A doctor preparing the Moderna COVID-19 vaccine at the Naval Hospital in Bremerton, Washington, US.

Moderna’s COVID-19 vaccine was approved for use in children 12 to 17 years of age by the European Medicines Agency (EMA), making it the second vaccine recommended for use in children in Europe, following the EMA’s approval of Pfizer’s Comirnaty child vaccine formulation in May.

The effects of Moderna’s vaccine in adolescents was evaluated in a study with 3,732 participants. The study demonstrated that the vaccine produced a similar antibody response in those aged 12-17, as compared to young adults 18-25, for whom the vaccine was already approved.

None of the 2,163 children receiving the vaccine became infected with SARS-CoV2, while four of the 1,073 children that were given a placebo injection developed COVID-19.

The side effects in children were similar to those in people over the age of 18, including pain and swelling at the injection site, fatigue, headache, muscle and joint pain, chills, nausea, and fever.

The safety of the Moderna vaccine, as seen in adults, was confirmed in the adolescent study, the EMA stated. .

Although the EMA’s vaccine advisory committee noted that the study was too small to detect new uncommon side effects, the EMA concluded that the benefits of the vaccine outweigh the risks.

Pfizer’s COVID-19 vaccine was similarly evaluated in a study of 2,260 children aged 12 to 15 years. Of the 1,005 children that received the vaccine, none developed a COVID infection, compared to 16 children out of the 978 who received a placebo jab.

The most common side effects in children were pain at the injection site, tiredness, headache, muscle and joint pain, chills, and fever. The side effects were usually mild or moderate and improved within a few day of the vaccination.

The EMA said that it will continue to monitor the safety and efficacy of both vaccines in children as it is used across the region in vaccination campaigns.

Image Credits: Flickr – Official US Navy.

COVAX / vaccine equity
COVAX vaccine deliveries in Africa.

Without urgent action to boost supply and ensure equitable access to vaccines across every country, COVID-19 vaccine inequity will profoundly impact and impede socio-economic recovery in low- and middle-income countries (LMICs).

This is according to the Global Dashboard for COVID-19 Vaccine Equity, a joint initiative of the United Nations Development Programme (UNDP), the World Health Organization (WHO), and the University of Oxford’s Blavatnik School of Government.

A high price per COVID-19 vaccine dose, in addition to other vaccine and delivery costs, has the potential to place a strain on fragile health systems, undermining routine immunization and other essential health services. 

Alternative, accelerated scaled-up manufacturing and vaccine sharing with LMICs could have added $38 billion to the countries’ GDPs, if these countries had similar vaccination rates as high income countries. 

“Vaccine inequity is the world’s biggest obstacle to ending this pandemic and recovering from COVID-19,” said WHO Director-General Dr Tedros Adhanom Ghebreyesus.

“Economically, epidemiologically and morally, it is in all countries’ best interest to use the latest available data to make lifesaving vaccines available to all.”

According to the new dashboard, richer countries are projected to vaccinate quicker and recover economically quicker from COVID-19, while poorer countries haven’t been able to vaccinate even their health workers and most vulnerable populations. 

Some low- and middle-income countries have less than 1% of their population vaccinated, said UNDP Administrator Achim Steiner. These countries may not achieve pre-COVID-19 levels of growth until 2024. 

In addition, Delta and other variants are forcing some countries to reinstate strict public health social measures, further worsening social, economic, and health impact.

Steiner called for ‘swift, collective action’ on behalf of governments and policymakers to promote vaccine equity worldwide. 

“It’s time for swift, collective action – this new COVID-19 Vaccine Equity Dashboard will provide Governments, policymakers and international organizations with unique insights to accelerate the global delivery of vaccines and mitigate the devastating socio-economic impacts of the pandemic.”

The Dashboard is facilitated by the Global Action Plan for Healthy Lives and Well-being for All, which aims to improve collaboration across the countries and organizations, in support of an equitable and resilient recovery from the pandemic. 

Image Credits: UNICEF.

On 2 March, Nigeria received a delivery of vaccines from COVAX which landed in Abuja.

IBADAN – Africa’s most populous country, Nigeria, has officially exhausted all the doses of Oxford/AstraZeneca COVID-19 vaccine it received in March from COVAX, according to Dr Faisal Shuaib, CEO of Nigeria’s National Primary Health Care Development Agency (NPHCDA).

Twenty-one African countries have seen COVID-19 cases rise by over 20% for at least two weeks running, and the current peak is 80% higher than Africa’s previous peak when data from South Africa (which accounts for 37% of cases) is excluded, according to the World Health Organization (WHO) Africa region.

“Be under no illusions, Africa’s third wave is absolutely not over.  Many countries are still at peak risk and Africa’s third wave surged up faster and higher than ever before. The Eid celebrations which we marked this week may also result in a rise in cases. We must all double down on prevention measures to build on these fragile gains,” Dr Matshidiso Moeti, WHO Regional Director for Africa, told the regional media briefing on Thursday.

Vaccine doses are slowly inching upwards. One million Johnson & Johnson COVID-19 vaccine doses – part of approximately 25 million doses donated by the US government to Africa – were delivered this week, according to Jessica Lapenn, US Ambassador to the African Union.

The doses had gone to Burkina Faso, Djibouti, Ethiopia, the Gambia and Senegal. An additional 1.2 million vaccine doses will soon be delivered to Cameroon, Lesotho, Niger republic, Zambia and the Central African Republic, Lapenn told an Africa CDC press briefing on Thursday.

“These deliveries are the first tranche of approximately 25 million COVID-19 vaccine doses being donated to Africa. That’s out of 80 million doses that the Biden administration announced for global donations last month. In the next coming weeks, we’ll continue to see additional deliveries to reach this 25 million,” Lapenn said.

Jessica Lapenn, US Ambassador to the African Union

 

 

This comes as WHO urges African countries to urgently ramp up COVID-19 vaccinations as the squeeze on vaccine shipments eases.

“Around 60 million doses are set to arrive in the coming weeks from the US, Team Europe, the United Kingdom, purchased doses and other partners through the COVAX Facility. Over half a billion doses are expected through COVAX alone this year,” according to the WHO.

“A massive influx of doses means that Africa must go all out and speed up the vaccine rollout by five to six times if we are to get all these doses into arms and fully vaccinate the most vulnerable 10% of all Africans by the end of September,” said Dr Moeti.

Nearly 70% of African countries will not reach the 10% vaccination target for all countries by the end of September at the current pace. Around 3.5 million to 4 million doses are administered weekly on the continent, but to meet the September target this must rise to 21 million doses at the very least each week, according to the WHO.

Just 20 million Africans, or 1.5% of the continent’s population, are fully vaccinated so far and just 1.7% of the 3.7 billion doses given globally have been administered in Africa.

US assists African Union to achieve vaccine target

The African Union (AU) has a target of vaccinating at least 60% of people on the African continent, and Lapenn confirmed that the US government is engaging with the Africa CDC and the Africa Vaccine Acquisition Task Team (AVATT) to coordinate the allocation of the vaccine doses to African countries. 

A breakdown of the shipments provided by the Africa CDC showed Burkina Faso, Djibouti, Senegal, Gambia, Zambia, Niger and Cameroon got 151,200 doses of J&J vaccine while Ethiopia received 453,600 doses.

In addition to these deliveries, Health Policy Watch recently reported the US government will also donate an additional 500 million Pfizer vaccine doses globally starting in August, as committed by US President Biden before the recent G7 Summit.

While Africa’s share of this donation, which will be delivered through COVAX, has yet to be determined, Strive Masiyiwa, the AU Special Envoy and coordinator of the AVATT, requested half of the total donation – 250 million doses.

The US government has also pledged its support to the local manufacture of COVID-19 vaccine doses in Africa with its recent contribution, through the US International Development Finance Corporation (DFC), to a $700 million loan being made to expand Aspen pharma in South Africa. It has also signed an agreement with Senegal and other partners for production of COVID-19 vaccines in Senegal. 

DFC said the technical assistance will help mobilize technical and financial resources from public and private entities to contribute to the development of Fondation Institut Pasteur de Dakar (IPD), a vaccine manufacturer in Dakar, Senegal, to bolster the production of COVID-19 vaccines in the country.

“These commitments are part and parcel of the US’ historic leadership on humanitarian and health assistance across the continent, including our support to combat COVID-19,” said Lapenn.

“Since the outbreak of the pandemic, the US has provided roughly $541 million, and health humanitarian and economic support assistance to sub-Saharan Africa for COVID response. This follows a roughly $100 billion worth of investment in Africa’s public health over the last two decades.”

Urgently refilling Africa’s vaccine stocks

Dr John Nkengasong, Director of the Africa CDC

Dr John Nkengasong, Director of the Africa CDC, said the vaccines donated by the US government will help to ensure that vaccination continues or resumes in African countries that are either running out of doses or had already exhausted the doses received even though only 1.3% of people in Africa have been fully immunised.

“As of today, the continent has acquired 82.7 million COVID-19 vaccine doses among 51 Member States. Of that number, 61.3 million doses have been administered, representing about 74%. In order words, doses are not being wasted as up to about 75% of the doses have been used,” Nkengasong said.

According to the Africa CDC, Morocco has used up about 80% of its supplies. South Africa has also exhausted 64% of its supplies, Egypt (68%), Nigeria (99.97%) and Algeria (68%).

In Nigeria, Shuaib announced on Wednesday that the country had used 3,938,945 doses of Astrazeneca vaccines across 36 states and the country’s capital city, representing 98% utilization of the 4,024,000 doses of Oxford/AstraZeneca vaccine it received from COVAX. 

“This comprises 2,534,205 people who have been vaccinated for the first dose, and 1,404,205 who have received their second dose of the vaccine. This is to say that all vaccines given to Nigeria in this first phase have been exhausted,” Shuaib said.

He also announced that during the vaccination exercise, Nigeria recorded 14,550 cases of mild to moderate side effects out of which only 148 cases were considered to be severe and no deaths. 

“As plans and preparation for the second [vaccination] phase commences, ‘a whole family approach’ vaccination mechanism would be utilized. This is because Nigeria is plagued with other preventable and treatable diseases. We will use the opportunity of COVID-19 vaccination to integrate with other health systems,” he added.

J&J vaccine delivery timeline emerges

Elaborating on a recent deal struck between AVATT and Johnson & Johnson for 400 million doses, Masiyiwa confirmed that at least 45 African countries will be receiving the J&J vaccine through COVAX in two phases. 

In the first phase, J&J will ship six million single doses of its COVID vaccine to 27 African countries that have already paid for their vaccines. 

By the end of August, 45 African countries will have received their first shipment. Thereafter, J&J will ship an average 10 million doses per month from the Aspen facility in South Africa to African countries till the end of the year.

“In January, we would have moved to 20 million doses a month and we will continue exponentially increasing that until all 400 million doses have been delivered by September next year,” Masiyiwa said.

Strive Masiyiwa, the AU Special Envoy and coordinator of the AVATT

More local COVID-19 vaccine production deals

On Wednesday, Pfizer-BioNTech announced a deal with South Africa’s Biovac Institute, which will see the African company helping manufacture about 100 million COVID-19 vaccines for the African Union in the coming year.

“The deal is to ‘fill and finish’ the vaccine, the final stages of manufacturing where the product is processed and put into vials. It does not cover the complicated processes of mRNA drug substance production, which Pfizer and BioNTech will do at their own facilities in Europe,” Nkengasong said.

Under the deal, Biovac will get the ingredients for the vaccine from Europe, blend the components, put them in vials and package them for distribution. This deal is similar to the arrangement between South Africa-based Aspen and Johnson and Johnson.

Morocco has also signed a Memorandum of Understanding with Swedish company Recipharm to establish and scale-up COVID-19 vaccine manufacturing capacity in the country while South Africa has also signed an agreement between Biovac, Afrigen Biologics & Vaccines, a network of universities, WHO, COVAX, and Africa CDC for the establishment of the first COVID-19 mRNA vaccine technology transfer hub in Africa. 

In April 2021, Egypt also signed two agreements between Holding Company for Biological Products and Vaccines (VACSERA) and Sinovac for COVID-19 vaccine manufacturing in the country. Algeria has also announced production of the Sputnik V COVID-19 vaccine in partnership with Russia.

Masiyiwa described local production of COVID-19 vaccines in Africa as an effective opportunity for the continent to tackle “vaccine nationalism” that had largely limited the continent’s ability to quickly access and roll out COVID-19 vaccines even though it is willing to pay for the doses. 

“The countries with the production assets control the release of vaccines. So we at least could rely on production assets on African soil,” he said.

 

Image Credits: NPHCDA.

Arid soils in Mauritania, crops have failed and the region faced a major food crisis in 2012. Over 700,000 people were affected in Mauritania and 12 million across West Africa.

Biodiversity sits at the heart of the simultaneous fight against both COVID-19 and the climate crisis, said experts during a Wednesday event hosted by the Society for International Development (SID). 

At the event, ‘The Vaccine for Biodiversity’, panelists discussed re-focusing attention on the current health and climate crisis, and how new pandemics should and can be prevented in the future by looking at humankind’s relationship with nature. 

Two competing approaches have emerged – one that focuses on the interconnectedness between planetary health and human health and the other that sees health as a commodity – noted Ruchi Shroff, Director of Navdanya International based in Italy.

The view of health as something to be purchased through the pharmaceutical industry or found in biomedical vaccines “separates us from nature”, said Shroff. 

“[We see ourselves] as those that can control and can predict nature, and can also manipulate nature without any thought of the consequences.” 

Such a paradigm has led to disastrous effects, both on the planet’s health and our health. 

“It has exposed the extent and the interconnective precarities of all our global systems, and has shown the health emergency we are facing is deeply connected to the health emergency the earth is facing.” 

New zoonotic diseases rise from global food industry 

biodiversity
Antibiotics are commonly used in animals—often without the input of veterinarians—to boost their growth and keep them from picking up infections

Safeguarding biodiversity has provided a “heavy blanket of resilience”, but the global industrial food system threatens this protection with new zoonotic diseases arising as a result. 

Neglected zoonotic diseases kill at least two million people annually, mostly in low- and middle-income countries. 

“We are, ironically, becoming connected to disease rather than to diversity,” said Shroff. 

The evolutionary interaction between people and nature in the past has built up an extraordinary reservoir of biodiversity. 

But in spite of biodiversity’s impact and calls to curb mass extinction, none of the 20 Aichi Biodiversity Targets have been met for the second consecutive decade. 

Biodiversity loss has worsened, with ten million hectares of forests cut down globally between the years 2015 and 2020, for industrial and agricultural use. Pesticides have led to soil erosion and water depletion, and plant varieties that have existed for generations have also been substituted by highly uniform and commercial varieties. 

In addition, the growing use of antimicrobials in farm animals has become a major contributor to drug resistance. 

Shroff proposes that the upcoming UN 2021 Food Systems Pre-Summit shifts away from existing models that sideline real solutions, and instead focuses on a holistic and integrated response, bringing back an agro-ecological and biodiversity-based paradigm.

“This means farming in nature’s way, as co-creators, as co-producers with diversity, respecting nature’s ecological cycles, respecting people’s rights.” 

Food crisis worsened by COVID-19 

Inka Santala of Woolongong, Australia

A study conducted by the Community Economies Research Network (CERN) that examined the food systems of various countries during the pandemic, found that Finland, typically considered a relatively stable and secure state within the European Union, had several structural weaknesses in its food production and distribution systems in the early onset of COVID-19.  

Since the national recession of the 1990s, Finland has been heavily dependent on food aid distributed by local profit organizations, and has supported the import of products from overseas. 

However, COVID-19 restrictions and border closures placed even more pressure on already trained charity organizations, with their limited capacity, to respond to growing demand. 

This only fueled the currently inequitable and distracted food system, eventually escalating the unfolding climate crisis, said Inka Santala of Woolongong in Australia. 

Santala called for just and sustainable food systems during and post-pandemic to tackle the climate crisis. This includes more climate-friendly agricultural programs and support for organic farmers, subsidies to focus on social enterprises and local food initiatives, and the introduction of more progressive taxes that balance growing income inequalities. 

“It remains necessary to expand food systems not only locally, but also on a planetary scale, considering we are all sustained by the same biosystem.” 

Alternative community-based food systems turn food into ‘common good’  

Vegetable seller at Gosa Market in Abuja, Nigeria. Traditional markets provide access to healthy, fresh foods that play critical roles in feeding individuals and households globally.

With COVID-19 essentially hitting a ‘pause button’ on normal life, CERN researchers also found sustainable food systems that provided for those most vulnerable during the pandemic, and examined how such community-based programs could serve as a transitional process towards more just and equitable ways of dealing with the pandemic. 

This includes food distribution networks in cities such as Sydney that were able to coordinate and expand the use of emergency use provisioning, and the New Zealand National Food Network that redirected food surpluses to people who needed it most. 

There are also traditional markets, where food safety is well-assured, that support food security, local farm production, and more sustainable agro-ecosystems. 

Stephen Healy of Western Sydney University called these diverse forms of food systems a way of making food “common”, shifting the way we access resources that nourish, sustain, and protect us into a good that can be shared worldwide, and can be extended for the “common good”.

“The pandemic does offer us an opportunity to think about how mutuality can be made to endure through time.” 

Image Credits: Oxfam International/Flickr, Commons Wikimedia, SID, Michael Casmir, Pierce Mill Media.

Since the high hopes of February, when a plane carrying the first shipment of COVID-19 vaccines distributed by the COVAX Facility landed at Kotoka International Airport in Accra, the promise of massive COVAX vaccine deliveries to the continent have crashed.

CAPE TOWN – The two men at the centre of Africa’s COVID-19 response – John Nkengasong and Strive Masiwiya – vowed that the pandemic would not follow the same pattern as for HIV, where millions of Africans died because they could not get access to the life-saving antiretroviral (ARV) medicine available in wealthy Western countries.

For over a year, Nkengasong, director of Africa Centres for Disease Control and Prevention (CDC), and Masiwiya, the African Union’s (AU) Special Envoy on COVID-19, have been meeting virtually every night between 9pm and 11pm to plan how to get vaccines for the continent.

“Before I joined this position, I spent 29 years in the area of HIV/ AIDS. I saw firsthand the suffering, the trauma of our continent between 1996 and 2006, where about 12 million Africans died because ARV drugs to treat HIV patients were available, but they were not accessible to the continent,” Nkengasong told a recent briefing on vaccine access. 

“We say to ourselves when we meet every evening to discuss [COVID-19]: never again, never should history repeat itself on our watch.”

But as the Delta variant tears through African countries and promises of COVID-19 vaccines have repeatedly failed to materialise, that familiar divide between wealthy nations with access to medicine and poorer countries without has re-emerged.

The global vaccine access facility, COVAX, has only been able to deliver 25 million of the 700 million vaccines the AU had expected this year. Deliveries ground to a halt in March when its main supplier, the Serum Institute of India (SII), halted all deliveries outside India – due to the huge spike seen in domestic cases. Although Aurélia Nguyen, Managing Director of the COVAX Facility recently promised that the pace will pick up again in the fall with the dispatch of hundreds of millions more doses around the world  – clearly senior African officials are also wary. Too many unmet promises have littered the way, while lives also are being lost every day. 

COVAX – undermined and outmanoeuvred

Effectively, COVAX has largely been undermined and outmanoeuvred by wealthy countries that have struck bilateral deals with pharmaceutical companies – the “vaccine nationalism” that has made many wealthy nations’ platitudes about global solidarity sound like cynical spin-doctoring.

But COVAX is also accused of being opaque about its operations, unable to be honest about its supply problems, and unable to escape the paradigm of a charity-based approach to Africa. 

Critics on all sides also point to one singular tactical failing of the initiative. Despite pledges from major donors, COVAX’s lack of adequate cash in hand in late 2020, left it at the back of the line when rich countries were placing their major pre-orders. For an initiative that was anchored in the status quo, this inability to compete in the open marketplace was a fatal design flaw. 

COVAX Left AU in the dark about financial shortfalls 

Zimbabwean-born billionaire Masiwiya, who also heads the AU’s African Vaccine Acquisition Task Team (AVATT), has become increasingly vocal about COVAX’s lack of transparency at critical moments.  

He recently charged that the vaccine facility withheld “material information” about its supply problems early in 2021. And once vaccine supply problems surfaced more visibly,  it was too late for the AU to plug the holes.

One key moment was in January 2021, when COVAX provided AVATT with a written schedule of vaccines that would be delivered from February.  But according to Masiwiya, COVAX  “failed to disclose that they were still trying to get money, that pledges [of $8.2 billion] which had been made by certain donors had not been met.

“That’s pretty material information,” added Masiwiya, who took leave from his telecom firm, Econet Global, to support the AU response to the pandemic. “Had we known that actually this was hope and not reality, we may have acted very differently. 

“We found ourselves in March, scrambling. Now we are told that is India’s problem. And we think the problems are much deeper than that.”

Masiwiya also questioned COVAX’s reliance on vaccines from the Serum Institute of India (SII), saying that it had been evident to AVATT after meeting the SII late last year that the company would be unable to meet all its orders.

Strive Masiyiwa, African Union Special Envoy and head of the AU COVID-19 Vaccine Acquisition Task Team (AVATT)

Slow performance and secrecy

Kate Elder, Senior Vaccines Policy Advisor at Médecins Sans Frontières (MSF) Access Campaign, agrees with his critique of COVAX.  Along with opaque decision-making, she criticised the secrecy around the terms of advanced purchase agreements signed between COVAX and the pharmaceutical industry, as well as “deals made with “self- financing countries”, for which key details such as monies paid and vaccines procured, have not been disclosed publicly. 

“The global rollout of COVID-19 vaccines has been grossly inequitable, largely due to wealthy governments hoarding vaccines, but also due to the very slow performance of the COVAX facility”, which has failed to deliver on “big promises’,” Elder told Health Policy Watch.

“We heard from many developing countries that they were under a lot of pressure to join COVAX, but that they had difficulty getting information on what they could expect to receive from COVAX, what volumes of vaccines and in what timeframe,” Elder said.

“But it was presented as the global solution so many governments, rightly so, signed up to it and put their reliance in COVAX to deliver vaccines. Fast forward to July 2021 and we see all the challenges that COVAX has experienced, most importantly what that’s meant for developing countries in terms of accessing COVID-19 vaccines, which is absolutely devastating as Africa now enters a third wave of the pandemic with such low vaccination coverage rates.”

In South Africa, the African country worst affected by COVID-19, Cyril Ramaphosa’s government has come under intense pressure from opposition parties, medical professionals and civil society for failing to procure vaccines. However, Ramaphosa had been the chairperson of the AU for most of 2020, and pursued a continental approach to vaccine procurement – but continental negotiations struggled to secure vaccine deliveries as a January deal for 270 million doses failed to materialise.

After South Africa’s brutal second COVID-19 wave in December and January, the country pursued bilateral deals with pharmaceutical companies, including an order for AstraZeneca vaccines from SII for which it was charged double that paid by the European Union. Since June, the country – now in a deadly third wave – has been receiving the BioNtech-Pfizer vaccine – but at “prohibitive cost”, according to government officials. It is also using the Johnson and Johnson vaccine and had covered 13,6% of its population with at least one dose by Wednesday.

The only other African countries that have managed to vaccinate more than 10% of their populations – Seychelles, Mauritius, Comores, Morocco, Djibouti, Zimbabwe and Botswana – have done so primarily with vaccines supplied by China, according to Africa CDC.

Paternalistic and donor-driven? 

Catherine Kyobutungi

Ugandan epidemiologist Catherine_Kyobutungi, head of the African Population and Health Research Center in Nairobi head, has described COVAX as being “paternalistic, donor-driven” and based on a “rich-countries-helping-poor-countries mentality”.

“COVAX is unravelling,” and there is a need to go back and fundamentally re-think the approach, Kyobutungi told Development Today.

“A small group of ‘experts’ sat down and defined the problem and defined the solution for a continent of 1.3 billion people. They packaged it in an attractive way, marketed it, and drove the narrative. Until the rubber hits the road, and you run into headwinds, and you see that this solution is not working. Africa is getting one percent of the global [vaccine] total. So, you have to ask yourself, who thought this up? What was on their minds?”

Gavi, the Global Vaccine Alliance, which manages COVAX, declined requests by Health Policy Watch for comment on this article, and on the criticisms that have been levelled at COVAX by Masiyiwa, MSF and others.  

After initially promising a response from Gavi CEO Seth Berkley, a Gavi spokesperson later deferred. She said only that a response from Berkley was not possible as COVAX is “anticipating some announcements on upcoming partnerships with the AU”.

However, COVAX’s managing director, Aurelia Nguyen, addressed a WHO Africa media briefing shortly after Masiwiya’s criticisms, reporting that the facility expects to deliver some 520 million COVID-19 vaccine doses to Africa this year, but mostly from September onward – and stressed that she was unhappy with the lack of progress.

By Wednesday, COVAX had delivered 134,6 million doses to 134 countries globally – but planned to deliver two billion doses by the end of 2021.

Europeans return to football stadiums – Africans remain trapped in lockdowns

The anxiety of Africans about vaccine access comes as the continent is seeing its biggest peak yet in daily COVID cases, along with the biggest wave of COVID-related mortality due to the lack of vaccinations combined with woefully inadequate hospital infrastructure. 

“Just talked to the Manager of Heal Africa,” related one appeal for aid from Goma, DR Congo on a private chat group Monday. “Three died tonight of Covid, one of them because they ran out of oxygen. He can produce 15 bottles per day but would need 20. He said they also ran out of protective material [PPE for health care workers].” 

In some developed countries, like the UK and Israel, new COVID-19 infections, driven by the Delta variant, also are rising sharply again. But there, hospitalizations and deaths have risen much more slowly – due to high rates of vaccination coverage of 60% or more. Similarly, in Europe, as well as the United States, where 57% of the population over the age of 12 is fully vaccinated, deaths continue to decline, or plateau at levels not seen since the beginning of the pandemic – despite gradually rising numbers of Delta-driven infections. 

Even countries like India, where nearly 30% of the population is now vaccinated, are finally seeing lower hospitalization and death rates as a result of mass vaccination, permitting a slow return to normalcy. 

In contrast, with only 1.3% of Africans are fully vaccinated, African countries have been forced to impose new lockdowns as their public health weapon of last resort – resulting in  hunger, unemployment and political instability. 

“Europe has vaccinated a large chunk of its population and so has the United States,” lamented Nkengasong at a recent Africa CDC special vaccine briefing. 

He pointed to the recent Euro Cup seen the world over, with televised images of “stadiums full with young people shouting and hugging and doing what we cannot in Africa”.

“If we have a predictable supply of vaccines, we can break the backbone of this pandemic by the end of next year,” says Nkengasong. “But if vaccines are not available to enable us to vaccinate at speed and at scale then, past next year we’ll be moving towards the endemicity of this virus on our continent and the consequences will be catastrophic.

“Our economy will continue to be damaged, the death rate will continue to increase. We will see the fourth, fifth, sixth waves, and it will be extremely difficult for us to survive as a people.”

Changing the narrative – African Union makes its own plan

 Masiwiya is determined to ensure that the narrative is different this time around. 

“We are not going to allow this pandemic to become like HIV, and go on and on and on and on killing our people,” he said recently.  

“We’re not going to allow the fourth, the fifth and the sixth wave of this pandemic. That’s what I wake up every day to do. I spend 10 hours a day on it. I don’t go to my business office because I believe that we can defeat it, and we must.”

As a result, AVATT is moving ahead with its own procurement programme, including securing a commitment for the supply of some 400 million vaccines from Johnson & Johnson.  AVATT is also holding talks with Chinese vaccine manufacturers, and others. 

Interestingly, the US is channeling the African portion of its newly-pledged 80-million vaccine donations via both the AU and COVAX.  A similar split is expected for the recently announced US donation of 500 million doses of Pfizer vaccines, to be distributed over end 2021 and 2022.

For Masiwiya, reliance on donations is a non-starter: “We will not solve our problem because of donations. We will solve our problem because we’ve gone out and we have bought our vaccines,” he added, disclosing that all but two African countries had secured loans to pay for the AVATT-acquired vaccines.

Ultimately, AIDS on the continent was brought under control when ARV prices were slashed once they were made by generic producers and African countries, assisted by donors, negotiated directly with these producers. 

Local Production is Key Long-term Goal 

Most African leaders now agree that for COVID-19 vaccines to start flowing more freely, they also need to be produced in Africa, for Africans. 

Wednesday’s announcement by Pfizer/BioNtech that it had signed a letter of intent with South African company, Biovac, to  manufacture its COVID-19 vaccine for distribution within the African Union, has been widely hailed as an important step in the right direction for the continent – even if the 100 million plus doses to be produced in 2022, still  remain relatively small in comparison to the needs today. 

South African President Cyril Ramaphosa described it as  “a breakthrough in our effort to overcome global vaccine inequity”. 

Masiyiwa added his support, saying: “The only way to guarantee Africa’s access to vaccines now and in the future is through this type of strategic manufacturing partnerships, which we welcome greatly.”

But global health experts also were quick to note that the deal will not solve the immediate shortfalls faced – which can be addressed only through more dose-sharing by rich countries.

At the same time, medicines access critics have already slammed the deal.

Although this is the first African company to pay a part in the production of an mRNA vaccine, it will relegate Biovac to the task of vaccine “fill and finish” – as compared to production of active vaccine ingredient.  Production of active ingredient, access advocates say, would involve a higher level of technology and capacity-building for African companies.

The arrangement also effectively maintains the exclusivity of Pfizer/BioNTech mRNA manufacturing knowledge with the pharma firms, the critics charge.

That is in comparison to earlier WHO efforts to engage Biovac in an open-license vaccine technology transfer hub arrangement  – which nonetheless failed to gain the required support from a pharma partner.

“The world so badly needs actual tech transfer and expanded mRNA production in the global South that it’s deeply disappointing to see so much good PR for what I’d call a deeply colonial arrangement,” Matthew Kavanagh, professor of global health at Georgetown University, told Health Policy Watch.

“Pfizer keeps control of the entire production process and distribution; does not share the know-how to make mRNA vaccines; and Biovac gets the privilege of putting vaccine made in the global North into vials in 2022.”

The IP waiver alternative 

Winnie Byanyima, Executive Director of UNAIDs, challenges Germany’s position on COVID IP waiver at Global Health Centre session last week in Geneva.

Meanwhile, voices like UNAIDS Executive Director Winnie Biyanyima and WHO Director-General Tedros Adhanom Ghebreyesus have sharply challenged the pharmaceutical  industry for failing to more dramatically expand voluntary sharing of vaccine technology – or else agree to a waiver on COVID vaccine-related intellectual property – as proposed by India and South Africa. 

Speaking at one recent Geneva event featuring the German Health Minister, Jens Spahn, Byanyima warned that history was repeating itself – and challenged the European minister’s contention that voluntary industry collaborations are the best route for expanding vaccine access. 

She questioned why pharmaceutical companies should have the power to determine “when and with whom to share [vaccine know-how] with, at the time they want.” 

“Here is my challenge, my dilemma,” she told Spahn.  “When antiretrovirals were first found in the west, in Europe and America, people in the south continued to die. It was only when a global movement came to demand access to ARVs.  And it took six more years before the prices came down. 

“Nine million people died who could be alive today…. Now their survivors are now at risk of severe disease and deaths from COVID,” said Biyanyima. “How many years will they have to fight to have a vaccine that would protect them?”

Rich countries and dose-sharing

At the same time, pharma industry leaders have pointed out that no manufacturing arrangement can change the status quo immediately – and in fact global health leaders should be putting more pressure on rich countries, as compared to industry, to share doses right away.

Either way, while HIV/AIDS has not yet seen a vaccine for the disease that killed millions in low- and middle-income countries before the turn of the millennium, the tools to end the COVID-19 pandemic are ‘in our hands”,  Tedros declared Wednesday. 

“Our common goal must be to vaccinate 70% of the population of every country by the middle of next year. The reason why we’re not ending it is the lack of real political commitment,” he told the International Olympic Committee on the eve of the start of the summer Olympics. 

“If they choose to, the world’s leading economies could bring the pandemic under control globally in a matter of months by sharing doses through COVAX, funding the ACT Accelerator, and incentivizing manufacturers to do whatever it takes to scale up production.”

 

Image Credits: UNICEF, WHO, Billy Miaron/ Wikipedia, Africa CDC, Health Policy Watch.

‘Free the Vaccine’ activists in Seattle call on wealthy nations to support the WTO TRIPS Waiver.

The World Trade Organisation’s (WTO) Council for Trade-Related Aspects of Intellectual Property Rights (TRIPS) remains deadlocked on the “fundamental question” of whether a waiver on intellectual property rights of COVID-related products is the best way to address equitable vaccine access during the pandemic.

This is according to a draft oral status report adopted at Tuesday’s TRIPS Council meeting, along with a WTO statement issued late Wednesday.

“Disagreement persists on the fundamental question of whether a waiver is the appropriate and most effective way to address the shortage and inequitable distribution of and access to vaccines and other COVID related products,” according to the oral statement.

Positions remain polarised between those countries that support the India-South Africa waiver proposal and the European Union’s (EU) proposal submitted on 21 June, that such a waiver is not necessary.

“The EU proposal calls for limiting export restrictions, supporting the expansion of vaccine production, and facilitating the use of current compulsory licensing provisions in the TRIPS Agreement, particularly by clarifying that the requirement to negotiate with the right holder of the vaccine patent does not apply in urgent situations such as a pandemic, among other issues,” according to a statement issued by the WTO on Wednesday.

“The two texts discussed in the TRIPS Council reflect that positions remain divergent” about the most effective way to ensure fast, equitable and affordable access to vaccines and medicines for all, according to the WTO.

Ambassador Dagfinn Sørli of Norway, the TRIPS Council chairperson, reported that text-based discussions on the waiver discussed “scope” both from the perspective of products and of IP rights, “duration”, “implementation” and “protection of undisclosed information”, said the WTO. 

“In the area of implementation, discussions focused on a number of specific questions, including transparency and provisions to limit the long-term impact of disclosure of confidential data during the waiver period.”

The waiver proposal is currently co-sponsored by Kenya, Eswatini, Mozambique, Pakistan, Bolivia, Venezuela, Mongolia, Zimbabwe, Egypt, the African Group, the Least Developed Countries Group, the Maldives, Fiji, Namibia, Vanuatu, Indonesia and Jordan.

Nine Months Later and No Progress

This means that the TRIPS General Council meeting on 27 and 28 July will not be asked to formally consider a TRIPS Waiver and negotiations on the proposal will begin again in September.

The TRIPS waiver proposal was made nine months ago, and has been discussed at numerous forums, receiving a huge boost in May when the US announced its support for an IP waiver related only to COVID-19 vaccines.

However, the EU has refused to budge, claiming that a waiver is not necessary and would jeopardise pharmaceutical industries.

World Health Organization (WHO) Director General Dr Tedros Adhanom Ghebreyesus reaffirmed his organisation’s support for the waiver at Wednesday’s High Level Dialogue with the WTO on “Expanding COVID-19 Vaccine Manufacture To Promote Equitable Access”. 

Stressing that 11 billion vaccine doses were needed to vaccinate 70% of the world’s population by next year, Tedros said this “can be done by removing the barriers to scaling up manufacturing, including through technology transfer, freeing up supply chains, and IP waivers”. 

“I want to emphasise that WHO values highly the role of the private sector in the pandemic and in every area of health. The intellectual property system plays a vital role in fostering innovation of new tools to save lives,” said Tedros.

“But this pandemic is an unprecedented crisis that demands unprecedented action. With so many lives on the line, profits and patents must come second. 

“Of course, we can’t snatch your property. What we’re proposing is for high-income countries to provide incentives to the private sector because you deserve recognition, and we don’t want you to have financial problems because of IP waiver.”

In a milestone deal for Africa, Pfizer/BioNTech announced Wednesday that it would partner with the Cape Town-based pharma firm Biovac to produce over 100 million doses annually of it’s cutting edge mRNA vaccine – for distribution within the African Union.  

The deal was quickly hailed as a major breakthrough on a continent that is desperately short of vaccines, and so far has had no capacity to manufacture highly efficacious mRNA vaccines against COVID. 

But the plan to produce 100 million doses, beginning in early 2022, won’t solve the here-and-now problems of vaccine supply shortages in a region where only about 1.5% of the population is fully vaccinated, public health advocates also stressed. That, in comparison to 40-60% vaccine rates in high-income countries, and even 30% coverage in emerging economies such as India.  

“It’s great to see that doses will be made closer to where they’re needed the most.  But they won’t be ready until next year.  Until then, rich countries need to share doses ASAP,” said the Wellcome Trust in a statement summing up the current state-of-play.  

Under the deal, announced by the US-based Pfizer and the German firm BioNTech in a joint statement, Biovac will manufacture at the ”fill-and-finish” stage of the company’s mRNA COVID vaccine, using active ingredients produced from facilities in Europe. 

“To facilitate Biovac’s involvement in the process, technical transfer, on-site development and equipment installation activities will begin immediately,” the pharma announcement said.

“The facility will be incorporated into the vaccine supply chain by the end of 2021. Biovac will obtain drug substance from facilities in Europe, and manufacturing of finished doses will commence in 2022. At full operational capacity, the annual production will exceed 100 million finished doses annually. All doses will exclusively be distributed within the 55 member states that make up the African Union.”

Said Pfizer CEO Albert Bourla, “From day one, our goal has been to provide fair and equitable access of the Pfizer-BioNTech COVID-19 Vaccine to everyone, everywhere. Our latest collaboration with Biovac is a shining example of the tireless work being done, in this instance to benefit Africa. We will continue to explore and pursue opportunities to bring new partners into our supply chain network, including in Latin America, to further accelerate access of COVID-19 vaccines.”

Albert Bourla, Pfizer CEO

“We are thrilled to collaborate with Pfizer and BioNTech to produce and distribute the Pfizer-BioNTech COVID-19 Vaccine within Africa,” said Biovac CEO Morena Makhoana,  “This is testament of the long-standing relationship we have had with Pfizer through the Prevenar 13 vaccine,” he added referring to Biovac’s production of a pneumococcal vaccine now used widely around the world to protect infants and young children against bacterial pneumonia. 

“This is a critical step forward in strengthening sustainable access to a vaccine in the fight against this tragic, worldwide pandemic,” Makhoana added. “We believe this collaboration will create opportunity to more broadly distribute vaccine doses to people in harder-to-reach communities, especially those on the African continent.”

South African President Cyril Ramaphosa also welcomed the deal in a special statement. Speaking in his capacity as African Union Champion on COVID-19, Ramaphosa said: “Today’s agreement will contribute significantly to health security and sustainability on our continent, which currently has the least access to vaccination in the world.”

Pharma heaps praise – vaccine advocates level more criticism on deal 

Meanwhile, the new license agreement doesn’t appear likely to break the ice between medicines access advocates – who support a World Trade Organization waiver on all vaccine-related IP and trade secrets – and pharma voices contending such a move is impractical, and advocate voluntary license deals like the Pfizer/BioNTech-Biovac one as the preferred route.  

 “This is a far cry from full technology transfer to allow independent manufacture of mRNA vaccines and therapeutics,” said Professor Brook Baker, a law and medicines specialist at Northeastern University, of the Pfizer/BioNTech accord with Biovac.

“This agreement is nothing more or less than a contract manufacturing agreement for sterile formulation, fill, and finish.  Biovac will not be an ‘independent producer’- it will instead be a contract ‘subsidiary’ facility, subject to rigid control by Pfizer. In addition to the vaccine having a BioNTech/Pfizer ‘brand’, it will have a price set by them,” he noted in a blog posted on the list-serv IP-Health. 

“The announcement does not indicate the technology transfer/sharing agreement would ever result in the ability of Biovac to produce the mRNA active ingredient,” Baker added. “Thus, the underlying mRNA tech platform continues to be exclusively controlled by BioNTech/Pfizer, and Biovac will not be given the ability to further develop its own internal technical capacity and expertise that might allow it to manufacture other mRNA vaccines and therapeutics in the future.”  

“A somewhat more favorable aspect of the agreement is that the Biovac-produced BioNTech/Pfizer vaccine will be distributed only to 55 countries in Africa,” he conceded. “At least vaccine manufactured in Africa will stay in Africa, unlike the initial J&J agreement with Aspen Pharmacare.”

He was referring to the first Johnson & Johnson deal in South Africa, where most of the initial Aspen fill-and finish doses were contracted for delivery abroad. A subsequent deal with the African Union has secured 400 million J&J doses for use specifically on the continent. But there, too, production will only ramp up fully in the last quarter of 2021. 

IFPMA – more dose-sharing urgently needed as immediate solution to vaccine shortages

Meanwhile, Thomas Cueni, director-general of the International Federation of Pharmaceutical Manufacturers and Associations, hailed the deal as “great news demonstrating the vaccine innovators’ huge contribution to tackling the pandemic”.  

“It is in line with our industry’s commitment from the first days of the pandemic where we recognised that collaborations would be needed to achieve the massive ramping up production of any COVID-19 vaccine.  Indeed, the first ones were agreed in April 2020; and today there are more 200 collaborations underway, many of which involve technology transfer. Industry is on track to producing 11 billion doses by the end of this year. 

“This would be enough to vaccinate the world’s adult population, if doses are shared equitably. But this will only happen if the world wakes up. Since May, we have been calling for five steps to urgently advance COVID-19 vaccine equity – top of the list is dose sharing, lives depend on it.”  

The COVID-19 pandemic has carried secondary impacts on children orphaned or bereft of their caregivers, adding to the “hidden pandemic of orphanhood.”

An estimated 1.5 million children worldwide have lost a parent, grandparent, or caregiver due to COVID-19, according to a new study published in The Lancet on Tuesday. 

The study, which was conducted by international researchers, including scientists from the World Health Organization (WHO), US Centers for Disease Control and Prevention (CDC), and the University of Oxford, offers the first global estimates of the secondary impacts of the pandemic on children.

Worldwide, the COVID-19 pandemic caused over 190 million cases and four million deaths. Beyond morbidity and mortality, the pandemic carries indirect impacts, such as robbing children of their caregivers. 

Children who lose a primary caregiver have a higher risk of experiencing mental health problems; physical, emotional and sexual violence; and family poverty. These raise the risk of suicide, adolescent pregnancy, infectious diseases, and chronic diseases, such as heart disease, diabetes, cancer, or stroke. 

Children that go into institutional care can experience developmental delays and abuse.

Modelling to Estimate Magnitude of Hidden Impact of Pandemic on Children

The researchers used mortality and fertility data to model minimum estimates of COVID-related deaths of primary and secondary caregivers of children younger than 18 years of age in 21 countries. The data collected accounted for nearly 76.4% of global COVID deaths as of late April. 

A primary caregiver was defined as parents and custodial grandparents and secondary was considered co-residing grandparents or older kin. Caregivers provide psychosocial support; feeding, teaching, or supervising; and financial support.

In 21 countries, the researchers estimated that by April 2021, 862,365 children had been orphaned or lost a custodial grandparent due to COVID-19-associated death. Of these, 788,704 children lost one or both parents; 73,661 lost at least one custodial grandparent; and 355,283 lost at least one co-residing grandparent or older kin. 

South Africa, Peru, the US, India, Brazil, and Mexico were the countries with the highest numbers of children losing primary caregivers. In Peru, 14.1 children lost a primary or secondary caregiver per 1000 children, compared to 6.4 children in South Africa and 5.1 children in Mexico.

In India, the researchers estimated a 8.5-fold increase in the number of children newly orphaned between March 2021 and April 2021. This was associated with India’s catastrophic surge from the end of March to mid-June. 

COVID-related deaths were more common in men than women, particularly in middle-aged and older parents, leaving a greater number of paternal versus maternal orphans. 

Between two and five times more children had deceased fathers than mothers. 

The model was used to extrapolate global figures. 

Over a Million Children Globally Left Behind by COVID Deaths

Between March 1, 2020 and April 30, 2021, the researchers estimated that 1.5 million children experienced the death of primary or secondary caregivers, 1.13 million experienced the death of primary caregivers, and 1.04 million were orphaned by their parents. 

“For every two COVID-19 deaths worldwide, one child is left behind to face the death of a parent or caregiver,” said Dr Susan Hillis, one of the lead authors of the study and senior advisor to the CDC. 

“By April 30, 2021, these 1.5 million children had become the tragic overlooked consequence of the 3 million COVID-19 deaths worldwide, and this number will only increase as the pandemic progresses,” said Hillis.

A rapid escalation in the study estimates was observed between March 2021 and April 2021, with the total number of children that lost a caregiver increasing by 220,000. This coincides with third waves of the pandemic across Europe and Southeast Asia. 

The more transmissible SARS-CoV2 variants are driving the current global increase in both cases and deaths, after the world saw a nine consecutive week decline in the number of weekly deaths. 

“Our study establishes minimum estimates…for the numbers of children who lost parents and/or grandparents. Tragically,…the true numbers affected could be orders of magnitude larger,” said Dr Juliette Unwin, a lead author and member of the Imperial College COVID-19 response team. 

The under-reporting of deaths around the world could underestimate the number of at-risk children.

For instance, in Brazil, the actual number of deaths at the start of the pandemic are estimated to be 33.5% higher than the officially reported deaths. 

“In the months ahead, variants and the slow pace of vaccination globally threaten to accelerate the pandemic, even in already incredibly hard-hit countries, resulting in millions more children experiencing orphanhood,” said Unwin. 

The increase in orphanhood associated with COVID adds to the existing 140 million orphans worldwide, who are in need of global health and social care prioritisation, said the authors.

The adverse psychosocial consequences of children bereft of caregivers can be compounded by the COVID mitigation measures, leading to school closures, isolation, and disruptions to bereavement practices. 

Solutions to the ‘Hidden Pandemic of Orphanhood’

The study authors called for urgent investment in services to support children who lost their caregivers, specifically focusing on strengthening family-based care. Programmes should combine economic interventions, positive parenting, and education support, said the authors. 

“Our findings highlight the urgent need to prioritise these children and invest in evidence-based programmes and services to protect and support them right now and to continue to support them for many years into the future – because orphanhood does not go away,” said Hillis. 

“We need to support extended families or foster families to care for children, with cost-effective economic strengthening, parenting programmes, and school access,” said Lucie Cluver, study author and Professor of Child and Family Social Work at Oxford University and the University of Cape Town.

In addition, deaths of caregivers can be prevented by accelerating equitable access to diagnostics, therapeutics, and vaccines.

“We need to vaccinate caregivers of children – especially grandparent caregivers. And we need to respond fast because every 12 seconds a child loses their caregiver to COVID-19,” said Cluver. 

The global community needs to capitalise on the momentum from the pandemic to mobilise resources and implement systemic, sustainable support for bereaved youth around the world, said the authors. 

“The hidden pandemic of orphanhood is a global emergency, and we can ill afford to wait until tomorrow to act,” said Dr Seth Flaxman, one of the study’s lead authors and a lecturer in statistics at Imperial College London.

Image Credits: Unicef.

The World Trade Organization (WTO) Secretariat has issued a list of bottlenecks and trade-facilitating measures on critical COVID-19 products, ahead of Wednesday’s  High-Level Dialogue between itself and the World Health Organization (WHO) on how to expand COVID-19 vaccines manufacturing to ensure equitable access.

“One common theme that emerges from the list is that essential goods and inputs need to flow efficiently and expeditiously to support the rapid scaling up of COVID-19 production capacity worldwide,” according to the WTO. 

“The delay of a single component may significantly slow down, or even halt, vaccine production given the globally integrated supply chains that underpin COVID-19 vaccine manufacturing.”

The list is based on issues raised at two WTO meetings last month, ‘Regulatory Cooperation during the COVID-19 Pandemic’ (2 June) and  ‘COVID-19 Vaccine Supply Chain and Regulatory Transparency’ (29 June). 

Below is a summary of the key points:

BOTTLENECKS 

Vaccine manufacturing 

  • There are no expedited procedures for vaccines, which are subject to standard import and export procedures, including rigorous documentation and frequent renewal of licences and certificates. 
  • Vaccine manufacturers may find it difficult to send non-commercial samples to specialized laboratories located abroad for testing, as these samples are subject to the same import and export procedures as commercial shipments.
  • Exports by vaccine manufacturers to foreign ‘fill and finish’ sites can be subject to export restrictions, both for sites owned by the manufacturer and the contract development and manufacturing organisations (CDMOs). 
  • Donations of supplies and vaccines (eg to COVAX) can be subject to stringent controls as well as tariffs and internal taxes. 
  • Some embassies and consulates are closed as a result of lockdowns, making it impossible to complete consular transactions or to submit documents needed for cross-border trade of vaccine inputs. 
  • Tariffs are high for certain inputs in some manufacturing countries. 
  • Complicated visa entry requirements and closed borders make it hard for highly qualified personnel to move across borders to support vaccine manufacturing. 

Vaccine regulatory approval 

  • Differences between countries in terms of regulatory frameworks, procedures and timelines adds complexity for manufacturers. 
  • Significant variation among registration requirements across different regions can make it onerous for manufacturers to apply for registration in multiple locations. 
  • Some national regulatory authorities (NRAs) require local retesting of vaccines or bridging clinical trials, which can lead to delays and spoilage. 
  • The rapid development of COVID-19 vaccines has led to additional challenges and burdens for vaccine manufacturers following the initial emergency use authorization (EUA), such as gathering data and optimizing processes. 
  • Some NRAs have not established accelerated pathways for post-approval changes to vaccines under EUA, which could hinder availability due to delays in approval. 
  • There can be uncertainty about when EUA will expire and the accompanying processes to move to regular approval and registration of vaccines (including against new coronavirus variants). A particular concern is that rules and accompanying data and legal requirements will differ between regulatory agencies. 

Vaccine distribution

 While few obstacles were identified for the distribution and border clearance of COVID-19 vaccines, border clearances for related products to administer vaccines (eg syringes, refrigerators) was flagged as a potential problem. 

Therapeutics and pharmaceuticals

  • There can be different technical requirements for the same product between countries (e.g. 3.5 ml versus 3.51 ml, different sterilization requirements). This requires vaccine manufacturers to establish separate production lines, which increases costs and compromises speed of delivery. 
  • NRAs request different process changes to approved products in an uncoordinated manner, which requires manufacturers to carry multiple manufacturing processes. 
  • Some NRAs require local population-based studies for medicines with no evidence of ethnic pharmacokinetic differences
  • Applied tariffs are high in many countries, making it costly to import essential therapeutics to treat COVID-19 patients. 

Diagnostics and other medical devices 

  • Divergent regulations and barriers to accessing viral samples that are needed to develop effective diagnostic tests. 
  • Some NRAs may still require a consularized apostille of the original paper document to confirm information already provided to the NRA and available online. 
  • Duplication of rigorous local testing can lead to delays and uncertainty for suppliers. 
  • An unclear process for regulatory approval of diagnostics can lead to diagnostics of varying quality. Inefficient and overly complex regulatory systems slow down activation of clinical trials and hamper the adoption of results.

TRADE-FACILITATING MEASURES 

General import, export and transit procedures 

  • Implementation of the provisions in the Trade Facilitation Agreement (TFA), such as those concerning pre-arrival procedures, could help to expedite the movement of essential products to combat COVID-19.
  • The digitalization and simplification of import, export and transit procedures (e.g. paperless trade) should be accelerated. 
  • Identification of Harmonized System (HS) codes for medical goods essential for the treatment of COVID-19 by the World Customs Organization (WCO) and the WHO helps to ensure expedited procedures for border clearance. 

Vaccine manufacturing 

  • Bilateral and regional agreements could ease import and export restrictions on key routes. 
  • A communication channel between vaccine manufacturers and other relevant stakeholders can raise awareness about bottlenecks at domestic and regional levels 
  • A national dialogue with manufacturers and other relevant stakeholders could be established to understand the current conditions for trade in critical vaccine inputs. 

Vaccine regulatory approval 

  • Measures can include the facilitation of Emergency Use Authorization (EUA) based on the prequalification procedure of the WHO EUL and regional networks
  • WHO special procedures can be used to share regulatory dossiers under confidentiality agreements and to promote the use of reliance to allow low and middle-income countries to authorize emergency use of vaccines quickly and efficiently.
  • Authorization of COVID-19 vaccines could be fast tracked. 
  • Rapid approval of clinical trials (phases undertaken in parallel in real time) could expedite approval of vaccines.
  • The pharmaceutical industry could improve transparency and data integrity by providing better access to clinical data for all new medicines and vaccines 
  • Sharing data between regulators can facilitate multi-country approvals. 
  • Regulatory systems in developing countries can be strengthened for scaling up the local manufacture of vaccines. 

Therapeutics and pharmaceuticals 

  • Global harmonization with guidelines set by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use would allow pharmaceuticals to be developed faster and to move more quickly between countries by overcoming conflicting or varying pharmacopeia requirements. 

Diagnostics and medical devices

  • The Medical Device Single Audit Program of the International Medical Device Regulators Forum (IMDRF) could be used to overcome barriers to on-site inspection during a pandemic. 
  • The IMDRF could establish guidance for the regulatory flexibility needed during a pandemic. 
  • The WHO provides recommendations in Global Model Regulatory Frameworks and Regulatory Reliance for Medical Devices. • NRAs could implement a good regulatory practice (GRP) policy and related standard operating procedures. 
  • WHO guidance on recognition and reliance for pre- and post-market activities could be implemented. 
  • National standards and conformity assessment procedures (based on international standards) could be developed for local manufacturing of PPE. 
  • The streamlining of existing EUA pathways in the context of pandemics could result in diagnostics being registered and made accessible with less delay. 
  • Multiple-source supply chains can ensure that trade flows as freely as possible and with minimal export restrictions. A delay in the shipment of a single component could halt the entire production in a factory. 

General regulatory aspects 

  • Mutual recognition agreements could be promoted, as well as the recognition of marketing authorization procedures and the unilateral recognition of marketing authorizations.
  • Inspection Co-operation Scheme could help to avoid duplication, and inspections could be further harmonized through enhanced cooperation between regulators.
  • Global alignment of clinical trial requirements can increase the pace at which vaccines, therapeutics and diagnostics can be developed. 
  • Timelines for the evaluation and approval of medical products and clinical trials could be shortened if approval has already been granted by trusted regulatory authorities. •
A Tanzanian mother and her baby.

Children living with HIV in six African countries will soon get access to the antiretroviral (ARV) drug, dolutegravir (DTG), which is more effective, easier to take and has fewer side effects than many other ARVs.

DTG will soon be recommended for children in Uganda, Benin, Kenya, Malawi, Nigeria and Zimbabwe, Kenyan AIDS activist Jacque Wambui told Health Policy Watch. Wambui has been advocating for DTG for a number of years following her own struggles with ARV side effects.

“The drug I was using before was giving me dizzy spells and nightmares and I could not sleep. So when I heard about dolutegravir, I told myself, this is the kind of drug that I would like to use and I also want it in my country as soon as possible,” said Wambui, who is as an alternate representative for Kenya on the African Community Advisory Board (AfroCAB), a network of African HIV treatment advocates.

“We are excited that what happened for us will now happen to the children. With dolutegravir, treatment outcomes are better and you notice you are no longer lethargic. We’re having more productive lives,” said Wambui.

Drug also suitable for toddlers

DTG also has a high genetic barrier to developing drug resistance, which is important given the rising trend of resistance to efavirenz and nevirapine-based regimens.

The World Health Organization (WHO) last week welcomed results of a study presented at the International Pediatric HIV Workshop on the superiority of dolutegravir (DTG)-based regimens in young children.

Last year, the ODYSSEY trial demonstrated superior treatment efficacy for DTG plus two nucleoside analogue drugs versus standard-of-care (SoC) ARVs in children over 14 kg with an average age of 12.

A follow-up study completed last month found that DTG is also superior for toddlers with a median age of 1.4 years. Only 28% had treatment failure by 96 weeks in the DTG arm in comparison to 48% in the SoC arm, and 76% of children in the DTG arm had undetectable viral loads (<50copies/ml) compared with half in SOC. 

“​​Children living with HIV continue to be left behind by the global AIDS response,” according to the WHO. “In 2020, only 54% of the 1.7 million children living with HIV received antiretroviral therapy compared to 74% among adults living with HIV.” 

WHO recommends dolutegravir back in 2018

The WHO has recommended DTG as a first-line treatment for adults and children with HIV since 2018, but this has not been rolled out properly in many African countries, according to a presentation at the International AIDS Society (IAS) HIV science conference that opened on Sunday.

Of the 20 sub-Saharan countries with the highest burden of HIV treatment guidelines, only eight – Uganda, Rwanda, Botswana, Eswatini, South Africa, Tanzania, Zimbabwe, and Zambia – recommend DTG for adults in line with the current WHO guidelines.  

Five countries – Kenya, Malawi, Namibia, Côte d’Ivoire and Ethiopia – recommend DTG except for pregnant women.

Lesotho and Nigeria only recommend it as an alternative regimen, while Angola, Mozambique, Cameroon, Democratic Republic of Congo and South Sudan do not recommend it at all, according to researchers Somya Gupta and Dr Reuben Granich.

An initial study in Botswana had highlighted a possible link between DTG and neural tube defects (birth defects of the brain and spinal cord that cause conditions such as spina bifida) in infants born to women using the drug at the time of conception.

This potential safety concern was reported in May 2018 from the Botswana study that found four cases of neural tube defects out of 426 women who became pregnant while taking DTG.

Based on these preliminary findings, many countries advised pregnant women and women of childbearing age to not take it. Activists who met in Kigali and interrupted a meeting in Amsterdam helped to press for more research on DTG.

“There is a lot of exciting science, both in treatment and in prevention, but that is not why we do this work. It’s how people like Jacque and other advocates make it happen in terms of policies and programmes and actual work on the ground,” said Mitchell Warren, the executive director of AVAC, the non-profit HIV prevention organisation. 

The researchers called for speedy processes to translate scientific research into policy and services at the IAS meeting.

“We are going to send out this information to caregivers. We’re even starting to develop materials for advocacy for DTG for children. We are also going to ask different ministers of health across countries to adopt it,” said Wambui. 

Image Credits: WHO.