Category: COVID

Stellenbosch Doctors Urge Patience on Ivermectin

The South African public should be patient and wait for data on Ivermectin’s effectiveness against COVID, according to Stellenbosch doctors, who urge patience. The doctors wrote an article published in the South African Medical Journal explaining that further studies need to be completed before ivermectin can be authorised for use.

A veterinarian parasiticide that may have relevant antiviral and anti-inflammatory properties, ivermectin has gathered considerable attention for possible use in COVID prophylaxis and treatment since a number of small trials appeared to show effectiveness. However, close examination shows that they are very weak. Doubts have been raised over whether the necessary concentrations used in vitro can be achieved in vivo.

In their article, the doctors noted that several large randomised controlled trials are underway, and the results of these will allow the possible effectiveness of ivermectin to be gauged. “Data for Ivermectin from larger RCTs are expected in early 2021,” the doctors wrote. “These data are very promising, showing large treatment effects and acceptable adverse effect profiles for ivermectin against Covid-19, especially when combined in meta-analyses.”

They pointed out that the hoped-for effectiveness of other medications had not been borne out. “As a recent example, the widely proclaimed benefits of hydroxychloroquine and chloroquine from observational studies proved to be unfounded in larger RCTs,” they wrote.

Ivermectin use has been banned by the government, to considerable resistance. A number of organisations have already demanded that ivermectin be administered as a COVID treatment, including Black First Land First, the New Economic Rights Alliance and AfriForum. Afriforum is contemplating legal action to have ivermectin authorised. These calls have come despite the South African Health Products Regulatory Authority (SAHPRA) repeatedly counselled against the use of ivermectin.

The doctors cautioned that although the data trends indicated a possible efficacy for ivermectin, the optimal dosage if effective still needed to be determined: “Higher than standard Ivermectin doses appear to be safe in humans, but at the time of writing there is still much uncertainty regarding the human dose required to achieve antiviral activity and a favourable benefit-to-risk balance.”

Source: IOL

Johnson & Johnson is Behind on Vaccine Production

Despite releasing promising data on its COVID vaccine, Johnson & Johnson may fall up to two months behind on its vaccine production schedule, Politico reported. The company is still committed to releasing the trial data on its 45 000 participants by the end of January to pave the way for approval.

If approved, as seems likely, the vaccine would be extremely beneficial for vaccination efforts as it would only require a single dose to confer protection and also would not require sub zero refrigeration, greatly simplifying vaccination efforts.

The company’s effort is part of the Operation Warp Speed initiative to vaccinate the US population as fast as possible, with a goal of vaccinating 80% of the country’s 330.7 million population by the end of June. The previous goal to distribute 20 million doses by the end of 2020 had already fallen short owing to insufficient production.

The co-director of Operation Warp Speed, Moncef Slaoui, hinted at a production slowdown, telling the media that the company was expecting to produce “single-digit million” doses by the second half of February. “We’re trying to make that number get as close to a double-digit number as possible, and then a larger number in March and a much larger number in April,” he added.

Johnson & Johnson had previously made a pledge to deliver 12 million doses by the end of February and as many as 100 million by June.

Despite the delay, there is good news in that initial data from 400 participants shows that the vaccine is safe and has a 90% efficacy in establishing antibodies, with immunity for most subjects established 29 days after the shot and lasting at least 57 days. Adverse reactions were reported to be be mild, and younger subjects were more likely to report them, with one subject experiencing a brief, mild fever.

Source: Politico

Telemedicine Promising for Visits After Low-Risk Surgery

A pair of reports suggests that modern communication methods may be appropriate for post-surgery recovery, albeit at the risk of exacerbating the downsides of any language barriers and digital literacy.

In the midst of the COVID pandemic, telemedicine uptake and use has been greatly expanded by health care providers. In one small trial, cut short by COVID, researchers investigated whether telemedicine was an adequate form of patient follow-up after low-risk surgery.

The video-based post-discharge visits were as effective in terms of getting patients to return to the hospital within 30 days for a hospital encounter. The video visits were half an hour shorter but provided patients with the same amount of time with their surgeons.

However, out of 1645 individuals screened, many participants were excluded due to language difficulties, and 50 were excluded due to a “technology barrier”.

Caroline Reinke, MD, MSHP, of Carolinas Medical Center in Charlotte, North Carolina, and her team wrote, “Patients and clinicians should be reassured that the critical visit portion, time together discussing medical needs, is preserved. This information will help surgeons and patients feel more confident in using video-based virtual visits.”

Reinke and her team noted that COVID cut the study short: “Although we did not reach target enrollment, noninferiority was demonstrated for postdischarge virtual visits in our study sample and was further supported via a simulation model.”

In another study, Marie-Laure Cittanova, MD, PhD, of Clinique Saint Jean de Dieu in Paris, and her team compared using SMS to contact patients as opposed to calling them. When contacted after being told to expect a contact throughout the following day, 46.2% of patients were reachable by phone, compared to 85.3% by SMS.

Patients expressed similar levels of satisfaction with the SMS service, which was significantly cheaper than using phone calls. However, the single-centre study lacked generalisability.

Source: MedPage Today

Journal information (primary source): Harkey K, et al “Postdischarge virtual visits for low-risk surgeries: a randomized noninferiority clinical trial” JAMA Surg 2021; DOI: 10.1001/jamasurg.2020.6265.

Journal information (secondary source): Cittanova M, et al “Association of automated text messaging with patient response rate after same-day surgery” JAMA Surg 2021; DOI: 10.1001/jamanetworkopen.2020.33312.

WHO Team Arrives in China for COVID Origin Investigations

Following months of negotiations, and then a list minute hiccough when two team members were denied entry last week, a team of 10 specialists from the WHO arrives in China to carry out their investigations into the origins of COVID.

China, through rapid action and total lockdowns, managed to clamp down on the coronavirus outbreak inside its borders, preventing it from spreading significantly outside of Wuhan, while in Wuhan itself, life has largely returned to normal. In recent weeks, however, new cases have been appearing in Hebei province around Beijing and in Heilongjiang province in the northeast.

Just before travelling, team leader Peter Ben Embarek told AFP news agency that it “could be a very long journey before we get a full understanding of what happened”.

He cautioned against expecting instant results, saying, “I don’t think we will have clear answers after this initial mission, but we will be on the way,” he said.

For a number of months, China has been saying that the virus may not have originated in Wuhan. There has been a lot of unsubstantiated speculation that the SARS-CoV-2 might have been accidentally released from a lab.

Prof Dale Fisher, chair of the global outbreak and response unit at the WHO, told the BBC that he hoped the rest of the world would regard this as a scientific visit. “It’s not about politics or blame but getting to the bottom of a scientific question,” he said.

When the WHO team arrives in China, they will still have to wait through a two week quarantine. Fabian Leendertz, a professor in the epidemiology of highly pathogenic microorganisms at Germany’s public health institute and working remotely with the team, says that their plan of action will be developed over the next two weeks while they are still in quarantine. The team is expected to look at the infamous wet market in Wuhan where it was originally believed the virus made the jump from animals to humans, as well as working with Chinese colleagues and local clinics to establish a picture of the virus’ origins.

Source: BBC News

SinoVac’s Vaccine 50.4% Effective in Brazilian Trial

The vaccine from Chinese pharmaceutical company Sinovac is only 50.4% effective, according to updated data from a Brazilian trial.

Sinovac’s vaccine uses inactivated virus particles to trigger an immune response. Both the Sinovac vaccine and the Oxford vaccine have requests for emergency use in Brazil which are expected to soon to be granted.

This new number is lower than what was suggested last week by Butantan Institute, which distributes 65% of the vaccines in the country, and is running the trials. They had reported that the vaccine was 78% effective in “mild-to-severe” COVID cases, but reported on Tuesday that this number had not included cases with very mild COVID symptoms.
Interim results from late stage trials in Turkey and Indonesia reported that SinoVac was 91.25% effective and 65.3% effective, respectively. 

All of these discrepancies show just how hard to it is to compare the effectiveness of vaccines as measured by different trials in different countries. Other countries only count cases of COVID which generate obvious symptoms; including cases which are almost asymptomatic will lower the reported effectiveness.

However, there has been concern that the Chinese vaccine trials have not been subject to the same level of scrutiny and transparency as those in the West. Conversely, claims that the Russian Sputnik vaccine has a 95% effectiveness have been met with some suspicion, especially given its haphazard roll-out, which combined a trial (now cut short) with a release for emergency use. 

Source:BBC News

Link Found Between Telomeres and COVID Lung Damage

Researchers developing a therapy to regenerate lung tissue damaged by severe COVID have postulated that shortened telomeres are associated with the damage.

Telomeres are structures at the ends of chromosomes that maintain their integrity, and a small portion of them are lost with each cell division, such as when regenerating damaged tissue. As the telomere sections shorten, they eventually become unable to divide and are senescent. The team was already working on a way to regenerate lung tissue in pulmonary fibrosis, and adapted their research to the COVID pandemic. In pulmonary fibrosis, lung tissue becomes scarred and rigid, resulting in reduced lung capacity. In previous research, they had shown that telomere damage to the alveolar type II pneumocytes – which happen to be the same cells targeted by SARS-CoV-2.

Maria A Blasco, a researcher at CNIO said, “When I read that type II alveolar pneumocytes were involved in COVID-19, I immediately thought that telomeres might be involved.” The researchers believe short telomeres hinder tissue regeneration after severe COVID.

Blasco explained, “we know that the virus infects alveolar type II pneumocytes and that these cells are involved in lung regeneration; we also know that if they have telomeric damage they cannot regenerate, which induces fibrosis. This is what is seen in patients with lung lesions after COVID-19: we think they develop pulmonary fibrosis because they have shorter telomeres, which limits the regenerative capacity of their lungs.”

To support this, the team analysed the telomeres of 89 COVID patients. Although it might be expected that older patients had shorter telomeres, the researchers found that all of those with severe COVID had shorter telomeres – regardless of age.

The researchers wrote: “These findings demonstrate that molecular hallmarks of aging, such as the presence of short telomeres, can influence the severity of COVID-19 pathologies.”The involvement of shorter telomeres opens up the possibility of using telomerase to lengthen them again, as a potential treatment.The team will now move to an experimental mouse model, infecting mice with short telomeres and no telomerase with COVID, giving telomerase to some to see if the lung tissue can regenerate after severe COVID.

Source:News-Medical.Net

Journal information: Sanchez-Vazquez R, Guío-Carrión A, Zapatero-Gaviria A, Martínez P, Blasco M. Shorter telomere lengths in patients with severe COVID-19 disease. Aging (Albany NY). 2021. doi:10.18632/aging.202463

Gauteng Doctors’ Struggle in COVID “Fever Tents”

Angry doctors have opened up concerning recent images of severely ill patients at Steve Biko Academic Hospital (SBAH) being treated in tents amid pouring rain. These images came as David Makhura and MEC for Health Dr Nomathemba Mokgethi visited the hospital on Monday.

Speaking on condition of anonymity, two doctors at SBAH spoke to Daily Maverick about the reality of the situation. The doctors described a desperate situation of overwhelmed facilities, with patients possibly dying as much from the cold and rain as from untreated COVID – or indeed, a condition that presents similarly to COVID.

The image presented to the public by the government is “smoke and mirrors”, said Dr Felicia (not her real name). “This is a show. They [health officials] are lying to you people. They are lying. They are covering it up,” she said.”Fever tents” have been set up outside the Emergency Department, where patients remain while they are being screened for COVID. If they test negative, they are admitted to SBAH If they test positive, they are sent to Tshwane District Hospital.”

According to Dr Felicia, conditions in the tents are abysmal. “There is no nursing, there is no oxygen or beds in these tents. There is no oxygen in the tanks, we actually just do 10 minutes of CPR and many times we don’t have PPE to do it in.”

As infections continue to rise in South Africa, approaching 250 000 active cases, hospitals are buckling under the pressure, and doctors are expecting the worst to come.

Dr Monica (not her real name) spoke of her feelings of the situation. “I don’t feel like I am being protected by our hospital right now. I am running around like a chicken without a head. I feel very hopeless. I feel like I should not care anymore. Caring is actually just hurting me and the patients because instead of me doing what I said I was going to do when I left medicine, I am treating these people like numbers. Someone dies and you have to shrug your shoulders and move on to the next. There is not even a minute to mourn a person or to figure out what went wrong. I feel completely hopeless,” she said.

Dr Monica said people need to stop politicising the pandemic, and get the hospitals the resources they need. She also implored the reporters to convey their message. “Tell the people out there, this is serious. They must wear masks, they must social distance,” she said, breaking off and running to attend to a patient.

Source: Daily Maverick

US Health Workers’ Vaccine Hesitancy Is Cause for Concern

Health care workers in various parts of the United States are showing extraordinarily high rates of COVID vaccine hesitancy: 20% to 40% of front line workers in Los Angeles, and 60% of nursing home workers said they would refuse to take the vaccine. This has generated great concern along with some instances of shaming, but failing to address these worries is potentially going to worsen the progression of the pandemic.

Fortunately, national surveys show that vaccine hesitancy is decreasing with some 60% of Americans now intending to receive a vaccine, but the high numbers among healthcare workers demands attention. Speaking to the Guardian, Dr Whitney Robinson, an epidemiologist at the University of North Carolina, said that if this is not addressed, “It could mean after all this work, after all this sacrifice, we could still be seeing outbreaks for years, not just 2021, maybe 2022, maybe 2023.”

In Atlanta, while hundreds of healthcare workers were on the list for vaccines, the doses were literally “sitting in the freezers” because no-one would take them.In one survey, up to 55% of New York firefighters said would not take the vaccines, so the Uniformed Firefighters Association president put together a 50 minute video with a virologist friend, addressing their concerns. Subsequent calls from firefighters showed the video had helped to change minds and increase vaccination numbers.

The concerns are varied. Some are concerned about possible side effects and long term consequences, or have read misinformation online. Others are worried about the effect it will have on pregnant and breastfeeding women. Still others believe that having the vaccine is unnecessary after having recovered it, as they have the antibodies in their system. A lot of the distrust may be from minority groups’ deep-rooted distrust of large-scale health programs such as vaccinations, according to Dr Nikhila Juvvadi, the chief clinical officer at Loretto hospital in Chicago. Many specifically mentioned the Tuskegee Study, where federal health officials studied African-American men with sexually transmitted diseases which were deliberately not treated.

“I’ve heard Tuskegee more times than I can count in the past month – and, you know, it’s a valid, valid concern,” said Juvvadi.
However, she said that individual conversations were effective in helping alleviate concerns about the vaccines.

Source: The Guardian

COVID Variants May Increase False Negative Results, FDA Warns

The UK variant of the SARS-CoV-2 virus, known as B.1.1.7 could affect the accuracy of certain molecular COVID tests, causing increased false negative results, the US Food and Drug Administration (FDA) has warned.

A false negative from the UK variant could happen if the variant’s mutation happened to be in a part of the virus’ genome that was assessed by that test. However, genetic tests that target multiple parts of the virus genome are less likely to be affected by the new variants, the FDA advises.

Although the possibility of false negative results are to be expected from almost all tests, the effect of the COVID variants could impact the ability to properly monitor the disease, as well as complicating diagnosis.  

The FDA issued an alert on Friday, saying that they monitor tests which have received an Emergency Use Authorisation (EUA). They highlight three tests as being affected, with potentially less sensitivity to the mutations:

  • Accula SARS-Cov-2 Test, from Mesa Biotech
  • TaqPath COVID-19 Combo Kit, from Thermo Fisher Scientific)
  • Linea COVID-19 Assay Kit, from Applied DNA Sciences

However, the warning for Accula test was a result of “an abundance of caution”, and the latter two assess multiple genetic targets, so they are not likely to be impacted. The FDA issued recommendations for the users of these devices.The FDA’s warning was prompted by computer simulations showing reduced efficacy in certain tests for the virus variant.

In their press release, the FDA did not specifically mention whether any tests may be affected by mutations in the South African virus variant.

Source: MedPage Today

Pfizer/BioNTech Vaccine Effective against SA and UK COVID Variants

Amidst concerns that the SARS-CoV-2 virus might escape the protection of vaccines, initial results from new research shows that the Pfizer/BioNTech vaccine remains effective against the South African and UK COVID variants.

The new variants, which are much more transmissible, had created concern that due to mutations in their structure, they might not achieve the full protection of the current vaccines, especially in the SA variant.

However, this is a preliminary study that has not yet been through a peer review process, and the worrying E484K mutation in the South African strain which has been shown to reduce antibody recognition has not been tested on – that is still to be done.

Using blood samples from 20 individuals who had received the Pfizer/BioNTech vaccine, antibodies in the samples successfully defended against the virus variants. The results were made available on the bioRxiv site. Pfizer chief scientific officer Dr Philip Dormitzer said that “it was a very reassuring finding that at least this mutation, which was one of the ones people are most concerned about, does not seem to be a problem” for the vaccine.

However, should future mutations of SARS-CoV-2 achieve viral escape from the vaccines, the necessary adjustments to counter this could be made to the vaccines within a matter of weeks. Dormitzer said that this work was only the start “ongoing monitoring of virus changes to see if any of them might impact on vaccine coverage.”

Source: Medical Xpress