Afrigen is the lead partner in the South African mRNA hub

Africa could start producing its own cutting-edge COVID-19 vaccines within a year via an mRNA technology transfer hub that is being set up in South Africa, the World Health Organization (WHO) announced on Monday.

But the speed at which the new hub may be able to swing into full-scale vaccine production depends on whether pharmaceutical companies with proven mRNA vaccines will commit to supporting the initiative, according to WHO Chief Scientist Soumya Swaminathan.

WHO is in discussions with “the larger companies that have proven mRNA technology”, and is “hoping very much that they will come on board”, Swaminathan revealed.

If a big pharma partner does indeed come forward, vaccines could be produced in South Africa ”within nine to 12 months”, she declared at a WHO media briefing Monday.

South African President Cyril Ramaphosa described the hub as a “landmark initiative” that “will put Africa on a path to self-determination” in terms of vaccine development and manufacturing capacity.

“We just cannot continue to rely on vaccines that are made outside of Africa because they never come. They never arrive on time. And people continue to die,” Ramaphosa told the WHO briefing.

The hub consists of South African companies Afrigen Biologics and Vaccines and Biovac, a network of universities, and the Africa Centre for Disease Control.

Afrigen will manufacture the mRNA vaccines and provide training to Biovac, according to WHO Director General Dr Tedros Adhanom Ghebreyesus.

“In time, Afrigen could provide training to other manufacturers in Africa and beyond,” said Tedros.

Timelines Depend on Big Pharma Support

WHO Chief Scientist Soumya Swaminathan

If the major mRNA manufacturers – primarily Pfizer and Moderna – do not support the South African hub, the WHO was considering “several options” from smaller biotech companies” that are further back in the development pathway – but this would mean running clinical trials. 

“The timelines of when vaccines can be produced in the country will depend on whether there’s a tried and tested technology that can be much more easily transferred to the facility in South Africa, which by the way already exists,” said Swaminathan.

“There’s already a pilot plant there, so all we would need is to put in some equipment and train the workforce on this new process, and … [source] all the raw materials and things that are going to be needed for this.”

Running trials would delay manufacture, but “the good thing is South Africa has huge capacity in clinical trials in R&D and the regulatory agency there is very strong and up to speed,” she added. 

French Welcome Hub to ‘Respond to Variants’

The hub has the support of the French government, and President Emmanuel Macron said in a recorded message that it would “allow for a rapid response to develop new vaccines to address new variants of COVID-19 or newly emerging pathogens on the African continent, and for the benefit of the entire world”.

The announcement follows the recent visit to South Africa by Macron, who said his country was committed to supporting African efforts to scale up their local manufacturing capacity of COVID-19 vaccines and other medical solutions.

However, Ramaphosa stressed at the briefing that the hub needed to go hand in hand with the TRIPS waiver that his country and India are pushing for at the World Trade Organization, to ensure that “real intellectual property can be transferred”.

The hub stems from a call made by the WHO in April for Expressions of Interest (EOI) to establish COVID mRNA vaccine technology transfer hubs to scale up production and access to COVID vaccines. 

“Technology transfer hubs are training facilities where the technology is established at industrial scale and clinical development performed,” according to the WHO.

“Interested manufacturers from low- and middle-income countries can receive training and any necessary licenses to the technology. WHO and partners will bring in the production know-how, quality control and necessary licenses to a single entity to facilitate a broad and rapid technology transfer to multiple recipients.”

WTO is Addressing Vaccine Production Bottlenecks, Local Production Forum Hears

World Trade Organization Director-General Ngozi Okonjo-Iweala

Earlier in the day, governments, agencies and the private sector met virtually for the start of the World Local Production Forum, a global arena to discuss “opportunities and mechanisms for the promotion of local production and technology transfer”.

Addressing the opening of the forum, WTO Director-General Ngozi Okonjo-Iweala said that “before the pandemic, 10 countries accounted for 80% of global vaccine exports”. 

“We have now seen that over-centralization of vaccine production capacity is incompatible with equitable access in a crisis situation,” said Okonjo-Iweala.

“At the same time, the complexity of global supply chains necessary to manufacture COVID-19 vaccines makes clear that it is difficult for any one nation to produce everything in the entire value chain,” she added.

She and other speakers promoted the idea of regional production hubs, pointing out that Africa is already working with the European Union and other partners to advance such a hub involving South Africa, Senegal and Rwanda.

“Regional hubs can combine economies of scale with increased geographical diversification as called for by the World Health Assembly Resolution on strengthening local production,” she added.

“In the current crisis, the WTO can help by freeing up supply chains, by removing export restrictions and facilitating cross border trade.”

The WTO is hosting a supply chain transparency symposium later this month to identify blockages in supply. Next month it will co-host a meeting with WHO and vaccine manufacturers “to explore potential partnerships and investment opportunities particularly in emerging markets and developing countries”. 

Meanwhile, UNICEF executive director Henrietta Fore told the forum: “When products are manufactured closer to the people who need them, supply chains are more efficient,  shipping costs are lower, shipping times are faster, and our operations have a much smaller environmental impact.”

South Africa’s Director-General of Health, Sandile Buthelezi, said that Africa is reliant on India and China for generic medicine and active pharmaceutical ingredients. 

“Importation of medical commodities from these countries, while critical for meeting the healthcare needs of many low-income countries, has an impact on the trade balance of African countries,” said Buthelezi.

He identified training of personnel – particularly chemical engineers, pharmaceutical scientists and technicians –  and a supportive regulatory environment that included the “removal of obstacles related to intellectual property” as being priorities to enable local production.

Image Credits: Afrigen.

Civil society advocates around the world rally in early June to support a WTO waiver on IP rights associated with COVID tests, treatments and vaccines.

Proponents of a sweeping World Trade Organization ‘waiver’ on intellectual property rights for all COVID-19 treatments, tests and vaccines face an uphill battle to reach consensus on a text ahead of a WTO General Council meeting scheduled for 27-28 July. 

This is despite the recent agreement of the initiative’s opponents, including the European Union, Korea, Switzerland and the United Kingdom, to launch “text-based discussions”.

But according to the EU, those negotiations should also include elements covered by its own counter proposal submitted in early June.  

That was the EU position at the first “informal” meeting of the WTO’s TRIPS Council since countries reached agreement on 9 June to enter a “text-based process” on the IP waiver proposal – a move waiver advocates hailed as a breakthrough. 

As the next stage,TRIPS Council members are staging a series of informal and formal talks – expected to last for at least the next six weeks.  

European Union – More ‘Targeted’ Approach

The EU proposal focuses on some highly technical, but potentially significant, changes in the the existing rules around the WTO’s  Agreement on Trade-Related Aspects of Intellectual Property Rights (​TRIPS). 

The proposed changes in the highly-technical set of rules, EU proponents say, would make it faster, easier and cheaper for countries to issue compulsory licenses for the manufacture of much-needed COVID drugs and vaccines both domestically and for export to other countries lacking such manufacturing capacity by:

  • Waiving requirements that the manufacturing country first negotiate with the IP/patent rights holder before issuing a compulsory license;
  • Setting out principles Fixing standard rates of “adequate remuneration” to the IP rights holders for health products produced under a compulsory license;
  • Reducing now complex requirements around detailed notification to the WTO of products being exported and where  – which can delay their implementation;

The EU proponents claim that a “more targeted approach” to WTO rule changes would make the existing TRIPS flexibilities more fit to the purposes of the pandemic  – precluding the need for a blanket IP waiver. 

Along with the rule changes, other elements of the initiative, yet to be refined further, would support expanded production, while curbing the power of countries to impose export restrictions on raw materials needed for health products. 

The EU proposal comes in response to a much more sweeping waiver of all forms of IP, championed by India and South Africa, and supported by 61 other countries. 

South African and Indian Delegations – Discuss Scope of Waiver and Products Covered

At the informal talks on Thursday, the South African and Indian delegations said that the starting point for the negotiations should not be revisions to existing TRIPS formulas, but rather the “product” and “IP” scope of the waiver proposal that they have co-sponsored, Geneva-based trade officials attending the meeting observed.  

Waiver advocates meanwhile, are already beginning to mount the next stage of a campaign – this time targeting the new EU proposal – with Médecins Sans Frontières calling it an “insufficient solution in a pandemic”. 

Among the objections are the fact that the proposal only refers to vaccines and treatments – but not COVID tests or other health tools that may be essential to fighting the pandemic.  

The proposal also focuses only on patent obligations, whereas the waiver would go further – waiving rights on copyright, trade secrets and other kinds of IP-related knowledge, MSF said.   

And despite the streamlining of compulsory license rules that the EU has proposed,  MSF contended that even bigger changes would be needed “to make existing rules on compulsory licenses effective.” 

“Compulsory licenses come with unnecessary delays and complications when it comes to exporting medical tools, such as strict requirements for the packaging and colour of the products,” MSF said in its latest position statement. “The EU’s counter-proposal does nothing to address these issues, which means it falls short of the flexibility that a global crisis of this urgency demands.”  

United States: Focus On Common Objectives

The United States, in Thursday’s talks, said that rather than focusing on the “scope” of a proposed waiver, they would prefer to focus on “common objectives” – around which broader agreement might be reached.  

US officials also reportedly stressed that they could not accept the WTO General Council meeting on 27-28 July as a hard end-date for the negotiations – stressing that any outcome still has to be reached by consensus.  

The United States, in May, came out in support of a waiver on IP associated with COVID vaccines, but not medicines or tests.  The position, set by new President Joe Biden, appears to be picking up steam more broadly, including among mainstream groups such as the American Medical Association, which voted at an annual meeting this week to support the waiver proposal.  

The United Kingdom delegation at the WTO meeting, meanwhile, stressed that initial discussions over the course of the month should address the question of how a waiver – if agreed – would rapidly increase the supply of COVID-19 goods?

Switzerland, as well, has taken a strong position against a blanket WTO waiver on IP, following the lead of its large pharma industry.

“The fact that, since the outbreak of the pandemic, several vaccines against COVID-19 have been developed, industrially produced and authorised in record time impressively demonstrates that this incentive system anchored in the TRIPS Agreement also works during a pandemic,” stated the Swiss Patent Office, (IPI) in a statement. 

“Switzerland is therefore convinced that suspending the established international legal framework would be the wrong approach. Ïf the TRIPS Agreement were suspended, the WTO rules, which have been in force for over 25 years and accepted by 164 states, would no longer apply. Switzerland is convinced that established international rules provide an important basis, especially when dealing with a crisis.” 

 

 

 

Image Credits: Shutterstock.

From Indonesia and the Seychelles, to Chile and China itself, there are some worrisome indications that the Chinese Sinopharm and Sinovac COVID vaccines sold by the hundreds of millions to vaccine-strapped low- and middle-income countries may not be performing as well as expected – particularly against rapidly spreading variants of SARS-CoV-2.  

At the same time, it is too early to draw any conclusions, cautioned WHO’s Chief Scientist, Soumya Swaminathan on Friday – because there is a dearth of well-designed, real-life studies on the massive COVID vaccine rollout underway at either global or national levels.  

“We need more data, again from well designed studies on the efficacy of the different vaccines that are in use in different countries against the different variants,” said Swaminathan, speaking at a biweekly WHO press conference on Friday.

WHO Chief Scientist Soumya Swaminathan

She was responding to growing concerns that rapidly advancing vaccination drives are not necessarily leading to the hoped-for sharp reductions in new infections, hospitalizations, and deaths – possibly because some vaccines, including the Sinopharm and Sinovac vaccines from China, are weaker than other frontrunners like Pfizer, Moderna, AstraZeneca, or even Russia’s Sputnik V. 

Said Swaminathan, WHO has “actually compiled and provided on its website different study designs, to see what happens when people have one dose of the vaccine, two doses of the vaccine”. 

Such studies would compare COVID illness among those who get vaccines – as compared to those who do not, as the vaccines are rolled out. 

However, the overwhelming focus of WHO so far, has been getting any approved vaccines to low- and middle-income countries. Comparing how well different vaccine formulations are working once they arrive and get into peoples’ arms has received little attention from the global health agency so far.  

Spate of COVID Surges In Countries Dependent on Sinovac & Sinopharm 

Against that background, a spate of recent COVID surges in Latin American and Asian countries that have relied heavily on either the Chinese Sinovac or the Sinopharm vaccines are prompting more questions about the efficacy of those vaccines, in particular. 

This includes recent reports that over 350 Indonesian healthcare workers who were vaccinated with Sinovac, were reinfected with COVID in mid-June – although only a dozen of those required hospitalization. 

The Seychelles has seen a significant recent surge of COVID-19 despite almost 70% of the population having been vaccinated, mostly with the Sinopharm vaccine. Of those who were infected, a third reportedly received both shots – but none of them died, according to the country’s health minister.

Chile is another country that has scientists scratching their heads. Initially lauded for quickly vaccinating 62% of the population with at least one jab and almost 50% with both jabs, the country went into lockdown last week to contain an outbreak that is triggering 70,000 new cases a day – a caseload that is on par with the heights of the first wave seen last year. 

About 87% of the vaccines administered in Chile were procured from Sinovac in a deal that is to include procurement of some 60 million doses over three years – making Chile among the largest buyers of Chinese vaccines in Latin America, along with Brazil and Mexico. 

Together, Latin America and the Asia-Pacific region have bought up some 80% of the 759 million doses of Chinese vaccines sold until now. Most of those doses, about 511 million, were sold by Sinovac, with Sinopharm’s vaccine accounting for the bulk of the remainder of sales so far.

Latin America is the second largest buyer of Chinese vaccines after the Asia Pacific region

Vaccine Efficacy Ratings For Sinovac And Sinopharm

According to the WHO, which recently granted both vaccines “Emergency Use Listings”, Sinovac’s vaccine efficacy stands at 51% against symptomatic disease and 100% against severe disease, while Sinopharm’s efficacy seems to fare slightly better, at 79% against mild and hospitalized disease. 

But that data fails to include efficacy estimates for older people, one of the main COVID risk groups, as too few took part in large-scale clinical trials.

 The WHO EUL’s for those two vaccines were unique in that unlike the Pfizer, AstraZeneca, Moderna, and Jonhson & Johonson vaccines that it had also approved, neither had undergone review and approval by a strict national or regional regulatory authority such as the US Food and Drug Administration or the European Medicines Agency. Nor have Phase 3 results of the Sinopharm and Sinovac trials been published in a peer-reviewed medical journal. 

More to the point, post-approval, any large-scale tracking of the efficacy of the Sinovac and Sinopharm vaccine rollouts by WHO or national authorities seems to be missing.

In contrast, rollouts of other vaccines have seen careful monitoring and assessment by the regulatory agencies of the US, UK, Europe, as well as independent researchers. The massive Israeli rollout of Pfizer’s vaccine by countries, for instance, saw the detailed reporting of data on illness, hospitalizations, and among hundreds of thousands of people who were vaccinated as compared to similar groups of people who had not received their jabs.

The massive tracking of outcomes, including peer reviewed publication of results, helped boost confidence in the mRNA vaccines. But outside of developed countries, such tracking appears to be much weaker – or non-existent.  

One exception is a report by the Uruguayan government this week on a study of some 800,000 people who received two Sinovac vaccine shots – representing some 35% of the population.  

The study, which so far has not been published in a peer-reviewed journal, concluded that deaths among people immunized with the Sinovac vaccine had been cut by 95%, intensive care admissions by 92% and infections by 61%. 

At the same time, Uruguay has also recently seen one of the largest COVID spikes in the world – with over 766 cases per million on 17 June, as compared to 50 per million in India and just 36 in the United States on the same day.

Complex Factors At Work 

The lack of hard data on the efficacy of different vaccines being used in large scale rollouts has left WHO – as well as other health experts –  to respond anecdotally.  

Dr Bruce Aylward, Senior Advisor to the WHO Director General

For instance, with regards to the reinfection of Indonesian health workers with COVID-19, WHO Senior Advisor to the Director-General Bruce Alyward noted that this is not necessarily unexpected, especially during intense periods of community transmission.

“There are reports of people who received Sinovac [who] caught the disease, the health care workers,” Aylward acknowledged, referring to the Indonesian reinfection case. 

“But that does not mean failure of the vaccine because as you know, vaccines are not going to protect everybody who receives them,” he explained. “The vaccine efficacy estimate [for Sinovac] is between 50% to 76%…it’s not unexpected in areas where everyone gets a vaccine as we get intense transmission, there will be some [COVID] cases in people who are vaccinated.”

Although Sinovac’s weaker efficacy rating may have contributed to Chile’s current outbreak, Ian Jones, Professor of Virology at the University of Reading in the UK, contended that the nation’s complacency also has a role to play:

“In Chile, it seems clear that there was a sense of success after only part of the population had been immunised with the inactivated vaccine,” he told Health Policy Watch:

“That led to a false sense of security as the single dose only provided about 55% protection and, in addition, many people remained unvaccinated and naive. The opening up allowed ample mixing and the case rate took off again – even if those vaccinated were protected from severe infection.”

Antoine Flahault, Director of the Global Health Institute at the University of Geneva, added that we should also “keep in mind that these Latin American countries are entering their cold season”, which favors the spread of respiratory viruses like SARS-CoV-2.

WHO’s Swaminathan has also cautioned that more documentation is needed to shed light on whether people who are vaccinated still contract milder, or more severe forms of the disease, and to what extent.

“If there’s a lot of community transmission there will be more infection among health workers, but are they getting ill, are they needing to be hospitalised and what’s the proportion between the vaccinated, unvaccinated and those with a single dose and complete doses?”  said Swaminathan.

“I think we have to be very careful about suggesting there’s evidence that a vaccine is failing because there certainly isn’t the evidence to suggest that at this point.”

Data On Vaccine Efficacy Against Variants “Limited” To “Very Limited”

People waiting to register for the Sinopharm vaccine at the Pakistan Institute of Medical Science.

WHO’s Weekly Epidemiological Update from 8 June acknowledged that the evidence around vaccine efficacy against variants remains “limited” to “very limited” – adding that the vaccines still are “likely” to confer some degree of protection against COVID-19 disease.

Those variants of concern include Alpha, first discovered in the UK, Beta (South Africa), Gamma (Brazil), and Delta (India). All of those have now been identified in the Latin American context, notably in Chile and Brazil.

The Epidemiological update from early June cites a number of studies suggesting that the Beta and Gamma variants, in particular, appear to lead to “minimal-to-modest” reductions in neutralization capacity of Sinopharm and Sinovac vaccines; although the alpha variant appears to lead to “no/minimal loss” in neutralization capacity in both cases.

Experts have meanwhile warned that studies of vaccine performance against new variants are limited mainly to small populations or laboratory analyses of the so-called  “neutralizing antibodies” found in blood samples – as compared to real-life epidemiological surveys. 

WHO has also highlighted that all vaccines, including the most efficacious mRNA vaccines, perform less well against new variants. It cites, as an example, one study from Qatar, which found the Pfizer vaccine to be less effective against symptomatic diseases against Alpha and Beta variants – although not necessarily for hospitalizations and deaths. 

On the other hand, studies from Israel, where some 53% of the population was vaccinated with the Pfizer mRNA vaccine, have confirmed the high protection the mRNA vaccines appear to confer against the alpha variant, at least. 

Weak Chinese Vaccines Could Deal COVAX & Latin America Big Blow

If the two Chinese vaccines turn out to perform poorly in real-life contexts, it could deal the vaccine-thirsty COVAX facility a large blow. 

The Facility, led by Gavi, the Vaccine Alliance and WHO plans to seal deals with Sinopharm and Sinovac on large-scale procurement of the vaccines for developing countries – in the wake of WHO’s recent decision to grant both vaccines an Emergency Use Listing.

If more problems emerge, it also would be particularly unfortunate for Latin America, which is currently seeing higher rates of COVID transmission than most regions in the world – including India. 

Latin America has so far procured 289 million of the 759 million doses of Chinese vaccines produced so far. As such, it is the second largest regional buyer of Chinese vaccines after the Asian Pacific region, according to the China Vaccine Tracker – a joint initiative by the Beijing-based Bridge Consulting and New York-based Global Health Strategies. 

China has already delivered 272 million doses to at least 40 countries

‘Literally Everyone Needs to be Vaccinated’

Even if the Chinese vaccines are efficacious against severe disease and death, they may be less effective in halting transmission of SARS-CoV-2. 

That could explain some of the spikes being seen now in Latin America, Beate Kampmann, Director of The Vaccine Centre at the London School of Hygiene and Tropical Medicine, told Health Policy Watch.

She added, however, that “the only way to be certain is to conduct nasal carriage studies of Sars-CoV2 to show if viral load remains high/virus present in vaccinated people” – adding that no such studies have been done for the Sinopharm and Sinovac vaccines. In contrast, multiple studies undertaken on Pfizer as well as AstraZeneca vaccines have shown they significantly cut SARS-CoV-2 transmission.

If this is indeed the case, then a much larger proportion of the population will have to be vaccinated with the Chinese vaccines to really curb local transmissions, she warned. 

“As far as transmission is concerned, these [Chinese] vaccines are not going to be helpful unless literally everyone is vaccinated,” said Kampmann. “And even then, the virus would still circulate and subsequent cohorts need to be protected via vaccination as well.”

-Elaine Ruth Fletcher contributed to this story.

Image Credits: Twitter – Chinese Ambassador to Zimbabwe, Bridge Consulting, Rahul Basharat Rajput.

WHO Chief Scientist Soumya Swaminathan

The Indian Bar Association (IBA), a voluntary organisation, say it has served a second legal notice to WHO Chief Scientist Soumya Swaminathan for allegedly “running a disinformation campaign against Ivermectin”, after WHO failed to recommend use of the anti-parasitic drug as a COVID-19 treatment – due to a lack of evidence of efficacy.

The Mumbai-based IBA sent a 51-page notice to Swaminathan on 25 May, and a follow-up on 13 June, reacting to her statements saying that WHO does not recommend the use of the drug as a treatment for COVID-19, except in the context of clinical trials. 

A tweet by Swaminathan specifically advising against the use of Ivermectin for COVID-19, which the IBA has called “controversial”, has since been deleted. 

The tweet, issued under Swaminathan’s handle, @doctorsoumya, on 10 May 2021 stated that “Safety and efficacy are important when using any drug for a new indication. @WHO recommends against the use of Ivermectin for #COVID19 except within clinical trials.”

The WHO has said there is, to date, insufficient evidence to demonstrate Ivermectin’s effectiveness against COVID-19, and has thus not included it as a recommended COVID treatment – except in clinical trial studies that might yield better evidence. 

In her role as WHO’s Chief Scientist, Swaminathan has also spoken out against the use of politically popular, but scientifically unfounded, treatments, including hydroxychloroquine and Remdesivir – the latter of which even received United States Food and Drug Administration emergency use approval, despite what WHO said was a lack of evidence about efficacy. 

The IBA, which Indian insiders say tends to parrot positions of the government of Prime Minister Narendra Modi, has attacked Swaminathan, a former senior Indian medical official, on a personal level, calling her statements “highly unconscionable, misleading and issued with ulterior purposes and deliberate intention to underplay the effectiveness of Ivermectin in treatment COVID-19.” 

“The legal notice is just the first step. We are going to be taking it forward. There are forces working to repress Ivermectin for reasons mentioned in the notice,” said Dipali Ojha, the author of the notice and head of the IBA’s legal cell. 

In a response, WHO said it “regretted” the unwarranted attacks against senior officials in the media,” adding that despite the publication of the alleged suit, it was unaware of any formal proceedings having been filed by the IBA. Of note, the group is a voluntary organisation with no statutory or regulatory status in India. 

“WHO’s assessment of Ivermectin for treatment of COVID-19 is based on the current state of scientific evidence.  WHO guidelines are developed by an independent global guidelines development group and are updated regularly when new data becomes available,” a spokesperson said. 

UK and US Medical Associations in Support of Ivermectin for COVID-19 Treatment 

Anti-parasitic drug Ivermectin

The IBA has said its case is anchored in expert recommendations favouring the use of Ivermectin, and issued by the US-based ‘Front Line COVID-19 Critical Care Alliance’ (FLCCC) and the British Ivermectin Recommendation Development (BIRD) Panel, which claim some studies have shown that Ivermectin use can reduce the risk of contracting COVID by over 90% and mortality by 68-90%. 

An FLCCC public statement issued in mid-May also criticised the negative findings of the European Medical Agency as well as a WHO Ivermectin expert group vis a vis use of the drug. 

The FLCCC said the WHO Ivermectin Guidelines Development Group (GDG) had “arbitrarily and severely limited the extent and diversity of study designs considered” in its review – excluding a large number of observational and quasi randomized-controlled studies that had yielded positive results for Ivermectin’s use.  

It described the WHO exclusion criteria as “highly irregular and inexplicable” which could have “but one rational explanation: the GDG Panel had a predetermined, nonscientific objective, which is to recommend against Ivermectin.”  

Both the FLCCC and BIRD also issued a joint statement supporting inclusion of Ivermectin in the COVID treatment guidelines of India’s Ministry of Health and Family Welfare. 

Even so, the directorate general of health services at India’s Ministry of Health and Family Welfare recently dropped ivermectin from its list of recommended COVID treatments.  

Following the national ministry’s decision, Swaminathan described the revised guidelines as “simple, rational, and clear guidance for physicians, though the IBA alleges that the intention was to “misguide and confuse the doctors and the public at large.” 

 

Health workers in Cape Town, South Africa, getting vaccinated against COVID-19 in March 2021.

The World Health Organization (WHO) warned on Friday that the COVID-19 pandemic in Africa was expected to get worse, as 22 countries are facing surges and less than 1% of the continent’s population is vaccinated against the virus.

“Cases have increased by 52% just in the past week, and deaths have increased by 32%, and we’re expecting things to only get worse,” WHO Director-General Dr Tedros Adhanom Ghebreyesus told the global body’s weekly COVID-19 press briefing.

“Vaccines donated next year will be far too late for those who are dying today, or being infected today, or at risk,” he added.

Earlier in the week, Health Policy Watch reported that only two African countries – Morocco and the tiny island of Seychelles – have vaccinated more than 10% of their populations, while vaccination rollouts are faltering on the continent because of dose shortages.

“The brutal reality is that, in an era of multiple variants with increased transmissibility and potentially increased impact, we have left the vulnerable population in Africa unprotected by vaccines in a context where health systems are already weak,” said Mike Ryan, Executive Director of WHO’s Health Emergencies Programme.

Ryan added that this was “the consequence of the current unfair distribution of vaccines”. 

“If we had been distributing vaccines fairly and equitably, we may by now have protected those people most vulnerable on the African continent. We simply have not done that,” added Ryan.

Negotiations with AstraZeneca

WHO’s COVAX lead, Bruce Aylward

Bruce Aylward, WHO’s lead on COVAX, told the briefing that “30 or 40 countries”, particularly in sub-Saharan Africa, have had to suspend their vaccine rollouts and were unable to provide their citizens with their second doses of AstraZeneca vaccines. 

This follows the decision by the Serum Institute of India (SII) in late March to stop supplying COVAX with the AstraZeneca vaccine it was manufacturing and redirect its doses for domestic use in India.

“We are now urgently trying to work with AstraZeneca itself, as well as SII and the government in India, to restart those shipments so that we can get those second doses into those populations because we are running to a longer interval than we would have liked,” said Aylward.

He stressed that it was hard for countries to deal with this stop-start dynamic as it disrupted systems and undermined public confidence.

“It takes a long time to get the logistics in place to operate at scale,” said Aylward. “When countries with weak systems are forced to continually interrupt, reorganise and redirect their programmes, they are going to have real trouble as additional doses arrive.”

In addition, he said, because rollouts have been “interrupted, staggered and slowed”, this undermined community mobilisation. 

“We hear this repeatedly from political leaders who are so keen to mobilise their populations, but so concerned that they are having to do that prematurely” because of supply problems.

Kate O’Brien, WHO’s director of vaccines, said that it had taken the most successful countries with secure supplies around four months to get to their peak pace.

“Those are countries that had clarity on what their supply was going to be, could mobilise demand, could communicate with their populations and their communities what the order is going to be, where you go for vaccination,” said O’Brien. “One of the worst things that you can do in an immunisation programme is to be communicating out to the community that doses will be available, and then you cannot deliver.”

Vaccine Inequity is ‘Fuelling Two-track Pandemic’

WHO Director General Dr Tedros Adhanom Ghebreyesus

“The global failure to share vaccines equitably is fuelling a two-track pandemic that’s now taking its toll on some of the world’s poorest and most vulnerable people,” said Tedros.

“More than half of all high- and upper-middle-income countries and economies have now administered enough doses to fully vaccinate at least 20% of their populations. Just three out of 79 low and middle-income countries have reached the same level,” said Tedros.

This week, New York lifted almost all COVID-related restrictions as 70% of adults in the state have been vaccinated.

Aside from Africa, many Latin American countries have rapidly increasing epidemics while Indonesia is also facing a surge in cases.

Tedros reminded the briefing that the WHO had set the global targets of vaccinating at least 10% of the global population by September, at least 40% by the end of the year, and 70% by the middle of next year. 

“We very much appreciate the vaccine donations announced by the G7 and others. And we thank those countries including the United States that have committed to sharing doses in June and July. We urge others to follow suit. We need vaccines to be donated now to save lives.”

Tedros added that the WHO would make an announcement on Monday about plans to increase vaccine production in Africa.

 

Image Credits: EAC, Western Cape government, WHO.

Poverty, harmful cultural beliefs and lethargic enforcement of laws have fuelled child labor in the tobacco industry, while exposing minors to physical abuse and respiratory infections. An estimated 1.3 million children work in tobacco fields around the world

Children’s rights activists and anti-tobacco campaigners called on governments this week to implement stricter laws, impose hefty fines and carry out public campaigns to eradicate child labor in tobacco value chains.

With an estimated 1.3 million children working in tobacco fields around the world, Adriana Blanco Marquizo, head of the Secretariat of WHO’s  Framework Convention on Tobacco Control (FCTC), called on lawmakers and the tobacco industry to work hand-in-hand to eradicate child labour and protect children from a variety of hazardous exposures while slaving on tobacco farms.

Addressing a webinar this week, Marquizo said: “Eliminating child labor in tobacco farms and other supply chains should be a matter of urgency since it has denied children the right to education while exposing them to health hazards.” 

In addition to punitive laws against tobacco farmers who engage child labour, Marquizo called for legislation that will make it mandatory for all minors to be in school to protect them from exploitation and abuse.

“This is, of course, a health, moral and human rights issue,” noted Marquizo in her keynote remarks at Tuesday’s webinar, hosted jointly by the Stop Project and WHO FCTC.

Child Labour Increases For the First Time in Two Decades

The webinar took place days after the release of a joint report by the International Labour Organisation (ILO) and UNICEF. Issued to commemorate the World Day Against Child Labour observed on 12 June, the report found that one out of 10 children was engaged in labour at the beginning of 2020, while 79 million children were involved in hazardous work including tending to tobacco farms.

It paints a bleak picture of how the number of children forced into labour had increased by over a million in the last four years, reaching a figure of 160 million worldwide. Yet, things are not looking up either, due to Covid-19.

According to Marquizo, the COVID-19 pandemic has forced millions of children to work in tobacco farms in developing countries for meagre wages and in unhygienic conditions. The pandemic threatens to drag another 8.9 million children into the labourforce by the end of next year, according Marquizo.

She believes that raising taxes on the tobacco industry, coupled with financial incentives for poor households during the pandemic, could boost efforts to eradicate child labor.

According to the report, the number of children aged 15 and 17 years working in hazardous work environments has risen by 6.5 million to 79 million since 2016. It also notes that 70% of all child labour – or 112 million children in total – are in agriculture. A 2020 report by the US Department of Labour shows that goods produced by child labour, particularly tobacco, are spread in a number of countries all over the world.

These include Argentina, Brazil, Mexico, Nicaragua in Latin America, and Kenya, Malawi, Mozambique, Tanzania, Uganda, Zambia and Zimbabwe in Africa. There is also  Kyrgyz Republic in Eastern Europe as well as Bangladesh, India in South Asia and Philippines and Vietnam in Southeast Asia.

Human Rights Violation: Five-year-olds Forced to Work on Tobacco Farms

Dr Adriana Blanco Marquizo, Head of the Secretariat of WHO Framework Convention on Tobacco Control.

In Brazil, the third biggest producer of tobacco, 80,000 children aged 9 to 17 years old work in tobacco farming.

Rita Surita, from the Oswaldo Cruz Foundation, said children working on the Brazilian tobacco farms are exposed to pesticides that are forbidden in the US and Europe.

“What is most cruel is that these children aged between 13 and 17 years old do most of the hard work. The children are intoxicated by working in tobacco warehouses handling tobacco leaves,” said Surita.

In Zambia, child labour is widespread in more than 20 districts, with children as young as five working in tobacco fields. Tobacco Free Association of Zambia (TOFAZA) executive director Brenda Chitindi said her country has ratified most key international conventions concerning child labour, but children were still forced into working on tobacco farms and were being exposed to hazardous environments.

“Children begin working at the age of 5 years to prepare the seedbed by turning the soil and even felling trees, weed the fields, fertilize the tobacco plants, and spray pesticides without wearing any protective clothing. During harvest of green tobacco leaves, children are exposed to contracting nicotine poisoning,” said Chitindi.

Even worse is the situation in Bangladesh where children are exposed to toxic pesticides, engaged in unpaid labour and prevented from attending school.

Farida Akhter, executive director of non-governmental organisation UBINIG, said for Bangladeshi farmers to reduce production costs, they engage unpaid family members including children. In different stages of tobacco growing, children are exposed to most agrochemicals including pesticides and of nicotine. 

“Throughout the year, children work day and night at harvesting time. Two-thirds of children cannot attend school in tobacco growing areas. Tobacco companies continue to purchase leaves that are produced by child labour.”

Poverty is the Driver of Child Labour

Usually, tobacco farmers find themselves in a cycle of debt because they rely on loans each planting season to sustain the practice. They cannot afford to hire farm hands, so they end up engaging cheap labour from children who usually are family members.

And that is why, explained Marquizo,  sections of the WHO FCTC calls for the provision of support for economically viable alternatives to tobacco and for the protection of the environment. 

“This is in line with one of the paths of action proposed by the ILO/ UNICEF report,” said Marquizo, whose aim is to solve the problem of child labour in order to achieve Sustainable Development Goals 8.7 that calls for and end to child labour by 2025.

She explained that at national level, raising taxes on tobacco products as per the WHO FCTC could be a source of domestic funding, an approach explicitly recognising the 2015 Addis Ababa Action Agenda.

Partners in Development

The tobacco industry often portrays itself as a partner in the development agenda. In 2014, the Altria Group, one of the world’s largest producers and marketers of tobacco and cigarettes, signed a global pledge to eliminate all forms of child labour in its worldwide supply chain as part of an initiative promoted by the Eliminating Child Labour in Tobacco-Growing (ECLT) Foundation. The Foundation itself is a creation of the British American Tobacco (BAT).

Pascal Diethelm, the president of OxySuisse, noted that the ECLT is known to be a tobacco front group whose board is filled with tobacco industry people as opposed to the civil society as required. 

This led IUF, a global union of workers to cut ties with ECLT in 2013, charging that it was a corporate social responsibility arm of the tobacco industry. The ILO too followed suit in severing ties with the organisation in 2019.

“I can say that the ECLT is not a front group of the tobacco industry,” said Diethelm, “It is the tobacco industry,” he added.

Mechanism Developed to Help the Transition of Tobacco Farmers.

One of the tangible and concrete ways to help tobacco growers feasibly and sustainably transition to alternative livelihoods, is the implementation of  WHO FCTC Article 17 and 18. The sections of the FCTC  recognises the need to promote economically viable alternatives to tobacco production for those whose livelihoods depend on tobacco production and  calls for the protection of the environment and the health  of those involved in the cultivation and manufacture of tobacco.

The United Nations Development Programme (UNDP), in partnership with the WHO FCTC secretariat, the SDG Fund, Tobacco Free Portfolios, American Cancer Society and the University of Zambia, have developed a social impact bond to help achieve this objective two years ago.

“We targeted specifically small holder farmers who want to transition,” said Dudely Tarlton, a programme specialist in health and development at UNDP.

A feasibility study they conducted showed that if implemented over a 4-year period with inputs of $4.9 million, up to 7,000 Zambian smallholder farmers will transition away from growing tobacco. “That is half the total of smallholder farmers in Zambia who are growing tobacco,” said Tarlton.

This will also see an increase of 70% in household resources for those who choose alternative livelihood streams away from tobacco farming. Up to 17,000ha of forests would be protected, which would otherwise have been cleared to pave way for tobacco farming.

But also, the input investment of the $4.9 million will generate outcome payments of $5.4 million. All these are besides the secondary benefits of increased food security, reduction in the prevalence of child labour (crop farming is less labour intensive compared to tobacco cultivation) and reduced incidents of green tobacco sickness.

Already, an impact investor has been identified ready to put its funds to work. “However, we are not there yet, as we still need to identify an outcome funder to link with the impact investor,” said Tarlton.

Once it is up and running, said Tarlton, the social impact bond can easily be replicated beyond Zambia.

Image Credits: Unfairtobacco.org, WHO FCTC.

Uganda is dealing with five different coronavirus variants that have fuelled aggressive transmission as the country enters the second wave of the pandemic.

Uganda is suffering an acute shortage of oxygen and intensive care beds as the country grapples with a deadly second wave of the pandemic that is being fuelled by five different virus variants.

Regional referral hospitals and the country’s biggest hospital, Mulago National Referral Hospital, have run out of oxygen or have reported acute shortages,  forcing medical staff to decide who gets the life-saving treatment.

At least 22 countries on the African continent are in the midst of new infection waves, with Uganda, Namibia, South Africa, Tunisia and Zambia being the worst-hit. 

On 16 June, Uganda recorded 1,564 new infections and 42 new deaths.

On Wednesday, the country received 75,200 doses of the AstraZeneca vaccine, donated by the French government through the COVAX facility.

Ugandan Health Minister Dr Jane Ruth Aceng, told a WHO Africa Region press briefing on Thursday, that her country was dealing with five major variants and that COVID-19 transmission was “very aggressive”.

Aceng said the variants registered in Uganda include Delta (B.1.617.2 first identified in India), Eta (B.1.525), Beta (B.1.351 from South Africa), Alpha (B.1.117 identified in the UK) and the local strain, which she identified as B.1.617.  These strains are on the rise and are fuelling the transmission, according to Aceng.

“We have started a robust intervention in the communities. We are handing the pandemic back to the community to take it up themselves and ensure that everybody adheres to [standard operating procedures] and account for all the infected,” said Aceng, adding that more research is being conducted into how the variants are spreading.

Last week, the WHO warned of a third wave of the pandemic across Africa, with 90% of countries likely to miss the global vaccination target of at least 10% of their populations by September.

No New Vaccinations 

Ugandan Health Minister Dr Jane Ruth Aceng (left) and French Ambassador to Uganda Jules-Armand Aniambossou (right) on 17 June received the 75,200 doses of the AstraZeneca COVID-19 vaccine donated by the French government through the COVAX facility.

The new vaccine doses delivered on Wednesday brings the total number of COVID-19 doses received in the country to 1,139,200. Uganda’s first two batches, totalling 964,000 doses, arrived in the country in March and are expected to expire by 10 July.  

By 15 June, over 812,000 people including health workers, teachers, security personnel, airport staff, the elderly and people with diabetes, hypertension and other underlying conditions had been vaccinated.

However, Aceng said that health workers, teachers and all those who got a first shot will be prioritized to get their second shots, as the demand for vaccines rises among the public.

Out of the targeted 160,000 registered health workers in the country only 69,000 have been fully vaccinated according to the Ministry of Health.  President Yoweri Museveni recently decreed that all teachers should be vaccinated before being allowed  back in the class.

“Vaccine hesitancy was real at the beginning and we opened up beyond the categories we wanted to target, but now we have more demand than we can meet. Many people are now rushing to get vaccinated,” presidential adviser on epidemics Dr Monica Musenero told reporters at a press briefing on Wednesday.  

Last week, 14,460 COVID-19 vaccine doses went to waste as they were opened, but not used. Scientists say vaccines lose their potency and effectiveness if they are exposed to temperatures outside of the required range or when exposed to light.

Once a vial’s seal is punctured, workers have only six hours within which to administer the vaccine. Each vial can vaccinate 10 to 12 people. 

Catherine Makumbi Ntabadde, UNICEF’s country communication specialist, said Uganda is expected to receive another batch of 688,000 vaccine doses in August,  which will also be administered as a second jab. The country aims to vaccinate 21 million people in a phased manner.

Acute Oxygen Shortages

Uganda’s medical oxygen demands outweigh the current supplies due to an increasing number of critically ill patients. Although the oxygen production capacity is available in the private sector and from neighbouring Kenya, Aceng said the country did not have enough cylinders. An additional 8,000 cylinders would help reduce the COVID-19 death rate.

However, according to intensive care staff, more piped oxygen is needed instead of cylinders as patients are not responding to nasal oxygen that is distributed via the cylinders.

The oxygen shortage is further fuelled by the private sector, the biggest provider of health services in the country, charging exorbitant treatment prices,

“The private sector is fleecing desperate Ugandans. Why charge for oxygen? It should be given out free of charge,” said a frustrated Aceng.

Some private providers have been caught out charging for vaccines meant to be distributed for free. Government had allowed the private sector to import and distribute COVID-19 vaccines  as they were already key players in immunisation of children on behalf of the government.

“It is not that they accessed the vaccine through the wrong route. The government gave them the vaccine to distribute on its behalf, but now there is just no truth and transparency in the distribution,” said Aceng. 

It is likely that Uganda will follow Kenya in banning private sector participation in the procurement and distribution of vaccines if the vice does not stop.

Stricter Control Measures to Help Curb the Pandemic

Last week, President Museveni instituted a ban on inter-district travel and restricted the number of people to attend weddings and burials to 20 in a bid to contain the virus.

Aceng however said the surge in new cases in Uganda was due to citizens becoming complacent after the first wave and when some schools reopened.

“When we opened up after the first strict lockdown last year, people wanted to have their normal lives and regain economic stability so they became complacent and the number of cases started rising,” said Aceng, referring to the two-month lockdown that started last March.

WHO Regional Director for Africa Dr Matshidiso Moeti, speaking at the same briefing,  warned that the continent’s third wave is gaining pace and is nearing the first wave’s peak of more than 120,000 weekly cases recorded in July 2020.

“Africa is in the midst of a full blown third wave. The sobering trajectory of surging cases should rouse everyone into urgent action. We’ve seen in India and elsewhere just how quickly COVID-19 can rebound and overwhelm health systems. So, public health measures must be scaled up fast to find, test, isolate and care for patients and to quickly trace their contacts,” Moeti said.

Image Credits: © WHO/Otto B., Health Journalist Network.

Last Ebola patients leave a treatment centre in the Democratic Republic of Congo at the end of March, marking the countdown to declaring the end of the pandemic.

The government of Guinea is a few days away from declaring the end of the country’s Ebola outbreak after 45 days of reporting no new case, World Health Organization Officials said on Thursday. 

On 14 February, a new Ebola outbreak was declared in Guinea, but four months later, the outbreak will be declared over according to Guinea’s Health Minister Dr Remy Lama.

Speaking at a WHO AFRO press briefing on Thursday, Lama attributed the country’s ability to quickly control the outbreak to swift mobilisation to organise the response to the disease and break the transmission. 

“We made a huge adjustment to involve communities in this response, so that they would accept the proposed measures. We chose as a priority to involve communities,” Lama said.

Initial challenges regarding vaccine hesitancy were quickly resolved by actively engaging communities who became aware of the reasons behind the recommended lines of action, said Lama. 

The Republic of Guinea was one of the countries at the center of West Africa’s Ebola virus epidemic that raged from 2014-2016 claiming 11,000 lives.  The DRC faced a major outbreak in 2018, which concluded a year later, but has been followed by others. During the most recent DRC outbreak in February, 12 cases were confirmed leading to six deaths – while 1,737 people were vaccinated against the virus, according to the WHO – with IFRC teams on the ground providing key support.

In the case of Guinea, the outbreak declared on 14 February 2021 in the N’Zerekore region led to 14 confirmed cases, leaving five people dead.   However, the even more worrisome aspect of the current Guinea outbreak was its apparent source – a survivor of Guinea’s previous 2014-2016 outbreak who appears to have harbored the virus for as long as five years, before infecting someone else.

Lessons learned from the Ebola response have also better positioned the country to respond to COVID-19 considering engagement with its citizens has also been crucial in encouraging vaccine adoption. 

WHO Regional Director for Africa Dr Matshidiso MoetiMoeti noted the overlap between responses to Ebola and COVID-19 and said both required political leadership, quick decision making and collaboration with various partners.

“All of this is valuable in both responding to pandemics, and in putting in place the kind of resilient health systems that we need so that next time there is a threat, we’re better positioned to respond and contain the outbreak,” Moeti said.

Image Credits: WHO African Region.

WHO Regional Director for Africa Dr Matshidiso Moeti has warned that unless Africa gets more COVID-19 vaccines immediately, the third wave the continent is currently experiencing will be deadlier than the first two waves.

Tanzania, which for months denied the existence of COVID-19 until vaccine-sceptic President John Magufuli finally succumbed to the virus in March – is now trying to belatedly join the WHO co-sponsored COVAX facility to acquire COVID vaccines. The news comes as the African continent experiences a deadly third wave of COVID-19 infections – affecting eastern and southern Africa in particular.

In a press briefing on Thursday, World Health Organization Regional Director for Africa Dr Matshidiso Moeti said that WHO is now working with the country to prepare a COVID-19 vaccine deployment plan – which is a major prerequisite to securing vaccine doses from the COVAX facility. 

“These are the preliminary steps to receive vaccines through COVAX, and we are expecting the vaccines to arrive in the country in the next couple of weeks,” said Richard Mihigo, Immunisation and Vaccines Development Programme Coordinator at WHO’s Regional Office for Africa at the briefing.

Tanzania has not requested any specific vaccines, but like other countries accessing doses through COVAX, it will be able to procure vaccines that have been issued with WHO’s Emergency Use Listing, the WHO officials said.

Beyond approaching COVAX for vaccine donations, the new government of Tanzania, led by President Samia Suluhu Hassan, has also made moves to raise funds to finance vaccine purchases, including approaches to the International Monetary Fund (IMF) for an emergency loan of $US 574 million.

The IMF has however demanded that the government first update its data on the transmission of the SARS CoV2 virus in the country.  Data on new virus cases and related deaths has not been reported since May 2020 – after the late Magufuli ordered health authorities to stop tracking cases of the disease. 

“When applying for pandemic-related emergency financing, evidence of the pandemic has to be available to substantiate the claim,” the IMF’s resident representative, Jens Reinke was quoted as saying by Reuters.

Africa’s Third Wave Could Be More Deadly Than The First Two Waves

Tanzania’s appeal for the lifesaving vaccines comes as the African continent experiences a third wave of the pandemic with Tunisia, South Africa and other southern and eastern African neighbors seeing sharp spikes in cases over the past few weeks.  Even countries such as Rwanda, which have remained “green” with very low COVID transmission, are now at risk of becoming “orange”.

South Africa on Wednesday recorded 13 246 new cases, with the percent testing positive increased to 21.7%, while Tunisia has seen one of the highest rates of new cases daily on the continent, per million people. 

Moeti warned that the continent’s third wave is gaining pace and is nearing the first wave’s peak of more than 120,000 weekly cases recorded in July 2020.

“Africa is in the midst of a full blown third wave. The sobering trajectory of surging cases should rouse everyone into urgent action. We’ve seen in India and elsewhere just how quickly COVID-19 can rebound and overwhelm health systems. So, public health measures must be scaled up fast to find, test, isolate and care for patients and to quickly trace their contacts,” Moeti said.

According to WHO data, new COVID-19 cases rose to over 116,500 in the week ending on 13 June, up from the previous week’s nearly 91,000 cases. This was after a month period of more gradual increases in case numbers that pushed the continent over the 5 million case mark. In 22 African countries, cases rose by over 20% within the same period while deaths also spiked by nearly 15% to over 2200 across 36 countries.

African countries are recording a surge in COVID-19 cases with South Africa registering 13 246 new cases on June 16.

Rwanda, which has a population of some 12.6 million people has seen a spike in new cases rising to 263 on 16 June.  That remains low in comparison to many European countries, but still of concern for the country that saw only 45 new cases daily at the start of the month.  That means the country is now approaching the all-time  peak of its second wave, of January 2021, when some 334 new cases daily were recorded.  

A Rwandan cabinet meeting on 12 June, resolved to shut down all business activities by 8pm, with residents under curfew from 9pm to 5am. Prevsiously, a curfew was in place only between 10pm to 4am.

At a separate press briefing on Thursday, Dr John Nkengasong, Director of the Africa CDC, said that a total of 15 African countries are now experiencing the third wave of the pandemic while Tunisia is already in a fourth wave.

Both Nkengasong and Moeti attributed the spike in new cases to, among other reasons, poor adherence to transmission prevention measures, including non-compliance with social distancing – which has made it difficult to suppress the spread of the pandemic.

The surge also coincides with colder seasonal weather in southern Africa, even as more contagious variants spread. The Delta variant (originally identified in India) has been reported in 14 African countries while the Alpha and Beta variants (originally identified in the United Kingdom and South Africa) have been found in more than 25 African countries.

“We expect the number of African countries in the third wave of the pandemic to increase,”  said Nkegasong. “What is very characteristic of this wave is that the peak of the third wave is normally higher than the peak of the second wave, and is more severe than the previous wave.”

Vaccines Needed Sooner Than Promised Donations Will Arrive 

Africa needs more COVID-19 vaccines immediately if the continent wants to curb the third wave.

Several initiatives have been announced to make more doses of vaccines available to African countries, including a one billion vaccine dose donation by the G7 to poorer countries and a  $US 1.5-billion COVID-19 vaccine procurement partnership between Africa CDC and the MasterCard Foundation. The U.S. government has also promised to donate 500 million doses of Pfizer’s COVID vaccine to support vaccine rollout in several low- and middle-income countries. And the potential inclusion of made-in-China COVID-19 vaccines into the COVAX Facility is also on the table. \

But Moeti and Nkengasong stressed that the continent needs vaccines even faster than those promised donations – while national governments need to step up vaccination of doses already received.

Seven African countries have already used 100% of the vaccines they received through COVAX and seven more have administered over 80% of available vaccines. On the other hand, some 23 African countries have used less than half of the doses they received so far, including about 1.25 million AstraZeneca doses on hand in 18 countries that must be used by the end of August to avoid expiration. 

“The rise in cases and deaths is an urgent wake up call for those countries lagging behind to rapidly expand vaccination sites, to reach priority groups for vaccination and to respond to community concerns. A number of African countries have shown that they can move vaccines quickly, so while we welcome the recent international vaccine pledges, if we are to curb the third wave, Africa needs doses here and now,” said Moeti.

Image Credits: Our World in Data.

The development of antibody medicines in Regeneron’s lab. The biotech company’s COVID therapy could be a valuable tool for tackling severe COVID-19 cases.

A COVID-19 antibody cocktail developed by the US-based company, Regeneron, dramatically reduced the risk of mortality and shortened hospital stays in patients who didn’t naturally produce antibodies against SARS-CoV2 in a recent large-scale trial. 

Meanwhile, the US government announced that it would invest some US$3.2 billion in developing new forms of antiviral COVID-19 treatments to reduce COVID-related hospitalizations and deaths.

The Regeneron trial, published as a pre-print on medrxiv on Wednesday, is the first to demonstrate that an antibody treatment improved survival in patients hospitalised with COVID-19. The randomized controlled trial of the therapy was conducted by researchers at the University of Oxford.

Regeneron’s monoclonal treatment, dubbed REGEN-COV™, uses a combination of two antibodies that bind to the SARS-CoV2 spike protein, neutralizing the ability of the virus to infect human cells. 

Between September 2020 and May 2021, 9,785 hospitalised patients were selected to receive usual care in addition to the antibody treatment or standard care alone. 

The standard care treatment for patients was dexamethasone, a steroid treatment, which cuts death risks up to a third for seriously ill patients by reducing dangerous over-reactions of the immune system.

Significantly, however, one-third of hospitalised participants didn’t have a natural antibody response – as compared to some 54% of patients who had a strong natural antibodies response.

And those patients whose bodies lacked a natural antibody response had a greater risk of mortality. 

“Among all patients randomized, there was no significant difference in the primary outcome of 28-day mortality between the two randomized groups,” said the authors. 

Some 20% of patients in the treatment group died, compared to 21% in the usual care group. The primary efficacy of the drug was seen when comparing those without a natural antibody response in the Regeneron group to those lacking an antibody response in the control group. 

Among those without natural antibody responses, some 24% of hospitalised patients receiving the antibody combination died, in contrast to 30% of patients in the usual care group. 

The antibody combination reduced the 28-day mortality in patients lacking an antibody response by one-fifth – as compared to those receiving usual care alone. 

Among those lacking an antibody response, the treatment also shortened the duration of the hospital stay by an average of four days and reduced the risk of needing to use invasive mechanical ventilation

For every 100 patients treated, there would be six fewer deaths, calculated the study authors. 

“It’s the first time that any viral treatment has been shown to save lives in hospitalised COVID-19 patients,” said Martin Landray, Professor of Medicine and Epidemiology at the University of Oxford and Joint Chief Investigator of the trial, in a press release. 

‘Groundbreaking’ New COVID Therapy

“It is wonderful to learn that even in advanced COVID-19 disease, targeting the virus can reduce mortality in patients who have failed to mount an antibody response of their own,” said Peter Horby, Professor of Emerging Infectious Diseases at the University of Oxford and Joint Chief Investigator of the trial. 

“These results provide hope to patients who have a poor immune response to either the vaccine or natural infection, as well as those who are exposed to variants for whom their existing antibodies might be sub-optimal,” David Weinreich, the Executive Vice President of Global Clinical Development at Regeneron, said in a press release. 

The trial also provides an important indicator that hospitalised patients who made their own antibodies likely will not benefit from the treatment. 

“Patients who have made their own antibodies to the virus do not benefit from the new treatment, which is also important information given the cost of drugs,” said Fiona Watt, Executive Chair of the UK Medical Research Council, which helped fund the study. 

“If you already have antibodies, giving you more may not make much difference,” said Horby.

This is useful for guidance on use of the treatment given its high cost, which is between £1,000 and £2,000.

The cost may render the drug only available to those in wealthy countries; in addition, the drug cocktail needs to be administered by infusions. As a result, monoclonal drugs are typically best adapted to use in  high-resource health systems, and only a few monoclonals are available in low- and middle-income countries.

“There really must be initiatives to make these drugs accessible…you have to scale up manufacturing, and they have to be affordable,” Horby told the Guardian. 

Regeneron to Request Expanded Authorization

The therapy was first granted a United States Food and Drug Administration (FDA)  emergency use authorization (EUA) in December. That  EUA was updated in early June to permit a lower 1,200 mg dose of the REGEN-COV™ treatment, based on the recent trial results (600 mg casirivimab and 600 mg imdevimab) – half the dose originally authorised. The treatment is authorised by the FDA for adults and pediatric patients with mild to moderate COVID-19 who are at a high risk of developing severe illness. 

Previous clinical trials have shown that Regeneron’s treatment reduced viral levels, shortened the duration of symptoms, and reduced the risk of hospitalisation and death in non-hospitalised patients. 

“Definitive Phase 3 trials have now demonstrated that REGEN-COV can alter the course of COVID-19 infection from prevention, to very early infection, all the way through to when patients are on a ventilator in the hospital,” said George Yancopoulos, the Chief Scientific Officer at Regeneron.

“We intend to rapidly discuss these results with regulatory authorities, including in the US, where we will ask for our EUA to be expanded to include appropriate hospitalised patients,” Yancopoulos added. 

The trial data suggests that Regeneron’s antibody cocktail could be a valuable tool for tackling severe COVID-19 cases and reducing the worst manifestations of the virus. 

“It is fantastic news that the RECOVERY trial has provided evidence to establish another lifesaving treatment against COVID-19 through this monoclonal antiviral antibody combination,” said Nick Lemoine, Medical Director at the National Institute for Health Research, which supported the trial. 

Commitment to Invest in COVID Treatments

Investment in COVID-19 research has primarily focused on the development of vaccines instead of therapeutics. The new influx of money from the US government will fund clinical trials of drug candidates, with the aim of making COVID treatment pills available within the year.

Experts are concerned that the SARS-CoV2 virus will become a perennial threat. In addition, the current inequitable distribution of vaccines likely means that herd immunity is in the distant future for much of the world. A treatment in pill form could keep people out of hospitals and save lives over the years to come.

“There will always be a threat,” said Dr Anthony Fauci, Director of the National Institute of Allergy and Infectious Diseases. “I think there’s going to be a long-range need for drugs.”

The hope “is that we can get an antiviral by the end of the fall that can help us close out this chapter of the epidemic,” Dr David Kessler, Chief Science Officer of President Biden’s COVID-19 response team, told the New York Times.

Ideally, antiviral pills would be available at pharmacies for those who test positive or develop COVID-19 symptoms.

“I wake up in the morning, I don’t feel very well, my sense of smell and taste go away, I get a sore throat,” said Fauci. “I call up my doctor and I say, ‘I have COVID and I need a prescription.'”

Investment in further research on drugs to prevent and treat SARS-CoV2 infection “could help with this pandemic and potentially provide a first line of defense for the next one,” said Mark Namchuk, Director of Therapeutics Translation at Harvard Medical School.

Image Credits: Flickr – US Navy, Regeneron.