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Friday, 9 April 2021

Fresh blow for AstraZeneca as vaccine is linked to another dangerous blood condition in Europe - while regulators review four cases of brain clots linked to Johnson and Johnson's single-dose jab that UK has bought 30million doses of

  • Five cases of capillary leak syndrome reported after AZ vaccine on continent
  • Condition sees blood leak from tiny vessels into muscles and body cavities
  • The issue could mean AstraZeneca jabs being banned for the under-40s 
  • J&J vaccine was also linked to four cases of brain clots, one of which was fatal
  • Use of the jab was stopped in North Carolina following 18 'adverse reactions'Another potentially dangerous blood condition has been spotted in a handful of patients given the AstraZeneca coronavirus vaccine, the EU's drug watchdog has announced. 

    The European Medicines Authority (EMA) said five cases of capillary leak syndrome had been reported in vaccinated patients on the continent.

    The rare condition sees blood leak from tiny vessels into muscles and body cavities, resulting in a sudden drop in blood pressure. If left untreated, it can cause organ failure.

    Data suggests the UK's regulator, the MHRA, had spotted three cases of capillary leak syndrome out of 20million people given the AstraZeneca vaccine by late March. 

    It is another blow for the British-made jab, which has been restricted for certain age groups in various countries around the world, including under-30s in Britain, after reports of rare blood clots in the brain and abdomen.

    Officials insisted there is still no evidence the jab causes the blood conditions and stressed the benefits of vaccination far outweighed the risk.

    Meanwhile, the EMA revealed it is also reviewing reports of rare clots involving Johnson and Johnson's Covid vaccine, which uses the same technology as AstraZeneca's.

    Four serious cases of rare blood clots with low platelets were detected in people vaccinated with the jab, one of which died.

    A vaccination site in North Carolina has stopped the use of the jab after 18 people had adverse reactions 'out of an abundance of caution'.

    'The reactions people experienced today were consistent with known common side effects from receiving the vaccine,' Wake County officials said in a statement about the adverse reactions at PNC Arena in Raleigh.

    Wake County said it will announce 'guidance' about its use in the coming hours after Centers for Disease Control and Prevention experts assess the batches. They have affected less than one per cent of recipients. 

    Just hours earlier, a similar incident forced a Colorado clinic to shut down. Eleven people suffered adverse reactions 'such as nausea and dizziness' at a pop-up vaccination site at a Dick's Sporting Goods in Commerce City and two had to be hospitalised. 

    The J&J jab, made by the US-firm's Belgium arm Janssen, had been earmarked by UK officials for young people because it is given as a single dose.

    The vaccine has been approved in the EU and was due to be rolled out in the coming months. It is currently under review by the UK's medicines watchdog and the UK Government has ordered 30million doses.

    The EMA has said that 'at this stage, it is not yet clear whether there is a causal association' between either vaccines and the reported conditions.

    J&J said that it was aware of the reports of blood clots and is working with regulators to assess the data and provide relevant information. 

    'At present, no clear causal relationship has been established between these rare events and the Janssen Covid vaccine,' the company said in a statement.

    The European Medicines Authority said five cases of capillary leak syndrome had been reported in people given the AstraZeneca vaccine

    The European Medicines Authority said five cases of capillary leak syndrome had been reported in people given the AstraZeneca vaccine 

    The EMA revealed it is also reviewing reports of rare clots involving Johnson and Johnson's Covid vaccine, which uses the same technology as AstraZeneca

    The EMA revealed it is also reviewing reports of rare clots involving Johnson and Johnson's Covid vaccine, which uses the same technology as AstraZeneca

    It comes as Johnson & Johnson's COVID-19 shot was paused at the PNC Arena site (pictured) in Raleigh, North Carolina after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals

    It comes as Johnson & Johnson's COVID-19 shot was paused at the PNC Arena site (pictured) in Raleigh, North Carolina after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals 

    Stacey Beard, a spokesperson at the Raleigh site, also told WRAL that about 2,000 shots a day had been given out at the site, and only a 'handful' of the J&J shots it gave resulted in adverse reactions.

    Generally, the shot is thought to have a milder side effect profile compared to vaccines made by Pfizer and Moderna. Similarly, the reactions at the Colorado clinic represented less than one percent of the 1,300 shots it was giving a day. 

    Both AstraZeneca and the J&J vaccines are viral vector types, which use a weakened version of a different virus to deliver instructions to human cells.

    So far over 20 million AstraZeneca jabs have been given out in the UK, and 5 million J&J vaccinations in the US.  

    They tell the cells to produce a harmless piece of Covid, known as a spike protein, so the body can recognise it if the real virus infects them.

    WHAT IS CAPILLARY LEAK SYNDROME?

    Capillary leak syndrome, also known as Clarkson's disease, sees blood leak from tiny vessels into muscles and body cavities.

    This can result in a sudden drop in blood pressure and, if left untreated, organ failure.

    Initial symptoms may include fatigue, nausea, abdominal pain and extreme thirst. 

    The condition is extremely rare and thought to affect just one in a million people a year, according to the US National Institutes of Health.

    In most cases the cause is not known, but some people have reported having a viral infection before the episode. 

    Patients are treated with an infusion of fluids or blood medications.

    Scientists are interested in whether the clotting issues are related to the engineered spike protein specifically, a senior SAGE source said today.  

    This could explain why clotting conditions have been widely reported in people who catch the real coronavirus. 

    However, the SAGE member said this would not account for why clotting issues have not been linked to the Pfizer or Moderna vaccines.

    Those vaccines use different technology to deliver the genetic instruction to the cells but they also trigger the body to make and recognise spike proteins. 

    Meanwhile, it was claimed today AstraZeneca's Covid vaccine may also be restricted for under-40s when Britain's immunisation drive moves down to younger groups. 

    Medical watchdogs will assess data on the jab's links to extremely rare blood clots in 'scrupulous detail' in order to paint a clearer picture on the exact risk-benefit ratio.

    They have already advised 18 to 29 year olds are given an alternative to the UK-made jab because their odds of falling seriously ill with Covid are so small that the benefits of AstraZeneca's do not clearly outweigh the potential clot risks.

    Analysis of the UK vaccine rollout has found that younger people appear more prone to clotting after vaccination but there is no set cut-off age. Experts have told MailOnline there is a 'gradual age gradient of risk'. 

    Professor Jeremy Brown, a member of the JCVI, which advises No10 on jabs, told the Daily Telegraph: 'We're going to start vaccinating phase two healthy adults, starting with the 40 to 50-year-olds, and then we'll go to the 30 to 40-year-olds.

    'When we are approaching that point we'll need to think about this a little bit more to be absolutely sure at what point in that age cut-off – given the situation we are facing at that time, and any more data that comes through on this rare complication, because more data will come through – then that might alter the age range.'  

    GPs have warned the announcements this week have unintentionally caused 'panic' and sparked a wave of cancellations for the AstraZeneca jab.

    Doctors in Nottingham and Peterborough said they had also been inundated with calls from concerned patients who have already had their first dose.

    Statisticians insist the risk of under-30s developing blood clots from AstraZeneca's jab is so tiny that if Wembley stadium was filled with people in the age group, only one would be struck down. 

    Britons still back the Oxford-AstraZeneca Covid vaccine - as 75 per cent tell pollsters (pictured) they consider it to be safe

    Britons still back the Oxford-AstraZeneca Covid vaccine - as 75 per cent tell pollsters (pictured) they consider it to be safeFor older adults, the risk of blood clots is even smaller - but their risk of dying from Covid is much higher, meaning the risks versus benefits swings heavily in favour of vaccination.

    The move to recommend under-30s get a different jab does not mean it is unsafe for young people, with neither the UK's drug regulator or the EU's ordering the jab to be banned for certain age groups. 

    But both acknowledge cases of blood clots from the life-saving jab appear to be occurring slightly more often in younger adults.

    EU nations - who have been embroiled in a stand-off with AstraZeneca for months - have defied guidance based on statistical analysis showing the vaccine's benefits outweigh the risks of the vast majority of adults. Germany has halted the jab for under-60s, while France has made the same move for under-55s. 

    France and Germany have both advised younger adults already given AstraZeneca's jab should get a second dose of Pfizer or Moderna's - taking the opposite stance to British counter-parts. 

    But the World Health Organization (WHO) today said there was 'no adequate data' on switching doses. The UK is currently trialling this dosing regimen, and scientists say it is likely to be safe and effective but results are not expected until later in the year. Amid fears the guidance could scupper the UK's vaccination roll-out, which is heavily reliant on AstraZeneca's jab, ministers yesterday sought to dismiss blood clot fears. Health Secretary Matt Hancock compared the risk of blood clots overall - one in 250,000 - to taking a long-haul flight.

    Nottingham GP partner Dr Irfan Malik told Pulse Magazine the new advice ‘created panic’ among patients.

    He said: ‘Patients and the public have become very concerned about the risk of clots with the Astra Zeneca vaccine – they are declining to have it. I’m afraid this has been badly managed and stopping the under-30s from having the vaccine has alarmed the public.

    ‘The changes have led to a substantial increase in calls to practices creating a further huge increase in workload.’

    Peterborough GP Neil Modha said the vaccine hesitancy was not just exclusive to under-30s, adding: 'It’s not just under-30s who are calling, the person who I just spoke to was 53, so it’s just general increased anxiety unfortunately about the vaccine programme. 

    'And then people have been signposted to their GPs for conversations and they’re not easy and simple conversations, you need to give people time and space to have them.’

    But polls show 75 per cent of the public still consider the jab to be safe.

    Professor Anthony Harnden, the deputy chairman of the JCVI, said the public 'should remain confident' in the vaccine programme despite the changes to guidance.

    He stressed to The Telegraph that the link with blood clots was a 'very, very rare, extremely rare safety signal'. However, he said the new advice that those under 30 should be offered an alternative to AstraZeneca – is unlikely to change.

    Professor Harnden said his team was poring over data for other groups and that they will have a 'much more clear' view a by the time the programme moves to thirty-somethings.

    Any decision to restrict AstraZeneca jabs to adults in their thirties could damage the UK's roll-out.

    Ministers insist there is enough doses of Moderna and Pfizer to cover the remaining 8.5million under-30s who have yet to be jabbed. 

    But estimates suggest there is around 10million adults in the 30-39 age bracket - and most won't have been offered their first dose yet.

    No10 has bought 40million doses of Pfizer's jab, but is rationing it for second doses to ensure the 11million people already given their first dose get their top-up within 12 weeks.

    Britain has also purchased 17million doses of Moderna's vaccine. It means that if the UK was to completely reserve supplies, there would be enough of the alternatives for around 17.5million people - similar to how many under-40s still need to be jabbed. 

    But there is no guarantee all the supplies will come by July 31 - the date ministers have set for offering every adult their first dose. 

    Other jabs, including ones made by Novavax and Johnson and Johnson, are set to come on stream in the coming months, which could provide the roll-out a much-needed boost in the face of any other age-restrictions on AstraZeneca's. 

    The rashes people claim occurred after receiving the AstraZeneca jab 

    Mild side effects have been common from all of the Covid vaccines approved so far, including AstraZeneca's.

    The Anglo-Swedish firm acknowledges that its shot can cause a host of symptoms that are usually nothing to worry about.

    The most common are pain, itchiness and bruising around the injection site, tiredness, chills, headaches, nausea and joint pain.  

    But number of people have reported suffering sore rashes after getting the shot and shared images of the painful blotches on social media.

    Britain's drug regulator lists rashes as an 'uncommon' side-effect of the AstraZeneca jab — affecting up to one in 100 people — and has recorded 3,795 cases so far. 

    Experts say the rashes, or any mild side effects, are actually a good thing, signalling that a person's immune system is responding to the vaccine.

    However, they warn that if symptoms persist for more than four days then people should seek urgent medical care.    

    Leigh King, a 41-year-old hairdresser from North Lanarkshire, said her skin erupted into rashes almost immediately after she got the AstraZeneca vaccine

    Leigh King, a 41-year-old hairdresser from North Lanarkshire, said her skin erupted into rashes almost immediately after she got the AstraZeneca vaccine 

     

    Johnson & Johnson vaccinations are paused at North Carolina site after 18 people have 'adverse reactions' and four are hospitalized following similar reactions at Colorado site

    ByNatalie Rahhal U.S. Health Editor 

    Vaccinations with Johnson & Johnson's COVID-19 shot have been paused at a North Carolina site after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals.  

    'The reactions people experienced today were consistent with known common side effects from receiving the vaccine,' Wake County officials said in a statement about the adverse reactions at PNC Arena in Raleigh. 

    The site stopped giving the J&J shot for the day 'out of an abundance of caution.' 

    Officials from Wake County, where Raleigh is located, are consulting with the state health department to decide how the clinic's vaccination program should proceed, according to local outlet CBS17. 

    Wake County said it will announce 'guidance' about its use in the coming hours after Centers for Disease Control and Prevention experts assess the lot.  

    It was not immediately clear what types of reactions the 'number' of people suffered following the shot, and the Wake County Health Department did not immediately respond to request for comment. 

    Just hours earlier, a similar incident forced a Colorado clinic to shut down. Eleven people suffered adverse reactions 'such as nausea and dizziness' at a pop-up vaccination site at a Dick's Sporting Goods in Commerce City and two had to be hospitalized. 

    It comes as Johnson & Johnson's COVID-19 shot was paused at the PNC Arena site (pictured) in Raleigh, North Carolina after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals

    Vaccinations with Johnson & Johnson's COVID-19 shot have been paused at the PNC Arena site (pictured) in Raleigh, North Carolina after 18 people had adverse reactions on Thursday. Four have been taken to area hospitals 

    Just hours earlier, a similar incident forced a Colorado clinic to shut down. Eleven people suffered adverse reactions 'such as nausea and dizziness' at a pop-up vaccination site at a Dick's Sporting Goods in Commerce City (pictured) and two had to be hospitalized

    Just hours earlier, a similar incident forced a Colorado clinic to shut down. Eleven people suffered adverse reactions 'such as nausea and dizziness' at a pop-up vaccination site at a Dick's Sporting Goods in Commerce City (pictured) and two had to be hospitalized

    It's worth noting, however, that the Raleigh site gives up to about 2,000 shots a day, and only a 'handful' of the J&J shots it gave resulted in adverse reactions, spokesperson Stacey Beard told WRAL. 

    Similarly, the reactions at the Colorado clinic represented less than one percent of the 1,300 shots it was giving a day.   

    So far, more than 4.5 million Americans have received J&J's one-dose vaccine. 

    Generally, the shot is thought to have a milder side effect profile compared to vaccines made by Pfizer and Moderna.

    Side effects are to be expected with any vaccine, but it comes at a tense time for Johnson & Johnson's vaccine. 

    Earlier this week, 15 million doses of the shot had to be thrown out because a manufacturing plant in Baltimore, Maryland used an ingredient meant for AstraZeneca's vaccine - which it was also producing at the time - in the shots. 

    U.S. officials assured Americans that shipments of Johnson & Johnson's vaccine shipped this week and last were not affected, however.  

    A New York Times report last week revealed that workers at an Emergent BioSolutions facility in Baltimore, which produced both AstraZeneca Plc and J&J doses, mixed up ingredients of the two vaccines, ruining 15 million J&J doses.

    The Baltimore facility has not been authorized by the U.S. Food and Drug Administration, and a federal health official told Reuters last week that none of the vaccine doses from the plant have been used in vaccination efforts so far. 

    The Colorado pop-up vaccination site also shut down after 11 people suffered reactions to the Johnson & Johnson shot, 'such as nausea and dizziness,' said a spokesperson for Centura Health, which oversees the clinic. 

    CDC and local officials are investigating the reactions, which accounted for less than one percent of vaccinations at each site 'out of an abundance of caution.' 

    By Thursday evening, officials concluded that the reactions in Colorado were not signs of anything worrying about the vaccine. 

    'After reviewing each patient’s symptoms, analyzing other vaccinations from the same lot of the vaccine and speaking with the CDC to confirm our findings, we are confident in saying that there is no reason for concern,' said Dr Eric France, chief medical officer at the Colorado Department of Public Health and Environment. 

    'We are committed to making sure every community clinic is well-staffed with medical professionals who take patient safety with the utmost seriousness, just as they did at yesterday’s clinic.' 

    The investigation at the Raleigh clinic is still ongoing.  

1 comment:

  1. If voting worked, they wouldn't use it.
    If vaccines worked, they wouldn't use it.

    ReplyDelete