An advisory body of the UN health agency is not recommending the use of the high-profile antiviral drug Remdesivir for hospitalized COVID-19 patients, saying on Thursday there is insufficient evidence that it improves survival outcomes or cuts down on the need for patients to be put onto ventilators.
A World Health Organization (WHO) Guideline Development Group (GDG) panel of international experts made the recommendation in the BMJ – the weekly peer-reviewed medical journal, published by the British Medical Association – as part of so-called “living guidelines” to manage the coronavirus and help doctors make better decisions in consultation with patients.
“Living guidelines are useful in fast moving research areas like COVID-19 because they allow researchers to update previously vetted and peer reviewed evidence summaries as new information becomes available”, said WHO, in a press release on the findings.
Remdesivir has received global attention in treating severe coronavirus cases and is increasingly being used for hospitalized patients. But its role in clinical practice has remained uncertain.
WHO’s recommendation is based on new evidence comparing the effects of several drugs on treating the virus and includes data from four international randomized trials involving more than 7,000 COVID-19 inpatients.
After reviewing the evidence, the WHO GDG expert panel, which includes four patients who have had the coronavirus, concluded that the intravenously administered Remdesivir “has no meaningful effect on mortality or on other important outcomes for patients, such as the need for mechanical ventilation or time to clinical improvement”.
Arguing its use
The panel acknowledged that the certainty of the evidence is low and did not prove that Remdesivir has no benefit; but rather, “there is no evidence based on currently available data that it does improve important patient outcomes”, according to the WHO release.
However, the GDG supported the continued enrolment of patients into Remdesivir evaluation trials to determine whether more substantial evidence can be obtained, especially with regards to specific groups of patients.
The WHO press release also cites a feature article linked in the panel’s BMJ report, which says that the full story of Remdesivir will not be understood until its manufacturer, Gilead, releases full clinical study reports.
In the meantime, reports the journalist who wrote the feature, Jeremy Hsu, alternative treatments such as widely available corticosteroid, dexamethasone, that has been proved to reduce mortality among some severely-ill COVID-19 sufferers, are “now impacting discussions about Remdesivir’s cost-effectiveness”, in the words of the WHO press release.
COVAX and World Bank to Accelerate Vaccine Access for Developing Countries
COVAX and the World Bank will accelerate COVID-19 vaccine supply for developing countries through a new financing mechanism that builds on Gavi’s newly designed AMC cost-sharing arrangement. This allows AMC countries to purchase doses beyond the fully donor-subsidized doses they are already receiving from COVAX.
COVAX will now be able to make advance purchases from vaccine manufacturers based on aggregated demand across countries, using financing from the World Bank and other multilateral development banks. Participating developing countries will have greater visibility of available vaccines, quantities available, and future delivery schedules, enabling them to secure doses earlier, and prepare and implement vaccination plans more effectively.
“This important and timely financing mechanism, made possible now by the World Bank and Gavi teaming up on the AMC cost-sharing arrangement, will allow COVAX to unlock additional doses for low- and middle-income countries,” said Dr. Seth Berkley, CEO, Gavi, the Vaccine Alliance. “As we move beyond initial targets and work to support countries’ efforts to protect increasingly large portions of their populations, World Bank financing will help us advance further towards our goal of bringing COVID-19 under control.”
The scalable mechanism brings together COVAX’s ability to negotiate advance purchase agreements with vaccine manufacturers with the World Bank’s ability to provide predictable financing to countries for vaccine purchase, deployment and broader health systems investments. The new mechanism will mitigate risks and uncertainties in country demand and financing ability.
“Accessing vaccines remains the single greatest challenge that developing countries face in protecting their people from the health, social, and economic impacts of the COVID-19 pandemic,” said World Bank Group President David Malpass. “This mechanism will enable new supplies and allow countries to speed up the purchase of vaccines. It will also provide transparency about vaccine availability, prices, and delivery schedules. This is crucial information as governments implement their vaccination plans.”
Countries with approved World Bank vaccine projects that confirm the purchase of additional doses through COVAX will agree with COVAX on the number of doses of a specific vaccine as well as related windows of delivery. On receiving a request from the country, the World Bank will provide COVAX a payment confirmation, allowing COVAX to make advance purchases of large amounts of vaccine doses with manufacturers at competitive prices.
Under the cost-sharing arrangement for AMC countries (92 low- and middle-income countries), COVAX plans to make available up to 430 million additional doses, or enough to fully vaccinate 250 million people, for delivery between late 2021 and mid-2022. There will be several supply offerings where countries will have the opportunity to select and commit to procuring specific vaccines that align with their preferences.
COVAX is co-led by the Coalition for Epidemic Preparedness Innovations (CEPI), Gavi, the Vaccine Alliance and the World Health Organization (WHO). The World Bank and COVAX will work in partnership with UNICEF and the PAHO Revolving Fund as key implementing partners to ensure safe vaccine delivery and supply of materials such as syringes, safety boxes and other items essential for vaccination campaigns.
Study Finds That India Might Have Half Of All Covid-19 Deaths Worldwide
On July 20th, an analysis that was published of India’s “excess mortality estimates from three different data sources from the pandemic’s start through June 2021 … yields an estimate of 4.9 million excess deaths.” As-of July 20th, the total number of deaths that had been officially reported worldwide from Covid-19 was 4,115,391, and only 414,513 (10%) of those were in India. If this new study is correct, then the possibility exists that around half of all deaths that have occurred, thus far, from Covid-19, could be in India, not merely the currently existing 10% that’s shown in the official figures.
This study doesn’t discuss why the actual number of deaths in India from Covid-19 might be around ten times higher than the official Indian figures, but one reason might be a false attribution of India’s greatly increased death-rate from the Covid-19 epidemic not to Covid-19 but to other causes, such as to Covid-19-related illnesses.
The new study is titled “Three New Estimates of India’s All-Cause Excess Mortality during the COVID-19 Pandemic”, and the detailed version of it can be downloaded here. The study was funded by U.S.-and-allied billionaires and their foundations and corporations, and by governments that those billionaires also might control. However, this doesn’t necessarily mean that its methodology is in any way unscientific or otherwise dubious. The study raises serious questions — it does not, in and of itself, answer any. It’s a serious scientific study.
On 1 August 2020, I headlined “India and Brazil Are Now the Global Worst Coronavirus Nations”, and reported that, “India and Brazil have now overtaken the United States as the world’s worst performers at controlling the cononavirus-19 plague. The chart of the numbers of daily new cases in India shows the daily count soaring more than in any other country except Brazil, whereas in the United States, the daily number of new cases has plateaued ever since it hit 72,278 on July 10th, three weeks ago.” At that time, there was great pressure upon India’s Government to stop the alarming acceleration in the daily numbers of people who were officially counted as being patients (active cases) from the disease, and of dying from it. One way that a government can deal with such pressures is by mis-classifying cases, and deaths, from a disease, as being due to other causes, instead.
Sharp rise in Africa COVID-19 deaths
COVID-19 deaths in Africa have risen sharply in recent weeks, amid the fastest surge in cases the continent has seen so far in the pandemic, the regional office for the World Health Organization (WHO) said on Thursday.
Fatalities are rising as hospital admissions increase rapidly as countries face shortages in oxygen and intensive care beds.
COVID-19 deaths rose by more than 40 per cent last week, reaching 6,273, or nearly 1,900 more than the previous week.
The number is just shy of the 6,294 peak, recorded in January.
Reaching ‘breaking point’
“Deaths have climbed steeply for the past five weeks. This is a clear warning sign that hospitals in the most impacted countries are reaching a breaking point,” said Dr Matshidiso Moeti, WHO Regional Director for Africa.
“Under-resourced health systems in countries are facing dire shortages of the health workers, supplies, equipment and infrastructure needed to provide care to severely ill COVID-19 patients.”
Africa’s case fatality rate, which is the proportion of deaths among confirmed cases, stands at 2.6 per cent compared to the global average of 2.2 per cent.
Most of the recent deaths, or 83 per cent, occurred in Namibia, South Africa, Tunisia, Uganda and Zambia.
Six million cases
COVID-19 cases on the continent have risen for eight consecutive weeks, topping six million on Tuesday, WHO reported.
An additional one million cases were recorded over the past month, marking the shortest time to reach this grim milestone. Comparatively, it took roughly three months for cases to jump from four million to five million.
Delta, variants drive surge
The surge is being driven by public fatigue with key health measures and an increased spread of virus variants.
The Delta variant, the most transmissible, has been detected in 21 countries, while the Alpha and Beta variants have been found in more than 30 countries each.
Globally, there are four COVID-19 virus variants of concern. On Wednesday, a WHO emergency committee meeting in Geneva warned of the “strong likelihood” of new and possibly more dangerous variants emerging and spreading.
Delivering effective treatment
WHO is working with African countries to improve COVID-19 treatment and critical care capacities.
The UN agency and partners are also delivering oxygen cylinders and other essential medical supplies, and have supported the manufacture and repair of oxygen production plants.
“The number one priority for African countries is boosting oxygen production to give critically ill patients a fighting chance,” Dr Moeti said. “Effective treatment is the last line of defence against COVID-19 and it must not crumble.”
The rising caseload comes amid inadequate vaccine supplies. So far, 52 million people in Africa have been inoculated, which is just 1.6 per cent of total COVID-19 vaccinations worldwide.
Meanwhile, roughly 1.5 per cent of the continent’s population, or 18 million people, are fully vaccinated, compared with over 50 per cent in some high-income countries.
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