The inequitable distribution of COVID-19 vaccines is the result of the “complete collapse of global co-operation and solidarity”, Dr John Nkengasong, Director of the Africa Centres for Disease Control and Prevention (Africa CDC), told a panel on vaccine equity at the World Economic Forum on Tuesday.

“The moral failures that we witnessed over the last two years cannot be repeated in 2022,” he added.

“We have to remain optimistic in Africa that, as a continent, we should strive to get to the 70% [global vaccination] target, but we are on 10%. How do we get from 10% to 70%? We really have to bring all forces to bear to increase our global cooperation, partnership, solidarity and coordination to try to move from where we are to 70%, recognising that it is only through that massive coordinated efforts that we could all be safe.”

Nkengasong added that Omicron’s rapid spread had borne out predictions that global safety involved global vaccination.

“We’ve seen what Omicron has done. We all said this at the start: that if we did not protect and invest at speed, even those who have been vaccinated will be challenged. We truly don’t know what the next variant will look like and the only way to prevent other variants is to vaccinate at scale and that includes Africa.”

COVAX hit ‘barrier after barrier’

Seth Berkley CEO of Gavi, the vaccine alliance that manages COVAX, said that “the original plan was to have every high-risk person in the world vaccinated at the same time, and every health worker and then moving to low-risk people”.

“Of course, that’s not what happened,” said Berkely, noting that while COVAX had managed to deliver the first vaccine to a developing country 39 days after high-income countries, the vaccine platform then “hit barrier after barrier”.

“We had export bans, we had vaccine nationalism, we had companies not meeting their requirements to put doses forth,” said Berkley.

He also warned that delays had also fuelled vaccine hesitancy and complicated delivery.

“The good news is that, in general, developing countries actually appreciate vaccines more because they see the diseases and so the vaccine demand has always been higher, and vaccine hesitancy is actually been lower. But it’s more complicated at this point,” said Berkley.

More COVID deaths related to inequality than old age

Gabriela Bucher, Executive Director of Oxfam International

Gabriela Bucher, Executive Director of Oxfam International, told the WEF session that research showed “inequality is a higher predictor of COVID-19 deaths than age”.

“We have seen vaccine hoarding over and over again, and [governments protecting pharmaceutical monopolies”, said Bucher.

Oxfam published a report this week on COVID-related inequity, including that the wealth of the world’s 10 richest men has doubled since the pandemic began, while the incomes of 99% of humanity are worse off because of COVID-19.

Bucher said that lifting intellectual property rights from the beginning of the pandemic and allowing vaccines to be produced at scale across the world would have been “a game danger”.

“We would have avoided not only deaths directly from COVID but all the deaths that have been associated with growing inequality and crippled health systems across the world,” she added.

Breakdown of trust

Dr Michael Ryan, Executive Director of the World Health Organization (WHO) Health Emergencies Programme, said that while COVID-19 would not be eliminated this year–  and SARS-CoV2 might never be eliminated – “we can end COVID as a public health emergency”. 

But, said Ryan, the global pandemic response system was not “fit for purpose” to end this or future pandemics.

“What is very clear is that the current mechanisms that are in place for the production of vaccines do not lead to the equitable distribution of these vaccines,” said Ryan.

“One of the most scarce commodities in this whole pandemic response has been trust: trust between communities and government, trust between countries, trust between manufacturers,” he added.

Serum Institute of India appeals to African countries to ‘get in touch’

Adar Poonawalla CEO of the Serum Institute of India (SII), said that his company had 1.5 billion vaccine doses in the past year, and “actually have to stop production in December because we had 500 million in stock”.

“Vaccine supply is no longer a constraint,” said Poonawalla. “We’ve supplied vaccines to the African continent and it supported over the last many decades. We are ready to support you again. Please get in touch.”

SII was supposed to be the key supplier for COVAX of a generic version of the AstraZeneca vaccine, but stopped its supply to attend to India’s domestic vaccine needs. This generated bad blood between the company and African countries.

However, according to Poonawalla, the SII will “probably supply a billion-plus doses in the first quarter of 2022 through COVAX to the African continent.”

protest fine
Tens of thousands of people protested against COVID-19 vaccine passes across France

France’s newest measure to tackle COVID-19 – requiring a certificate of vaccination at public places such as restaurants, cafes, cinemas, and long-distance trains – was approved by its parliament on Sunday. 

With lawmakers in the lower house of parliament voting 215 to 58 in favour, the law is set to be enforced in coming days.

President Emmanuel Macron told Le Parisien paper in an interview this month that he wanted to “piss off” unvaccinated people by making their lives so complicated they would end up getting the COVID vaccine. 

“The unvaccinated, I really want to piss them off. And so we’re going to continue doing so until the end. That’s the strategy,” said Macron.

Currently, unvaccinated people can enter these places with recent proof of a negative COVID-19 test. 

The new law is part of a string of mandates that have been implemented across the European Union (EU) in an effort to quell the rise in cases. Greece, Italy, and Austria have begun to implement fines or mandatory vaccinations for adults. 

France is experiencing its fifth COVID-19 wave, with daily cases hitting record highs of over 300,000. However, the number of serious hospitalizations is much lower than compared to the first wave in March and April 2020. 

Unvaccinated Greeks to pay monthly fines

Individuals 60 and over will be fined if they do not receive their COVID vaccination in Greece.

Greeks over the age of 60 who have not yet scheduled an appointment to get their first jab against COVID-19 will be fined every month, starting on Monday, o boost lagging vaccination rates and reduce pressure on healthcare in Greece.  

The monthly fine will be 50 euros ($57) in January, but will rise to 100 euros ($115) in subsequent months.

Speaking on Greece-based Skai Television, Health Ministry General Secretary Marios Themistocleous said there would be no extension to the rule for those over 60: “Whoever does not get vaccinated will pay the fine every month,” he said.

This decision follows a rise in cases as Omicron sweeps through Greece, with 20,409 new cases reported in the last 24 hours. 

Authorities have also decided to extend other COVID-19 measures, including midnight curfew for bars, restaurants and cafes; no music at venus; and mandatory high-protection masks at supermarkets and on public transport until 23 January. 

Prime Minister Kyriakos Mitsotakis told seniors that the simplest way to avoid the fine is to get vaccinated. Greek authorities say the non-vaccinated remain at high risk for hospitalization from coronavirus.

Some 90% of COVID-19 related deaths have been among people 60 and above, while 70% of those hospitalized from the virus are over 60, and of those 80% are unvaccinated. 

Over 50 fined in Italy without booster shot 

Italy is implementing a similar fine with its population – people 50 and over could be fined 100 euros ($115) if they fail to get their booster shot, according to the country’s latest COVID restrictions.

The government’s 5 January decree now requires people over 50 to have a ‘super green pass’ health certificate showing that they are either vaccinated or recently recovered from COVID, in order to enter the workplace. Anyone in this age group, employed or not, is also at risk of being fined 100 euros if they do not get vaccinated by 1 February. 

In addition, those who do not get their booster shot also could face a 100 euro fine.  

“We are working in particular on the age groups that are most at risk of being hospitalized,” said Italian Prime Minister Mario Draghi. 

This new mandate applies to anyone currently 50 or over living in Italy, or anyone due to turn 50 by 15 June. 

The fines will be collected by Italy’s Agenzie delle Entrate (Inland Revenue-Recovery Agency). 

People notified they are in violation will have ten days to communicate to their local health office, the reason for their vaccination status. 

COVID-19 vaccinations to become mandatory for 18 and over in Austria 

Protests in Vienna, Austria over compulsory vaccination.

Austria plans to make COVID-19 vaccinations mandatory from February for Austrian residents 18 and older, the government confirmed on Sunday. 

Presenting the final version of a draft law at a press conference on Sunday, Chancellor Karl Nehammer sought to reassure Austrians that the vaccine works.

“It’s not about fighting the vaccinated against the unvaccinated,” but rather to underscore that “vaccination is the best guarantee that we can live together in freedom.” 

The mandate will apply to Austrian residents 18 and older, with exemptions for pregnant women and people who cannot receive the vaccine due to medical reasons. 

While the law will take effect 1 February, police checks won’t be carried out until 15 March. Unvaccinated people then face a penalty of around 600 euros (US $684) and up to 3600 euros (US $4105). 

Those noncompliant with the mandate will be fined up to four times a year; however, the fine will be dropped if the recipient is vaccinated within two weeks of receiving the penalty notice.

Though the Austrian parliament still has to vote on Thursday on the vaccination mandate, the law is expected to pass. Around 74% of Austria’s population is vaccinated against COVID. 

Image Credits: akilligundem/Twitter, John Perivolaris/Flickr, Ama Bushman/Twitter.

On 24 February 2021, a plane carrying the first shipment of COVID-19 vaccines distributed by COVAX landed in Ghana.

Rwanda became the recipient of the one-billionth COVID-19 vaccine delivered by COVAX, the global platform set up to ensure equitable access to the vaccines,announced last Friday.

After numerous supply problems – most seriously when its key supplier, the Serum Insitute of India, was banned from exporting its vaccines by the Indian government – COVAX was forced to slash its 2021 delivery target from two billion to 930 million doses.

However, since mid-December, COVAX delivery has escalated substantially, and 100 million vaccine doses were delivered in the last week of December alone.

“COVAX is leading the largest vaccine procurement and supply operation in history, with deliveries to 144 countries to date,” said the World Health Organization (WHO) over the weekend.

“But the work that has gone into this milestone is only a reminder of the work that remains. As of 13 January 2022, out of 194 Member States, 36 WHO Member States have vaccinated less than 10% of their population, and 88 less than 40%,” said the WHO.

“COVAX’s ambition was compromised by hoarding or stockpiling in rich countries, catastrophic outbreaks leading to borders and supply being locked. And a lack of sharing of licenses, technology and know-how by pharmaceutical companies meant manufacturing capacity went unused.”

Dr Seth Berkley, CEO of Gavi – the vaccine alliance that manages COVAX – said he was “proud that nearly 90% of the first billion doses COVAX has delivered have been fully-funded doses sent to the low and lower-middle countries supported by the Gavi COVAX Advance Market Commitment (AMC)”.

 

This had been made possible thanks to donations of over $10 billion to COVAX, added Berkley.

“Inequality in vaccination is enormous with 41% of the world not yet vaccinated with even one dose,” added Berkley. “In 2022, Gavi will be fundraising to make sure lower-income countries are able to access variant-adapted vaccines, boosters or additional doses as needed. COVAX will be focusing on supporting lower-income countries’ vaccination objectives – that means also raising money to ensure tailored support for preparedness and delivery, particularly for the highest-risk countries, to increase their ability to absorb the doses delivered as rapidly as possible.”   

Richard Hatchett, CEO of the Coalition for Epidemic Preparedness Innovations (CEPI), which is a COVAX partner, also welcomed the milestone, but warned that while supply constraints had eased, “booster programs and the potential production of Omicron-specific vaccines may yet create pressure on supply”.  

Meanwhile, Eva Kadilli, director of UNICEF’s supply division, which carries out the COVAX deliveries, also welcomed the billionth delivery and thanked her teams throughout the world.

 

 

 

 

 

Image Credits: WHO, UNICEF.

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.

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. 

 

 

A Palestinian health worker administers a COVID-19 test to young child

Some researchers and governments are questioning the accuracy of rapid antigen tests to identify Omicron – and it has been suggested that rapid tests based on throat- instead of nasal swabs might be more accurate in detecting the highly infectious COVID-19 variant.

Last week, a small pre-print study reported that 29 fully vaccinated and boosted individuals who became infected with Omicron during December were diagnosed by PCR tests three days sooner on average than testing positive with antigen tests (also called lateral flow tests). 

The study, which tracked COVID-19 in five workplaces in New York and California through daily employee testing, used saliva-based PCR tests and antigen tests using nasal swabs.

Lead author Dr Blythe Adamson told Health Policy Watch that the median time from the first positive PCR to the first detectable antigen-positive test was three days and that the viral load appeared to peak in an individual’s saliva as much as one to two days before in their nasal cavities. 

“We did epidemiological investigations and contact tracing and had four confirmed transmissions in the time period between phase zero and one, when the antigen test was negative and the PCR was positive,” added Adamson.

All individuals developed symptoms within two days of the first positive PCR test results, but the antigen tests only revealed a positive result after they developed symptoms. 

UK sticks to rapid tests

The US Food and Drug Administration (FDA) recently warned: “Early data suggests that antigen tests do detect the Omicron variant but may have reduced sensitivity.” 

However, the FDA acknowledged that antigen tests “are generally less sensitive and less likely to pick up very early infections compared to molecular tests”, adding that “if a person tests negative with an antigen test but is suspected of having COVID-19, such as experiencing symptoms or have a high likelihood of infection due to exposure, follow-up molecular [PCR] testing is important for determining a COVID-19 infection”. 

Meanwhile, the UK Health Security Agency reported last month that the antigen tests it was using “indicate a comparable sensitivity [to Omicron]  to that observed for previous strains of SARS-CoV-2 including Delta, which has been the predominant strain in the UK from May to December 2021”.

Rapid tests are accurate once symptoms start

A Cochrane review of 64 studies measuring the accuracy of antigen tests published in March last year, before Omicron emerged, found that the rapid tests detected almost three-quarters of COVID-19 cases once people showed symptoms but only 58% of cases in people without symptoms.

“Tests were most accurate when used in the first week after symptoms first developed (an average of 78% of confirmed cases had positive antigen tests). This is likely to be because people have the most virus in their system in the first days after they are infected,” according to the review.

“In people who did not have COVID-19, antigen tests correctly ruled out infection in 99.5% of people with symptoms and 98.9% of people without symptoms.”

Meanwhile, in the face of its growing COVID-19 caseload, Israel recently switched to home testing, opting to reserve PCR tests for older people. However, this week it urged those who have come into contact with someone with the virus to take an antigen test 72 hours after exposure rather than 12 to 24 hours and asked people to put the swab in the throat and not just the nose.

Scientists believe that one of the reasons the antigen tests may be less effective is that Omicron infects the throat more than the lungs so throat swabs or saliva tests would be more effective.

“The method of testing only from the nose probably misses Omicron,” said Dr. Gili Regev-Yochay, director of the Infectious Disease Epidemiology Unit at Sheba Medical Center in an interview with Israeli media. “The swab should be inserted into the pharynx and from there into the nose, and only then will the sensitivity increase.”

However, most health professionals have been slow to give such advice for fear that users would swab their throats too deeply or in a way that could cause them harm. 

“You have to use the right test at the right time,” Adamson continued. “Omicron will not be the last variant. We need to make sure we are ready and able to better identify variants as they come.”

 

Image Credits: Alia Ameen/Twitter .