India is wasting 6.5% of its vaccines, data released by the country’s government shows.

Pune – Despite ramping up its coronavirus vaccination drive and amidst a deadly second wave of infections, India is wasting 6.5% of its vaccines, data released by the country’s government shows.

Experts this week told Health Policy Watch that while the high vaccine wastage is also a sign of vaccine hesitancy – particularly among poor groups traditionally suspicious of government – there are other factors contributing to inefficiencies in the vaccine delivery.

“Wastage is caused due to inadequate numbers”, said Rajeev Sadanandan, chief executive officer of the New Delhi-based Health Systems Transformation Platform (HSTP) – referring to the lackluster response and no-shows that have characterized the vaccination campaign in some regions, and among some populations.

“A vial once opened cannot be recapped. Each vial is meant for 10 persons. If they do not get 10 persons per vial they have to throw away the vial. The solution is to plan the vaccination coupled with mobilisation of eligible persons.”

The data on vaccine waste, released on March 17, shows that vaccine wastage is highest in big southern states; 17.6% in Telangana and 11.6% in Andhra Pradesh. Union health secretary Rajesh Bhushan has emphasised that vaccines are invaluable commodities and public health goods and that they must be optimally utilised.

Some states have also raised concerns over supply shortage. On Wednesday, the Central Government released a scathing response, accusing the state governments of spreading “panic” among people.

India’s health minister Harsh Vardhan speaking at a meeting to review COVID situation in the country on Tuesday.

Spike in Covid-19 Cases and Vaccine Roll-out

On April 5 India reported over 100,000 new COVID cases – its highest ever tally since the pandemic began. Even at the peak of its first wave last year the country’s highest single day tally was at 97,000 cases.

Daily new Covid-19 cases have surged to an all-time high in India.So far India has delivered nearly 80 million doses of vaccines, according to government figures. Most of the earlier doses were given to healthcare workers and high-risk groups like the elderly and those above the age of 60. On April 1 the government lowered the age of those eligible for vaccines to everyone over 45 and the authorities said the aim to keep the vaccine wastage down to less than 1%.

The state of Maharashtra has requested that the age of those eligible for the vaccines be lowered further to 25. Highly urbanized, Maharashtra has densely populated cities like Mumbai, and is responsible for 58.19% of all new Covid-19 cases in India. The state that was functioning near normal at the start of the year is back to resorting to night and weekend lockdowns to slow down the spread of the virus.

India offers its residents two vaccines – the homegrown Covaxin vaccine, developed by Bharat Biotech and the Oxford/AstraZeneca vaccine, Covishield, which is being manufactured under a license by the Serum Institute of India. Those receiving the vaccine do not get to choose between the two.

There are multiple social, logistical and economic reasons why wastage is occurring. However, Gagandeep Kang, vaccine expert and professor at the Christian Medical College (CMC), Vellore explained that it is also rooted in conventional health service protocols: to improve India’s low immunization coverage for childhood vaccination, instructions were given to the staff to not worry about keeping wastage low and to focus on ensuring that every child is vaccinated.

“When the same people are now told to not waste a single dose of vaccine then it becomes challenging for them as it is different from the protocol that they are used to,” Kang said. She added that by not allowing healthcare workers to give vaccines that are about to go waste to non-priority groups, the government is trying to ensure that the vaccines were not misused in the name of wastage.

Take Vaccines to the People

Another reason why wastage is occurring is because the vaccination drives are being conducted in a few centralized locations. Travelling to a vaccine centre that is far away costs money; for some it might mean a day’s lost wages.

This issue, however, must not be confused with hesitancy, experts caution: “Unless we address that economic and social difficulty of the vulnerable population, we cannot expect the numbers to go up,” said Sadanandan, saying that vaccine sites must be made more accessible to people.

However, the poorest groups in India also do harbor significant distrust of the government generally. As a result, vaccine drives in some poor communities may yield lower than hoped for turnout – leading to wastage of the temperature sensitive doses.

Another issue, linked to vaccine hesitancy, relates to safety concerns – particularly as the Indian government was not transparent about the data about the Bharat Biotech vaccine in the early months. The AstraZeneca vaccine also has seen major concerns emerge in Europe over rare blood clots among younger groups.

Kang said that the data for vaccines is always evolving and while there can be rare safety concerns with one in every 50,000 or 100,000 people, it would only be known after millions of people are vaccinated. “If you look at the benefit and risk, the benefit of the vaccine even in the one in a million clotting event (as is being reported about the AstraZeneca vaccine) is very firmly in favour of the vaccine.”

Early on in the pandemic the World Health Organization (WHO) pushed countries to ramp up their COVID testing, using communications and advocacy strategies to convince people to get tested as well. Experts now point to the need for countries like India, that are in the process of expanding its vaccination programme, to shift to effectively communicating the benefits of getting a jab.

As the government expands coverage to a larger pool of people the wastage also could come down, experts also believe – because more people will be eligible to claim unused doses at the end of the day, avoiding wastage.

At the same time, it’s important to expand eligibility for the jabs only after sufficient supplies are assured.

“If we aggressively push (for people to take vaccines) and the vaccine is not available that will also be a problem,” said Kolandaswsmy K, former director of Public Health Preventive Medicine for the government of Tamil Nadu in southern India.

Disha Shetty is an independent science journalist based in Pune, India

Image Credits: Ministry of Health and Family Welfare, Govt of India, Ministry of Health and Family Welfare, Government of India, https://pib.gov.in/PressReleasePage.aspx?PRID=1709600.

Brazil on Tuesday recorded 4,195 COVID-19 deaths – bringing the total number of deaths in the country to 366, 000- second only to the United States.

The World Health Organization on Wednesday urged governments in the Americas Region to take decisive action to slow a surge of COVID-19 cases after recording more than 1.3 million new cases and 37 000 deaths in just the past week.

Describing the new rate of infections as “worrisome”, Carissa Etienne, director of the WHO’s regional office, the Pan American Health Organization, said health care facilities in the region were being stretched to the limit as the rate of infections continued to climb, ICU beds were nearing capacity.

Brazil alone recorded more than 4,000 deaths in its deadliest 24 hours of the pandemic so far.

“Over the last week, the United States, Brazil and Argentina were among the 10 countries in the world, registering the highest number of new infections worldwide” said Etienne, adding that “more than half of all global deaths reported last week were in the Americas.

“The United States, Brazil and Argentina were among the 10 countries in the world registering the highest number of new infections worldwide,” she noted, with many other countries in the region not far behind. 

Despite the skyrocketing numbers, people are steadily increasing their movement and travelling within and between countries. “If these trends continue, our health systems will be in deeper trouble,” warned Etienne, urging people to stay home to drive down infections.  

Infection rates Slowing in United States & Mexico 

“Cases are mounting in nearly every country. In areas of Bolivia and Colombia cases have doubled in the last week. All four countries in the southern code have been experiencing acceleration in COVID-19 cases with one interrupted community transmission in recent weeks,” she said.

Rising rates of new infections were also still being recorded in countries including Costa Rica, Honduras,  Ecuador, Guatemala, as well as in smaller islands like Martinique Bermuda and the US Virgin Islands.

The exceptions were the United States, Mexico, Salvador and Panama, where the rate of new cases was now finally slowing down. 

In the United States, US government officials said that the slowdown in the US in new cases may be attributable to the huge US vaccine drive which has seen some 60 million vaccine doses distributed so far – the most in absolute terms anywhere in the world. 

Brazil’s Grim COVID-19 Numbers – ‘A Biological Fukushima’

The Brazilian Health Ministry on Tuesday said 4,195 people had died ín the past 24 hours due to the virus – bringing the total number of deaths in the country to 366,000- second only to the United States.

Sylvian Aldighieri, PAHO incident manager for COVID, said: “Our concern at the moment is also for the Brazilian citizens themselves in this context of services that are overwhelmed by the number of severe cases to be managed”.  He added that PAHO was working with Brazil to acquire more vaccines.

Brazilian hospitals across the country are being stretched to their limits as the rate of infections continues to climb. More young people are falling ill, and needing medical care, he noted, as the current wave of the pandemic is marked by more easily transmissible strains of the virus.

“It’s a nuclear reactor that has set off a chain reaction and is out of control. It’s a biological Fukushima,” Dr Miguel Nicolelis, a Brazilian medic and professor at Duke University, was quoted as saying.  Over the course of April 2021, Brazil appears set to hit an all-time record of 200,000 deaths per month, with 50% of those due to COVID19.  It would be the first time deaths surpass births in the country, Nicolelis remarked in a tweet. 

“Never in Brazilian history have we seen a single event kill so many people in 30 days,”, added the Duke professor, who also coordinates COVID response in Brazil’s northeastern region, speaking to AFP, adding that with winter now approaching, Brazil is facing “a perfect storm.”

Speaking on local Brazilian TV, Nicolelis held President Jair Bolsonaro largely responsible – due to his pushback against mask-wearing, social distancing, and lockdown measures. 

“We’re in a dreadful situation, and we’re not seeing effective measures by either state or federal governments” to respond, epidemiologist Ethel Maciel of Espirito Santo Federal University also told the AFP.

Despite the recent surge, Brazilian officials have tried to retain an upbeat note, insisting that the country can soon return to something resembling business as usual. 

“We think that probably two, three months from now Brazil could be back to business,” Economy Minister Paulo Guedes said during an online event on Tuesday. “Of course, probably economic activity will take a drop but it will be much, much less than the drop we suffered last year … and much, much shorter.”

Economic Impact of the Pandemic

Overall for the region, however, the financial strain of this pandemic has been devastating and effectively fighting COVID-19 is impossible without addressing some of the inequalities and supporting the most vulnerable as they struggle to protect themselves, said Etienne.

“While many of us have been lucky enough to continue working during the pandemic from the comfort and safety of home, half of our workforce relies on the informal economy. Staying at home would have meant forgoing their livelihoods, “she said, adding that 22 million people fell into poverty this year in the region. 

Despite the gloom and doom, there is some good news, according to Etienne.

To date more than 210 million doses of COVID-19 vaccines have been administered across 49 countries and territories in the Americans. While the United States is leading the region and the world in its vaccine campaign, other countries, such as Chile, are also vaccinating at high rates. 

PAHO has also developed an interactive platform where countries can visualize the public health measures that were implemented. This will help countries, among others, identify peaks and mobility during specific periods such as Christmas New Year and inform pandemic responses.

“As we continue to fight this virus, we must do more than just stop COVID-19.  We must commit to working together to build a fairer healthier world, we must also take this opportunity to build a healthier region that’s better prepared to tackle the next challenge, and realises our promise of health for all,” said Etienne.

 

Emer Cooke, EMA Executive Director, at Wednesday, 7 April press conference.

Following a second meeting of the EMA’s safety committee in as many weeks, the European Medicines Agency said that there appears to be a link between receipt of the AstraZeneca vaccine and very rare cases of blood clots being seen in some people – mainly younger women – within two weeks of their jab.

The linkage, however rare, is another blow to the rollout of the vaccine which is currently the most affordable and the most widely available, the world over.

It could stimulate more hesitancy and confusion about the vaccine’s use not only in Europe but in the dozens of low- and middle-income countries that are right now almost exclusively reliant upon AstraZeneca vaccine supplies – being provided free-of-charge by the WHO co-sponsored COVAX initiative. In India, where the vaccine is being produced under license, the vaccine, produced under license by the Serum Institute, is the centerpiece of a major vaccination rollout that aims to blunt a new wave of COVID cases, which saw over 100,000 new cases reported in the past 24 hours.

“The blood clots occurred in veins in the brain (cerebral venous sinus thrombosis, CVST) and the abdomen (splanchnic vein thrombosis) and in arteries, together with low levels of blood platelets and sometimes bleeding,” noted the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) in a statement issued on Wednesday.

Speaking at a press briefing, EMA Executive Director Emer Cooke stressed that the benefits of vaccination still outweigh the risks: “Our safety committee … has confirmed that the benefits of the AstraZeneca vaccine …. outweigh the risk of side effects. This vaccine has proved to be highly effective. It is preventing hospitalizations and saving lives.” However at the same time, she noted that “after a very in-depth analysis, the PRAC after a very in depth analysis had concluded that the reported cases of unusual blood clotting following vaccination with the AstraZeneca vaccine should be listed as possible side effects of the vaccine.”

She said that as of now, no specific risk factors had been identified that make people vulnerable to the rare condition – although the EMA statement noted that most of the cases reported have occured in women under the age of 60.

EMA Committee Stops Short of Policy Recommendations On Groups Most At Risk


At the same time, the committee stopped short of issuing a recommendation that the AstraZeneca vaccines be withheld from younger groups, or from younger women – saying there was still insufficient evdience to establish “a definite cause for these complications” or to link the cases to specific risk factors – including age or gender.

“Because of the different ways that the vaccine is being used in different countries, the commiteee did not conclude that age and gender were very clear risk factors for these very rare side effects,” said Sabine Straus, chair of the EMA’s PRAC safety committee, at the press briefing.

The EMA findings were also echoed by the World Health Organization, which issued its own statement Wednesday on the findings of the WHO Global Advisory Committee on Vaccine Safety, concluding that: “Based on current information, a causal relationship between the vaccine and the occurrence of blood clots with low platelets is considered plausible but is not confirmed. Specialised studies are needed to fully understand the potential relationship between vaccination and possible risk factors.”  However, based on the evidence so far, the WHO committee, like the EMA, did not recommend curbing vaccine administration among younger people, or younger women, at this time.

However, in the United Kingdom, regulators said on Wednesday that they would issue a new recommendation for people under the age of 30 to receive other types of vaccines.  And other Europan countries, such as Germany, recently limited the AstraZeneca vaccine to people over the age of 60.

The committee statement, however, urged that  “healthcare professionals and people receiving the vaccine [need] to remain aware of the possibility of very rare cases of blood clots combined with low levels of blood platelets occurring within 2 weeks of vaccination… People who have received the vaccine should seek medical assistance immediately if they develop symptoms of this combination of blood clots and low blood platelets.”

WHO, meanwhile, warned vaccinated individuals and their healthcare professionals to be on the lookout for specific symptoms, stating that: individuals who experience any severe symptoms – such as shortness of breath, chest pain, leg swelling, persistent abdominal pain, neurological symptoms, such as severe and persistent headaches or blurred vision, tiny blood spots under the skin beyond the site of the injection – from around four to 20 days following vaccination, should seek urgent medical attention. Clinicians should be aware of relevant case definitions and clinical guidance for patients presenting thrombosis and thrombocytopaenia following COVID-19 vaccination.

The EMA statement also stressed that risks associated to COVID remain much higher than those attributable to the vaccine: “COVID-19 is associated with a risk of hospitalisation and death.The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of the vaccine in preventing COVID-19 outweigh the risks of side effects.”

The most recent data from a large scale trial conducted in the United States, Peru and Chile, suggested that the AstraZeneca vaccine, developed together with Oxford University, is 79% effective at reducing the risk of symptomatic Covid-19, rising to 80% among people over the age of 65 – and 100% effective against severe disease.

But the statement also tacitly acknowledged that member states will also decide their policies, based on the mix of vaccines available: “Use of the vaccine during vaccination campaigns at national level will also take into account the pandemic situation and vaccine availability in the individual Member State.”

Committee Conducted In-depth Review of 86 cases of Blood Clot Conditions

The Committee said that it carried out an in-depth review of 62 cases of cerebral venous sinus thrombosis and 24 cases of splanchnic vein thrombosis reported in the EU drug safety database (EudraVigilance) as of 22 March 2021, 18 of which were fatal.

As of 4 April 2021, a total of 169 cases of CVST and 53 cases of splanchnic vein thrombosis had been reported to EudraVigilance among the 34 million people had been vaccinated in the European region and the United Kingdom by that date. “The more recent data do not change the PRAC’s recommendations. The cases came mainly from spontaneous reporting systems of the EEA and the UK, where around 25 million people had received the vaccine,” the commtitee also noted.

As for the mechanism, the committee said that the current thinking is that the vaccine may trigger an immune response leading to the blod clotting condition, which is similar to a reaction some people have to the administration of the blood thinner, heparin, called heparin-induced-thrombocytopenia like disorder.

Healthcare professionals involved in giving the vaccine in the EU will receive a direct healthcare professional communication (DHPC). The DHPC will also be available.

See the complete EMA statement here and the WHO Global Advisory Committee on Vaccine Statement here.

 

 

Neglected Tropical Diseases go largely unnoticed, but the new road map for (NTDs) 2021–2030 is vitally important in accelerating action towards ending these preventable and treatable diseases.

The World Health Organization’s new road map for neglected tropical diseases (NTDs) 2021–2030 is a turning point in our fight against NTDs. It provides us with a clear route forward and the opportunities to effectively control and eliminate these debilitating diseases.   On World Health Day 2021, dedicated to the theme of building a healthier, fairer world, it’s important to remember how NTDs, which are deeply linked to unhealthy environments, and unequal social and economic conditions, also perpetuate long-term cycles of suffering and poverty. 

Although NTDs continue to go largely unnoticed, they comprise a group of 20 diseases and disease groups that affect more than 1.5 billion people worldwide, with a third living in Africa. NTDs occur predominantly in the poorest communities with little or no access to healthcare systems. These diseases often cause severe disfigurement and other long-term disabilities that hinder education, economic growth and overall development. 

I have seen first-hand the disability and suffering these diseases inflict, and I know only too well their devastating impact on communities already struggling with poverty. The new road map is vitally important in accelerating action towards ending these preventable and treatable diseases. The Global Summit on Malaria and NTDs in Kigali, Rwanda in June 2021 is an opportune moment to support this activity. 

Global leaders will meet during the Commonwealth Heads of Government Meeting to discuss our next steps in the battle against NTDs and to help build momentum into the next decade. The road map is central to our upcoming work and has firmly placed NTDs in the global spotlight. It is essential that we take this opportunity to raise awareness and capitalise on increased momentum.

With 600 million people in Africa requiring treatment for NTDs every year, too many vulnerable people continue to suffer from these treatable and preventable diseases. NTDs have been the subject of less research than other diseases – this has meant that new treatments have developed more slowly. And it is estimated that just 0.6% of global healthcare funding is earmarked for the control of NTDs. This lack of investment is one of the greatest obstacles we face in the fight against NTDs. 

NTD Road Map To Address Critical Gaps Across Multiple Diseases

To ensure sustainable progress is achieved, countries should take the lead in controlling these diseases and the conditions that cause them. In March 2020, the African Union Commission held its first experts’ meeting on NTDs to advocate for prioritising the fight against NTD levels through the allocation of sufficient resources to strengthen national programmes. The meeting revised the African Union Continental Framework for NTDs (2021–2030) and the Common African Position on NTDs. Once endorsed, these documents aim to provide guidance to Member States on fighting NTDs on the continent. The African Union Commission, in collaboration with its Member States, called for accelerated efforts towards the elimination of NTDs in the wake of WHO’s new road map.

The road map is designed to address critical gaps across multiple diseases by integrating and mainstreaming approaches and actions within national health systems, and across sectors. By setting clear targets and milestones, it also provides opportunities to evaluate, assess and adjust programmatic actions as needed over the next decade. Its 4 overarching global targets for 2030 are:

  • reduce the number of people requiring treatment for NTDs by 90%;
  • eliminate at least 1 NTD in at least 100 countries;
  • eradicate 2 diseases (dracunculiasis and yaws); and
  • reduce the disability-adjusted life years related to NTDs by 75%.

Furthermore, the road map will track a set of disease-specific targets and 10 cross-cutting targets, including: a reduction by more than 75% in the number of deaths from vector-borne NTDs; and the promotion of full access to basic water supply, sanitation and hygiene in areas endemic for NTDs. 

Not Enough Progress On Eliminating NTD

The new road map for neglected tropical diseases (NTDs) 2021–2030 will address critical gaps across multiple diseases.

The global NTD community has made great progress in recent years, eliminating at least 1 NTD in 42 countries, including Togo and Ghana. With the right approach and funding, we can achieve even greater progress in the coming years. By combining increased investment with stronger accountability and intensified collaboration across sectors, as called for in the new road map, I believe we will go from strength to strength as we unite to combat NTDs.

The COVID-19 pandemic has taught us that rapid progress is possible when we come together in partnership and solidarity. The new NTD road map will help ensure that the global health community is engaged in our mission to eliminate NTDs and to raise the funding needed to control, eliminate and eradicate these diseases. Investment in NTDs is not only vital for those directly affected but also one of the most cost-effective investments in public health – treatment for the top 5 NTDs costs less than US$ 0.50 per person. 

Now is the time to stimulate our efforts and sharpen our focus: I encourage all policymakers, donors, political leaders and private sector organizations to embrace the new road map. It will provide guidance, momentum and enthusiasm to our global community. 

World Health Day 2021 focuses on building a fairer, healthier world. We cannot achieve this without tackling NTDs. With the direction provided by the road map, I believe we can mobilise the resources needed to strengthen our health systems, to treat and prevent these diseases of poverty, and, ultimately, to end NTDs once and for all.

  • Dr Mwelecele Ntuli Malecela is the Director, Department of Control of Neglected Tropical Diseases, World Health Organization (WHO)

 

One in three COVID-19 survivors received a neurological or psychiatric diagnosis within 6 months of infection with the virus.

A new study published by the journal Lancet Psychiatry estimates that one in three COVID-19 survivors received a neurological or psychiatric diagnosis within six months of infection with the SARS-CoV-2 virus. 

The study, conducted with researchers from both the United States and United Kingdom, analyzed the electronic health records of 236,379 COVID-19 patients primarily from the US, also comparing them to 105,579 patients diagnosed with the flu and 236,038 patients diagnosed with any respiratory tract infection (including flu). 

Overall, it was estimated that 34% of patients were diagnosed with a neurological or psychiatric disorder in the first six months after after a COVID diagnosis – with some 13% having a first-time ever diagnosis. Results also showed that the risks were greatest in, but not limited to, those with severe COVID-19.

Professor Paul Harrison, University of Oxford, lead author of study

Professor Paul Harrison, lead author of the study, from the University of Oxford, said: “These are real-world data from a large number of patients. They confirm the high rates of psychiatric diagnoses after COVID-19, and show that serious disorders affecting the nervous system (such as stroke and dementia) occur too. While the latter are much rarer, they are significant, especially in those who had severe COVID-19.”

And while countries around the world are now focused on vaccine rollouts, in hopes of achieving herd immunity, the study underlines how effects of COVID-19 will be felt for much longer, said Dr Jonathan Rogers, who was not involved in the study, from University College London (UCL), UK, in a separate comment on the study.

“Sadly, many of the disorders identified in this study tend to be chronic or recurrent, so we can anticipate that the impact of COVID-19 could be with us for many years.”

Neurological and Mental Health Risk Increase Following COVID-19, When Compared to Flu or Respiratory Tract Infections, Says Study 

Additionally, neurological and psychiatrist outcomes were more frequent in COVID-19 patients than those patients who had suffered from the flu or respiratory tract infections –  suggesting the specific impact of COVID-19, the researchers found. 

After taking into account underlying health characteristics, such as age, sex, ethnicity, and existing health conditions, there was overall a 44% greater risk of neurological and mental health diagnoses after COVID-19 than after flu, and a 16% greater risk after COVID-19 than with other respiratory tract infections.

Ischaemic Stroke and Hemorrhage Risks Also Elevated
Associations between COVID-19 and ischemic stroke and intracranial hemorrhage is “concerning”

The risk of ischemic stroke and intracranial hemorrhage was elevated after COVID-19, with incidence of stroke increasing almost one in ten in patients with delirium (encephalopathy). Substance use disorders and insomnia were also more common. 

The study authors called the associations between COVID-19 and brain diseases and psychiatric disorders “concerning”, with additional research needed on disease severity and development. 

“We now need to see what happens beyond six months. The study cannot reveal the mechanisms involved, but does point to the need for urgent research to identify these, with a view to preventing or treating them,” Dr Max Taquet, a co-author of the study, from the University of Oxford, said.

The results also point to a substantial impact on health systems and social care networks, given the potentially chronic nature of many of these conditions, added Harrison.

“Health care systems need to be resourced to deal with the anticipated need, both within primary and secondary care services,”  he advised. 

Will Mental Health Or Neurological Conditions Predominate Over Time?  
COVID-19
Patients who received a psychiatric or neurological diagnoses 6 months after COVID-19

In the wake of these findings, health experts also questioned if the severe, chronic, and less common mental health conditions linked to these findings will manifest more as neurological disorders or common mental disorders over time. 

While this study found that anxiety (17%) and mood disorders (14%) were the most common diagnoses, diagnosis of stroke and dementia were more common in patients who required hospitalization (83%), and even more so in those who required intensive treatment (46%) and in those with delirium (encephalopathy) during COVID-19 infection (62%). 

Writing in a linked comment to the study, Rogers, found the link with encephalopathy [delirium caused by a brain disease typically caused by infection, tumor or stroke] “important, even if the underlying mechanism turns out to be indirect.” 

But Rogers issued a note of caution about the apparent connections between encephalopathy and COVID-19, citing difficulties in distinguishing between psychotic disorders and delirium. 

On the one hand, the average age of patients with first-onset mental health disorders (53 years old) was on average much greater than those in the general population, where onset usually occurs in early adulthood. But, in some cases, however, that psychosis may have been exacerbated by pre-existing conditions unknown to the health-care provider, he argued. 

However, Rogers added that the study has important implications pointing “us towards the future, in both its methods and implications. 

“Researchers need to be able to observe and anticipate the neurological and psychiatric outcomes of future emerging health threats by use of massive, international, real-world clinical data,” Rogers added, calling on countries with public health-care systems to “enable truly comprehensive national data to be available for research.” 

Image Credits: AMSA/Flickr, Flickr: Florey Institute of Neuroscience & Mental Health.

Azerbaijan’s President Ilham Aliyev

Some of the world’s smallest countries joined the World Health Organization (WHO) to appeal for equitable access to COVID-19 vaccines on the eve of World Health Day – as the pipeline of global vaccine supplies to low- and middle-income countries risk drying up for the coming few months. 

Barbados Prime Minister Mia Amor Mottley told the WHO press briefing on Tuesday that her country was simply too small to negotiate with large pharmaceutical companies, while Namibian President Hage Geingob said that his country had only received small donations of vaccines from China and Russia.

“The bald reality is that our market size is simply too small to command the attention of global pharmaceutical companies, or indeed other suppliers of goods,” said Mottley, who added that her country had received its first delivery of COVAX vaccines just today – but only enough to cover 3% of its population.

“We’ve not had access, even when we are prepared to pay,” said Mottley, who also expressed concern for the health of Tom Rowley, Prime Minister of Trinidad and Tobago who had been diagnosed with COVID-19 earlier in the day, a mere hours before he had been due to be vaccinated.

WHO Director-General Dr Tedros Adhanom Ghebreyesus made a five-point global call to action ahead of World Health Day on Wednesday, calling for:

  • Accelerated equitable access to COVID-19 technologies between and within countries;
  • Investment in primary health care;
  • Prioritizing health and social protection;
  • Building safe, healthy and inclusive neighbourhoods;
  • Strengthening data and health information systems.

“At the start of the year, I made a call for every country to start vaccinating health workers and older people in the first 100 days of 2021. This week [10 April] will mark the 100th day, and 190 countries and economies have now started vaccinations.”

Even so, he added that although COVAX has delivered 36 million vaccine doses to 286 countries and economies, “equitable distribution remains the major barrier to ending the acute stage of this pandemic” – with supplies running dry after initial deliveries are completed.

“It is a travesty that health workers and most at-risk groups remain completely unvaccinated” in some countries, the WHO DG said. “We need to invest in equitable production and access to COVID-19 rapid tests, oxygen treatments and vaccines, between and within countries.”  

Azerbaijan’s President Ilham Aliyev, speaking via a recorded video, said that his country had co-sponsored the resolution adopted in the March session of the UN Human Rights Council calling for “equitable, affordable, timely, and universal access for all countries” to COVID-19 vaccines. 

Access to ‘Concessionary Capital’ to Address Pandemic Impact

Appealing for more investment in primary healthcare, Tedros said that the pandemic has “exposed the fragility of our health systems”.

“At least half of the world’s population still lacks access to essential services, and out-of-pocket expenses on health drive almost 100 million people into poverty each year,” he said.

In the past year, the pandemic is estimated to have driven between 119 and 124 million more people into extreme poverty, according to the WHO.

Mottley, who chairs the development committee of the World Bank and the International Monetary Fund, said she would propose to the committee at its meeting this week that it needed to use “different criteria” to determine how countries get access to “serious concessional capital” to stave off the pandemic and its long-lasting consequences.

President Carlos Andrés Alvarado Quesada of Costa Rica also appealed for “multilateral organisations” to provide financing for poorer countries to address the medium and long-term effects of the pandemic. 

“Today, developed economies have managed to achieve special packages to help their countries to overcome the effects of COVID-19 but that’s not something that poorer countries can do,” said Quesada, appealing for “debt forgiveness” and long-term financing at zero or low rates.

“There is no magic bullet. and there is no magic recipe,” concluded Mottley. “The answer is simply for us to work together to get that fairer world and for there to be a level of global moral leadership, recognising that the singular pursuit of individual countries will not rid the world of the major problems because human beings cannot be contained behind boundaries easily in this globally interdependent world.”

Risk-benefit for AstraZeneca Still ‘Positive’ But More Data Expected in Next Day

Rogerio Pinto de Sa Gaspar, the WHO’s Director of Regulation and Prequalification

On a related matter, WHO’s Director of medicines Regulation and Prequalification, told the media briefing that it expected to have more data about possible linkages between the AstraZeneca vaccine and rare “thrombolytic events” in the next few days.

However, Rogerio Pinto de Sa Gaspar, stressed that “at the present moment, and under the assessment that we have from the data submitted up to yesterday, we are confident that the benefit-risk assessment for the vaccine is largely still positive.”

The European Medicines Agency (EMA) was meeting again Tuesday and Wednesday over  the issue, as was the United Kingdom’s Health Products Regulatory Authority following a decision by Germany last week to suspend the vaccine’s use among people under the age of 60 – after further rare blood clot events occurred.

 WHO’s own Global Advisory Committee on vaccine safety was due to meet on Wednesday, said De Sa Gaspar amind the ongoing controversy about the vaccine.

European Medicines Agency Meeting is Viewing All Data

The WHO also has observers at the EMA meeting, which is assessing “the core clinical data that was submitted by AstraZeneca”.

Describing the events as “rare”, De Sa Gaspar said there was “no evidence that the benefit-risk assessment for the vaccine needs to be changed, and we know from the data coming from countries like the UK and others, that the benefits are really important in terms of reduction of the mortality of populations that are being vaccinated”. 

He added that the WHO expected to have “a fresh conclusive assessment from our experts” by Wednesday or Thursday.

 “There’s no link for the moment between the vaccine and thrombolytic events with thrombocytopenia, but of course it’s under evaluation, and we wait for some feedback from those communities in the coming days and coming hours just to give a full assessment,”  asserted De Sa Gaspar.

“WHO is relying heavily on the national pharmacovigilance systems, but also on the assessment committees from national regulatory authorities, and also from regional regulatory authorities like the EMA,” he said.

Mariangela Simão, WHO’s Assistant Director-General, added that data was being assessed from all regions of the world: “Millions and millions of AstraZeneca doses have been distributed and used in Latin America, Africa, India and other countries in Asia so we are very actively proactively collecting data from different national regulatory authorities,” said Simão. “We are also in touch with AstraZeneca, as AstraZeneca has an obligation to monitor the safety data and report to the WHO.”

‘Let’s Not Speculate’ About Serum Institute of India Vaccine Supplies to COVAX 

Dr Bruce Aylward

Related to the vaccine shortage issue, Bruce Aylward, Tedros’ special advisor and the WHO’s lead on COVAX, dismissed a reporter’s question about the possibility that the Serum Institute of India (SII) might delay vaccine deliveries to COVAX until as late as June – well beyond the April suspension date announced by Gavi, The Vaccine Alliance late last month.  SII suspended its exports abroad after being asked by the Indian government to redirect its production to the domestic Indian market – which is seeing a surge in coronavirus cases. 

“Let’s not speculate on what’s going to happen in terms of future deliveries from any of the companies that we’re working with,” said Aylward.

“Right now, every country we talk to, every company, is trying to make sure that they prioritise COVAX and that we get the vaccines that we need. Obviously, if we have an interruption with any one of our suppliers for a short time, a month or so, we can find ways to manage as best we can, but if it prolongs for longer, that would be a challenge.”

Aylward added that some additional supplies from SII had come through in the past few days to enable “which are important to all countries being able to start vaccination by the end of the 100-day period”.

Aylward also stressed that the vaccine supply situation was “fluid” and COVAX also had deals with other pharma manufacturers, most notably Johnson and Johnson and Novavax, which are due to come online in the coming weeks and months.

 

Ugandan private health providers have been given the green light to import and distribute their own COVID-19 vaccines.

In what may be a first for the African continent, the Ugandan government has decided to allow private sector health providers to import and distribute their own COVID-19 vaccines amidst strict regulations – in an effort to expedite the country’s vaccination drive, which is caught in the crosswinds of vaccine supply shortages plaguing the entire region and low-income countries more generally.

The Ugandan decision comes just after the Kenyan government decided last week not to allow the private importation of vaccines –  due largely to fears of fake vaccines swamping markets.

The immediate future of vaccine roll-outs in African countries remains uncertain in the wake of India’s recent decision to suspend for the immediate future, its bulk supplies of AstraZeneca vaccines, produced by the Serum Institute of India (SII), to low-income countries in Africa, Asia and the Americas.  Those countries are largely  dependent on vaccine deliveries arranged through the WHO co-sponsored COVAX facility.   Meanwhile, South Africa and Nigeria have also made strategic decisions to shift away from further bilateral purchases of the AstraZeneca vaccine in favour of the Johnson and Johnson jab – which will nonetheless take longer to deliver.

In an effort to expedite the vaccination drive, the Ugandan Ministry of Health last week outlined the rules whereby the private sector will be able to participate in the  COVID-19 vaccine supply chain, including an accreditation process which will require them to source the vaccine, detail the quantities to be imported and the cold chain capacity of the provider.

Providers will  be required to import only those vaccines that have received an “Emergency Use Listing” from the World Health Organization as well as being cleared by the national drug regulator, the Uganda National Drug Authority.

Uganda has thus far vaccinated 80,836 people since vaccinations commenced on 10 March.  The country received a first tranche of 864,000 doses of the AstraZeneca COVID-19 vaccine on 5 March from the COVAX facility – out of a total expected COVAX supply of about 3.5 million doses that was supposed to be delivered over the course of 2021.  But as with many African countries, COVAX vaccine deliveries for April, May and possibly even beyond, are now in jeopardy due to the suspension of Indian exports – as SII redirects its vaccine production to domestic use in India, which is seeing a surge of COVID cases.  

“A list of facilities will be provided and a Memorandum of Understanding will be  signed spelling out the modalities of the collaboration,” said Jane Ruth Aceng, the Minister of Health, regarding the private procurement arrangements. She added that the vaccines authorized for import to private sector health service providers, would have to be administered by that same health care provider – and could not be resold again. The ultimate goal, said Aceng, was to protect the consumer.

Ugandan Health Minister Jane Ruth Aceng

Safety of Citizens is Paramount

Alfred Driwale, the programme manager of Uganda National Expanded Programme on Immunisation echoed Aceng’s sentiments: “One of the roles of the government is to protect the public so we want to know most importantly the source of the vaccine. The safety of the people is paramount”.

The private sector represents half of all health services delivered in Uganda.  But up until the pandemic, private health care providers have not been deeply involved in mass immunisation programmes. In Uganda, over 90% of immunisations are administered free of charge by the public health system, which receives support from GAVI, The Vaccine Alliance.   

The Private sector will also be required to import the vaccines through the National Medical Stores which is the national agency for the storage, importation and distribution of all drugs in Uganda. This will ensure that the maintenance of the cold chain and viability of the vaccines, officials said.

“If the private sector will help us to acquire COVID-19 vaccines it is good and we have created rules to have order ” said Driwale. He said a few private players have approached the Ministry of Health, but none have qualified yet.

High Demand, Low Supply Opens Market for Fake Vaccines

However, allowing the private sector to participate in the COVID-19 supply chain at a time when demand outweighs supply, opens the market to fake vaccines and exploitation and abuse, Gideon Badagawa, the Executive Director of the Private Sector Foundation-Uganda told Health Policy Watch. Badagawa said he is against complete liberalisation of the COVID-19 vaccines for the private sector in Uganda  and said the government should remain in control to maintain standards and enable the private sector to follow specifications. 

In cases where private sector health services are authorized, participation should be in a ‘phased manner’ – allowing only those who meet the government specifications to participate. In the case of COVID vaccines, he said, only about 10 health sector entities would have the capacity.  “They can allow just a few players initially because the COVID-19 vaccines are delicate and not everybody can participate in the market,” said Badagawa, adding that: “If we import in partnership with the government it will enable us to follow the specifications that are required”.

Grace Kiwanuka, Executive Director of the Uganda HealthCare Federation had mixed reactions to the decision. “It is a right step to mobilise domestic resources and it helps us to achieve herd immunity which would be difficult if only left for the government,” she said. But on the other hand, she warned that Uganda is an open economy – and privatizing the vaccine market opens the way for profiteers to substitute saline and glucose solutions for genuine vaccines.

For just those reasons, Uganda’s neighbory, Kenya, on Friday said that it would ban the “ importation, distribution and administration of vaccines, until such time there is greater transparency and accountability in the entire process”.  The Kenyan government’s ban comes amid fears that counterfeit inoculations may otherwise infiltrate the market.  

WHO Risk communication and Infection Prevention and Control teams provide massive community sensitization on COVID-19 vaccinations

South Africa’s Medical Aid Giant Ready To Help With Vaccinations

Meanwhile, frustration over the slow pace of vaccination in South Africa also saw the health services giant, Discovery Health, announce plans last week to vaccinate up to 550, 000 of its high risk members within weeks of vaccines becoming available, through a partnership with the South Africa government.  In the case of South Africa, however, the supplies would still be procured by the government, and then distributed by Discovery Health. 

The private medical aid company said it plans to vaccinate up to 50, 000 of its members a day. 

Discovery Health CEO Adrian Gore said the company would be establishing  20 large-scale vaccination sites and plans to vaccinate three million adult beneficiaries, beginning on May 1.

Gore  said Discovery would not be importing any vaccines, but that it was ready to vaccinate its members in high volumes when the supply of vaccines became available from the South African government’s health department.

“Our segmentation approach is aligned with the national prioritisation framework, as guided by the ministerial advisory committee. Simply, this means that we know exactly who should receive the vaccine first, and we will communicate quickly with our scheme members to confirm their place in the roll-out, contingent on vaccine supply,” Gore explained.

“This would help realise meaningful health and economic outcomes, and avoid many preventable Covid-related deaths,” he said, adding that those who qualify to receive the vaccine, will be contacted by the medical aid.

Abacus pharma Limited , one of the companies hoping to participate in the COVID-19 vaccine supply chain in East Africa, said collaborating with the government would help expedite the COVID-19 vaccination drive.

“Opening up the vaccines to the private sector will help accelerate the process of providing protection as long as it is done in a thoughtful manner and in line with regulatory requirements,” said Rajaram Sankaran, Group Chief Executive Officer & Director on Board at Abacus Pharma (Africa) 

“We would be glad to collaborate with the government such that we complement their efforts and not duplicate. Such public-private partnerships would be more sustainable in the long run,” Sankaran told Health Policy Watch. 

Image Credits: ABC7 News.

A new survey shows that the use of family planning services in Kenya increased from 56% in 2019 to 61% despite curfews and lockdowns.

Kenya’s family planning services experienced a 5% increase in the uptake of modern contraceptives at the height of the COVID-19 pandemic last year, possibly contributing to a decline in unwanted pregnancies in the country, a new survey has shown.

The survey, conducted by Performance Monitoring for Action (PMA), shows that the use of family planning services increased from 56% in 2019 to 61% in 2020 in married women and from 40% to 46% in all women, despite curfews and lockdowns.

The PMA generates surveys of key health indicators in nine countries in Africa and Asia, whose open-resource data is available for research, programme planning and policymaking. 

The increased use of contraceptives is likely to have contributed to the decline of unintended pregnancies over the same period from 42% to 37%. 

The survey – done between November and December last year in 11 counties (Nairobi, Kilifi, Nandi, Nyamira, Kiambu, Bungoma, Siaya, Kericho, Kitui, Kakamega and West Pokot) – also found that unmarried women prefer short-acting methods, while their married counterparts chose longer-acting methods.

The most popular method for unmarried women were male condoms (29%), injectables and implants (both at 26%). The married women, on the other hand, preferred injectables (39%) and implants (37%).

Family Planning is an Essential Service 

Albert Ndwiga, the National Family Planning Program manager in the Ministry of Health, said family planning was an essential service and that the country “had to come up with guidelines quickly to ensure continued care in public health facilities during the pandemic”.

Family planning services are offered free of charge in public health facilities in Kenya. The guidelines were formulated in April last year, giving directives to facilities on how to protect the client and the service provider.

The government is now collaborating with the private sector, which supplies over a quarter of Kenyans (28%) with their family planning methods and commodities. 

“Some may choose to get services from the private sector because of the convenience it offers to them, therefore reducing the burden on government-owned facilities,” Ndwiga said, adding that the health ministry has formulated a “total market approach” as a result. 

The ministry has also actively engaged with communities “because issues around culture and religious beliefs have for a long time affected the uptake of family planning,” observes Josephine Kinyua, the director of Delivering Equitable and Sustainable Increases in Family Planning (DESIP) in Kenya, a program funded by the UK.

The DESIP program is implemented in 19 counties where the modern method contraceptive prevalence rate is less than 45%.

Commodity Financing and Economic Empowerment

Ndwiga said family planning was going to be included as one of the government’s four key agendas, of which universal health coverage is a key component. The agendas include food security, affordable housing, manufacturing and affordable healthcare for all.

Kenya’s government has committed to financing 100% of family planning commodities by 2023, and Ndwiga said they were now able to use health insurance to fund family planning.

Linking family planning with economic empowerment has contributed to increased uptake, according to Kinyua, who said some counties were now introducing bills geared towards funding maternal and child health alongside family planning.

“This will ensure that later, even if the programme is no longer there, some funding will be available to support maternal and child health,” she said.

However, cutting back on family planning commodities wastage would also go a long way towards saving money. This could be achieved by improving the quality of family planning services.

Ndwiga said an example of preventing wastage would be if a mother is counseled properly so that if she chooses to have a long-term contraceptive method, she will not change her mind after two months to have it removed.

“Because if that implant is meant to last for five years, but is removed after only two months, you lose four years and 10 months that it could have been used,” he says.

Data is Important to Inform Policies and Programs

Contraceptive use is known to be one of the determinants that influence fertility, according to Dr Anne Akonyo, senior lecturer and director of population studies at the University of Nairobi.

“It is one of the greatest inhibitors of fertility when used properly,” she explains.

Professor Peter Gichangi, the lead investigator of the PMA, says that the data collected should not just be used to inform programmes, policies and scientific publications, but as data sets that can be used for different purposes.

The data presented also posed some questions that need further investigating such as stock-outs for Intrauterine Devices (IUDs), which increased from 7% in 2019 to 11% in 2020.

Image Credits: iStock.

A “human error” at a Johnson & Johnson production facility caused millions of doses of its COVID-19 vaccine to be spoiled and unusable.

A mix-up with vaccine ingredients at a production site in Baltimore, Maryland, which is manufacturing both the Johnson & Johnson and AstraZeneca COVID-19 vaccines, has led to the contamination of 15 million J&J doses, which risks delaying national and global deliveries of the recently-approved vaccine. 

The pharma company, which is producing the world’s first single dose COVID-19 vaccine, announced Wednesday that a batch of doses failed its “rigorous quality control” standards. The doses were manufactured at a facility run by Emergent BioSolutions, which has production deals with both J&J and AstraZeneca.

Federal officials have described the issue as human error, as workers at the plant reportedly confused components for the two vaccines in late February. It took several days for the mistake to be recognised, ruining a batch of millions of doses.

The Emergent Bayview Facility in Baltimore has not yet, in fact, been authorised by the US Food and Drug Administration (FDA) to manufacture the J&J drug substance, but is currently under review for Emergency Use Authorization. 

The authorization has been held up by the FDA’s investigation into the site’s lapse in quality control.  

J&J will send experts in manufacturing, technical operations, and quality monitoring to supervise and support activity at the facility and gain more control over the manufacturing processes to avoid another public hiccup in production.

The production of Johnson & Johnson’s one-shot COVID-19 vaccine, delivered through an inactivated adenovirus.
Potential Delays in Vaccine Shipments

J&J stressed, however, that the error won’t impact its upcoming delivery to the US of 11 million doses, forecasted to arrive this week from a manufacturing site in the Netherlands. However, the company had been expected to deliver 24 million more doses to US destinations from the Baltimore site in April.

Although J&J officials said that they intend to remain on schedule with deliveries, US health officials said that they anticipate fluctuations in the vaccine delivery timetable, saying it could still take weeks to get the facility up to regulatory standards.

The US has ordered a total of 100 million doses from J&J, which are to be shipped by the end of June.

As of Thursday, approximately 7.8 million J&J doses were delivered and 3.4 million doses administered, according to the US Centers for Disease Control and Prevention.

The J&J vaccine has widely been regarded as essential to speed up vaccination campaigns globally due to the fact it is a one-jab vaccine as well as its logistical advantages: it can be stored for at least three months at temperatures of 2-8°C and can be transported using existing cold chain technologies and standard vaccine distribution channels.

“Changing the trajectory of the pandemic will require mass vaccination to create herd immunity, and a single-dose regimen with fast onset of protection and ease of delivery and storage provides a potential solution to reaching as many people as possible,” said Mathai Mammen, Global Head of Research and Development at Janssen Pharmaceuticals – a Belgian pharma company owned by J&J and responsible for developing the vaccine – in a press release published in late February.

J&J expects to deliver one billion doses globally by the end of 2021, including some 400 million doses to African Union member states beginning in the third quarter of 2021. An agreement is also underway between J&J and Gavi, the Vaccine Alliance to provide 500 million doses to the WHO co-sponsored global COVAX Facility through 2022. The facility is trying to ensure more equitable distribution vaccines to low- and middle-income coutnries.  

However, insofar as J&J has already faced previous manufacturing delays in January, it remains to be seen if J&J will succeed in scaling up production to meet its commitments. 

CDC Warns – US Facing Fourth Wave of COVID-19 In ‘Critical Moment’ for Pandemic

Meanwhile, the US could be facing an imminent fourth wave in the pandemic, with COVID-19 cases increasing in 25 states, and an average of 64,000 new cases reported daily over the past week, officials from the US Centers for Disease Control warned. The rise in cases coincides with multiple states loosening COVID restrictions on social distancing and other measures.

Cases have increased by 12% from last week, accompanied by higher hospitalisation and death rates, with a seven day average of deaths at 940 per day. 

“This is a critical moment in our fight against the pandemic. As we see increases in cases, we can’t afford to let our guard down,” said Dr Rochelle Walensky, Director of the CDC, at a White House press briefing of the COVID-19 Response Team.  

“We need to keep taking the mitigation measures, like wearing a mask and social distancing, as we continue to get more and more Americans vaccinated every single day,” Walensky added, speaking at a White House press briefing on Wednesday. 

The B.1.1.7 variant, first identified in the United Kingdom, is responsible for 26% of the SARS-CoV2 variants circulating across the US, and it is the predominant strain in at least five regions of the country. 

“We do know it’s more transmissible – somewhere between 50 and 70 percent more transmissible than the wild-type strain,” said Walensky. “So to the extent that people are not practising those standard mitigation strategies, we do think that more infections will result because of B.1.1.7.”

At the same time, however, several states have begun abandoning mask mandates and allowing for more social gatherings, which may provide an opportunity for the virus to spread as well as to mutatey, developing new deadly variants. 

“The failure to take this virus seriously [is] precisely what got us in this mess in the first place [and] risks more cases and more deaths,” said President Joe Biden at a press conference on Monday.

Joe Biden, US President, delivering his presidential remarks on COVID-19 response and vaccinations on Monday.

BIden pledged that the US will continue scaling up its vaccination campaign, setting the goal of having a vaccination site within five miles of every American by 19 April.

“We are in a ‘life-and-death race’ against the virus. We are facing an accelerating threat,” said Andy Slavitt, Acting Administrator of the Centers for Medicare and Medicaid Services, at the White House press briefing on Wednesday.

This will simultaneously require continued adherence to public health measuring and the improvement of vaccine access nationally.

Image Credits: Johnson & Johnson, Johnson & Johnson, C-Span.

Community health worker distributes ivermectin – the mainstay treatment against onchocercisasis (river blindness) – for the past several decades.

A recent trial of ivermectin, a mainstay treatment for the parasitic disease onchocerciasis for the past three decades, has failed to show significant impacts against COVID-19, a new study,  published in JAMA, reports. The study by a group of researchers in Cali, Colombia found that the use of the antiparitic drug, typically used to treat onchocersiasis  (river blindness) endemic to West Africa, did not not significantly shorten the durationof COVID symptoms in patients with mild disease.

The study of some 400 people found that those trated with the drug had a resolution of symptoms in 10 days, on average, as compared to 12 days – but the two day difference was not deemed statistically significant. “Further trials of ivermectin as a treatment against COVID-19 are, however, still underway. The ANTICOV Consortium, for example, is considering adding ivermectin – in combination with another drug – as an additional arm of its ANTICOV series of clinical trials underway in Africa.  The clinical trials, coordinated by DNDi, are testing the efficacy of different drugs as a potential treatment against mild to moderate cases of COVID-19.”

In light of the inconclusive evidence, WHO, meanwhile, has issued a recommendation that use of ivermectin be limited to clinical trials, until more data is available. This recommendation, which applies to patients with COVID-19 of any disease severity, is now part of WHO’s guidelines on COVID-19 treatments.

Ivermectin is a broad spectrum anti-parasitic agent, included in WHO essential medicines list, and a mainstay of treatment against river blindness for the past four decades or more. Following the breakthrough discovery of efficacy in trials conducted by WHO in the 1970s, it was put into widespread use in West Africa, where river blindness is endemic, under programmes of preventative, mass community administration of the drug once a year.  Only in the past several years has a new treatment for river blindness, moxidectin emerged, which shows promise of even greater efficacy against onchocerciasis. Ivermectin is also used for the tratment of scabies, strongyloidiasis and other diseases caused by soil transmitted helminthiasis.

Ivermectin is traditionally used against onchocerciasis and scabies

The current WHO guidance on ivermectin was issued following a review of the evidence by an international panel of experts. The group reviewed pooled data from 16 randomized controlled trials (total enrolled 2407), including both inpatients and outpatients with COVID-19. They determined that the evidence on whether ivermectin reduces mortality, need for mechanical ventilation, need for hospital admission and time to clinical improvement in COVID-19 patients is of “very low certainty,” due to the small sizes and methodological limitations of available trial data, including small number of events. The panel did not look at the use of ivermectin to prevent COVID-19, which is outside of scope of the current guidelines.  Other WHO recommendations on COVID-19 treatments include:

  • Strong recommendation for the use systemic corticosteroids (e.g. dexemethesone) for severe or critically ill COVID-19 patients; with a conditional recommendation against their use in patients with mild/moderate COVID-19;
  • Conditional recommendation for the use of low dose anticoagulants in hospitalized patients (this recommendation is part of the clinical management guidelines). We suggest the use of low dose anticoagulants rather than higher doses, unless otherwise indicated;
  • Conditional recommendation against administering remdesivir in addition to usual care;
  • Strong recommendation against the use of hydroxychloroquine or chloroquine for treatment of COVID-19 of any severity;
  • Strong recommendation against administering lopinavir/ritonavir for treatment of COVID-19 of any severity.

Updated on 6 April 2020. 

Image Credits: Mectizan Donation Programme, Sarang.