
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


Daily Mail
20 hours ago
- Daily Mail
GSK strikes £370m deal with Chinese rival Jiangsu Hengrui to develop up to a dozen new medicines
GSK has struck a £370million deal with a Chinese rival to develop up to a dozen medicines, including a promising candidate for a chronic lung condition. The deal with Jiangsu Hengrui Pharmaceuticals comes as GSK focuses on growing its pipeline to negate declining revenues from top drugs and vaccines amid slowing demand and rising competition. Under the deal, GSK will gain an exclusive licence to Hengrui's HRS-9821, which is being studied as a treatment for chronic obstructive pulmonary disease. GSK shares rose 0.4 per cent, or 5.5p, to 1398p.


Reuters
a day ago
- Reuters
Celcuity's triple drug combo tops AstraZeneca's treatment in breast cancer trial
July 28 (Reuters) - Celcuity (CELC.O), opens new tab said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer in a late-stage study, sending the biotech firm's shares surging to a record high. The drug, gedatolisib, in combination with Pfizer's (PFE.N), opens new tab Ibrance and AstraZeneca's (AZN.L), opens new tab endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients. HR+/HER2- breast cancer accounts for about 70% of all breast cancers. The study showed "unprecedented results", Leerink Partners analyst Andrew Berens said. Gedatolisib could become a new standard of care as a second-line treatment in breast cancer, especially in the community settings, Berens said. Celcuity's triple combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' (NOVN.S), opens new tab Afinitor and AstraZeneca's Truqap. Celcuity projects revenue potential of $5 billion for the treatment in the second-line treatment setting. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, the company said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from the late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm more than doubled to $38.02 in early trading.


Reuters
a day ago
- Reuters
Celcuity's triple cancer drug combo tops AstraZeneca's in cutting progression in study
July 28 (Reuters) - Celcuity (CELC.O), opens new tab said on Monday its experimental combination treatment delayed the progression of a type of advanced breast cancer, sending the biotech firm's shares surging more than twofold in premarket trading. The drug, gedatolisib, in combination with Pfizer's (PFE.N), opens new tab Ibrance and AstraZeneca's (AZN.L), opens new tab endocrine therapy Faslodex, reduced the risk of disease progression or death by 76%, compared to Faslodex alone in previously treated HR+/HER2- advanced breast cancer patients in a late-stage study. HR+/HER2- breast cancer accounts for about 70% of all breast cancers. The combination treatment helped patients live for an average of 9.3 months without progression of the disease, compared to about two months with Faslodex. Gedatolisib belongs to a class of drugs called PAM inhibitors, which include Novartis' (NOVN.S), opens new tab Afinitor and AstraZeneca's Truqap. The treatment was better tolerated in the late-stage trial than a previous early-stage study, with lower rates of high blood sugar and inflammation in the tissue lining the mouth, Celcuity said, without offering further details. The study also showed that a double combination of gedatolisib and Ibrance reduced the risk of disease progression or death by 67%, compared to Faslodex. This combination increased survival without progression of the disease in patients by 7.4 months on average, compared to about two months with Faslodex. Celcuity plans to report full results from this late-stage study and data from a separate trial in patients whose tumors had alterations in some genes later this year. It expects to apply for U.S. marketing approval in the fourth quarter. Shares of the Minnesota-based firm jumped nearly 114% to $29.4 before the bell.