Regulator warns of small risk of serious condition in people having RSV jab
Guillain-Barre syndrome is a rare but serious condition which needs urgent treatment in hospital to prevent it progressing.
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
Yahoo
2 hours ago
- Yahoo
6 insect bites and stings to watch out for
With temperatures soaring over the past few weeks, many of us have been spending more time outdoors, making the most of the warm weather. But while barbecues and picnics are summer highlights, all that fresh air can sometimes come with unwanted side effects – insect bites. Most insect bites are harmless and will clear up within a few days, according to the NHS, but some can trigger allergic reactions, infections or – in rare cases – more serious complications. From ticks to horseflies, here's what you need to know about the bites to watch out for – and when it's time to get medical help. Ticks are small, spider-like creatures that live in grassy areas and woodland and feed on the blood of animals and people. It doesn't hurt when a tick bites you, so you might not realise you've been bitten until you find one attached to your skin. The biggest concern with tick bites is Lyme disease. The UK Health Security Agency (UKHSA) estimates between 4% and 10% of ticks in the UK carry this bacterial infection, which can lead to flu-like symptoms, fatigue and, in some cases, serious long-term complications like arthritis and nerve problems. If you're bitten by a tick, you should remove it as soon as you see it. How to treat: To remove the tick safely, use fine-tipped tweezers to grasp it as close to the skin as possible Pull upwards slowly without twisting or crushing it Wash the area with soap and water Keep the tick in a container to show your GP if needed Never burn the tick off or cover it with chemicals, as this can increase infection When to see a doctor: A circular rash that looks like a bullseye around a tick bite can be an early symptom of Lyme disease. This usually appears within one to four weeks of being bitten, according to the NHS. If you notice a rash or feel unwell after a tick bite, contact your GP straight away. Horseflies are large, dark flies with powerful mouthparts that saw into the skin. Only female horseflies bite but the bite can be painful and quickly causes redness, swelling and itchiness. In some cases, horsefly bites can lead to fluid-filled blisters or infection. How to treat: Wash the area and apply antiseptic Cover up with clothing if you're near fields Horseflies are attracted to dark colours, so opt for light clothing Use insect repellent that specifically mentions horseflies on the label When to see a doctor: If the bite becomes increasingly swollen, warm or oozes pus, speak to a pharmacist or GP as you may need antibiotics. Most bee or wasp stings cause redness and pain, but in rare cases they can trigger a severe allergic reaction called anaphylaxis. Hornet stings are similar but can be more painful because hornets inject more venom. Unlike bees, hornets and wasps can sting repeatedly. How to treat: Remove the sting if visible by scraping sideways with a credit card Wash with soap and water Apply a cold compress for swelling Take painkillers if needed When to see a doctor: Call 999 or got to A&E straight away if you have difficulty breathing, dizziness or swelling in your face or throat, or you develop a rash that spreads rapidly. While UK mosquitos generally don't transmit diseases like malaria (the risk is currently very low), their bites can still cause red, itchy bumps that sometimes blister. Children can react more strongly, developing large, inflamed areas. How to treat: Use a cold compress to reduce swelling Apply an antihistamine cream or take an antihistamine tablet Avoid scratching to lower the risk of infection Wear long sleeves and trousers if mosquitos are about Avoid scented products that can attract them. When to see a doctor: Most bites and stings improve within a few days, but you should get medical help if You were bitten near your eyes, throat or mouth, the swelling is severe or spreading rapidly, you have symptoms of infection (redness, pus, warmth) or if you feel dizzy or nauseous. If you or someone else develops severe symptoms of an allergic reaction, like difficulty breathing, tight chest or swelling in the mouth or throat, call 999 immediately. Harvest mites are tiny red or orange mites that are most active in late summer and early autumn. Their bites often appear as clusters of small, intensely itchy red bumps, typically around the ankles, waistline or under tight clothing. Most bites are harmless, but severe reactions can occur if they become infected through scratching. How to treat: Wash skin with soap and water Apply cold compresses to reduce itching Use an antiseptic cream to lower infection risk When to see a doctor: If the bites become swollen, ooze pus, or you feel generally unwell, speak to your GP. Red ants (including flying red ants) can bite or sting, releasing formic acid that causes a sharp, burning pain and local swelling. While most reactions are mild, some people develop large areas of redness and swelling that last days, and rarely, a severe allergic reaction. How to treat: Wash the area with soap and water. Apply a cold pack for 20 minutes. Take an antihistamine if it's very itchy. When to see a doctor: Call 999 or go to A&E if you have trouble breathing, feel faint or develop swelling in your mouth or throat. Read more about insects: The truth about flying ant day and the best way to get rid of the pesky insects (Yahoo Life UK, 4-min read) If you've been bitten by a tick, follow these 5 steps (Yahoo Life UK, 5-min read) Not All Garden Bugs Are Bad—Here's a Guide to the Insects That Actually Benefit Your Plants (RealSimple, 4-min read)
Yahoo
3 hours ago
- Yahoo
Social and economic factors having negative influences on health in North East
A doctor's prescription pad can be 'useless' when it comes to combating social and economic contributions to ill health, councillors have been told. Councillors from across seven regional local authorities gathered at Gateshead Civic Centre on Monday for a presentation on the state of the region's health and economic disparities. Previous reporting has highlighted alarming statistics on life expectancies and the average weekly earnings per council area. According to the NHS's presentation, not one council area in the LA7 (Gateshead, Northumberland, North Tyneside, South Tyneside, Sunderland, Durham, Newcastle) matched the national average weekly earnings of £566. In addition, only Northumberland matched the national average life expectancy for women, 83.3 years. All council areas fell below the national life expectancies for men. READ MORE: Gateshead supported housing scheme to help those at risk of homelessness READ MORE: New kind of bacteria found in Gateshead park that could help clean up rivers and treat disease Councillors were informed that health can be influenced by wider social issues, including environment, employment and economic success. Medical director at North East and North Cumbria Integrated Care Board (ICB), Dr Robin Hudson said: 'I trained at Newcastle University medical school a long time ago, and one of the things I realised over the last ten to fifteen years, is my medical qualifications are useless when it comes to poor housing, pollution, diet. Our ChronicleLive Daily newsletter is free. You can sign up to receive it here. It will keep you up to date with all the latest breaking news and top stories from the North East. 'With lifestyle we can have a bit of influence with smoking and healthy weights, but actually the tools in my tool box are very limited. If you look at health outcomes, only about 20% of the time it is related directly to the quality of care people receive at hospital or GPs. 30% is to do with lifestyle, so alcohol, smoking and healthy weights. '50% is to do with wider social determinants, like employment. Good employment. All those things which we know make people happy and feel involved in their communities.' However, Dr Robin went on to say the work of social prescribers can often help patients where a strictly medical response is not appropriate. Such prescribers can offer help and advice on societal influences on people's health and wellbeing. Dr Hudson continued: "Social prescribing has been really popular over the last eight-nine years, they work in GP practices. So when I have a prescription pad that is useless, because I don't know anything about debt management, a social prescriber does.' The presentation also went on to highlight the work of the Voluntary Organisations' Network North East, in helping to combat wider inequalities that affect patients' health in the region.
Business Wire
4 hours ago
- Business Wire
GenSight Biologics Reports Cash Position as of June 30, 2025
PARIS--(BUSINESS WIRE)--Regulatory News: "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics." Share GenSight Biologics (" GenSight Biologics" or the " Company") (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today reported its cash position as of June 30, 2025. "The second quarter of 2025 marked a period of significant operational progress for GenSight Biologics. We successfully completed the technology transfer of LUMEVOQ's upstream manufacturing process to our new partner Catalent, secured the ANSM's agreement to consider opening the AAC program in France, and closed our private placement financing in July, ' commented Jan Eryk Umiastowski, CFO of GenSight Biologics. ' We continue to actively pursue non-dilutive financing options to support our critical value-driving activities. With the AAC program launch planned for Q4 2025, we have established a clear financial pathway through H2 2026, when we expect to initiate our Phase III RECOVER trial and submit our marketing application to the MHRA of the UK." Cash position as of June 30, 2025 GenSight Biologics' cash and cash equivalents totaled €0.3 million as of June 30, 2025, compared to €0.9 million as of March 31, 2025. With the equity-with-warrants-attached and pre-funded warrants financing announced on July 1, 2025 (approximately €3.9 million) and the anticipated collection of approximately additional €0.2 million in Research Tax Credit (CIR) in September, and based on current operations, plans, and assumptions, this balance should fund operations until early October 2025. EUR 0.7 million of the proceeds from the financing has been used for the repayment in principal on the convertible bonds held by Heights Capital through offset against their subscription. The funds are insufficient to cover operational requirements for the next 12 months. However, the anticipated opening of the AAC program in France in Q4 2025 (targeted for October) will establish a clear cash pathway until H2 2026, when the company expects to initiate the RECOVER Phase III clinical trial and to submit the UK MHRA marketing application for LUMEVOQ ®. The company is pursuing strategic options that could generate funds for the Phase III trial and UK regulatory submission. These include: Licensing of LUMEVOQ outside Europe and the United States Exploring paid compassionate access programs in other countries Release of the second tranche of the EIB loan In the first quarter of 2026, the company will have a precise view of residual financing needs and will make a strategic decision on additional financing modalities. If necessary, GenSight Biologics may access financial markets. Options in the medium term include partnering or M&A arrangements. Recapitulation of Recent Milestones Regulatory Progress and Named Early Access Program (AAC) In June 2025, GenSight achieved a significant regulatory milestone when the ANSM agreed to consider opening the LUMEVOQ ® AAC program, contingent upon approval of a dose-ranging study. The Company has submitted a preliminary study design to the agency and expects to finalize the protocol in Q3 2025. Concurrently, GenSight is working with the ANSM to establish AAC program access for patients who may not qualify for the study but could benefit from early access to LUMEVOQ ®. The AAC program is targeted to launch by Q4 2025, with an anticipated opening in October 2025. Manufacturing Partnership and Scale-Up In June 2025, the Company successfully completed the transfer of LUMEVOQ ® 's upstream manufacturing process to its new manufacturing partner, Catalent, Inc. The technology transfer is expected to be finalized by the end of 2025, positioning Catalent to manufacture the drug product for both the planned global Phase III RECOVER trial and regulatory submission requirements. Number of outstanding shares As of July 8, 2025, GenSight Biologics' number of outstanding shares was 152,717,762 ordinary shares. Financial Agenda The Company will report its interim H1 financial results by the end of September 2025. About GenSight Biologics S.A. GenSight Biologics S.A. is a clinical-stage biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders. GenSight Biologics' pipeline leverages two core technology platforms, the Mitochondrial Targeting Sequence (MTS) and optogenetics, to help preserve or restore vision in patients suffering from blinding retinal diseases. GenSight Biologics' lead product candidate, GS010 (lenadogene nolparvovec) is in Phase III in Leber Hereditary Optic Neuropathy (LHON), a rare mitochondrial disease that leads to irreversible blindness in teens and young adults. Using its gene therapy-based approach, GenSight Biologics' product candidates are designed to be administered in a single treatment to each eye by intravitreal injection to offer patients a sustainable functional visual recovery. Forward-Looking Statements This press release contains forward-looking statements. All statements, other than statements of historical facts, included in this press release are forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the completion expected proceeds and anticipated use of proceeds of the Private Placement; the anticipated cash runway of the Company; and future expectations, plans, and prospects of the Company. Words such as 'anticipates,' 'believes,' 'expects,' 'intends,' 'projects,' and 'future' or similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions and no assurance can be given that the proposed securities offering discussed above will be consummated on the terms described or at all. Completion of the proposed Private Placement and the terms thereof are subject to numerous factors, many of which are beyond the control of the Company, including, without limitation, market conditions, failure of customary closing conditions and the risk factors and other matters set forth in the filings the Company makes with the AMF from time to time. The Company expressly disclaims any obligation to update any forward-looking statements, whether because of new information, future events or otherwise, except as may be required by law.
