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Content Article
Molnupiravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORAMIC): an open-label, platform-adaptive randomised controlled trial (22 December 2022)
Patient Safety Learning posted an article in Data, research and statistics
The safety, effectiveness, and cost-effectiveness of molnupiravir, an oral antiviral medication for SARS-CoV-2, has not been established in vaccinated patients in the community at increased risk of morbidity and mortality from COVID-19. In this study, Butler et al. aimed to establish whether the addition of molnupiravir to usual care reduced hospital admissions and deaths associated with COVID-19 in this population. The authors conclude that molnupiravir did not reduce the frequency of COVID-19-associated hospitalisations or death among high-risk vaccinated adults in the community. -
News ArticleThe World Health Organization (WHO) announces that the Ministry of Food and Drug Safety, Republic of Korea, has achieved maturity level four (ML4), the highest level in WHO’s classification of regulatory authorities for medical products. WHO has formally assessed the medical product regulatory authorities of 33 countries, of which only the Republic of Korea is listed as attaining this level in regulation for both locally produced as well as imported medicines and vaccines. This achievement represents an important milestone for the Republic of Korea and for the world, signifying that the Ministry of Food and Drug Safety (MFDS), the national regulatory authority for medicines and vaccines, is operating at an advanced level of performance with continuous improvement Only about 30% of the world’s regulatory authorities have the capacity to ensure medicines, vaccines and other health products are produced to required standards, work as intended and do not harm patients. WHO’s benchmarking efforts identify regulatory authorities that are operating at an advanced level so that they can act as a reference point for regulatory authorities that lack the resources to perform all necessary regulatory functions, or which have not yet reached higher maturity levels for medical product oversight. “This is a great testament for Republic of Korea’s commitment for ensuring safe and effective medicines and vaccines, and investing in building a strong regulatory system,” said Dr Mariângela Simão, Assistant Director-General, Access to Medicines and Health Products. “We hope the achievement will be sustained and also help promote confidence, trust and further reliance on national authorities attaining this high level”. Read full story Source: WHO, 29 November 2022
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News Article
Former vaccines chief sounds warning about UK pandemic readiness
Patient Safety Learning posted a news article in News
The UK is not in a significantly better place to deal with a new pandemic, the former vaccine taskforce chief has said, as a leading public health expert suggested Covid infections may be on the rise again. Dame Kate Bingham, the managing partner at the life sciences venture capital firm SV Health Investors, headed the UK’s vaccine taskforce between May and December 2020. Speaking to a joint session of the Commons health and social care committee and the science and technology committee, about lessons learned during the pandemic, Bingham said many of the initiatives set up by the taskforce had been dismantled, while key recommendations it had provided had not been acted upon. “To begin with, I thought it was lack of experience of officials since we don’t have a lot of people within Whitehall who understand vaccines, relationships with industry, all of that, but actually, I’m beginning to think this is deliberate government policy, just not to invest or not to support the sector,” she said. Among her concerns, Bingham cited the failure to create bulk antibody-manufacturing capabilities in the UK and the proposed termination of the NHS Covid vaccine research registry through which the public could indicate their willingness to participate in clinical trials for Covid vaccines. The decision by the National Institute for Health and Care Research to close the registry was eventually reversed after Robert Jenrick, then a health minister, stepped in. “I am baffled as to the decisions that are being made,” she said. Bingham also raised concerns about the length of time it is taking to agree a contract with Moderna – a US-based company that produces mRNA Covid vaccines – to create a research and development, and manufacturing, facility in the UK. Read full story Source: The Guardian, 30 November 2022 -
News Article
Parents urged to get children flu vaccine as infections rise
Patient Safety Learning posted a news article in News
Parents of children under five are being urged to get them a flu vaccine after a 70% jump in hospitalisations. The UK Health Security Agency (UKHSA) said an 11% fall in the uptake of the vaccine among two and three-year-olds came as flu circulated at higher levels than in previous years. Anjali and Ben Wildblood from Bristol saw their two-year-old son Rafa become "very sick" with flu just days before he was due to have the vaccine. The pair, who are both NHS consultants, said their concerns prompted them to take him to A&E where he was treated and sent home. "But his condition got worse again, with a soaring temperature and exhaustion - he had no strength whatsoever and what was so extremely worrying was that he barely had the strength to breathe - every parent's worst nightmare," they said. After returning to hospital, Rafa was admitted to a paediatric intensive care unit where he was put under general anaesthetic and intubated. Covid restrictions have meant most young children have never encountered flu and have no natural immunity to the virus, the UKHSA said. This increased risk has coincided with the uptake of the flu vaccine among two-year-olds standing at 31% and 33% among three-year-olds. All children under five can get vaccinated at their GP surgery. Read full story Source: BBC News, 30 November 2022 -
News Article
Measles now an 'imminent' global threat due to pandemic, say WHO and CDC
Patient Safety Learning posted a news article in News
There is now an "imminent threat" of measles spreading in every region of the world, the World Health Organisation and the US public health agency has said. In a joint report, the health organisations said there had been a fall in vaccines against measles and less surveillance of the disease during the COVID pandemic. Measles is one of the most contagious human viruses but is almost entirely preventable through vaccination, though it requires 95% vaccine coverage to prevent outbreaks. A record high of nearly 40 million children missed a dose last year because of hurdles created by the pandemic, according to the report by the WHO and the US Centers for Disease Control and Prevention. This has left millions of children susceptible to the disease. "We are at a crossroads," Patrick O'Connor, the WHO's measles lead, said. "It is going to be a very challenging 12-24 months trying to mitigate this." Read full story Source: Sky News, 24 November 2022 -
Content ArticleIn this episode of 'Better Never Stops', Virginia Mason Institute Senior Partner Melissa Lin interviews Dana Nelson-Peterson, Vice President of Nursing Operations at Virginia Mason Franciscan Health, who shares what happens when you trust a management system and improvement process to solve your toughest challenges. Dana shares her story of leading a critical part of Virginia Mason’s Covid response.
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News Article
Antibody jab approved for common winter virus RSV
Patient Safety Learning posted a news article in News
A new treatment to protect babies against a common and potentially dangerous winter virus has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA). Respiratory syncytial virus (RSV) is the main reason children under five end up in hospital. In a normal winter, RSV mostly causes coughs and colds which clear up in a couple of weeks - but it can be particularly serious in infants under the age of two, causing severe lung problems such as bronchiolitis and pneumonia. Every year, about 29,000 babies need hospital care for RSV and most have no other health issues beforehand. The new antibody treatment, called nirsevimab, from Sanofi and AstraZeneca, has already been shown to reduce lower respiratory tract infections caused by RSV by 74.5% in trials involving 4,000 babies. It works by preventing RSV from fusing to cells in the respiratory tract and causing infections. But it still needs more research in larger numbers of babies before it can be used on the NHS. Researchers now plan to investigate whether it can cut the number of babies needing hospital care for RSV, and are urging parents to sign up to their study. The study is open to newborn babies and those up to 12 months old. Only one visit for the antibody injection is needed, and follow-up sessions happen via an app. Co-study leader Dr Simon Drysdale, consultant paediatrician in infectious diseases at London's St George's Hospital, said the treatment could eventually be given at birth to offer protection for the first months of life, or during routine immunisations at two months old. Read full story Source: 10 November 2022 -
News Article
NHSE investigates concerns over-65s have received ineffective flu jab
Patient Safety Learning posted a news article in News
NHS England is investigating a “potential serious incident” in its flu programme following concerns that people aged 65 and over are being given a vaccination jab known to be ineffective for this age group. Details of the investigation were set out in a letter by NHS England’s South East regional team. The letter, seen by HSJ, said: “The NHS regional direct commissioning team are investigating reported administration of QIVe flu vaccine to patients aged 65 years or older by a number of primary care providers (primary care and pharmacy) across the region. QIVe is not recommended for use in this age group due to its poor effectiveness.” It said officials were contacting practices and pharmacists directly where there was a record of QIVe vaccine having been given to the older age cohort to identify whether this is a recording coding error, or a genuine administration of QIVe. Initial investigations “suggest a mixture of both”, it said. The letter added: “If any patient 65 or over has received QIVe, we will be asking the practice or pharmacist to treat this as an incident. Patients will need to be contacted, informed of the error, its potential implications and offered the opportunity to receive a vaccine which is appropriate for their age group." It is unclear how many patients have been given the wrong jab. Read full story Source: HSJ, 8 November 2022 -
News Article
US hospital flu cases hit 10-year high as vaccinations fall
Patient Safety Learning posted a news article in News
US influenza hospital admissions have hit the highest rate in a decade as vaccinations sag, US officials say. They said adults have received five million fewer influenza jabs this year compared with the same time last year. Health experts are worried a so-called tripledemic of flu, respiratory syncytial virus (RSV) and coronavirus could swamp hospitals this winter. At least 730 people have died of flu this year, according to the Centers for Disease Control and Prevention (CDC). While older people are the most vulnerable age group, at least four children are among the dead. CDC data shows there have been at least 1.6 million flu cases overall and some 13,000 people have been taken to hospital. This season's severity has not been matched at this point in the year since the H1N1 swine flu pandemic hit the US in 2009. "There's no doubt we will face some challenges this winter," Dawn O'Connell, the US Department of Health and Human Services' (HHS) assistant secretary for preparedness and response, said at a media briefing on Friday. Read full story Source: BBC News, 5 November 2022 -
News Article
Warning for parents after rise in hospitalisations for flu in children under 5
Patient Safety Learning posted a news article in News
Parents are being told to urgently bring their children forward for flu vaccinations as new data reveals the rate of hospitalisation and ICU admission for people with the virus is rising fastest among those under five years old. New figures published in the UK Health Security Agency’s (UKHSA) National flu and Covid-19 surveillance report show that cases of flu have climbed quickly in the past week, indicating that the season has begun earlier than normal. According to the UKHSA, vaccination for flu is currently behind last season for pre-schoolers (12.1% from 17.4% in all two-year-olds and 12.8% from 18.6% in all three-year-olds). It has also fallen behind in pregnant women (12.4% from 15.7%) and under 65s in a clinical risk group (18.2% from 20.7%). Dr Mary Ramsay, director of public health programmes at the UK Health Security Agency, said: “Our latest data shows early signs of the anticipated threat we expected to face from flu this season. “We’re urging parents in particular not to be caught out as rates of hospitalisations and ICU admissions are currently rising fastest in children under 5. “This will be a concern for many parents and carers of young children, and we urge them to take up the offer of vaccination for eligible children as soon as possible.” Read full story Source: The Independent, 20 October 2022 -
News Article
Thousands of children at risk as vaccination rates fall in England
Patient Safety Learning posted a news article in News
Thousands of children face an increased risk of catching deadly diseases in England, and significant outbreaks are likely, child health experts have warned, as “alarming” figures show vaccination levels have plunged across virtually all jabs. The UK Health Security Agency (UKHSA) is urging parents and guardians to ensure their children have received the routine jabs against potentially serious diseases, such as polio and measles, after official data revealed a drop in vaccination rates. NHS Digital data published Thursday showed vaccine coverage fell in 13 out of the 14 routine programmes for children up to five years old in England in 2021-22, compared with the year before. “Today’s publication of the childhood vaccination statistics in England is extremely worrying,” said Dr Doug Brown, the chief executive of the British Society for Immunology. “Immediate action to reverse this alarming multi-year downward trend and protect our communities from preventable diseases is urgently needed.” Helen Bedford, a professor of child public health at UCL’s Institute of Child Health, said the country was now facing “the concerning double whammy of many children being unprotected and the inevitability of disease rates increasing”. “In this situation, as night follows day, significant outbreaks of disease are likely. Measles disease is a particular concern as it is so highly infectious that any small decline in vaccine uptake results in outbreaks. Read full story Source: The Guardian, 29 September 2022 -
News Article
‘Twindemic’ warning as health chiefs launch Covid and flu vaccination drive
Patient Safety Learning posted a news article in News
Health chiefs have warned of a Covid and flu “twindemic” this winter as they launched a renewed vaccination drive. Around 33 million people in England will be eligible for a free flu vaccination this year, while 26 million are also eligible for an autumn Covid-19 booster. Officials at the UK Health Security Agency (UKHSA) warned there will be lower levels of natural immunity to flu this year after the past few winters saw the public socialising less during restrictions. The UKHSA warned of a possible "difficult winter" ahead as respiratory viruses, including flu and Covid, circulate widely as the public return to pre-pandemic levels of mixing. One expert said they were more worried about flu than they had been for several years because of the reduction in population immunity. There are also concerns patients may have vaccine fatigue and may choose to have one vaccine but not the other. Read full story (paywalled) Source: The Telegraph, 28 September 2022 -
News Article
Flu poses 'significant threat' in Wales this winter, officials warn
Patient Safety Learning posted a news article in News
Flu could pose a "significant" threat this winter for the first time since the Covid pandemic, public health expert have warned. There are concerns the flu season may start earlier and affect more people, as other respiratory viruses re-emerge following Covid restrictions. Public Health Wales is urging adults and children who are eligible for a free flu jab to take up the offer. The announcement comes as cases of flu have already been detected in Wales. All children between two and 16 are eligible for a free flu vaccine - although only certain groups of children over five are eligible for Covid-19 boosters. The warning comes after Australia experienced its highest number of flu cases in five years, with its season starting early. Experts fear Wales and the UK could see similar levels this winter. Read full story Source: BBC News, 27 September 2022 -
News Article
Rollout of omicron vaccine threatened by ‘flimsy needles’
Patient Safety Learning posted a news article in News
NHS staff have warned that needles supplied with a Covid vaccine which targets the omicron strain are “not fit for purpose” and could place vaccinators and members of the public at risk. Dozens of messages shared on an NHS staff forum reveal widespread concerns about the needles supplied with the Moderna SpikeVax vaccine, which are said to bend when vaccinators pierce the top of the vial containing the Covid-19 vaccine doses. The SpikeVax bivalent vaccine was the first to target both the original and the omicron strain of the virus. It is due to play a key role in the NHS’s autumn Covid vaccination booster programme. One pharmacist said: “They [the needles] just are not fit for purpose and as such we are not using them and are using the original needles until a solution is found”. A UK Health Security Agency spokesperson confirmed the problem, stating: “We are aware that some NHSE sites are experiencing some problems with the use of the new needle and syringe being supplied for administrating the Moderna bivalent vaccine. We are in touch with the supplier about these concerns, including the facilitation of additional training support, but if necessary will also offer an alternative suitable product to avoid any disruption to the vaccination programme.” Read full story (paywalled) Source: HSJ, 15 September 2022 -
News Article
Covid-19: Commission describes “massive global failures” of pandemic response
Patient Safety Learning posted a news article in News
The global response to the first two years of the Covid-19 outbreak failed to control a pandemic that has led to an estimated 17.7 million deaths to date, a major review has concluded. The Lancet Commission on lessons for the future from the Covid-19 pandemic, produced by 28 world leading experts and 100 contributors, cites widespread failures regarding prevention, transparency, rationality, standard public health practice, operational coordination, and global solidarity. It concludes that multilateral cooperation must improve to end the pandemic and manage future global health threats effectively. The commission’s chair, Jeffrey Sachs, who is a professor at Columbia University and president of the Sustainable Development Solutions Network, said, “The staggering human toll of the first two years of the Covid-19 pandemic is a profound tragedy and a massive societal failure at multiple levels.”In its report, which used data from the first two years of the pandemic and new epidemiological and financial analyses, the commission concludes that government responses lacked preparedness, were too slow, paid too little attention to vulnerable groups, and were hampered by misinformation.Read full story Source: BMJ, 14 September 2022 -
Content Article
Opposition to vaccines has a long history (26 April 2022)
Patient Safety Learning posted an article in Blogs
In January 2019, not long before the COVID-19 pandemic began, Laurent-Henri Vignaud and Françoise Salvadori published what would turn out to be a very timely book, Antivax: Resistance to Vaccines from the 18th Century to the Present Day. In a recent presentation at the French College of General Medicine's 15th Congress of General Medicine, Vignaud, a historian of science, gave examples from the past to show that opposition to vaccines, which has come to light during the COVID-19 pandemic, is neither a recent phenomenon nor specific to France. -
Content ArticleEuropean Union Directive 2010/32/EU legally enforces a set of strategies aimed at preventing sharps injuries and determining the risk of bloodborne infections and psychological distress in healthcare workers. This article in the International Journal of Environmental Research and Public Health looks at the results of a national survey conducted in Italy in 2017 and repeated in 2021 to evaluate the progress of the Directive's implementation. The authors assessed the impact of the Covid-19 pandemic on implementation.
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News Article
Malaria booster vaccine could cut deaths in children, study suggests
Patient Safety Learning posted a news article in News
A malaria vaccine created by Oxford researchers “is really exciting” and could contribute towards drastically reducing the number of children who die from the infection, experts suggest. A new study reports on the effectiveness of a malaria booster vaccine which shows long-lasting high efficacy in African children, meeting the World Health Organisation (WHO) specified 75% efficacy goal. The research found that a vaccine booster dose one year after children received three doses as their primary vaccination regime maintained high efficacy against malaria. Adrian Hill, director of the Jenner Institute and Lakshmi Mittal and Family Professor of Vaccinology, University of Oxford, said: “We think these data are the best data yet. “And very importantly, this is a vaccine that we think can be manufactured and deployed, very widely.” He added that the vaccine could be produced for a few dollars a dose, and together with existing measures, like mosquito nets and sprays, could help save children’s lives. Read full story Source: The Independent, 8 September 2022 -
News Article
Anger at plans to roll back Covid vaccines to under-11s in England
Patient Safety Learning posted a news article in News
The decision to reduce the number of children who are offered Covid jabs has prompted outcry from parent groups and academics. The UK Health Security Agency (UKHSA) said children who had not turned 5 by the end of last month would not be offered a vaccination, in line with advice published by the UK’s Joint Committee on Vaccination and Immunisation (JCVI) in February 2022. UKHSA said the offer of Covid jabs to healthy 5 to 11-year-olds was always meant to be temporary. UKHSA’s Green Book, which provides information on the vaccine rollout for public health professionals, states: “This one-off programme applies to those aged 5 to 11 years, including those who turn 5 years of age before the end of August 2022". “Subject to further clarification, on-going eligibility in 2022/23, after the one off-programme, is expected to be for children in the academic years where children are aged 11 or 12 years.” However, Prof Christina Pagel, of University College London, criticised the move. “JCVI itself considered there to be a benefit to young children to be vaccinated – even if most of them had already been infected,” she said. “There is also the additional benefit to children of providing additional protection from developing long Covid, missing school during the acute illness and reducing transmission to household members, other children and teachers.” Pagel said that at least one serious Covid wave was expected later this year, but that many children about to start school would now have to wait six years for vaccination, with likely relatively frequent infections in that time. “When we know there is a safe and effective vaccine available this seems unjustifiable to me,” said Pagel, adding that – while rare – children had died from Covid. Read full story Source: The Guardian, 6 September 2022 -
News ArticleMillions of people will be invited for their autumn Covid booster jab in England and Scotland, with care home residents the first to receive them. Although infections are falling, health bosses are predicting a resurgence of Covid and flu this autumn and winter. They are urging those eligible to protect themselves from serious illness by getting vaccines against both. A recently approved vaccine against the Omicron variant will be used first. However, there is not enough of Moderna's "bivalent" vaccine to protect everyone aged over 50 so health officials say people should take whichever booster they are offered. These will be the vaccines used in the spring. The UK's Medicines and Healthcare products Regulatory Agency (MHRA) announced on Saturday that it had approved a second "bivalent" coronavirus vaccine from Pfizer/BioNTech for people aged 12 and over. Read full story Source: BBC News, 4 September 2022
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News Article
Covid: Pregnant women targeted with false vaccine claims
Patient Safety Learning posted a news article in News
Covid vaccination advice in pregnancy has not changed, contrary to false social media posts, UK health agencies have clarified. Inaccurate messages shared by thousands claimed that pregnant or breastfeeding women were now recommended not to take the vaccine. In fact, the NHS says the vaccine is both safe and strongly recommended for this group. The misleading claim came from a now out-of-date document from 2020. The document went viral after a Twitter user - whose account has since been suspended - shared a post stating incorrectly that the UK government had, "quietly remove[d] approval for use of Covid vax in pregnant and breastfeeding women". She linked to a report from December 2020 which said, "reassurance of safe use of the vaccine in pregnant women cannot be provided at the present time", because of an absence of data and that, "women who are breastfeeding should also not be vaccinated". This was true at the time, but since then data has been gathered finding no link between the vaccine and problems in pregnancy or birth. In fact, the Covid vaccine seems to reduce the risk of still-birth and pre-term delivery. And unvaccinated pregnant women are more likely to need hospital treatment if they catch Covid, especially in the third trimester. This evidence led to the recommendation being changed - so the statement found in this report no longer stands. Read full story Source: BBC News, 1 September 2022 -
Content ArticleThis report revisits the conclusions of The Health Foundation's Covid-19 impact enquiry, which found that poor health and existing inequalities had left parts of the UK more vulnerable to the virus and had influenced its devastating impact. A year on from the impact inquiry, more than 90% of the UK population have had at least one Covid-19 infection, and 74% of adults had received three vaccinations by April 2022. This report considers: the further direct impact of Covid-19 on health outcomes. the broader implications for social determinants of health. the extent to which previously highlighted risks to health have been addressed. the implications for the country of ‘living with Covid-19’.
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News Article
‘Vaccine fatigue’ could hit autumn Covid boosters
Patient-Safety-Learning posted a news article in News
Britain faces a low uptake of the Covid booster jab this autumn amid “vaccine fatigue” and complacency about the virus, the new Pfizer boss has warned. The booster campaign starts next week, with care home residents and the housebound the first to be invited. Over-75s and the clinically vulnerable will be able to book appointments from September 12, with a wider rollout for over-50s taking place in phases. Roughly 26 million in England will be eligible. Susan Rienow, who was appointed UK managing director at Pfizer in February, said: “We have to remain vigilant. I recognise there may be some vaccine fatigue in the population. But making sure that people are boosting their immunity, so that we can prevent people from being hospitalised, is going to be really important.” Read full story (paywalled) Source: The Times (28 August 2022) -
News Article
Biden administration plans for new booster campaign soon after labor day
Patient-Safety-Learning posted a news article in News
The Biden administration plans to offer the next generation of coronavirus booster shots to Americans 12 and older soon after Labor Day, a campaign that federal officials hope will reduce deaths from Covid-19 and protect against an expected winter surge. Dr. Peter Marks, the top vaccine regulator for the Food and Drug Administration, said in an interview on Tuesday that while he could not discuss timing, his team was close to authorizing updated doses that would target the versions of the virus now circulating. Even though those formulations have not been tested in humans, he said, the agency has “extremely good” data showing that the shots are safe and will be effective. “How confident am I?” he said. “I’m extremely confident.” Read full story Source: The New York Times (23 August 2022) -
News Article
Polio was almost eradicated. This year it staged a comeback
Patient-Safety-Learning posted a news article in News
At the beginning of this year, there was a thrum of excitement among global health experts: Eradication of polio, a centuries-old foe that has paralyzed legions of children around the globe, seemed tantalizingly close. But there were several ominous setbacks. Malawi in February announced its first case in 30 years, a 3-year-old girl who became paralyzed following infection with a virus that appeared to be from Pakistan. Pakistan itself went on to report 14 cases, eight of them in a single month this spring. In March, Israel reported its first case since 1988. Then, in June, British authorities declared an “incident of national concern” when they discovered the virus in sewage. By the time New York City detected the virus in wastewater last week, polio eradication seemed as elusive as ever. “It’s a poignant and stark reminder that polio-free countries are not really polio-risk free,” said Dr. Ananda Bandyopadhyay, deputy director for polio at the Bill & Melinda Gates Foundation, the largest supporter of polio eradication efforts. The virus is always “a plane ride away,” he added. Read full story (paywalled) Source: The New York Times (18 August 2022)
