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News ArticleNHS trust chief executives have told HSJ they need more clarity the Pfizer-BioNTech covid vaccine is safe to reassure their worried staff. Trusts were told last week they need to be ready to start vaccinating their staff from early next month. On Tuesday, it was confirmed that they would initially be asked to use the covid vaccine produced by Pfizer and BioNTech, assuming it is granted a licence by the Medicines and Healthcare products Regulatory Agency. Speaking at the HSJ Provider Virtual Summit, St George’s University Hospitals Foundation Trust chief executive Jacqueline Totterdell said there was a lot of “anxiety” around the vaccine among her staff. Leeds Community Healthcare Trust chief Thea Stein added leaders in her city feel “anxious and uncertain”. Ms Totterdell said: “As a responsible officer for 9,000 staff, I also need to be clear that the vaccination is safe. That bit of narrative just needs to come out from the centre, about the reasons why they think it is safe. “I think there is a lot of anxiety, and some of the polls we’ve done around south west London show that as little as 50 per cent of people are willing just to have it without any of that [assurance]." Northumbria Healthcare FT chief executive Sir Jim Mackey, who also spoke at the summit, admitted he was “a bit surprised” by some staff who said they were not going to get the vaccine. The former NHS Improvement chief added: “I think when it actually comes to it, and we get the messaging right about it, not just the responsibility for you but also your responsibility for the people you work with… then the vast majority of people will get it and take confidence in the fact that it’s been developed really quickly and effectively. “These things don’t get signed off if they’re dangerous, so we need to embrace it as the thing that’s going to get us back to normal.” Read full story (paywalled) Source: HSJ, 26 November 2020
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Hospital staff likely to get covid vaccine first
Patient Safety Learning posted a news article in News
Hospital trusts have been put on notice that the challenging storage requirements of the first covid vaccines are likely to mean the vaccination of their staff will have to form the vanguard of the planned roll-out next month due. HSJ reported last week that healthcare staff would share priority with “care home residents and staff” in the vaccine roll-out. However, a letter sent to trust chief executives by NHS England seeks to clarify the situation by stressing that “different vaccines are likely to be better suited to different settings because the vaccines are likely to have different storage, reconstitution and administration requirements”. “Given what we currently know about the first expected vaccine, the imperative is that NHS trusts are ready to start vaccinating from the beginning of December.” Trusts are one of several components of the vaccination programme that includes primary care-run sites, mass vaccination centres, and “roving” visits to those who need them. Local systems and regional teams will decide “the most appropriate combination of models required to deliver the vaccine to their local populations based on local needs” the letter says. However, during the early stages of the roll-out this is likely to be dictated by the vaccine types that become available. Read full story (paywalled) Source: HSJ, 25 November 2020 -
News ArticleNews that the Medicines and Healthcare products Regulatory Agency (MHRA) will review the data from trials of one of the most promising COVID-19 vaccine candidates, to see whether it meets the agency’s robust standards of quality, safety and effectiveness, has been welcomed by the UK Government. Initial data had shown the Pfizer/BioNTech vaccine is 94% effective in protecting people over 65 years of age from coronavirus, with no serious safety concerns having been raised during the clinical trials. Already the UK Government has pre-ordered 40 million vaccine doses – enough to provide vaccinations for up to a third of the population – and is expected to receive the total amount by the end of 2021. The majority of doses are anticipated to be received in the first half of next year. As well as successfully protecting those over the age of 65, trial data also showed that the vaccine candidate also performed equally well in people of all ages, races and ethnicities. Approval from the MHRA, as the UK’s independent regulator, is required for the COVID-19 vaccine to be authorised for consistent manufacture and supply. To achieve this approval, it must demonstrate that it meets strict quality, safety and effectiveness standards set by the MHRA. Business Secretary Alok Sharma added: “Today, we have renewed hope that we are on the brink of one of the most significant scientific discoveries of our time, as we reach the crucial last stage to finding a COVID-19 vaccine. “While this news is a cause for celebration, we must make sure that this vaccine, like all new medicines, meets standards of quality, safety, and effectiveness." Read full story Source: National Health Executive, 24 November 2020
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NHS planning to start covid vaccination of under 50s by end of January
Patient Safety Learning posted a news article in News
The NHS’ current plan for the covid vaccine rollout — dependent on the arrival of supplies — would see the whole adult population able to begin receiving it before the end of January, according to leaked documents seen by HSJ. Under the plan, everyone who wants to would have been vaccinated by early April. NHS England’s draft COVID-19 vaccine deployment programme, seen by HSJ, reveals when each cohort is likely to begin receiving it, based on its plans to create huge capacity across GP-run facilities, “large scale mass vaccination sites”, NHS trusts, and “roving models” for those who cannot travel. It relies on a range of assumptions including that there will be 75% takeup, outside of residential settings like care homes and prisons, where 100% is expected. The plan also relies on supplies, including more than 7 million doses being available in December. It is not clear what impact a delay to this would have on the rollout. With most doses due to be administered between early January and mid March — at a rate of 4-5 million every week — a small delay may not make a huge impact to the overall schedule. The document is dated 13 November and was shared among some senior NHS regional leaders yesterday. Read full story (paywalled) Source: HSJ, 23 November 2020 -
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Covid antibodies 'last at least six months'
Patient Safety Learning posted a news article in News
Coronavirus antibodies last at least six months and offer protection against a second infection, a study of healthcare workers suggests. Staff at Oxford University Hospitals were regularly tested both for COVID-19 infections and for antibodies revealing a past infection. The more antibodies people had, the lower their chances of re-infection. A separate study found pre-existing immunity from other coronaviruses also protected against Covid. Infection consultant Dr Katie Jeffery described the Oxford findings as "encouraging news" ahead of forthcoming Covid vaccines. They indicated that having the virus once "provides at least short-term protection" from getting it again, she said. Read full story Source: BBC News, 21 November 2020 -
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COVID-19: Oxford University vaccine is highly effective
Patient Safety Learning posted a news article in News
The coronavirus vaccine developed by the University of Oxford is highly effective at stopping people developing COVID-19 symptoms, a large trial shows. Interim data suggests 70% protection, but the researchers say the figure may be as high as 90% by tweaking the dose. The results will be seen as a triumph, but come after Pfizer and Moderna vaccines showed 95% protection. However, the Oxford jab is far cheaper, and is easier to store and get to every corner of the world than the other two. So the vaccine will play a significant role in tackling the pandemic, if it is approved for use by regulators. "The announcement today takes us another step closer to the time when we can use vaccines to bring an end to the devastation caused by [the virus]," said the vaccine's architect, Prof Sarah Gilbert. Read full story Source: BBC News, 23 November 2020 -
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Free flu jab offered to all over 50s in England
Patient Safety Learning posted a news article in News
People aged 50 to 64 in England will be able to get a free flu jab from 1 December in an attempt to fight the "twin threats" of flu and COVID-19. The group has been added to a list of people who are already eligible for a flu jab in England, such as those over 65 and health and social care workers. Thirty million people are being offered the vaccine in England's largest flu-immunisation programme to date. Health Secretary Matt Hancock said it was a winter "like no other". "We have to worry about the twin threats of flu and COVID-19," he said, adding that the coronavirus pandemic meant it was "more important than ever" that people got their flu jabs. Mr Hancock told BBC Breakfast that all over 50s would be able to get the vaccine by January. Read full story Source: BBC News, 20 November 2020 -
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Black and Asian people ‘up to twice as likely to be infected with Covid’
Patient Safety Learning posted a news article in News
Black and Asian people are up to twice as likely to be infected with COVID-19 compared to those of white ethnicities, according to a major new report. The risk of ending up in intensive care with coronavirus may be twice as high for people with an Asian background compared to white people, data gathered from more than 18 million individuals in 50 studies across the UK and US also suggests. The report, published in the EClinicalMedicine by The Lancet, is the first-ever meta-analysis of the effect of ethnicity on patients with COVID-19. The scientists behind it said their findings should be of "importance to policymakers" ahead of the possible roll out of a vaccine. Read full story Source: The Independent, 12 November 2020 -
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Thousands fewer children immunised against common diseases because of lockdown
Patient Safety Learning posted a news article in News
Lockdown measures in England led to thousands fewer children receiving vital immunisations for a range of diseases include measles, diphtheria and whooping cough, Public Health England (PHE) has warned. PHE has warned parents they should continue to get their children immunised regardless of lockdown and restrictions brought on by coronavirus. During the first wave of coronavirus the government advised that children should continue to receive vaccinations as scheduled but despite these some appointments were delayed and the numbers of children vaccinated against common diseases fell compared to 2019. PHE looked at data from almost 40% of GP surgeries for use of the common 6-in-1 vaccination for diseases including diphtheria, tetanus, whooping cough, and polio as well as uptake of the measles, mumps and rubella (MMR) vaccine to 19 October. In total 167,322 children had the 6-in-1 vaccine, a drop of 6,600 on the same period in 2019, a fall of almost 4%. A total of 167,670 children had the MMR jab, 4,700 fewer than in 2019, a drop of 2.8%. Although the vaccinations recovered after lockdown the rates are still lower overall than 2019. Dr Mary Ramsay, head of immunisations at Public Health England, said: “Vaccines remain the best defence against infection. It’s essential we maintain the highest possible uptake to prevent a resurgence of serious and sometimes life-threatening diseases. “Routine vaccinations are still available throughout the pandemic – it’s vital that we continue to make it as easy and safe as possible for parents to take their children to appointments.” Read full story Source: The Independent, 11 November 2020 -
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Russian Covid vaccine shows encouraging results
Patient Safety Learning posted a news article in News
Early results from trials of a Covid vaccine developed in Russia suggest it could be 92% effective. The data is based on 20 cases of COVID-19 from 16,000 volunteers given the Sputnik V vaccine or a dummy injection. While some scientists welcomed the news, others said the data had been rushed out too early. It comes after Pfizer and BioNTech said their vaccine could prevent 90% of people getting Covid-19, based on a study of 43,500 people. Although the Sputnik data is based on fewer people being vaccinated and fewer cases of Covid developing during the trial, it does confirm promising results from earlier research. The Sputnik V vaccine, developed at the National Research Centre for Epidemiology and Microbiology in Moscow, is currently going through phase III clinical trials in Belarus, UAE, Venezuela and India. So far there are no safety issues, with Russian researchers saying there were "no unexpected adverse events" 21 days after volunteers received their first of two injections. Read full story Source: BBC News, 11 November 2020 -
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Covid: NHS ready for new vaccine roll-out, says Hancock
Patient Safety Learning posted a news article in News
The NHS is ready to start providing the new coronavirus vaccine "as fast as safely possible", Health Secretary Matt Hancock has said. Asked whether it could be available by Christmas, he said that was "absolutely a possibility" - but he expected the mass roll-out "in the first part of next year". He said vaccination clinics would be open seven days a week, and he was giving GPs an extra £150m. On Monday, early results from the world's first effective coronavirus vaccine showed it could prevent more than 90% of people from getting Covid. The vaccine has been developed by pharmaceutical companies Pfizer and BioNTech and is one of 11 vaccines that are currently in the final stages of testing. The UK has already ordered 40 million doses - enough to vaccinate up to 20 million people as each person will need two doses for it to work effectively. Asked how many people would need to be vaccinated before life can return to normal, Matt Hancock said: "Well the answer to that is we just don't know." "So the trials can tell you if a vaccine is clinically safe and if it's effective at protecting an individual from the disease. What we can't know, until we've vaccinated a significant proportion of the population, is how much it stops the transmission of the disease." Mr Hancock told BBC Radio 4's Today programme it would be "a mammoth logistical operation" and highlighted some of the challenges, including getting it from Belgium to the UK while not removing from a temperature of -70C more than four times. Older care home residents and care home staff are at the top of a list from government scientific advisers of who would get immunised first, followed by health workers. Mr Hancock said NHS staff would go into care homes to vaccinate residents, as well as setting up vaccination venues. Children would not be vaccinated, he said. However, Prof Sir John Bell from Oxford University said: "I would worry about not giving this to as wide a percentage of the population as we can." "I'm more of the view that we need to vaccinate further into the population and vaccinate younger people as well, partly because we don't really know what the long term effects of this disease are." The vaccine will not be released for use until it passes final safety tests and gets the go-ahead from the Medicines and Healthcare products Regulatory Agency. Read full story Source: BBC News, 10 November 2020 -
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Pfizer coronavirus vaccine is 90% effective, early data suggest
Patient Safety Learning posted a news article in News
Pfizer and BioNTech have said that their coronavirus vaccine may be more than 90% effective, after the two pharmaceutical firms released interim data from their ongoing large-scale trial. Preliminary analysis, conducted by an independent data monitoring board, looked at 94 infections recorded so far in the vaccine’s phase 3 study, which has enrolled nearly 44,000 people in the US and five other countries. Of those participants who were infected with COVID-19, it is currently unclear how many had received the vaccine versus those who had been given a placebo. The current efficacy rate, which is much better than most experts expected, implies that no more than eight volunteers will have been inoculated. The data have yet to be peer-reviewed, and Pfizer said the initial protection rate might change by the time the study ends. The longevity of the immune response provoked by the mRNA-based vaccine also remains unknown. However, the findings are the most promising indication to date that a vaccine will be effective in preventing disease among infected individuals, handing humanity a crucial tool in tackling the pandemic. Pfizer and its German partner BioTech will continue with the phase 3 trial until 164 infections have been reported among volunteers - a figure that will give regulatory authorities a clearer idea of the vaccine’s efficacy. This number is expected to be reached by early December in light of the rising US infection rates, Pfizer said. The two companies said they have so far found no serious safety concerns and expect to seek US emergency use authorisation later this month. Read full story Source: The Independent, 9 November 2020 -
News ArticleThe NHS has erroneously written to thousands of patients who have had glandular fever in the past asking them to get a flu jab from their GP. The error left some GPs with practice phone lines blocked last week while reception staff have had to explain to patients they are not actually eligible for free flu vaccination. Nearly 40,000 letters were sent out to patients with a past history indicating glandular fever because of a coding error at NHS Digital. This was meant to identify patients with suppressed immune systems which would include those who currently have glandular fever and encourage them to contact their GP practice to arrange vaccination. However, the historical cases were not excluded, leading to the letters being automatically generated even when the glandular fever diagnosis was decades old. When NHS Digital realised the error, it contacted NHS England – which was responsible for posting out the letters – and managed to stop others being sent out. An NHS Digital spokesman said: “During a process to identify patients eligible for a flu vaccination, glandular fever was incorrectly included in a complex list of conditions that cause persistent immunosuppression. This led to some patients incorrectly receiving a letter encouraging them to seek a flu vaccination. “There has been no adverse clinical impact for patients and the issue was quickly resolved before the majority of letters were sent.” NHSD said patients who had received the letter would receive another one to explain and to reassure them." Read full story (paywalled) Source: HSJ, 4 November 2020
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News ArticleLevels of protective antibodies in people wane "quite rapidly" after coronavirus infection, say researchers. Antibodies are a key part of our immune defences and stop the virus from getting inside the body's cells. The Imperial College London team found the number of people testing positive for antibodies has fallen by 26% between June and September. They say immunity appears to be fading and there is a risk of catching the virus multiple times. More than 350,000 people in England have taken an antibody test as part of the REACT-2 study so far. In the first round of testing, at the end of June and the beginning of July, about 60 in 1,000 people had detectable antibodies. But in the latest set of tests, in September, only 44 per 1,000 people were positive. "Immunity is waning quite rapidly, we're only three months after our first [round of tests] and we're already showing a 26% decline in antibodies," said Prof Helen Ward, one of the researchers. The fall was greater in those over 65, compared with younger age groups, and in those without symptoms compared with those with full-blown COVID-19. The number of healthcare workers with antibodies remained relatively high, which the researchers suggest may be due to regular exposure to the virus. There have been very few confirmed cases of people getting Covid twice. However, the researchers warn this may be due to immunity only just starting to fade since the peak infection rates of March and April. The hope is the second infection will be milder than the first, even if immunity does decline, as the body should have an "immune memory" of the first encounter and know how to fight back. The researchers say their findings do not scupper hopes of a vaccine, which may prove more effective than a real infection. One of the researchers, Prof Graham Cooke, said: "The big picture is after the first wave, the great majority of the country didn't have evidence of protective immunity. The need for a vaccine is still very large, the data doesn't change that." Read full story Source: BBC News, 27 October 2020
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News ArticleA wider range of healthcare workers—including midwives, paramedics, physiotherapists, and pharmacists—are now allowed to give flu and potentially COVID-19 vaccines after the introduction of new laws by the UK government. The changes to the Human Medicines Regulations 2012, first proposed in August1 and consulted upon last month, came into effect on 16 October. The Department of Health and Social Care said that the expanded workforce will have to undergo additional training to ensure patient safety. It added that government planning will “ensure this does not affect other services in hospitals and in GP and community services, by drawing on a pool of experienced NHS professionals through the NHS Bring Back Scheme.” Commenting on the changes, England’s deputy chief medical officer Jonathan Van-Tam said, “The measures outlined today aim to improve access and strengthen existing safeguards protecting patients.” Read full story Source: BMJ, 16 October 2020
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Content ArticleThe ACT-Accelerator is organized into four pillars of work: diagnostics, treatment, vaccines and health system strengthening. Each pillar is vital to the overall effort and involves innovation and collaboration. Dr Jake Suett from the UK, has been selected as a community and civil society representative on the WHO ACT-accelerator diagnostics pillar. You can hear more about Jake's own experience of Long Covid on the hub. To read more about the Access to COVID-19 Tools (ACT) Accelerator, follow the link below.
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Pregnant women must have flu jab this winter, warn health bodies
Patient Safety Learning posted a news article in News
All pregnant women have been urged by doctors to get a free flu vaccination this winter to ensure they and their babies are protected. People can get infected with flu and coronavirus at the same time - with Public Health England finding if you get both simultaneously you may get more seriously ill. Researchers previously said those who have been infected with both viruses face a serious increase to their risk of death and warned the public “not to be complacent” in the wake of fears flu could circulate around the country alongside COVID-19. The Royal College of Obstetricians and Gynaecologists (RCOG) and Royal College of Midwives note while getting flu is not a big deal for most people, getting the virus while you are pregnant can be serious for a small proportion of women and their babies. Flu can occasionally lead to stillbirth, maternal death and raise the chances of having a miscarriage. Dr Edward Morris, president of RCOG, said: “We are keen to reassure pregnant women that flu vaccination is safe for women to have at any stage in pregnancy - from the first few weeks right up to their due date, and while breastfeeding." "Over the last 10 years, the flu vaccine has been routinely and safely offered to pregnant women in the UK. The vaccine can also pass some protection to babies, which lasts for the first months of their lives." Read full story Source: The Independent, 12 October 2020 -
News ArticleGP surgeries are waiting up to a month for supplies of this winter’s flu vaccine amid unprecedented numbers of patients seeking jabs ahead of the second wave of COVID-19, family doctors have said. The Royal College of GPs (RCPG) has written to the health secretary, Matt Hancock, seeking assurances that they will have enough doses of the vaccine to cope with demand. The struggle to get jabs has prompted fears that vulnerable groups, including elderly people and those with underlying conditions, will go unprotected. “We have heard anecdotally that some surgeries are waiting up to a month for replenished supplies of vaccine, which raises concerns that there are significant distribution problems,” Prof Martin Marshall, the RCGP’s chair and a family doctor in London, said in the letter. One GP in Nottingham said there had been “a huge uptake compared to previous years, well over what we anticipated” at their surgery among groups eligible for the free jab, “so supplies ran out quickly”. “The next delivery is several weeks away and there are patients in at-risk groups who are having to wait. We have a patient aged 70 with heart disease who wants the vaccine but we currently have none to give her until the next delivery in mid to late October,” the GP said. Shortages mean that people aged 50 to 64, who are being offered a jab for the first time on the NHS, may have to wait until those with a greater medical need have been immunised first. Read full story Source: The Guardian, 4 October 2020
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Less than half UK population to receive coronavirus vaccine, says task force head
Patient Safety Learning posted a news article in News
Less than half of the UK population will get a Covid vaccine with the elderly being top priority - a top advisor has warned. Kate Bingham, who was appointed as the chair of the Vaccine Taskforce back in May has claimed that the public has been “misguided” when it comes to availability of a vaccine. In an interview with the Financial Times, she said the government “needs to vaccinate everyone at risk”. She said: “People keep talking about ‘time to vaccinate the whole population’, but that is misguided." “There’s going to be no vaccination of people under 18. It’s an adult-only vaccine, for people over 50, focusing on health workers and carehome workers and the vulnerable.” Read full story Source: Financial Times, 4 October 2020 -
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News ArticleExperts say robust legal protections are needed to inspire public confidence. The UK government has set out plans to amend drug regulations in case it decides that COVID-19 vaccines should be used before they are licensed, in a bid to roll them out more quickly. In a consultation on the proposals that ran from 28 August to 18 September the Department of Health and Social Care for England explained that if a suitable vaccine emerged with strong evidence of safety, quality, and efficacy the government would seek to license it through the usual route but could supply it in the meantime. The document added, “A COVID-19 vaccine would only be authorised in this way if the UK’s licensing authority was satisfied that there is sufficient evidence to demonstrate the safety, quality, and efficacy of the vaccine. ‘Unlicensed’ does not mean ‘untested.” The consultation, and the timeframe in which it was conducted, prompted some people to post their concerns on social media. However, the Human Medicine Regulations 2012 already allow the licensing authority to temporarily authorise the supply of an unlicensed product in response to certain public health threats, including the suspected spread of pathogens. The proposed change would allow conditions to be attached “to ensure product safety, quality, and efficacy” The 2012 regulations also give healthcare professionals and manufacturers immunity from being sued in the civil courts for the use of some unlicensed products recommended by the licensing authority in response to a public health threat. The new regulations would extend the immunity to drug companies that have not manufactured the product but placed it on the market with the approval of the licensing authority, and they clarify the consequences for a breach of conditions imposed by the authority. Social media posts play into existing concerns that many people might not accept the vaccine, as surveys indicate. Lawyers have told the Department for Health and Social Care that to inspire public confidence it must provide redress for the few people who might experience adverse effects. Bozena Michalowska, a partner specialising in product liability at the law firm Leigh Day, said, “I do not believe that people will want to play Russian roulette with their health by taking a vaccine which they know nothing about, especially when they know that the risks they take are just taken by them and not a shared risk and they will not have sufficient protection should things go wrong.” Read full story Source: The BMJ, 28 September 2020
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