Latest news with #PRAC
Medscape
6 days ago
- Health
- Medscape
EMA: Varicella Vaccines to Warn of Rare Encephalitis Risk
The European Medicines Agency's (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) has recommended an update to the product information of the varicella (chickenpox) vaccines Varilrix and Varivax to describe the severity of the risk for encephalitis. This follows a safety review prompted by a fatal case of encephalitis in a child in Poland after receiving Varilrix, a live-attenuated varicella vaccine. 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.
Yahoo
11-07-2025
- Health
- Yahoo
Valneva Announces Lifting of European Medicines Agency's Temporary Restriction on Use of Chikungunya Vaccine IXCHIQ® in Elderly
Saint Herblain (France), July, 11 2025 – Valneva SE (Nasdaq: VALN; Euronext Paris: VLA), a specialty vaccine company, today announced that the European Medicines Agency (EMA) will lift the temporary restriction on vaccinating people aged 65 years and above after concluding a thorough review of Valneva's single-dose chikungunya vaccine IXCHIQ® by EMA's safety committee (PRAC). The committee initiated its review at the beginning of May following the occurrence of serious side effects mainly in elderly people with several underlying medical conditions. In a press release published today on its website1, EMA underlined that the vaccine is already contraindicated for people with a weakened immune system and concluded that, for people of all ages, IXCHIQ® should be given when there is a significant risk of chikungunya infection and after a careful consideration of the benefits and risks. Additionally, EMA noted that while most serious side effects occurred in older people, IXCHIQ® is effective at triggering the production of antibodies against the chikungunya virus which may be of particular benefit for older people who are at increased risk of severe chikungunya disease. IXCHIQ® was authorised in the European Union in June 20242 and, in March 2025, the European Commission granted a label extension in adolescents 12 years of age and older3. About ChikungunyaChikungunya virus (CHIKV) is a mosquito-borne viral disease spread by the bites of infected Aedes mosquitoes which causes fever, severe joint and muscle pain, headache, nausea, fatigue and rash. Joint pain is often debilitating and can persist for weeks to years4. In 2004, the disease began to spread quickly, causing large-scale outbreaks around the world. Since the re-emergence of the virus, CHIKV has now been identified in over 110 countries in Asia, Africa, Europe and the Americas5. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas6 and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem.7 About Valneva SEWe are a specialty vaccine company that develops, manufactures, and commercializes prophylactic vaccines for infectious diseases addressing unmet medical needs. We take a highly specialized and targeted approach, applying our deep expertise across multiple vaccine modalities, focused on providing either first-, best- or only-in-class vaccine have a strong track record, having advanced multiple vaccines from early R&D to approvals, and currently market three proprietary travel from our growing commercial business help fuel the continued advancement of our vaccine pipeline. This includes the only Lyme disease vaccine candidate in advanced clinical development, which is partnered with Pfizer, the world's most clinically advanced tetravalent Shigella vaccine candidate, as well as vaccine candidates against the Zika virus and other global public health threats. More information is available at Media and Investor Relations Contacts Laetitia Bachelot-FontaineVP Global Communications & European Investor RelationsM +33 (0)6 4516 Joshua Drumm, Global Investor RelationsM +001 917 815 Forward-Looking Statements This press release contains certain forward-looking statements relating to the business of Valneva, including with respect to use and regulatory review of existing products. In addition, even if the actual results or development of Valneva are consistent with the forward-looking statements contained in this press release, those results or developments of Valneva may not be sustained in the future. In some cases, you can identify forward-looking statements by words such as 'could,' 'should,' 'may,' 'expects,' 'anticipates,' 'believes,' 'intends,' 'estimates,' 'aims,' 'targets,' or similar words. These forward-looking statements are based largely on the current expectations of Valneva as of the date of this press release and are subject to a number of known and unknown risks and uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievement expressed or implied by these forward-looking statements. In particular, the expectations of Valneva could be affected by, among other things, uncertainties and delays involved in the development and manufacture of vaccines, unexpected clinical trial results or new adverse events, unexpected regulatory actions or delays, competition in general, currency fluctuations, the impact of the global and European credit crisis, and the ability to obtain or maintain patent or other proprietary intellectual property protection. Success in preclinical studies or earlier clinical trials may not be indicative of results in future clinical trials. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements made in this press release will in fact be realized. Valneva is providing this information as of the date of this press release and disclaims any intention or obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. 1 Ixchiq: temporary restriction on vaccinating people 65 years and older to be lifted | European Medicines Agency (EMA)2 Valneva Receives Marketing Authorization in Europe for the World's First Chikungunya Vaccine, IXCHIQ® - Valneva3 2025_02_28_IXCHIQ_Ado_Extension_CHMP_Positive_Opinion_PR_EN_Final.pdf4 5 PAHO/WHO data: Number of reported cases of chikungunya fever in the Americas (Cumulative Cases 2018-2023 and Cases per year 2013-2017). Last accessed 01 Aug 2023.7 Geographical expansion of cases of dengue and chikungunya beyond the historical areas of transmission in the Region of the Americas ( Attachment 2025_07_11_EMA_IXCHIQ_Restrictions_Lifting_PR_EN_FinalError 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
Medscape
11-07-2025
- Health
- Medscape
EMA Lifts Chikungunya Vaccine Restriction
The European Medicines Agency (EMA)'s Pharmacovigilance Risk Assessment Committee (PRAC) has issued a safety update on the chikungunya vaccine after review of the Ixchiq live-attenuated jab. It said that it would now lift the temporary restriction put in place in May on vaccinating people aged 65 years and above as a result of reports of serious side effects. However, the committee emphasized that the vaccine should only be used after careful consideration of risks and benefits when there is significant risk of chikungunya infection. Chikungunya is a viral disease that is most common in Africa, Asia, the Caribbean, and South and Central America, with a few cases also reported in Europe and the US. It is carried by mosquitoes, most often Aedes aegypti and Aedes albopictus , that may also transmit dengue and Zika viruses. Person-to-person transmission does not occur, though rarely the infection may be passed on via blood. Crippling Joint Pain The incubation period is 3-7 days. Common symptoms are fever, rash, muscle pain, and severe arthralgia. The name chikungunya comes from a Tanzanian word to describe the way severely affected patients often assume a stooped appearance due to crippling pain. Most infections are mild, with only about 2% leading to severe symptoms. There may be a risk of encephalitis, but this is rare and unclear. Most of those affected recover within a week to 10 days of the start of symptoms. But 30%-40% of those affected develop ongoing chronic joint pain and chronic arthritis that can last for months or even years. Treatment is largely symptomatic. Side Effect Risk Groups Ixchiq was authorized in the EU in June 2024. When the recent PRAC review began, around 36,000 doses of the vaccine had been used worldwide. Safety data recorded 28 cases of serious side effects, mainly in people aged 65 years and older and those with multiple underlying comorbidities, particularly chronic or uncontrolled medical conditions such as cardiovascular diseases, diabetes mellitus, or chronic kidney disease. There had been three deaths. Although serious vaccine side effects most often affected this group, these were also the people at highest risk of severe chikungunya infection, the PRAC noted. Many of the serious side effects reported were similar to symptoms of chikungunya infection itself, the committee said. These could include fever, malaise, anorexia, and confusion, which can lead to falls. In some cases, vaccine side effects had worsened patients' medical conditions or caused deterioration in their general health, in some instances resulting in hospitalization. Avoid Vaccinating Immunocompromised People The committee also reminded healthcare professionals that Ixchiq must not be given to people whose immune system is weakened because of disease or medical treatment, as they are at greater risk of having complications from vaccines containing live-attenuated viruses. This contraindication remains in place following the review. The product information for Ixchiq will be updated with the latest recommendations following the review. A direct healthcare professional communication will be sent to healthcare professionals prescribing, dispensing, or administering Ixchiq and will be published on a dedicated page on the EMA website. The PRAC recommendations will now be sent to the Committee for Medicinal Products for Human Use, which will adopt the agency's opinion before adoption by the European Commission of a legally binding decision applicable in all EU Member States.
Medscape
11-07-2025
- Health
- Medscape
EMA Questions Valproate Prescribing Restrictions for Men
The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) has announced it is assessing new data on the potential risk of neurodevelopmental disorders (NDDs) in children born to men treated with valproate during spermatogenesis. The announcement comes after controversial new precautionary measures for the treatment of male patients with valproate medicines were imposed in January 2024. The cautionary approach to valproate — a medicine used to treat epilepsy, bipolar disorders, and in some countries migraine — came about as a result of a post-authorization safety study (PASS) funded by a consortium of marketing authorization holders for valproate and related substances. After examining the results, PRAC recommended that valproate treatment in male patients be started and supervised by a specialist in the management of epilepsy, bipolar disorder, or migraine. It also said that valproate treatment of male patients should be reviewed regularly to consider whether it remains the most suitable treatment, particularly if the patient is planning to conceive a child. Original Study Suggests Risk PASS was a population-based retrospective study that used data from multiple Scandinavian registry databases in Denmark, Norway, and Sweden, together with other available information, to evaluate the association between paternal exposure to valproate and the risk of NDDs in offspring, including autism spectrum disorders, intellectual disability, communication disorders, attention deficit/hyperactivity, and movement disorders, as well as congenital abnormalities. The results suggested a potential increased risk to children born to men treated with valproate during the 3 months before conception. This led PRAC , and later the UK's Medicines and Healthcare products Regulatory Agency, to recommend precautionary measures for the treatment of male patients with valproate medicines. These measures were in addition to restrictions already in place since 2018 to avoid valproate exposure in pregnancy due to evidence of an increased risk of malformations and developmental problems. Second Study Casts Doubt At that time, the committee acknowledged that the PASS data had limitations but concluded that the potential risk warranted informing patients and healthcare professionals. However, a study published in JAMA in June 2024 using a subset of the same data cast doubt on the PASS findings. That study aimed to replicate the PASS results using the nationwide Danish data sources that had been used in PASS. In this later study, 1336 children among the total cohort of 1,235,353 children had been born to fathers who filled prescriptions for valproate during spermatogenesis. No association was found between paternal valproate use and risk of major congenital malformations or NDDs, the researchers said. The researchers highlighted that the PASS results stemmed from an observational study report prepared by contract research organization IQVIA. "We were unable to replicate the IQVIA study results," they said. Latest Study Shows No Risk The same research team subsequently published a research letter in JAMA in May 2025, in which they said that they had access to only limited information about the IQVIA study at the time of their 2024 report. Following publication of the detailed IQVIA report, the team conducted analyses to explore the impact of methodological choices and definitions used in that study. "Paternal valproate exposure was not associated with an increased risk of NDDs," they concluded. This was the case for the composite endpoint of all NDDs and "remained robust" across analyses of specific NDDs, expanded definitions of NDDs, valproate dose, time trends, polytherapy, and analyses restricted to fathers with epilepsy. PRAC said that, in the light of this latest study's inability to replicate the signal for NDDs in children with paternal valproate exposure and a more recent systematic review from Australia that also showed "no clear evidence for an adverse impact of paternal antiseizure medication use on offspring outcomes," the committee has initiated a signal procedure to understand the difference in the findings across the studies. It has also requested further information and analysis from valproate marketing authorization holders. The EMA will communicate further when more information becomes available, it said.
Medscape
20-06-2025
- Health
- Medscape
EMA Reviews Alcohol Dependency Drug After French Concerns
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has announced it will review the use of medicines containing sodium oxybate, a drug used in narcolepsy, in people with alcohol dependency. The review comes at the request of the French Medicines Agency and has been initiated under Article 31 of Directive 2001/83/EC. This procedure is used to address concerns over the safety or benefit-risk balance of a medicine or a class of medicines; to resolve disagreements between member states on issues related to the authorization of medicines; or to give an opinion on an issue of Europe-wide interest so that the agency can make a recommendation for a harmonized position across the EU. The European Commission, any member state, or the company that markets the medicine can initiate a referral. In a referral, the European Medicines Agency (EMA) is requested to conduct a scientific assessment of a particular medicine or class of medicines on behalf of the European Union. It involves the matter being referred to the Pharmacovigilance Risk Assessment Committee (PRAC) after due notice to the EMA, all member states, and the European Commission. Narcolepsy Indication Sodium oxybate (Xyrem) is the sodium salt of gamma-hydroxybutyric acid. As an oral solution (500 mg/mL), it is indicated for the treatment of narcolepsy with cataplexy in adult patients, adolescents, and children from the age of 7 years. The drug is a central nervous system depressant believed to act by attaching to brain cell receptor molecules to promote delta (slow) brain waves and nighttime sleep. When taken at bedtime, Xyrem increases sleep depth and length, reducing the number of sleeping periods during the day and improving symptoms of narcolepsy. Because of the drug's potential for abuse, it can only be obtained with a special prescription, and treatment should be initiated and maintained under the guidance of a doctor with experience in treating sleep disorders. Doctors are advised to check for a history of or susceptibility to drug abuse before treatment, and to monitor for misuse and abuse during treatment. Approved for Alcohol Abuse in Austria and Italy The drug has also been suggested to reduce pain and improve function in fibromyalgia, but the EMA said the data were insufficient to support its use for this in the European population. However, sodium oxybate is also approved in Italy and in Austria, under the name Alcover, to treat alcohol dependence and alcohol withdrawal syndrome. It is this use that the review will examine. The EMA has confirmed the positive benefit-risk profile of the treatment as prescribed in Italy and Austria. France, however, despite having a high prevalence of alcohol problems, has resisted its use for this purpose. Trials have suggested that sodium oxybate can rapidly alleviate symptoms of alcohol withdrawal syndrome and was at least as effective as diazepam and clomethiazole. It can also be used in the maintenance of abstinence in alcohol-dependent patients, in whom it is reportedly as effective as naltrexone or disulfiram. Because existing approved medications are only modestly effective, there is a pressing need for effective treatments with an alternative mode of action, particularly in patients with very high consumption levels. Sodium oxybate also has a favorable safety profile. However, studies in alcohol use disorder have been limited and further investigations have been recommended.
