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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 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- Posted
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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- Posted
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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- Posted
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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- Posted
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Content ArticleThere has been increasing public concern that COVID-19 vaccination causes menstrual disturbance regarding the relative effect of vaccination compared to SARS-CoV-2 infection. The objectives of this study, published in Science Direct, were to test potential risk factors for reporting menstrual cycle changes following COVID-19 vaccination and to compare menstrual parameters following COVID-19 vaccination and COVID-19 disease.
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Content ArticleIn this study, Tsampasian et al. looked at what the risk factors were for developing post−COVID-19 condition (also known as Long Covid). The systematic review and meta-analysis of 41 studies, including 860 783 patients, found that female sex, older age, higher body mass index, smoking, preexisting comorbidities, and previous hospitalisation or ICU admission were risk factors significantly associated with developing Long Covid, and that SARS-CoV-2 vaccination with two doses was associated with lower risk of Long Covid. The findings of this systematic review and meta-analysis provide a profile of the characteristics associated with increased risk of developing Long Covid and suggest that vaccination may be protective against Long Covid.
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Content ArticleIn this blog, TranspariMED Founder Till Bruckner reviews The Truth Pill: The Myth of Drug Regulation in India, a new book that looks at problems with the medications regulatory system in India. The book's authors, Dinesh S. Thakur and Prashant Reddy T, draw on in-depth legal and regulatory analyses, numerous case studies and responses to hundreds of Freedom of Information requests to document glaring gaps in India’s legal framework and severe shortcomings in regulatory oversight and enforcement.
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Content ArticleCo-produced by young people and researchers from the University of Bristol and London School of Hygiene and Tropical Medicine, ‘EDUCATE’ will help teach students about the human papillomavirus (HPV) vaccine and provide reassurance about receiving the vaccine, which is usually offered to teenagers at school as part of the national vaccination programme.
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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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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- Posted
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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- Posted
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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- Posted
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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- Posted
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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- Posted
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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- Posted
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News ArticleThe development of a promising COVID-19 vaccine has been put on hold due to an adverse reaction in a trial participant. A spokesman for AstraZeneca, the company working with a team from Oxford University, told the Guardian the trial has been stopped to review the “potentially unexplained illness” in one of the participants. The spokesman stressed that the adverse reaction was only recorded in a single participant and said pausing trials was common during vaccine development. “As part of the ongoing randomised, controlled global trials of the Oxford coronavirus vaccine, our standard review process was triggered and we voluntarily paused vaccination to allow review of safety data by an independent committee,” the spokesman said. “This is a routine action which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials. In large trials illnesses will happen by chance but must be independently reviewed to check this carefully." “We are working to expedite the review of the single event to minimise any potential impact on the trial timeline. We are committed to the safety of our participants and the highest standards of conduct in our trials.” Read full story Source: The Guardian, 9 September 2020
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Midwives and paramedics to deliver flu and Covid vaccines, proposes DHSC
Patient Safety Learning posted a news article in News
An 'expanded workforce' will be delivering flu and a potential COVID-19 vaccine, under proposals unveiled by the Government today. The three-week consultation also focuses on a proposal of mass vaccinations against COVID-19 using a yet-to-be-licensed vaccine, if one becomes available this year. The Department of Health and Social Care (DHSC) is hoping new legislation could come into effect by October, ahead of the winter season. The consultation proposes to amend the Human Medicine Regulations 2012 to "expand the workforce legally allowed to administer vaccines under NHS and local authority occupational health schemes, so that additional healthcare professionals in the occupational health workforce will be able to administer vaccines". It said this would include 'midwives, nursing associates, operating department practitioners, paramedics, physiotherapists and pharmacists'. The consultation said: "This will help ensure we have the workforce needed to deliver a mass COVID-19 vaccination programme, in addition to delivery of an upscaled influenza programme, in the autumn." The consultation also said that "there is a possibility that both the flu vaccine and the COVID-19 vaccine will be delivered at the same time, and we need to make sure that in this scenario there is sufficient workforce to allow for this". Read full story Source: Pulse, 28 August 2020- Posted
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UK to give emergency approval to any Covid vaccine breakthrough
Patient Safety Learning posted a news article in News
Any new and effective Covid vaccine will be given emergency approval for use in the UK and an expanded workforce will be trained to give the injections to immunise as much of the population as possible quickly, the government has said. A change in the law will allow the UK regulator, the Medicines and Healthcare Products Regulatory Agency (MHRA), to grant temporary approval for a vaccine from October, before it has been given a licence by the European authorities, which would be the normal procedure. The UK will be out of the EU from January and will approve drugs and vaccines without Brussels’ involvement. Ministers say there will be no shortcut on safety or effectiveness, and that any vaccine will be approved for the UK only if it meets the highest standards. The deputy chief medical officer for England, Prof Jonathan Van-Tam, said: “We are making progress in developing COVID-19 vaccines, which we hope will be important in saving lives, protecting healthcare workers and returning to normal in future. “If we develop effective vaccines, it’s important we make them available to patients as quickly as possible but only once strict safety standards have been met. The proposals consulted on today suggest ways to improve access and ensure as many people are protected from Covid-19 and flu as possible without sacrificing the absolute need to ensure that any vaccine used is both safe and effective.” The MHRA has the power to grant an unlicensed medicine or a vaccine temporary authorisation where a product is proven safe and effective and in the best interest of the patient on the basis of available evidence. Read full story Source: The Guardian, 28 August 2020 -
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UK flu jab rates prompt complacency warning
Patient Safety Learning posted a news article in News
Complacency over the flu jab risks overwhelming the NHS, experts warn, as data reveals the scale of the challenge in expanding the vaccination programme. Last month, the government announced plans to double the number of people who receive the influenza jab. But BBC analysis has found the take-up rate among people in vulnerable groups eligible for a free jab has declined. Health secretary Matt Hancock said he did not want a flu outbreak "at the same time as dealing with coronavirus". The government wants to increase the number of people vaccinated from 15 million to 30 million amid fears coronavirus cases will rise again in the autumn. Local authorities in England saw an average 45% of people with serious health conditions under 65 take up the offer of a free vaccine last winter, data shows. That represents a drop from 50% in 2015. The UK government has an ambition to vaccinate 55% of people in vulnerable groups, which includes people with multiple sclerosis (MS), diabetes or chronic asthma. The World Health Organization (WHO) has previously said countries should vaccinate 75% of people in "vulnerable" categories. Read full story Source: BBC News, 27 August 2020- Posted
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News ArticleThe coronavirus vaccine candidate being developed by AstraZeneca and Oxford University induces a strong immune response and appears to be safe, according to preliminary trial results. The early stage trial, which involved 1,077 people, has found that the vaccine trains the immune system to produce antibodies and white blood cells capable of fighting the virus. It also causes few side effects. Professor Sarah Gilbert, co-author of the Oxford University study, described the findings as promising but said there “is still much work to be done before we can confirm if our vaccine will help manage the Covid-19 pandemic”. The results came as the UK secured 90 million doses of other promising Covid-19 vaccines, while clinical trials of a new inhaled coronavirus treatment showed it significantly reduced the number of hospitalised patients needing intensive care. Read full story Source: The Independent, 21 July 2020
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Oxford vaccine results ‘promising’ as initial data set for release in days
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The initial data on a trial of the coronavirus vaccine being developed by Oxford University will be released in the coming week, The Lancet medical journal has announced amid reports its findings have been promising. The development of a vaccine to fight against the virus has been touted as pivotal in returning the world to life as it was before the pandemic by protecting vulnerable people and building up immunity among populations. Now Oxford University’s contribution - one of the world’s leading candidates for a viable vaccine – is understood to have made promising results in initial testing. Read full story Source: The Independent, 16 July 2020 -
News ArticleNew data has shown the number of coronavirus patients being admitted to hospital and intensive care units across the country has risen as lockdown rules are set to be eased further on Monday. The Public Health England (PHE) data, published on Friday, covers 134 NHS trusts across the country and shows the daily rate of new patients admitted to hospital and critical care with COVID-19 has risen compared to recent weeks, with London experiencing a sharp spike in new admissions in the past week. The south east region also saw an increase. The surveillance data on the spread of COVID-19 throughout England has also revealed an increase in the number of people testing positive at their GP. Read full story Source: Independent, 31 May 2020
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