Tag: 2/2/22

Categories : VaccinesTags :

Promising Zika Vaccine Protects Foetus in Animal Trial

On By ModernMedia
Mosquito
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US researchers have shown that a Zika virus vaccine candidate is effective at preventing the Zika virus passing from mother to foetus in preclinical animal studies, according to a new study published in npj Vaccines.

“The vaccine has been shown to be safe for non-pregnant humans, but of course we need to know if it is safe and effective for the people at greatest risk: pregnant women and their fetuses,” said first author In-Jeong Kim, PhD, a viral immunologist at Trudeau Institute. “Our proof-of-concept studies conducted at Trudeau and Texas Biomed show very promising results that the vaccine given before pregnancy will provide high levels of protection for mothers and babies.”

The 2015–2016 Zika outbreak in Brazil and other countries in the Americas caused a surge in miscarriages and a constellation of birth defects, called Congenital Zika Syndrome, including abnormally small heads and neuro-developmental disorders.

“It’s important to test vaccines before the next large outbreak, because there will be another,” said senior author Jean Patterson, PhD, a virologist at Texas Biomed. “Zika is part of a family of viruses known to go through cycles. These viruses tend to spread rapidly through naïve populations that have never been exposed to the virus before, then infections drop down for years because most people have been exposed. As more and more people are born, there is a new group of naïve individuals in which the virus can once again wreak havoc. We want to help break that cycle.”

The purified, inactivated Zika vaccine (ZPIV) candidate was been tested in non-pregnant animals, showing it effectively clears the virus from blood. In Phase 1 human trials, it has been shown to be safe and elicit a protective immune response.

However for ethical and safety reasons, it is not possible to test whether the vaccine protects women and their foetuses from both infection and severe malformations, so animal models are used as a substitute.

Researchers tested the vaccine in pregnant mice and marmosets, respectively. The mouse studies, led by Dr Kim and Marcia Blackman, PhD, a viral immunologist at Trudeau, showed the vaccine prevented around 80% of foetal malformations, and neutralising antibodies were detected in foetal blood samples eight days after infection.

“We were able to detect maternal antibodies in the fetus during pregnancy and the results suggest the antibodies play a critical role in protecting fetuses from Zika virus,” Dr Kim said.

Marmosets are more sensitive to Zika infection than other nonhuman primates; previous research showed foetuses were aborted within two weeks of maternal infection.

In this study, four marmosets were immunised with the ZPIV vaccine and then exposed to Zika virus after they became pregnant. Only 1 of 12 offspring tested positive for Zika virus, demonstrating more than 90% effectiveness.

“Because the animals became pregnant at different times, our study was able to show the vaccine confers protection for at least 18 months after vaccination, which is important for showing long-lasting immunity,” Dr Patterson said.

The researchers are already testing what happens when the vaccine is administered during pregnancy.

“These studies add evidence that the Zika vaccine WRAIR developed not only protects animals against Zika virus infection, but also the congenital defects that mimic what has been observed in people,” says Kayvon Modjarrad, MD, PhD, who leads the US Army Zika vaccine programme. “Together with the early phase clinical trials, we believe these data lend even more support that this vaccine platform is a viable approach for countering the persistent threat of Zika.”

Source: Texas Biomedical Research Institute

Categories : HospitalsTags :

Netcare Seeking a Buyer for Bougainville Hospital

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Credit: Netcare

Netcare is looking for a buyer for its 60-bed Netcare Bougainville Hospital in Pretoria West, which first opened its doors in 1997.

Commenting on the development, Johan Smal, regional director of Netcare’s North East region said that unless a suitable buyer was found, the hospital would close its doors on 30 April 2022.

In outlining the reasons for the closure of the facility, Smal said that Netcare’s hospital division continually conducted strategic reviews of its asset portfolio in which Netcare Bougainville Hospital was identified as an under-performing facility for a sustained period.

“The hospital’s under-performance has prevailed from before COVID and this was further exacerbated by the adverse effects of the pandemic, in the past 24 months. These and other circumstances have rendered it uneconomical to retain Netcare Bougainville Hospital in the current business environment.”

“We have been in consultation with staff, doctors and facility management to notify them that the hospital may have to close. In addition the Department of Health, unions and other key stakeholders have been kept firmly updated on developments,” he added.

Sydney Masalla, general manager of Netcare Bougainville Hospital has confirmed that there are at present only three resident specialists on site at the hospital who also work at other facilities.

“In addition we have only 37 active staff members with whom we are in discussion regarding viable alternative employment options.”

Smal concluded by thanking patients, doctors, staff as well as healthcare service providers for their support through the years stating that they were an integral part of the history of Netcare Bougainville Hospital and the greater South African landscape.

“I am confident that we will continue working together, as we have in the past, in other Netcare facilities – this is therefore not farewell,” he concluded.

Categories : COVID HospitalsTags :

Bleeding from Full-dose Anticoagulants in COVID ICU Patients

On By ModernMedia
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COVID patients in intensive care units (ICU) receiving full-dose anticoagulants are significantly more likely to experience heavy bleeding than patients prescribed a smaller yet equally effective dose, according to a recent study.

The research, which compared the safety and effectiveness of blood clot treatment strategies for more than 150 critically ill COVID patients at two hospitals, found that almost all patients who experienced significant bleeding were on mechanically ventilation and receiving full-dose anticoagulants.

The results, published last month in Hospital Pharmacy, may inform treatment guidelines for blood clots in hospitalised COVID patients, who are at an increased risk for both blood clots and severe bleeding. Previous reports have found that 17% of hospitalised COVID patients experience blood clots, said first author Maya Chilbert, PharmD, clinical assistant professor in the UB School of Pharmacy and Pharmaceutical Sciences.

“A wide variety of practice exists when it comes to approaching blood clots in hospitalized patients with COVID, and there is little data to suggest improved outcomes using one strategy versus another,” said Chilbert. “Caution should be used in mechanically ventilated patients with COVID when selecting a regimen to treat blood clots, and the decision to use full-dose blood thinners should be based on a compelling indication rather than lab markers alone.”

The study analysed the outcome of blood clot treatments and the rate of bleeding events for more than 150 patients with COVID-19 who received either of two blood thinner regimens: a full-dose based on patient levels of D-dimer, and the other a smaller but higher-than-standard dosage.

Patients’ average age was 58, and all experienced elevated levels of D-dimer, fibrinogen, and prothrombin time.

Significant bleeding events were experienced by almost 14% of patients receiving full-dose anticoagulants, compared to only 3% of patients who received a higher-than-standard dosage. All patients who experienced bleeding events were on mechanical ventilation. No difference was reported in the regimens’ effectiveness at treating blood clots.
Further investigation is needed to determine the optimal strategy for treating blood clots and bleeding in hospitalised COVID patients, said Asst Prof Chilbert.

Source: University at Buffalo

Categories : Healthcare Politics and RegulationsTags :

National Treasury Proposes e-Cigarette Tax

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The National Treasury is proposing to impose a tax on both the non-nicotine and nicotine solutions in e-cigarettes (EC), and is asking for public comment by 7 February 2022.

The National Treasury published a draft discussion paper in December 2021 on the proposed taxation of e-cigarettes (ECs). The National Treasury defines e-cigarettes as battery powered devices that do not burn or use tobacco leaves but vaporise e-liquid solutions for inhalation.

In its discussion paper, the Treasury notes the uncertainty of e-cigarettes’ health risks, so it seeks stakeholder engagement on its proposal for the taxation of ECs.

The National Treasury proposes to introduce a specific excise tax on both the non-nicotine and nicotine solutions used in ECs and intends to use its existing policy guidelines applicable to other excisable products to do so. For example, traditional tobacco products are subject to excise duties at a rate of 40% of the price of the most popular brand in each tobacco category. 

For EC users, that would mean paying R2.03 per mL of EC solution nicotine-containing nicotine and R0.87 per mL of nicotine-free EC solution, if the draft proposals are accepted and become legislation. It is also proposed that EC products with a higher nicotine content will attract a higher duty rate.
Certain stakeholders may question that the Treasury’s proposed EC tax extends to nicotine-free liquids, as it does not necessarily support the government’s stated policy intention of reducing the consumption of tobacco products. The use of ECs as a means of quitting tobacco products is well established, with a Cochrane review showing that nicotine-containing ECs resulted in increased odds of quitting than nicotine-free ECs. 
It could also generate a knock-on illicit trade in e-cigarettes, as has  already happened in the tobacco sector.

Manufacturers and importers who would be taxed on ECs will need stringent certifications by accredited laboratories, which use either South African National Accreditation or International Laboratory Accreditation Cooperation (ILAC) approved methodologies.  Where such certifications are not available, a penalty rate of duty is being proposed.

Comments on the draft discussion document are due by 7 February 2022.

Source: Webber Wentzel

Categories : COVIDTags :

Nitazoxanide Flops in South African COVID Trial

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Interim analysis of a South African clinical trial has revealed that nitazoxanide, an oral antiparasitic agent with antiviral properties, was ineffective in improving outcomes in ambulatory patients with mild-to-moderate COVID.

Funded by the South African Medical Research Council (SAMRC), the study was performed at four sites in South Africa. The primary goal of the trial was to evaluate the effectiveness of nitazoxanide (1g twice daily for 7 days) in reducing the progression from mild to severe COVID in ambulatory patients. Progression to severe disease was defined as hospitalisation or death. The trial underwent an interim analysis at 67% of the recruitment target (290 participants), and the data was reviewed by an independent data and safety monitoring board (DSMB). Following the interim analysis, the DSMB recommended halting recruitment of the trial on the grounds of futility.

No significant difference was seen in serious adverse events, which included all causes of hospitalisation and death, between the nitazoxanide and the placebo groups [12/144 (8.3%) vs 10/146 (6.8%)]. Hospitalisation and death specifically due to COVID showed the same pattern [7/144 (4.9%) vs 8/146 (5.5%)].

Principal investigator Prof Keertan Dheda from the University of Cape Town (UCT) and the London School of Hygiene and Tropical Medicine, said that the results of the trial, although disappointing, contributes to the growing body of evidence, clarifying what works and what doesn’t for the treatment of COVID. Thus, clarifying what does not work is as important as finding effective therapies so that clinically useful management algorithms can be developed.

Nitazoxanide is a low-cost broad-spectrum antiviral drug with an extensive safety record. Originally developed as antiparasitic, it seemed promising against SARS-CoV-2 in the lab but the real world test did not show any benefit. It is still possible that nitazoxanide may be of benefit at higher doses (greater than the dose used in the trial, which was already twice the normal dose), however this will most likely cause an increase in intolerable gastrointestinal side effects. “The next step will be to focus on formally publishing the data in a peer reviewed journal and to evaluate secondary objectives of the study, including assessing the efficacy of nitazoxanide in reducing the duration of illness, reducing SARS-CoV-2 viral load, and its efficacy, if any, in preventing COVID in close contacts,” said Prof Dheda.

Prof Dheda concluded that nitazoxanide could have a less than 30% benefit which may be detectable in a larger study. However, it is questionable whether such an effect size is clinically relevant given the number needed to treat to prevent disease progression, adverse events, cost and that other therapies have emerged (eg paxlovid) with an efficacy benefit of greater than 80%.

SAMRC President and CEO, Prof Glenda Gray said although the study did not meet its primary endpoint, the results are an important addition into the scientific repository. “COVID and HIV in their very nature are unique and complex viruses which have posed unprecedented challenges for vaccine development, globally – however, the knowledge gained from this trial will help us advance our pursuit of effective therapies and vaccines for both COVID and HIV alike,” said Prof Gray.

Prof Gray, who also has led numerous trials in search of effective HIV and COVID vaccines, said COVID poses substantial challenges for those living with HIV which evades the immune system. “Until an effective vaccine has been found, all people living with HIV should take all recommended preventive measures to minimise their exposure to COVID,” concluded Prof Gray.

Source: South African Medical Research Council