Category: COVID

Categories : COVID VaccinesTags :

US Rollout of Johnson & Johnson Vaccine As It Gets FDA Approval

On By ModernMedia

Johnson & Johnson’s single shot COVID vaccine is set to roll out in the US after its approval, but concerns linger as to the public’s perception of its relative effectiveness.

The vaccine received an emergency use authorisation (EUA) on Saturday from the FDA, and received approval from the CDC the following day. On Sunday night White House officials stated that distribution of 3.9 million doses of the J&J vaccine would begin immediately, with J&J expecting to deliver some 16 million more doses by the end of March. These vaccines will be allocated proportionally, as per the procedure for Pfizer/BioNTech and Moderna vaccines.

At a Saturday media briefing, acting FDA Commissioner Janet Woodcock, MD, reiterated issues raised by the FDA advisory committee, that the J&J product’s lower efficacy number (70% vs 95%) may cause people to think it is less effective than the alternatives. She said that wasn’t necessarily so, urging Americans to “take the vaccine they are able to access.”

“All these vaccines meet our standards for effectiveness. They were not studied in head-to-head trials, so [they’re] difficult to compare … due to differences in development programs,” she said. (Preventing moderate-to-severe COVID illness was the J&J endpoint, whereas in the Pfizer and Moderna studies the endpoint was all symptomatic COVID.)

“We need to be clear on our messaging regarding comparisons with other vaccines,” said Jason Goldman, MD, of the American College of Physicians. “As a primary care physician, many of us are eager to vaccinate” patients and this vaccine will be “helpful in achieving that goal.”

Macaya Douoguih, MD, of J&J’s Janssen unit where the vaccine was developed, talked about the potential advantages of a one-dose vaccine, referencing the company experience with the Ebola vaccine

“For an outbreak setting, a single dose has a tremendous advantage in terms of being able to rapidly roll out mass vaccination” without the complexity of following up for a second dose, she said.

Dr Douoguih addressed the company’s planned two-dose study, saying that while a two-dose regimen might be “more immunogenic and lead to durable efficacy,” she thought there was room for both options. The two-dose option would be preferable in an ‘everyday’ COVID setting. The company was trying to enroll 16-17 year olds for additional data in a study starting next week, Dr Douoguih said.

The CDC researchers discussed preliminary data on asymptomatic infection, which assessed seroconversion between days 29 and 71. Those data showed vaccine efficacy against seroconversion was 74% (95% CI 48%-87%), but the CDC urged caution as the data was only preliminary.

“Our level of confidence in asymptomatic infection is tempered by low numbers and that is important for us to remember,” said Advisory Committee on Immunization Practices committee member Sarah Long, MD, of Drexel University College of Medicine in Philadelphia. “I appreciate the workgroup concluding the confidence is not that high.”

Source: MedPage Today

Categories : COVID General InterestTags :

Gratitude for Engineer’s ‘Hack’ Website for Vaccination Appointments

On By ModernMedia

Frustrated with the difficulties faced in scheduling a vaccination appointment, a New York software engineer developed a website to make it easier for his fellow New Yorkers to schedule an appointment.

Huge Ma was trying to get a COVID vaccination appointment for his mother. “You had to basically open three tabs, one for each major government vaccine portal, and then refresh all day until you got an appointment,” the 31-year-old told The Guardian. This experience inspired him to create a website, Turbovax, that helped people to book their appointments more easily. After taking a “look under the hood” in January and doing two weeks of coding, he unveiled his website – essentially a bot that trawls relevant New York sites for appointments and shares them on Twitter and on a website.

Almost immediately, the website took off, with one million page views a day, with tens of thousand of people having booked appointments using the bot, Mr Ma estimated. People have even asked him to bring TurboVax to their cities.

“The response has been incredibly overwhelming,” he said. “There’s been so much gratitude. Hundreds, thousands of emails from people who have gotten appointments through TurboVax, which is honestly kind of just mind-blowing, and humbling as well.” 

He was unprepared for the reaction. “I would never have thought that I could have built something that has such tangible impact on other people’s lives.” 

However, running the site is difficult as Mr Ma has to balance this with his day job working at Airbnb, and the Google Docs-based site is buckling under the demand.

“Technically it’s kind of a hack. It’s not built in the way that modern websites are supposed to be built,” said Ma. “These are the shortcuts that we take to put something in the world that we think is useful and I think that’s a trade-off that I would still make.”

Though it is free, Mr Ma accepts donations and has gathered $35 000 so far. TurboVax is one of a number of citizen-led services that have popped up to help Americans deal with the difficulties of vaccine appointment bookings, such as NYC Vaccine List in New York and VaccinateCA in California.

Mr Ma shut down the website over the weekend in protest against a spate of hate crimes targetting Asian Americans, tweeting, “Anti-Asian hate crimes are out of control. I am taking a stand because I fear for my friends and family.” However, local law enforcements said there is no sign that a number of recent assaults against Asian Americans were racially motivated.

Since far more white people have received vaccinations than black or Latino people, Mr Ma said the technology can “help level the playing field”.

“Not everyone has the ability to sit in front of a computer and refresh all day,” he explained. “That said, I know that no system is perfect. This tech can help but it can’t solve other inequities in the system.”

Source: The Guardian

Categories : COVID Medical IndustryTags :

SA Medical Aid Schemes May Not Have to Pay for Public’s Vaccines

On By ModernMedia

Medical aid scheme executives have pointed out that the latest budget means that medical aid schemes may no longer need to contribute for the vaccination of the South African population without medical insurance. 

South Africa’s medical insurance schemes had been in discussions on funding at least part of the government’s vaccine rollout for uninsured members of the public.

The R9 billion allocated in the budget may be enough to cover the vaccine costs of the entire country, said executives from the two leading medical aid schemes.

About 7 million people are covered by medical aid schemes, about a quarter of the country’s population. Discovery Health, Medscheme and Momentum together administer some 80% of private sector medical aid plans.

“I think the government is looking at this and saying this is our role,” said Damian McHugh, executive head of sales and marketing at Momentum Health Solutions. He agreed with the idea that the budget figure implied that schemes may not have to help cover vaccinations for non-members, although it did not remove the discussion of subsidies.

McHugh went on to explain that the costs would depend on which vaccines were procured, and schemes would still have to contribute in case booster shots or new vaccination rounds became necessary.

However, given record additions to their reserves last year due to medical services not being taken or postponed, along with not having to contribute to the vaccination of non-members, medical aid schemes stand to reap even greater benefits.

Source: Reuters

Categories : COVID Lab Tests and ImagingTags :

Siemens COVID Antigen Test Kit Receives German Approval

On By ModernMedia

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

Categories : COVID Medical IndustryTags :

Global COVID Recovery Needs to Address Oxygen Shortages

On By ModernMedia

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

Categories : COVID General InterestTags :

Pope Appoints New Personal Doctor After Predecessor Died of COVID

On By ModernMedia

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

Categories : COVID VaccinesTags :

Why It’s So Hard to Compare Vaccines

On By ModernMedia

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

Categories : COVID General InterestTags :

Recent Mother With COVID to Have Life Support Withdrawn

On By ModernMedia

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

Categories : COVIDTags :

Ghana Receives First Vaccines from Covax

On By ModernMedia

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

Categories : COVID ImmunologyTags :

COVID Tracking in Space Company Employees Yields Antibody Clues

On By ModernMedia

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.