would reflect the risk.
‘Based on that information we ask national vaccination authorities to make up their mind on who they would like to vaccinate with which kind of vaccine.’
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) said the blood clots reported had been found in veins in the brain, the abdomen and arteries, combined with low levels of blood platelets and sometimes bleeding.
It said symptoms associated with the blood clots include shortness of breath, chest pain, swelling in the leg, persistent abdominal pain, severe headaches, blurred vision and tiny blood spots under the skin where the injection was administered.
Anyone who displayed them should seek medical attention, the EMA said.
The committee carried out an in-depth review of 62 cases of clots in the brain and 24 cases of clots in the abdomen as of March 22, with 18 of the combines cases proving fatal.
The European Medicines Agency (EMA) said most of the cases of blood clots reported have occurred in women under 60 within two weeks of vaccination with the company’s jab.
They came from reporting systems in the European Economic Area and the UK, from around 25 million people who had received the vaccine.
Ms Cooke said its review ‘confirmed that the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects’.
Britain’s daily Covid cases fall by a third in a week with 2,763 more infections – while deaths rise slightly to 45
Britain’s daily Covid cases have fallen by a third in a week but deaths rose slightly, official figures revealed today.
Department of Health data showed there were 2,763 new lab-confirmed cases recorded and 45 Covid deaths, which was two more than last Wednesday.
More than 31.7million Britons – or three in five adults – have also now received their first dose, after the national drive began to pick up the pace yesterday following the Easter bank holiday.
In a boost to Britain’s roll-out today, however, Wales became the first UK nation to start dishing out the Moderna Covid vaccine.
More than 100,000 doses of the US-made jab are set to arrive in the country this month, with deliveries expected to ‘significantly increase’ from May.
A TIMELINE OF THE ASTRAZENECA BLOOD CLOT SAGA
March 7: Austria suspended the use of one batch of the vaccine after a woman, 49, who had been given it died of a ‘severe coagulation disorder’ and a 35-year-old developed a blood clot in her lung.
March 11: Authorities in Denmark, Norway and Iceland suspended all use of the vaccine following a 60-year-old woman in Denmark died of a blood clot after the reports emerged in Austria. Danish health minister Magnus Heunicke said: ‘It is currently not possible to conclude whether there is a link.’
March 11: European Medicines Agency’s safety committee began an investigation into the cases. It confirms 30 cases of ‘thromboembolic events’ – clots – were reported after five million vaccines in the EEA.
March 12: Thailand suspended the use of the vaccine off the back of European worries. Bulgaria also stops using it.
March 12: The European Medicines Agency, Britain’s Medicines and Healthcare products Regulatory Agency, Health Canada, the World Health Organization and AstraZeneca itself, all spoke out to defend the vaccine and say there is no proof it’s linked to blood clots.
March 13: The Netherlands, Italy and Ireland temporarily stopped using the vaccine as fears about the cases in Austria and Denmark snowballed.
March 14: Germany and France suspended the vaccine.
March 15: Spain, Portugal and Slovenia suspended use of the jab.
March 15: Professor Andrew Pollard, the Oxford expert who ran the clinical trials of the jab, insisted safety data are ‘reassuring’ and said ‘clearly those blood clots still happen’ as often as they would in unvaccinated people.
March 16: World Health Organization officials met to discuss the issue. European Medicines Agency is still investigating.
March 17: Scientists accuse governments of banning the jab on political grouns. AstraZeneca’s vaccine has been a flashpoint in the past.
March 18: European Medicines Agency holds a press conference on its investigation and rules that the vaccine is ‘safe and effective’. It said there wasn’t enough evidence to rule out a link to blood clots, but also not enough to prove one. On balance, it would be safer for countries to keep using the vaccine to stop Covid. The investigation would continue.
March 18: Germany, France and Italy resume use of the jab after the EMA’s conclusion.
March 19: Finland suspends the jab after finding blood clot cases in its own population.
March 19: Bulgaria, Cyprus, Ireland, Latvia, Lithuania, Netherlands and Spain all confirm they will start using the jab again. Scandinavian countries did not follow suit and kept the ban in place.
March 22: A study is published that found public trust in the AstraZeneca vaccine collapsed in Europe at the time of the blood clot saga. A YouGov survey found more than half of people in Germany, France, Italy and Spain believed the jab was unsafe.
March 30: Germany bans the vaccine for people under the age of 60 after officials said they had found 31 cases of CSVT after 2.7million vaccinations.
April 2: UK regulators announce a total of 30 blood clots, 22 in the brain, have now been discovered in Britons vaccinated with the AZ jab.
April 5: UK regulators begin reviewing their guidance amid concern the jab is considerably more likely among younger people.
April 7: The UK’s chief vaccine advisory group concludes the jab should not be given to Brits aged between 18 and 29. It said an ‘alternative’ vaccine should be given, if one is available.
April 7: The EU’s regulator took a different approach, saying that blood clots should be listed as a ‘very rare’ side effect of the AstraZeneca vaccine but stopping short of imposing any age restrictions on its use.
She said: ‘Vaccination is extremely important in helping us in the fight against Covid-19.
‘This vaccine has proven to be highly effective. It is saving lives, vaccination is extremely important in helping us in the fight against Covid and we need to use the vaccine we have to protect us from the devastating effects.
‘We will continue to monitor the scientific evidence and issue further recommendations, if necessary, on the grounds of science and robust evidence.
‘When millions of people receive these vaccines, very rare events can occur that were not identified in clinical trials.
‘Our conclusion is that these clotting disorders are very rare side effects of the vaccine.’
Ms Straus said the benefits of the AstraZeneca vaccine in preventing Covid-19 overall outweigh the risk of side effects.
She said: ‘This vaccine has proven to be highly effective, it prevents severe disease and hospitalisation and it is saving lives.
‘Vaccination is extremely important in helping us in the fight against Covid-19 and we need to use the vaccines we have to protect us from the devastating effects.
‘Prac, after a very in-depth analysis, has concluded that the reported cases of unusual blood clotting following vaccination of the AstraZeneca vaccine should be listed as possible side effects of the vaccine.’
She added: ‘I think that the cases that we have evaluated, the 62 together with the expert group, those cases provided quite good and extensive information.
‘But nevertheless, the number is very limited. On the one hand, that’s of course very good and fortunate that the number of cases is limited. At the same time, that also makes it very difficult to find common factors.
‘And on the other hand, what we also know is a lot of cases that are spontaneously reported, they are not as complete as we would like to have them in order to further analyse them.
‘So I would like to repeat again, my kind request for people who suspect that they might have a side effect, please report it, and report it as extensively, and as complete, as possible.’
Some 34million AstraZeneca jabs had been dished out in the EU by April 4, with 169 cases of CVS and 53 cases of splanchnic vein thrombosis. This is the equivalent of one in every 150,000 doses, according to Google.
The EMA said the updated figures – which were slightly higher than the headline numbers in the main release – did not change the recommendations.
Scientists believe the combination of clots and low blood platelets could be caused by an immune response leading to a condition similar to those seen in heparin patients.
Patients who use the blood thinner sometimes fall into heparin induced thrombocytopenia — a condition involving thrombosis.
Professor Van-Tam insisted that the MHRA’s updated guidance would not impact Boris Johnson’s roadmap out of lockdown, which will see restrictions lifted fully on June 21.
Officials have put the AstraZeneca jab at the heart of the country’s rollout and the leaked delivery schedule reveal the Government is expecting it to make up 75 per cent of its Covid vaccine supplies over the next two months.
The document, published on the Scottish Government’s website in January and quickly taken down, showed the UK was anticipating about 29.4million doses of AstraZeneca’s jab between April and the first week of June.
For comparison, officials expected just 8.5m of Pfizer’s vaccine — which is already being rationed for second doses — in the next two months. Britain’s supply comes entirely from the EU, which has threatened to block exports of the jab.
Officials were also only expecting 1million doses of the new Moderna jab, which is being rolled out for the first time in Wales today. But supply will trickle in at around 160,000 doses a week, if the leaked plans are still correct. And the UK has only bought 17million – enough to vaccinate 8.5million people.
Professor Adam Finn, from the University of Bristol and a member of the Government’s vaccine advisory group, the JCVI, admitted pausing the AstraZeneca jab could threaten Britain’s roadmap out of lockdown.
He said today: ‘We do need to keep the programme going if the plan to open things up and allow things to get back to normal is to proceed without another wave of the pandemic coming through. So it’s quite a tricky balancing act here, getting the balance right, getting vaccines coming through… getting the risk-benefit right for people coming forward.’
One Tory MP told MailOnline that halting the jab would ‘certainly put things back’, adding: ‘Clearly it would have very adverse consequences because AstraZeneca is the workhorse of the vaccination programme.’
However, the UK inoculation programme could be bolstered if two other promising jabs under review are given approval by the UK Medicines and Healthcare products Regulatory Agency in the coming weeks.
The chief scientist behind the US-developed Novavax vaccine, which Britain has secured 60million doses of, has said he expects it to be given the green light this month and rolled out in May. All of the Novavax supplies on order will be manufactured within the UK under a new Government deal announced last week, which could drastically speed up its distribution.
A separate vaccine made by American pharmaceutical giant Johnson and Johnson, which uses the same type of technology as AstraZeneca’s but is administered via a single injection, is slated for a summer rollout. Because people given the J&J vaccine don’t need a 12-week follow-up appointment, it means ministers don’t have to reserve supplies for second doses and can unleash them all at once.
MHRA sources originally said it would be ban for under-30s, which wouldn’t pose as much damage to roll-out. But there are fears that any ban could dent public confidence.
Britain’s inoculation drive drastically slowed down over the Easter weekend, figures show. Just 100,000 vaccines were dished out on Sunday and Monday, reaching 88,000 Britons.
Number 10’s scientific advisers have already hinted that supplies of Moderna’s jab could be reserved for younger people, if the MHRA pressed ahead with a German-style ban.
Last night Oxford University halted trials of its coronavirus vaccine in children until the Medicines and Healthcare products Regulatory Agency (MHRA) concluded on its safety in younger people, with formal advice expected in as early as today.
Other leading experts today leapt to defend the AstraZeneca vaccine — which is the mainstay of the UK’s roll-out.
Former chief executive of the MHRA, Sir Kent Woods, said he has ‘no reservations’ about the jab because the risks of Covid are ‘much higher’. SAGE adviser Professor Calum Semple said he is ‘not worried one little bit’ about the fears and that it was a ‘no-brainer’ that he, as a 53-year-old, should get the jab.
One Cambridge scientist downplayed calls to pause the roll-out, saying he would ‘certainly come forward for that vaccine at the moment’.
Last night it was revealed Oxford University had paused its vaccine trial on children amid concerns around blood clotting.
The university said the decision to pause its trial was precautionary and that there were no health issues among any of the youngsters involved.
The university began studying the vaccine in five-to-17-year-olds in February, with the aim of eventually scaling up the trial and testing it in 200 people.
Researchers have stopped recruiting new volunteers and it is not clear how many children have already been given a dose.
Oxford said it was waiting for more information from the UK’s regulator, the Medicines and Healthcare products Regulatory Agency, before restarting the study.
Britain’s study of AstraZeneca’s vaccine on children was also going to give 200 youngsters a placebo. An AstraZeneca spokesman told the WSJ the company was awaiting the outcomes of the regulatory reviews and declined to comment further.