Zeng Yixin, Vice Minister of the National Health Commission, rejecting the WHO strategy at the latest Chinese government press conference on the SARS-CoV2 origins on Thursday, 21 July.

Chinese officials have rejected WHO’s proposal for a more rigorous Phase II investigation of the origins of the SARS-CoV2 virus, including renewed consideration that the virus may have escaped from a laboratory, describing the new plan as “impossible” at a press conference.   

“We will not accept such an origin-tracing plan as it, in some aspects, disregards common sense and defies science,” said Zeng Yixin, Vice Minister of the National Health Commission, at the press conference organized by the Chinese State Council Information Office on Thursday, rejecting the WHO plan out of hand. 

“We hope the WHO would seriously review the considerations and suggestions made by Chinese experts and truly treat the origin tracing of the COVID-19 virus as a scientific matter, and get rid of political interference,” Zeng said.  

 New WHO plan would address omissions of first virus origins mission to Wuhan

WHO Director General Dr Tedros Adhanom Ghebreyesus calls for a new approach to the SARS-CoV2 quest and more Chinese “transparency.”

The plan for a revamped second phase of investigations was presented by WHO Director General Dr Tedros Adhanom Ghebreyesus to member states at a closed-door meeting last week. 

WHO’s new and tougher strategy, includes the creation of an international Scientific Advisory Group on Origins of Novel Pathogens (SAGO) to replace the international group that led the first mission to Wuhan in January 2021. 

That first mission yielded a report that was widely criticized as papering over Chinese data omissions. It also failed to carefully consider the hypotheses that the virus might have escaped from the Wuhan Institute of Virology (WIV) that was researching bat coronaviruses – a theory that dozens of experts around the world say remains just as plausible as the theory that the virus escaped somewhere along the food chain – until more evidence is gathered.

In response to those concerns, WHO now wants to obtain and review more data on Wuhan’s sensitive coronavirus research laboratories, as well as data on wild animal species on sale in 2019 at the city’s live animal markets, to assess the likelihood that the virus may have escaped from a laboratory – as compared to infecting humans via a food-borne source. 

WHO also is requesting more raw data from China on the first COVID patients, and on population-level serology screening in Wuhan, which could lend insight into where and when in 2019 the first COVID cases really began to appear. China had previously refused to provide the data, saying that it violated privacy laws. 

WHO applying more pressure on China

In his remarks last week to member states, Tedros explicitly described the new plan of attack, as including:

  • “First, integrated studies of humans, wildlife, captive and farmed animals, and environment, as part of a One Health approach.
  • “Second, studies prioritizing geographic areas with the earliest indication of circulation of SARS-CoV-2, and neighbouring areas where other SARS-related coronaviruses have been found in non-human reservoirs;
  • “Third, studies of animal markets in and around Wuhan, including continuing studies on animals sold at the Huanan wholesale market;
  • “Fourth, studies related to animal trace-back activities, with additional epidemiology and molecular epidemiology work, including early sequences of the virus;
  • “And fifth, audits of relevant laboratories and research institutions operating in the area of the initial human cases identified in December 2019.”

“We expect China to support this next phase of the scientific process by sharing all relevant data in a spirit of transparency. Equally, we expect all Member States to support the scientific process by refraining from politicising it,” Tedros told member states at the closed-door meeting.

In a subsequent media briefing on Thursday, the WHO DG also publicly called upon China to share data more transparently, while acknowledging in the strongest terms to date, the plausibility that the virus may have escaped from a laboratory. 

The Wuhan Institute of Virology, guarded by police officers during the visit of the WHO team in early February, 2021.

“There was a premature push to reduce one of the [origins] options, the laboratory theory,” the WHO DG said, referring to the report on the virus origins that came out of the WHO-led mission to Wuhan in January. “I was a lab technician myself, an immunologist, and have worked in the lab and lab accidents happen.”

While WHO’s new move has been criticized by China, it has been applauded by former critics of the global health agency.

“Last week, Tedros showed tremendous courage when he called on the Chinese government to be more transparent in the sharing of raw data,” Jamie Metzl, a senior fellow at the Atlantic Council and one of the co-authors of a series of open scientific letters that criticized the WHO-led investigation for inadequately exploring the possibility that the SARS-CoV2 could have “escaped” from the WIV, said in an op-ed published on CNN.

“Given the leadership and moral courage Tedros has shown by calling for a full examination into the pandemic origins, the United States and its partners around the world must come together in support of the integrity of the WHO and his leadership,” said Metzl. 

China supports conclusions of the first origins report 

The report by the first SARS-CoV2 origins team concluded that of the four possible hypotheses about where the virus originated, the possibility of a laboratory biosafety incident was “extremely unlikely.”

The report generated widespread criticism from member states as well as an ad-hoc group of scientists, who published a series of open letters to WHO detailing how the investigation was limited by China and lacked the data and access necessary to carry out an unrestricted inquiry. 

China, on the other hand, has said that it continues to support the conclusions made by the report. Officials insist that SARS-CoV2 has natural origins, most likely the result of a natural spillover event involving zoonotic transmission.

At a press briefing on 16 July, Zhao Lijian, Spokesperson of China’s Ministry of Foreign Affairs, called on countries to “respect the opinions of scientists and scientific conclusion, instead of politicizing the issue.” 

Zhao Lijian, Spokesperson for China’s Foreign Ministry, at a press conference on 16 July.

In addition, the WIV has not reported any leaks or staff infections since it first opened in 2018, said Chinese officials. 

“We believe a lab leak is extremely unlikely and it is not necessary to invest more energy and efforts in this regard,” said Liang Wannian, the Chinese team leader of the joint WHO-China mission in January, speaking at the State Council Information Office press conference on Thursday. 

Chinese officials express disappointment

Senior Chinese health officials have expressed keen disappointment with the new WHO approach. 

“I was surprised when I saw WHO’s origin-tracing plan for the second phase,” said Zeng, at the Thursday media event. “The plan has set the assumption of China leaking the virus due to violating research instructions as one of the research priorities. We can’t possibly accept such a plan for investigating the origins.” 

At yesterday’s conference, the Chinese panelists proposed an alternative approach to the second phase of the investigation, focusing on zoonotic transmission and investigating early cases in other countries.

A panel of senior Chinese health officials discussed the COVID-19 origin investigation at a press conference on Thursday organized by the State Council Information Office.

“In the next step, I think animal tracing should be the priority direction,” said Liang. “It is the most valuable field for our efforts.”

“The second phase of origin-tracing should be extended on the basis of the first phase, guided by the relevant WHO resolutions, and carried out after full discussion and consultation among member states,” said Zhao, in a separate press briefing yesterday organized by the Chinese Foreign Ministry.

“The work that has already been done in the first phase should not be repeated, especially when a clear conclusion has been reached,” Zhao added. “Instead, we should promote origin-tracing on the basis of full and extensive consultations among member states, including search of early cases in various places and countries around the world.”

Chinese officials call for investigation into US military lab

In an attempt to deflect attention and blame, Chinese authorities also have tried to suggest that the virus could also have escaped from a laboratory in the Untied States, pointing in particular to the US Army Medical Research Institute of Infectious Diseases at Fort Detrick in Maryland.

Chinese officials have suggested that the US should invite an international team of scientists to conduct an independent investigation into Fort Detrick.

Conspiracies, largely peddled by Chinese officials, continue to swarm around Fort Detrick, with reports of some five million people in China signing a petition calling on WHO to investigate the bio-lab.

“What dark secrets are hidden out of sight at Fort Detrick?” asked Zhao at a press briefing on Wednesday. 

“Facing the 630,000 American lives lost to the coronavirus, the US should be transparent, take concrete measures to thoroughly investigate the origins of the virus at home, thoroughly investigate the reason of its botched response and who should be held accountable, thoroughly investigate the mysteries over Fort Detrick and its over 200 overseas bio labs,” said Zhao. 

The prominent military germ lab was temporarily shut down in 2019 by the US Centers for Disease Control and Prevention (CDC) because it didn’t have “sufficient systems in place to decontaminate wastewater” from its highest-security labs.

The lab reopened in March 2020 and was accompanied by an announcement from officials that no dangerous pathogens had escaped the lab.

US ‘deeply disappointed’ with China’s response

“[China’s] position is irresponsible and frankly dangerous,” said Jen Psaki, the White House Press Secretary on Thursday at a press briefing. “We are deeply disappointed.”

“Alongside other member states around the world we continue to call for China to provide the needed access to data and samples, and this is critical so we can understand and prevent the next pandemic,” Psaki said.

Jen Psaki, White House Press Secretary, at a press briefing on Thursday.

Relations between the US and China have suffered as a result of the probe, increasing tensions between the nations. 

“This is about saving lives in the future and it’s not a time to be stonewalling,” said Psaki.

In late May, US President, Joe Biden, instructed the country’s scientific and intelligence communities to investigate and publish a report on the pandemic’s origins by late August. One of the theories being examined is the possibility that the novel coronavirus emerged from a lab accident. 

“I have now asked the Intelligence Community to redouble their efforts to collect and analyze information that could bring us closer to a definitive conclusion, and to report back to me in 90 days,” said Biden. 

The US has expressed its dissatisfaction with the joint origins investigation, describing the report as “insufficient and inconclusive” in late May. The Biden Administration even appears to be positioning itself to take independent action if the WHO investigative process doesn’t succeed. 

“Unfortunately, phase one…did not yield the data and access from China that we think is necessary,” said Psaki. “But [the US] support[s]…the phase two plan…because it’s rigorous and science-based.”

Experts express concern over the future of the origins investigation

China’s refusal to participate in WHO’s next phase of the origin probe is “outrageous & absolutely unacceptable,” tweeted Metzl. 

According to Metzel, the “process has been compromised from the very beginning,” he told CNN.

The joint study by the international committee and their Chinese counterparts was agreed upon at the World Health Assembly last year, which gave the Chinese government a certain degree of control over the process.

“It’s been clear from day one that the Chinese have no interest in a full investigation into the pandemic origins and…they’ve been doing everything possible to block that,” Metzl said. 

“Given the critical importance of fully investigating the origin of Covid-19 and preventing future pandemics, China’s rejection of a full investigation poses a threat to the world that cannot be tolerated,” said Metzel in an op-ed on CNN. 

An alternative strategy is needed to conduct the SARS-CoV2 investigation without China’s cooperation. This will require the US and its partners both to support the WHO-organized process and set up a separate mechanism for an in-depth probe, said Metzl. 

The US should involve the Group of 7 (G7), an intergovernmental political forum for the world’s seven largest advanced economies, Quadrilateral Security Dialogue (Quad) countries, or the Organisation for Economic Co-operation and Development (OECD), a group of 37 member countries that develop economic and social policy.

“Although not having full access to all of the relevant resources in China would hamper this investigation, a great deal of progress can be made by pooling efforts, accessing materials available outside of China, and creating secure whistleblower provisions empowering Chinese experts to share information,” said Metzl.

“The international community must proceed with a forensic investigation, with or without China’s cooperation,” Dr Richard H. Ebright, a professor of chemical biology at Rutgers University, told Health Policy Watch.

“Many threads of forensic investigation are available outside China. In particular, information relevant to the origin of SARS-CoV-2 may exist at the US-based research partner of the Wuhan Institute of Virology (EcoHealth Alliance), at the US-government research funders of the Wuhan Institute of Virology and EcoHealth Alliance (USAID, DTRA, DARPA, DHS, and NIH), and at the US- and UK-based scientific publishers that handled publications of the Wuhan Institute of Virology and EcoHealth Alliance (Springer-Nature, Lancet, and PLoS),” Ebright added.

Creation of new body and expert group to investigate disease origins

In the meeting with WHO member states last week, Dr Tedros announced the establishment of a new body to investigate the origins of SARS-CoV2 and future pandemics.

The permanent International Scientific Advisory Group for Origins of Novel Pathogens (SAGO), which will be composed of experts nominated by member states, will “play a vital role in the next phase of studies into the origins of SARS-CoV2,” said Tedros. 

“The world needs a more stable and predictable framework for studying origins of new pathogens with epidemic or pandemic potential,” said Tedros.

“Finding where this virus came from is essential not just for understanding how the pandemic started and preventing future outbreaks, but it’s also important as an obligation to the families of the 4 million people who have lost someone they love, and the millions who have suffered,” said Tedros.

WHO will launch an open call for nominations for “highly qualified” members of the new advisory group from member states.

Image Credits: China Daily, WHO, CNN, Ministry of Foreign Affairs of the People's Republic of China, C-Span.

Cambodia, Iran and Bangladesh are the first lower-income countries to receive delivery of a donation from Japan of over 11 million doses of the AstraZeneca COVID-19 vaccines, beginning this weekend.

Cambodia and Iran received 332,000 and 1,087,570 doses respectively on Friday, while Bangladesh is scheduled to receive 2,45,200 doses on Saturday, Gavi, the Vaccine Alliance said in a statement.

The Japanese vaccine donations are being distributed via Gavi’s COVAX Advance Market Commitment scheme – that provides vaccines free of charge to some 92 low-income countries in Southeast Asia, the Eastern Mediterranean region, Western Pacific, Latin America, and elsewhere.

Announcing the donations, the government of Japan said: that “In order to overcome COVID-19, it is important to promote equitable access to vaccines not only in Japan but also throughout the world. Japan will continue to work towards securing equitable access to safe, effective and quality-assured vaccines through various support, responding to the needs of developing countries and the world, in cooperation with relevant countries and international organizations.”

Japan itself has lagged in its own vaccination campaign, despite being a high-income country – creating added risks of a spike in serious COVID cases as the 2020 Olympics get underway – a year late.

Seth Berkley, Gavi CEO said in the statement: “ In operationalising its dose donation, the Government of Japan has further grown its commitment to global equitable access. We look forward to seeing Japanese doses flowing to a number of countries in the coming weeks.”

Read more here…

Image Credits: Gavi .

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.