COVID patient in hospital
COVID patient in hospital

Two new treatments for COVID-19 were recommended on Thursday by the World Health Organization’s Guideline Development Group of international experts – one for severely ill patients and the other for those patients who are not severely ill but most likely to develop severe disease.

The recommendations were announced Friday morning in the BMJ. Both drugs, however, are patented and could be expensive and lack accessibility for some low- and middle-income countries, some advocates warned.

The first drug, baricitinib – a type of drug known as a Janus kinase (JAK) inhibitor – was “strongly recommended” for patients in severe or even critical condition from COVID-19. The drug has been used to treat rheumatoid arthritis and it is recommended that four milligrams be given once daily for 14 days in addition to previously-recommended corticosteroids.

“The strong recommendation is based on evidence that it reduces mortality, shortens hospital stays and reduces the risk of requiring mechanical ventilation, with no observed increase in adverse effects,” explained François Lamontagne, Professor of Medicine at the Université de Sherbrooke, who sits on the panel, in an interview with Health Policy Watch.

He explained that JAK inhibitors modulate the body’s response to an infection.

The WHO experts noted that two other JAK inhibitors – ruxolitinib and tofacitinib – should not be used to treat patients with severe disease because “low certainty evidence from small trials failed to show benefit and suggests a possible increase in serious side effects with tofacitinib.”

COVID-19 treatments and vaccines
COVID-19 treatments and vaccines

‘Uncertain’ effectiveness against Omicron

The second treatment that the panel recommended is a monoclonal antibody called sotrovimab, which is meant for patients with non-severe COVID-19 but who are at risk for developing severe disease.

Sotrovimab, Lamontagne said, consists of antibodies directed against a specific part of the virus that prevents entry of the virus into cells. This drug is given intravenously, requiring one infusion.

Lamontagne noted, however, that the panel only provided a “weak” recommendation of the treatment because the effectiveness of sotrovimab against Omicron is still uncertain.

The recommendations are based on evidence from four trials (three for baricitinib and one for sotrovimab) involving several thousand people, Lamontagne said. WHO noted that “the panel considered a combination of evidence assessing relative benefits and harms, values and preferences and feasibility issues.”

Baricitinib and sotrovimab join a concise list of drugs recommended by WHO experts, including the use of interleukin-6 receptor blockers and systemic corticosteroids for patients with severe or critical COVID-19, and conditional recommendations for the use of casirivimab-imdevimab in selected patients. WHO has recommended against the use of convalescent plasma, ivermectin and hydroxychloroquine.

No formal recommendation yet from WHO on new oral drugs – Paxlovid and monulpiravir

Significantly, WHO has not yet made a formal recommendation on the two new oral drug treatments that have now come on the market – Pfizer’s Paxlovid or Merck’s Molnupiravir. This is despite the fact that both drugs have been approved by the US Food and Drug Administration, and the Medicines Patent Pool has also contracted with Pfizer and Merck to produce generic versions of each drug for low-income countries.  Countries around the world are rushing to secure doses of Paxlovid, in particular, due to its high efficacy and safety profile in the FDA reviews – where it has been reported to be 90% effective in preventing severe disease when administered early in the course of infection.

Asked why the Organization had not yet made a recommendation on either drug, a WHO spokesperson pointed to a WHO Guidelines Development Group meeting that is scheduled to review Paxlovid [nirmatrelvir] on 9 February.

“Based on an assessment of the totality of the evidence, WHO will make a recommendation,” the spokesperson said, saying that safety monitoring, affordability and access all need to be considered in any WHO recommendation on either drug.

The WHO spokesperson, also stressed that “even if proven safe and effective, these drugs will not be an alternatives to vaccines.”

The spokeperson also stressed that any new oral drugs also “should be made available and affordable in all countries”.

Access advocates have complained that the current generic production arrangements for Paxlovid, aimed at 95 low-income countries, still leaves many gaps in affordability and access among lower-middle and middle-income countries which cannot afford the high prices of patented versions.

‘Baricitinib example of why TRIPS Waiver urgently needed’

Similarly, the cost and availability of both of the newly WHO-recommeded drugs could still also be barriers to their use in low- and middle-income countries, Lamontagne said.

“These additional therapies are newer, not produced on the same scale [and some other drugs], not as available and are more costly,” Lamontagne said. “The panel that makes those favorable recommendations is aware of this and is aware there is a risk that these interventions won’t be available similarly everywhere and that this could worsen the differences in access to healthcare.

“But at same time, in making those recommendations and stating that those are potentially life-saving and important therapies, the panel hopes to stress how important it is to strive to improve the accessibility of these emerging therapies across the board – in lower income areas just like in higher income areas,” he continued.

Médecins Sans Frontières/Doctors Without Borders (MSF) reacted to the recommendations by calling on governments to “take immediate steps to ensure that patent monopolies do not stand in the way of access to this treatment.”

The organization said that in many countries, generic baricitinib will not be available as the drug is under patent monopoly, including in some countries hit hard by the pandemic, such as Brazil, Russia, South Africa and Indonesia. In most cases, the patents do not expire until 2029.

“Baricitinib is another example of why the TRIPS Waiver is urgently needed,” MSF said in a statement.

“As new treatments emerge, it will be simply inhumane if they remain unavailable in resource-limited settings, just because they are patented and too expensive,” stressed Dr.  Márcio da Fonseca, an infectious disease medical advisor who spoke on behalf of MSF. “With these proven therapeutics recommended by the WHO, it’s time now for low- and middle-income countries to finally access these therapies that are already in routine use in many high-income countries.”

Image Credits: Wikimedia Commons, Bicanski on Pixnio.

Dr Abdou Salam Gueye, Director of Emergency Preparedness and Response, WHO Regional Office for Africa

COVID-19 vaccination in Africa may be shifting from a supply challenge – to one of effective vaccine distribution, declared  a senior World Health Organization official in the African Region on Thursday. 

African countries will have adequate access to COVID-19 vaccine supplies in 2022, said Dr Abdou Salam Gueye, Director of Emergency Preparedness and Response, WHO Regional Office for Africa. 

However, significant challenges remain in ensuring that available doses are administered efficiently, and vaccine hesitation is overcome, Gueye stressed. 

“We can tell you that in 2022 in Africa, the countries that express the need to receive vaccines will receive it, and they will receive enough vaccines,” he said at a press briefing hosted by the Africa Regional Office, based in Brazzaville. 

https://twitter.com/i/broadcasts/1kvJpAlZmZZxE

 

“The problem will be though what we are doing regarding operationalizing those vaccines in the countries. From taking them from the capital cities to where they are needed including at the sub-regional level,” Gueye told Health Policy Watch.

In Geneva, however, WHO’s Director General, Dr Tedros Adhanom Ghebreyesus sounded a somewhat different note.  He warned a meeting of WHO’s emergency committee that so far some 1 billion Africans, 85% of the continent’s population, have yet to receive a single vaccine dose, and  “ending the inequitable distribution of vaccines, therapeutics and diagnostics remains the key to ending the pandemic.” 

Need for the right mix of strategies to promote vaccine uptake 

A vaccination site in South Africa, co-sponsored by USAID.  Vaccines are now more available to African countries – the challenge now is for efficient distribution and uptake.

According to Gueye, however, there are now many vaccines within the delivery pipeline for Africa – and countries are now being offered more from various suppliers every day. 

So finding the right strategy in order to provide vaccines to all the people who are demanding vaccines is now a higher priority for the continent considering several studies showed largely wide acceptance of the vaccines among Africans.

“In a World Bank-sponsored study, more than 80% of African participants demanded and accepted the vaccines when they were offered the vaccination. There is a positive side if the governments are working toward a good operationalization of  vaccination,” he added.

Treatment also is now a priority

Gueye stressed that treatment options now need to be reinforced, as well, in the African context. 

“COVID is the first pandemic in our lifetime of this level and it has so much impact but it is not the only pandemic that existed and testing, treating were pivotal resources used to fight those diseases (HIV). I do believe also that in the third year of COVID-19, testing, caring for patients and treating them will be an important pillar to develop in all countries,” he said.. 

“It will not be only for cases that are severe or critical, it will be for almost all the cases where something may be done. If the treatment is done appropriately and on time, it might limit the infection of other patients. This is why testing, caring and treating are the priorities for WHO and we are working with countries already in order to do the best to scale it up.

Race for Paxlovid

Africa CDC Director Dr John Nkengasong

At an earlier briefing Thursday by the Africa CDC, the Director John Nkengasong, told journalists that talks with Pfizer are underway to assure African countries access to the company’s new Paxlovid treatment.

“We are in really close discussions with Pfizer to see what can be done to make the drugs available on the continent and accessible on the continent, that is, the Paxlovid drugs,” said Nkengasong.

In clinical trials, the treatment has demonstrated a 90% success rate in prevention of severe disease if taken at early stages of infection. 

Already approved by the US FDA and the United Kingdom’s Medicines and Healthcare products Regulatory Agency, the global race for the pills is already underway.

The United States government alone has signed an agreement for 10 million courses of the drug at $530 per course.  

And according to other reports, a handful of rich countries have already secured most of Pfizer’s own supply of the new drug. 

This means that low-income countries will need to rely up generic versions that are to be produced royalty-free, under the terms of a recent licensing agreement between Pfizer and the Medicines Patent Pool – with the first such license with Bangladesh struck just this week. 

https://twitter.com/RebeccaDRobbins/status/1480633419528687617

However, Pfizer’s new agreement with MPP coveres only 95 of the lowest income countries. It thus leaves many lower-middle and middle-income countries out in the cold –  and potentially unable to secure either the discounted generics or the higher-priced Pfizer versions of the pill. 

Is the shift to a focus on treatment – also a reflection of the failure of vaccination campaigns? 

Dr Anita Graham, internist, University of Witwatersrand, South Africa

Meanwhile, Dr Anita Graham, an internist at the University of Witwatersrand in South Africa noted that the decision to commence conversations in Africa around treatment implies failure to protect Africans against severe infection, in addition to dealing with a predominantly unvaccinated population.

“So once we have failed and we are dealing with a population who now has severe disease, we need to think about pharmaceutical management and there definitely are agents like the new Pfizer drug that has a therapeutic advantage — decreases the chance of death or ICU admissions and these drugs have been shown with early evidence to work. H

Hwever, they come with contingencies, and this is mostly cost and availability,” Graham told Health Policy Watch.

“So I don’t think that is an isolated solution, although I do think it is part of the plan, and part of the way forward in treating severe COVID,” Graham said.

Omicron hospitalization in South Africa – unvaccinated cases seem to predominate

With Omicron now accounting for up to 95% of new cases in South Africa, Graham provided said that most of the patients that she has admitted and treated for COVID-19 were largely unvaccinated – or in some cases vaccinated over a year ago. 

“Anecdotally, I can say that I have not had a single patient that is fully vaccinated, hospitalized,” she said, adding, “The patients that were hospitalized are those who are unvaccinated, partially vaccinated, patients who have been vaccinated more than a year ago whose immunity might have waned, and patients who have severe comorbidities,” she said.

For patients with comorbidities, Graham noted that those with comorbidities that are fully vaccinated but are hospitalized are often hospitalized for non-COVID-related disease.

“For instance, they are admitted for cancer and they coincidentally swabbed positive for Omicron,” she said.

Graham also noted that while all answers are not yet available, what is increasingly becoming important is the duration of the first infection to ascertain whether a previously infected individual would have some protection against new infections.

“With time, there is natural waning of immunity and with time there will be no leftover residual antibodies to fight a new variant. However, with a seroprevalence of more than 70% in some parts of Cape Town in South Africa, this high seroprevalence may be contributing to why we are having a less severe fourth wave. But my belief is that it is multifactorial — natural seroprevalence together with vaccination and the Omicron variant possibly being less virulent,” she added.

COVID Infections rising in North & West Africa; waning in South; high test positivity rates reflect under-reporting 

While COVID cases in southern Africa have now plateaued or are declining, those in West Africa and North Africa are now rising at worrisome rates – and overall deaths rose by 64% in the first week of January, the Orgaization said. 

“South Africa, where Omicron was first reported, saw a 9% fall in weekly infections. East and Central Africa regions also experienced a drop. However, North and West Africa are witnessing a rise in cases, with North Africa reporting a 121% increase this past week compared with the previous one,” WHO’s Gueye stated.

Nkengasong also revealed that the case fatality rate (CFR) of COVID-19 in Africa is 2.3% which is higher than the global average of 1.8%. Africa also accounts for 4.3% of deaths reported globally – disproportionate to the number of overall cases reported. 

Regarding testing, Africa has conducted over 91 million COVID tests with a cumulative positivity rate of 11.1%.  That high positivity rate also suggests high levels of under-reporting of overall infections, experts say. 

60% of African-acquired doses have been distributed while expired dose donations from rich countries also remain an issue 

Some 241 million unused COVID-19 vaccine doses purchased by the G7 and EU will expire by March, 2022 – Airfinity.

As of now, Africa CDC reports that a total of 563 million COVID-19 vaccine doses have been procured by 54 Member States out of which 340 million doses have been administered (60.4% of Africa’s total supply). So far only 10.1% of the African population has been fully vaccinated.

On Thursday, the global health analytics firm Airfinity estimated that 241 million COVID-19 vaccine doses purchased by the G7 and EU will go unused and will expire by March 2022. Airfinity said its forecast is based on analysis of G7 and EU vaccine supply while accounting for doses administered, boosters for everyone over 12 years-old, vaccine hesitancy and donations.

Rasmus Bech Hansen, Airfinity’s co-founder and CEO said the numbers illustrate, once more, how vaccinating the world is now largely a distribution problem, rather than a supply issue. 

“Even after successful booster rollouts, there are surplus doses available that risk going to waste if not shared very soon. The emergence of Omicron and the likelihood of future variants shows there is no time to waste,” Hansen said in a press release.

In a separate interview, Seth Berkley, the CEO of Gavi, the Vaccine Alliance and a leader of the WHO co-sponsored COVAX global vaccine facility, also underlined the distribution challenges faced. He said that by July 2022, it is possible for the world to produce vaccine doses sufficient to immunize 70% of the global population, as per WHO’s global target for 2022.

He added that there are “between 20 and 25 coutries that have been problematic on absorption. And those are getting special attention.”  

“In terms of the number of doses that will exist in the world, it is possible in terms of what we have visibility on. But at the end of the day, we don’t know what’s going to happen with Omicron, boosters, new variants, manufacturing problems, etc.,” he told Politico.  “The critical issue is what does each country want? At the end, we will serve what the countries want…”

Image Credits: Paul Adepoju, USAID, Airfinity .

At a WHO press briefing, the organization’s Director General described the grim status of the health and humanitarian crisis in Ethiopia’s conflict-torn Tigray region.

The leadership of the World Health Organization (WHO) has slammed Ethiopia’s “complete blockade” on health and humanitarian aid to Ethiopia’s Tigray region, saying it has been unable to deliver life-saving medications for nearly six months – in a situation that is “unprecedented” even in comparison to conflict-wracked Syria or Yemen. 

“Humanitarian access even in conflict is the basics. Even in Syria, we had access, even during the worst of conflicts in Syria. In Yemen, we have the same access. We delivered medicines. Here [however], it’s a complete blockade especially since mid-July. Nothing. This is six months without medical support, without food without all the rest of the things I have said. It’s been impossible,” said WHO’s Director General Dr Tedros Adhanom Ghebreyesus who hails from the Tigrayan region himself.

The region  is at the heart of the ongoing civil war that began on 3 November 2020, displacing hundreds of thousands of people. Despite recent Ethiopian government signals that it might now consider peace talks with Tigrayan rebel forces, WHO’s attempts to deliver health and humanitarian relief to the war-torn region continue to be denied for nearly six months now, said Tedros and WHO’s Executive Director of Health Emergencies, Mike Ryan at a Wednesday press briefing.  

‘Insult to humanity’

Mike Ryan, WHO Executive Director of Health Emergencies

Ryan noted that the government of Ethiopia has refused the global health body access to the Tigray region to deliver basic insulin, other oral antidiabetic drugs, and drugs for other diseases since last summer. He said that the region is quickly running out of essential health care commodities, including IV fluids.

“Our access has not improved and quite frankly, it’s very upsetting. In fact the situation is getting worse” Ryan said. “They’re running out of IV fluids for managing diabetic ketoacidosis. The doctors and nurses can’t even manage the more severe complications of a disease like diabetes which has catastrophic, immediate health consequences for people. The politics of it are beyond me. 

“Whatever the cause of that situation, those who have no access to the very basic life-saving interventions that we in the West, that we’re sitting here in Geneva, would expect immediately, instantly,” Ryan added.

“This is an insult to humanity to allow a situation like this to continue. To allow no (zero) access. Access is the lifeblood, the starting point for humanitarian intervention and we simply do not have that access. Access for our staff access to the field, getting basic medical supplies in there.” 

He called on all parties involved in the situation in the region to  find a solution to allow humanitarian and healthcare workers, including doctors and nurses, to do their jobs which he said is to treat patients and save lives.

WHO DG: Tigray under “complete blockade” since mid-July – barring humanitarian relief 

A family from Samre, in south-western Tigray, walked for two days to reach a camp for displaced people in Mekelle.

Confirming the impasse, Tedros added that the situation in the region is getting more complicated and deteriorating – despite recent talk about peace overtures between the government and rebel troops. 

The region with a population of seven million people – about equal to that of Norway and Estonia combined – has been under a humanitarian blockade for more than a year – which has only worsened in past months with the denial of health emergency relief too, he said. 

“Imagine a complete blockade of seven million people for more than a year and there is no food, no medication, no medicine, no electricity and no telecommunication. No media, nobody can report and when there is no telephone, I think accessing families is difficult. No cash, no bank service. Imagine the impact of all of these. 

“Lack of medicine has a direct impact and people are dying, but lack of food also kills,” the Director General said. 

Apart from the Tigray region, other areas of Ethiopia also are being impacted by the crisis, including the Amhara Region and Afar regions. However, while WHO has been granted access to the other regions – it has not been allowed to bring supplies or support to Tigray.

“Since July, no medication was allowed from WHO, none whatsoever. We have approached the prime minister’s office, we have approached the Foreign Ministry. 

“We have approached all relevant sectors, but no permission. So there is a blatant measure which has been taken that is blockade and siege against more than 7 million people,” the DG added.

A few weeks ago, the Ethiopian government did finally allow UNICEF to provide measles vaccines to the Tigray region.

But the WHO DG noted that the measles vaccine alone cannot significantly improve the overall health and humanitarian crisis. He described that as “unprecedented” considering that the global health body was granted access during previous worse wars.

“Humanitarian access even in conflict is the basics. Even in Syria, we had access, even during the worst of conflicts in Syria. In Yemen, we have the same access. We delivered medicines. Here [however], it’s a complete blockade especially since mid-July. Nothing. This is six months without medical support, without food without all the rest of the things I have said. It’s been impossible,” he added.

Meanwhile, African Centers for Disease Control officials have also been unable to access the region for nearly a year now, Africa CDC Director, Dr John Nkengasong, said in a separate briefing on Thursday.

A woman brings her child to a clinic in Wajirat in Southern Tigray in Ethiopia to be checked for malnutrition in late summer – since then a blockade on all health supplies has devastated the region even more.

State of the War

In December the Geneva-based Human Rights Council agreed to set up an international probe on the Tigrayan conflict, after the Deputy High Commissioner for Human Rights Nada Al-Nashif said that an estimated 400,000 people in Tigray were living in famine-like conditions.

Official accounts traced the commencement of the war to minutes before the clock chimed at midnight on 3 November 2020. Tigray Special Forces and allied local militia attacked the Ethiopian National Defense Force (ENDF) Northern Command headquarters in Mekelle, the Fifth Battalion barracks in Dansha, and other Northern Command bases. Several people were killed and the Tigray People’s Liberation Front (TPLF) claimed the attack was carried out in self-defense or preemptive self-defense.

According to Human Rights Watch, all sides in the war have committed war crimes during the conflict with the war creating a deepening humanitarian crisis. More than 10,000 people have died since war began, and rape has reportedly been used as a weapon.

In December Ethiopian government officials sent out an olive branch, saying they would pause at their current positions.  And just last week, the Ethiopian government announced it was exploring political dialogue to end the war, starting with the release of some opposition leaders.

“The key to lasting peace is dialogue,” the Ethiopian government stated.

Image Credits: UNICEF/Christine Nesbitt, Paul Adepoju, UNOCHA/Saviano Abreu.

A child with disability plays oin Brazil.People with disabilities have been some of the biggest silent sufferers in the COVID-19 pandemic, according to speakers at the Pre-Summit of the Global Disability Summit 2022 on Wednesday.

“Now, more than ever, if we want to be ready for a new pandemic, we need to ensure that disability inclusion in the health sector becomes a reality,” said Yannis Vardakastanis, President of the International Disability Alliance. “Nothing about us, without us.”

This pre-summit was co-hosted by the governments of Norway and Ghana and the International Disability Alliance, in collaboration with the World Health Organization (WHO) ahead of the summit on 16-17 February, which is expected to see participants commit to the inclusion of disabilities in the health sector. 

“In many low and middle-income countries, persons with disabilities are among the most marginalized people in the world. They are also often the last to gain access to health care,” the Prime Minister of Norway Jonas Gahr Støre said.

He added that while poverty and disabilities are mutually reinforcing, the pandemic has only compounded the situation more for the marginalised communities. “We must take steps to safeguard the health and well being of persons with disabilities including mental health.” 

Over a billion people suffer from disabilities 

WHO Director-General Dr Tedros Adhanom Ghebreyesus highlighted at the pre-summit that the way individuals with disabilities suffered during the pandemic was “unacceptable”, particularly considering that over a billion people in the world have some form of disability.

“Recognizing what needs to be done is only the first step; the second step is committing to building a disability-inclusive health sector,” he said. He added that such inclusion makes it easier for people with disabilities to access the health services they need and work with other sectors to foster greater inclusion in society more broadly.

The conversation at this pre-summit was more around making the health sector more inclusive. This is in tandem with the adoption of a landmark World Health Assembly resolution on achieving the highest attainable standard on health for persons with disabilities in January 2021. The resolution called on countries and health sector partners to move away from an exclusively medical approach to disability towards adopting a comprehensive people-centred and human rights-based approach.

Females  With Disabilities Are More Affected 

According to Dr Natalia Kanem, Executive Director of the United Nations Population Fund, nearly one-fifth of women have disabilities, and these women are up to 10-times more likely to experience gender-based violence.

Kanem said that for women and girls with disabilities, the right to health is not just about being able to obtain health services without judgment or discrimination also about the right to make their own decisions about their own bodies and sexuality, free from coercion or violence. 

Healthcare Inclusion is a privilege for many 

People with disabilities and rehabilitation need more attention and have different needs but the country’s healthcare system and its recognition of these needs matters.

“Rehabilitation often does not have high priority within the health systems,” said Dr Tom Shakespeare, Professor of Disability Research at the London School of Hygiene and Tropical Medicine.

He believes this is because it is seen as “less attractive” by funders due to the nature of rehabilitation being enabling a better life rather than curing. 

He said that his condition of dwarfism was recognised in the UK and it enabled him to get free vaccination and booster shots for COVID-19, but those with intellectual disabilities may have lost out on this and perished.

“Globally, many people both with my condition, and many, many others don’t have access to needed health care or rehabilitation. And that violates article 25 of the Convention on the Rights of Persons with Disabilities,” said Shakespeare.

Israel has tried to make its hospitals more inclusive during the pandemic which is in accordance with legal obligations in the country to make medical services accessible at all levels, said Nitzan Horowitz, Israel’s Minister of Health.

He added that information was presented in sign language, transparent masks were worn at hospitals so that people with hearing difficulties were able to understand and communicate with their physicians. 

However, that is not the case in many countries which do not prioritise or include disabilities in all aspects. Individuals with disabilities need to be included at the table while policies are being designed.

“If a health system is not inclusive and accessible for people with disabilities prior to a crisis, it’s not likely to be enough when a crisis hits,” said Robert Mardini, Director-General, International Committee of the Red Cross.  

Image Credits: clipper round the world .

WHO’s Dr Bruce Aylward

Over 15 million new cases of COVID-19 were reported globally in the past week – by far the most cases ever reported – but deaths have remained constant since last October at about 48,000 a week, according to World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus.

“While the number of patients being hospitalised is increasing in most countries, it’s not at the level seen in previous waves. This is possibly due to the reduced severity of Omicron as well as widespread immunity from vaccination or previous infection,” said Tedros, addressing the WHO’s weekly COVID-19 briefing on Wednesday.

However, he stressed that while Omicron may cause less severe disease than Delta, it remains a dangerous virus particularly for those who are unvaccinated. 

Referring to the statement made on Tuesday by the WHO’s Europe director, Dr Hans Kluge,  that 50% of Europeans would be infected with Omicron in the coming weeks, WHO lead on COVID-19, Dr Maria van Kerkhove, said this was based on modelling.

“This variant is that it transmits incredibly efficiently between people,” said Van Kerkhove, but stressed that people could still protect themselves through vaccinations, masking and physical distancing.

Van Kerkhove added that the new cases were literally off the charts – the WHO had to readjust the scale of its latest graph to accommodate the explosion of cases.

WHO COVID-19 cases (11 January 2022)

WHO special advisor and COVAX representative Dr Bruce Aylward described the case increase as “absolutely staggering”. 

“We have not, in 30 years working on infectious diseases, seen an epidemic curve like this before, certainly not with a pandemic-prone virus,” he said.

“In the face of a staggering upsurge in a disease, we’re hearing two responses. One group is saying,’ Gosh, throw in the towel, let this thing immunise the world’. While the other group, led by Maria [van Kerkhove], is saying: wear a mask and get vaccinated. And the first response is the wrong choice.”

Kluge reported that there were over seven million new cases of COVID-19 in the first week of January, more than doubling over a two-week period.

“As of 10 January, 26 countries report that over 1% of their population is catching COVID-19 each week,” said Kluge.

“At this rate, the Institute for Health Metrics and Evaluation (IHME) forecasts that more than 50% of the population in the Region will be infected with Omicron in the next six to eight weeks.”

Main barriers to vaccine rollouts

Dr Kate O’Brien

Thirty-six countries have vaccinated less than 10% of their populations while 90 have not reached 40%, said Tedros.

Dr Kate O’Brien, WHO Director of Immunisation and Vaccines, said the “foundational issue” hampering these countries was the constrained and uncertain supply of vaccines.

However, O’Brien cited a number of other issues including lack of financing to roll out vaccines, weak health services, conflict and other humanitarian emergencies.

Aylward decried the “dangerous narrative” emerging in many high-income countries that some lower-income countries can’t use the vaccines or did not want them.

“If you look at the map of polio or measles [elimination] and you see that the same countries that have gotten very low coverage for COVID-19 have eliminated or eradicated polio or eliminated measles or achieve very high routine immunisation for some other diseases,” said Aylward.

“We’ve made it twice as hard or three times as hard for low-income countries to be able to achieve high coverage. We did not share vaccines for six, seven, eight months. What we did share was a lot of misinformation, a lot of bad practice, a lot of false problems.”

COVAX had recently been able to increase its vaccine deliveries to low and middle-income countries and has delivered 980 million doses.

Aylward also criticised vaccine donations with short expiry dates “which make them very, very difficult to use in complex environments”.

“These countries know how to run vaccination at scale. It’s a really tough environment they’re operating in right now. How do we fix that? Number one, we have to provide full support for the financing, for the delivery, the information support, the right products, right time frames.”

A Medical Diagnostic staff member works on the antigen tests.

CAPE TOWN – A locally produced COVID-19 rapid antigen test that was recently approved by South Africa’s medicines regulator is able to detect Omicron, according to its developer.
This follows some controversy about whether antigen tests were able to detect Omicron, and suggestions that throat swabs might be more effective than nasal swabs as Omicron affects the upper respiratory tract rather than the lungs.
But Dr Lyndon Mungur, COO of Medical Diagnostech, said that his company’s antigen test has been able to detect every COVID-19 variant, including Omicron.
“Most antigen tests detect the nucleoprotein and not the spike protein. There are only two mutations on the nucleoprotein for the Omicron variant, and both mutations are embedded in the centre of the protein, and not on the antigenic sites,” explained Mungur, a biotechnologist who helped with the research and development of the local antigen test.
“We have an ongoing clinical study program so that we can be abreast of new variants as they become evident. Our antigen tests were able to detect every one, and we also compare results to PCR tests on the same specimens,” said Mungur, adding that the Medical Diagnostech test used nasal swabs.

Cheaper than imported tests

“If current tests were able to detect at a lower sensitivity, this would only affect the very beginning and very end stages of infection. There is a very small window at the start and at the end in terms of low viral load.”
The Medical Diagnostech test is likely to be around 35% cheaper than imported tests, and it was approved by the South African Health Products Regulatory Authority (SAHPRA) in December.
Company CEO Ashley Uys said that his company “has a production capacity of 20 million units per annum”.
The company received funding from the South African Medical Research Council (SAMRC) to develop its test.
Medical Diagnostech had already developed a prototype antigen detection test, but required support to increase its sensitivity and complete the testing and approvals for market entry, according to SAMRC official Dr Michelle Mulder,
“The local ownership and manufacture of these test kits will not only increase South Africa’s self-sufficiency in a time of high demand, but also contribute to reducing the trade imbalance with respect to medical devices and local economic development and job creation,” added Mulder.
“This [antigen test] not only benefits the country but will also be made available to the rest of Africa,” said Dr Phil Mjwara, Director-General of the Department of Science and Innovation.

A few months earlier, the country’s regulator approved a locally produced PCR test.

Image Credits: MedicalDiagnostic.

WTO Director-General Ngozi Okonjo-Iweala addresses the meeting alongside General Council Chair Ambassador Dacio Castillo

The European Union (EU) has described India’s call for an urgent meeting of the World Trade Organization (WTO) Ministerial Conference to discuss the body’s response to the COVID-19 pandemic, including a proposed waiver of relevant intellectual property protections, as “premature”.

Addressing the WTO General Council informal meeting on Monday, EU Ambassador João Aguiar Machado said that while the pandemic response was important, it “must not lead to a loss of momentum on the other key components” – including “the fisheries subsidies negotiations, agreeing on a way forward on agriculture, and finalising the Ministerial Declaration with a strong commitment on WTO reform”.

General Council Chair Ambassador Dacio Castillo (Honduras) had convened the 10 January virtual meeting in response to India’s recent proposal – sent in a letter to the WTO last month. 

India and South Africa tabled a proposal well over a year ago to waive certain provisions of the TRIPS Agreement for COVID-19-related vaccines, therapeutics, and diagnostics.

At Monday’s meeting, WTO Director-General Ngozi Okonjo-Iweala urged member states to urgently step up their efforts, suggesting that “with the requisite political will, members can in the space of the coming weeks reach multilateral compromises on intellectual property and other issues so that the WTO fully contributes to the global response to COVID-19 and future pandemics”, according to a WTO statement.

“More than two years have passed since the onset of the pandemic. The emergence of the Omicron variant, which forced us to postpone our Twelfth Ministerial Conference, reminded us of the risks of allowing large sections of the world to remain unvaccinated,” said Okonjo-Iweala.

“We at the WTO now have to step up urgently to do our part to reach a multilateral outcome on intellectual property and other issues so as to fully contribute to the global efforts in the fight against COVID-19,” she added.

‘No better time than now’

The Director-General also updated members on her efforts, together with Deputy Director-General Anabel González, “to support an informal group of members to converge around a meaningful acceptable outcome that can be built upon by the wider membership to bring a successful conclusion to the intellectual property issue.” 

“It is slow but steady progress, and we are hopeful that this approach can help us together find the direction we need,” she said. “There is no better time to build convergence than now.” 

She noted that while pandemic response remained the most urgent endeavour facing WTO members, many members had reached out to her to emphasise the importance of other items on the WTO agenda, including fisheries subsidies, agriculture and WTO reform. She stressed that these areas remained priorities for outcomes, and expressed hope “that we can all agree on getting results as soon as possible.”

Describing the meeting as “useful,” General Council Chair Ambassador Castillo said he would continue to hold consultations with members on the Indian proposal, underlining “the urgency and importance of reaching a meaningful outcome.” A common WTO response to COVID-19 “remains an urgent priority for the membership,” he said.

However, the EU Ambassador Machado said that “before any decision to call a virtual Ministerial meeting and topics to be decided, we believe the WTO Director-General and the Chair of the General Council should hold consultations with Members, to assess the way forward on all four issues that I referred to”.

“Any virtual Ministerial should take place only once there is a consensus both on intellectual property rights and on the Declaration and Action Plan on the wider pandemic response,” he added.

“Only a comprehensive trade response to the pandemic can make a difference and address the identified bottlenecks as regards the production and distribution of COVID-19 vaccines such as restricted access to raw materials and other inputs as well as complex supply chains.”

 

“Including the experiences and skills of people living with disabilities in the design and delivery of health systems is fundamental to achieving #HealthForAll,” wrote World Health Organization (WHO) Director-General Dr Tedros Adhanom Ghebreyesus on Twitter last week.

His tweet was a reminder of the upcoming Thematic Pre-Summit on Disability Inclusion in the Health Sector, which takes place virtually on Wednesday (12 January). 

The pre-summit will formalize a new engagement among participants of the second Global Disability Summit, scheduled for 16-17 February, around the importance of inclusion within the health sector. Discussions around the health theme that will also feed into the larger summit taking place next month, hosted by the governments of Norway and Ghana, and the International Disability Alliance.

The pre-summit focusing on the health sector is a first, insofar as the topic of disability and health services was not part of the first Global Disability Summit held in 2018. 

Wednesday’s two-hour pre-summit will include several panels covering topics such as the need for the health sector to listen to the voices of people who live with disabilities, to how inclusion of people with disabilities could help achieve national health objectives and opportunities for international collaboration. 

The high-level line-up of speakers include WHO DG Tedros; Yannis Vardakastanis, president of the International Disability Alliance; Norwegian Prime Minister Jonas Gahr Støre; and Dr Natalia Kanem, Executive Director of the United Nations Population Fund.

Mental health to be addressed

Atmiyata’s community and volunteer-based support network for people in distress in Gujarat, India.

One other focus of the health pre-summit event will be the need to improve services for persons with mental health conditions and psychosocial disabilities. A panel on that issue will include Olga Runciman, co-founder of the Danish Hearing Voices Network.  A psychiatric nurse, she will discuss her own lived experience with schizophrenia, as well as her experience in the health sector to articulate her views about how mental health treatment needs to change to recognize and empower individuals.

“I hear voices, and I don’t want my voices to be removed or go away,” Runciman told Health Policy Watch. “But when you are given the devastating label of schizophrenia, you lose your voice, you most likely experience abuses within the psychiatric system – forced seclusion, forced medication, being tied to beds. It is really difficult to get people to hear and listen to what you are saying.”

Western psychiatry has harmed people with mental health conditions and psychosocial disabilities, she asserts. Hearing Voices and other rights-based organizations offer models for how treatment can be handled differently. Other alternative models, described in a recent report by the World Health Organization, include the “open-dialogue” approach being practiced in Western Lapland, the Atmiyata community and volunteer-based service in India, and the BET Unit, an open-door psychiatric ward in Norway, which operates around principles of voluntary choice of treatment and minimal drug use.

“The goal is that people will sign on to some of these best practices, quality-of-life programs and help people change their attitudes and to work in different ways,” Runciman said. 

Health systems often neglect people with disabilities 

The idea of bringing the topic of inclusion in the health sector into the summit came following the adoption of a landmark World Health Assembly resolution on achieving the highest attainable standard on health for persons with disabilities in January 2021. The resolution called on countries and health sector partners to move away from an exclusively medical approach to disability towards adopting a comprehensive people-centred and human rights-based approach.

Very often, health systems neglect to consider the needs of people with disabilities, organizers say.  And with around a billion individuals around the world with disabilities, inclusion is essential for countries to reach universal health coverage – something further highlighted by the COVID-19 pandemic. 

Although WHO has been working on disability and health for many years, Wednesday’s pre-summit event represents the building momentum on the issue across a range of WHO programmes, as well as the growing partnership between WHO and the international disability community. 

While the pre-summit will stay focused on disability inclusion in the health sector, the larger summit in February will tackle a broader set of themes covering: Inclusive education, health, employment and livelihood, and inclusion in situations of crises and conflict, including a focus on climate change.

Februrary’s summit will also push for countries to adopt concrete commitments contributing to successful inclusion around themes such as: access to communication and information, enabling independent living; ensuring people with disabilities can access land and property rights. 

To sign up for the pre-summit event, click here. To maximize inclusion in the pre-summit, International Sign Language and American Sign Language, closed captioning in English, as well as language interpretation in English, Spanish, French, Chinese, Russian and Arabic will be available.  

To learn more about the larger summit, visit https://www.globaldisabilitysummit.org/. 

Image Credits: Rasmus Gerdin/ Unsplash, Amiyata, Gujarat, India.

Bexlovid, the world’s first generic of the successful Pfizer antiviral, is already on sale in Bangladesh.

The first generic version of Paxlovid, the Pfizer pill that has proven highly effective in treating COVID-19, is already available in Bangladesh.

However, Indian generic company Dr Reddy’s, which has started to produce the Merck antiviral, molnupiravir, might be in trouble after the country’s National Task Force for COVID-19 resolved on Monday that there were too many safety risks associated with the drug for it to be included in national treatment protocols, according to the Times of India.

Molunpiravir, which has been shown to reduce hospitalisations by 30% in clinical trials, has also been associated with birth defects and other issues.

However, Bangladesh’s generic company Beximco started distributing its version of Paxlovid – called Bexlovid – last week after Bangladesh’s Directorate General of Drug Administration issued an Emergency Use Authorisation (EUA) for its production on 30 December.

A week earlier, the US Food and Drug Administration (FDA) had issued an EUA for Paxlovid, allowing doctors to prescribe a five-day course for adults and children 12 years of age upwards within five days of symptoms for people who “are at high risk for progression to severe COVID-19, including hospitalization or death”. This includes people with obesity, diabetes and those over the age of 60.

The antiviral is a combination of two drugs – nirmatrelvir and ritonavir – and has been found 89% effective in preventing at-risk people with mild to moderate COVID-19 infections from severe disease and death.

“Having previously introduced the world’s first generic COVID-19 treatments of remdesivir and molnupiravir, we are pleased to add this breakthrough therapy to our portfolio,” said Beximco managing director Nazmul Hassan.

“It is further testament to our commitment to making affordable treatments accessible as soon as possible. As data continues to emerge demonstrating the effectiveness of nirmatrelvir and ritonavir against the the fast-emerging Omicron variant, we believe that Bexovid has the potential to be a powerful tool in combating the ongoing pandemic.”

Nirmatrelvir inhibits a SARS-CoV-2 enzyme to stop the virus from replicating, while ritonavir slows nirmatrelvir’s breakdown to help it remain in the body longer. 

Voluntary licenses for Pfizer pill

Last November, Pfizer signed a voluntary license agreement with the Medicines Patent Pool (MPP), enabling the MPP to grant sub-licenses to qualified generic medicine manufacturers, to produce and supply Paxlovid to 95 countries, covering up to approximately 53% of the world’s population. 

According to the agreement, Pfizer will not receive royalties on sales in low-income countries and will waive royalties on sales in all countries covered by the agreement while COVID-19 is classified as a Public Health Emergency of International Concern by the World Health Organization (WHO).

Unlucky Dr Reddy’s?

After entering into a voluntary licensing agreement with Merck late last year, Indian generic company Dr Reddy’s announced this month that it will sell its generic version of Merck’s COVID antiviral, molnupiravir, for about $0.50 per capsule, or $20 for a five-day treatment course of 40 capsules – in comparison to Merck’s US price of around $700 per course.

But although India last week gave EUA to molnupiravir, the head of India’s Council of Medical Research, Dr Balram Bhargava, said that the drug had “major safety concerns” and would not be included in the country’s treatment protocols.

Meanwhile, wealthy nations have ordered around 30 million doses of Paxlovid, according to Luis Gil Abinader,, a researcher with Knowledge Ecology International (KEI), who has been tracking the orders. 

 

 

Members of a community group in Ghana vote on measures to address malaria.

In the wake of the COVID-19 pandemic, putting communities and countries at the centre in the fight against Neglected Tropical Diseases, which affect some 1.5 billion people globally, is more important than ever before. New digital health tools can help us increase transparent reporting on progress and setbacks in achieving the NTD-related Sustainable Development Goals.

The severity of neglected tropical diseases (NTDs) has been overlooked and underestimated for generations – and in the wake of the COVID pandemic, multiple WHO and other reports have revealed how longstanding prevention, diagnosis and treatment measures have stagnated or even rolled backwards in many countries.

Africa carries nearly 40% of the NTD burden. And with a disproportionate number of people and communities continuing to suffer from malnutrition, stunted growth and cognitive impairment caused by diseases like intestinal worms and lymphatic filariasis, we need to look at new ways to keep this agenda uppermost in the minds of policymakers.

More transparent, digitalized reporting of progress and setbacks can be part of the solution – insuring that NTDs remain priorities in global and continental health agendas. Digital Health Week observed in early December has reminded us of how better data can help enhance decision making and propel action.

ALMA scorecards and hub

A page from Rwanda’s digital malaria and NTD scorecard

The African Leaders Malaria Alliance (ALMA) Scorecard Hub, launched this year by Kenyan President Uhuru Kenyatta, is a game-changing digital health solution that can help revolutionise how countries and national programmes can share information.

 The hub is the first open-access platform dedicated to scorecards including on health-related NTDs, allowing countries to regularly post their scorecards on the website for every citizen to have access to the latest data. 

It also is a knowledge platform, sharing country best practices to improve scorecard management tools for accountability and action in malaria, reproductive maternal neonatal and child health (RMNCAH), and NTDs as well as online learning material.

The platform makes use of the ALMA Scorecard for Accountability and Action as well as country-owned scorecards,  which track progress, enhance community engagement, quickly identify bottlenecks and steer action in the fight against NTDs.

The ALMA scorecard, which provides key data in a colour-coded user-friendly way, is used primarily by Heads of State and Government, ministers, other high-level national leaders and key partners to strengthen accountability and action to address public health priorities.  

It tracks progress in the fight against malaria, RMNCAH, HIV/AIDS and more recently NTDs.  

Over 40 African countries have scorecards

Over 40 of Africa’s 55 countries have developed malaria, RMNCAH, NTDs, nutrition and/or community scorecards. Reviewing such scorecards, allows one to see where bottlenecks to access remain – such as children’s access to HIV/AIDS diagnosis and treatment, and in the case of NTDs, coverage of Mass Drug Administration. 

For example, the third quarter of the year illustrated strong progress in the total population living with HIV who have access to antiretroviral therapy at 64%, up from 58% in the previous year. 

The percentage of children receiving the same treatment, however, is almost half of this, at 39%. In addition, only 54% of children have access to vitamin A, despite this being a simple and cost-effective intervention. These figures highlight the notable challenges that countries in Africa face when addressing these critical diseases. As the health crisis goes beyond national borders, it must also be addressed by regional and global actors.

In the fourth quarter of 2017, ALMA in collaboration with WHO and Uniting to Combat NTDs, added the NTD coverage index to the ALMA scorecard. This is an indicator on NTDs used to track progress in the coverage of drugs distributed for the five NTDs amenable to preventive chemotherapy (trachoma, lymphatic filariasis, onchocerciasis, schistosomiasis, soil-transmitted helminths). 

The index is based on the geometric mean of coverage rates for those interventions for which data are routinely reported by countries to WHO and is calculated by WHO/Headquarters on an annual basis and submitted to ALMA for dissemination via the ALMA scorecard. 

To accommodate the scorecard “traffic light” system, countries are categorized as “On track” (green) when the coverage index is >75%; “Progress but more effort required”,(orange) when the coverage index between 25-75%; and “Not on track”, (red) when it is below 25%.

The 75% threshold is based on the WHO NTD Roadmap target coverage overall for the five NTDs eligible for preventive chemotherapy. The NTD coverage index is methodologically comparable to the Universal health coverage (UHC) index. The ALMA scorecard is helping to ensure that these often-forgotten diseases are visible at the highest level.

The national scorecards are composed by priority indicators selected from the national strategic plans and other country guiding documents. The data are real-time data coming from the country’s Health Information System and programmes.  

Scorecards are country-managed and used within the national systems, hosted on the Scorecard Web Platform which is an online service to manage the scorecard tool. The scorecard accountability mechanism serves to visually highlight in which specific areas countries are doing well and in which areas they are experiencing bottlenecks to facilitate action, as a key step towards identifying African-owned and led solutions. ALMA continue to maintain, support and update the online service and to train countries on the proper use of the tool.

Demonstrated to lead to better health outcomes

The ALMA scorecard has demonstrated how a data-driven approach can contribute to better health outcomes, leading to rapid policy change, enhanced donor and domestic resources, accelerated procurement to avoid stock-outs and addressing emergencies.

The Republic of Congo is an example of a country that has adopted the NTD country scorecard with positive change. The development of the scorecard there revealed supply chain problems, which allowed the Ministry of Health to react quickly and restock. 

This resulted in significant improvement of therapeutic coverage for onchocerciasis and Lymphatic Filariasis, from 79% in the second half of 2018 to 83% in the first half of 2019, illustrating the game-changing impact of this tool.

The scorecard is now incorporated in the country’s NTDs Annual Report. In 2019, using the scorecard to present the programme gaps, the National NTDs programme mobilised funds from the government and a budget line on NTDs was created with a commitment of 100,000 million CFA francs (nearly US$170,000) to support the four NTDs programmes.

Community scorecard tools

Community scorecard tools, in particular, are used to engage the community for assessment, planning, monitoring and evaluation of health services, and joint action.

Used during routine community meetings such as town halls, they allow members of the community to rate the local health facilities, using quality of care indicators such as waiting times or availability of medicines.

Actions are then taken and monitored to improve the quality of service and facilities. The Community scorecard approach is a crucial initiative in global health as it provides a mechanism for accountability that is community-owned and led.

Civil Society are critical partners

Civil Society Organisations (CSOs) are a critical pillar, working as active community agents driving change through health campaigns but also playing a powerful and critical role in health campaigns, bringing together communities for collective action, mobilizing the population to articulate demands, and voicing concerns across all levels of society. The involvement of CSOs, combined with utilising mechanisms like the community scorecards, will see an increase in accountability for countries across Africa, fuelling progress in the fight against NTDs.

The results of civil society action are evident. The CSO Network on NTDs, established in 2019 is providing a platform for CSOs to consult and collaborate to beat NTDs, with the ambition to increase sustainable funding and accelerate progress across the continent. Already the No to NTDs Civil Society Network has engaged more than 647 stakeholders across Africa. Through this network parliamentarians in Guinea are now committed to increasing the budget allocation to the National NTDs Programme, helping 6.5 million people who are unable to receive fundamental treatment in the country.

To achieve the 2030 sustainable development goal and reduce the number of people requiring NTDs treatment by 90%, greater, and more urgent action is needed. As we come to the end of another challenging year, shaken by the COVID-19 pandemic, we must make sure we are utilising all the available tools to end suffering from NTDs once and for all.

 

Joy Phumaphi is the Executive Secretary of the African Leaders Malaria Alliance. She also serves as co-Chair of the Independent Expert Review Group, for Every Woman Every Child, reporting annually to the UN Secretary General on developing country progress on Women’s and Children’s health. She also sits on the Board of several international non-profits in Global Health, including CIFF (Children’s Investment Fund Foundation); ACHAP (African Comprehensive HIV/AIDS Partnership; MMV (Medicines for Malaria Venture); RBM (Roll Back Malaria Partnership), and is an advisor for Hilleman Laboratories, the Gates Foundation Malaria Program, and the Harvard Health Ministerial Leadership program. 

 

Yacine Djibo founded Speak Up Africa in 2011 to discover and implement effective, sustainable solutions to the most challenging problems facing the African people. Focusing on strategic communications, policy and advocacy, Speak Up Africa is dedicated to empowering African leaders and citizens to take on issues such as malaria, neglected tropical diseases and sanitation in order to save and improve lives. Previously, she worked as the Senegal country director for Malaria No More, where she developed and managed high-profile national programs and campaigns to promote malaria prevention and treatment.