Category: COVID

Siemens COVID Antigen Test Kit Receives German Approval

Siemens Healthineers announced on Wednesday that their antigen self-test kit, which uses samples from a nasal swab, has received limited special approval from the Federal Office for Drugs and Medical Devices (BfArM) for self-use by laypeople in Germany. The regular conformity assessment procedure for the standardised ‘CE‘ mark was also initiated for personal use by laypeople.

“With the provision of the COVID-19 antigen rapid test for possible use by laypeople in Germany, we are breaking new ground and are thus continuing to fulfill our social responsibility to support a return to normal social life,” said Bernd Ohnesorge, Head of Europe, Middle East, and Africa Regions, Siemens Healthineers

The practicability of the kit was confirmed by a study in which 50 participants without medical training personally carried out the test by following the instructions for use. The test already has a CE mark for use by specialist groups for taking samples in the nose.

“The CLINITEST COVID-19 Antigen Self-Test offers users a high degree of flexibility in performing the test with very good quality results,” said Christoph Pedain, Head of Point of Care Diagnostics at Siemens Healthineers.

Siemens’ COVID-19 Antigen Self-Test takes 15 minutes to give a result, using samples taken from both nostrils using a swab. The swab is then washed out in a reagent, which detaches a specific protein from the surface of the virus. The resulting liquid is dripped into a recess in the test cassette.

The test liquid migrates into the field of view of the cassette within 15 minutes, becoming visible as a line. The position and number of lines indicate as to whether there is a positive or negative test result, or whether there was a problem, necessitating a repeat of the test.

In the instructions, the tester is shown the steps to achieve a test result, including instructions on how to proceed according to the test result. A negative test result does not exempt the user from any local COVID regulations. Currently, the test kit is also available in the UK.

Source: Siemens

Global COVID Recovery Needs to Address Oxygen Shortages

At the virtual launch of Global Citizen’s Recover Better Together Campaign, access to vaccines and medical resources was highlighted as a key area to address.

“Covid-19 has threatened the lives and livelihoods of everyone on the planet. To respond, we must take several urgent actions. The only way that we will be able to recover better, together is by defeating the virus everywhere through universal access of vaccines, diagnostics, and therapeutics,” said World Health Organization Director-General Dr Tedros Adhanom Ghebreyesus.

To this end, the Recover Better Together Campaign, an initiative organised by the Global Citizen, the European Commission and the WHO, aims to create momentum for global COVID pandemic recovery, with a return to the implementation of global goals.

“To fight the pandemic, we need to pool resources, capabilities, knowledge and intellectual property. That is why we continue to call on world leaders to support the COVAX facility to ensure rapid and equitable access to Covid-19 vaccines for all countries. Another important step is to enable the transfer of medical technology for the duration of the pandemic,” said President Cyril Ramaphosa.

One of key medical resource is oxygen, which is in short supply in many low- and middle-income countries, which have to provide enough for up to half a million COVID patients. WHO data shows that 1.1 million cylinders are needed daily in developing countries, with Africa seeing the biggest surge in demand. Hospitals in Nigeria have reported running out of oxygen, leading to preventable deaths.

According to the WHO, public hospitals across 41 African countries have fewer than 2000 working ventilators. In comparison, the United States has more than 170 000 ventilators. The South African private sector has about 4000 ventilators, and around 2000 in the public sector. The WHO said the launch of the Covid Tools Accelerator Therapeutics pillar, co-led by Unitaid and Wellcome, has improved access to oxygen. On 25 February the Covid-19 Oxygen Emergency Taskforce was also launched by the WHO.

Unitaid Executive Director Dr Philippe Duneton said the Taskforce now needs an additional $90 million US for delivery of oxygen in up to 20 countries including Malawi, Nigeria and Afghanistan.

“This is a global emergency that needs a truly global response, both from international organisations and donors. Many of the countries seeing this demand struggled before the pandemic to meet their daily oxygen needs,” said Duneton. “Now it’s more vital than ever that we come together to build on the work that has already been done, with a firm commitment to helping the worst-affected countries as quickly as possible.”

Source: Health-e News

Pope Appoints New Personal Doctor After Predecessor Died of COVID

The 84 year-old Pope Francis today appointed a new personal doctor to replace his previous one, 78 year-old Fabrizio Soccorsi, who passed away on January 9 from COVID related complications. He had served in the role since 2015.

Dr Soccorsi had been admitted to Rome’s Gemelli hospital on 26 December because of cancer, but died due to “pulmonary complications” caused by COVID. Pope Francis had held a funeral service on 26 January for the late Dr Soccorsi.

During his medical career, he had been head physician of the hepatology ward in Rome’s San Camillo-Forlanini hospital and director of its department of liver diseases, the digestive system and nutrition; he also taught immunology at medical schools.

His replacement, Roberto Bernabei, is an expert in health care for the elderly. Dr Bernabei, 69, leads the geriatrics and rehabilitative medicine department at Rome’s Gemelli, which is the Catholic hospital where popes traditionally go to be treated.

It is believed the pontiff remains in good health, despite having had part of his lung removed after developing pleurisy as a young man. He received a COVID vaccine in early January alongside former pope Benedict.

Source: Eyewitness News

Why It’s So Hard to Compare Vaccines

While the world is looking to vaccinations to end the COVID pandemic, a MedPage Today article explains that even with vaccines that have high efficacy, ending transmission is not guaranteed, and there are a lot of differences between simple figures like 94% for Pfizer and 95% for Moderna vaccines.

Firstly, asymptomatic cases are not tracked, simply because assembling tens of thousands of people for a clinical trial is a monumental logistic task, and in the current pandemic, a race against time.

Internist Jeffrey Carson, MD, who managed the Johnson & Johnson COVID vaccine trial’s site at Rutgers University in New Jersey, explained to MedPage Today that it would be difficult but not impossible to create a vaccine trial that provided rapid data about asymptomatic cases.

“You might have people swab themselves every couple days, or every week. You’ll be picking up a lot of disease that way, and you’ll be able to see if the vaccine prevents asymptomatic disease,” Dr Carson said. The current Novavax trial, for example, only asks participants to test themselves for COVID with provided swabs if they believe they are developing symptoms. The Novavax vaccine had also prompted alarm as it was only 49.4% effective against the B501Y.V2 variant, its efficacy reduced by the low rate of protection for HIV positive participants.

The New York Times explained that efficacy is merely how well a vaccine did in a clinical trial, effectiveness is how well it performs in the real world.
Vaccine statistics are difficult even for medical experts to grasp. An infectious diseases expert wrote in a letter to the Lancet explaining that they had misunderstood what 94% to 95% efficacy means for Moderna and Pfizer vaccines and asymptomatic spread.

“It does not mean that 95% of people are protected from disease with the vaccine — a general misconception of vaccine protection.” Instead, it “means that in a population such as the one enrolled in the trials, with a cumulated COVID-19 attack rate over a period of 3 months of about 1% without a vaccine, we would expect roughly 0.05% of vaccinated people would get diseased [with symptomatic infections]. … Accurate description of effects is not hair-splitting; it is much-needed exactness to avoid adding confusion to an extraordinarily complicated and tense scientific and societal debate around COVID-19 vaccines.”

A further problem for scientists is that viral diseases can spread to people unaware that they are infected, something they are still working on understanding. “It makes a lot of sense for survival of the invaders, if you think about it. Humans who feel unwell are not going out to meet up with others, but ones who feel fine will continue along with their daily schedules, allowing the infection to spread,” Bryn Boslett, MD, an infectious disease physician at the University of California San Francisco, told MedPage Today.

Regardless of how well vaccines interrupt the transmission of COVID, it’s important that mask-wearing, social distancing and disinfecting habits are maintained.

“One major worry going forward is that vaccinated people will change their behaviour and stop taking COVID-19 precautions,” Dr Boslett said. “It’s very tempting to do so, very understandable. However, the stars are not yet aligned for us to go back to ‘normal.’ There is still a lot of COVID-19, and most of us are still vulnerable. We need to continue to focus on behavior to reduce new cases of COVID-19.”

Source: MedPage Today

Recent Mother With COVID to Have Life Support Withdrawn

In the UK, a comatose woman with COVID who had recently delivered her son via caesarean section should be allowed to die, a judge has ruled.

Mr Justice Hayden said that doctors should cease the woman’s life support treatment as it was no longer preserving her life but rather dragging out her death.

He said that the situation was “a tragedy of an almost unimaginable dimension” and was told there was “zero” chance of the woman making any meaningful recovery.

The woman (whose identity is withheld) was rushed to hospital a month ago while 32 weeks pregnant, after falling ill with COVID at home.

The judge was told that she had Addison’s disease, an acquired primary adrenal insufficiency from bilateral autoimmune damage to the adrenal cortex. The woman’s pancreas had ceased to function and one of her lungs had “died”, with a specialist saying that she had “essentially no normal lung function”.

The woman, who is of the Muslim faith, has a husband and a three year old son. Her husband and sister opposed the decision to withdraw life support as it was against their beliefs.

“To unplug the machine, this is for us like asking someone to kill us,” the woman’s sister said. “When God has written our death, that is when we will die.”

In an urgent court application, the judge took the case in a virtual hearing held late on Tuesday. The judge concluded that ending the woman’s life was in her best interests, adding that doctors had prepared a palliative care plan.

“This family is seeking a miracle,” he said. “This is a very young mother in circumstances of almost unspeakable sadness.”

Source: The Guardian

Ghana Receives First Vaccines from Covax

Wednesday was a day to celebrate in Ghana as the country took delivery of the first 600 000 vaccines from the Covax inoculation scheme for poorer countries. According to the AFP, some 217 million people have been inoculated so far. 

The Covax scheme, which is led by Gavi the Vaccine Alliance, the World Health Organization and the Coalition for Epidemic Preparedness Innovations , is seeking to ensure low and middle-income countries equitably receive vaccines. head Tedros Adhanom Ghebreyesus cheered on the first delivery of the Covax vaccines with an enthusiastic tweet.

“At last!” he wrote. “A day to celebrate, but it’s just the first step.”

Healthcare experts had long been warning that global access to vaccines was necessary to put an end to the pandemic. Thus far, some 112 million people (and likely more, especially in Africa) have been infected with COVID and 2.4 million people have died from the disease. The recession has caused millions of job losses, and set back development in many areas.

The delivery of the Oxford/AstraZeneca vaccines was broadcast live on Ghanian TV, and will be administered in Ghanaian cities from Tuesday. About two billion doses are expected to be distributed this year under the Covax scheme, although it is unclear if this goal will be met, given the difficulty many advanced nations have experienced in getting vaccines. The European Union, for example, has suffered setbacks in deliveries from AstraZeneca and Pfizer. EU member nation Hungary has meanwhile decided to forge ahead with its own vaccine acquisition, ordering five million doses from Chinese firm Sinopharm, and this week began its first vaccinations.

The Ivory Coast is set to receive the next batch from Covax later this week. 

Source: Eyewitness News

COVID Tracking in Space Company Employees Yields Antibody Clues

SpaceX, an aerospace manufacturing company currently providing satellite launch services as well as transport of crew  to the International Space Station, collaborated with researchers from MIT to monitor the spread of COVID amongst its employees. 

Unusually, the paper included SpaceX CEO Elon Musk as a byline author. The technology entrepreneur is known to be quite hands-on in his company’s projects. However, he has also courted controversy by openly questioning COVID tests and saying he and his family would not take COVID vaccines, saying that achieving herd immunity naturally was a better strategy.

SpaceX was seeking data-driven methods to safeguard its essential workforce. The collaboration allowed the researchers to track the emergence of mild and asymptomatic cases in a cohort of adults as early as April, when data for such cases were rare.

“Essentially, this study indicates that it’s not simply the presence or absence of antibodies that matter; rather, the amount and type of antibodies may play a defining role in the development of a protective immune response,” said Professor Galit Alter, Harvard Medical School and Immunologist, Division of Infectious Diseases, Massachusetts General Hospital. 

The study was originally aimed at measuring antibody levels over time, but when reinfections began to be reported, the team realised their samples had some valuable information.

“In early spring, we weren’t sure if asymptomatic infection could drive long-lived antibodies,” said Prof Alter, “nor whether they possessed the capability to neutralise or kill the virus.”

The researchers knew that 120 participants had mild or asymptomatic COVID infections, resulting in their bodies producing antibodies. Using sophisticated techniques to analyse those antibodies, they found that individuals with stronger symptoms in mild COVID, had a larger number of antibodies and developed immune functions associated with natural immune protection. 

The study found that although the presence of antibodies was sufficient to determine whether an individual had experienced a COVID infection, they did not automatically mean that individual is protected against the virus in the long term.

Antibody effector functions (on the ‘long arm’ of the antibody) linked to long-term protection, such as T cell activation and virus neutralisation were only seen in certain immune responses. These involved high levels of antibodies targetting a part of the virus known as the receptor binding domain.

“Once you hit a certain threshold of these antibodies, it’s like a switch turns on and we can observe antibody effector functions,” said first author Yannic Bartsch, PhD. “These functions were not observed in individuals with lower antibody binding titers, and the level of protection from reinfections is uncertain in these individuals.”

Source: News-Medical.Net

Journal information: Bartsch, Y. C., et al. (2021) Discrete SARS-CoV-2 antibody titers track with functional humoral stability. Nature Communications. doi.org/10.1038/s41467-021-21336-8.

Confusion Results in Vaccine Priority for ‘6.2cm’ Tall UK Man

As a result of an error at his GP surgery, a healthy man aged 32 was offered an early COVID vaccination because his height was recorded as 6.2cm – giving him a calculated Body Mass Index (BMI) of 28 000.

Liam Thorp, political editor at The Liverpool Echo’s, said he was left “really confused” after he was offered the vaccine ahead of the government’s rollout, sharing the “frankly surreal” experience in a Twitter thread.  Vaccinations are not expected to begin until later in the year for the UK’s under-50s without underlying health conditions, perhaps as soon as March.

Manchester Evening News politics and investigations editor, Jennifer Williams, replied: “Should they not have been in touch before to see how the man the size of a thumb was getting on?” And palliative care doctor Rachel Clarke said: “This, for me, is the single best tweet of the entire pandemic, Liam. And may I please commend your decency in not exploiting your remarkable BMI to jump the queue?”

Despite being “on the chunky side”, Thorp didn’t think of his himself as obese. He said he was “uneasy”, thinking that he still ought to accept the invitation for vaccination, he contacted his GP about the situation whereupon he learned of the error which resulted in his height being recorded as 6.2cm – a mixup of his height as 6ft 2in (188cm). This resulted in his bizarre BMI of 28 000.

“If I had been less stunned, I would have asked why no one was more concerned that a man of these remarkable dimensions was slithering around south Liverpool. But he was very apologetic and really nice and I think he was just relieved that I found it so funny,” recalled Thorp.

Dr Fiona Lemmens, chair of NHS Liverpool clinical commissioning group, said: “I can see the funny side of this story but also recognise there is an important issue for us to address.”

Source: The Guardian

COVID in Zambia More Widespread Than Believed

A new study from Zambia has found almost a fifth of recently-deceased people in mid-2020 tested positive for COVID. 

The study, from the Boston University School of Public Health (BUSPH) study in Zambia, upends the notion that Africa somehow ‘dodged’ the worst of the COVID pandemic. Rather, the low reported rates are merely reflective of a lack of testing ability.

“Our findings cast doubt on the assumption that COVID-19 somehow skipped Africa or has not impacted the continent as heavily,” said study co-author Dr Lawrence Mwananyanda, a BUSPH adjunct research assistant professor of global health based in Lusaka. “This study shows that with proper diagnostics and testing, we can begin to identify the scale of COVID-19 in African countries such as Zambia. I hope this study will encourage African governments to look closer at the rollout of COVID-19 testing, as well as empower Africans to take proactive steps–such as wearing masks, physically distancing, and skipping handshakes–to protect themselves from COVID-19.”

The findings have important implications for global policy makers, who will need to ensure access to vaccines worldwide, along with monitoring.

The University Teaching Hospital morgue sees roughly 80% of people who die in Lusaka pass through it. From June to September, polymerase chain reaction tests detected COVID in 70 out of 364 recently-deceased people. A peak of 31% positive results was observed in July. Unlike the typical pattern of COVID deaths elsewhere, most of the deceased people who tested positive in this study were under 60 years old, including seven children. Given how rare paediatric COVID deaths are elsewhere, this is surprising, the researchers noted.

The researchers sought information about the symptoms of the 70 who tested positive. “In nearly all cases where we had those data, we found typical symptoms for COVID-19, yet only 6 had been tested before death,” Gill said. Of 75% of deaths outside hospital, none had been tested.

Monitoring COVID is not a simple task, especially in a country with limited resources. Zambia’s Ministry of Health has been very proactive and supportive of this and other COVID studies, the researchers said.

“They’re really grateful that we can provide them this data, and they can make informed decisions moving forward with this epidemic,” said Dr Mwananyanda.

The researchers were well-positioned to track COVID in Zambia, having conducted the ongoing Zambia Pertussis/RSV Infant Mortality Estimation Study (ZPRIME) at the morgue.

“Building studies such as this from scratch can take time and resources that can be difficult in the time needed to tackle the COVID-19 pandemic. We invested a lot of time and money and human resources to building infrastructure that allowed for that extensive surveillance,” said co-author Rachel Pieciak, a research fellow at BUSPH. “So, what we’ve done was repurpose ZPRIME study capacity to focus on enrolling all deaths across all ages and testing for COVID-19.”

The researchers expressed hope that similar studies could be repurposed for the COVID fight.

Source: News-Medical.Net

Journal information: Mwananyanda, L., et al. (2021) Covid-19 deaths in Africa: prospective systematic postmortem surveillance study. BMJ. doi.org/10.1136/bmj.n334.

Volunteers to Take Part in COVID Human Challenge Trial

The first trial of its kind is set to start in the UK, with healthy volunteers being sought to be deliberately infected with COVID in a human challenge test.

The study will seek 90 healthy volunteers aged 18-30 to be infected with COVID in a safe, controlled environment. Among the study’s objectives is a desire to find out exactly how much of a viral load is needed to infect someone with COVID.

The window of opportunity in the UK for a large-scale study of this type is gradually closing because eventually it will no longer be possible to find people have not been vaccinated. However, a significant amount of information can be gleaned from even small-scale studies. This includes how second-generation vaccines compare to how well vaccines protect against new variants.

Human challenge tests have been an important part of developing understanding of and treatments for a number of diseases. The first human challenge trials for dengue fever took place in the 1900s. Although abandoned in favour of animal testing, animals were not sufficiently close to humans to advance research. Recent human challenge trials helped to develop an effective vaccine for the disease.

Clive Dix, interim chair of the Vaccines Taskforce, explained: “We have secured a number of safe and effective vaccines for the UK, but it is essential that we continue to develop new vaccines and treatments for Covid-19.

“We expect these studies to offer unique insights into how the virus works and help us understand which promising vaccines offer the best chance of preventing the infection.”

Applicants will be screened, including determining if they had COVID before, and then be intranasally infected with the virus. Volunteers will receive compensation of £4500 (about R90 000) over the course of a year, which will include follow-up tests.

Source: BBC News