There is a “possible link” between the Johnson & Johnson COVID-19 vaccine and very rare cases of blood clots, but the benefits of the single-dose vaccine outweigh the risks, the European Medicines Agency (EMA) has announced.

In a statement released on Tuesday, the EMA safety committee said that the rare, but serious blood clot disorders, should be listed as “very rare side effects” of the vaccine. The EMA statement followed a similar decision with respect to the AstraZeneca vaccine, just two weeks ago. 

The European regulator had reviewed eight reports of “serious cases of unusual blood clots associated with low levels of blood platelets”, one of which was fatal – among seven million who received the jab in the United States. 

No cases of deaths associated with the J&J vaccine have so far been reported in the European Union, said EMA executive director Emer Cooke – but vaccine administration on the continent is also far less advanced.

Along with Europe, South Africa and the US had also announced a pause in J&J vaccinations over the blood clot reports in response to reports of a rare cerebral blood clot disorder that combines clots with low blood platelets (CVST).  Since then, vaccines in South Africa have resumed, but in the US, they remain on hold.  

Announcing its decision, the EMA said the risks associated with the virus itself are still higher than the vaccine.

“Covid-19 is associated with a risk of hospitalisation and death,” it said. “The reported combination of blood clots and low blood platelets is very rare, and the overall benefits of [the Johnson & Johnson] Covid-19 vaccine in preventing Covid-19 outweigh the risks of side effects.”

European Commission President Ursula von der Leyen welcomed “the announcement on the safety of the Johnson & Johnson vaccine”.

“This is good news for the roll-out of vaccination campaigns across the EU,” she tweeted.

Johnson & Johnson Rare Blood Clotting Cases

The cases of clotting in the US “occurred in people under 60 years of age within three weeks after vaccination, the majority in women”, the EMA regulator said in its statement. 

“One plausible explanation for the combination of blood clots and low blood platelets is an immune response, leading to a condition similar to one seen sometimes in patients treated with heparin called heparin induced thrombocytopenia, HIT,” it said. Heparin is a blood thinner given to people with clotting disorders.

The EMA said healthcare workers and those who have received the vaccine should be aware of potential symptoms of these rare blood clots. They include shortness of breath, chest pain, leg swelling, abdominal pain, headache, blurred vision or tiny blood spots under the skin.

The early intervention of a specialist can change the outcome for the patient, Cooke said.

‘Similarities’ with AstraZeneca

Emer Cooke, EMA Executive Director.

The cases reported with  J&J’s vaccine were similar to the rare blood clot cases linked to the AstraZeneca vaccine, EMA also noted.

Earlier this month, the EMA made the same recommendation for the Covid-19 vaccine produced by Oxford-AstraZeneca.

That recommendation, made on 7 April, came after 86 people, out of 25 million Europeans who had received the jab, developed the unusual blood clots. Germany has since halted administration of the vaccine to people under the age of 60, the UK has ceased giving the vaccine to people under age 30, and Denmark has halted it altogether. 

Both vaccines use a disabled, or inactive adenovirus vector [viruses that typically cause colds or flu-like symptoms] to deliver a double stranded DNA containing the genetic instructions for part of the SARS-CoV2 characteristic spike protein. That stimulates the body’s immune system to develop antibodies to the virus.

However, Sabine Straus, chairperson of EMA’s evaluation committee of risks and pharmacovigilance (PRAC) noted there were differences between both vaccines since Johnson & Johnson’s vaccine uses an inactivated human adenovirus as the “vector” to deliver the spike protein DNA, while AstraZeneca’s is chimpanzee-based. Both vaccines also target a different part of the SARS-CoV2’s spike proteins, she said.

Considering that the Russian-made Sputnik-V vaccine also uses adenovirus vectors to deliver its jab (in this case different ones for first and second jabs), the EU regulator will “pay close attention” to the issue of rare blood clots as it reviews the vaccine, she added.

According to the latest available data, a total of 287 cases of unusual blood clots have been  reported following the administration of the AstraZeneca vaccine; 25 in the case of the Pfizer-BioNTech vaccine and 5 for the Moderna vaccine, the EMA officials told reporters.

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 .

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.

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.

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.

infectious disease
A villager’s eyes are being examined for African eye worm by Dr Philippe Urwotho, a medical doctor and Provincial Coordinator of the DRC’s Neglected Tropical Disease National Programme.

Global funding to develop new drugs for some of the world’s leading infectious disease killers, such as HIV/AIDS, TB, and malaria, was US $3.876 billion, with the drop of US $185 million from 2018 reflecting COVID-related difficulties in data collection, according to the G-Finder Report, which tracks annual global investments.

However, once participation is accounted for, the report estimates that 2019 funding was virtually unchanged from its record high in 2018, with only a marginal decline of US $8 million. 

On the other hand, funding for neglected tropical diseases (NTDs) remains stagnant as it had for the past decade, with most NTDs seeing little change to their individual funding levels (although the majority did receive small increases), according to findings in the report, launched on Thursday by the Australia-based Policy Cures Research group. 

Mixed Signals in Global Trends; Policy Makers Need to Step Up to Address NTDs 
Nick Chapman, CEO, Policy Cures Research

The G-Finder Report is a comprehensive analysis of global investment into research and development of new products to prevent, diagnose, control or cure neglected diseases. It is widely used by national governments, industry, civil society, and the World Health Organization to identify gaps in progress and areas where investments would be needed. 

Reactions to the news remain mixed, in line with the good and bad news the report contains. 

“It’s not necessarily a good one or a great one. I don’t think that the level or the distribution of global funding for neglected disease is as we wanted or as it should be,” said Nick Chapman, CEO of Policy Cures Research, during the launch of the report. 

Ricardo Baptista Leite, member of the Parliament of Portugal, called on policy makers, who have both the legal and moral obligations to represent underserved populations, to tackle neglected diseases. 

“Policymakers are the ones who are at the interface of academia, social science, civil society, philanthropy, private sector, and media, be it social or conventional, and therefore they can truly represent the multi-sectoral approach needed to fight poverty and therefore tackle directly the root causes of these diseases.” 

Leading Infectious Diseases Account for Three-Quarters of Funding

Changes in neglected disease funding – increases in TB, HIV/AIDS, salmonella infections, and snakebite, decreases for helminth infections, malaria, hep C, and diarrhoeal diseases

The G-FINDER report tracks investments across 36 diseases including HIV/AIDS, tuberculosis, and malaria – which together represent the world’s leading infectious disease killers. The three accounted for US $2.7 billion, or three-quarters of global funding in 2019 

While global funding for HIV/AIDs and tuberculosis research and development increased from 2018 (up US $29 million for both), funding for malaria dropped slightly, falling US $32 million – the first drop since 2015. 

The latter quarter of R&D investment was split between the remaining 33 diseases, with funding remaining relatively stagnant, although the majority of diseases did receive small increases in funding.

Increased funding was the result of two United Kingdom public funders – Department for International Development (DFID) and Department for Health and Social Care (DHSC) – which supported a Global Health Research Group on African Snakebite Research, and ongoing funding from the UK NHS. 

Dengue, a WHO-categorized NTD listed as one of the top ten threats to global health, had its funding increased slightly by US $3.2 million. The only other NTD to see increased funding in 2019 was Buruli ulcer, which rose (up US $0.2 million) to US $2.8 million.

US Primary Contributor, But Report Calls for Diversity in Funding

The US NIH contributes to most of global infectious disease funding

Investment by public sector and philanthropic groups reached another year of growth and record highs, while private sector funding declined in 2019, according to the report.

The United States contributed close to three-quarters of total public funding, once again making it the largest public funder at US $1.878 billion. The UK was the second-largest contributor (US $210 million), followed by the European commission.

According to Paul Barnsley, senior analyst at Policy Cures Research, this “warrants celebration”, but also a “small amount of concern” as Policy Cures Research Group warned in the past about dependence on only a few major funders, and pushes for diversity in funding. 

“It’s fair to wonder whether decision makers are paying as much attention to G-FINDER report briefings as they ought to be.” 

Alongside the US, the next largest increases in funding came from low- and middle-income countries – Brazil and Colombia – with France and Switzerland following.

Most of the increase in public funding was directed to HIV/AIDS, TB, and malaria. 

Philanthropic funding for neglected disease R&D totaled US $782 million in 2019. Increases came mainly from the Gates Foundation (up US $35 million) and the Wellcome Trust. The Open Philanthropy Project became the third largest Philanthropic Funder, increasing their funding US $9.3 million from their modest investment of US $14 million. 

COVID-19 Funding Unprecedented 

COVID-19’s unprecedented funding may result in fiscal tightening that impacts NTD investment

In spite of  concerns surrounding lack of diversified funding, the Policy Cures Research Group still found the funding pledged in the last year for COVID-19 to be positive.

“Even if a chunk of these [pledges] turned out to be empty promises more than 9 billion pledged in the first 9 months of 2020 still represents an unprecedented response, much bigger than anything we saw for Ebola, much bigger than our annual spending across all neglected diseases combined,” said Paul Barnsley. 

Barnsley said high income economy interest rates remained “mostly low” and nations that had to “spend their way through COVID still have the means to spend the way out of recession.” 

While this initial picture is relatively welcoming, future fiscal tightening may impact neglected disease funding.

“We have anecdotal evidence that funding designed to help people in other countries fares badly during general belt tightening,” said Barnsley.  

But COVID-19 does speak to the need for collaboration across sectors in order to combat both pandemics and neglected diseases. 

“It is not just the science of product development, but it’s really the science of partnerships. The COVID experience will give us valuable lessons about how to be really good scientists in creating the best possible partnerships to address global health needs,” said Mark Feinberg, President and CEO of the International AIDS Vaccine Initiative (IAVI). 

Image Credits: DNDi, Policy Cures Research Group .

No new medicine is in the development pipeline to combat antimicrobial resistance.

Despite growing awareness of the urgent threat of antibiotic resistance, the world is still failing to develop needed antibacterial treats, according to a new report by the World Health Organization (WHO). 

Of the 43 antibiotics and 27 non-traditional antibacterial agents in the current clinical antibacterial pipeline, none is sufficient to tackle the challenge of increasing emergence and spread of antimicrobial resistance (AMR). 

The persistent failure to develop, manufacture, and distribute effective new antibiotics is further fueling the impact of antimicrobial resistance and threatens our ability to successfully treat bacterial infections,” said Dr Hanan Balkhy, WHO Assistant Director General on AMR.

WHO’s annual Antibacterial Pipeline Report reviews antibiotics that are in the clinical stages of testing as well as those in early product development. The aim is to assess and identify gaps in relation to urgent threats of drug resistance, and encourage action to fill those gaps.

The report evaluates the potential of the candidates to address the most threatening drug-resistance bacteria, as outlined in the WHO Bacterial Priority Pathogens list, which includes 13 priority drug-resistant bacteria, including Mycobacterium tuberculosis and Clostridioides.

Static Antibiotic Pipeline 

The 2020 Report reveals a near static development pipeline, with only a few antibiotics approved by regulatory agencies in recent years. 

Of the 43 antibiotics, 26 are active against WHO priority pathogens, 12 against M. tuberculosis and five against C.difficile.

Eleven new antibiotics have either been approved by the US Food and Drug Administration (FDA) or the European Medicines Agency (EMA), since 1 July 2017. However, the newly approved antibiotics have limited clinical benefit over existing treatment, as over 80% of them are from pre-existing classes where resistance is well-known 

Of the traditional antibacterials, only three new products entered the clinical pipeline while seven were discontinued or do not have any recent information.  

For the preclinical antibacterial pipeline, there are currently 292 diverse antibacterial agents in progress with commercial and non-commercial entities. 

Novel Solutions and Global Initiatives Needed 

The lack of progress on antibiotic development highlights the need to explore more innovative approaches to treat bacterial infections. 

While the COVID-19 crisis accentuated the gaps in sustainable funding to address the health and economic implications of an uncontrolled pandemic, it also revealed the opportunity that exists when there is both political will and enterprise. 

“Opportunities emerging from the COVID 19 pandemic must be seized to bring to the forefront the needs for sustainable investments in R&D o f new and effective antibiotics, said Haileyesus Getahun, Director of AMR Global Coordination at WHO.

“Antibiotics present the Achilles heel for universal health coverage and our global health security. We need a global sustained effort including mechanisms for pooled funding and new and additional investments to meet the magnitude of the AMR threat.”

Several global initiatives have been created to address gaps in funding in antibiotics development. WHO and its partner Drugs for Neglected Diseases Initiative (DNDi) have set up the Global Antibiotic R&D Partnership (GARDP). In addition, WHO is working closely with non-profits such as the United States-based Combating Antibiotic-Resistant Bacteria (CARB-X) to accelerate antibacterial research.

There is also the AMR Action Fund, a partnership set up by pharmaceutical companies, philanthropies, the European Investment Bank, with the support of the WHO, that aims to strengthen and accelerate antibiotic development through global pooled funding. 

Image Credits: Interpol, Shutterstock.