EMA: Varicella Vaccines to Warn of Rare Encephalitis Risk
The amended product information will provide more specific detail on encephalitis as a known adverse reaction to live-attenuated varicella vaccines, including acknowledgment of rare cases with fatal outcomes.
Patients and caregivers should be advised to seek immediate medical attention if symptoms suggestive of brain inflammation — such as persistent headache, altered mental status, or seizures — occur following vaccination.
The update serves as a reminder to assess patients thoroughly for any immunocompromising conditions prior to administering live vaccines. It also highlights the importance of postvaccination counseling.
The revised guidance will also extend to combination measles, mumps, rubella, and varicella (MMRV) vaccines such as Priorix-Tetra and ProQuad, which include the same live-attenuated varicella component. Updated product information will include more specific descriptions of encephalitis symptoms and timing, helping clinicians and patients recognize early warning signs and seek timely medical attention.
A 2024 case series spanning 15 years documented 20 instances of varicella vaccine-associated meningitis or encephalitis in immunocompetent children and adolescents. These cases, identified using cerebrospinal fluid PCR and metagenomic sequencing, underscore that serious neurologic events can occur but remain exceptionally rare.
A 22-year global review of live-attenuated varicella vaccine analyzed data from more than 212 million doses administered between 1995 and 2017, finding that common adverse events decreased over time — from approximately 500 reports per million doses (in 1995) to approximately 40 per million (in 2016). Serious adverse events were extremely rare, at 0.8 per million doses.
A recent Chinese postmarketing study involving more than 7.4 million administered doses reported that serious neurologic events represented only 0.51% of all adverse events following immunization, with no reported fatalities.
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
9 hours ago
- Yahoo
Janssen's Darzalex new indication gains EC approval for SMM
The European Commission (EC) has approved the Johnson & Johnson company Janssen-Cilag International's new indication for Darzalex Faspro (daratumumab) subcutaneous (SC) formulation to treat adults with smouldering multiple myeloma (SMM) at high-risk of developing MM. Daratumumab is co-formulated with Halozyme's drug delivery technology, Enhanze. The EC approval is based on outcomes from the Phase III AQUILA study, which assessed the safety and efficacy of fixed-duration daratumumab SC administration against active monitoring in patients with high-risk SMM. The primary endpoint of the study is progression-free survival, while secondary endpoints encompass overall response rate, time to progression and overall survival. Patients included in the study had been diagnosed with SMM within the previous five years. Those with prior exposure to either approved or investigational treatments for SMM or multiple myeloma were excluded from participation. Halozyme president and CEO Dr Helen Torley stated: "This approval reinforces DARZALEX Faspro with ENHANZE as a foundational treatment across all stages of multiple myeloma. "We are pleased that the new treatment paradigm addresses the critical needs of people living with this complex blood disease." Halozyme's Enhanze drug delivery technology, featuring the enzyme rHuPH20, enables rapid SC delivery of drugs and fluids, enhancing patient experience and reducing treatment burden. It has been licensed to companies including Takeda, Roche, Pfizer, AbbVie and Acumen Pharmaceuticals. Johnson & Johnson innovative medicine multiple myeloma disease area leader and vice-president Jordan Schecter stated: 'Until now, there have been no approved treatment options for patients diagnosed with high-risk smouldering multiple myeloma. 'We can now offer physicians and patients the option to treat with daratumumab earlier, significantly delaying progression and the need for more intensive, continuous therapy, as well as extending overall survival.' "Janssen's Darzalex new indication gains EC approval for SMM" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
9 hours ago
- Yahoo
Thousands of cancer cases could be prevented with more breast removal surgeries
Thousands of breast cancer cases could potentially be prevented if more women were offered 'risk reducing' breast removal surgery, a study suggests. Breast removal surgery, also known as a mastectomy, is offered to treat breast cancer in some women. It can also be offered to women who are deemed to be high risk of the disease to prevent them from getting it in the first place. A study has found that if more women were given preventative mastectomies, then about 6,500 cases of breast cancer could be prevented each year. Risk-reducing mastectomies (RRM) are currently only offered to women with the BRCA1, BRCA2, PALB2 genes, experts said. But the new analysis suggests that some women with other genes linked to a higher risk of breast cancer – including ATM, CHEK2, RAD51C, RAD51D – who may also be at higher risk due to a number of other factors may benefit from RRM if they are assessed as having a high risk of disease. These other factors can include a family history of breast cancer, the number of children they have had, whether or not they breast fed and mammogram density. Women in the UK have an 11% chance of developing breast cancer across their lifetime. Medics can calculate a woman's risk of breast cancer using tools which combine the effect of various risk factors. This is your breast check reminder! Learn the signs and symptoms of breast — Breast Cancer Now (@BreastCancerNow) May 6, 2025 Researchers from Queen Mary University of London and the London School of Hygiene and Tropical Medicine (LSHTM) found that if health officials could identify all women aged 30 to 55 who have a 35% or higher risk of breast cancer, and they all went on to have RRM, then an estimated 6,538 breast cancer cases could be prevented in the UK each year. This is the equivalent of around 11% of the 59,000 women in the UK who are diagnosed with breast cancer each year. The academics point out that women who have one of the other genes linked to breast cancer, who may be at high risk of disease, could potentially be found by a mechanism called 'cascade testing' – where genetic tests are offered to family members of women who have been found to have these different genes linked to breast cancer. The economic evaluation study, published in the journal JAMA Oncology, concludes: 'Undergoing RRM appears cost-effective for women at 30-55 years with a lifetime BC-risk 35% (or more). 'The results could have significant clinical implications to expand access to RRM beyond BRCA1/BRCA2/PALB2 pathogenic variant carriers.' Corresponding author on the paper, Professor Ranjit Manchanda, professor of gynaecological oncology at Queen Mary and consultant gynaecological oncologist, said: 'We for the first time define the risk at which we should offer RRM. 'Our results could have significant clinical implications to expand access to mastectomy beyond those patients with known genetic susceptibility in high penetrance genes- BRCA1/ BRCA2/ PALB2 – who are traditionally offered this. 'This could potentially prevent can potentially prevent (around) 6500 breast cancer cases annually in UK women. 'We recommend that more research is carried out to evaluate the acceptability, uptake, and long-term outcomes of RRM among this group'. Dr Rosa Legood, associate professor in health economics at LSHTM, added: 'Undergoing RRM is cost-effective for women (aged) 30 to 55-years with a lifetime breast cancer risk of 35% or more. 'These results can support additional management options for personalised breast cancer risk prediction enabling more women at increased risk to access prevention.' Women deemed to be at high risk of breast cancer can also be offered regular screening and medication. Louise Grimsdell, Breast Cancer Now senior clinical nurse specialist, said: 'While this modelling provides valuable insights into the cost-effectiveness of risk-reducing mastectomy for women with a high risk of developing breast cancer, each individual must be offered all risk-management options that are suitable for them. 'Choosing to have risk-reducing surgery is a complex and deeply personal decision that comes with emotional and physical implications. 'So, it's vital women can consider all their options, including screening and risk-reducing medications, and are supported by their clinician to make an informed decision that's right for them. 'It's also crucial that the unacceptably long waits that far too many women who chose risk-reducing surgery are facing are urgently tackled.'
Yahoo
10 hours ago
- Yahoo
New study reaches landmark conclusion about impact of wind turbines on human health: 'Not a cause-and-effect relationship'
New study reaches landmark conclusion about impact of wind turbines on human health: 'Not a cause-and-effect relationship' A new peer-reviewed study from researchers at Poland's Adam Mickiewicz University has found no evidence that wind turbine noise causes mental harm, putting to rest a persistent and unsubstantiated claim that clean energy projects may be harming our health. Medical Xpress reported that the study measured brainwave activity in 45 university students exposed to different sounds — including traffic, wind turbines, and silence — without revealing the sources. Participants described the turbine noise as white noise and did not report it as any more stressful than city traffic. The researchers also found no measurable differences in brain activity, nor any signs of psychological harm, across the various sound environments. "Although these results cannot be generalized, they support the concept that the interlinkage between exposure to wind turbine noise and human cognitive functioning is not a cause-and-effect relationship," the authors wrote in the study, published in the journal Humanities and Social Sciences Communications. While they acknowledged that their research is not definitive on long-term exposure, they concluded that "wind turbine syndrome" — the conspiracy theory suggesting these sounds cause cancer or mental illness — has no scientific basis. This is reassuring news for consumers and communities. Wind turbines are among the most cost-effective sources of clean energy and can offer great economic and health benefits. They reduce dependence on dirty energy sources like oil and gas, helping to curb rising health risks tied to air pollution. They can also help stabilize public energy grids and lower utility costs for homeowners. Plus, by reducing the amount of heat-trapping air pollution the energy industry generates, we're working toward a safer, cleaner future for all of us. Studies like this help cut through misinformation that could dampen public reception to clean power sources. "This interpretation is compatible with previous findings showing social contexts, such as socialization and misinformation, as a moderator of the interlinkage between wind turbine noise and human functioning," the study authors wrote. A discussion on Reddit shared similar viewpoints on the topic. "Colleague of mine [used] to do community engagement," one commenter said. "Received lots of calls about how the wind turbines were making people in the area sick. She had to tell them that the newly built turbines hadn't actually been switched on yet. Not saying some people weren't having a reaction though as the mind can be a powerful tool (look up the Nocebo effect)." Do you worry about air pollution in your town? All the time Often Only sometimes Never Click your choice to see results and speak your mind. Join our free newsletter for weekly updates on the latest innovations improving our lives and shaping our future, and don't miss this cool list of easy ways to help yourself while helping the planet. Solve the daily Crossword
