UK health regulator approves Moderna's RSV vaccine for adults aged 60 and older
Feb 28 (Reuters) - Britain's health regulator said on Friday it has approved Moderna's (MRNA.O), opens new tab vaccine for respiratory syncytial virus in adults 60 years and older.
The shot, branded as mRESVIA, is for the prevention of lower respiratory tract disease in older adults, the Medicines and Healthcare products Regulatory Agency (MHRA) said.
RSV is a common virus that spreads very easily and causes infections that can be mild, with cold-like symptoms, but can also cause more serious problems, such as lung infections and pneumonia.
Older adults are at risk of more serious complications that could lead to hospital admission and even death.
GSK's (GSK.L), opens new tab vaccine Arexvy and Pfizer's shot Abrysvo are approved for use in individuals over the age of 60 in the UK.
Keep up with the latest medical breakthroughs and healthcare trends with the Reuters Health Rounds newsletter. Sign up here.
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North Wales Live
a day ago
- North Wales Live
Women warned over weight-loss jabs amid reports of 'unforeseen pregnancies'
Women using weight-loss injections are being cautioned to ensure they use reliable contraception, following reports that dozens have become pregnant while on the medication. The Medicines and Healthcare products Regulatory Agency (MHRA) has issued its first warning to the public about the combined use of contraception with weight loss and diabetes injections due to concerns over safe usage. These injectables have been associated with an unexpected surge in pregnancies, with online accounts mentioning unforeseen pregnancies even among women using contraception. To date, over 40 cases of pregnancy in women using weight-loss and diabetes injections have been reported to the MHRA. There are also cautions regarding the unknown risks of these injections, which include Ozempic, Mounjaro, Wegovy, Saxenda, and Victoza, for pregnant women. Ozempic isn't approved as a weight-loss medication in the UK, where it's used for treating diabetes instead. The MHRA says that such drugs—known as glucagon-like peptide-1 receptor agonists (GLP-1 or GLP-1 RAs)—should not be used by those who are pregnant, attempting conception, or breastfeeding. In the event of pregnancy during treatment, patients are advised to discontinue the medication immediately, reports Wales Online The agency stated: "This is because there is not enough safety data to know whether taking the medicine could cause harm to the baby." In some cases, women are also advised to continue using contraception for up to two months between stopping the medicine and trying to get pregnant. The MHRA said effective contraception includes the oral contraceptive pill, contraceptive implants, the coil and condoms. Those patients taking Mounjaro – which may reduce the effectiveness of oral contraceptives in people who are overweight – should also use condoms if they are on the pill. The MHRA said: "This only applies to those taking Mounjaro and is especially important for the four weeks after starting Mounjaro and after any dose increase." The advice on contraception is also contained in patient information leaflets that come with the medicines. MHRA data shared with the PA news agency shows it has received 26 pregnancy-related reports for Mounjaro. It is not necessary for women to say whether the pregnancy was unintentional, though one report did say the pregnancy was such. There have been a further eight reports relating to pregnancy in people taking semaglutide (the ingredient in Ozempic and Wegovy). A further nine have been recorded for liraglutide (Victoza or Saxenda), of which one recorded the pregnancy was unintentional. The MHRA is also reminding people that weight-loss jabs should not be bought from unregulated sellers such as beauty salons or via social media, or taken without speaking to a health professional. Anyone who suspects they have had an adverse reaction or suspects their drug is not a genuine product should report it to the MHRA Yellow Card scheme. Dr Alison Cave, MHRA chief safety officer, said: "Skinny jabs are medicines licensed to treat specific medical conditions and should not be used as aesthetic or cosmetic treatments. They are not a quick fix to lose weight and have not been assessed to be safe when used in this way. "Our guidance offers patients a 'one-stop shop' for our up-to-date advice on how to use these powerful medicines safely. This guidance should not be used as a substitute to reading the patient information leaflet or having a conversation with a healthcare professional as part of the prescribing process." The latest guidance also reminds patients taking jabs of the symptoms to look out for in the event of acute pancreatitis which, although uncommon, can be serious. The main symptom is severe pain in the stomach that radiates to the back and does not go away, and people should seek immediate medical help. GLP-1 or GLP-1 RAs help people feel fuller by mimicking a natural hormone released after eating. Some, like Mounjaro, also act on a second hormone involved in appetite and blood sugar control.
Reuters
3 days ago
- Reuters
Novo's Ozempic, Wegovy linked to rare cases of dangerous eye disorder, EMA says
June 6 (Reuters) - The European Medicines Agency's safety committee has concluded that the use of Novo Nordisk's ( opens new tab popular weight-loss drug Wegovy and its treatments for type 2 diabetes may cause rare occurrences of a potentially dangerous eye condition. Called non-arteritic anterior ischemic optic neuropathy (NAION), the condition may affect up to 1 in 10,000 people taking semaglutide, the active ingredient in Wegovy and Novo's diabetes drugs Ozempic and Rybelsus, the regulator said on Friday. The EMA, which started its review in December, said the use of the drugs is linked to about twofold increase in the risk of developing the condition compared to people not taking the medicine. NAION develops from insufficient blood flow to the optic nerve and causes sudden painless vision loss in one eye. It is the second most common cause of blindness due to optic nerve damage, after glaucoma. Studies have linked semaglutide to NAION in the past. But this is the first time a regulator has made the link. Semaglutide belongs to a class of drugs known as GLP-1 receptor agonists, which work by helping control blood sugar levels and triggering a feeling of fullness. A large study of nearly 350,000 diabetics published earlier this year had showed that the risk of developing NAION more than doubled after long-term use of semaglutide, compared to patients taking medicines from other classes. The EMA said it has reviewed all available data on NAION with semaglutide, including data from non-clinical studies, clinical trials and post-marketing surveillance. It has recommended the drugmaker to update prescribing information for medicines containing semaglutide to include NAION as a side effect with a frequency of "very rare". The U.S. Food and Drug Administration did not immediately respond to a Reuters request for comment.
Reuters
3 days ago
- Reuters
Health Rounds: Roche's Tecentriq reduces recurrence, deaths for certain colon cancer patients
June 6 (Reuters) - (This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays. To receive the full newsletter in your inbox for free sign up here.) Adding Roche's (ROG.S), opens new tab immunotherapy drug Tecentriq to chemotherapy after surgery in certain patients whose colon cancer had spread to the lymph nodes led to a 50% reduction in cancer recurrence and death compared to chemotherapy alone, according to trial data presented at recent medical meeting. Patients in the study had tumors with a genetic defect known as deficient DNA mismatch repair, or dMMR. About 15% of colon cancer patients have dMMR tumors, which do not respond well to chemotherapy. "The findings from our study represent a major advance in the adjuvant treatment of dMMR stage 3 colon cancer and will now change the treatment for this type of cancer," study leader Dr. Frank Sinicrope of the Mayo Clinic in Rochester, Minnesota said in a statement. The data, opens new tab were presented at the ASCO meeting that concluded earlier this week. The trial enrolled 712 patients with dMMR stage 3 colon cancer that had been surgically removed and who had cancer cells in their lymph nodes. Half of the study participants received chemotherapy along with Tecentriq, which activates the immune system to attack and kill cancer cells, for six months, followed by the immunotherapy alone for another six months. The other half of the patients received chemotherapy for 12 months. The benefit of Tecentriq was seen even in the oldest patients and those at particularly high-risk. "It's extremely rewarding to be able to offer our patients a new treatment regimen that can reduce the risk of recurrence and improve their chances of survival," Sinicrope said. As patients recover after a minimally invasive heart procedure, they might be better off continuing to take a certain type of blood-thinning drug to help prevent a heart attack or stroke, instead of continuing with the traditional aspirin, a new study suggests. Early after percutaneous coronary intervention (PCI) - a procedure to prop open blocked arteries either after a heart attack, or to prevent one - patients often receive dual anti-clotting therapy with both a P2Y12 inhibitor such as clopidogrel, the generic version of Plavix, or AstraZeneca's (AZN.L), opens new tab Brilinta (ticagrelor), and aspirin. After several months, patients are usually switched from dual therapy to lifelong daily aspirin use. But pooled data looking at patients who took part in five earlier clinical trials found that continuing to prescribe the P2Y12 inhibitors and stopping the aspirin was associated with lower rates of death, heart attack and stroke compared with continuing the aspirin, with no increased risk of major bleeding, researchers reported in The BMJ, opens new tab. Overall, the trials involved 16,117 patients who received either a P2Y12 inhibitor or aspirin after completing dual therapy following PCI. After an average follow-up period of around 4 years, P2Y12 inhibitor therapy was associated with a 23% lower risk of a composite of heart-related death, heart attack, or stroke, compared with aspirin, with no significant difference in major bleeding. That translates into one prevented cardiovascular death, heart attack, or stroke for every 46 patients taking a P2Y12 inhibitor instead of aspirin after dual therapy. Overall, the findings suggest that P2Y12 inhibitor drugs should be preferred over aspirin 'due to reductions in major adverse cardiac and cerebrovascular events without increasing major bleeding in the medium term,' according to an editorial published with the study. But the editorial said that since patients are advised to continue the post-PCI therapy for life, large trials directly comparing the different strategies with longer follow up are needed. Some diabetes and weight-loss drugs from the class known as GLP-1 agonists were linked with a small but elevated risk for an age-related eye disease in patients with diabetes, according to a study published on Thursday in JAMA Ophthalmology, opens new tab. In 139,000 patients with diabetes, including 46,334 who had been using the GLP-1 drugs semaglutide or lixisenatide, researchers identified 181 new cases of neovascular age-related macular degeneration, also known as wet AMD. Wet AMD is a degenerative eye disease marked by the abnormal growth of blood vessels under the retina that leak fluid or blood and can lead to blindness. The risk of developing AMD during up to three years of follow-up was low, at 0.2% in GLP-1 users versus 0.1% in non-users. Still, the researchers point out, after accounting for patients' individual risk factors, the odds of AMD were doubled with at least six months of GLP-1 use and tripled in patients with the longest duration of use. Semaglutide is the active ingredient in the widely used Novo Nordisk ( opens new tab drugs Ozempic and Wegovy, while lixisenatide is the main ingredient in Sanofi's ( opens new tab discontinued Adlyxin. GLP-1 drugs have also been associated with higher risks for an eye condition known as nonarteritic anterior ischemic optic neuropathy, or NAION. Researchers did not have information about the dose, route of administration, or frequency of administration of the medications used in the study. Even with that information, the study could not have proved cause and effect. At least one earlier study with longer follow up reported that GLP-1 use was linked with a lower, rather than higher, risk for AMD. 'Our findings are not directly contradictory' with that earlier report, said study leader Dr. Reut Shor of the University of Toronto. 'Factors such as timing and duration of exposure, disease stage, and patient characteristics may all influence outcomes," Shor said. "Our results add another layer to the emerging understanding of this complex relationship and emphasize the need for further research to clarify these trends.' (To receive the full newsletter in your inbox for free sign up here)
