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Monkeypox: British agencies win CEPI funds to develop tools - 0 views

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    British health agencies have secured funding to develop a standardised approach to test the performance of vaccines being used or in development against monkeypox, days after the World Health Organization labelled the growing outbreak a global health emergency. The Coalition for Epidemic Preparedness Innovations (CEPI) said it would give up to $375,000 to the Medicines and Healthcare products Regulatory Agency (MHRA) and Health Security Agency (UKHSA) to develop standard tools to assess the strength and duration of immune responses generated by current vaccines, and for tests used to detect monkeypox antibody levels. Apart from administration fees, these tools will be made freely available to the global scientific community, paving the way for a common standardised assessment between countries documenting vaccine performance against monkeypox, CEPI said. Until this year, the viral disease has rarely spread outside Africa where it is endemic. But reports of a handful of cases in Britain in early May signalled that the outbreak had moved into Europe. So far, there have been more than 16,000 confirmed cases of monkeypox in more than 75 countries.
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Pharmaceutical Hygiene: The Role of Sanitary Clamps in UK - 0 views

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    In the pharmaceutical industry, maintaining strict hygiene standards is paramount to ensure the safety and efficacy of products. One of the critical components in achieving this goal is the utilization of sanitary clamps. These clamps play a vital role in securing various connections within pharmaceutical equipment, preventing contamination, and upholding sterile conditions. In this article, we delve into the reasons why sanitary clamps are indispensable for maintaining hygiene in pharmaceutical settings. Contamination Prevention Sanitary clamps serve as a crucial barrier against contamination in pharmaceutical environments. With stringent regulations governing pharmaceutical manufacturing, any compromise in hygiene can result in significant consequences, including product recalls and compromised patient safety. Sanitary clamps are designed to create secure and airtight connections between pipes, hoses, and other components, effectively sealing off potential entry points for contaminants such as bacteria, viruses, and particulate matter. By minimizing the risk of contamination, these clamps help pharmaceutical companies uphold the integrity of their products and adhere to regulatory standards. Moreover, the design of sanitary clamps ensures ease of cleaning and sterilization, further reducing the risk of cross-contamination between batches. Unlike traditional fastening methods that may harbor bacteria or residue, sanitary clamps feature smooth surfaces and minimal crevices, making them easier to sanitize. This not only enhances hygiene but also promotes efficiency in the cleaning process, allowing pharmaceutical manufacturers to maintain high levels of cleanliness without compromising production timelines. Overall, by preventing contamination and facilitating thorough cleaning, sanitary clamps play a crucial role in safeguarding the quality and safety of pharmaceutical products.
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MHRA Warning: Beware Counterfeit Anti-Choking Devices - 0 views

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    The Medicines and Healthcare products Regulatory Agency (MHRA) has advised the public to exercise caution when buying anti-choking devices online, ensuring these products are purchased from reputable sellers. As estimated by the regulator, more than 10,000 counterfeit or unbranded anti-choking devices have been purchased by the public within the last two years through listings on online marketplaces such as Amazon and eBay, as well as drop-shipping websites. People are cautioned that the use of such products poses a substantial risk of failure in clearing blockages and could exacerbate the situation by pushing obstructions further down into the airway passage. Dr Alison Cave, MHRA Chief Safety Officer, said: "Buying anti-choking devices that do not have a valid UKCA or CE mark increases the risk of receiving a product which does not include appropriate instructions and is either fake or does not meet the UK's regulatory requirements. "These products do not meet our strict quality standards and may put your health and safety at significant risk by failing to resolve or even worsening choking incidents."
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Pfizer BioNTech Covid-19 Vaccine For Under 12s Approved - 0 views

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    UK regulator has approved a new age-appropriate formulation of the Pfizer BioNTech Covid-19 vaccine for use in children aged 5 to 11 years old. The new paediatric formulation of Covid vaccine meets the required safety, quality and effectiveness standards, the Medicines and Healthcare products Regulatory Agency (MHRA) announced on Wednesday (December 22). Dr June Raine, MHRA chief executive said that parents and carers can be reassured that this approval has been given after robust review of safety data. These data showed a favourable safety profile for use in 5-11-year olds compared with that seen in other age groups, the regulator said. Raine said: "We have carefully considered all the available data and reached the decision that there is robust evidence to support a positive benefit risk for children in this age group.
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UK Approves Novavax Covid Jab As Fifth In Country - 0 views

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    Britain has approved Novavax's Covid-19 vaccine for use in those 18 years of age and older, the country's medicines regulator said on Thursday (February 3), bringing a fifth coronavirus shot to its roster amidst the rapid spread of the Omicron variant. The vaccine, Nuvaxovid, was approved as a first and second dose as it met the required safety, quality and effectiveness standards, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) said in a statement. The British approval for Nuvaxovid comes days after the drugmaker filed for US authorisation of the vaccine following months of struggles with development and manufacturing problems, and follows a German backing earlier in the day. "We are continuing our vital safety work in monitoring the use of all Covid-19 vaccines, to ensure that their benefits in protecting people against Covid-19 disease continue to outweigh any risks," MHRA chief executive June Raine said.
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MHRA Approves Cabotegravir: A Game-Changer in HIV Prevention - 0 views

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    In a significant leap forward in the fight against HIV, the Medicines and Healthcare products Regulatory Agency (MHRA) has given the green light to two groundbreaking formulations of cabotegravir. Apretude 30 mg film-coated tablets and Apretude 600 mg prolonged-release suspension for injection are now authorized for preventing sexually transmitted HIV-1 infection in adults and adolescents weighing at least 35kg at increased risk. This approval marks a pivotal moment in HIV (human immunodeficiency virus) prevention, offering an alternative to existing standard pre-exposure prophylaxis or PrEP treatments. HIV, a virus notorious for compromising the immune system, has long been a global health concern. Cabotegravir, a member of the integrase inhibitor group, works by blocking a key enzyme necessary for the replication of HIV-1, thereby reducing the virus's ability to spread.
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