Regulator warns of small risk of serious condition in people having RSV jab
It can affect people's senses, movement, breathing and heartbeat – usually starting in the arms and legs before spreading to other areas.
The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a drug alert for the Abrysvo (made by Pfizer) and Arexvy (GSK) vaccines for RSV after they were linked to 21 suspected cases of Guillain-Barre syndrome in adults aged 60 and over.
However, the Commission on Human Medicines still advises that 'the benefits of vaccination against RSV outweigh the small risk of developing Guillain-Barre syndrome in older adults'.
In its alert, the MHRA said: 'Healthcare professionals should advise all recipients of Abrysvo and Arexvy that they should be alert to signs and symptoms of Guillain-Barre syndrome and, if they occur, to seek immediate medical attention as it requires urgent treatment in hospital.'
It warned staff to be alert to the signs and symptoms of the syndrome.
It added that there is currently no evidence of an increased risk of Guillain-Barre syndrome in pregnant women following vaccination with Abrysvo, the only RSV vaccine approved for use during pregnancy.
The RSV vaccine helps protect against respiratory syncytial virus, which can make older adults and babies seriously ill.
RSV can cause bronchiolitis in babies which can cause breathing problems, while it can cause pneumonia in older people, both of which may require hospital stays.
The Pfizer RSV vaccine Abrysvo is currently offered on the NHS to adults aged 75 to 79 and to pregnant women.
The GSK RSV vaccine Arexvy is not currently available on the NHS but may be available privately in the UK.
Symptoms of Guillain-Barre syndrome can include tingling, numbness or pins and needles in feet and hands, muscle weakness and difficulty moving joints.
There may also be problems breathing and drooping face muscles or trouble swallowing or speaking.
Up to June 2, the MHRA has received 21 Yellow Card reports of suspected Guillain-Barre syndrome in older adults (aged 75-79 where known) following Abrysvo.
This is in the context of over 1.9 million doses of Abrysvo administered, it said.
Over the same time period, the MHRA has not received any Yellow Card reports of suspected Guillain-Barre syndrome following Arexvy, however there has been very limited use of this vaccine in the UK to date.
In the US, one study suggested Abrysvo and Arexvy were associated with nine and seven excess Guillain-Barre syndrome cases per million vaccine doses administered, respectively.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Reuters
4 hours ago
- Reuters
Jiangsu Hengrui grants GSK global rights to drug portfolio in $500 million deal
HONG KONG, July 28 (Reuters) - China's Jiangsu Hengrui Pharmaceuticals ( opens new tab said on Monday it has agreed to license the global rights of its HRS-9821 drug and 11 other programmes to GlaxoSmithKline Intellectual Property (GSK) for $500 million upfront. The Chinese pharma group said, opens new tab it could earn up to $12 billion in milestone payments if all options are exercised and targets are met. HRS-9821 is being developed to treat chronic obstructive pulmonary disease (COPD), while the other projects are in early development across areas such as oncology, respiratory, immunology, and inflammation. Shanghai shares of Jiangsu Hengrui climbed 6.6% and its Hong Kong-listed stock jumped 8.5%, outperforming the blue-chip CSI 300 Index's (.CSI300), opens new tab 0.1% slip and the Hang Seng Index's (.HSI), opens new tab 0.3% gain.
Evening Standard
8 hours ago
- Evening Standard
Pharmacies warn of unsustainable demand for weight loss medication
Mounjaro and Wegovy are licensed by the Medicines and Healthcare products Regulatory Agency (MHRA) for use in patients with a BMI of over 30 or between 27 and 30 but with a weight-related co-morbidity. This occurs when an individual who has obesity develops another medical condition due to their weight.
Daily Mail
a day ago
- Daily Mail
Health officials were warned of rogue Botox beauticians a YEAR ago - but failed to act
Drug safety chiefs were warned last year about rogue beauty therapists injecting illegal Botox-style products but failed to act before the jabs hospitalised dozens. The procedures, carried out by beauticians using unlicensed versions of botulinum toxin, left 38 people across the North East, North West, East of England and Midlands seriously ill with paralysis-like symptoms and breathing difficulties. The alarming outbreak this month has exposed 'gaping holes' in regulation, claim senior doctors now calling on the Government to ban medically unqualified practitioners from administering cosmetic injections. Dr Steven Land, a Newcastle-based expert in aesthetic medicine, said he first raised concerns in November 2023 with the Medicines and Healthcare products Regulatory Agency (MHRA). 'Our only surprise is that this didn't happen sooner,' he said. 'I was getting WhatsApp messages and emails every week from people selling knock-off toxin – illegal, unlicensed products that you can buy online with no checks.' Dr Land said he provided the MHRA with names, phone numbers, pricing information and screenshots of practitioners openly advertising cut-price anti-wrinkle jabs using unlicensed botulinum toxin. He added: 'When I followed up in April, they told me the matter would be dealt with 'in due course'. Nothing happened. If action had been taken when I raised the alarm, dozens might not have ended up in hospital.' MHRA was asked to comment. Due to the severity of the situation, the UK Health Security Agency (UKHSA) announced this month it had launched an inquiry. The practitioners involved are said to be cooperating, although no further detail has been given. Dr Land said two beauty therapists operating in his area had been identified as the primary source of the outbreak. Both had used a Korean-manufactured product called Toxpia. 'Neither had any medical qualifications – just basic beauty therapy training – and both were injecting clients in salons and private homes using the same unlicensed product,' he said. 'We believe they were buying this toxin online and administering it with no clinical oversight.' HJ Corporations Co. Ltd, the maker of Toxpia, was approached for comment. More than seven million people in the UK undergo cosmetic treatments – including Botox and fillers – each year and demand is growing. The industry is now worth an estimated £3.6billion. Yet in Britain, anyone can legally offer cosmetic injections regardless of medical training – a situation many doctors have long condemned. A recent study by University College London found that two in three procedures are carried out by non-medics, including hairdressers and beauty therapists. Dr Christopher Rowland Payne, president of the Royal Society of Medicine Section of Aesthetic Medicine and Surgery, said: 'The current situation is quite terrifying. It is irresponsible for the Government to allow this to continue. 'Britain is the odd man out in Europe in allowing non-medics to perform these procedures.' Dr Rowland Payne, who gave evidence to the women and equalities committee on the issue, also highlighted the stark differences in training between medics and non-medics offering Botox. Botulinum toxin – the active ingredient in Botox – is one of the most powerful poisons known, being found in soil and contaminated food. When consumed, it can cause botulism – a potentially fatal illness that leads to muscle paralysis and respiratory failure. Its potency is staggering: gram-for-gram, botulinum toxin is estimated to be 100,000 times more toxic than cyanide. Experts stress that the risk is not with approved brands – such as Botox, Dysport, Xeomin and Jeuveau – but with counterfeit or unlicensed versions used by untrained individuals. Toxpia is not licensed for use in the UK though industry insiders say it is available to buy online. In 2023, the Government launched a consultation on new rules for the aesthetics sector and Health Secretary Wes Streeting suggested this month a crackdown was imminent. Kaylie Bailey, 36, from Peterlee, County Durham, was left fighting for her life and now wears an eye patch after developing paralysis and losing the ability to breathe. She had paid £75 for cut-price anti-wrinkle jabs from beautician Gemma Gray – who has since admitted the product caused widespread harm but claimed it was a 'nationwide problem'. 'I remember lying on the bed thinking 'I'm dying',' added Ms Bailey, who spent three days in intensive care with botulism. We're having to live with what she [the beautician] did to us. I nearly died because of it.'
