Encouraged by how fast vaccines have been developed for COVID-19, tuberculosis advocates launched a “TB vaccine roadmap” on Tuesday and aim to use lessons from the pandemic to jumpstart the quest for a TB vaccine.

The purpose of the roadmap, said Frank Cobelens of the Amsterdam Institute for Global Health and Development, is to provide “key actionable priorities” to develop affordable vaccines for use in low and middle income countries.

TB vaccine research and development (R&D) needs to focus on “diversifying the vaccine pipeline, accelerating clinical development, and ensuring public health impact,” he added.

But Willem Hanekom, head of the African Health Research Institute, warned that implementation of the roadmap was key, pointing out that a similar “TB blueprint” had been published 10 years ago.

“We need to establish COVID-19 as a global crisis,” said Hanekom, adding that TB deaths in India, Indonesia and South Africa exceeded COVID-19 deaths.

He also called for more investment in TB, pointing to $78.6-billion spent on R&D for COVID-19 vaccines whereas $1-billion is spent annually on TB vaccine development.

Rethinking and Repurposing

Delivering the keynote address at the TB Vaccine Conference, South Africa’s Professor Helen Rees said that COVID-19 had taught researchers the importance of “rethinking and repurposing”.

“Everyone is rethinking how we have traditionally done clinical trials,” said Rees. “What do we do to bridge from the pre-clinical to clinical development phases that is innovative and much stronger than what we already have?

“What biomarkers can be used to support and accelerate decisions? When we move from phase two to phase three trials, what kind of trial designs and very innovative, adaptive and seamless designs can be  introduced?” she asked.

The HIV field was looking at the development of mRNA vaccines “backwards”, to see whether the same approach could be applied to HIV, added Rees, who chairs the SA Health Products Regulatory Authority (SAHPRA).

She also said drugs were also being repurposed for COVID-19 and this was also the case for TB.

“We’ve been doing a lot of rethinking about [the TB vaccine] BCG, and there have been a number of trials, for example, in adolescents, seeing whether the use of a BCG booster will have an impact on disease outcome for TB. 

“There have also been trials looking at different timing of offering BCG to newborns. So this is taking an existing technology and saying, can we adapt it and do something different with it and get a better outcome?”

Studies were also looking into whether BCG could be “repurposed” for COVID-19. 

“Can we use the BCG vaccine phenomenon that is known to induce both humoral and adaptive immunity, that it has this nonspecific immune response that can be used to boost the immune system?” she asked.

Affordability and Access

Rees added that the COVID-19 pandemic had highlighted issues of “access and affordability”, reminding the conference that the Coalition for Epidemic Preparedness Innovation (CEPI) had been set up in 2017 as a public health innovation and funding mechanism in response to  Ebola “to enable equitable access of these vaccines for affected populations during outbreaks”. 

“CEPI has definitely been thrown into the forefront in terms of COVID,” said Rees, who chairs the initiative’s scientific advisory committee.

“Vaccine innovation and introduction is something that COVID has just revolutionised. The timeline between identification of a vaccine and registration was under a year – unprecedented,” said Rees. 

“If there are good things to come out of COVID-19, one of them is to say how important vaccines are in terms of control and elimination of diseases.

“If we want to eliminate TB, we desperately need better vaccines and the clock is ticking.”

 

Image Credits: Socios en Salud .

DELHI – In a twin bid to get ahead of a surging COVID-19 epidemic, the Indian government said that it will make “advance payments” totally some US$ 550 million to domestic COVID-19 vaccine makers – as well as opening up the market to private sector import and sales of other approved COVID-19 vaccines. 

Under the plan, the Serum Institute of India, which is producing the AstraZeneca vaccine (Covishield) will be given an advance of Rs 300 billion rupees (US $400 million) and Bharat Biotech, the Hyderabad-based company producing an India-made vaccine, called Covaxin, will receive a 150 billion rupees ($US 200 million) advance.  

At the same time, domestic vaccine manufacturers will be able to sell up to 50% of the vaccines that they produce on the private market – to further incentivize the production ramp-up, the government said.  

And imported vaccines by other manufacturers can also be imported and sold privately – after the government fast-tracks emergency approval.  

Finally, the Indian government said it would change its vaccine eligibility policy – allowing for all adults to be vaccinated as of Monday – as another measure to accelerate vaccinations. 

India has a population of 1.38 billion, including about 966 million adults over the age of 18 – but so far only about 127 million vaccine doses have been administered – with only about 17 million people receiving two doses.  And until this week, only  health workers, essential workers, and people over the age of 45 had been allowed to get the vaccinations. 

Incentive to Vaccine Makers – Private Market Sales 

As per the new policy, the Indian government said that domestic vaccine makers may supply up to 50% of their doses for India to the open market or to individual state governments within India. Half the doses will be earmarked for the Central Indian government. 

Foreign-manufactured vaccines, including those approved by United States and European regulatory agencies (as well as the recently Indian-approved Sputnik) may also be allowed to be sold in the private market. Both the vaccine makers and private hospitals can fix their prices for the doses sold in the open market – apparently without government controls, although they must be reported transparently. 

The Indian government said that the liberalized pricing policies have been made to incentivise vaccine-makers and boost vaccine production as well as imports. The government press release said that this policy “would augment vaccine production as well as availability, incentivising vaccine manufacturers to rapidly ramp up their production as well as attract new vaccine manufacturers, domestic and international.”

Just a couple of weeks ago, the Serum Institute’s Adar Poonawala had lamented in an interview given to NDTV that the company was unable to  make “super-profits” via exports – and the consequent lack of capital was hampering the capacity of the institute to scale up its production. He clarified that he was making profits selling vaccines (about 2 dollars per dose) to the Indian government, but the profit margin was not big enough. The Serum Institute had earlier sold the vaccine doses to the Uganda government for three times more than European Union.

R Ramakumar, a professor at the Centre for Study of Developing Economies in Tata Institute of Social Sciences, Mumbai questioned this move in an editorial for Scroll.in and said that this policy will drive up the price of vaccines “excluding millions of (Indian) people from voluntarily coming forward to take the vaccine.”

On Wednesday, just after getting permission to sell vaccines on the private market, the Serum Institute posted the new prices that it would charge for the AstraZeneca vaccine – equal to about US$ 8 a dose in private hospitals and US $5 a dose for Indian state government facilities. In comparison, the central government will still pay the original price of $US 2 per dose.

The vaccine price hikes prompted an immediate backlash from social and health advocates on social media.

“This is unacceptable” said one comment. The Centre [central government] must buy vaccines and distribute in a transparent, equitable manner free to states.  For 70 years India always had a free, universal vaccine programme.”

“Is the Serum Institute setting vaccine policy now?” tweeted Malini Aisola, co-convenor of All India Drug Action Network (AIDAN). She noted that SI had set the price without even engaging in a procurement process with the State governments.

Serum Institute CEO Warns Again That Supplies To COVAX Will Be Delayed 

Poonawala said that he will be able to renew vaccine supplies to COVAX by June or July,  provided he is able to ramp up production. SII had sought funds from the Indian government to increase its monthly capacity from up to 65 million currently to more than 100 million doses per month. 

He attributed the delay in ramping up the production due to the massive fire at Serum Institute’s facility in Pune and the sudden increase in demand by India owing to a massive surge of cases. At the time of the fire, Poonawala had earlier claimed that the damaged unit was a brand new facility which was to be used for future production of BCG and Rotavirus vaccine.

In order to provide the new support for domestic vaccine production, the Indian Finance Ministry offered credit to the two Indian manufacturing companies without the usual guarantee requirements, the Indian Express reported. 

India is currently seeing more than 200,000  COVID-19 cases per day. Many cities of the country have experienced stock outs of vaccines. In addition to halting COVAX supplies, the Indian government has also delayed bilateral vaccine exports to other countries, on account of the shortfall of vaccines in India.

Delay in Supply to COVAX

As of Monday, some 38.7  million doses had been distributed through the COVAX facility, said senior WHO advisor Bruce Aylward in a press conference Monday evening. These were mostly sourced from India’s Serum Institute in February and March before the current infection surge – although he acknowledged continuing uncertainty about when SII exports through COVAX could fully resume.

But, Serum Institute’s Poonawala said that their company is giving its entire capacity of production to India. 

“It has been difficult to explain to other countries that for a temporary period of two months we need to prioritise the needs of India over contractual obligations,” Poonawala told CNBC-TV-18 in the first week of April.

“The severe and sheer burden in cases in India, demands that we service the needs of our nation first. At least for two months and then we review the situation going forward,” Poonawala said.

Poonawala had also sought lifting of embargo of raw material exports from the US, including filters and cell culture media which are relevant for the COVID-19 vaccines. 

Poonawala explained to CNBC that while these materials do not affect the production of Covishield, they would affect the production of the vaccine Covovax which SII developed jointly with  the American company Novavax. He said that Covovax is being produced at 50% capacity for stockpiling from April- May in case the ban on raw materials is not lifted.

Public Health Experts Critique COVAX

Indian public health experts, however, have criticised both the Indian government, and international agencies for not anticipating vaccine shortages of this kind.  – leading to stock outs in several parts of India and a shortfall of doses promised to other developing countries that were reliant on Serum Institute’s stocks of the AstraZeneca vaccine. 

Rohit Malpani, a public health consultant based in Paris said that there is always a risk inherent to the structuring of the international vaccine market in such a way that a large proportion  of the vaccines destined for low and middle income countries, provided by COVAX or bilaterally,  come  from India.

“There was always a possibility or risk that eventually India would in itself require vaccines from its domestic production.” said Malpani, who also represents non-governmental organisations on the Board of Unitaid.

High income governments have felt the pinch as well. The UK government bought 5 million Covishield (the locally produced AstraZeneca vaccine) doses in the first week of March. However, the Serum Institute could not supply 5 million more after the Indian government delayed SII exports. The UK government then claimed that their vaccine roll out had been hampered as a result – although Indian observers said this is unjustified insofar as the UK has so far managed to vaccinate some 30% of its eligible population. The Canadian government also  bought about 5 million doses from Serum Institute early March. 

“The COVAX initiative did not anticipate that companies would go to the highest bidder [to sell vaccines]. They expected countries to share the vaccines. This has turned out wrong,” said Malpani. 

In an op-ed in The Guardian, access to medicine Indian activists Achal Prabhala and Leena Menghaney blamed the production shortage firstly on the decision of Oxford University to reneg on an earlier commitment to keep their vaccine technology as open-source, and sign over exclusive rights to AstraZeneca, “acting on advice from the Gates Foundation.”   

“Oxford University should have stuck to its plans of allowing anyone, anywhere, to make its vaccine. AstraZeneca and Covax should have licensed as many manufacturers in as many countries as they could to make enough vaccines for the world,” the op-ed by Prabhala and Menghaney stated.

In a recent interview, a senior Gates official denied that charge – saying that while the Foundation had assisted Oxford in finding a suitable pharma partner to scale up R&D – it had not intervened on the details of the license that Oxford signed with AstraZeneca.  

Malpani said that the international agencies need to think about what changes can be put in place to ensure that we do not have similar problems of inequitable distribution of vaccines again in the future.

He said, “If we do not make changes in the way the market is structured, how vaccines are produced..if we do not learn from these problems then criticism is very much warranted.”

–Updated 21 April 2021

An advertisement in favour of a tax on sugary drinks run in South Africa as part of a campaign by advocacy group Health Living Alliance (HEALA)

CAPE TOWN – South Africans are consuming fewer sugary drinks since their government introduced a tax on these in 2018 – but powerful multinational food and beverage companies are inhibiting neighbouring countries from following suit, according to research published on Tuesday.

South Africa was the first African country to impose a tax of approximately 10% on the sugar in sweetened soft drinks in an attempt to curb rising obesity and related diseases including diabetes and hypertension.

Last week, the Lancet published a four-year study that looked at the sugar consumption of 113,000 South African households and found per capita daily sugar consumption dropped from 16.25g before the tax was announced to 10.63g in the year after the tax was implemented.

But research published on Tuesday by the Global Health Action on seven other countries in southern and east Africa found that the path to introducing a similar tax is being blocked by industries.

There was little information in the seven countries about citizens’ consumption of sugary drinks, taxes or the industry itself, yet sub-Saharan Africa has been identified as a “growth market” for soft drinks, according to the research.

Sugary Drinks are ‘Vectors of Disease’

Professor Karen Hofman

“Obesity and its related diseases are escalating like a tidal wave across the continent of Africa,” said Professor Karen Hofman, director of Wits University’s Centre for Health Economics and Decision Science (known as Priceless). 

“It is fueled by colonisers in the guise of the processed food and beverage industry, and their associates in the advertising and marketing industries, who see our continent as a final growth market and who, for many decades have ensured that even our children are brainwashed to buy the products, because it will make them feel cool,” Hofman told the virtual launch of the research

She described ultra processed food and beverages as “vectors of disease” available at local supermarkets and transmitting “diabetes, cancer, and high blood pressure”.

Although a number of the seven countries – Botswana, Namibia, Zambia, Uganda, Kenya, Rwanda and Tanzania – do tax soft drinks, none target the sugar content or do so for health reasons.

Uganda has a general excise tax on soft drinks but despite NCDs now accounting for one-third of the country’s deaths, there is “limited recognition” of the link between sugary drinks and NCDs, according to the Uganda research.

“The soft drink industry has been influential in framing the taxation debate, and the Ministry of Finance previously reduced taxation of sugar-sweetened beverages,” according to the report.

Tension Between Economic and Health Considerations

In 2018, the Ugandan Finance Ministry proposed to cut the tax on non-alcoholic drinks from 13% to 10% – apparently because investment from Coca-Cola was contingent on this. After objections from the health ministry, the tax was reduced by to 12%, but the agreed plan of action is to gradually reduce the tax to 10%. 

After the tax was cut, Coca-Cola Uganda’s CEO is quoted as saying: “This $15 million investment was made on a promise of reducing taxes (on soft drinks), from 13% excise duty to 12% in the 2018/19 financial year, and we are glad it was implemented. This is confirmation that a favorable tax regime can attract more investment for the industry.”

While taxing sugary drinks in Kenya “has been identified as an effective mechanism to address nutrition-related non-communicable diseases”, the country is not yet committed to this.

“Government has competing roles: advocating for industrial growth, such as sugar and food processing industries to foster economic development, yet wanting to control nutrition-related non-communicable diseases,” according to the report.

An unnamed representative from the Kenyan Ministry of Health told researchers that “the Kenya Association of Manufacturers come out guns blazing whenever any of the clients is subjected to scrutiny in terms of ‘we need to tax ‘or ‘what is the health of this product’.” 

Another health official conceded that “unfortunately there’s a lot of industry interference with policy” on taxing sugary drinks, and that  it was not simply a decision about health but  [“an industrialisation issue and also a manufacturing practice issue … an industry like that, of course, has a lot of policy interference because they have big money they can compete with us.” 

Proliferation of Unhealthy Food

Botswana and Zambia appear better prepared and more interested in taxing sugary drinks, according to research presented at the launch.

However, said Zambian researcher Mulenga Mukanu, “The priority of most African governments is towards economic growth, as evidenced by policies that encourage the growth of industries that produce unhealthy commodities like sugar-sweetened beverages. This context should not be ignored.”  

Researcher Safura Abdool Karim said the growing problem of NCDs in sub-Saharan Africa “is partly due to the nutrition transition and proliferation of unhealthy foods across the continent, coupled with a lack of regulation and a lack of enforcement of existing policies”. 

But Abdool Karim concluded: “There are a number of cost-effective population-level interventions that can be implemented, particularly in low and middle-income countries, including regulating food labels, regulating marketing to children, and adopting taxes on sugary beverages.”

South Africa succeeded in introducing a tax, she added, because it based its campaign on robust local evidence, key policy-makers had political will, there was support from civil society advocacy organisations and “industry interference was neutralised”.

 

Image Credits: Kerry Cullinan, Healthy Living Alliance.

The EU has announced a €100 million fund that prioritises humanitarian settings and capacity building of national health authorities in Africa.

The European Union (EU) today pledged €100 million towards a humanitarian fund that will assist with COVID-19 vaccine roll-out in Africa.

The initiative was announced today at a press briefing addressed by Dr John Nkengasong, Director of the Africa CDC and Janez Lenarčič, European Commissioner for Crisis Management.

According to the EU, the new fund will support two complementary dimensions of the vaccination campaigns in Africa. A quarter of the fund will support the roll-out of the vaccination campaigns in African countries. It will also support capacity building of national health authorities and health care workers and will also support the management of information and vaccination coordination platforms.

“It will also address critical logistical gaps, including equipment. This implementation at country and continental level will ensure better and independent monitoring of the roll-out of the COVID-19 vaccination campaigns across Africa, supporting Africa CDC’s ongoing work. From a long-term perspective, it would also seek to reinforce national health systems’ resilience to address future epidemic outbreaks,” the EU said in a statement.

A second tranche of €65 million is set aside to support the roll-out of vaccination campaigns in specific humanitarian settings, notably in conflict and hard-to-reach areas, implemented through needs-specific activities, in close cooperation with various EU humanitarian partners. A further €10 million in reserve will be allocated to any of the two tracks as needed.

Continuous Support for Africa

Africa’s public health stakeholders have repeatedly decried vaccine nationalism of several rich countries including some in Europe that have an oversupply of COVID-19 vaccines for their citizens while groups at most risk in several African countries are yet to get vaccine doses.

But Lenarčič noted that the EU has continued to support Africa and is doing a lot to expand and ensure equitable access to COVID-19 vaccine doses in Africa through the COVAX Facility and several other bilateral and unilateral actions. “Almost half of what is produced in the EU is exported,” he said.

According to him, the EU believes and supports a global approach towards tackling the COVID-19 pandemic.

“The EU has demonstrated its solidarity in many respects with regard to this pandemic, including through its financial contribution to the COVAX facility, and through export of vaccines produced in the EU. Together(with Africa CDC), we will be able to assist members of the African Union in rolling out their vaccination campaigns. This is part of what we see as a global approach,” Lenarčič said.

The EU has not always agreed with the Africa CDC on how best to approach poor access to COVID-19 vaccines in Africa. It opposed calls for intellectual property rights for COVID-19 vaccines to be waived so that more vaccine producers, including some in Africa, are able to be involved in mass production so that sufficient doses are available across the world.

Fund Allocation

John Nkenkasong, Director of the Africa Centres for Disease Control.

Nkenkasong told Health Policy Watch that while the estimate of what each African country will receive through the initiative is not yet available, there are broad indications of the kinds of efforts the fund can support in AU member states.

“The fund is not to get vaccines and distribute them to countries; it is to first aid countries to set up vaccination centres, and the roll-outs mechanism. The breakdown of exactly how much will go to each country is not an issue that we can put on the table now; it will be based on their strategic plans,” he told HPW.

He said every African country now has a vaccination plan and to disburse the fund will require engaging the countries, look at the interface between Africa CDC’s discussions with them, where they are with their vaccination plans and needs they still have.

“Some countries are very capable of doing their own things and they may not need this kind of support. However, some countries would need tremendous support to get to where they have to be, and then the specificity of this program is very important—the humanitarian component is extremely valuable because it has to be tailored to meet those goals of the targeted nature of the funds,” he added.

Image Credits: European Union.

Some studies have suggested that administration to travelers of a rapid COVID test upon arrival may be just as effective as lengthy quarantine requirements, to control the import of COVID-19 cases.

After months of stalemate, WHO looks set to update its guidance on managing COVID-19 infections in the context of international travel – but proof of vaccination should not be required as a condition of entry to any country, emphasized WHO’s International Health Emergency Committee.

This was among the wide-ranging recommendations issued on Monday by the International Health Regulations Emergency Committee, which first declared that the COVID-19 outbreak constituted an International Public Health Emergency (PHEIC), in January of 2020.

That advice seemed to clash head-on with the political winds in many countries, and the travel industry, regarding the adoption of vaccine certificates to reopen travel while containing virus spread and variants. Groups ranging from the International Air Transport Association to the European Commission have proposed the creation of a digital COVID vaccine/recovery certificate to facilitate safer international travel.

The statement also follows months in which WHO has resisted taking a stance in favor of now widely used measures such as pre-flight or post-flight COVID testing  – even though this is now widely practiced around the world – from Europe and North America, to Africa and Asia.

In a press release issued after its seventh meeting on the COVID pandemic, the Committee said that WHO should indeed: “update the WHO December 2020 risk-based guidance for reducing SARS-CoV-2 transmission related to international travel (by air, land, and sea) based on current science and best practices that include clear recommendations for testing approaches and traveler quarantine duration, as appropriate.”

It added that the updated travel guidance should “take into consideration COVID-19 vaccination roll out, immunity conferred by past infection, risk settings, movements of migrants, temporary workers, and purpose of travel (non-essential versus essential),” the Committee stated.

But in an explicit message to member states, the Committee added: “Do not require proof of vaccination as a condition of entry, given the limited (although growing) evidence about the performance of vaccines in reducing transmission and the persistent inequity in the global vaccine distribution. States Parties are strongly encouraged to acknowledge the potential for requirements of proof of vaccination to deepen inequities and promote differential freedom of movement.”

Strict COVID-related controls in travel and COVID testing at airports helped ‘bend the curve’ of the outbreak,in some countries, experts say. But WHO has so far not provided guidance.  
Other Advice – Control Food Safety in Wild Animal Markets to Reduce Pathogen Spillover to Humans

In other recommendations, the Committee also advised WHO and member states to proceed with rapid implementation of recommendations that have emerged from the international expert committee investigating the origins of the SARS-CoV2 virus, including new WHO guidance to temporarily suspend the sales of wild mammals in the so-called “wet animal markets”, where wild animals are held in captivity, and slaughtered on site for customers in many Asian and African cities.

The WHO international expert committee had said that infected wild mammals that were slaughered and sold in Wuhan wet markets were one “very likely” pathway for the introduction of the SARS-CoV2 virus into the city – although other scientists have charged that the theory the virus escaped from a Wuhan virology laboratory investigating coronaviruses should not be discounted either.

According to the Emergency Committee recommendations, WHO should:

  • Encourage research into the genetic evolution of the SARS-CoV-2 virus.
  • Promote One Health approaches to better understand and reduce the risk of spill-over of emerging infections from animal to human populations and from humans to animals, including from domestic animals.
  • Work with partners to develop and disseminate joint risk-based guidance for regulation of wet markets and farms to reduce transmission of novel pathogens from humans to animals and vice-versa.

The Committee also urged WHO to continue its appeals to “global solidarity efforts to increase equitable access to COVID-19 vaccines and ancillary supplies by supporting the COVAX Facility and engaging in technology transfer, where feasible.”  And it said that WHO and member states should strengthen its epidemiological and virologic surveillance as part of a comprehensive strategy to control the development of COVID-19 variants, including member state’s sharing of variant gene sequences and meta-data with WHO and on publicly available platforms.

 

Image Credits: Wikimedia Commons: Nemo.

New COVID-19  cases climbed again globally last week for the eighth week in a row – while only 1% of the 100 million vaccine doses administered last week were in low- and middle-income countries – said senior WHO officials on Monday, citing two key barometers of pandemic policies.

Meanwhile, speaking at a WHO press conference ahead of this week’s planned White House Climate Summit, the teenage climate activist Greta Thunberg called upon global leaders to ensure that front line health workers and other high-risk groups in low- and middle-income countries are vaccinated more rapidly – saying it was morally unacceptable that younger people in affluent countries should be able to access the vaccine ahead of high-risk groups elsewhere.

“We have the tools we need to correct this great imbalance that exists around the world today in the fight against COVID-19, just with the climate crisis, Thunberg said. “Those who are the most vulnerable need to be prioritized in global problems require global solutions… But so far, on average, one in four people in high-income countries have received the coronavirus vaccine, compared with just one in 500 in low and middle-income countries,” she said.

Thunberg, whose foundation announced a 100,000 Euro donation to the WHO co-sponsored COVAX initiative, added: “It is completely unethical that high-income countries are vaccinating young and healthy people, if that happens at the expense of people in risk groups, and on the front lines in low- and middle-income countries.”

Regarding the upcoming climate summit, the pandemic has highlighted how health and climate are inextricably intertwined with deforestation and environmental degradation that causes climate change and the spillover of animal-borne diseases into human populations, Thunberg stressed.

“In the future, we will most likely experience more frequent and more devastating pandemics unless we drastically changed the way our ways and the way we treat nature,” she said.

“Today, up to 75% of all emerging diseases come from animals. As we are cutting down forests and destroying habitats, we are creating the ideal conditions for diseases to spill over from one animal to another, and then to us. And we can no longer separate the health crisis from the ecological crisis, and we cannot separate the ecological crisis from the climate crisis. It’s all interlinked.”

Youth Climate Activist Greta Thunberg speaking at WHO press conference

COVID Infections Also Increasing Among Younger People at ‘Alarming’ Rate 

Meanwhile, COVID cases were increasing among younger people aged 25-29 at an “alarming rate” Tedros said, possibly as a result of the propagation of more transmissible SARS-CoV2 variants as well as increased social mixing among younger adults. That mixing, added WHO COVID-19 lead Maria Van Kerkhove, is not only due to more socializing and pandemic fatigue, but also for work and religious reasons following the Easter holidays and Ramadan.

More than 5.2 million new cases were reported just last week, the largest so far, and the world also topped the record of 3 million deaths.  “It took nine months to reach 1 million [deaths], four months to reach 2 million and just 3 months to reach 3 million deaths. Big numbers can make us numb. But each one of these lives lost is a tragedy for families, communities and nations,” Tedros said.

COVAX Facility Facing Immediate Supply Problems Related to India Case Surge

WHO’s Bruce Aylward

The COVAX facility had, as of Monday, distributed just over 38.7 million vaccine doses in low- and middle-income countries, noted WHO senior advisor Bruce Aylward.

“The whole vaccine supply situation remains precarious, and the challenge still because of such competing demands for these doses remains a very difficult one to manage,” said Aylward.

The surge in COVAX cases in India has put constraints on COVAX access to vaccines produced by the Serum Institute of India (SII) – one of the main COVAX vaccine suppliers to date, he explained For the time being, SII has had to redirect much of its recent production to domestic cases. COVAX remains short on donations of other alternative vaccines, as well as funds to make strategic purchases.

“It all it all comes back again also to the COVAX facility having the resources it needs so that it can put the contracts in place, upfront to make sure the supplies are there, not just the supplies in terms of the vaccines, but… syringes and the other supplies, including … cold chain equipment, and sometimes very specialized cold chain equipment to get these products to people,” said Aylward.

While the African Union and the World Trade Organization last week held major conferences on the topic of expanding vaccine manufacturing in the short term the focus needs to be on the redistribution of doses being produced right now, Aylward stressed.

“The challenge is how we’re actually using the doses that are being made.  Last week, while those conferences were taking place, 100 million more doses of vaccines were administered around the world. And the issue is where they’re being administered – because … 99 million doses of vaccines last week went into high, upper middle income and some lower-middle-income countries but only 1% went to the lowest income countries.”

Aylward and other WHO officials lauded recent gestures by countries such as Sweden and Norway to donate excess vaccines that they don’t plan to use – urging other high-income countries that are currently hoarding vaccines to follow suit.

“If we have a lot more weeks, where 99% of the vaccines go to a set of countries that already have most of the vaccine, we’re not going to get out of this crisis as rapidly and efficiently and with as least, you know lives lost as possible,” Aylward noted.

Meanwhile, WHO’s Chief Scientist Soumya Swaminathan said that there remains considerable global vaccine “fill and finish” capacity that has not yet been harnessed by pharma producers capable of making larger quantities of active vaccine ingredients.  She said that a new COVID Vaccine Manufacturing Task Force, co-sponsored by WHO, COVAX, and other partners, is looking at opportunities to quickly address bottlenecks and ramp up the production of more vaccine supplies.

WHO Chief Scientist Soumya Swaminathan

“We know that there is a lot of unused fill and finish capacity globally, and therefore we need manufacturers who have the capacity to make a bulk [active vaccine ingredient] product, to link them with existing fill and finish capacities in facilities around the world,” Swaminathan said.

The Task Force is trying to help link suppliers of critical vaccine ingredients and raw materials to manufacturers, and ensure that export bans “don’t interfere with the process of vaccine manufacturing”. A longer-term goal would be to actually build more manufacturing capacity, particularly in low- and middle-income countries through technology transfer arrangements, she added.

In a thinly veiled appeal to Moderna and Pfizer, Swaminathan said that WHO is calling upon “owners of technology, particularly mRNA technology, to come forward to work with us, to share that technology, that know-how, and experience with recipient companies that will be selected according to a set of criteria that we are developing, and that will ensure not only supplies for this pandemic, but will also help with future regional health security for regions which currently do not have any vaccine manufacturing capacity.  And this obviously can be extended to vaccines for many other infectious diseases.”

On Friday, WHO issued a call for expressions of interest from small and mid-sized pharma firms, as well as from “owners of technology and intellectual property rights” to mRNA vaccines –  to support the creation of a COVID-19 mRNA vaccine technology transfer hubs, particularly in low- and middle-income countries.

“The intention is for these hubs to enable the establishment of production process at an industrial or semi-industrial level permitting training and provision of all necessary standard operating procedures for production and quality control. It is essential that the technology used is either free of intellectual property constraints in LMICs, or that such rights are made available to the technology hub and the future recipients of the technology through non-exclusive licenses to produce, export and distribute the COVID-19 vaccine in LMICs, including through the COVAX facility,” stated the WHO call.

It added that it was seeking expressions of interest from:

  1. Small/middle-sized (public or private) manufacturers of medical products (drugs, vaccines or drug substances) preferably, but not exclusively, in LMICs, which could host a COVID-19 mRNA hub and:
    • Assemble the technology up to good manufacturing practices-grade pilot lots for clinical trials;
    • Transfer the appropriate know-how and technology to existing or new manufacturers in LMICs to enable them to develop and produce COVID-19 mRNA vaccines;
  2. Owners (public or private) of technology and/or intellectual property rights. These may be academic institutions, pharmaceutical companies, non-governmental organizations, or any other entity willing to contribute these to a technology transfer hub, under the auspices of WHO, to enable the production of mRNA-based COVID-19 vaccines in LMICs.

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Africa, Ghana

Six weeks after receiving 1.7 million doses of the AstraZeneca COVID-19 vaccine from COVAX, the Democratic Republic of Congo (DRC) finally started to vaccinate people on Monday.

The delay followed concerns about the safety of the vaccine amid reports about possible links between the vaccine and blood clotting.

In a bid to build public confidence, Health Minister Eteni Longondo became one of the first people to receive the vaccine at Kinshasa University’s medical school. The European Union’s Ambassador to the DRC, Jean-Marc Chataigner, and UN Humanitarian Affairs Coordinator David McLachlan-Karr were also vaccinated.

The rollout was initially due to start on 15 March.

Interior Minister Gilbert Kankonde said last week that the country’s medical experts were satisfied that the vaccine posed no danger to citizens.

“The vaccination will be voluntary and priority will be given to healthcare personnel, vulnerable people, those with chronic illnesses and all those who are greatly exposed while carrying out their work,” Kankonde said.

The country of more than 80 million people has received 1.7 million doses of AstraZeneca through COVAX, a World Health Organization-backed effort to procure and distribute inoculations to poor countries. In addition, India has also donated 50,000 doses to the country.

The vast central African country has officially registered 28,956 cases of COVID-19, with 745 deaths, since the start of the pandemic last year.

Kankonde added that the country would also ease its curfew, currently between 9pm to 5am, to 10pm – 4am in provinces with low caseloads.

According to official statistics, the 80-million strong country has only recorded 28,665 infections and 745 deaths.

In early April, UN peacekeepers from the Southern Sector at Democratic Republic of Congo received their first dose of COVID-19 vaccine from a donation from the Indian government. Other UN agency staff members are expected to start being vaccinated from today.

 

Image Credits: WHO.

A new study has found that there is a higher risk of blood clots from COVID-19 than vaccines.

The risk of developing a rare brain blood clot is eight to ten times higher in people infected with COVID-19 than those who get a vaccine, a new study has found.

The study by Oxford University last week reported that the risk of the rare blood clotting known as cerebral venous thrombosis (CVT) following COVID-19 infection is around 100 times greater than normal, several times higher than it is post-vaccination or following influenza.

The study follows investigations into links between the AstraZeneca vaccine and rare blood clots and also looked at those who had a Pfizer or Moderna vaccine. According to the study, four people in one million people experience CVT after getting the Pfizer or Moderna vaccine, versus five in one million people for the AstraZeneca vaccine. In comparison, 39 in one million patients who get COVID-19 develop CVT.

Rollouts of AstraZeneca’s vaccine have been halted or limited in many countries, based on concerns about blood clots.

Led by Professor Paul Harrison and Dr Maxime Taquet from Oxford University’s Department of Psychiatry and the NIHR Oxford Health Biomedical Research Centre, the study examined the health records of 81 million people in the US, looking at the number of CVT cases diagnosed in the two weeks following a diagnosis of COVID-19 and the number of cases occurring in the two weeks after people had their first coronavirus vaccine.

They then compared these to calculated incidences of CVT following influenza, and the background level in the general population. The risk of a CVT from COVID-19 is about 10 times greater than the mRNA and eight times greater than the AstraZeneca vaccine. In addition, 80% of people who developed the clots survived.

Reassuring Findings

Based on US data, the Oxford research team said people being vaccinated should be reassured by the findings.
The study has not been through a final review and is still a work-in-progress, but the researchers say it must be “interpreted cautiously because it is difficult to calculate with certainty how common CVTs are in the general population, partly because of just how rare they are”.

According to Harrison: “We’ve reached two important conclusions. Firstly, COVID-19 markedly increases the risk of CVT, adding to the list of blood clotting problems this infection causes. Secondly, the COVID-19 risk is higher than we see with the current vaccines, even for those under 30; something that should be taken into account when considering the balances between risks and benefits for vaccination”.

Prof Beverley Hunt of Thrombosis UK told BBC news that the mechanisms behind people getting clots after COVID-19 and those experiencing clots after vaccines were likely to be different.

“Patients who are hospitalised with COVID-19 have very pro-thrombotic (sticky) changes in their blood, which persist after they have been discharged. This will lead to an increased rate of blood clots.
“The mechanism for the very rare blood clots and low platelet counts seen after the AstraZeneca vaccine is different. It is associated with an immune response.”

People are “likely” to need a third dose of the coronavirus vaccine within 12 months of getting the first two doses of the Pfizer-BioNTech vaccine, Pfizer CEO Albert Bourla said during a recent interview.

The third booster jab could be necessary “somewhere between six and 12 months” after the second one and possibly even annually, Pfizer CEO Albert Bourla told CNBC television during a recording broadcast on 15 April.

“A likely scenario is that there will be likely a need for a third dose, somewhere between six and 12 months and then from there, there will be an annual revaccination, but all of that needs to be confirmed. And again, the variants will play a key role,” he told a CNBC reporter.

Bourla said that the Pfizer-BioNTech vaccine has proved to provide immunity for six months.

Variants “will play a key role” in how regularly people will need to have their COVID immunity topped up as time goes on – in a similar way to how flu vaccines are updated and re-administered year on year.

“But protection goes down by time. It is extremely important to suppress the pool of people that can be susceptible to the virus,” Bourla said. 

Earlier this month, Pfizer said its COVID-19 vaccine was more than 91% effective at protecting against the coronavirus and more than 95% effective against severe disease up to six months after the second dose.

Beyond the study of 12,000 vaccinated people, exactly how long immunity lasts with two doses “remains to be seen”, Bourla said. Researchers say more data is needed to determine whether protection lasts after six months. 

In February, Pfizer and BioNTech said they were testing a third booster dose of their COVID-19 vaccine to better understand the immune response against new variants of the virus.

Nadhim Zahawi, the UK’s Minister for Business & Industry and COVID Vaccine Deployment, has said that his country’s top four priority groups could be invited for a third booster dose as soon as September.

The over-80s, clinically extremely vulnerable, health and social care staff and care home workers were the first to be vaccinated against coronavirus in December and the first weeks of this year.

They were offered the Pfizer-BioNTech or the Oxford-AstraZeneca jab, but Zahawi says he expects eight different vaccines to be available later in the year.

In the US, health officials are already preparing for booster doses to be issued between nine and 12 months after people are fully vaccinated.

This would mean a third dose for people who have received the Pfizer or Moderna jabs and a second dose for the Johnson & Johnson single-shot vaccine. 

Bourla’s comments come after Johnson & Johnson CEO Alex Gorsky told CNBC in February that people may need to get vaccinated against COVID-19 annually.

 

 

 

 

 

 

 

Image Credits: Flickr – World Economic Forum.

Polluted air in New Delhi

NEW DELHI, India – Delhi State aims to fight air pollution as a “mass movement” with public participation,  according to Environment Minister Gopal Rai – but a recent conference he called with experts on the issue concluded with no firm commitments.

Rai convened the two-day virtual conference with air pollution experts and clean air advocates to brainstorm ideas for a “long-term action plan to tackle pollution” ahead of north India’s seasonal winter peaks.

New Delhi is the most polluted city in the world and on certain days citizens are exposed to such poor air quality that it is the equivalent of smoking 40-50 cigarettes per day.

“The government will focus on changing the mindset and behaviour of people,” Rai told the meeting. “Within the constraints of the pandemic and restrictions on mass mobilisation, we need to create a mass movement. Our three-pronged approach needs to focus on policy, technology and making the environment a mass concern,” he said. 

Although the government has taken some steps, including an electric vehicle policy (aiming for a quarter of new vehicles licensed to be electric by 2024) and introducing bio-decomposers to curb stubble burning, Rai admitted these were not enough.

Delhi state Environment Minister Gopal Rai

“A plan is needed that can work through the year, and in the coming days we will come up with an action plan to further better Delhi’s air quality index. Nobody knows until when the pandemic will rage, and it’s not feasible to wait that long. We would like your suggestions to create a viable and effective plan for the city,” he said. 

“While we have identified hotspots, it is still challenging to measure the timing, the rate, source and impact of pollution. The Delhi government is working at a technological level to find appropriate tools to measure these indicators which would in turn help us devise the correct policy,” he explained.

However, no commitments were made at the meeting, and experts pointed out that a similar meeting had been called in February 2020, which yielded little in terms of actual pollution control.

Lots of Ideas, But No Follow Through

There is no dearth of ideas on how to control pollution – from banning the manufacture of firecrackers to installing filters in the chimney stacks of industrial units to reduce emissions or mandating norms for fuel and engines. But none is popular because commercial interests are harmed, and defensive lobbies are pushing back in courts.

In October last year, the Delhi government had announced a “war on pollution,” with great fanfare, led from a war room personally commanded by Chief Minister Arvind Kejariwal. 

His arsenal comprised a seven-point action plan that included:  tracking the city’s hotspots; launching a ‘green Delhi’ mobile app to address open air burning complaints; and repairing the city’s potholed roads to control dust. 

His most powerful weapon at the time was a cheap and simple rapid compost brew, Pusa Decomposer, that Kejriwal had hoped would inspire farmers in surrounding rural states to turn their crop waste into valuable fertilizer rather than burning it. 

Rai told the conference that teams from the adjoining states of Punjab and Haryana had visited a government decomposer pilot, but didn’t offer more details or any commitments made by them to adopt the decomposer.

Unexpected Revival of Air Quality Management Body

The experts suggested taking a proactive, year-round and an airshed approach to reducing air pollution, working collaboratively with neighboring states; creating walking and cycling paths, improving public transport, managing garbage better, choosing cleaner fuel, encouraging electric vehicles for transport and delivery, and enforcing existing pollution control laws. 

The meeting follows an unexpected move by the federal government to approve the re-promulgation of an ordinance to set up a statutory body to manage air quality in India’s polluted National Capital Region, which includes Delhi, and adjoining areas of the Indo-Gangetic plain, which includes Punjab, Haryana, Rajasthan and Uttar Pradesh. Significantly, the new ordinance envisages an expanded statutory body that will include the interests of the farming, industry and construction sectors.

The ordinance was first promulgated last October at the peak of north India’s annual ‘airpocalypse’, before being inexplicably allowed to lapse last month, when air quality was beginning to improve slightly. 

But a recent meeting of federal ministers and their bureaucrat counterparts approved the re-promulgation of the ordinance, and the government is expected to introduce it as a Bill in the monsoon session of Parliament, according to environment secretary RP Gupta.

There has been no official word on this development but Solicitor General Tushar Mehta, who represents the government in the courts applied to court to place the ordinance on record, which was accepted by the court. 

Once the ordinance is re-promulgated and enacted by presidential decree, the commission is expected to be reconstituted with most of the original members. Although there is no official notification as yet, the original members are expecting to be retained, according to government sources who declined to be named.

The erstwhile 18-member Commission on Air Quality Management (CAQM) had been headed by M.M. Kutty, a former bureaucrat who had once headed the ministry of petroleum and natural gas. The other members included Arvind Nautiyal, a joint secretary in the environment ministry, KJ Ramesh, former head of the India Meteorological Department and Ashish Dhawan of the Air Pollution Action Group as an NGO representative.

Key stakeholders including the health, agriculture, rural development and labour ministries, had been left out. 

Sources told Health Policy Watch that the government let the ordinance lapse because the CAQM’s ability to prosecute polluters meant it could impose stringent penalties on farmers for burning crop stubble.

“The farmers’ protests have become a very sensitive topic,” the source said.

Until March, the CAQM was functioning out of a temporary space in the office of the Indian Oil Corporation, and meeting every two to three weeks to outline and discuss its strategy. It had started working on a pilot project on estimating hyper-local pollution using curb-side laser measurements of vehicular pollution.

“The committee had made decent progress,” a source said, noting that if a brand new committee is constituted, this progress would be lost. 

“The only concern we had was around funding. It is still not clear where the funds will be allocated from,” another person close to the committee said. 

They added however that they expect the commission to retain its statutory powers, including those empowering it to impose strict penalties on polluters. These penalties include a jail term of up to five years as well as fines.

The unexpected, and unexplained, dissolution and, now, re-promulgation has taken atmospheric scientists and clean-air advocates by surprise. “#CAQM on the way back; for real or just another charade?” Bhavreen Kandhari, a clean air activist, tweeted.

“The CAQM is a major improvement over the EPCA. The devil is in the details, what is the fund allocation, how large will be the secretariat, how will it be able to carry out punishment and fines, etc. – all this need to be known,” Dr Laveesh Bhandari, economist and director of the Indicus Foundation, said. “It is these details that will decide whether this initiative will be effective.”

 

Image Credits: Neil Palmer.