How 175 British children were infected with HIV

Published6 October 2022Shareclose panelShare pageCopy linkAbout sharingImage source, Family photoBy Jim ReedHealth reporterAt least 175 children with the blood disorder haemophilia were infected with HIV in the 1980s, according to documents from the national archives seen by BBC News. Some of the families affected are giving evidence at a public inquiry into what has been called the worst treatment disaster in the history of the NHS. It was almost 36 years ago – in late October 1986 – but Linda will never forget the day she was told her son had been infected. She had been called into a consulting room in Birmingham Children’s Hospital, with 16-year-old Michael. As a toddler, he had been diagnosed with haemophilia, a genetic disorder that stopped his blood clotting properly. Linda assumed the meeting was to discuss moving his care to the main Queen Elizabeth Hospital in the city.”It was so routine that my husband stayed in the car outside,” she says. “Then, all of a sudden, the doctor said, ‘Of course, Michael is HIV positive,’ and he came out with it like he was talking about the weather outside. My stomach just fell.”We got in the car, I told my husband and we were silent all the way home. We never spoke – it was such a shock.”Tested positiveIt was still early in the Aids crisis – a few months before the government’s Don’t Die of Ignorance TV campaign brought the illness into every British living room. But the stigma of the disease was already very real.In 1985, dozens of parents had taken their children out of a primary school in Hampshire after a nine-year-old pupil – also a haemophiliac – had tested positive for Aids antibodies, as HIV was then known.Michael did not want his friends or family told. “That’s the way he coped with it – he kept it to himself,” Linda says.”He never told his friends or anything because he just wanted to feel normal.”Between 1970 and 1991, 1,250 people with blood disorders were infected with HIV in the UK after taking Factor VIII – a new treatment that replaced the clotting protein missing from their blood.Now, documents from the National Archives reveal that included at least 175 children who were given the medication by NHS doctors in hospitals, schools or haemophilia clinics.Tens of thousands of others are believed to have been exposed to hepatitis C, which can cause liver failure and cancer, either through the same treatment or a blood transfusion.About half of those infected with HIV died of an Aids-related illness before life-saving antiretroviral drugs became available. Drug usersAt that time, the UK was not self-sufficient in blood products, so Factor VIII was imported from the United States. Each batch was made from the pooled, or mixed, blood plasma of thousands of donors. If just one of those donors was HIV positive, then the virus could be passed on. Drug companies in the US paid individuals to donate – including some in high-risk groups, such as prisoners and drug users. Linda remembers being first told about Aids at a presentation at Birmingham Children’s Hospital in 1984 and warned to look out for certain symptoms. But she says the family were never made fully aware of the dangers – at one point, she was told by a nurse not to worry as “Michael was fine”. Through this whole time, her son continued to be treated with the same American medication. In his late teens, Michael started having health problems – from night sweats to glandular fever to a bad bout of flu.But he continued to live life to the full – travelling, listening to music and supporting West Bromwich Albion football club.”There was a big match at Wembley and he was very, very poorly,” Linda says. “So we decorated all the car up and he met his friends down there. It didn’t matter how he felt, if he could get there he would.”Later in his life, as his immune system started to break down, Michael lost weight and experienced fatigue and memory loss.Image source, family photoHe was transferred to Heartlands Hospital, in Birmingham, where Linda, who gave up her job as a cook in a care home, helped nurse him though the last few months of his life. “He said to me, ‘Mum, you’re never going to be a nan,’ and I just said, ‘Don’t worry about it.’ That’s all I could think of saying,” Linda says.Michael developed meningitis and pneumonia – both caused by the HIV he was infected with as a child. He died on May 26, 1995, exactly a week before his 26th birthday. Special sessionAlmost three decades later, Linda is giving evidence to the long-running public inquiry into the treatment disaster. She will appear alongside other parents, in a special session about the experiences of families whose children were infected in the 1970s and 80s. “I felt as though I needed to do it because I want to help get to the bottom of it,” she says. “We all want to know why it was allowed to happen and to keep on happening as well.”A Department of Health and Social Care Spokesperson said: “The infected blood tragedy should never have happened and the ongoing public inquiry was set up to get to the truth and give families the answers they deserve.”We are committed to co-operating fully with the inquiry and will carefully consider any recommendations.”Linda asked that her surname be withheldYou can follow Jim on Twitter.More on this storyInfected blood transfusions killed 1,820 – studyPublished17 September 2022’I’ve been a carer rather than a daughter’Published17 August 2022’I’ll keep fighting until everyone is compensated’Published17 August 2022

Read more →

Monkeypox infections rise as guidance advises cases to abstain from sex

SharecloseShare pageCopy linkAbout sharingImage source, ReutersAnother 71 cases of monkeypox have been identified in England over the weekend bringing the UK total to 179, the UK Health Security Agency (UKHSA) says.New guidance is advising anyone with the virus to abstain from sex while they have symptoms.They are also told to use condoms for eight weeks after an infection as a precaution.The risk to the population is low, but people should be alert to new rashes or lesions, the UKHSA says.In total, 172 cases have been confirmed in England, with four in Scotland, two in Northern Ireland and one in Wales.What is monkeypox and how do you catch it?The Covid conspiracies being recycled for monkeypoxHow UK hospitals are tackling monkeypox outbreakCondom useNew guidance for doctors and other healthcare workers to help control the latest outbreak has now been agreed by the four health authorities in England, Wales, Scotland and Northern Ireland. People who have tested positive for the virus and their close contacts are being told to isolate at home for 21 days. They should avoid contact with other people until all lesions – or blisters – have healed and scabs have dried off. Anyone with a confirmed infection is now being advised to abstain from sex while they have symptoms.The guidance says that while there is currently no available evidence that monkeypox can be spread in sexual fluids, people confirmed to have the virus are advised to use condoms for eight weeks after infection as a precaution. Monkeypox: Handing out health advice without stigmaConfirmed cases and their close contacts should take extra care if they need to leave the house to see a doctor or other health worker. This means making sure any lesions are covered by clothes, wearing a face covering and avoiding public transport where possible.Protection for staffDr Ruth Milton, monkeypox strategic response director, at UKHSA said: “The highest risk of transmission is through direct contact with someone with monkeypox. “The risk to the UK population remains low and anyone with unusual rashes or lesions on any part of their body should immediately contact NHS 111 or their local sexual health service.”The new guidance also says healthcare workers who are pregnant and people with severely weakened immune systems should not care for anyone who is suspected or confirmed to have monkeypox.Staff working with confirmed cases should wear personal protective equipment, including FFP3 respirators, aprons, eye protection and gloves as a minimum, it adds.Those working with possible cases are recommended to wear surgical face masks which are fluid repellent, gowns, gloves and eye protection.UK health officials have purchased over 20,000 doses of a smallpox vaccine called Imvanex.It is being offered to close contacts of those diagnosed with the virus to try and reduce the risk of symptomatic infection and severe illness.More on this storyMonkeypox: Handing out health advice without stigmaMonkeypox: Time to worry or one to ignore?Got a new rash? How to tell if it is monkeypox

Read more →

Monkeypox patients should avoid pet contact

SharecloseShare pageCopy linkAbout sharingImage source, Getty ImagesMonkeypox patients should avoid any contact with their pets for 21 days, according to new advice from the UK Health Security Agency (UKHSA). So far, 106 people in the UK have been confirmed as infected with the virus.Gerbils, hamsters and other rodents could be particularly susceptible to the disease and the concern is it could spread in the animal population. The government said no cases have been detected in pets so far and the risk is still low.”The worry is the virus could get into domestic animals and essentially ping-pong between them and humans,” said Prof Lawrence Young, a virologist at the University of Warwick.”If you are not careful you might create an animal reservoir for the disease that could result in it spreading back into humans, and we’ll be in a loop of infection.”What is monkeypox and how do you catch it?How to tell if a rash is monkeypoxMonkeypox: Handing out health advice without stigmaThe guidance from the UKHSA and other health authorities recommends that pet guinea pigs, rats, mice and other rodents should be removed from the household of someone infected with monkeypox for 21 days, and be tested for the disease. There are thought to be two million households in the UK with a pet rodent of some kind, according to sales data.Other pets like dogs and cats should be placed under household isolation with regular vet checks to “ensure no clinical signs are observed”.Related advice from the Department for Environment, Food and Rural Affairs (Defra) says that “where possible” the patient should avoid preparing food or grooming their pet if this can be done by someone else in the household. England’s chief veterinary officer Christine Middlemiss said: “No cases of monkeypox have ever been suspected or reported in pets in the UK and the risk remains low. “We will continue to monitor the situation closely and work with veterinary and public health colleagues, both in the UK and across the world, to manage the animal health associated risks with monkeypox.”Reservoir riskSeparate advice published by the European Centre for Disease Control (ECDC) this week said that rodent pets belonging to monkeypox patients should “ideally” be isolated in monitored facilities and tested for the disease before their quarantine period ends.The animals should only be put down as a last resort in situations where isolation is not feasible, the document said. Larger pets, such as dogs, could quarantine at home with regular checks on their health status. Image source, Getty ImagesScientists say little is currently known about how monkeypox might behave in the domestic pet population. But rodents and a particular species of squirrel are likely to be capable of catching and spreading the disease more easily than humans. The ECDC says a “spillover” event, where a human infects a pet animal, could potentially lead to the virus establishing itself in European wildlife, although it describes the risk as “very low”.The concern is that monkeypox could become what’s known as an endemic zoonoses, where a disease jumps between animal species and is constantly present in that new population. More on this storyMonkeypox: Handing out health advice without stigmaMonkeypox: Time to worry or one to ignore?Got a new rash? How to tell if it is monkeypox

Read more →

Spike in child hepatitis cases linked to common virus

SharecloseShare pageCopy linkAbout sharingImage source, Getty ImagesHealth officials are now investigating 108 cases of sudden-onset hepatitis – or liver inflammation – in children in the UK since the start of this year.They say it is increasingly likely a virus which causes flu symptoms, known as adenovirus, could be the cause.Officials are examining 79 confirmed cases in England, 14 in Scotland and 15 across Wales and Northern Ireland.The UK Health Security Agency (UKHSA) said eight children had received a liver transplant as a result.Childhood hepatitis: Why are we seeing an unusual spike in cases?Cases of hepatitis in young children investigated The first sign of an unusual rise in young children with liver inflammation was spotted in Scotland in late March.Most of the children hospitalised so far are thought to be between the ages of one and five years old. Common virusUKHSA’s chief medical advisor, Professor Susan Hopkins, says that officials were still looking at a range of possible factors that could be behind the increase, but “the most likely” trigger was an adenovirus – a group of common viruses which usually cause colds, vomiting and diarrhoea in children.”Transplants in this age group are extremely rare so therefore we are concerned, and we want to understand why this is happening and what else we can do,” she told the BBC.Prof Hopkins says 77% of childhood hepatitis cases currently under investigation have tested positive for some form of adenovirus. Scientists and clinicians are now investigating whether there has been a change in the genetic make-up – or genome – of the virus that might trigger liver inflammation more easily.Another possible explanation is that restrictions imposed in the pandemic may have led to young children being first exposed to adenovirus at a slightly later point in their lives, leading to a “more vigorous” immune response.The UKHSA says it is keeping an “open mind” and not ruling out other possible causes, including Covid-19, other infections or an environmental trigger.But it says there is “no link” with the Covid-19 vaccine, as none of the children involved has been vaccinated.Good handwashingTo minimise the chance of an infection, Prof Hopkins says parents should supervise good handwashing and hygiene at home. “The good things that we’ve learnt from reducing transmission of Covid will help us reduce the transmission of whatever is causing this as well,” she says.The UKHSA has told parents and guardians to be on the lookout for the signs of hepatitis such as jaundice – a yellowing of the eyes and skin – and contact a GP if they are concerned.Other symptoms of the liver condition include:dark urineitchy skin muscle pain loss of appetiteEarlier this week, the European Centre for Disease Control said an undisclosed number of childhood hepatitis cases had also been detected in Denmark, Ireland, the Netherlands and Spain. In the US, Alabama’s public-health department said nine cases had been found in one- to six-year-olds, with two needing liver transplants.What is hepatitis?It’s a broad term used to describe inflammation of the liver.Usually the result of a viral infection, it can also be caused by exposure to some chemicals, drinking too much alcohol, drugs and certain genetic disorders.There are five main types of hepatitis caused by specific viruses – known as A, B, C, D and E – but none of those so far appears to have caused the liver inflammation seen in these children.Some types of hepatitis can pass without any serious problems, while others can be long-lasting.Source: Hepatitis – NHSMore on this storyRise in childhood hepatitis – what we know so farCases of hepatitis in young children investigated

Read more →

Ukraine war: WHO says attacks on health facilities are rising daily

SharecloseShare pageCopy linkAbout sharingImage source, Volodymyr MatsokinThere have been more than 70 separate attacks on hospitals, ambulances and doctors in Ukraine with the number increasing on a “daily basis”, says the World Health Organization (WHO).It says the targeting of healthcare facilities has become part of the strategy and tactics of modern warfare.A recent casualty on 8 March was the newly refurbished central hospital in Izyum, south of Kharkiv. It was hit by what the Ukrainian authorities said were Russian shells.Video and photos posted online by the city’s deputy mayor showed extensive damage to the main hospital building. A new reception area built last year was completely destroyed. The footage has been verified by the BBC and other media outlets, although the exact circumstances of the attack are impossible to establish at this time. “After the first bombing, the windows of the hospital blew out,” the deputy mayor Volodymyr Matsokin told the BBC. A second attack destroyed the hospital’s operating rooms, he added.Ukraine: The doctors racing aid from the UK to the front lineOxygen stocks running dangerously low in UkraineUkraine war: The road to safety for Ukraine’s cancer childrenThat day hospital staff were treating children, pregnant women and three newborn babies as well as soldiers and civilians injured in fierce fighting in the region, according to the Ukrainian authorities.They were sheltering in the basement at the time of the attack and no-one was killed.”The government had invested millions to provide good facilities with modern equipment,” said Mr Matsokin.”Patients had to climb out of the rubble on their own to escape.”The BBC has contacted the Russian embassy in London about the attack but has received no response, although in the past Moscow has denied deliberately targeting civilians.Since 24 February, the WHO has reviewed and verified 72 separate attacks on healthcare facilities in Ukraine causing at least 71 deaths and 37 injuries. Image source, Google (l) and Volodymr Matsokin (r)Most have damaged hospitals, medical transports and supply stores, but the WHO has also recorded the “probable” abduction or detention of healthcare staff and patients.”We are concerned that this number is increasing daily,” the WHO’s Ukraine country representative Jarno Habicht told the BBC. “Health facilities should be safe places for both doctors and nurses, but also patients to turn to for treatment. This should not happen.”Because the war in Ukraine is an international armed conflict between two states, the Geneva Conventions apply.Expanded in the aftermath of World War Two, the conventions set out the basic rights of civilians and military personnel, and establish protection for the wounded and sick. They were ratified by what was then the Soviet Union in 1954.War in Ukraine: More coverage LIVE: Latest updates from Ukraine and nearbyWATCH: Destruction of Ukraine’s cities from aboveZELENSKY: How Ukraine’s leader tailors his addressesREAD MORE: Full coverage of the crisisUnder Article 18 of the Conventions, civilian hospitals “may in no circumstances be the object of attack, but shall at all times be respected and protected”.A breach of that rule can be investigated by the International Criminal Court in the Hague and, if found to be a war crime, individual perpetrators can be prosecuted and punished.There are though exemptions to the Conventions. The protection from attack is lost if the medical facility is placed near a legitimate military target or is thought to be committing an act “harmful to the enemy”. According to the International Committee of the Red Cross (ICRC), that could include the use of a hospital as a shield for healthy fighters or the staging of a medical unit in a position which impedes an enemy attack.Image source, Sergei OrlovNeve Gordon, professor of international law and human rights at Queen Mary University of London, said: “What we have today, in effect, is a situation where hospitals and medical units have become fair game.”If there are soldiers outside the hospital or it is simply next to a train station, it can be attacked. Or it could be that a wounded soldier has a cellphone and is calling other troops and telling them that there is someone nearby.”All these loopholes render it possible to claim the attack was legitimate.”The ICRC says that, in theory, before targeting a hospital which might be in breach of those rules, the attacking side should always give a warning, with a time limit, and the other side must have ignored that warning.There is no evidence this has happened in the Ukraine conflict.Prof Gordon would like to see a far stronger blanket ban on any attack on medical facilities under international law, similar to the ban on torture adopted by the United Nations which came into force in 1987. From Vietnam to SyriaExemptions to the Geneva Conventions have been used to justify attacks on hospitals and medical units in post-World War Two conflicts from Korea and Vietnam onwards.The trend though appears to be accelerating rapidly, driven in part by the use of ballistic missiles, drones, and other longer range munitions. The US advocacy group Physicians for Human Rights claims that Russian or local forces have been linked to at least 244 separate attacks on healthcare facilities in Syria since 2011.At one point, the charity Médecins Sans Frontières even made the decision to stop sharing the GPS co-ordinates of some health clinics it operated with the Syrian government or its Russian allies, amid concerns they were more likely to become direct targets as a result.Russian officials denied deliberately attacking hospitals in Syria and suggested “jihadists” in the country were routinely sheltering in protected civilian buildings.Image source, LUHANSK REGIONAL ADMINISTRATIONThe WHO is concerned that all this means attacks on medical facilities are fast becoming part of the wider “strategy and tactics” of modern warfare, regardless of the Geneva Conventions rules. Destroying health facilities, it warned, “is about the destruction of hope” and the denial of basic human rights. “We’ve never seen globally… this rate of attacks on healthcare,” its emergencies director Michael Ryan told a news conference this week.”This crisis is reaching a point where the health system in Ukraine is teetering on the brink. “It needs to be supported… but how can you do that if the very infrastructure that those people will go in to support is under direct attack?” You can follow Jim on Twitter.

Read more →

Libmeldy: World's 'most expensive' drug recommended for NHS use

SharecloseShare pageCopy linkAbout sharingImage source, Nicola ElsonThe NHS has struck a confidential deal for what’s thought to be the most expensive drug ever developed. The gene therapy Libmeldy is used to treat an extremely rare condition, MLD, which causes severe damage to a child’s nervous system and organs.Around four babies are born with the disorder in England every year. The one-off treatment has a list price of £2.8 million but can be offered on the NHS after the health service negotiated a confidential discount.NHS chief executive Amanda Pritchard said: “This revolutionary drug is a life-saver for the babies and young children who suffer from this devastating hereditary disorder and will spare their families untold heartache and grief.”‘Completely out the blue’Nicola Elson’s daughter, Connie, first displayed symptoms of the condition as a toddler – tripping up and losing her concentration more easily. “It was not long after that, that we got the diagnosis of MLD,” she said. “It was completely out of the blue, there was nothing like this in my family or my husband’s family.”Nicola was told there was a one-in-four chance any child she had with her husband would be affected. She had Connie’s younger brother Joe tested and was told he was also carrying the defective gene. “It’s the most unimaginable situation you can ever think of being in,” said Nicola. “For too long, doctors were saying, we’re sorry but there is no hope and there’s nothing we can do.”Both children were referred onto an early clinical trial in Italy for a new treatment. By then Connie’s condition had deteriorated and she was not well enough to be given the drug – which needs to be taken at a very early stage after symptoms develop.MLD, or Metachromatic Leukodystrophy, is an extremely rare hereditary disorder caused by a crucial enzyme deficiency. Over time the nerves in the brain and other parts of the body stop working properly. It first develops in babies and toddlers younger than 30 months and can lead to loss of sight, speech and hearing, as well as difficulty moving and seizures. Average life expectancy is between just five and eight years old. Libmeldy is a form of gene therapy that works by replacing the faulty gene that causes the disorder. On 5 December 2014 – on what his family now call his re-birthday – Joe had an operation to remove stem cells from his bone marrow. They were treated and re-injected back into his body as part of the clinical trial.Image source, Nicola ElsonSeven years later, his mum says he is a typical 11-year-old boy now helping to look after his older sister. “If you were a stranger on the street, you wouldn’t know Joe even had this condition,” says Nicola. “He swims, he is in mainstream school, and he plays far too many computer games for my liking.”The long-term prognosis for children given the drug is still unknown, and Joe will need to be monitored for years to come, but both doctors and families are hopeful it could offer a permanent cure for the condition. ‘Orphan drug’Libmeldy is a so-called orphan drug – a pharmaceutical agent developed to treat a medical condition which, because it is so rare, may not be profitable to produce without some form of government assistance.Last year, it was reviewed and rejected by the drug price watchdog for England. In draft guidance, the National Institute for Health Care Excellence (NICE) said it was too expensive and yet to be proven in the long term. Costing £2.8 million at its list price, the watchdog said it was the most expensive single treatment it has ever evaluated. But following discussions, specialist drugmaker Orchard Therapeutics increased a confidential discount to the price the NHS actually pays. It has now been recommended for children with no symptoms or who can still walk independently.It will be delivered by a specialist service through the Centre for Genomic Medicine at Saint Mary’s hospital in Manchester, one of five European sites that will administer the treatment. Professor Simon Jones, a consultant at Manchester University NHS Foundation Trust, described the announcement as a “major deal”. “These kinds of therapies are going to be expensive, they are going to be hard to deliver and only a few centres are going to be able to do that,” he said. “There are probably quite a few different disorders which can be treated with this approach, but Libmeldy is the first to really break ground.”The drug has been recommended for use by Nice in England only at this stage. Patients from Scotland, Wales and Northern Ireland would need their national health systems to fund the treatment in Manchester.You can follow Jim on twitter.

Read more →

Novavax Covid jab approved by UK drugs regulator

SharecloseShare pageCopy linkAbout sharingImage source, ReutersThe UK has approved a fifth Covid-19 vaccine, developed by US company Novavax, which offers up to 89% protection against Covid illness.The Medicines and Healthcare products Regulatory Agency has said it is safe as a first and second dose in adults.Millions of doses are currently being manufactured at a plant on Teesside.Health Secretary Sajid Javid says independent scientists on the Joint Committee on Vaccination and Immunisation will now consider its use.’Invaluable research’The vaccine could then be used immediately as part of the UK vaccination programme. But, with more than 91% of the UK population already double vaccinated, it is more likely to be used later in the year as part of a possible autumn or winter booster rollout.Before that can happen, the company would need additional authorisation from the medicines regulator. “It’s a testament to the country’s first-rate research and development capabilities for vaccines,” Mr Javid said, “with tens of thousands of people taking part in clinical trials here in the UK, contributing to the invaluable research that shows our vaccines are safe and effective.”The Novavax product – known by the brand name Nuvaxovid – was shown to be 89% effective against catching symptomatic Covid-19 in clinical trials.The original research was conducted against both the earlier Wuhan and Alpha variants of the virus.Image source, PAIn December, Novavax said two doses were also effective in generating an immune response against the now dominant Omicron variant, first identified in South Africa. The company has also started working on a version specific to Omicron.MHRA chief executive Dr June Raine, said: “Our approval of Nuvaxovid follows a rigorous review of the safety, quality and effectiveness of this vaccine, and expert advice from the government’s independent scientific advisory body, the Commission on Human Medicines.”Immune responseThe jab, a protein adjuvant vaccine, is based on technology used for decades to protect people from diseases such as hepatitis and shingles.It delivers copies of the spike protein on the surface of the virus directly into a person’s cells, stimulating the immune system to produce antibodies and T-cells. An extra ingredient, an adjuvant, then helps boost the immune response.Scientists say this approach makes it simpler to produce than some other vaccines and means it can be stored in a refrigerator. Prof Sir Munir Pirmohamed, who chairs the independent Commission on Human Medicines, said: “Nuvaxovid is distinct from other Covid-19 vaccines currently in use in the UK as it uses recombinant protein-based technology which has been used for many years in the development of vaccines to prevent other illnesses, for example hepatitis B.”Manufacturing setbacksIn August 2020, the government agreed to buy 60 million doses and support the final – or phase-three – trials of the jab. And a factory in Billingham, Stockton-on-Tees, has been producing a key ingredient of the vaccine since February 2021.But setbacks to the approval process around the world have led to concerns about jobs in the area.Novavax had to delay its submission to US regulators multiple times because of development and manufacturing setbacks.It was eventually filed on Monday.OXFORD JAB: What is the Oxford-AstraZeneca vaccine?YOUR QUESTIONS: We answer your queriesVACCINE: When will I get the jab?NEW VARIANTS: How worried should we be?COVID IMMUNITY: Can you catch it twice?

Read more →

Covid: First UK patients given take-at-home pill

SharecloseShare pageCopy linkAbout sharingImage source, MerckThe first at-home treatment for Covid has been given to patients in the UK as part of a major national study. Molnupiravir will be tested on 10,000 people at risk of serious illness in research led by University of Oxford.Last month, the UK became the first country in the world to approve its use – a move described as a “game-changer” by health secretary Sajid Javid. But some scientists have questioned its effectiveness after its early clinical trial results were downgraded.’More at risk’Molnupiravir, initially developed to treat influenza, works by inserting errors into the genetic code of coronavirus every time it copies itself, limiting its ability to multiply in the body.The UK has agreed to purchase 480,000 courses of the drug which is designed to reduce the risk of more vulnerable patients needing hospital treatment after catching the virus.Image source, Sonia BryanIt is the first antiviral medication for Covid which can be taken at home in tablet form, rather than injected or given intravenously.Earlier this week Sonia Bryan, a 65-year-old nurse from Redditch in Worcestershire, became one of the first people in the world to be given the pill outside of a clinical trial run by a drug company. “I’m in the older age group, so I’m a little bit more at risk,” she said. “If it works, they can get this drug into the community, help people get back to normal more quickly, and prevent hospital admissions so Covid doesn’t get out of hand.”Sonia, who looked after Covid patients herself in the first wave of the pandemic, has no idea how she caught the virus, but started to feel unwell last week and tested positive on 9 December. The following day she was sent a course of the pills by courier as part of a national study called Panoramic led by University of Oxford and funded by the National Institute for Health Research. The trial is aiming to rapidly recruit 10,600 people across the UK to test whether the pill cuts the need for the over-50s and those with underlying health problems to be admitted to hospital.The chief investigator of the study, Prof Chris Butler, said: “There are good grounds for believing that this drug could be a game-changer, but that’s not proven in the UK context at the current time.”All the initial clinical trials were done in unvaccinated people, and with the variants that were circulating at that time. How will that play out in the UK setting where the population is largely vaccinated? “We don’t know. And that is exactly why we need to do the [Panoramic] trial.”Molnupiravir is the first of several new treatments for Covid that are likely to be tested over the course of the study.All the new antivirals in development have to be taken within five days of symptoms appearing to have much of an effect – before high levels of the virus are present in the body.GPs participating in the study can sign up their patients – with the drugs couriered to their front door the next day. Those over 50 or in another high-risk group can also enrol for the trial online as soon as they test positive.Another 1.3 million of the highest risk patients, including those with Down’s syndrome or undergoing chemotherapy, are also eligible to access molnupiravir and other hospital based Covid treatments, such as monoclonal antibodies, on the NHS from today, outside of the Panoramic study.Image source, MSDIn October, the drug companies behind molunpiravir – Merck Sharp & Dohme (MSD) and Ridgeback Biotherapeutics – reported initial trial results in a press release suggesting the pill reduced the risk of hospital treatment in vulnerable patients with Covid by 50%. But new data was recently provided to the US medicines regulator, the FDA, as part of the approval process in the United States. It showed that in a later, second part of the trial, there was no significant difference in outcomes between the group given the drug and a similar group given a dummy pill or placebo. Combined with the results from the first part of the trial, it reduced the overall efficacy of the treatment from 50% to 30%.Drug regulators in other countries have been more cautious as a result. Last week the French National Authority of Health refused to approve the medicine, saying it was less effective than initially hoped.Prof Penny Ward, a visiting professor in pharmaceutical medicine at King’s College London, said: “We have to really understand why that happened because it isn’t a usual phenomenon within a clinical trial.”But nonetheless, even a 30% reduction in the severity of illness or needing to go to hospital is still a valuable benefit in that very high-risk population.”The Panoramic study will start by evaluating molnupiravir, but has been designed so it can also test the effectiveness of other antiviral treatments on a rolling basis.That is likely to include Paxlovid – a new combination therapy developed by the US drugs giant Pfizer and based in part on one of its older HIV medications. The company said this week that it is 90% effective at preventing hospitalisation and death in high-risk patients in clinical trials and can work against the Omicron variant now spreading throughout the world.LOOK-UP TOOL: How many cases in your area?SYMPTOMS: What are they and how to guard against them?YOUR QUESTIONS: We answer your queriesTREATMENTS: What progress are we making to help people?NEW VARIANTS: How worried should we be?

Read more →

Covid antiviral pill can halve risk of hospitalisation

SharecloseShare pageCopy linkAbout sharingImage source, MerckAn experimental drug for severe Covid cuts the risk of hospitalisation or death by about half, interim clinical trial results suggest. The tablet – molnupiravir – was given twice a day to patients recently diagnosed with the disease. US drug-maker Merck said its results were so positive that outside monitors had asked to stop the trial early.It said it would apply for emergency use authorisation for the drug in the US in the next two weeks.Volunteers take part in Covid-19 drug trialFirst oral treatmentIf authorised by regulators, molnupiravir would be the first oral antiviral medication for Covid-19. The pill, which was originally developed to treat influenza, is designed to introduce errors into the genetic code of the virus, preventing it from spreading in the body.An analysis of 775 patients in the study found:7.3% of those given molnupiravir were hospitalisedthat compares with 14.1% of patients who were given a placebo or dummy pillthere were no deaths in the molnupiravir group, but eight patients who were given a placebo in the trial later died of CovidThe data was published in a press release and has not yet been peer-reviewed. Unlike most Covid vaccines, which target the spike protein on the outside of the virus, the treatment works by targeting an enzyme the virus uses to make copies of itself. Merck, known by the name MSD in the UK, said that should make it equally effective against new variants of the virus as it evolves in the future. Daria Hazuda, Merck’s vice-president of infectious disease discovery, told the BBC: “An antiviral treatment for people who are not vaccinated, or who are less responsive to immunity from vaccines, is a very important tool in helping to end this pandemic.” Trial results suggest molnupiravir needs to be taken early after symptoms develop to have an effect. An earlier study in patients who had already been hospitalised with severe Covid was halted after disappointing results.Global approvalMerck is the first company to report trial results of a pill to treat Covid, but other companies are working on similar treatments. Its US rival Pfizer has recently started late-stage trials of two different antiviral tablets, while Swiss company Roche is working on a similar medication.Merck has said it expects to produce 10 million courses of molnupiravir by the end of 2021. The US government has already agreed to buy $1.2bn (£885m) worth of the drug if it receives approval from the regulatory body, the FDA. The company said it is in ongoing discussion with other countries, including the UK, and has also agreed licensing deals with a number of generic manufacturers to supply the treatment to low and middle-income countries.Prof Penny Ward, from King’s College London, who was not involved in the trial, said: “It is greatly hoped that the antiviral task force has, like the vaccines taskforce, pre-ordered courses of this medication.”[This is] so that the UK can, at last, properly manage this condition by treating vaccine breakthrough disease, and relieve pressure on the NHS during the forthcoming winter.”Prof Peter Horby, an expert in infectious diseases at University of Oxford, said: “A safe, affordable, and effective oral antiviral would be a huge advance in the fight against Covid. “Molnupiravir has looked promising in the lab, but the real test was whether it shows benefit in patients. Many drugs fail at this point, so these interim results are very encouraging.”LOOK-UP TOOL: How many cases in your area?SYMPTOMS: What are they and how to guard against them?YOUR QUESTIONS: We answer your queriesTREATMENTS: What progress are we making to help people?NEW VARIANTS: How worried should we be?

Read more →

Covid: Which countries are vaccinating children and why?

SharecloseShare pageCopy linkAbout sharingimage source, Damien StoranChildren in the UK aged 12 to 15 are set to be able to get a Covid jab, following advice from the UK’s chief medical officers.They have recommended the youngsters should be offered one dose of the Pfizer vaccine.Some other countries have been vaccinating younger teenagers for some time – but approaches do differ.Why vaccinating all teens is a difficult decisionCovid: Which children are being vaccinated and why?What’s happening in Europe? In May, the European Medicines Agency (EMA) approved the Pfizer vaccine for 12 to 15-year-olds. Since then, different EU countries have moved at different speeds.Denmark (12 to 15-year-olds) and Spain (12 to 19-year-olds) have both now vaccinated most of their child population with at least a single dose. France too has been moving quickly with 66% of those aged 12 to 17 now single jabbed, and 52% fully vaccinated. By October the country’s health pass – or pass sanitaire – will be extended to under-18s, meaning all teenagers will need to show proof of vaccination or a negative Covid test to access places like cinemas, museums, restaurants and indoor shopping centres. In June Germany’s scientific advisers recommended the vaccine should only be offered to children aged 12 to 15 with underlying health conditions. But in August, after the Delta variant started spreading more widely, the rollout was extended to all those over 12 years old.In Sweden children aged 12 to 15 are only eligible for a vaccine if they have lung disease, severe asthma or another high-risk medical condition. In Norway, not part of the EU, the vaccine rollout was recently extended to children aged 12 to 15, but only a first dose will be offered, with a decision on a second dose to be made later.The US – mandatory vaccination In May, US and Canadian regulators were the first to approve the Pfizer jab for use in children from 12 years and older. The rollout started immediately at sites across the US with two injections given three weeks apart. By the end of July, 42% of 12 to 17-year-olds had received their first dose and 32% their second dose of either the Pfizer or Moderna shots. The drive to vaccinate children came as the US started to battle a rise in infections driven by the Delta variant.image source, Getty ImagesThe latest report from the Centre for Disease Control said that the number of children hospitalised with Covid was between 3.4 to 3.7 times higher in states with the lowest vaccination coverage.A handful of US school boards have voted to make the jab mandatory for children aged 12 and over to attend class, despite objections by some parents.In Los Angeles the order was recently extended to 600,000 pupils, while in New York staff but not students must be inoculated.Pfizer has also started testing its Covid vaccine on younger children. The first results, in those between five and 11 years old, are expected in September with data for infants aged six months to four years old likely to follow by the end of the year.President Biden has already indicated that vaccines for that younger age group could be available “soon” after regulators review the clinical data.China – jab approved for children three and overIn June, China began to allow some children from three to 17 years old to be offered shots of a vaccine produced by drug-maker Sinovac, making it the first country to approve a jab for such a young age group.The country has set a rough target of vaccinating 80% of its 1.4 billion population by the end of the year, a figure impossible to meet without jabbing large numbers of under-18s.In theory the Covid vaccine is voluntary in China, although some local governments have said that students will not be allowed back to school this term unless their entire family is double jabbed. The Sinovac vaccine is also widely used in many countries in Asia, Africa and South America. In Chile, it has already been approved for use in children from six years old, while the company has recently started clinical trials to test its vaccine on children in South Africa aged from six months to 17 years old.image source, Getty ImagesIndia – adult jabs come firstIndia is thought to have the largest adolescent population in the world, estimated at about 253 million by Unicef. The latest data from the National Serological Survey suggests about 60% of children have been exposed to coronavirus since the start of the pandemic, and are likely to have built up some immunity from past infection. In August, the country’s drug regulator granted emergency use for a new vaccine developed by local drug firm Zydus Cadila in all those aged 12 years and over, the first approval to cover children.The jab currently needs to be given in three separate doses using a needle-free applicator, rather than a traditional syringe. The firm has said it soon hopes to start trials in younger children aged two and over. Government scientific advisers have said vaccination for children aged 12 to 17 with serious health conditions could start in October, but a wider rollout will only take place after the adult programme in India is completed, currently slated for the end of the year.Follow Jim Reed on Twitter

Read more →