Sputnik V vaccine

Two leading researchers who have raised questions about the reliability of Sputnik V’s vaccine efficacy ratings across age groups shared their concerns with Health Policy Watch. One called the results “impossible” and “very concerning”.

More than 70 countries have approved the use of Sputnik V, Russia’s COVID-19 vaccine, based on the reported 91.6% efficacy across nearly all age groups in the first part of its Phase III trial published by The Lancet in 2021. 

But a number of scientists have since raised a red flag about the reliability of the published data. 

In exclusive interviews, two of the leading critics told Health Policy Watch that such consistent efficacy is not only nearly impossible but also unmatched by any other vaccines. 

These findings “may have substantial implications for the utility of the vaccine and thus regulatory approval and the ongoing use to prevent COVID-19,” wrote Dr Kyle Sheldrick, author of the most recent report, published in  American Therapeutics.

In a recent interview with Health Policy Watch, Sheldrick said that data on the Sputnik vaccine as reviewed in independent analyses, such as one published by the Mexican Ministry of Health, is “very reassuring that this is a vaccine that works.” 

Another vocal critic, the Italian researcher Enrico M. Bucci, echoed that, telling Health Policy Watch in an interview that Sputnik is essentially a combination of two proven vaccine delivery platforms, the Chinese CanSino vaccine and Johnson & Johnson dose.    

But the question still remains, the researchers said: does the Sputnik vaccine work as well as its developers have claimed? 

Concerns about transparency and homogeneity of results 

Concerns about a lack of transparency with regards to aspects of the clinical trials for Sputnik V, as well as the unusual homogeneity of results among different age groups, have been raised about Sputnik since Russia first approved the jab back in August 2020. At that time, it was the first vaccine to receive a green light from any country’s regulatory agency. 

To date, the World Health Organization, European Medicines Agency and the US Food and Drug Administration have not authorized the vaccine, despite repeated statements by Russian officials and representatives of the Russian Direct Investment Fund (RDIF) that funds and sells it that all necessary data has been submitted to those bodies. 

In Sheldrick’s recent paper, he asserts that “the results contained with the phase-III RCT of Sputnik by Logunov et al showed a distribution [among age groups] inconsistent with what would be expected from genuine experimental data.” 

He was referring to the fact that the reported Sputnik results showed equal efficacy amongst all age groups. 

“It is our opinion that it is not possible for a journal or reader to have confidence in the results, and the article should be thoroughly investigated, including immediate release of anonymized individual patient data to an unbiased statistical expert. If the authors are not willing to do this, the paper should be retracted.”

Sputnik results ‘too perfect’

Using data from the Ministry of Health of the Republic of San Marino, the Russian Direct Investment Fund (RDIF) announced in 2021 that Sputnik V efficacy is significantly higher than Pfizer vaccine after 6-8 months

Specifically, Sheldrick and his team performed a simulation study that assessed the statistical probability that the results for different age subgroups participating would fall in the results ranges reported for the Sputnik vaccine in The Lancet article. They compared their findings for Sputnik with those of other US and Australia-approved vaccines, including AstraZeneca, Johnson and Johnson, Moderna and Pfizer. 

To do this, they ran statistical simulations for all of the vaccines 1,000 and then 50,000 times – so as to yield probability factors for the likelihood that results by age subgroup would line up exactly as they did in the real, reported results of the trials. 

“We used study-wide efficacy and infection rate for all age groups,” the paper explained. “We recorded the observed vaccine efficacies in each age group and summated how many simulations had all observed efficacies fall within the range of efficacies described in the relevant article.

“We calculated how many times, on average, a trial would need to be repeated to obtain results that fell within the range of efficacies from the relevant published article,” the authors reported. 

Their findings: The simulations showed that each of the vaccines except Sputnik has a range of efficacy results, by age subgroup, which is not unexpected, when considering the prevailing infection rates in the country at the time,  number of participants, and reported study-wise efficacy.  

“You would only have to repeat the studies two or three times to get a similar result for these other vaccines,” Sheldrick explained. “For Sputnik, you would have to repeat it 3,800 times to get results as perfect as they claimed.”

For instance, in the 1,000-trial simulation for the AstraZeneca vaccine, in 23.8% of simulated trials, the observed efficacies of all age subgroups fell within the efficacy bounds for age subgroups in the published article, according to the report. For J&J: 44.7%, Moderna 51.1%, Pfizer 30.5%. For Sputnik, the result was 0.0%. 

“In 50,000 simulated trials of the Sputnik vaccine, 0.026% had all age subgroups fall within the limits of the efficacy estimates described by the published article, whereas 99.974% did not,” it said in the report. 

Australian scientist: ‘Very uncommon to raise accusations against Lancet’

Sheldrick said that it is improbable that the Russian researchers “just got very lucky,” a notion that has been seconded by a number of other scientists in the US, Italy, Europe and Australia. 

“It is very uncommon to have accusations such as this raised against papers in journals as big as The Lancet,” Sheldrick told Health Policy Watch, “maybe because concerns are rare or because we don’t have a culture of double-checking. At first I thought I was just being suspicious.”

But after completing his study: The combination of the rapid approval timeline, the lack of availability of the data and the unexpected results “are very concerning to me.” Although he said he still believes that the Russian vaccine is likely to be at least somewhat effective against fighting COVID.

“Just because the data is not genuine, does not mean the vaccine does not work at all,” he stressed. 

Time and political pressures could have led to shortcuts 

Russia, which only offered its citizens Sputnik, is experiencing a slight increase in cases like the rest of the world, but at a much slower pace, according to official data.

The Reuters COVID-19 tracker, for instance, reported only 15 infections per 100K people in the last seven days. That as compared to 385.23 infections and 324.38 infections per one million people in nearby European countries of Estonia and Latvia.

But Sheldrick said that given the lack of transparency seen in other areas, he is unsure whether one can trust the daily cases as reported by the Russian government.  

He also stressed that he and his colleagues had been attempting to raise its concerns about the Russian researcher in private long before the country’s invasion of Ukraine, so the recent paper has nothing to do with the war.

“We raised these concerns with The Lancet before the invasion occurred,” he told Health Policy Watch. Some people like to link the two. I try to stay out of the political side.”

So why does he think that the Russian scientists would have fudged the data, assuming that they did? Time, Sheldrick said. 

“There was internal pressure to produce results before other vaccines,” he said. “Also, the vaccine was already being given to the general public. If you had by random chance found low results in one group, this would have looked particularly bad.”

Not the first to raise concerns

Sheldrick is not the first to raise concerns over Sputnik’s Phase III data. 

Within days of  Sputnik publishing its Phase I/II data in The Lancet, Italian researcher Enrico M. Bucci published a “note of concern” on his website about the data. 

Bucci and his team also were concerned that the homogeneity of results for different age groups, as reported in the Sputnik V trials was improbably high. They estimated that  the probability of results falling within the ranges reported in The Lancet study was less than 0.1%. But they had concerns beyond that as well. 

“We noted several gross inconsistencies, including several data points from different experiments which look identical, as well as inconsistencies in the number of enrolled patients and some more problematic data,” Bucci explained to Health Policy Watch. 

“With 15 other colleagues from several international institutions, we signed a letter asking for access to the full data set documenting the results purportedly obtained in the Phase I/II study,” Bucci recounted to Health Policy Watch. 

“In disregard of our and others’ requests, access to the data set used for the study publication was never granted.”

A version of that letter was ultimately published by The Lancet in September 2020 under the title “Safety and efficacy of the Russian COVID-19 vaccine: more information needed.” 

In it, Bucci stressed that “while the research described in this study is potentially significant, the presentation of the data raises several concerns which require access to the original data to fully investigate.”

Sputnik: All has data been double-checked

A Gamaleya National Center’s Employee, where Sputnik V was developed

Sputnik immediately responded to Bucci’s points, stressing in a formal letter that the data had all been “double-checked.”

“Some data that repeated itself was what elicited the greatest number of questions from Bucci and his colleagues: nine of the volunteers from day 21 to 28 in the vaccination process registered antibody indicators that were completely identical,” Sputnik wrote on its website. “Logunov stated that in small-sized groups of test subjects this possibility ‘cannot be ruled out.’

“‘It is possible that immune system indicators could reach the kind of plateau that we observed during the research,’ the letter states. Logunov also stated that all of the data obtained by scientists during the experiment was double-checked.”

But Bucci said that it was not only the Phase I/II study that raised eyebrows. 

There have now been three Lancet articles on Sputnik, all of which were problematic and subjected to several partial corrections after the errors were flagged, including the most recent Phase III study. 

Errata were published by The Lancet on 22 September 2020; 7 January 7 2021, 9 January 2021, 20 February, 2022 and finally on 11 June, 2022 – the latter in response to an Argentinian paper on Sputnik.  

‘Doubts about the reliability of data

“The published corrections did not address most of the flagged problems,” Bucci contended. “This is why several criticisms were raised in several scientific journals by researchers from all over the world.”

In May 2021, for instance, Vasiliy Vlassov, vice president of the Society for Evidence-Based Medicine in Moscow, published a piece on the BMJ blog in which he stated that “the quality of the reports and secrecy over trial data raise deep concerns about research integrity.”

Another paper titled, “Controversy surrounding the Sputnik V vaccine,” was published in October 2021 by independent researchers in the journal Respiratory Medicine in which they, too, stated there are “doubts about the reliability of the [Phase III] study and that while “Sputnik V could meet the need to provide equitable access to COVID-19 vaccines for people living in low- and middle-income countries …there are still many concerns regarding the use of this vaccine.”

Still… Sputnik V vaccine should work 

Because The Lancet left the paper online and no action was taken, Bucci ultimately put out yet another assessment, this time in March 2022. In this report, he stressed once again his belief that the vaccine works, but that the data was incorrect. 

From the early days of vaccine roll-outs, the Sputnik vaccine has received considerable uptake in many low- as well as middle and even upper-middle income countries, particularly in Latin America – where it was more widely available and affordable than mRNA options. 

“The Russian Sputnik V vaccine should work much like any others,” Bucci wrote. “I am convinced of this because Sputnik V basically can be seen as a combination of a Chinese adenoviral vaccine and a Johnson & Johnson dose. Such vaccines use disabled adenoviruses (cold viruses) to deliver an inactive fragment of the SARS-CoV2 spike protein into the body, prompting an immune reaction.   

“The [Sputnik] production problems are linked precisely to the fact of combining two different vaccines in one, with what follows for the simplicity of the process and the quality control; but this does not mean that the idea, from a scientific point of view, is not valid, or that once the vials are obtained, they should not be useful.”

Bucci also said he had observed instances of sloppiness in data reporting, which nonetheless made it to press. For instance in the original online version of an article on Sputnik’s rollout in Argentina, published in The Lancet on 15 March, 2022, one chart showed that in the 60-69 age group,  49.7% of vaccine recipients were women and 80.7% were men – obviously impossible. The currently available version online shows the data as 49.7% women and 50.3% men -although it acknowledges that a correction version was posted on 9 June. 

Sputnik’s rollout in Argentina, published in The Lancet

The final results of Sputnik’s Phase III trials have not yet been published by the Russian Direct Investment Fund (RDIF), which developed the vaccine together with the Gamaleya Institute – although their completion was announced by the Russian Health Ministry in September 2021. 

At the time, the Health Ministry explained to the Russian media agency Kommersant that the results would not be published at all, since “the results of clinical trials are a trade secret.”

RDIF: ‘Best vaccine in the world’

This has not stopped RDIF from continually stressing how good the vaccine is. 

The Gamaleya Institute told Health Policy Watch in an email that “the efficacy of the Sputnik V vaccine has been documented  in more than 50 real-world and scientific studies in 10 countries, involving more than 12 million people.” 

It highlighted studies in the United Arab Emirates, Bahrain, San Marino, Argentina, Iran, Belarus and Paraguay. 

 “A computer simulation is not the way to check the quality of clinical trials, as opposed to the multiple independent studies in different countries,” the Gamaleya Institute added in its reply to Health Policy Watch. 

“In international science, computer modeling is not a recognized method to cast doubt over outcomes of clinical trials and real-world studies whose peer reviewed results were published in respected medical journals.” 

In his own interviews, RDIF CEO Kirill Dmitriev has stated boldly that “Sputnik is the best vaccine in the world, we have proven it.” He said any challenges were “bureaucratic obstacles.”

Kirill Dmitriev, CEO of the Russian Direct Investment Fund
Kirill Dmitriev, CEO of the Russian Direct Investment Fund

In November 2021, RDIF also disclosed real world data of the Health Ministry of the Republic of San Marino on the Russian Sputnik V vaccine – which it said demonstrated that Sputnik V was 80% effective against COVID-19 infection up to eight months after receiving the second dose – a much higher percentage of efficacy more months after receipt than Pfizer or Moderna.

“Sputnik team believes that adenoviral vaccines provide for longer efficacy than mRNA vaccines due to longer antibody and T-cell response,” a release by Sputnik stated.

Ultimately, the vaccine received approval for use in 71 countries, RDIF reported, and more than 100 million people outside of Russia have received a Sputnik vaccine.

As of 31 January, “over 400 million Sputnik vaccine doses have been supplied worldwide including Russia to date to fight COVID-19 pandemic,” Sputnik tweeted less than a month before the war. “Over 800,000 doses of 1-shot Sputnik Light, standalone vaccine & universal booster effective against #Omicron & other mutations arrived in Turkmenistan.”

‘Science is based on trust’

Bucci said that the most important point at this stage is to address the potential shortcomings in  proper data checking and editorial controls by The Lancet, as well as its failure to press harder for more detailed data clarifications from the authors of the Sputnik studies when questions arose.  

“Science is based on trust stemming from the possibility of checking and reproducing published results,” he told Health Policy Watch. “When the scientific community is denied access to the data needed to reproduce the findings from a specific research group, we are no longer dealing with science but with unsubstantiated claims.”

In response to queries from Health Policy Watch, The Lancet Group said that it “takes issues relating to scientific misconduct extremely seriously and follows best practice guidelines set by the Committee on Publication Ethics (COPE)”. 

“We acknowledge the questions raised about the validity of Sputnik vaccine data published in The Lancet and we have invited the authors of the Lancet paper to respond to these latest questions,” it added.

Image Credits: RDIF, Sputnikvaccine/Twitter, The Lancet.

Scenes like this at Puerto Rico’s airport, January 2022, are now rare as countries drop COVID measures – but WHO says the pandemic remains a public health emergency says WHO.

With a surge in cases and the rapid rise of new subvariants, the COVID-19 pandemic continues to be a global health emergency posing significant risks to public health, a WHO committee of public health experts has concluded.

The statement by the COVID-19 Emergency Committee, was published Tuesday, four days after experts gathered for their 12th meeting since a COVID-19 global health emergency was first declared on 30 January 2020 under the terms of the WHO International Health Regulations.

“This is in no way over,” WHO’s Director General Dr Tedros Adhanom Ghebreyesus told a media briefing. He and his team pointed to the worldwide surge in cases driven by the Omicron BA.5 subvariant in particular.

“As the virus pushed at us, we must push back — we are in a much better position than at the beginning of the pandemic,” he said. “We have safe and effective tools that prevent infections, hospitalization and deaths. However, we should not take them for granted.” 

COVID Cases increased by 30% in last two weeks

The WHO committee cited the 30% global  increase in COVID cases over the last two weeks and the still-unpredictable evolution of key SARS-COv2 variants driving infections as key to its decision to maintaining the current level of emergency alert.

Dr Michael Ryan

It noted that “both the trajectory of viral evolution and the characteristics of emerging variants of the virus remain uncertain and unpredictable,” according to the statement.

“The resulting selective pressure on the virus increases the probability of new, fitter variants emerging, with different degrees of virulence, transmissibility, and immune escape potential,“ the committee added.

Other concerns, it said, are the “steep reductions in testing, resulting in reduced coverage and quality of surveillance as fewer cases are being detected and reported to WHO, and fewer genomic sequences being submitted to open access platforms.”

The decline in testing, the committee noted, also could “hinder the detection of cases and the monitoring of virus evolution,” citing remarks by Dr Mike Ryan, WHO’s Executive Director of Health Emergencies.

Along with that,  “inequities in access to testing, sequencing, vaccines and therapeutics, including new antivirals; waning of natural and vaccine-derived protection; and the global burden of post COVID-19 condition,” were other factors considered. 

Dr Maria Van Kerkhove

Speaking at the press briefing, Maria Von Kerkhove, WHO’s health emergency technical lead, said the BA.5 subvariant of Omicron is spreading “at a very intense rate at a global level” that far outpaces the other subvariants.

“We are seeing countries become concerned about this, but we feel that countries should be concerned about SARS COV-2 overall,” she said. 

Monkeypox Emergency Committee to reconvene next week

The statement on the continuing COVID emergency comes just ahead of a critical meeting of a WHO Emergency Committee on Monkeypox scheduled for the week of 18 July to determine if that outbreak should also be categorized under the IHR as a Public Health Emergency of International Concern (PHEIC).

As of today, there were some 9,200 Monkeypox cases in 63 countries, Tedros told the briefing.  

That means cases have increased by 50% in the week since WHO issued its last report on 6 July, which confirmed 6,027 cases in 59 countries. 

Those numbers represent cases reported largely outside of the the central and western African areas where the disease is endemic.  Altogether some 1,597 suspected cases were reported in WHO’s Africa Region as of mid-June, but most were unconfirmed due to a lack of testing capacity. 

Criteria for determining a monkeypox global emergency 

Tedros said the Monkeypox emergency committee will convene against next week to look at trends, counter-measures and recommendations on what countries can do. If it decides Monkeypox also constitutes a global health emergency, it would be a rare instance of WHO simulatenously confronting three global health emergencies, including Polio, designated a global health emergency since 2014. 

Key to their deliberations will be an assessment of the evolving situation in light of nine criteria, said Dr Sylvie Briand, who heads WHO’s Global Infectious Hazard Preparedness department. 

Dr Sylvie Briand

Those include questions of “increasing cases, deaths, diseases spreading outside of the initially affected community, changes in the virus and so on,” she said, noting the situation has evolved since the committee last met on June 25. “We see an increasing number of cases, we have also seen new geographies affected. So it’s worth looking at it again and see if we need to reinforce the advice.”

At the same time, Ryan said, it appears that “sexual contact is what is driving the outbreak” of Monkeypox infections in Europe and elsewhere that have occurred in circles of men who have sex with men.

He also cited evidence that transmission can occur as a result of contact with the virus on infected surfaces, particularly in health care settings.

Wild animals hunted for food are an infection risk – not supermarket purchases

Contact with virus-contaminated wild animals, hunted and killed for food, also is an important source of Monkeypox infection in central and western Africa which frequently experiences such  “zoonotic spillover” events. But food-based contamination is not an issue elsewhere, Ryan and others stressed. 

“You are not going to get the virus from food you buy in a supermarket,” Ryan stressed. 

Dr Rosamund Lewis, WHO’s Monkeypox lead, said the virus circulates in rodent populations, but also in primate populations in central Africa. “So there is potential of being exposed in the course of hunting and preparing wild game involving an infected animal,” she said.

Dr Rosamund Lewis

Von Kerkhove added there are many known pathogens that are zoonotic that spill over from animals to humans, and that have epidemic and pandemic potential. Identifying and targeting such risks, she said, requires “improved surveillance in communities and on farms, and improved laboratory capacity.”

WHO recently launched a 10-year strategy for improving the genomic sequencing of pathogens with epidemic and pandemic potential. That included bringing together veterinary and public health teams in countries to figure out what Ryan described as “how can we make these two systems work better together.”

Accelerating access to genomics – first ever WHO report

The statements about the importance of genomic tracking of both COVID and Monkeypox coincided with the release of a first-ever WHO report on “Accelerating Access to Genomics for Global Health” by the new WHO Science Council.

The report, also released Tuesday, calls for less-developed countries to gain better access to genomics technologies, which not only are critical to disease surveillance but also drives much of the groundbreaking research into health treatments today.

The field of genomics uses methods from biochemistry, genetics, and molecular biology to understand and use biological information in DNA and RNA, with benefits for medicine and public health. That has especially proven relevant during the COVID-19 pandemic and with agriculture, biological research and other such uses. 

While the costs of establishing and expanding genomic technologies are declining, making them increasingly feasible for all countries to pursue, those costs can and should be further lowered, the report finds.

Dr Harold Varmus

The report suggests using making genomic technologies more affordable for LMICs through tiered pricing; sharing of intellectual property rights for low-cost versions; and cross-subsidization, which involves using profits in one area to fund another.

“Genomic technologies are driving some of the most groundbreaking research happening today. Yet the benefits of these tools will not be fully realized unless they are deployed worldwide.” said WHO’s Chief Scientist Dr Soumya Swaminathan in a press release on the report.  

Harold Varmos, head of WHO’s Science Council., said the benefits of genomics have been illustrated in the COVID pandemic, namely, in the development of vaccines and tests and the identification of variants that continue to pose serious problems for the world.

“Genomics has been adopted in many poor countries” as costs decline, said Varmos. Nevertheless, he said, “we are concerned that the already widespread use of genomics in advanced countries should not leave low- and middle-income countries behind. WHO and member states can do more to promote the adoption of genomics.” 

Image Credits: Kevin Torres Figueroa/ US Army National Guard/ Flickr.

AMR Pathogens
A USAID-led session in Bangkok trains laboratory workers to identify drug resistant pathogens in food samples.

NAIROBI — With antimicrobial resistance (AMR) on the rise globally, the World Health Organization (WHO) Tuesday issued an urgent call to step up investment and research into vaccine candidates that can tackle the problem of drug-resistant bacteria in a new report that looks at key research gaps and opportunities. 

Antimicrobial resistance, which refers to bacteria, viruses and parasites that are resistant to drug treatment, results from factors such as the overuse and misuse of antibiotics and other antimicrobials in human and animal health.

But along with new drugs, the development of new vaccines can also help counter the problem, experts say.

AMR Pathogens
WHO consultant Isabel Frost

“Vaccines are highly vital tools in fighting AMR,” Isabel Frost, lead author of the analysis, told a virtual press briefing on Monday. “This analysis was needed to understand where opportunities for development were, and where there might be some vaccines available in the near future to fight some pathogens.”

Infections from drug resistant pathogens are the third leading cause of death after cardiovascular diseases. Some 1.27 million deaths were attributable to AMR in 2019, while nearly 5 million deaths were somehow associated with drug-resistant infections, according to a major study published in January  2022 in The Lancet. That is more people than the number of deaths from either HIV or malaria.

The death rate was highest in western Sub-Saharan Africa, where there were 27.3 deaths per 100,000 people. It was lowest in Australia, where there were 6.5 deaths per 100,000 people, according to the Lancet study of January 2022, published by the Global Burden of Disease Collaborative Network, led by the Seattle-based Institute of Health Metrics and Evaluation (IHME).

The World Bank estimates that by 2050, infections associated with AMR will cause 28 million more people to fall into poverty, as a result of catastrophic illness, as well as adding US$1 trillion in healthcare costs.

WHO Press Technical Briefing 11 July 2022

AMR pathogens are a silent pandemic that threaten global public health 

The report is the first to provide a detailed analysis of vaccines in development that have the potential to address drug resistance from priority pathogens. It also draws attention to a need to accelerate trials in AMR vaccines, and makes a case for increased investment that can lead to more global health equity.

For instance, vaccines with varying degrees of efficacy already exist for dealing with four priority pathogens: Streptococcus pneumoniae, Haemophilus influenza type B, Salmonella Typhi, and microbacterium tuberculosis. (In the case of the latter, there are advanced trials underway of new  TB candidate ‘subunit’ vaccines which could also be given in combination with the old BCG vaccine). But their uptake and access vary globally, in yet another example of the enormous inequities found in global public health.

On the other side of the spectrum, there are no vaccine candidates in clinical development against six bacterial infections on WHO’s list of priority list of drug resistant pathogens, including ones that commonly cause severe and chronic gastro-intestinal illness or blood, urinary track and lung infections: C. Jejuni, H. pylori, E. faecium, Enterobacter spp, A. baumanii and P. aerungi.

WHO Press Technical Briefing 11 July 2022

Having identified AMR as a silent pandemic, and in response to this major public health threat, WHO developed a global action plan in 2015 to combat AMR. 

The plan, adopted by the World Health Assembly (WHA) in May 2015, identifies five key strategic areas: 1) increasing awareness, surveillance and monitoring; 2) combating infection through control measures; 3) reducing inappropriate use of antimicrobials; 4) making an economic case for more investment in diagnostics, antimicrobials and new treatments; and 5) the need for vaccines to combat AMR.

WHO priority pathogen list for research and development of new vaccine candidates 

In 2017, WHO developed the first list of bacteria  for which new antibiotics are urgently needed. The intent was to curb AMR and develop an analysis to inform R&D, investment decisions and policy actions globally.

Those considered to be “priority pathogens” are ones that pose the greatest global health threat because of their widespread resistance to common drugs, according to Frost, who also works as a WHO consultant for the Department of Immunization, Vaccines and Biologicals.

“We have identified 61 vaccine candidates in active clinical development against these pathogens,” she told Health Policy Watch, but noted some pathogens in this list are challenging targets for vaccine development.

WHO Press Technical Briefing 11 July 2022

Vaccine equity still hampered by poor distribution, access and uptake in most vulnerable regions

Streptococcus pneumoniae remains the leading cause of death from resistant bacteria; it caused 122,000 deaths in 2019. “These deaths are concentrated in countries that have the lowest levels of access not only to vaccines but to antibiotics and other health services,” Frost said.

“The good news is there are several vaccine candidates in late stage clinical development that have the potential to impact AMR. These include TB, e-coli and gonorrhea,” she added.

But vaccine development is expensive, and failure rates are high, Frost noted, so even getting some of the vaccines into advanced stages of development doesn’t mean all of them will reach the market. Clinical trials also typically need large populations and take years to complete before vaccines reach the licensing and manufacturing stages.

And she laments the fact that there are still no vaccine candidates in clinical development against six key bacterial pathogens on WHO’s list of priority list.: C. Jejuni, H. pylori, E. faecium, Enterobacter spp, A. baumanii and P. aerungi.

Dr. Dr. Mateusz Hasso Agopdowicz, a WHO technical officer, noted many challenges remain to increase coverage of existing vaccines, especially for vulnerable populations in low- and middle-income countries where they are needed most.

“To introduce new vaccines and increase coverage of existing vaccines,” he said, “we need sufficient funding for vaccination campaigns [and to] look for cheaper methods of developing vaccines, alternative ways of vaccine administration, and delivery as well as addressing vaccine hesitancy.”

AMR Pathogens
Dr. Mateusz Hasso Agopdowicz. WHO

Investment in research and development vital to keep priority pathogens in check

More resources are needed to continue R&D for vaccines in clinical development. And for pathogens with new vaccines in late-stage clinical trials, like microbacterium tuberculosis, funds are needed to accelerate these trials so tthey’re finished and the vaccines made available for use.

And last month WHO raised the red flag over the lack of new antibacterial treatments being developed to address the mounting threat of antimicrobial resistance (AMR).

Agopdowicz emphasised the need for further analysis to establish demand trends for vaccines so researchers can determine the number of doses needed when vaccines are ready to be used. “For the next 10 years, we need to use alternative approaches to contain resistant pathogens and use disruptive ways of vaccine manufacturing like mRNA,” he said.

Even with promising vaccine candidates in the pipeline, questions remain around IP rights and trade issues that could hinder global vaccine equity.

“No one benefits unless vaccines are created and then delivered to everyone who needs them,” said Boston University law professor Kevin Outterson, who is executive director at Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (CARB-X). “This is exactly why every CARB-X-supported product is backed by a contractual promise to avoid the issues with access to COVID vaccines.”

Image Credits: Richard Nyberg, USAID.

COVID vaccine shipments to Africa began in February 2021, but subsequent shortfalls laid bare the acute access problems faced in many low-income countries.

Citizens and NGOs welcomed the United Nations Human Rights Council’s adoption of a much-debated draft resolution that calls on nations to ensure everyone has access to medicines and vaccines.

The resolution was adopted by consensus Friday shortly before the close of the HRC’s 50th session, sending what proponents called a “clear message” that access to medicines and diagnostics, including COVID-19 vaccines, tests, and treatments, is a human right.

Opponents such as the European Union, United Kingdom and United States, all home to major pharmaceutical companies, said the World Health Organization should be managing access.

“It is yet another rebuke to the rich countries and pharmaceutical companies that have chosen to uphold monopolies on life-saving medicines despite the human cost, which on one estimate is a preventable COVID-19 death every minute. That is a violation of human rights,” said a joint statement from Amnesty International, Human Rights Watch, Knowledge Ecology International, and the People’s Vaccine Alliance.

The UN Human Rights Council meeting last week in its 50th session.

Though the resolution is non-binding and may have little practical impact, it could influence similar debate at the World Trade Organization over a proposal by India, South Africa and some low- to middle-income countries to relax intellectual property rules for manufacturing COVID treatments and tests. 

At its meeting of trade ministers in June, the WTO approved a resolution on a “limited” waiver of IP rules around COVID vaccine production. The current surfeit of vaccines, however, means the resolution would have little practical impact.

But the WTO is supposed to decide within the next six months whether to extend the waiver to COVID tests and treatments that are costlier or in short supply in many countries.

Those talks have already begun in the WTO’s Council on Trade-related Aspects of Intellectual Property Rights (TRIPS), WTO’s Director General Ngozi Okonjo-Iweala said after an informal meeting with WTO heads of delegations in Geneva on Thursday.   

HRC resolution touches on wide range of topics

The final draft of the Human Rights Council resolution, co-sponsored by Argentina, Brazil, China, Egypt, India, Indonesia and 10 other nations, includes ambitious calls to countries to ensure access to immunization as a “global public good.”

It calls for the “de-linkage” of the costs of new research and development from medicines and vaccines prices to ensure their wider availability, in keeping with the wishes of citizens and NGOs. Countries are asked to promote research, build capacity, and take “all measures necesary to strengthen regional and local production.”\

Developing nations that sought the resolution and rich nations that opposed it engaged in heated, mostly backroom debates over the precedents it could set even from a rhetorical standpoint.

After the United Kingdom said “securing” immunization as a “global public good” is not necessarily up to government, the final text was changed to refer to “access to immunization as a global public good.”

And wealthy countries insisted on adding a caveat to the final text that says all transfers of technology and know-how to developing countries must be “on mutually agreed terms” rather than compulsory.

‘Commitment, where possible, to voluntary licensing’

The 47-nation Human Rights Council’s language linking the promotion of research and innovation to a “commitment, where possible, to voluntary licensing in all agreements in which public funding has been invested in research and development” is significant because of the way COVID vaccines and treatments were marketed under exclusive patents after being financed with public funds.

But language calling for “a strong spirit of international solidarity” was changed to merely “a strong spirit of solidarity,” reportedly at the behest of the EU and the UK, according to an analysis by Knowledge Ecology International (KEI).

“There were deliberate attempts from some states to water down the language of this resolution, and the United Kingdom and the European Union initially pushed back on the principle of international solidarity,” the analysis said. “Yet the final resolution clearly states that health is a human right and that international cooperation must be the world’s guiding principle for this pandemic and any future health crisis.”

The analysis said governments must live up to their human rights obligations in several international human rights treaties, and that means “addressing the disproportionate impact of global health crises on marginalized groups, as well as fostering knowledge and technology transfer, and making full use of flexibilities in global intellectual property rules to adequately respond to and prepare for public health needs.”

Image Credits: Bicanski on Pixnio, GovernmentZA/Flickr, European Union .

COVID-19 vaccine doses
Wasted COVID-19 vaccine doses since beginning of immunization drives

Some 1.1 billion COVID-19 vaccines are likely to have been wasted since the global rollout began,  according to new findings by Airfinity, a global health surveillance firm. 

Airfinity’s analysis, released Monday, assumed a 10% wastage rate from June 2021 when global dose sharing began. This rate is taken from confirmed wastage in the United States and factors in an average shelf life of six months. The team also collated all public reports of vaccine waste and expirations from around the world, totalling some 158 million doses. 

The majority of the reporting on wastage did not specify, however, which vaccine type was discarded. Of those which do name the manufacturer, Russia’s Sputnik V was the most squandered with over 25 million doses that are known to have been unused. This was followed by AstraZeneca’s reported 19 million wasted jabs.

Wastage of COVID-19 vaccine doses under-reported, but within range of Gavi assumptions   

The new estimate means that around 8% of the 1.1 billion doses reportedly disbursed until now have gone unused. Those estimates are within the recommended range of Gavi, the Vaccine Alliance, which assumed the wastage rate for COVID vaccines could be as high as 10%. But the estimates also reflect a certain level of uncertainty toward the underreporting of vaccine wastage in terms of individual reports from nations’ public health systems.    

Airfinity’s Analytics Director Dr Matt Linley said some degree of wastage is inevitable despite countries’ best efforts. 

“Large multi-dose vials can make efficiencies more challenging, as well as cold chain storage and predicting daily demand or simply a vial being dropped or left out too long,” Linley said.

“Vaccines in single-dose vials with a longer shelf life, which can be transported and stored more easily, will reduce wastage over time,” he said. “Pfizer/BioNTech’s most recent agreement with the U.S. includes single doses, a first for COVID-19 vaccines, and a stipulation we expect to be repeated by other nations.”

Airfinity’s CEO Rasmus Bech Hansen said no one wants to waste doses in any amount, but it’s a byproduct of an unprecedented level of vaccine production that has saved millions of lives.

“If we want a fast reacting global vaccine response system, we will have to accept some level of wasted doses,” he said. “But the less the better, and monitoring the wastage levels ongoing is an important piece of global health information.”

Image Credits: Asian Development Bank/Flickr, Airfinity .

COVID vaccination of older people.  The European Medicines Agency is now recommending boosters for people over 60,

With cases of Omicron BA.4 and BA.5 soaring in Europe and around the world, the European Medicines Agency (EMA) recommends everyone 60 and older get a second COVID-19 booster shot.

EMA’s recommendation came shortly before WHO reconvened its COVID Emergency Committee on Friday to reconsider its global recommendations for the pandemic – and if the state of global health emergency first declared on 30 January 2020, should be maintained.  So far WHO recommendations on a second booster, provided by another expert group in May, are limited to immunocompromised people. 

Speaking at a press conference Thursday, EMA’s head of vaccines, Marco Cavaleri said a fourth booster for people over 60 and other vulnerable groups is now warranted due to a regional increase in COVID cases. 

He said projections show the BA.4 and BA.5 sub variants are expected to become dominant across all European countries, likely completely replacing all other variants by the end of July.

COVID-19
Marco Cavaleri, head of vaccines for the European Medicines Agency

“As this new wave is unfolding over the EU, it is essential to maintain protection of vulnerable groups and avoid any postponement of vaccination,” Cavaleri said. “Although there is no evidence of increased infection severity in the BA.4 and BA.5 compared to other sub variants, the increased transmission among older age groups is starting to translate into severe disease.”

Globally, COVID-19 cases have increased by at least 30%, driven by variants BA.4 and BA.5 in Europe and the US, while a new sub-lineage of BA.2.75 is rising in India, WHO Director-General Dr Tedros Adhanom Ghebreyesus told a briefing on Wednesday. 

EMA and other regulators looking toward approval of “bivalent” COVID vaccines by September

While current vaccines offer “good protection” against hospitalization, severe disease and death, EMA and other regulatory agencies around the world are now looking closely at new “bivalent” COVID vaccine formulations, Cavaleri said.

EMA, the US Food and Drug Administration and other national regulatory authorities met last week under the auspices of the International Coalition of Regulatory Authorities (ICMRA) to examine available data on the new vaccines in light of the reduced protection that current vaccines offer against mild and moderate disease.

“Preliminary data from clinical trials indicate that adapted messenger RNA (mRNA) vaccines which incorporate an Omicron variant strain can increase and extend protection, when used as a booster,” Cavaleri said of ICMRA’s conclusions. “Bivalent mRNA vaccines which combine two strains of SARS-CoV-2, one of which is an Omicron strain … appear to offer an even wider immune response.”

But vaccines that include other variants or subvariants might also be considered for use as boosters, if clinical trial data demonstrate an adequate level of neutralization against Omicron and other variants of concern.

Cavaleri said his agency is evaluating initial data that mRNA vaccines manufacturers have submitted for review and is in close contact with manufacturers of vaccines based on different platforms other than mRNA, especially adjuvanted protein vaccines.

“Overall we expect to potentially have several vaccines to include … with an assortment of different platforms and technologies, and this is welcome,” he said.

EMA also is working towards approval of adapted COVID-19 vaccines in September, with an eye towards what Cavaleri described as “plans for an even broader rollout of vaccination campaigns in the autumn.”

Future Course of WHO Public Health Emergency Designation for COVID

WHO hasn’t changed its designation of COVID-19 as a pandemic, and it was not expected to do so at Friday’s COVID Emergency Committee meeting – although as of Sunday afternoon no statement by the Commitee had yet been made, raising questions about what directives might yet be issued.

Irregardless of current trends showing increased transmission in many parts of the world, there is growing acknowledgement that the COVID emergency is evolving into an endemic disease. 

That will likely mean further peaks and valleys, but be far less lethal than the initial waves of 2020. And sooner or later, that will prompt a re-evaluation of the status of COVID as a “Public Health Emergency of International Concern” (PHEIC), requiring countries to undertake special measures under the terms of International Health Regulations.  

At a press conference on Thursday, Dr Mike Ryan, WHO’s head of health emergencies, described it as more of “a series of national epidemics” and stressed the real work needed to take place “at the national level.”

In line with those trends, WHO and Gavi, the Vaccine Alliance acknowledged plans this week to “transition” the work of the Act Accelerator initiative for distributing COVID vaccines, tests and treatments into the work of key ACT-A partners and national health systems.  

Under the auspices of ACT-A, COVAX, the global vaccine facility has distributed hundreds of millions of doses of COVID vaccines to 92 low-income countries since March 2021 with the support of Gavi, UNICEF and WHO. Tthe vaccine facility was hampered early in the pandemic by severe vaccine supply shortages and later by widespread public uptake of vaccines as they became more available.

-Updated 10 July 2022

Image Credits: Flickr: IMF/ Raphael Alves.

Bats, captured from the Kitaka mine in Uganda were discovered to be the source of a Marburg virus outbreak in July 2007 in Uganda, where two infections were reported among miners.

Ghana has reported two suspected cases of the rare and deadly Marburg virus disease – the first to ever be recorded within its borders. Marburg is a highly infectious viral haemorrhagic fever in the same family as the more well-known Ebola virus disease, said WHO’s Ghana Country Office in making the announcement. It has a fatality rate of up to 88%. 

Preliminary analysis of samples taken from two patients by the country’s Noguchi Memorial Institute for Medical Research indicated the cases were positive for Marburg. The samples have been sent to the Institut Pasteur in Senegal, a World Health Organization (WHO) Collaborating Centre, for confirmation. The two patients from the southern Ashanti region – both  unrelated – showed symptoms including diarrhoea, fever, nausea and vomiting. They died after having been taken to a district hospital in Ashanti region. 

Preparations for a possible outbreak response are being set up swiftly as further investigations are underway, WHO said.

“The health authorities are on the ground investigating the situation and preparing for a possible outbreak response. We are working closely with the country to ramp up detection, track contacts, be ready to control the spread of the virus,” said Dr Francis Kasolo, World Health Organization (WHO) Representative in Ghana.

WHO is deploying experts to support Ghana’s health authorities by bolstering disease surveillance, testing, tracing contacts, preparing to treat patients and working with communities to alert and educate them about the risks and dangers of the disease and to collaborate with the emergency response teams.

Marburg
Geographic distribution of Marburg haemorrhagic fever outbreaks and fruit bats of Pteropodidae Family.

Ghana cases outside of endemic zone

The outbreak in Ghana is a source of concern not only because the virus is particularly deadly, but also because it has occurred outside of the central and southern African zone where most  cases have been previously reported. Previous outbreaks and sporadic cases of Marburg in Africa have been reported in Angola, the Democratic Republic of the Congo, Kenya, South Africa and Uganda, according to WHO.

Marburg has been detected in just one other West African country, Guinea.  The country confirmed a single case in an outbreak that was declared over on 16 September 2021, five weeks after that case was detected.

The deadly virus was first identified in 1967 after two outbreaks of cases simultaneously in Marburg and Frankfurt Germany and in Belgrade, Serbia – thus the naming of the disease. The outbreak was later raved to laboratory work with African green monkeys (Cercopithecus aethiops) that had been imported from Uganda.

Marburg is transmitted to people from fruit bats and following that, it can spread person-to-person through direct contact with the bodily fluids of infected people, surfaces and materials. Illness begins abruptly, with high fever, severe headache and malaise, said WHO. Many patients develop severe haemorrhagic signs within seven days. Case fatality rates have varied from 24% to 88% in past outbreaks depending on virus strain and case management.

Although there are no vaccines or antiviral treatments approved to treat the virus, supportive care – rehydration with oral or intravenous fluids – and treatment of specific symptoms, improves survival. A range of potential treatments, including blood products, immune therapies and drug therapies, are being evaluated.

Image Credits: Chris Black/WHO, World Health Organization .

Akinwumi Adesina, president of the African Development Bank, visits the ‘Mother and Child’ Hospital of Bingerville, Côte d’Ivoire, in 2020

The African Development Bank is establishing a foundation with the aim of spending at least $3 billion over the next decade to boost Africa’s access to technologies needed to make medicines, vaccines, and other pharmaceutical products.

The bank’s board approved the establishment of the African Pharmaceutical Technology Foundation with an eye to towards creating what the bank described in a statement on June 27 as “a new groundbreaking institution” for Africa’s 1.3 billion citizens.

AfDB President Akinwumi Adesina said Africa “must have a health defense system” that revamps its pharmaceutical industry while also building up its capacity to make vaccines and provide quality healthcare.

“Africa can no longer outsource the healthcare security of its 1.3 billion citizens to the benevolence of others,” said Adesina, a Nigerian economist.

AU priority to improve healthcare sector

African Union Headquarters, Addis Ababa 

The need for a foundation featured prominently at the African Union summit in February at Addis Ababa, where leaders called on AfDB to help Africa’s health care sector become more independent in light of the challenges it has faced from several devastating diseases and the COVID-19 pandemic.

WHO’s Dr Tedros Adhanom Ghebreyesus

The foundation’s creation signals a major shift in efforts to address inadequacies in the sector, including limited capacity to produce its own medicines and vaccines in part due to the intellectual property barrier.

Dr Tedros Adhanom Ghebreyesus, Director-General of the World Health Organization (WHO), said it “is a game changer on accelerating the access of African pharmaceutical companies to IP-protected technologies and know-how in Africa.”

Medicines and vaccines gap

The pandemic exposed Africa’s lack of capacity to manufacture and supply essential drugs and personal protective equipment (PPEs) needed to control the coronavirus.

Soon after the pandemic began in early 2020, many of the world’s top scientists scrambled to find a vaccine but government and business leaders paid less attention to how it would be made and delivered to low- and middle-income countries.

More focus was put on rapidly increasing supply to meet the surging demand, in a process largely driven by wealthier nations with greater purchasing power. In Africa, as in most other developing nations, citizens’ health care became dependent on the generosity of others.

Nigerian pharmacist Ezinne Victoria Chinemerem Onwuekwe, who works as a public health fellow for the Africa Centres for Disease Control and Prevention, said the main problem is that Africa’s pharmaceutical industry lacks manufacturing capacity.

“There are a few production companies here and there, and for it to be able to produce for these citizens, it will require the effort of public and private sector to bring together both the technical [and] financial support needed to push this forward,” she said.

The shortage of medicines and other pharmaceutical products has been a challenge to effective delivering quality healthcare services in Africa.

Pharmaceuticals are made in South Africa, Kenya, Morocco and Egypt, yet Africa spends US$16 billion to import 94% of its pharmaceutical and medicinal needs, according to the United Nations Economic Commission for Africa (UNECA).

As of 2019, the continent had roughly 375 pharmaceutical manufacturers, compared to about 5,000 and 10,500, respectively, in China and India.

And a 2019 study found many life-saving drugs are still inaccessible and unaffordable in low- and middle-income countries.

Game changer for medicines

Akinwumi Adesina, African Development Bank president, at the initiative launch,

The new foundation, which will raise its own funds and operate independently of AfDB, will be hosted in Rwanda and deal with IP rights and health policy.

One of its chief responsibilities will be mediating interests between Africa’s pharmaceutical sector and global companies with the aim of sharing IP-protected technologies, know-how and patented processes, according to documents on its establishment.

It also is being asked to prioritize technologies, products and processes aimed primarily at diseases widely prevalent in Africa, or those that involve current and future pandemics.

And it is expected to help build up the ranks of health care professionals and others who conduct research and development while upgrading manufacturing plant capacities and regulatory quality to meet WHO standards.

Challenges in the healthcare sector

Ezinne Onwuekwe

Small fragmented markets and weak regulatory frameworks, inadequate human resource capacity, poor procurement and supply chain systems, and policy incoherencies in countries’ trade, industry, health, and finance departments are some of the impediments to the growth of Africa’s pharmaceutical sector.

The continent is also burdened with fake and falsified medical drugs. In 2017, WHO revealed an estimated 116,000 additional deaths a year from malaria could be tied to substandard and falsified antimalarials.

To counter that, the foundation is being asked to help local pharmaceutical companies boost home-grown production with better technology in their manufacturing plants and to work with governments, research and development centers to improve their innovation capacities.

Onwuekwe said part of the problem is a lack of political will in some countries.

“This is about finding African solutions to African problems. That is the new public heath order,” Onwuekwe told Health Policy Watch. “The leadership of the countries have to invest financially and politically for there to be any progress in the sector.”

But the foundation, she said, also must become adept at negotiating with global pharmaceutical companies and must be “able to foster collaborations” with WHO, the African Union and other international organizations.

Image Credits: AfDB Group, IAEA.

With a 77% increase in new monkeypox cases in the past week, the World Health Organization’s (WHO) Emergency Committee is increasingly likely to declare the outbreak a public health emergency of international concern (PHEIC) when it reconvenes on or before 18 July.

By Thursday, 59 countries had reported monkeypox cases, with Spain (1804 cases), UK (1351), Germany (1304) and the US (605) recording the highest caseloads.

However, 10 countries have not reported new cases for over 21 days, which is the maximum duration of the incubation period of the disease, according to the WHO’s latest report.

So far, there have been 6027 laboratory-confirmed cases of monkeypox and three deaths, but most countries are unable to test for the virus.

However, the European Centre for Disease Prevention and Control (ECDC) reported on Wednesday that 5949 cases had been identified in 33 European countries alone through international health regulation mechanisms and public records.

The vast majority of cases (99%) were male and aged between 31 and 40 (42%). 

“The majority of cases presented with a rash (96.1%) and systemic symptoms such as fever, fatigue, muscle pain, vomiting, diarrhoea, chills, sore throat or headache (69%). No cases were reported to have died. Some (15) cases were reported to be health workers. However, further investigation is ongoing to determine whether infection was due to occupational exposure,” according to the ECDC.

Monkeypox cases, 6 July 2022 (Source: https://www.monkeypoxtally.info/)

Lack of testing 

Expressing his concern about the scale and spread, WHO Director-General Dr Tedros Adhanom Ghebreyesus acknowledged that “testing remains a challenge and it’s highly probable that there are a significant number of cases not being picked up”.

While most of the new cases have been identified in Europe and the US, Africa – where monkeypox was first identified in 1970 – has not recorded a huge jump in cases, and experts believe this could be due to a lack of proper testing. 

“I plan to reconvene the emergency committee so they are updated on the current epidemiology and evolution of the outbreak and implementation of countermeasures. I will bring them together during the week of 18 July or sooner if needed,” Tedros told the media briefing on Wednesday.

The emergency committee decided not to declare monkeypox a PHEIC when it met in late June.

Tedros also said that the WHO is working with countries and vaccine manufacturers to coordinate the sharing of “scarce” vaccines .

Tedros added that the WHO is also working closely with civil society and LGBTQI+ community in particular to “break the stigma around the virus and spread information so people can protect themselves”, and commended those sharing their stories on social media to inform others.

Child cases

According to the WHO’s latest report, the outbreak “continues to primarily affect men who have sex with men who have reported recent sex with one or multiple male partners, suggesting no signal of sustained transmission beyond these networks for now.”

However, WHO monkeypox expert Dr Rosamund Lewis confirmed that there were cases reported in children, about one-third of whom were under the age of 10.

“For older children aged 18 or 19, the mode of transmission may still be an open question, but for younger children, one would assume that that would be from exposure in the household setting,” said Lewis.

By Wednesday, 119 people had been diagnosed with monkeypox in New York City and city officials confirmed that the limited supplies of vaccines were usually snapped up in minutes by the group it was being offered to: men who have sex with men who had multiple sex partners, as well as close contacts of confirmed cases.

 

 

Image Credits: https://www.monkeypoxtally.info/.

In Pakistan, a healthcare worker listens to a child’s lungs for signs of pulmonary tuberculosis.

After year-long consultations, the Stop TB Partnership launched its global plan to end tuberculosis by 2030, which would involve the diagnosis and treatment of 50 million people at a cost of $250 billion.

TB, the second biggest infectious disease killer in the world after COVID-19, has been neglected by donors in the past – yet if the plan’s budget was realised, every $1 invested would yield an economic return of at least $40.

“If, instead, the status quo is maintained, TB is expected to continue to kill between 4,000-5,000 people every day, an additional 43 million people will develop TB and the cost in human life and disability would translate to a global economic loss of US$ 1 trillion,” according to Stop TB.

“The COVID-19 pandemic delivered a crystal-clear wake-up call: that we cannot ignore a disease just because it has been relegated only to the poorest parts of the world,” said Dr. Paula Fujiwara, who led the task force in charge of the development of theplan. 

“With our attention diverted—along with the absence of financial commitments—TB has strengthened its grip on our planet. But we can regain control and meet our commitments to end TB by 2030 as long as we assert our political will now.”

Tepid global response

Dr Lucica Ditiu, Executive Director of the Stop TB Partnership, said that while the global response to COVID-19 was to “plough money and resources into developing diagnosis tools, treatments and vaccines at lightning speed”, the response to TB, which infects 10 million people every year and kills 1.5 million,  “has been tepid at best”. 

“A similar airborne infectious disease, TB remains neglected, even though it is a health threat for every single person. It is in the interest of all of us to end TB,” added Ditiu.

However, she added that she was optimistic that the war against tuberculosis could be won by 2030. 

“A lot of optimism comes from what we have seen happening during COVID—it is possible to mobilize the resources –it is possible that researchers will work together, and share data to be able to develop new tools in such a short amount of time and it is possible to deploy and to organize amazing efforts at the grassroots level.”

The Global Plan highlights the need to invest in developing a new TB vaccine by 2025, and making sure that resources are available to reach adults and adolescents in countries where TB is most prevalent. 

The only TB vaccine currently available is the BCG vaccine, which was approved more than a century ago and has a very limited impact on disease prevention.

Dr Lucica Ditiu, Executive Director of Stop TB Partnership

“The proposed investment of $ 10 billion in new TB vaccines, a new tool we all are waiting for, is 10 times less than what was injected in the research and development for COVID-19 vaccines. It should be possible to have the TB vaccine,” said Ditiu.

Previous reports from the Stop TB Partnership noted that COVID-19 had cost the world 12 years of progress against TB. 

“Currently, almost 30% of funding per TB case comes from out-of-pocket costs and on average individuals with TB and their households lose 50% of their annual incomes as they suffer from and get treatment for the disease, even in places where TB services are provided free of charge,” according to Paul Mahanna, USAID’s Director of the Office of Infectious Diseases, 

“We cannot drive change without addressing the significant funding gaps that exist within high TB burden countries that result in lack of access to life-saving services and drive individuals, families and communities further into poverty.

Image Credits: Stop TB Partnership.