The US Food and Drug Administration classified the recall of Ellume’s over-the-counter Covid home test as Class 1, the most serious type of recall, after the Australian diagnostic test maker removed some of its tests from the market last month.
Ellume had cited higher-than-acceptable false positive test results for SARS-CoV-2 as the reason for the recall.
A ‘false positive’ indicates that a person has the virus when they actually do not.
The antigen test, which detects proteins from the SARS-CoV-2 virus from a nasal sample, is available without a prescription for use by people above two years of age with or without Covid symptoms.
The agency said on Wednesday there have been 35 complaints of the antigen test giving false positive results, but no death had been reported related to the test.
Ellume has so far recalled 2,212,335 tests in the United States.
Soaring coronavirus rates in Germany are threatening plans for a rollout of the country’s famous Christmas markets, due to open in about a week’s time.
There had been considerable fanfare over municipalities’ plans to stage the markets this year after they were called off a year ago.
Hopes that the vaccine campaign – which started in Germany on 27 December last year – would have enabled markets to go ahead have been thwarted by a low uptake rate – only about 67% of Germans are fully vaccinated – and the spread of the more infectious Delta variant.
Now authorities from Bavaria in the south to Saxony and Thuringia in the east have begun announcing the cancellation of many scheduled markets, saying a rising infection rate means it would be irresponsible for them to go ahead.
Full story here:
Here is my colleague Nicola Davis’s story on the pet dog in the UK who contracted Covid from its owners:
The UK reported another 39,329 Covid cases on Wednesday and a further 214 deaths within 28 days of a positive test, official data showed. The figures compared to 33,117 cases and 262 deaths reported on Tuesday.
One of the UK’s longest-suffering patients with Covid has revealed he was confronted by a conspiracy theorist during his 10-month stay in hospital and heard claims that the virus was a hoax.
Cancer survivor Andy Watts, 40, said her feared he would die after falling seriously ill with coronavirus in December last year. The father-of-two spent eight months in intensive care, including five weeks in an induced coma, when doctors considered switching off his ventilator after his condition deteriorated.
He was moved out of intensive care in August and spent another two months on a hospital ward as he learnt how to talk, eat and walk again.
Watts made a remarkable recovery, finally leaving to applause from medical staff at the Queen Elizabeth Hospital in Woolwich, southeast London, on 21 October – 300 days after being admitted for treatment.
Watts, from Bexley, said some visitors in his hospital ward believed the virus was a hoax despite his ordeal. He said he was confronted by one person visiting a non-Covid patient who told him the virus was “all a conspiracy”. He said:
I just thought: ‘Whatever’, and put my headphones back in. I don’t want to get involved in conversations like that. I didn’t want to get into an argument. It’s up to them what they want to believe. In the end, I just thought: ‘Here’s the proof – if you don’t want to believe it, what can I do?’
Now vaccinated, Watts said he still has oxygen therapy at night and has physiotherapy twice a week, along with daily exercises. He said:
The last two years have made me appreciate life a lot more. You never know what’s round the corner. Don’t take things for granted. Every day is special.
Frontline workers cannot expect to remain unvaccinated in a pandemic and to keep working with vulnerable people, writes Guardian columnist Frances Ryan.
Here are some extracts from her column:
In some ways, it is remarkable that requiring NHS staff who have face-to-face contact with patients to be vaccinated is even controversial. Healthcare workers have a professional duty of care not to harm patients, which is why the majority have already taken the vaccine, and few could expect to remain unvaccinated in a pandemic and to keep working with vulnerable people. However, mandating health measures is not something to be done lightly.
As I’ve written before, workers – especially pregnant women and people from minority ethnic groups – must be given time to overcome fears, as well as paid time off to get the jab and sick leave for any mild side effects. That’s why staff will be offered one-to-one meetings with clinicians if they want to discuss their concerns as they make their choice.
But “persuasion” cannot go on for ever. It has been almost a year since health and care workers were first given priority access to the jab. There surely comes a point when we must acknowledge that some staff will never take the vaccine without it being mandatory, and be honest about what we are asking the public to face in the meantime.Medics are not immune to doubting science or guaranteed to put their patients’ wellbeing first. Every request to give staff more time to feel comfortable with being vaccinated is another day that clinically vulnerable people’s lives are put at risk.
It’s important to be clear about what [Sajid] Javid has mandated. No one will be forced to have the vaccine. It is simply that those staff who choose to remain unvaccinated will not have the right to a job on the frontline of the NHS.
This is not unprecedented. Staff in some areas of the NHS, such as surgery, are already obliged to get vaccinated against hepatitis B. That’s because it’s widely understood that not taking sensible precautions to prevent passing on a disease to patients would be a form of neglect.
The myth that “patients are jabbed so no one else needs to be” is another straw man. Some clinically vulnerable people can’t have the vaccine because of their illness, while others will receive insufficient protection from the jab because they’re taking certain medications or because they have weak immune systems.
That’s why it’s so important for frontline health workers to be vaccinated; multiple studies show it significantly reduces the risk of transmission.We don’t stop making seatbelts compulsory in cars because some people still die in accidents. Many lives are saved by them, and that’s enough reason for us all to wear them.
The full column is here:
Far from being irresponsible Covid spreaders, the vast majority of students at English universities have been vaccinated at least once and would request a test if they had symptoms, according to a survey.
Students’ wellbeing has suffered this autumn, however, with a third of those surveyed reporting that their mental health had deteriorated since the start of term, the report by the Office for National Statistics (ONS) says.
The survey found the average life satisfaction score among students was 6.6 out of 10, significantly lower than among 16- to 29-year-olds in general, who scored 7.0, and the overall adult population in Great Britain, at 7.1.
The ONS report says mental health has worsened as the term has progressed, with 32% of students reporting that their wellbeing has deteriorated, compared with 26% in late September.
It is better than it was last May, when half of students who took part in the survey said their mental health had deteriorated. Most students at that time were studying online owing to lockdown restrictions, while this term students have returned to campuses for more face-to-face teaching.
On vaccination, the survey – which is based on experimental data drawn from responses from almost 1,000 students in England during October and November – found that 91% of respondents had been vaccinated against Covid at least once.
The proportion of students who have been double-vaccinated was 85%, up from 78% in late September. Of the 8% who said they had not been vaccinated, almost a third (32%) said they were fairly or very likely to take a vaccine if offered.
Students also showed they were willing to test for Covid: 92% said they would request a test if they developed symptoms, and 49% said they had taken a test in the previous seven days. Meanwhile,57% said they would stay at home for 10 days if they developed symptoms.
Last year students were often accused of spreading the virus by holding parties in breach of restrictions, and some were fined and threatened with exclusion from their university studies.
The full story is here:
A care home manager in England who has lost a sixth of her staff because of the UK government’s mandatory vaccination policy has told of the anguish of reading their “heartbreaking” resignation letters.
Niccii Gillett, manager of Elmfield House Residential Home in Woking, Surrey, said six of her 36 staff have already resigned due to the requirement rather than face dismissal.
Thursday is the deadline for care home staff in England to have been doubled jabbed, except for those who are medically exempt.
The latest figures from the NHS show more than 60,000 staff had not been recorded as fully vaccinated as of 31 October, meaning tens of thousands face losing their jobs.
Gillett said her staff “firmly stated” in every resignation letter that they did not want to stop working. Two had been at the 18-bed family-run home for seven years.
The 37-year-old told the PA news agency:
The sad thing is none of them wanted to leave. And reading their resignation letters was heartbreaking.
They’re so grateful for the opportunities and the first one that left, we gave gifts.
It was such an emotional afternoon and for days afterwards my residents were heartbroken because they saw this person as one of them, and even a resident, they have said ‘I wish she could come back, I don’t care that she’s not vaccinated’.
Tens of thousands of care home residents in England face losing vital support as unvaccinated carers clock off for the last time before double jabs become mandatory.
About 50,000 care home staff who have not had two doses will not be allowed to work from Thursday. Analysis by the Guardian suggests that on current staff/resident ratios without other measures to tackle the problem, the care of about 30,000 people could be affected.
Care operators and health chiefs have warned staff shortfalls could prevent thousands of people from being discharged from hospitals this winter, limiting admissions and clogging up wards. They say it will increase pressure on remaining care staff to work longer hours, despite many being already exhausted.
Full story here:
A pet dog has fallen ill with Covid in the UK after reportedly contracting the virus from its owners.
The dog tested positive for the virus following tests at the Animal and Plant Health Agency (APHA) laboratory in Weybridge, Surrey, on 3 November.
It is understood that the dog, who is recovering at home, contracted the virus from its owners, who had previously tested positive for coronavirus.
Experts claim there is no evidence the animal was involved in the transmission of the disease to its owners, or that pets or other domestic animals are able to transmit the virus to humans.
It is the first confirmed case of a dog becoming infected with Covid in the UK, after the virus was detected in a cat in the same laboratory last year.
Cat or dog owners who have Covid-19 should avoid their pets while infected, experts warned a few months ago.
While cases of owners passing on Covid to their pets bring negligible risk to public health, the scientists said there is a “potential risk” that domestic animals could act as a “reservoir” for coronavirus and reintroduce it to humans.
The latest UK government guidance for animal owners on how to care for their animals during the pandemic can be found here.
A fifth lion at Singapore Zoo has tested positive for Covid-19, the Animal and Veterinary Service (AVS) said on Wednesday.
The African lion, which showed signs of illness on Monday, tested positive along with four Asiatic lions from the Night Safari, who tested positive on Tuesday after displaying signs of sickness over the weekend. The lions, whose symptoms included coughing and sneezing, are isolated within their respective dens.
Asiatic lions in the “Night Safari” exhibition at the Singapore Zoo, as other lions in the same exhibit were found to be infected with Covid-19. Photograph: Mandai Wildlife Group/AFP/Getty Images
A Mandai Wildlife Group spokesman said in a statement on Wednesday that all its lions that have been unwell are “bright, alert and active for now”, adding:
While we expect them to fully recover soon, we are monitoring them very closely. We have added vitamin C to their diet but have not needed to administer other medications.
The World Health Organisation for Animal Health has advised that the risk of transmission from infected animals to humans is very low. Nevertheless, we have closed the exhibits while our lions rest.
It is believed the lions contracted the virus from three infected zookeepers.
Faecal samples taken from the lions returned positive Covid results from PCR tests. Photograph: Mandai Wildlife Group/AFP/Getty Images
It is one of the most recent cases of animal infection with the virus. There have been a small number of confirmed cases in pets, including cats and dogs, in countries in Europe, North America and Asia.
In June, 15 lions became infected at a zoo in Chennai, India. Two of the lions died, while the other 13 recovered. And last week, two spotted hyenas at Denver Zoo in the US became the first in the world to test positive for the virus and showed mild symptoms including “a little bit of coughing and sneezing”, nasal discharge and lethargy.
Other reported incidents from around the world include a wild white-tailed deer cluster in Iowa in the US, and infections on mink farms in Denmark, which led to mass nationwide culling and incineration of millions of minks.
After a troop of western lowland gorillas fell ill with Covid in San Diego Zoo in the US in January, four orangutans and five bonobos became the first non-human primates to be vaccinated against the disease in March. Several other zoos around the world have begun giving animals the vaccine to protect them from Covid.
Russia on Wednesday reported a record 1,239 deaths from Covid in the previous 24 hours, two days after most of its regions emerged from a week-long workplace shutdown designed to curb the spread of the virus.
It takes the official death toll to 250,454 deaths. Only four other countries have surpassed the grim quarter-million milestone. Officially, the US has reported 757,309 fatalities, Brazil 609,756, India 461,849, and Mexico 290,110, according to data from John Hopkins University.
A further 38,058 coronavirus cases were also recorded across Russia, including 3,927 in Moscow, in the past 24 hours, according to the government’s Covid task force.
New daily cases have retreated slightly in the past four days after hitting a peak of 41,335 on Saturday.
“For now we cannot say with confidence that the situation has stabilised and the infection rate is declining,” the deputy prime minister Tatyana Golikova told a government meeting.
Her assessment was markedly more downbeat than that of the health minister MikhailMurashko, who had said on Tuesday that the nationwide “non-working days” from 30 October to 7 November had turned the tide in Russia’s fight against the pandemic.
Murashko told parliament on Wednesday that oxygen reserves at hospitals in 12 of Russia’s regions would last for two days or less, unless they were replenished.
At the same time, he said, some regions were already reporting a decline in infections and the vaccination campaign was bearing fruit as only 3-4% of inoculated Russians have been infected.
More than 62 million Russians have received at least one dose of a Covid vaccine, Murashko said.
Golikova told a government meeting that 22 million more people needed to get inoculated and about 9 million needed to get a booster in order to have 80% of the adult population vaccinated and thus achieve a minimum level of collective immunity.
*I’m grateful to reader Francisco for flagging this to me.
Demand for Covid booster jabs jumped in France after Emmanuel Macron said a top-up dose would be necessary for people to retain their vaccine passes, the country’s main appointment booking site said on Wednesday.
“The Macron effect” prompted 149,000 requests for shots, most during and immediately after the president’s televised address on Tuesday evening, in which he warned that coronavirus cases were again on the rise, Doctolib told AFP.
Anticipation of tougher rules had already sparked 96,000 bookings on Monday, compared with an average of 50,000 a day in recent weeks.
Macron announced that from 15 December people over 65 would require a booster shot if they want to continue using their vaccine passes to gain entry to bars, restaurants, cinemas and other public venues.
He added that from the age 50, people would be allowed to request an additional vaccine dose, without it being mandatory for the Covid passes of 50- to 64-year-olds.
France has one of the strictest vaccination regimes in Europe, with the passes required to take intercity trains, visit museums and go to gyms, among other amenities.
That has pushed France’s overall vaccination rate to 75%, a level relatively unchanged in recent weeks. Doctolib said only 20,000 of the Tuesday bookings were for first-time vaccinations.
In his speech, Macron urged the roughly 6 million people in France yet to get even a first jab to do so:
This is an appeal for responsibility – get vaccinated.
He also said face masks will again be mandatory for all schoolchildren in a bid to avoid a new wave of cases.
The government is also considering making vaccines available to children under 12.
As of Tuesday, there have been an average of 36 daily Covid deaths in hospital over the past week, a 21% rise from the previous week, according to health ministry figures. France’s total death toll since the start of the pandemic stands at 118,023.
French vaccines company Valneva saw it shares jump more than 20% after it won approval from the European Commission for a deal under which it would supply up to 60m doses of VLA2001, its inactivated Covid vaccine candidate, over two years.
It is the eighth such deal by the executive body as it speeds up its fight against rising infections on the continent.
“The Valneva vaccine adds another option to our broad portfolio, once it is proven to be safe and effective by the European Medicines Agency,” the EU health commissioner Stella Kyriakides said. “The message remains the same: trust the science, and vaccinate, vaccinate, vaccinate.”
Valneva is hoping its candidate, which uses more traditional technology than the mRNA vaccines, could be a more reassuring option for Europeans still reluctant to be immunised.
It said last month that it demonstrated efficacy “at least as good, if not better” than AstraZeneca’s shot in a late-stage trial comparing the two, with significantly fewer adverse side effects.
The European Commission said the contract with Valneva provides the possibility for EU member states to purchase nearly 27m doses in 2022. Member states can then make a further order of up to 33m additional vaccines in 2023.
The deal includes the possibility to adapt the vaccine to new coronavirus variants.
“We are grateful to the European Commission for its support and are eager to help address the ongoing pandemic,” Valneva chief executive Thomas Lingelbach said in a statement.
In September, the UKscrapped a contract for about 100m doses of Valneva’s Covid vaccine over concerns the vaccine might not receive approval.
Thailand will set aside up to 500,000 doses of Covid vaccines for foreign workers as it prepares to welcome them back to the country to help ease a labour shortage, a government minister said on Wednesday.
The government plans to allow workers from neighbouring Myanmar, Cambodia and Laos to re-enter the country beginning next month and fill up shortages in big exporting industries such as food and rubber production.
Workers will be placed in a two-week quarantine and during that time the vaccines will be administered, labor minister Suchart Chomklin said. They will also be tested for Covid.
“We have prepared 400,000 to 500,000 doses to inoculate migrant workers,” he said. the Labor Ministry estimates there is an immediate demand for 420,000 migrant workers.
Easing the controls will also help stop smuggling of workers, the government said.
Nearly 11,000 people were arrested in cases linked to smuggling last month, compared to 1,456 arrests over the same period last year.
Italy has clamped down on protests against the country’s Covid-19 health pass.
The protests, at times violent, have become more prolific since Italy made the pass mandatory for all workers in October.
Demonstrations will no longer be able to take place in city or town centres.
“For weeks the so-called ‘no pass’ protests have been paralysing the centres of many cities every Saturday, creating inconvenience for citizens and shop-keepers, as well as creating crowds of unvaccinated people,” said Carlo Sibilia, undersecretary at the interior minister.
Protests in the northern city of Trieste are believed to have triggered a surge in coronavirus infections.
There was also controversy earlier this month after protesters marched through the streets of the city of Novara wearing striped bibs while comparing themselves to prisoners of Nazi concentration camps.
The so-called ‘green pass’, which shows evidence of vaccination, immunisation or a negative test, is required by Italians when entering their workplaces and for dining inside at bars or restaurants, travelling by plane or long-distance train as well as entering museums, theatres, cinemas, nightclubs and stadiums.
Boris Johnson has come under fire from the World Health Organization’s special envoy for Covid-19 after being photographed without a face covering during a hospital visit.
Asked about pictures of the British prime minister walking through Hexham General without a mask, Dr David Nabarro said:
We all need to be able to do what we’ve got to do, regardless of what politics we adopt.
He told Sky News:
I’m not sitting on the fence on this one – where you’ve got large amounts of virus being transmitted, everybody should do everything to avoid either getting the virus or inadvertently passing it on.
We know that wearing a face mask reduces the risk, we know that maintaining physical distance reduces the risk, we know that hygiene by regular hand-washing and coughing into your elbow reduces the risk.
We should do it all and we should not rely on any one intervention like vaccination on its own.
So, please, would every leader be wearing face masks, particularly when in indoor settings.
This virus is unforgiving and we need to do everything possible to prevent it getting in between us and infecting us.
Dr Nabarro also expressed regret that means of mitigating the spread of Covid, such as use of face masks, have been politicised. He told the broadcaster:
Perhaps that’s the toughest thing about Covid, is that the responses get politicised – in some places if you wear a mask, you’re taught to belong to a particular political party.
That’s the most regretful thing about the present situation; we all need to be able to do what we’ve got to do, regardless of what politics we adopt.
The latest row came after Johnson was pictured last week at the Cop26 climate change summit sitting maskless alongside the 95-year-old environmentalist and broadcaster Sir David Attenborough.
A No 10 spokesman earlier said of his visit to Hexham General hospital:
The prime minister followed the Covid measures that were in place throughout his visit, including wearing a mask in all clinical areas. He also took a PCR test before the visit. The hospital trust has issued a statement making clear the PM followed its guidelines.
A source told the Guardian on Monday that Johnson had just left a meeting where he was speaking, was not in a clinical area, and put a mask on shortly afterwards. Photograph: Reuters
Good morning from London. I’m Lucy Campbell, I’ll be bringing you all the latest global developments on the coronavirus pandemic for the next eight hours. Please feel free to get in touch with me as I work if you have a story or tips to share! Your thoughts are always welcome.
