Pandemic lockdowns left billions of people confined to their homes for work and socialization.

Long months of pandemic lockdown have only exacerbated the harms due to alcohol  experienced by billions of people worldwide.  Now, WHO is in the process of developing a new alcohol action plan, in an effort to re-energize a stagnant process and overcome a “lost decade” of little progress on alcohol policies.  Can it make a difference? 

The coronavirus crisis has brought into clear focus how important health is – for people, our families, and our societies at large. We can see that people deeply care about both personal and public health.

At the same time, the pandemic has also made painfully obvious those  public health issues that have been neglected for too long. Billions of people remain unprotected against the harms caused by alcohol – harms also exacerbated as a result of the social and economic distress created by the COVID-19 pandemic.

Since the adoption of the WHO Global Alcohol Strategy to reduce the harmful use of alcohol more than a decade ago, virtually no progress has been achieved in protecting more people from the harms caused by the products and practices of the alcohol industry.

That is why the WHO process of developing a new global alcohol action plan, 2022-2030, mandated by the WHO Executive Board in February 2022,  matters so much. 

More can and should be done to accelerate action on alcohol harm as public health priority, commensurate with the health, social, and economic burden it causes.

Lost Decade

The last decade has been a lost decade for alcohol policy development. For example,  the global SDG target to reduce per capita alcohol use by 10% by 2030 will not be met according to current forecasts. 

Without action, Africa could see increases in both the absolute number and proportion of people consuming alcohol; amounts consumed per capita, as well as heavy episodic alcohol use. Southeast Asia has seen a 29% increase in per capita alcohol use since 2010. Only the WHO European region has achieved the voluntary target of a 10% reduction of per capita alcohol use – showing that transformative change through proven, high-impact alcohol policy solutions is possible.

However, so far, most countries, especially low- and middle-income countries (LMICs) are affected by a heavy alcohol burden, and have NOT implemented a comprehensive set of alcohol policies. 

No low-income country has reported increasing resources for implementing alcohol policy in the last decade. Many countries are failing to implement the alcohol policy best buy solutions, with LMICs more likely to have fewer evidence-based and cost-effective policies.

Few countries use alcohol taxation for health goals 

Few countries impose taxes on alcohol purchases for public health goals.

Few countries use alcohol taxation as a public health policy to prevent and reduce harm and reinvest revenue in health promotion.
 Less than half of countries use price strategies such as adjusting taxes to keep up with inflation and income levels – which means alcohol has become more affordable in many parts of the world over the last decade.

Alcohol has also become more widely available. Less than one-third of countries have regulations on outlet density and days of alcohol sale. 
Some countries, mainly LMICs in Africa, still do not even have a legal minimum purchase age.

And alcohol marketing regulation continues to lag well behind technological innovations and e-commerce that stimulate alcohol consumption, including rapidly developing new delivery systems. Most of the countries that reported no alcohol marketing restrictions whatsoever across all media types were in the African or Americas regions – leaving their children, youth, and adults completely unprotected from the alcohol industry’s push to find ever more loyal consumers.

Alcohol industry profits from lax regulation, heavy consumption, and under-age sales 

Alcohol companies make profits from sales to youths

The alcohol industry profits from the current situation, and has been identified as a major obstacle to progress in promoting health through evidence-based alcohol policy solutions. Their fundamental conflict of interest has never been more clear. The biggest  profits reaped in by  Big Alcohol corporations come from heavy alcohol use. And the alcohol industry is also dependent on under-age alcohol use for their profits.

It is now time to learn the lessons from the current state of global alcohol policy. Country experiences around the world and scientific analysis reveal the strategies of the alcohol industry to misinform the public about the harm of their products, to delay, derail and even destroy alcohol policy development efforts, and to push ever more aggressively for new consumers and markets.

But we also know more about what solutions are effective to protect people and communities better from alcohol harm. Concrete examples show that the alcohol policy best buys hold vast potential to improve health, strengthen health systems, and generate returns on investment.

We know much more now about alcohol’s harms to health

And thirdly, we know much more today than in 2010 about alcohol harms and how to talk about these harms. It is proven that alcohol causes cancer and cardiovascular disease, among 200 other health conditions and diseases. 

And the scientific evidence today is unimpeachable that there is no safe or healthy amount of alcohol consumption, not for the heart, the brain, cancer, or mental health. But now it is important to raise awareness of both the public and policy makers. It is crucial to do away with myths and outdated language that do not reflect reality.

Historic opportunity 

This knowledge, and these insights, are what makes this opportunity historic. Now is the time to make the harm caused by the alcohol industry a public health priority. Now is the time to accelerate alcohol policy action.

For the next decade, the world needs a bold and ambitious new WHO Global Alcohol Action Plan. 

Bigger ambition means to focus more on alcohol policy “Best Buys” and WHO’s SAFER technical package to facilitate country action and impact on alcohol harm. Bolder efforts also mean to pursue targets that really make a difference in the lives and communities of people around the world.

WHO Best Buys for addressing alcohol’s harms

Countries should adopt a target to reduce per capita alcohol use by 2030 with 30%, and to maintain current levels of alcohol abstention. Bigger ambition also means to improve the alcohol policy infrastructure on all levels – learning from other public health priorities. A global ministerial conference on alcohol is needed to foster exchange and leadership, and cross-border collaboration, for instance. An inter-agency joint initiative to support alcohol taxation development is needed to accelerate action on high-impact alcohol policy, improve coordination, and unlock additional resources for alcohol prevention and control.

And bolder efforts also means that more work is needed to support countries in protecting alcohol policy development from alcohol industry interference.

The harm caused by the products and practices of the alcohol industry affects all aspects of our societies. But this also means that alcohol policy action, driven by an ambitious new action plan, has the potential to help improve health and health systems, as well as economic productivity and growth, and social justice and equity.

Developing such an action plan that facilitates comprehensive country action on alcohol harm is a historic opportunity to contribute to creating a world where everyone, everywhere can reach the full potential of a long and healthy life.

___________

Kristina Sperkova, international president of Movendi Int.

Kristina Sperkova is the International President of Movendi International, the world’s largest global social movement for development through alcohol prevention and control, including 130+ member organizations from 50+ countries. Movendi International is in Official Relations with WHO and in Special Consultative Status with the UN ECOSOC.  Ms. Sperkova is also part of the civil society working group on noncommunicable diseases (NCDs) that advises WHO Director General Dr Tedros Adhanom Ghebreyesus.

 

Image Credits: Movendi International, Neil Moralee/flickr , Jano Soto Cossio, WHO, Sophie Carroll/flickr, World Health Organization , WHO, 2017 .

Rwanda
Rwandans queue to receive the AstraZeneca COVID-19 vaccine delivered by COVAX in March.

The World Health Organization (WHO) believes that is possible to get 70% of the world vaccinated against COVID-19 by June – but only if wealthy countries redirect their doses and orders to poorer countries that are lagging behind.

Eleven billion vaccines are needed to reach the 70% target, said WHO Director-General Dr Tedros Adhanom Ghebreyesus at the launch of the global body’s Strategy to Achieve Global Covid-19 Vaccination by mid-2022.

More than 6.4 billion doses had already been administered globally, and one-third of the world’s population is fully vaccinated against COVID-19,” said Tedros.

“Contracts are in place for the remaining five billion doses, but it’s critical that those go where they are needed most, with priority given to older people, health workers and other at-risk groups,” said Tedros.

“We can only achieve our targets if the countries and companies that control vaccine supply put contracts for COVAX, and the African Vaccine Acquisition Trust (AVAT) first for deliveries, and donated doses.”

Tedros added that there was “horrifying inequity” as high and upper-middle-income countries had used 75% of all vaccines produced so far while low-income countries have received “less than half of 1% of the world’s vaccines”.

Earlier this year, WHO set three global vaccination targets to end the pandemic: 10% of the world’s population vaccinated by the end of September, 40% by December and 70% by next June.

Failed to meet 10% target

But 56 countries, mostly in Africa and the Middle East, failed to meet the 10% target last month. The average vaccination rate in Africa is 4.4%.

However, WHO’s Dr Kate O’Brien, head of vaccines and immunisation, said that around 200 million vaccines were needed for all countries to reach 10% coverage – less than a week’s production, as around 1.5 billion vaccine doses are being produced every month.

Bruce Aylward, Tedros’ special adviser, added that 40% of people were already fully vaccinated in North America, South America and Asia, while the Western Pacific was close to that. 

“Of course, the problem in sub-Saharan Africa,” said Aylward. “There’s enough vaccine in the world, but we have a distribution and delivery problem. If we can’t solve that problem in 12 weeks, that speaks poorly for the urgency we need to end the pandemic.” 

He challenged every country with over 40% coverage, saying that if they were not prioritising helping lower-income unvaccinated parts of the world and COVAX then “they’re simply not doing enough to help achieve global equity”. 

‘Costed, coordinated and credible’

United Nations Secretary-General António Guterres

Describing the WHO strategy as a “costed, coordinated and credible path out of the COVID-19 pandemic for everyone, everywhere”, United Nations Secretary-General António Guterres said that $8-billion was needed to meet the 70% target, both to buy doses and support in-country delivery.  

Guterres expressed frustration that neither the UN nor the WHO had the power to compel wealthy countries or vaccine manufacturers to distribute vaccines fairly.

“I’ve long been pushing for a global vaccination plan to reach everyone everywhere sooner rather than later; a plan that should be implemented by an emergency task force made up of present and potential vaccine production countries, the WHO, COVAX partners, international financial institutions, working with the pharmaceutical companies to guarantee the production of enough doses and their equitable distribution,” said Guterres.

“Unfortunately, I have not been heard. Yet instead of global, coordinated action to get vaccines where they are needed most, we have seen vaccine hoarding, vaccine nationalism and vaccine diplomacy.”

He warned that vaccine inequality is the best ally of the COVID-19 pandemic. 

“It’s allowing variants to develop and run wild condemning the world to millions more deaths and prolonging an economic slowdown that could cost trillions of dollars,” said Guterres.

Three steps

The WHO strategy proposes a three-step approach to vaccination, with all older adults, health workers, and high-risk groups of all ages, in every country vaccinated first, followed by the full adult age group in every country and finally adolescents.

It directs all member states to establish updated national COVID-19 vaccine targets and plans that “define dose requirements to guide manufacturing investment and vaccine redistribution”.

It appeals to countries with high vaccine coverage to swap their vaccine deliveries with COVAX and AVAT, accelerate donation commitments, and establish new dose-sharing commitments aimed at reaching the 70% target in every country.

It also calls for COVID-19 vaccine manufacturers to prioritize and fulfil COVAX and AVAT contracts, and be transparent about their monthly production.

 “We’ve heard the commitments. We’ve heard the talk. The DG has called for actions, and those are very clear in the strategy,” said O’Brien.

“Countries that have a substantial number of doses already and have achieved high vaccine coverage can swap their place in line for additional doses for the coming weeks and the coming months. The critical feature here is to get the doses to those places that are still lagging behind the target. The second part of this is that funding is needed for those countries to actually deliver the doses.”

Image Credits: WHO.

WTO chief spokesperson Keith Rockwell

Discussions over a controversial World Trade Organization waiver on intellectual property related to COVID vaccines, treatments and other tools, have become more “constructive” said a senior WTO spokesman on Thursday, in a press briefing on the first day of the WTO’s two-day General Council meeting. 

There has been a “subtle shifting in the direction of compromise from both sides,” said WTO chief spokesman Keith Rockwell, holding out hope of a possible agreement on the bitterly disputed initiative in time for the WTO’s big Ministerial Council meeting (MC12), November 30-12 December.

A waiver on intellectual property rights, enshrined in WTO’s TRIPS agreement, was first proposed by South Africa and India last year, as a way to expedite manufacture of desperately-needed COVID health products in lower-income countries that have lacked both capacity to make their own COVID vaccines and therapeutics, as well as purchasing power to acquire patented versions.  

But the initiative has also seen stiff opposition from developed countries, led by Germany and other EU nations, which contend that it could harm, rather than help, fledgling initiatives already underway to expand manufacturing capacity – and locate more of that capacity in low- and middle-income countries. 

The TRIPS waiver initiative is now co-sponsored directly by some 18 low- and middle-income countries along with dozens more nations affiliated with the WTO “African Group” as well as the “Least Developed Country (LDC) Group”.  

Today’s more positive tone at the WTO General Council followed on an announcement by Moderna, one of the world’s two top manufacturers of the newest, and most successful mRNA COVID vaccines, that it would invest in a state-of the-art mRNA vaccine facility in Africa capable of producing up to 500 million doses a year. (see related HPW story). 

In terms of ambition, the Moderna initiative well outpaces that of Pfizer, the world’s other mRNA vaccine powerhouse to jumpstart more vaccine manufacturing on the continent.  In July, Pfizer announced a partnership with South Africa’s Biovac, whereby the South African firm would perform the “fill and finish” for up to 100 million Pfizer vaccines, beginning next year.   

Two-pronged approach in WTO to COVID crisis 

While Rockwell did not cite any concrete points where progress on the waiver talks had been made, he said that the tone of discussions had changed significantly over the past two months. 

“While there is not an agreement on this, and I don’t want to overstate this, or be overly optimistic, I think it’s fair to say that the tone of the discussion was really quite constructive,” Rockwell stated. 

“There were very few highly politically charged interventions; a number of important delegations said that they were ready to look at any proposals that addressed all the concerns –  the issues here are ones with which you’ll be familiar,” Rockwell observed. 

Those issues include high-income countries assertions that IP protections reward innovation, and have been key to the rapid development of COVID vaccines, as well as more specific objections to: “scope of the waiver, including products, and the specific intellectual property elements, considered, and the duration. And the protection of undisclosed information.” 

In its current formulation, the waiver be for an initial period of three years, subject to further review. It would remove not only the existing WTO TRIPS patent protections on COVID health products, but also protections on copyright, trade secrets and other types of IP.   

“Now, I don’t want to oversell this, but the tone was really quite different…” Rockwell said. “I think there is certainly an understanding of how important his issue is, and how short time is for us to be able to come to an agreement.”

Rockwell also stressed that in addition to the highly legalistic negotiations over the IP waiver initiative, New Zealand’s WTO Ambassador, David Walker, is leading a parallel process on so-called “non-TRIPS” interventions that the WTO could take. 

This process, launched in June by General Council Chair Dacio Castillo, of Honduras, puts Walker in charge of finding a “multilateral and horizontal response to the COVID-19 pandemic.”

Walker, a former General Council chair himself, has been leading  discussions among members on how other WTO responses, could help facilitate trade in COVID health products and remove export restrictions which slow the international movement of vital goods. 

The process, which is “complimentary” to the TRIPS negotiations, could lead to an outcome document at MC12, Rockwell said, with both “broad political messages” as well as proposal for concrete decisions on WTO rules or regulations that could that includes both political declarations as well as proposals for concrete WTO decisions – to relieve export restrictions; foster greater regulatory coherence; and increase cooperation on issues such as tariffs that may impede access to essential medical products. 

“He [Walker] said that with respect to export restrictions, a large number of members had attached a very high priority to this; they said it’s been disruptive, these export restrictions, to global value chains and have made it difficult to ramp up productions,” Rockwell stated. 

Further work to unlock such bottlenecks could also be part of a “post-MC 12 Work Program, on trade facilitation, regulatory coherence and tariffs.” 

Image Credits: Shutterstock.

Moderna’s clinical development manufacturing facility in the US.

Moderna should work through the Partnership for African Vaccine Manufacturing (PAVM) if it wants to invest in vaccine production on the continent, according to the head of the Africa Centers for Disease Control (CDC).

The company announced on Thursday that it plans to invest $500-million in a “state-of-the-art mRNA facility” in Africa that can produce up to 500 million doses of vaccines each year.

Moderna says that wants the new facility to include drug substance manufacturing, fill and finish and packaging capabilities, but it has neither chosen a country nor committed to a timeline.

Africa CDC Executive Director Dr John Nkengasong said while the announcement was “very much welcome”, he had not seen the company’s media release or been informed about Moderna’s plans. 

Urging the manufacturer to work “very closely” with his organisation, Nkengasong added that the Africa CDC did not “tell manufacturers where to go to produce their vaccines”, but could help to facilitate their plans.

“We have a Partnership for African Vaccine Manufacturing (PAVM), which has a political backing, and our wish and hope is that Moderna works with that group, which looks at vaccine manufacturing in Africa from an ecosystem perspective, from the whole of Africa approach,” Nkengasong told a media briefing on Thursday.

“About 10 countries in Africa have expressed an interest in vaccine manufacturing. We can actually bring them all together and put Moderna at the centre of that to discuss and ask all the questions that will really speak to the need to be transparent, and also to be cooperative and coordinate our efforts,” said Nkengasong.

He stressed that Moderna’s plan would offer relief in the middle- to long-term, but it would not solve Africa’s pressing issues related to COVID-19. These he listed as “quick access to vaccines, redistribution of vaccines, and making sure that certain licences are provided so that manufacturing can start”.

Less than 5% of Africans have been vaccinated against COVID-19, and the continent has been desperately trying to buy vaccines via the African Vaccine Acquisition Trust (AVAT) in the face of massive inequity in access to vaccines.

‘Only the beginning’

Announcing its plans, Stephane Bancel, Moderna’s Chief Executive Officer, said that the company viewed its COVID-19 work as “only just beginning”.

“We are determined to extend Moderna’s societal impact through the investment in a state-of-the-art mRNA manufacturing facility in Africa,” said Bancel.

“While we are still working to increase capacity in our current network to deliver vaccines for the ongoing pandemic in 2022, we believe it is important to invest in the future. We expect to manufacture our COVID-19 vaccine as well as additional products within our mRNA vaccine portfolio at this facility.”

However, there is speculation that part of Moderna’s motivation for making the announcement is because it is under pressure to increase production from the US government, which has invested over $8-billion in its vaccine, according to a report in Politico. 

Some of Moderna’s clients (extract from COVID-19 Vaccine Market Dashboard).

US President Joe Biden has pledged to donate a billion vaccines to low and middle-income countries in a bid to end the COVID-19 pandemic by the end of 2022, and US government officials have reportedly had tense exchanges with Moderna officials about it not scaling up production.

Moderna is also under pressure from health activists as it has almost exclusively supplied high- and middle-income countries with its vaccines via bilateral agreements. According to the COVID-19 vaccines market dashboard compiled by UNICEF, Botswana is the only African country that Moderna has supplied with COVID-19 vaccines.

However, it has undertaken to supply 35 million doses to COVAX in May.

Moderna had not responded to questions by the time of publication.

 

Image Credits: Moderna.

Cuba is seeking WHO approval for its COVID-19 vaccines.

Jamaica, Nicaragua, and Haiti were the only three member countries of the Pan American Health Organization (PAHO) that failed to meet the World Health Organization (WHO) target of vaccinating 10% of their populations against COVID-19 by the end of September.

Around 37% of people in Latin America and the Caribbean have been fully vaccinated against COVID-19, while seven countries in the Americas have vaccinated more than 70% of their populations, according to PAHO.

While COVID-19 cases are down in the Americas, some local trends across the region remain worrisome, PAHO officials said during a press briefing Wednesday.

The Americas reported a 12% decrease in weekly new cases, according to the newest WHO Weekly Epidemiological Update on COVID-19. 

Worrying local trends

However, local trends paint a different story. Many Southwestern Canadian provinces and the US state of Alaska are reporting their highest hospitalization rates and ICU peaks, with emergency rooms in Alaska overwhelmed with COVID-19.

Chile is also seeing a rise in new cases, especially in urban regions, such as the metropolitan region of Santiago, and in port cities such as Coquimbo and Antofagasta. 

While cases continue to decrease in Central America, Costa Rica and Belize continue to see high rates of hospitalization and ICU peaks. 

In response, PAHO urged governments to remain vigilant on monitoring local COVID-19 trends in their areas.  

“We are reminding governments to keep a close eye on local trends because infection dynamics vary within each country, in part due to differences in vaccine availability and uptake. This small localized approach will be key to keep outbreaks under control,” PAHO Director Carissa Etienne implored.

Vaccine shortages

Although 875,000 vaccine doses have arrived in the region, this is not enough to protect everyone, said Etienne.

“We continue to urge countries with surplus doses to share them with countries in our region, where they can have life-saving impact.” 

PAHO continues to deliver COVAX-funded doses and donations, having already closed agreements with three emergency use listing authorized vaccines – Sinovac, Sinopharm, and AstraZeneca.

Nicaragua has recently announced that the country will receive 7 million doses of Cuban vaccines Abdala, Soberana, and Soberana 2 over the next 3 months.

Cuba had released information back in June regarding the vaccines – its three-dose Abdala vaccine was 92% effective, and its Soberana 2 vaccine is 91% effective when combined with a booster vaccine called Soberana Plus. 

The island’s national regulatory agency approved the Abdala vaccine in July and the Soberana 2 vaccine in August. 

Cuba is currently trying to seek WHO approval for its two home-grown vaccines, which would facilitate their delivery in other countries.  PAHO is supporting Cuba’s participation in the vaccine qualification process.

“Our interest is that all vaccines are able to participate in the WHO process for granting emergency use authorization because this will broaden the supply of vaccines that we are able to purchase through the Revolving Fund,” said PAHO’s Assistant Director Jarbas Barbosa.

For now, PAHO is working with the Nicaraguan government to increase its vaccine access – the country is receiving 223,000 doses from Pfizer starting next week, and an additional 81,900 vaccines from Pfizer are to be received over the rest of the month. 

Nicaragua is receiving other vaccines through COVAX, as well as vaccine donations from Spain. 

 

Image Credits: News Prensa Latina/Twitter.

Children under the age of five years in sub-Saharan Africa continued to account for approximately two-thirds of global deaths from malaria.

The World Health Organization (WHO) has given the go-ahead for children to get the first-ever malaria vaccine in areas where there is a high to moderate risk of infection.

The vaccine, known as RTS,S, is the first to have been approved against a parasitic disease.

It has been tested on 800,000 children in Ghana, Kenya and Malawi over two years as part of routine immunisations and found to reduce severe malaria-related hospitalisation by 30% and clinical malaria by 40%, researchers revealed at a WHO press conference on Wednesday.

“This is a historic moment. The long-awaited malaria vaccine for children is a breakthrough for science, child health and malaria control,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus, who started his medical career as a malaria researcher. 

“Using this vaccine on top of existing tools to prevent malaria could save tens of thousands of young lives each year.”

The WHO recommends that the vaccine – which acts against P. falciparum, the deadliest malaria parasite – is given in four doses to children from the age of five months to around 18 months.

Tedros said that progress against malaria “has stalled at an unacceptably high level, with more than 200 million cases, and 400,000 deaths every year – two-thirds of which are children under five in Africa”.

“Every two minutes, a child under five dies of malaria,” said Dr Matshidiso Moeti, WHO Regional Director for Africa, adding that 94% of malaria cases were in Africa.

Dr Matshidiso Moeti, WHO Regional Director of Africa.

“We have long hoped for an effective malaria vaccine and now for the first time ever, we have such a vaccine recommended for widespread use.”

Moeti added that the WHO would support the production of the vaccine in Africa.

However, GlaxoSmithKline (GSK), which has invested US$ 700 million in the development of RTS,S and donated up to 10 million doses for the pilot programme, will be working with an Indian generic producer to manufacture the vaccine for the foreseeable future. 

“GSK was clear at the time, as we’ve proceeded with this vaccine that, having provided a large degree of development funding and producing the vaccine for the implementation programme, was nevertheless seeking a tech transfer partner for the long term production of this vaccine,” said Dr Kate O’Brien, WHO head of immunisation.

“There was a programme opened up to initiate interest from vaccine manufacturers and the partner who will be with GSK for this tech transfer is Bharat Biotech in India.”

Protect children’s development

Dr Alejandro Cravioto, Chair of the WHO Strategic Advisory Group of Experts on Immunization (SAGE), said that his group recommended the use of the vaccine to ensure the healthy growth and development of children.

“The experience we have had before with other infections showed us clearly that a child that is repetitively sick is maimed for life,” said Cravioto.  “He or she is not capable of developing the capacities that he or she is born with, in the sense of achieving an adulthood that will be meaningful. So having anything that protects them, or helps them to be less sick during this growth phase, is essential.”

Global vaccine alliance, Gavi, health agency Unitaid and the Global Fund to Fight AIDS, Tuberculosis and Malaria committed nearly US$ 70 million to fund the pilot, which was designed to address several outstanding questions related to the public health use of the vaccine following the Phase 3 trial showing efficacy of RTS,S.

“We welcome this new tool in the fight against malaria,” said Peter Sands, Executive Director of the Global Fund. “In countries where the Global Fund invests, we have reduced malaria deaths by 45% since 2002 with testing, treatment and prevention tools such as mosquito nets.

“In the vaccine pilots, the RTS,S vaccine was most effective when used together with these existing tools. Significant additional resources will be necessary to enable wide deployment of the vaccine alongside other innovations, and as part of a sustained and comprehensive response in the countries that need it the most.”

Following the WHO recommendation, global stakeholders, including Gavi, will consider whether and how to finance a new malaria vaccination programme for countries in sub-Saharan Africa, according to a statement by Gavi, the Global Fund and Unitaid.

The vaccine will complement other WHO-recommended measures for malaria prevention, including the use of insecticide-treated bed nets, indoor spraying with insecticides, malaria chemoprevention strategies, and the timely use of malaria testing and treatment.

Image Credits: WHO.

The African Medicines Agency’s framework would help combat falsified products

Africans are a step closer to speedier access to newer, safer medicines following this week’s notification by 15 African Union (AU) member countries that they have formally ratified and deposited their accord to create a new African Medicines Agency (AMA).

Although the AU adopted the treaty to set up the AMA back in February 2019, 15 African countries had to formally notify the AU Commission that they had ratified the treaty before the agency could be set up.

On Tuesday, Cameroon became the 15th country to deposit its ratification instrument – finally pushing the AMA over the threshold into reality. According to the Treaty, the AMA will now come into force in 30 days time – on 5 November.  

The AMA aims to support African countries to better regulate medical products and harmonise the regulation of medicines across the continent. It will also test samples of medicines from time to time to eliminate fakes that plague the continent.

The 14 other countries to have both ratified the AMA and “deposited the instrument of ratification” at the AU (a letter from the head of state informing it of ratification) are Algeria, Benin, Burkina Faso, Gabon, Guinea, Mali, Mauritius, Namibia, Niger, Rwanda, Seychelles, Sierra Leone and Zimbabwe.

A further three countries have ratified the treaty but not formally informed the AU, while eight more have signed the treaty but not yet ratified it.

This means 36 of Africa’s 55 countries – predominantly Francophone countries – have expressed support for the AMA.

However, African powerhouses Ethiopia, Nigeria and South Africa have not yet expressed their support for the AMA.

The COVID-19 pandemic has highlighted the need for countries to speedily assess medicines and vaccines, a capacity that a number of African countries lack.

The African Centers for Disease Control and Prevention (CDC) has played a central role in co-ordinating the health response to the pandemic on the continent, and highlighted the value of a continental player during a health crisis.

Greg Perry, Assistant Director-General of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), welcomed the AMA’s ratification, describing it as taking “one step closer to achieving a continent-wide regulatory agency”.

“We look forward to the full implementation of the AMA,, which will be a game-changer for all Africans to access safe, effective and quality medical products in a timely manner,” said Perry.

Pharmaceutical companies have long complained about how complicated it is to get medicines approved in Africa and how long it takes particularly in comparison to Europe, which processes applications via a  central European Medicines Agency (EMA).

Perry added that for the agency to become fully operational, it was important for the AU to define the appropriate funding model and engage with the African Medicines Regulatory Harmonisation initiative “which has already set strong governance structures and pan-African guidance in place for the approval of COVID-19 treatments and vaccines”.

Reduce barriers to African market entry

Andy Gray, senior lecturer in pharmacology at the University of KwaZulu-Natal, said that AMA’s greatest potential lies “in the field of harmonisation of regulatory systems, which should reduce the barriers to market entry in Africa”. 

“The AMA is not intended to be a supranational regulator, and will not make decisions in the way the EMA does, but it could help in bringing national medicines regulatory authorities together, simplifying systems and reducing redundancy,” explained Gray.

“It can also make a major difference by promoting transparency of regulatory action across the continent, and showing how that can drive reliance models of regulation.”

Gray added that the AMA could learn lessons from the Africa CDC by providing “visible and credible leadership”, ensuring “practical outputs, not just talk” and ensure it had recognition in appropriate global forums.

Earlier this year, Michel Sidibé, the former Executive Director of UNAIDS and Mali’s Minister of Health, was appointed as the AU’s Special Envoy for the AMA. He has been leading efforts to ensure that countries ratify the agency, and could be in the running to head it.

Announcing Cameroon’s ratification of the AMA on Twitter this week, Sidibé described the agency as a “game-changer for our continent”.

 

 

 

 

 

Image Credits: United States Army , Marco Verch/Flickr.

UNFPA Executive Director Dr Natalia Kanem

Nineteen countries have been prioritised for support to implement new global targets aimed at preventing maternal and newborn deaths.

This emerged at the launch on Tuesday of the new targets, which were developed by the World Health Organization (WHO), UN Population Fund (UNFPA) and their partners in the Ending Preventable Maternal Mortality (EPMM) initiative.

UNFPA Executive Director Dr Natalia Kanem said that while the global community had committed to reducing the global maternal mortality rates to 70 deaths per 100,000 live births by 2030 as part of the sustainable development goals (SDG), it was not moving fast enough. 

“If the current pace prevails, we will not reach this goal before 2065,” said Kanem. “This is a wake-up call for us to urgently scale up and accelerate our efforts with less than 10 years to go.”

Fourteen of the chosen countries are in Africa and include Chad, which has one of the highest maternal mortality rates in the world, as well as Nigeria and Ethiopia.

The five non-African countries are Afghanistan, Pakistan, Mexico, Nepal and Laos. 

The 19 priority countries identified for action against maternal mortality.

The 19 countries will get support to implement and monitor the targets, according to the UN agency officials. There are five targets:

  • 90% pregnant women to attend four or more antenatal care visits (towards increasing to eight visits by 2030);
  • 90% of births to be attended by skilled health personnel;
  • 80% of women who have just given birth to access postnatal care within two days of delivery;
  • 60% of the population to have access to emergency obstetric care within two hours of travel time;
  • 65% of women to be able to make informed and empowered decisions regarding sexual relations, contraceptive use, and their reproductive health.

Country selection involved a number of factors including a high burden of maternal deaths and stillbirths, the strength of country midwifery and whether there were partners to support the ministries of health, according to World Health Organization’s (WHO)  Dr Anshu Banerjee, Director for Maternal, Child and Adolescent Health and Ageing.

Preventable deaths

Addressing the launch, WHO Director-General Dr Tedros Adhanom Ghebreyesus said that around 295,000 women died each year due to complications of pregnancy and childbirth, and there were two million stillbirths and 2.4 million newborn deaths annually.

“Most of these deaths are in low and middle-income countries,” said Tedros.

“Most of these [deaths] could have been prevented with quality pre- and post-natal care and birthing assistance from competent maternal and newborn health professionals,” said Tedros.

“The COVID 19 pandemic has badly disrupted essential health services around the world, including for maternal and newborn care. WHO is supporting countries to resume these services regardless of a woman’s COVID-19 status,” he added.

In 2017, the global maternal mortality ratio was around 211 maternal deaths per 100,000 live births, which was a 38% reduction compared to 2000 – a reduction of around 2,9% per year.

“Universal health coverage, including universal access to sexual and reproductive health care, will be key to providing equitable access to quality maternal health services,” said Kanem. 

Kanem said that her agency, the WHO and partners are “committed to helping countries achieve coverage targets by implementing action-oriented plans, and by tracking progress at the national and sub-national levels”.

She stressed that the targets “also incorporate key determinants of maternal health, including a woman’s ability to make decisions about her own sexual and reproductive health”. 

The SDG 3.1 sets out that by 2030, the global maternal mortality ratio (MMR) should be reduced to less than 70 per 100,000 live births, and no country should have an MMR more than 140 per 100,000 live births.

“The latest estimates are 211 per 100,000 live births – but increasing to 415 on average in the poorest countries,” according to the WHO.

 

Two jabs of the Pfizer-BioNTech vaccine are 90% effective against COVID-19 hospitalizations for all variants including Delta, for at least 6 months, confirmed a new study published by The Lancet.

The study, conducted by Kaiser Permanete and Pfizer, found that while effectiveness against all SARS-CoV-2 infections declined over the study period, effectiveness against hospitalizations remains at 90% overall for all variants. 

“Our study confirms that vaccines are a critical tool for controlling the pandemic and remain highly effective in preventing severe disease and hospitalization, including from the delta and other variants of concern. Protection against infection does decline in the months following a second dose,” said lead author of the study Dr Sara Tartof, of Kaiser Permanente. 

The study analyzed 3,436,957 electronic health records from the Kaiser Permanente Southern California (KPSC) health system between 4 December 2020 and 8 August 2021 to assess the effectiveness of the Pfizer vaccine against COVID-19 infections and related hospitalizations. 

Immunity declines after six months

In addition, the study also found that effectiveness against all SARS-CoV-2 infections declined over the study period, falling from 88% within one month after receiving two doses to 47% after six months, underscoring the importance of improving vaccination rates worldwide. Researchers did not observe a difference in waning between variants.

While this does provide evidence towards waning immunity against COVID-19, the CDC has called for additional research to determine which groups should be prioritized to receive booster shots. 

“In line with the recent FDA [3] and CDC recommendations [4], considerations for booster shots should take global COVID-19 vaccine supply into account as people in many countries around the world have not yet received a primary vaccination series,” said Tartof. 

Vaccine equity and booster shots have prompted increasing debate in recent weeks, with WHO calling for a global moratorium on COVID-19 boosters to be extended until the end of the year, and global health advocates protesting “vaccine apartheid” outside the UN during the General Assembly last month. 

US and Israeli studies find similar reductions in immunity 

Other findings from the US Centers for Disease Control (CDC) and the Israeli Ministry of Health had also found reductions of immunity from the Pfizer vaccine after six months. 

The Israeli findings reported that people over age 60 who received a third dose of the Pfizer vaccine were five times less likely to become severely ill if they had their first shot at least five months earlier. 

These results in particular were regarded as a critical factor in the recommendation from the US Food and Drug Administration (FDA) to amend its emergency use authorization (EUA) last month for the Pfizer vaccine.

The FDA now recommends a single booster dose to be administered at least six months after completion for: individuals 65 and older; individuals 18 through 64 at high risk of severe COVID-19; and individuals 18 through 64 with increased exposure of SARS-CoV-2 that puts them at high risk of health complications relating to COVID-19. 

 

Image Credits: International Monetary Fund/Ernesto Benavides.

Molnupiravir could make a significant difference to the global response to COVID-19.

Indian generic drug manufacturers are poised to make the antiviral pill, molnupiravir, which halved hospitalisations in a trial of high-risk people with COVID-19.

Merck, which developed molnupiravir in collaboration with Ridgeback Biotherapeutics, has awarded non-exclusive, voluntary licensing agreements to eight generic companies in India since April in anticipation of positive trial results.

According to Merck, it has been producing molnupiravir “at risk” and expects to produce 10 million courses of treatment by the end of 2021, the company said a media release last Friday.

Merck cut short the trial of molnupiravir in the light of the good results, and will make an application for emergency use authorisation (EUA) with the US Food and Drug Administration (FDA), “as soon as possible”, the company said.

It will also submit “marketing applications to other regulatory bodies worldwide”, it added.

Australia’s Therapeutic Goods Administration (TGA) granted provisional determination for molnupiravir in August.

Meanwhile, in anticipation of regulatory approval, the Access to COVID-19 Tools (ACT) Accelerator is working to “secure volumes” of the pills for people in LMICs, according to ACT-Accelerator partner Unitaid.

“Effective, simple to use, oral treatments that can avert the progression to severe illness are exactly the kind of breakthroughs we need to get the pandemic under control. Deployed alongside vaccines, such medicines could drive down hospitalizations and deaths due to COVID-19,” said Dr Philippe Duneton, Executive Director of Unitaid shortly after the Merck announcement.

Few treatment options

At present, there are very few treatment options for people infected with COVID-19, and those that exist – such as remdesivir and dexamethasone – are expensive, given intravenously or by injections and only for severely ill people already in hospital. 

White House medical adviser Dr Anthony Fauci told CNN on Sunday that the medicine was “extremely important”.

“It’s a pill that’s given by mouth, so you don’t need anything special other than taking a pill the way you take any pill. And the results are really quite impressive,” said Fauci.

However, he said that it only halved the risk of hospitalisation and to cut this risk by 100% people should “not get infected in the first place”.

Back in April, Merck entered into voluntary licensing agreements with five Indian companies – Cipla, Dr Reddy’s Laboratories, Emcure Pharmaceuticals, Hetero Labs and Sun Pharmaceutical Industries. All are World Health Organization (WHO) pre-qualified manufacturing facilities. 

It has since licensed Aurobindo Pharma, Torrent Pharmaceuticals, and Viatris, to manufacture the drug.

At least four of the companies are already manufacturing generic molnupirvir, which they have been supplying to a trial in India and all eight are ready for global supply, according to MSD India.

When it announced the licensing back in April, Merck said the intention was to enable the manufacturers to “supply molnupiravir to India and more than 100 low and middle-income countries (LMICs)”.

No deaths in trial

The molnupiravir trial involved 775 unvaccinated adults with mild-to-moderate COVID-19 with at least one risk factor for serious illness – most commonly, obesity, being over the age of 60, and living with diabetes and heart disease. 

Only 7,3% of those taking molnupiravir ended up in hospital in comparison to 14,1% of those on the placebo, announced Merck (known as MSD outside the US and Canada) in a media release last Friday.

“Twenty-nine days into the trial, no deaths were reported in patients who received molnupiravir, as compared to eight deaths in patients who received placebo,” it added.

The trial was conducted globally, including at sites in Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany, Guatemala, Israel, Italy, Japan, Mexico, Philippines, Poland, Russia, South Africa, Spain, Sweden, Taiwan, Ukraine, the United Kingdom and the US. 

Meanwhile, in June the US government ordered approximately 1.7 million courses of molnupiravir at a cost of $1.2 billion – about $700/patient – according to a June media release from Merck. 

However, this price is equal to about 35 times the estimated sustainable generic price using current market prices for the active pharmaceutical ingredients (API), according to Melissa J Barber from Harvard University’s Department of Global Health and Population and Dzintars Gotham from King’s College Hospital in London.

“Assuming optimization of molnupiravir synthesis, and a resulting drop in API cost, the US price would be equal to about 161 times the estimated sustainable generic price,” the two researchers noted in a brief published last Friday.

They identified that three companies appeared to be exporting API for molnupiravir –  Optimus Drugs Private, Honour Lab, and Maithri Laboratories. 

Meanwhile, Pfizer and Roche are also racing to develop an antiviral pill for COVID-19, according to Reuters.