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COVID-19: New study reveals how effective Pfizer's vaccine is after the first dose

A new COVID vaccine efficacy study from Israel has concluded that Pfizer/BioNTech's jab is up to 85% effective after the first dose.

The research, conducted by the Sheba Medical Centre, the country's largest hospital, has been published in the Lancet medical journal.

The hospital assessed the effectiveness of the first dose of the Pfizer/BioNTech vaccine among 7,000 of its healthcare employees. The workers each received their first dose in January and the research team observed an 85% reduction of clinical (symptomatic) COVID-19 between 15 and 28 days after the jab.

But critically, they also observed efficacy in asymptomatic patients.

The study found that all infections, including asymptomatic, were reduced by 75% after the first dose.

Professor Eyal Leshem, an infectious disease expert and director of Sheba's Institute for Travel and Tropical Medicine, told Sky News: "This is first real-world evidence of effectiveness that shows up after the first dose of the vaccine."

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Source: Sky News, 19 February 2021

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COVID-19: Millions of women and children at risk as visits to essential services plummet

The coronavirus pandemic is a “magnifier of inequality” that threatens the wellbeing of women, children, and adolescents worldwide, a roundtable of influential female leaders has heard.

The United Nations has predicted that 47 million women could lose access to contraception resulting in 7 million additional unintended pregnancies over the next six months1 because of “deadly and disabling” COVID-19, the virtual event was told.

There could also be 31 million additional cases of gender based violence in low and middle income countries. Policy makers have a clear duty to protect the most vulnerable and disadvantaged and to tackle the root causes of inequality with targeted policies and resources, the participants concluded.

Henrietta Fore, executive director of Unicef, said that, in countries with already weak health systems, COVID-19 was disrupting medical supply chains and straining financial and human resources. Visits to healthcare centres are declining owing to lockdowns, curfews, and transport disruptions, and as communities remain fearful of infection. 

She cited recent research that indicated there could be an increase in child deaths amounting to an additional 6000 a day over the next six months, and 56 700 more maternal deaths. “This is a statistic we want to avoid. We are concerned about access to services,” she said.

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Source: BMJ, 29 May 2020

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Covid-19: Mexico City gave ivermectin kits to people with covid in “unethical” experiment

The government of Mexico City handed out nearly 200 000 “ivermectin based kits” last year to people who had tested positive for Covid-19, without telling them they were subjects in an experiment on the drug’s effectiveness.

The results of that experiment were then written up by public officials in an article placed on popular US preprint server SocArXiv. It became one of site’s most viewed articles, claiming that ivermectin had reduced hospital admissions by 52-76%.

But those officials have been under fire at home since SocArXiv withdrew the paper earlier this month, calling it “either very poor quality or else deliberately false and misleading.”

Opposition deputies in Mexico City’s Congress demanded hearings and said they would bring legal action against the paper’s lead author, José Merino, head of the city’s Digital Agency for Public Innovation.

Explaining the decision to withdraw the article—the first to be taken down by SocArXiv—the site’s steering committee wrote that it had responded “to a community groundswell beseeching us to act” in order “to prevent the paper from causing additional harm.”

The committee wrote, “The paper is spreading misinformation, promoting an unproved medical treatment in the midst of a global pandemic. The paper is part of, and justification for, a government programme that unethically dispenses (or did dispense) unproven medication apparently without proper consent or appropriate ethical protections.”

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Source: BMJ, 22 February 2022

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Covid-19: Metformin reduces the risk of developing long term symptoms by 40%, study finds

Metformin—a cheap, safe, and widely available diabetes drug—could reduce the incidence of long covid if given during the acute phase of Covid-19, a new study indicates.

A two week course of metformin given within three days of testing positive for SARS-CoV-2 led to 40% fewer Long Covid diagnoses over the following 10 months compared with people who had taken placebo, according to a randomised controlled trial.

The authors of the study, published in Lancet Infectious Diseases, caution that the trial did not look at whether metformin would be effective as a treatment for those who already have Long Covid.

Jeremy Faust from Harvard Medical School, who was not involved in the research, said the findings, if confirmed, are “profound and potentially landmark.” Writing in a linked comment, he said, “This is the first high quality evidence from a randomised controlled trial to show that the incidence of long covid can be reduced by a medical intervention, metformin—an inexpensive treatment with which clinicians have ample experience".

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Source: BMJ, 8 June 2023

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Covid-19: medical students should not work outside their competency, says BMA

Medical students who are employed in the NHS as part of efforts to swell staff numbers to tackle covid-19 should not be expected to “step up” and act outside of their competency, says the BMA in new guidance.

This is the first set of guidance released by the BMA specifically for medical students, who have had placements and exams cancelled and are uncertain about how they might be employed in the NHS in the current crisis. It says that any employment should be voluntary and within the competency of the student, who should have adequate access to personal protective equipment.

The BMA refers to General Medical Council guidance that states that plans are not currently in place to move provisional registration forward from the normal August date. It warns that there are concerns around the boundaries of practice and the level of supervision that students who take on roles in the NHS would have, which could lead to unsafe working practices. The BMA is in talks to negotiate a safe national contract for such roles.

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Source: BMJ, 24 March 2020

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COVID-19: Many trusts have not done risk assessments for ethnic minority staff

Some NHS trusts in England are yet to complete /cOVID-19 risk assessments for their staff from ethnic minority groups more than two months after the NHS first told them to do so, an investigation by The BMJ has found.

On 29 April NHS England’s chief executive, Simon Stevens, wrote to all NHS leaders telling them to carry out risk assessments and make “appropriate arrangements” to protect ethnic minority staff, amid growing evidence that they were at greater risk of contracting and dying from COVID-19.

However, The BMJ asked England’s 140 acute care trusts for details of risk assessments they had carried out and what subsequent actions they had put in place. Seventy trusts responded. Of these, 27 (39%) said that assessments were yet to be completed for all ethnic minority staff, and 43 (61%) indicated that assessments had been completed. But the other 70 trusts were unable to provide a response within the 20 day deadline, citing “unprecedented challenges” posed by the COVID-19 pandemic, so it is not known what stage they are at in risk assessing staff.

Commenting on The BMJ’s findings, Chaand Nagpaul, the BMA’s chair of council, said, “Clearly, we know that a significant number of doctors have not been risk assessed. It is a shame that it has taken so long, because the risk assessments and mitigations would have been most useful and impactful during the peak of the virus.”

Doctors’ leaders have suggested that systemic race inequalities in the workplace may have exacerbated delays in risk assessing staff. Nagpaul said, “The BMA survey found that doctors from a BAME [black, Asian, and minority ethnic] background felt under more pressure to see patients without adequate protection. So it does beg the question of whether there’s also been this added factor of BAME healthcare staff feeling unable to demand their right to being assessed and protected."

“This is something the NHS needs to tackle. This is an issue that predates covid. It’s vital that we have an NHS where anyone is able to voice their concerns. No one should have to suffer or have fear in silence.”

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Source: The BMJ, 10 July 2020

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COVID-19: Lung damage 'identified' in study

COVID-19 could be causing lung abnormalities still detectable more than three months after patients are infected, researchers suggest.

A study of 10 patients at Oxford University used a novel scanning technique to identify damage not picked up by conventional scans. 

It uses a gas called xenon during MRI scans to create images of lung damage. Lung experts said a test that could spot long-term damage would make a huge difference to Covid patients. The xenon technique sees patients inhale the gas during a magnetic resonance imaging (MRI) scan.

Prof Fergus Gleeson, who is leading the work, tried out his scanning technique on 10 patients aged between 19 and 69.

Eight of them had persistent shortness of breath and tiredness three months after being ill with coronavirus, even though none of them had been admitted to intensive care or required ventilation, and conventional scans had found no problems in their lungs.

The scans showed signs of lung damage - by highlighting areas where air is not flowing easily into the blood - in the eight who reported breathlessness.

The results have prompted Prof Gleeson to plan a trial of up to 100 people to see if the same is true of people who had not been admitted to hospital and had not suffered from such serious symptoms. He is planning to work with GPs to scan people who have tested positive for COVID-19 across a range of age groups.

The aim is to discover whether lung damage occurs and if so whether it is permanent, or resolves over time.

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Source: BBC News, 1 December 2020

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COVID-19: Low dose steroid cuts death in ventilated patients by one third, trial finds

Low dose dexamethasone reduces deaths in patients hospitalised with COVID-19 who need ventilation, according to preliminary results from the RECOVERY trial.

The drug was also found to reduce deaths by one-fifth in other hospitalised patients receiving oxygen only, but no benefit was seen among COVID-19 patients who did not need respiratory support.

The chief investigators from the University of Oxford trial said that the findings represent a “major breakthrough” which is “globally applicable” as the drug is cheap and readily available.

Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and a chief investigator on the trial, added, “This is the only drug that has so far been shown to reduce mortality, and it reduces it significantly. It is a major breakthrough.”

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Source: BMJ, 16 June 2020

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COVID-19: London hospital where 70 staff had to self-isolate must improve infection control

A London hospital hit by a COVID-19 outbreak that required 70 staff to self-isolate has been ordered to take stringent measures to control infection.

Hillingdon Hospital NHS Foundation Trust declared a COVID-19 outbreak in July and revealed that 70 staff members, some of whom had tested positive, were self-isolating. Ambulances were forced to divert patients to other emergency departments.

An investigation later found that a nurse who had COVID-19 unwittingly infected 16 others during a training session on 30 June, described by one doctor as a “super spreading event.”

The Care Quality Commission (CQC), which carried out an unannounced inspection on 4-5 August, has used its urgent enforcement powers to place conditions on the trust’s registration to protect patients and staff.

Nigel Acheson, the CQC’s deputy chief inspector of hospitals, said, “We found a number of concerns relating to infection control and this is why we have taken action to ensure the safety of patients, staff and visitors."

“We have imposed urgent conditions upon the trust’s registration and expect the trust to focus on making the required improvements as a matter of priority. We will return to inspect and ensure that action has been taken and that improvements have been made and are being sustained.”

The trust has been told it must ensure that staff and patients observe social distancing, must place personal protective equipment (PPE) in easily accessible places, and must make sure that staff wear PPE before going into high risk areas.

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Source: BMJ, 9 September 2020

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COVID-19: Liverpool to pilot city-wide coronavirus testing

People in Liverpool will be offered regular COVID-19 tests under the first trial of whole city testing in England.

Everyone living or working in the city will be offered tests, whether or not they have symptoms, with follow-up tests every two weeks or so. Some will get new tests giving results within an hour which, if successful, could be rolled out to "millions" by Christmas, the government says.

Liverpool has one of the highest rates of coronavirus deaths in England. The latest figures show the city recorded 1,754 cases in the week up to 30 October. The average area in England had 153.

The pilot aims to limit spread of the virus by identifying as many infected people as possible, and taking action to break chains of transmission.

It is thought around four-fifths of people who are infected with coronavirus show no symptoms.

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Source: BBC News, 3 November 2020

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Covid-19: Lack of surveillance leaves UK in dark as hospital admissions rise, experts warn

The UK’s current method of recording Covid-19 cases “is not a sensible approach to managing the spread of infection,” virologists have warned.

Latest data showed an uptick in the number of UK covid cases and hospital admissions that experts said was “worrying, so early in autumn.”

The latest surveillance report from the UK Health Security Agency (UKHSA) showed that in the week starting 15 September the overall weekly hospital admission rate for covid was 2.73 per 100 000 people. This was up by 60% from a month prior, when the rate was 1.71 per 100 000 in the week starting 18 August. And latest data from the following week show that covid cases rose 22%—from 2012 weekly cases to 2459—in the week to 24 September.

Amanda Doyle, NHS England’s primary care director, said, “It’s concerning to hear flu and covid-19 cases are already creeping up ahead of winter,” urging people who were eligible to come forward for vaccinations as soon as they could.3

But Young warned that reduced data now collected by the UK on the virus could mean that health officials were flying blind into the winter period. “The lack of routine [covid] testing means we have no idea about the spread of SARS-CoV-2 in the general population, making it difficult to predict any future waves of infection,” he said.

Current testing predominantly focuses on hospital patients rather than community or primary care, which Young said could make it “difficult to identify and monitor outbreaks.” He added, “Relying on hospitalisations as a measure of surges in infection is not a sensible approach to managing the spread of infection and planning for pressures on the NHS.”

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Source: BMJ, 3 October 2025

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COVID-19: Is it possible to offer every over-18 a booster vaccine dose by New Year's Eve?

Everyone over the age of 18 in England has been promised they can book their coronavirus booster appointment by the end of this year.

In a televised address on Sunday evening, Prime Minister Boris Johnson promised to deliver up to a million vaccine doses a day to ensure everyone eligible is offered a slot a month earlier than planned.

As part of the "Omicron emergency national mission" he asked NHS staff "to make another extraordinary effort" to meet the new target. This will include more vaccine centres and walk-in sites with extended opening hours, "thousands" more volunteers to deliver jabs and help from the military to oversee operations.

However, COVID ICU anaesthetist Dr Ed Patrick told Sky News there are already staff shortages "all over" the NHS, including intensive care, with boosters threatening to make them even worse.

"It's a massive concern," he said. "You're taking a really scant resource and then you're pushing it elsewhere, which means that other services get cut."

Pat Cullen, general secretary of the Royal College of Nursing, said she is worried about the "scale and pace" of the new rollout, as the "same nurses are already facing huge demands under existing unsustainable pressures".

While Chris Hopson, chief executive of NHS providers, warned the health service is "already beyond full stretch" and the changes would see more procedures postponed in the coming days.

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Source: Sky News, 13 December 2021

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COVID-19: increasing demand for dialysis sparks fears of supply shortage

More than a quarter of patients with COVID-19 on ventilators also need renal support in the form of dialysis, raising concerns that there could be significant supply problems as countries attempt to stock up on the required fluid and plastic consumables.

Nephrology consultant Graham Lipkin told The BMJ, “This is an under-recognised challenge. While the original focus has been on whether we have enough ventilators and intensive care beds, it has become apparent that there is a high incidence of acute kidney injury (AKI) requiring some form of renal replacement therapy (RRT) through dialysis. With the volume of people coming into intensive care, there are increasing challenges to capacity across the system.”

Lipkin, who is president of the Renal Association, has been working with NHS England to develop new clinical guidelines for the prevention and optimal management of AKI in hospital. The guidance aims to reduce the incidence of AKI and therefore the demand for dialysis.

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Source: BMJ, 21 April 2020

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Covid-19: Incomplete lists of vulnerable patients left many unprotected, desperate, and afraid

Up-to-date registers of clinically vulnerable patients must be created to ensure that those who are most at risk during Covid-19 and any future pandemics are protected and can access the support they need, a report from the All-Party Parliamentary Group (APPG) on Vulnerable Groups to Pandemics has recommended.

The report considered vulnerable people’s experiences during the pandemic and makes 16 recommendations on what the government and the health service can do better to plan and prioritise extremely vulnerable patients during further Covid-19 outbreaks and future pandemics.

These tackle the format and content of information and guidance; access to medical services such as mental health support to help people deal with anxiety, fear, and isolation; provision of practical support such as food and finance when isolating; and the need for more research into how medical conditions make people more vulnerable to a threat and vaccines less protective.

At the launch of the report representatives of charities and patient groups described how the pandemic had left clinically vulnerable people feeling anxious, afraid, lonely, trapped, and desperate. They also described the “not on the list” scenario many had had to contend with, meaning they could not access priority services such as testing or support to isolate.

There were still patients whose doctors recognised that they should be on the list fighting to get their condition recognised, said Susan Walsh, chief executive of Immunodeficiency UK. This means that, under the government’s Living with Covid plans, they will no longer be able to access free testing. Lord Mendelsohn, co-chair of the APPG on Vulnerable Groups to Pandemics, said, “We should be more willing to allow the medical practitioners responsible for these patients to be able to overhaul computerised systems and find ways to make that happen.”

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Source: BMJ, 28 February 2022

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COVID-19: Impact of long term symptoms will be profound, warns BMA

A third of doctors have treated patients with long term COVID-19 symptoms, including chronic fatigue and anosmia, a survey conducted by the BMA has found.

Richard Vautrey, chair of the BMA’s GP committee for England, said it was clear that the long term impact of COVID-19 on patients and the NHS would be profound. 

“With more patients presenting with conditions as the result of infection, it’s essential that sufficient capacity is in place to support and treat them,” Vautrey said. “With the growing backlog of non-COVID-19 treatment, the likelihood of a season flu outbreak, and the possibility of a second wave of infections we need to see a more comprehensive long term plan to enable doctors to care for their patients this winter and beyond.”

The survey also asked doctors about their own experiences of COVID-19: 63% said they did not believe they had contracted the virus, 12% had had a diagnosis of COVID-19 confirmed by testing, and 14% believed they had been infected with the virus.

David Strain, co-chair of the BMA’s medical academic staff committee, said that the NHS could not afford more failures of quality and supply in personal protective equipment. “Risk assessments should be available to all working in the NHS and appropriate steps should be put in place to mitigate the risk of catching the virus, even in those that have a low risk of a bad outcome from the initial infection,” he said.

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Source: BMJ, 13 August 2020

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Covid-19: Ibuprofen should not be used for managing symptoms, say doctors and scientists

Scientists and senior doctors have backed claims by France’s health minister that people showing symptoms of COVID-19 should use paracetamol (acetaminophen) rather than ibuprofen, a drug they said might exacerbate the condition.

The minister, Oliver Veran, tweeted on Saturday 14 March that people with suspected COVID-19 should avoid anti-inflammatory drugs. “Taking anti-inflammatory drugs (ibuprofen, cortisone . . .) could be an aggravating factor for the infection. If you have a fever, take paracetamol,” he said.

Jean-Louis Montastruc, Professor of Medical and Clinical Pharmacology at the Central University Hospital in Toulouse, said that such deleterious effects from NSAIDS would not be a surprise given that since 2019, on the advice of the National Agency for the Safety of Medicines and Health Products, French health workers have been told not to treat fever or infections with ibuprofen.

Experts in the UK backed this sentiment. Paul Little, Professor of Primary Care Research at the University of Southampton, said that there was good evidence “that prolonged illness or the complications of respiratory infections may be more common when NSAIDs are used—both respiratory or septic complications and cardiovascular complications.”

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Source: BMJ, 17 March 2020

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COVID-19: ibuprofen can be used for symptoms, says UK agency, but reasons for change in advice are unclear

UK medicines agencies have changed their advice on ibuprofen to say that the drug can be used to treat patients with symptoms of COVID-19, although the evidence that prompted the revision has not been made public.

The change follows a review by the Commission on Human Medicines’ expert working group on COVID-19 which, along with previous reviews of evidence, concluded that there is currently insufficient evidence to establish a link between use of ibuprofen, or other non-steroidal anti-inflammatory drugs (NSAIDs), and contracting or worsening of COVID-19.

The group’s review has not been published, but prompted the Medicines and Healthcare Products Regulatory Agency (MHRA), NHS England, and the National Institute for Health and Care Excellence (NICE) to update their advice to say that patients can take paracetamol or ibuprofen for symptoms of COVID-19, such as fever and headache.

This is a change to NICE’s recommendation on 3 April that paracetamol should be used in preference to NSAIDs for managing fever in patients with suspected COVID-19 until more evidence is available.

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Source: BMJ, 17 April 2020

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COVID-19: Health workers 'back in eye of storm', says NHS chief

Health workers are "back in the eye of the storm" as coronavirus cases continue to rise, NHS England's chief executive Simon Stevens has said.

It has been the "toughest year" for the NHS, which has treated 200,000 severely ill Covid-19 patients, he added.

Hospitals in England are currently treating more Covid patients than at the peak of the first wave in April.

A government scientific adviser has warned national restrictions are needed to prevent a "catastrophe".

On Monday, a record 41,385 new Covid cases were reported in the UK, though it is thought the infection rate was higher during spring when testing was much more limited.

NHS England said 20,426 people were being treated for the virus in hospitals in England on Monday, which is higher than the previous peak of about 19,000 in April.

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Source: BBC News, 29 December 2020

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COVID-19: Health staff in plea for better protection

More than 20 healthcare organisations, including those representing nurses, doctors, surgeons and therapists, are calling for stricter UK guidelines to be introduced on face masks and other personal protective equipment (PPE).

In a virtual meeting with officials, they will say existing rules leave them vulnerable to infection through the air, especially by new Covid variants.

The unprecedented appeal will see them argue that other countries, such as the United States, protect their health workers with higher-grade equipment.

It is thought to be the first time health and care organisations have united on a single issue in this way - a sign of the desperation many feel about the need for staff to be kept safe.

The delegation will include representatives of the British Medical Association, the Royal College of Nursing and many other professional organisations and unions.

On the government side will be about 20 of the most senior officials from all four UK nations, many involved in setting the guidelines on personal protective equipment (PPE).

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Source: BBC News, 3 June 2021

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COVID-19: GPs opt to prioritise all patients with learning disabilities for vaccination

Local groups of GPs have decided to prioritise all patients with learning disabilities for COVID-19 vaccination, after fresh evidence showed that disabled patients were at much higher risk from the disease.

Latest figures from the Office for National Statistics1 showed that 60% of people in England who died from covid-19 from January to November 2020 (30 296 of 50 888) had a disability.

This week an extra 1.7 million people in England—including some with severe learning disabilities—are being added to the list of people identified as clinically extremely vulnerable to COVID-19, although this does not include people with mild or moderate learning disabilities. But some clinical commissioning groups (CCGs) have deviated from national guidance and said that they will prioritise all patients with learning disabilities for vaccination given the disproportionate impact on them.

In a statement published on its website, Kent and Medway CCG said that it had decided to include all adults with learning disabilities in the current priority phase for vaccination delivery. “Given the evidence of covid-19 inequalities increasing deaths amongst people with learning disabilities, the NHS in Kent and Medway has agreed to prioritise vaccinating the 9500 people on GP learning disability registers,” it said.

Oxfordshire CCG was also praised by local campaigners for adjusting its priority list so that everybody with a learning disability is included in priority group 6, regardless of its severity.

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Source: BMJ, 19 February 2021

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Covid-19: GPs need extra support to withstand second wave, BMA warns

General practices will struggle to cope with a second wave of COVID-19 unless urgent measures are put in place to support them, the BMA has warned.

It said that practices in England were reporting that they did not have the capacity to carry out all of the work required of them while managing ongoing patient care, dealing with the backlog of care put on hold during the first wave of the pandemic, and reconfiguring services.

Richard Vautrey, chair of the BMA’s General Practitioners Committee England, said, “GPs, like all doctors, are extremely concerned that without decisive action now services will be overwhelmed if we see another spike in the coming weeks and months.”

In the report, the committee called for a package of measures to support the GP workforce, including making occupational health services available to all staff to ensure that they are properly risk assessed and to provide free supplies of personal protective equipment. It also called for the suspension of routine inspections by the Care Quality Commission and of the Quality and Outcomes Framework, as part of efforts to reduce bureaucracy.

NHS England’s covid support fund for practices should be rolled over until March 2021 and expanded to ensure that all additional costs such as additional telephony and cleaning are included, it added.

Vautrey said, “The measures we’ve outlined are aimed at supporting practices and their staff to deliver high quality care while managing the increased pressures of doing so during a pandemic, and it is vital that the government and NHS England listen and implement these urgently, to ensure that primary care can continue to operate safely through what looks to be an incredibly difficult winter.”

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Source: BMJ, 1 October 2020

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COVID-19: Government’s handling of pandemic had “big mistakes,” MPs say

The government’s actions in dealing with the COVID-19 pandemic have received a mixed review from MPs in a report that set out the successes and failures of the UK response.

Although the joint report from the House of Commons’ Science and Technology Committee and Health and Social Care Committee  praised the UK’s covid vaccination programme as highly effective, it also condemned serious errors, especially delayed lockdowns and how a test, trace, and isolate system was set up.

Overall, the MPs’ inquiry found that some government initiatives were examples of global best practice but that others represented “serious mistakes.” 

The UK’s pandemic planning was based too narrowly on a flu model that had failed to learn the lessons from the SARS, MERS, and Ebola epidemics, said the MPs, which meant that its covid planning was worse than in other countries.

Delays in establishing an adequate test, trace, and isolate system hampered efforts to contain the outbreak, said the MPs, and the government’s initial decision to delay a comprehensive lockdown had revealed its then “fatalistic” assumption that it was impossible to suppress the virus, which amounted, in practice, to accepting that herd immunity by infection was inevitable.

The report said that many thousands of deaths could have been avoided if the government had not let hospitals discharge people into care homes in the initial phase of the pandemic and that this showed the “longstanding failure” to give social care sufficient priority and the same attention as the NHS.

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Source: BMJ, 12 October 2021

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COVID-19: Government poised to amend regulations to allow use of unlicensed vaccine

Experts 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.”

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Source: The BMJ, 28 September 2020

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Covid-19: Government failed to protect staff during height of pandemic, experts tell MPs

Healthcare staff working at the height of the covid-19 pandemic in England were not properly protected and were forced to work in an unsafe environment, MPs have been told.

Appealing before the health and social care committee on 21 July, experts criticised the government and NHS management for their failure to provide staff with sufficient testing and personal protective equipment (PPE). The committee was gathering evidence for its inquiry into the management of the COVID-19 outbreak.

Paul Nurse, director of the Francis Crick Institute, said he believed that the failure to implement better testing systems in the early days of the pandemic had contributed significantly to the problems.

He said, “At the height of the pandemic, our own research—which backs up what’s been done elsewhere—found that up to 45% of healthcare workers were infected and they were infecting their colleagues and infecting patients, yet they weren’t being tested systematically.

“In the healthcare environment we weren’t providing proper protection, and it’s important because it protects the most vulnerable in our society and it protects our healthcare workers. They deserve to work in a safe environment, and some of them are dying because of what they do. They deserve better.”

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Source: BMJ, 22 July 2020

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COVID-19: Frontline doctors speak out about struggle to maintain care standards

Frontline doctors have testified to deteriorating conditions in hospitals in London and the south east as the NHS deals with a surge in COVID-19 cases.

Speaking to the Independent SAGE group of experts on 30 December, Jess Potter, a respiratory doctor in east London, told how she and colleagues were afraid of resources running out.

“My greatest fear is having a patient that I cannot provide lifesaving treatment to,” she said. “We had one of our largest medical intakes yesterday, the vast majority with coronavirus. What do we do when we run out of resources, and who is going to provide that guidance? It will harm our patients and our staff, because we have a set of values by which we practise, and we will have to reduce the level of care we deliver.”

She added, “Back in April I never saw a case where we didn’t provide a bed to a patient who needed it in intensive care, and decisions were taken as if in normal times. Now I hear from medics across the country that things are very bad, and the situation is the same as in April, if not worse. We are afraid of what will happen if we don’t act now.”

Sonia Adesara, a doctor in London, spoke to Independent SAGE after a set of night shifts at her trust and told of a chronic shortage of continuous positive airway pressure (CPAP) capacity.

“In the past few days, despite my hospital significantly increasing intensive and critical care capacity, our intensive care unit has been full, and there is no spare CPAP capacity. Medics are spending shifts trying to closely monitor all of our patients who are on the highest level of oxygen that we can give with a normal mask, assessing who is most unwell and unstable—and then frequently checking on patients who are on CPAP and then swapping people [around]."

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Source: BMJ, 31 December 2020

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