Month: June 2021

High Risk for Upper GI Bleeding Developed During Hospital Stay

Photo by Anna Shvets from Pexels

Patients who developed upper gastrointestinal (GI) bleeding during a hospital stay experienced worse adverse outcomes than those admitted for upper GI bleeding alone, according to a new study from France.

Currently hospitalised patients (inpatients) with upper GI bleeding showed a significantly higher mortality rate at 6 weeks than patients hospitalised for GI bleeding alone (outpatients), at 21.7% versus 8.8%, respectively, as well as increased frequency of rebleeding .

Upper GI bleeding is a common problem that occurs in 80 to 150 out of 100 000 people annually, with mortality rates between 2 and 15%. The condition is described as blood loss from a gastrointestinal source above the ligament of Treitz. 

Though upper GI bleeding in patients has fallen over the past decades, rates of rebleeding and mortality remained stable or risen slightly. The authors said that modifiable risk factors need to be identified to help reduce this.

Researchers investigated the outcomes among inpatients and outpatients with upper GI bleeding, collecting data on 2498 patients with upper GI bleeding from 46 hospitals. Inpatients were defined as patients who developed variceal or non-variceal bleeding at least 24 hours after hospitalisation, and outpatients (75% of participants) were defined as presenting with bleeding upon admission.

Primary outcomes included mortality and rebleeding rates, assessed at 6 weeks from onset. Hospital stay duration, and the requirement for radiological or surgical intervention were secondary outcomes.

Outpatients were younger (average age 67), more likely to be smokers and consumed more alcohol than inpatients. Inpatients had a significantly higher rate of comorbidities (39% vs 27%, respectively), and more inpatients had a Charlson score above 3 than outpatients (38.9% vs 26.6%). There was no difference in sex or body weight.

Outpatients had a shorter hospital stay of 9 days compared to 16 for inpatients. The  authors noted that the groups did not differ in needing radiological or surgical intervention.

More inpatients were taking aspirin, steroids, and heparin, while more outpatients were taking oral anticoagulants and NSAIDs. At bleeding onset, more inpatients were on proton pump inhibitors (PPIs) than outpatients (41.6% vs 27.5%). However, more outpatients received intravenous PPIs than inpatients (87% vs 79%).

“Despite the more prevalent use of PPI among inpatients, their [upper gastrointestinal bleeding] was mainly related to peptic ulcer disease (PUD) and [esophagitis],” the authors explained. “This may be explained by the higher intake of aspirin and steroids, known to increase PUD-related haemorrhage risks especially in the elderly and hospitalized patients.”

For all patients, risk factors associated with 6-week mortality were rebleeding, Charlson score > 3, haemodynamic instability, pre-Rockall score > 5 and being an inpatient.

Independent  mortality risk factors for inpatients were prothrombin < 50% and rebleeding, though bleeding-related mortality was lower among inpatients compared to outpatients (10.8% vs 20.6%).

“We found that mortality in outpatients was more likely to be directly related to [upper gastrointestinal bleeding] as opposed to inpatients where death resulted more commonly from other causes,” the authors stated.

When looking at patient groups separately, cirrhosis and antiplatelets were independent outcome predictors among outpatients, in addition to rebleeding, comorbidities, haemodynamic instability and severity of bleeding.

Difficulty in comparability of results to previous studies is a limitation to this study due to the 6-week mortality timeline versus the 28-day one for previous studies. The reason for inpatient hospitalisation also was not recorded, which could impact the results.

Source: MedPage Today

Journal information: El Hajj W, et al “Prognosis of variceal and non-variceal upper gastrointestinal bleeding in already hospitalised patients: Results from a French prospective cohort” United European Gastroenterol J 2021; DOI: 10.1002/ueg2.12096.

Novel Approach Targets Pancreatic Cancers Which Depend on Mutant KRAS Gene

KRAS Protein Structure. RAS is a family of related proteins that is expressed in all animals. KRAS is one of three RAS genes found in humans. RAS genes are mutated in approximately one-third of all human cancers. Photo by National Cancer Institute on Unsplash

Researchers have identified a novel drug that effectively thwarts pancreatic tumours that are addicted to the cancer-causing mutant KRAS gene.

Because early detection of pancreatic cancer is difficult, it has a low survival rate, accounting for just over 3% of all new cancer cases in the US, but leading to nearly 8% of all cancer deaths, according to the National Cancer Institute.

The KRAS gene was recognised more that 25 years ago as the component of Kirsten sarcoma virus responsible for oncogenesis. Since then, mutations of KRAS have been described in a large proportion of solid tumors ranging from more than 90% of pancreatic carcinomas to 20% to 30% of pulmonary adenocarcinomas.

Through a pre-clinical study, Said Sebti, PhD, associate director for basic research at VCU Massey Cancer Center, identified a novel drug that effectively thwarts pancreatic tumors that are addicted to the cancer-causing mutant KRAS gene. 

“We discovered a link between hyperactivation of the CDK protein and mutant KRAS addiction, and we exploited this link preclinically to counter mutant KRAS-driven pancreatic cancer, warranting clinical investigation in patients afflicted with this deadly disease,“ said Dr Sebti, who is also the Lacy Family Chair in Cancer Research at Massey and a professor of pharmacology and toxicology at the VCU School of Medicine. “Our findings are highly significant as they revealed a new avenue to combat an aggressive form of pancreatic cancer with very poor prognosis due mainly to its resistance to conventional therapies.”

In 90 percent of pancreatic cancers, KRAS is mutated. Prior studies have shown that some tumours harbouring mutant KRAS are in fact addicted to the mutant gene, meaning they cannot survive or grow without it. Sebti set out to discover if there is a drug that can specifically kill those tumours with a mutant KRAS addiction.

Searching for a suitable drug

Dr Sebti and colleagues used a three-pronged approach to tackle this question.

First of all, they mapped the blueprint of pancreatic cancer cells through global phosphoproteomics, showing them how the addicted and non-addicted tumours differ at the phosphoprotein level. They found two proteins, CDK1 and CDK2, which signalled which cells were addicted to mutant KRAS.

Additionally, they analysed a comprehensive database from the Broad Institute of MIT and Harvard which contains genome-wide CRISPR gRNA screening datasets. They discovered that CDK1 and CDK2 as well as CDK7 and CDK9 proteins were associated with mutant KRAS-addicted tumors.

Finally, they evaluated 294 FDA drugs to selectively kill mutant KRAS-addicted cancer cells over non-KRAS-addicted cancer cells in the lab. They determined the most effective drug in preclinical experiments was AT7519, an inhibitor of CDK1, CDK2, CDK7 and CDK9.

“Using three entirely different approaches, the same conclusion presented itself clearly to us: pancreatic cancer patients whose tumors are addicted to mutant KRAS could benefit greatly from treatment with the CDK inhibitor AT7519,” Dr Sebti said.

To further validate these findings in fresh tumours taken from pancreatic cancer patients the researchers found that AT7519 suppressed the growth of xenograft cells from five mutant KRAS pancreatic cancer patients who relapsed on chemotherapy and/or radiation therapies.

Though AT7519 had previously been tested unsuccessfully in a number of clinical trials, none of the trials were for pancreatic cancer.

“If our findings are correct and translate in humans, then we should be able to see a positive response in pancreatic cancer patients whose tumors are addicted to mutant KRAS,” Dr Sebti said.

As well as pancreatic cancer, the study authors believe these findings may also have clinical implications for colorectal and non-small cell lung cancer patients with prevalent KRAS mutations.

Source: Virginia Commonwealth University

Journal information: Kazi, A., et al. (2021) Global Phosphoproteomics Reveal CDK Suppression as a Vulnerability to KRas Addiction in Pancreatic Cancer. Clinical Cancer Research. doi.org/10.1158/1078-0432.CCR-20-4781.

Call for More Neuroscience Research in Africa

Photo by MART PRODUCTION from Pexels

A team of neuroscientists are calling for greater support of neuroscience research in Africa based on an analysis of the continent’s past two decades of research outputs.  

The findings reveal important information about the nature of funding and international collaboration comparing activity in the continent to other countries, mainly the US, UK and areas of Europe. It is hoped that the study will provide useful data to help further develop science in Africa.  

The greatest human genetic diversity is found in Africa, and Eurasian genomes have less variation than African ones; in fact, Eurasian genomes can be considered a subset of African ones. This carries important implications for understanding human diseases, including neurological disorders.

Co-lead senior author Tom Baden, Professor of Neuroscience in the School of Life Sciences and the Sussex Neuroscience research group at the University of Sussex said: “One beautiful thing about science is that there is no such thing as a truly local problem. But that also means that there should be no such thing as a local solution – research and scientific communication by their very nature must be a global endeavour.  

“And yet, currently the vast majority of research across most disciplines is carried out by a relatively small number of countries, located mostly in the global north. This is a huge waste of human potential.”  

The team, made up of experts from the University of Sussex, the Francis Crick Institute and institutions from across Africa, analysed the entirety of Africa’s outputs in neuroscience over two decades. A lot of early neuroscience research took place in Egypt, it was pointed out.

Lead author Mahmoud Bukar Maina, a Research Fellow in the School of Life Sciences and the Sussex Neuroscience research group at the University of Sussex and visiting scientist at Yobe State University, Nigeria, explained: “Even though early progress in neuroscience began in Egypt, Africa’s research in this area has not kept pace with developments in the field around the world. There are a number of reasons behind this and, for the first time, our work has provided a clear picture of why – covering both strengths and weaknesses of neuroscience research in Africa and comparing this to other continents.  

“We hope it will provide useful data to guide governments, funders and other stakeholders in helping to shape science in Africa, and combat the ‘brain drain’ from the region.”  

Co-lead senior author Lucia Prieto-Godino, a Group Leader at the Francis Crick Institute, said: “One of the reasons why this work is so important, is that the first step to solve any problem is understanding it. Here we analyse key features and the evolution of neuroscience publications across all 54 African countries, and put them in a global context. This highlights strengths and weaknesses, and informs which aspects will be key in the future to support the growth and global integration of neuroscience research in the continent.” 

The study identifies the African countries with the greatest research outputs, revealing that most research funding originates from external sources such as the USA and UK.  

The researchers argue that a sustainable African neuroscience research environment needs local funding, suggesting that greater government backing is needed as well as support from the philanthropic sector.  
Professor Baden added: “One pervasive problem highlighted in our research was the marked absence of domestic funding. In most African countries, international funding far predominates. This is doubly problematic.  

“Firstly, it takes away the crucial funding stability that African researchers would need to meaningfully embark on large-scale and long-term research projects, and secondly, it means that the international, non-African funders essentially end up deciding what research is performed across the continent. Such a system would generate profound outrage across places like Europe – how then can it be acceptable for Africa?”

A number of the researchers involved in the study are members of TReND Africa, a charity supporting scientific capacity building in Africa.  

Source: University of Sussex

Journal information: M. B. Maina et al, Two decades of neuroscience publication trends in Africa, Nature Communications (2021). DOI: 10.1038/s41467-021-23784-8 , www.nature.com/articles/s41467-021-23784-8

CNN Anchor Christiane Amanpour Reveals Her Ovarian Cancer Diagnosis

Photo by Obi Onyeador on Unsplash

CNN anchor Christiane Amanpour told viewers on Monday that she has been diagnosed with ovarian cancer.

The 63 year-old international news veteran told viewers she had had “major successful surgery to remove it” and will now undergo several months of chemotherapy, adding that she was “very confident”.

Amanpour, who works in CNN’s London studio, said she feels “fortunate to have health insurance through work and incredible doctors who are treating me in a country underpinned by, of course, the brilliant NHS,” referencing the UK’s National Health Service.

After four weeks off, she said in Monday’s announcement, “I’m telling you this in the interest of transparency but in truth really mostly as a shoutout to early diagnosis.” Pointing out “millions of women around the world”, she added that she wanted to “urge women to educate themselves on this disease; to get all the regular screenings and scans that you can; to always listen to your bodies; and of course to ensure that your legitimate medical concerns are not dismissed or diminished.”

Amanpour has decades of experience reporting around the world, covering a wide range of conflicts and crises.

Ovarian cancer is the leading cause of death in women diagnosed with gynaecological cancers. It is also the fifth most frequent cause of death in women, in general. The symptoms, such as bloated, swollen or painful stomach, are easily mistaken for less serious health problems, making diagnosis difficult. Most cases are only diagnosed at an advanced stage, leading to poor outcomes. Existing screening tests unfortunately have a low predictive value.

Standard care treatment includes surgery and platinum-based chemotherapy; however, anti-angiogenic bevacizumab and Poly(ADP-ribose) polymerase (PARP) inhibitors are gaining ground in the treatment of this disease.

Source: BBC News

New Imaging Technique Picks up Earliest Stages of Neurological Disorders

A new imaging technique has the potential to detect neurological disorders such as Alzheimer’s disease at their earliest stages. 

The imaging methodology, called super-resolution, combines position emission tomography (PET) with an external motion tracking device to create highly detailed images of the brain. PET scanning, which is mostly used for oncology, where the activity of radioactive tracers introduced into the body is measured. Higher activity corresponds to greater uptake of that particular tracer.

In normal brain PET imaging, image quality is often limited by unwanted movements of the patient during scanning. In this study, researchers utilised super-resolution to make use of the normally unwanted head motion of subjects to enhance the resolution in brain PET.

Moving phantom and non-human primate experiments were performed on a PET scanner in conjunction with an external motion tracking device that continuously measured head movement with extremely high precision. Static reference PET acquisitions with no induced movement were also performed. After combining data from the imaging devices, researchers obtained PET images with higher resolution than the standard static reference scans.

Yanis Chemli, MSc, PhD candidate, Gordon Center for Medical Imaging, said: “This work shows that one can obtain PET images with a resolution that outperforms the scanner’s resolution by making use, counterintuitively perhaps, of usually undesired patient motion. Our technique not only compensates for the negative effects of head motion on PET image quality, but it also leverages the increased sampling information associated with imaging of moving targets to enhance the effective PET resolution.”

Though this super-resolution technique has only been tested in preclinical studies, researchers are preparing to try it with human subjects. Looking to the future, Chemli noted the important impact that super-resolution may have on brain disorders, specifically Alzheimer’s disease. “Alzheimer’s disease is characterized by the presence of tangles composed of tau protein. These tangles start accumulating very early on in Alzheimer’s disease–sometimes decades before symptoms–in very small regions of the brain. The better we can image these small structures in the brain, the earlier we may be able to diagnose and, perhaps in the future, treat Alzheimer’s disease,” he noted.

Source: Society of Nuclear Medicine and Molecular Imaging

Tougher Restrictions for Gauteng Being Debated

Image by Quicknews

As COVID cases continue to rise virtually unabated by the move to Level 2 lockdown, there are reportedly discussions at the National Coronavirus Command Council to tighten the lockdown restrictions.

The Gauteng government wants the province to have tighter lockdown restrictions, as it is host to about half of daily new infections of COVID in the country. Despite the high infection rate in the province, many in Gauteng are against tougher restrictions, such as the Gauteng Education Department and South African Council of Churches. Acting Health Minister Mmamoloko Kubayi-Ngubane says that she will speak to the National Coronavirus Command Council about the issue.

The province’s premier David Makhura said the province is asking for increased measures. “Level 2 as we know it currently is not having a sufficient impact,” he said. “People are going on as if we are really not in the middle of a raging pandemic.”

With Charlotte Maxeke Academic Hospital being indefinitely closed, the pressure is mounting on both public and private facilities which running out of ICU beds.

“So, we talk to the private hospitals almost on a daily basis, and they do indicate to us that they are running almost at about 80% of their capacity for ICU. In the public hospitals, we are also running at about 70%,” said Thabo Masebe, communications head of the Gauteng government.

He confirmed that the province was looking for tougher restrictions to curb new infections.

“That’s what the premier had said. He will be raising that with national government to see what added restrictions could be made to help slow down the rate of infections in the province,” Masebe said.

Source: ENCA

Vitamin D Deficiency Linked to Opioid Abuse

The human body needs adequate sunshine exposure to synthesise vitamin D, otherwise it must be supplied by supplements. Photo by Anders Jildén on Unsplash

Vitamin D deficiency enhances the craving for and effects of opioids, potentially worsening addiction risk, according to a new study.

These findings by researchers at Massachusetts General Hospital (MGH), published in Science Advances, suggest that the opioid crisis could partly be addressed by treating the common problem of vitamin D deficiency with inexpensive supplements.

In 2007, David E. Fisher, MD, PhD, director of the Mass General Cancer Center’s Melanoma Program and director of MGH’s Cutaneous Biology Research Center (CBRC) and his team found something unexpected: UVB ray exposure causes the skin to produce endorphin, which is chemically related to morphine, heroin and other opioids, which all activate the same receptors in the brain. Further research found that UV exposure raises endorphin levels in mice, which then display behaviour consistent with opioid addiction.

Endorphin induces a sense of mild euphoria. Research has suggested that some people develop urges to sunbathe and visit tanning salons that mirror the behaviours of opioid addicts. Dr Fisher and colleagues speculated that people may seek out UVB for the endorphin rush. But that suggests a major contradiction. “Why would we evolve to be behaviourally drawn towards the most common carcinogen that exists?” asked Dr Fisher.

Dr Fisher believes that the only explanation for why humans and other animals seek out the sun is that UV radiation exposure is necessary for production of vitamin D. One of vitamin D’s functions is promoting the uptake of calcium, essential for building bone. As humans migrated north during prehistoric times, they must have developed some kind of compulsion to venture outside of caves and on dark days, otherwise the vitamin D level would have debilitated them, especially the children.

This theory led Fisher and colleagues to hypothesise that sun seeking is driven by counteracting vitamin D deficiency for survival, and that vitamin D deficiency might also make the body more sensitive to the effects of opioids, potentially contributing to addiction. “Our goal in this study was to understand the relationship between vitamin D signaling in the body and UV-seeking and opioid-seeking behaviors,” says lead author Lajos V. Kemény, MD, PhD, a postdoctoral research fellow in Dermatology at MGH.

The researchers addressed the question from dual perspectives. One study arm compared normal laboratory mice with mice that were deficient in vitamin D (either through special breeding or by removing vitamin D from their diets). “We found that modulating vitamin D levels changes multiple addictive behaviours to both UV and opioids,” said Kemény. Importantly, when the mice were conditioned with modest doses of morphine, the vitamin D deficient mice continued seeking out the drug, more than the normal mice. Mice with low vitamin D levels were far more likely to develop morphine withdrawal symptoms.

The study also found that morphine relieved pain more effectively in mice with vitamin D deficiency – an exaggerated opioid response in these mice, and possibly concerning if it’s also true in humans, said Dr Fisher. For example, a surgery patient receiving morphine for pain control after the operation, and if they are deficient in vitamin D, the euphoric effects of morphine could be exaggerated, said Dr Fisher, “and that person is more likely to become addicted.”

This data suggesting vitamin D deficiency increases addictive behaviour was bolstered by analyses of human health records. One showed that, compared to those with normal levels, patients with modestly low vitamin D levels were 50 per cent more likely to use opioids, while patients who had severe vitamin D deficiency were 90 percent more likely. Another analysis found that patients with opioid use disorder (OUD) were more likely to be deficient in vitamin D.

Back in the lab, one of the study’s other critical findings could have significant implications, said Dr Fisher. “When we corrected vitamin D levels in the deficient mice, their opioid responses reversed and returned to normal,” he says. In humans, vitamin D deficiency is widespread, but is safely and easily treated with low-cost dietary supplements, notes Fisher. While more research is needed, he believes that treating vitamin D deficiency may be a new way to reduce the risk for OUD and bolster existing treatments for the disorder. “Our results suggest that we may have an opportunity in the public health arena to influence the opioid epidemic,” says Fisher.

Source: EurekAlert!

Innovative 3D Printing Makes Stronger and More Flexible Implants

Photo by Tom Claes on Unsplash

A new 3D printing process developed by University of Nottingham researchers, allows customised production of artificial body parts and other medical devices with built-in functionality offering shape and durability, while also cutting bacterial infection risk.

“Most mass-produced medical devices fail to completely meet the unique and complex needs of their users,” explained lead researcher Dr Yinfeng He, Centre for Additive Manufacturing. “Similarly, single-material 3D printing methods have design limitations that cannot produce a bespoke device with multiple biological or mechanical functions.”

“But for the first time, using a computer-aided, multi-material 3D-print technique, we demonstrate it is possible to combine complex functions within one customised healthcare device to enhance patient wellbeing.”

The team’s hope is that their new design process can be applied to 3D-print any highly customised medical device.

For example, the method could be adapted to create a single-part prosthetic limb or joint with greater comfort and functionality; or printing customised pills containing multiple drugs – known as polypills – optimised to release their contents in a planned sequence.

What it can do

For this study, the researchers applied a computer algorithm to design and manufacture 3D-printed objects made up of two polymer materials with differing stiffness that also prevent bacterial biofilm build-up. Combining these two materials, they produced an implant with the required strength and flexibility.

Artificial finger joint replacements currently use both silicone and metal parts, offering the wearer a standardised level of dexterity but must be rigid enough to implant into bone. The team 3D-printed a finger joint as a demonstration, which offered these dual requirements in one device, while also being able to customise its size and strength to meet individual patient requirements. They can even make use of intrinsically bacteria-resistant and bio-functional multi-materials, combating infection without extra antibiotics.

A new high-resolution characterisation technique (3D orbitSIMS) was used to 3D-map the chemistry of the print structures and to test the bonding between them throughout the part. This showed that the two materials were intermingling at their interfaces; a sign of good bonding and therefore a stronger device.

The study was carried out by the Centre for Additive Manufacturing (CfAM) and funded by the Engineering and Physical Sciences Research Council. The complete findings are published in Advanced Science, in a paper entitled: ‘Exploiting generative design for 3D printing of bacterial biofilm resistant composite devices’.

Prior to making the technique commercialised, the researchers plan to try out more advanced materials with extra functionalities such as controlling immune responses and promoting stem cell attachment.

Source: University of Nottingham

Journal reference: He, Y., et al. (2021) Exploiting Generative Design for 3D Printing of Bacterial Biofilm Resistant Composite Devices. Advanced Science. doi.org/10.1002/advs.202100249.

Drop in Heart Attacks Linked to COVID Pandemic

Photo by camilo jimenez on Unsplash

A sharp drop in heart attacks in Finland last year seems to be a result of the COVID pandemic, doctors believe.

Cardiologist Mika Laine noticed a roughly 30 per cent reduction in the number of patients suffering myocardial infarction at Helsinki University Central Hospital in April and May 2020. But what was even more surprising was that this was not an isolated occurrence.

“When we started to study this further, we noticed that exactly the same phenomenon happened everywhere else in Finland and also in other countries in Europe and in the United States. So it was a kind of global phenomenon that happened during the COVID pandemic,” he told Euronews.

What was behind the drop?

Dr Laine is of the opinion that the fall in heart attack patient numbers results from changes made in response to the COVID outbreak.

“We have the exact same genes that we had a year ago, two years ago. So it has to be something in the environment that has changed,” he said. One major factor could be the massive global shift to remote working for many people, as a result of the lockdowns.

“People are at home, they are less stressed because they don’t need to go through morning traffic, hurry to work and so forth,” Dr Laine added.

EU Science Hub data shows that even before the pandemic, Finns worked remotely more than almost any other EU country. Last May, EU labour research body Eurofound revealed that Finnish workers made the fastest switch to teleworking in the EU, with nearly 60 per cent switching over.

“We also see this decrease in those people who are retired, who don’t go to work, so it cannot be just because you’re commuting,” said Dr Laine.
He however cautioned that there could be other factors behind the fall in heart attack patients.

Was there a real fall in heart attacks in 2020?

“We know that many people stopped smoking because smoking was associated with severe COVID mortality,” he said.

Better air quality in urban areas as a result of the lockdown could be another cause, Laine said, since airborne particles are known to be a risk factor for heart disease.

However not all are convinced that the pandemic had a positive impact on patients with all types of heart conditions.

Research published in the Journal of the American College of Cardiology in January found that, during the early phase of the pandemic, deaths due to ischaemic heart disease and hypertensive diseases increased in some parts of the US. Some patients may have died as a result of avoiding hospital visits due to infection fears, the researchers noted. 

A temporary or permanent effect?

With Finland, however,Dr Laine believes that was not the case.

“We haven’t seen any increase in mortality in cardiac diseases and so currently we think that it’s a true decrease in the number of cases and not because patients are not seeking help,” he said. “People were not dying at home to myocardial infarction”.

According to Dr Laine, the number of heart attack patients in Finland remains about 5 per cent lower than average, despite the easing of COVID restrictions.

“I think this is a typical example that environmental factors can have profound effects on myocardial infarction. And I think it’s motivating us to change our lifestyle healthier,” Dr Laine said.

Source: EuroNews

Millions of J&J Vaccines for South Africa Unfit for Use

In yet another blow to South Africa’s flagging vaccination programme, millions of the Johnson & Johnson vaccine doses meant to be used have been declared unfit for use. This is due to contamination concerns at one of the group’s facilities in the US.

The US Food and Drug Administration said that the doses were not suitable for use. Upon reviewing this decision, the South African Health Products Regulatory Authority (SAHPRA) said in a statement that it had decided “not to release vaccine produced using the drug substance batches that were not suitable”.

J&J’s Emergent plant was ordered to pause production in April several weeks after it was determined that batches of a substance used to produce the vaccine were cross-contaminated with ingredients from another jab made by Anglo-Swedish pharma giant AstraZeneca. The FDA is yet to allow the factory to reopen.

Acknowledging the setback in South Africa’s vaccination programme, acting Health Minister Mmamoloko Kubayi-Ngubane said Saturday that the batches concerned were stored in a high-security laboratory in Port Elizabeth belonging to drugmaker Aspen. Aspen meanwhile promised that it is ramping up production elsewhere to meet the shortfall, and President Ramaphosa said that he discussed with President Biden the possibility of receiving US vaccine donations.

Along with other countries South Africa, is pushing for a patent waiver on COVID vaccines to allow low cost production of generics.

“If we are to save lives and end the pandemic, we need to expand and diversify manufacturing and get medical products to treat, combat and prevent the pandemic to as many people as quickly as possible,” President Cyril Ramaphosa told the G7 group of wealthy nations meeting in Britain on Sunday. The country needs 31 million doses of the J&J vaccine to help vaccinate its population of 59 million.

South Africa has secured 30 million doses of the highly effective Pfizer-BioNTech vaccine, but is a two-dose vaccine which has significant cold chain requirements.

Emergency shipment

SAHPRA stated that there is a new delivery of approximately 300 000 J&J doses “that have been cleared by the US FDA that meet the requirements and will subsequently be released and shipped to South Africa.” The expiry date of these doses have been extended, and will be ready for administration to South African teachers within days.

Vaccinations were already paused in April after reports of rare cases of blood clots. And in February, South Africa rejected over 1.5 million doses of AstraZeneca’s vaccine as it was deemed ineffective. The J&J vaccines were already facing expiry as they had been removed from long term storage.

South Africa has only vaccinated just over 1% of its population but as far as can be ascertained with limited testing in Africa is the hardest hit by COVID on the continent, with over 1.7 million recorded cases.
Source: Eyewitness News