Tag: 4/2/22

Categories : COVID VaccinesTags :

South African Biotech Company Replicates Moderna Vaccine

On By ModernMedia
Photo by Mat Napo on Unsplash

Afrigen Biologics and Vaccines, a South African biotechnology company, has nearly created a copy of Moderna’s COVID mRNA vaccine, without Moderna’s involvement, Nature reports.

The Cape Town-based company has so far made only microlitres of the vaccine, based on Moderna’s publicly available development data. This nevertheless is a success for a major initiative launched by the World Health Organization (WHO): a technology transfer hub meant to build vaccine manufacturing capacity in low- and middle-income countries.

During the COVID pandemic, the developers of mRNA vaccines, Moderna and Pfizer/BioNTech have sent more than 70% of their doses to wealthy nations. Meanwhile, millions of vaccine orders for southern hemisphere countries have been delayed. “Moderna and Pfizer-BioNTech’s vaccines are mainly still going to just the richest countries,” says Martin Friede, the WHO official coordinating the hub. “Our objective is to empower other countries to make their own.”

Much work needs to be done before Afrigen’s mRNA vaccine mimic can be distributed. But the WHO hopes that the process of creating it will lay the foundation for a more globally distributed mRNA vaccine industry in the future.

Gerhardt Boukes, chief scientist at Afrigen is proud to have helped complete this first step of the plan. Afrigen and its collaborators completed the process, beginning with mRNA encoding a modified portion of the SARS-CoV-2 coronavirus, and finishing by encapsulating it in a lipid nanoparticle that delivers the vaccine to cells. “We didn’t have help from the major COVID vaccine producers,” he says, “so we did it ourselves to show the world that it can be done, and be done here, on the African continent.”

When the mRNA hub was launched by the WHO in June 2021, Moderna, Pfizer and BioNTech did not respond to requests to help make their vaccines, so the WHO proceeded without their help. The Moderna vaccine was chosen to copy because there is more freely available data on it, and it has not vowed to enforce its patents.

The project started in late September, with a Wits University team spearheading the first step: making a DNA molecule that would serve as a template to synthesise the mRNA needed in the vaccine. While Moderna controversially patented this sequence, Stanford University researchers had deposited it into the online database Virological.org in March last year.

Patrick Arbuthnot, director of gene therapy research at Wits says, “We were not intimidated, because mRNA synthesis is a fairly generic procedure.” Despite delays in the shipment of raw materials, the team completed this process in ten weeks and sent vials of mRNA to Afrigen in early December.

Around this time, scientists worldwide emailed offers of assistance. Some were researchers at the US National Institutes of Health who had conducted foundational work on mRNA vaccines. Petro Terblanche, Afrigen’s managing director, said that it was “extraordinary”. “I think a lot of scientists were disillusioned with what had happened with vaccine distribution, and they wanted to help get the world out of this dilemma.”

On 5 January, Afrigen’s researchers accomplished another tricky part of the process: They encapsulated the mRNA in a fatty nanoparticle made of a mixture of lipids. Boukes says they haven’t yet used Moderna’s specific lipid mixture, but rather another one that was immediately available from the manufacturer of the machine that the laboratory uses to create lipid nanoparticles. They plan to use Moderna’s lipid mixture in the coming days, as soon as one last analytical instrument arrives. After that, the team will analyse the formulation to ensure that it is truly a near copy of Moderna’s vaccine.

Once a reliable copy is made, the next step is increasing production. Jason McLellan, a structural biologist at the University of Texas at Austin whose work was foundational to the development of several COVID vaccines, says he is not surprised that SA scientists seem to have copied Moderna’s vaccine, but he adds that scaling up production of that original shot required a lot of additional innovation by manufacturers.

For the next phase of the project, several southern hemisphere companies will learn from Afrigen and attempt to create batches of vaccines themselves, in preparation for animal testing. By end November, the WHO expects a Moderna clone to be ready for phase I trials in humans.

What happens beyond that is unclear. Moderna might choose to license its patent (lab research is usually not subject to patent rules), or alternatives may become available, such as next-generation mRNA vaccines that do not require ultracold storage.

Source: Nature

Categories : Obstetrics & GynaecologyTags :

Women in Labour Have Faster Gastric Emptying with an Epidural

On By ModernMedia
Photo by Jonathan Borba on Unsplash

A study published in Anesthesiology finds gastric emptying is substantially slower during labour – but somewhat faster in women who receive an epidural for anaesthesia.

There is an ongoing debate as to whether it’s safe for women to eat solid food during labour. Physician anaesthesiologists prefer that labouring women have an empty stomach because of the lower risk for aspiration of food in case general anaesthesia for a caesarean section becomes necessary.

“These results suggest anaesthesiologists should remain cautious about permitting solid food during labour, especially when epidural analgesia is not used,” according to the report by Lionel Bouvet, MD, PhD, and colleagues of Hospices Civils de Lyon, France. 

Researchers assessed gastric emptying rates in four groups of women: 10 who were non-pregnant, 10 who were pregnant at full term (around 39 weeks) but not in labour, 10 in labour without an epidural, and 10 in labour who received an epidural for labour pain. On an empty stomach, each woman ate a light meal of yoghurt. Ultrasound scans were then used to compare the rate of stomach emptying among the four groups.

Stomach emptying was delayed for women in labour without epidural, in line with previous studies. The rate of stomach emptying from 15 to 90 minutes after eating was 52% in non-pregnant women and 45% in pregnant women at full term, compared to 31% for labouring women who received an epidural and 7% for women in labour without an epidural.

With epidural analgesia, gastric emptying occurred much faster during labour than during labour without epidural analgesia. After 90 minutes, the stomach was empty in 3 out of 10 labouring women who received an epidural, compared to 0 of 10 women in labour who had not received an epidural. By 2 hours, the stomach was empty in 6 of the women who received an epidural, compared to just 1 woman without an epidural.

Although clinical practice varies, current guidelines of the ASA and Society for Obstetric Anesthesia and Perinatology (SOAP) state that “Solid foods should be avoided in laboring patients,” reflecting a concern over the risk of aspiration in case anesthesia and surgery are needed. This new study is one of the first to systematically compare the extent of gastric emptying delay during late pregnancy and childbirth and with versus without epidural labor analgesia.

The results confirm a “statistically and clinically significant” longer time to an empty stomach among women in labour. However for those receiving epidural analgesia, stomach emptying appears to occur faster. Based on their findings, Dr Bouvet and co-authors suggest that a light solid meal “could probably be allowed” for women in labour who are receiving epidural analgesia and considered at a low risk of caesarean section within at least the next two hours.

“The report by Dr Bouvet and colleagues enables us to rethink our current practice of fasting during childbirth,” commented Anesthesiology editor Yandong Jiang, MD., PhD. “It is desirable that women giving birth with an epidural do not have the additional stress of hunger, but instead be allowed to eat a light meal.”

This contrasts with the ASA/SOAP recommendation that women in labour should consume only clear liquids to prevent aspiration, noted Mark Zakowski, MD, FASA, chair of ASA’s Committee on Obstetric Anesthesia. “This study clearly shows that stomach emptying is quite a bit slower for women in labor, and that if they eat even a light meal of about 4 ounces [about 120g] of yogurt, many will still have food in their stomach a few hours later,” Dr Zakowski said. “Since the need for emergency caesarean may arise at any time, the current ASA/SOAP guideline of clear liquids only during labour seems justified.”

Source: American Society of Anesthesiologists

Categories : Obstetrics & GynaecologyTags :

Early Menopause and Oral Contraceptive Link

On By ModernMedia
Photo by Reproductive Health Supplies Coalition on Unsplash

Long-term use of oral contraceptives, as well as certain methods of tubal ligation (TL), were linked to lower levels of antimüllerian hormone, a biomarker for ovarian aging, suggesting an increased risk for early menopause, according to preliminary research.

Using data from the Nurses’ Health Study II, researchers at the UMass Amherst School of Public Health and Health Sciences examined the association of oral contraceptive use and tubal ligation with antimüllerian hormone (AMH).

Published in the journal Menopause, the results were “intriguing,” according to lead author Christine Langton, PhD candidate.

“We’re one of the larger studies to have looked at both of these contraceptive methods at the same time,” says Langton, now a post-doctoral researcher at the National Institute of Environmental Health Sciences. “We feel we’re contributing to the story, and to the literature, though nothing we did was definitive. This is a piece of the puzzle.”

Early menopause, which occurs before 45, puts women at greater risk for a range of health conditions including cardiovascular disease, osteoporosis and dementia. The researchers noted that oral contraceptives change hormone levels and prevent ovulation; tubal ligation may affect blood supply to the ovaries, and certain methods of the procedure may damage the ovary and surrounding neural tissue. 

“Recently, AMH has become an established marker for the timing of menopause and was found to be strongly associated with the risk of early menopause,” the authors wrote. “Yet, the association of reproductive and lifestyle factors with AMH levels remains unclear.”

The team focused on a subset of 1420 premenopausal women in the Nurses’ Health Study prospective cohort who had provided a blood sample between 1996 and 1999. A history of their oral contraceptive use and tubal ligation began in 1989 and was updated every two years until their blood was collected.

“Women who reported that their [tubal ligation] procedure included the use of a clip, ring or band had significantly lower AMH levels compared to women who never had a TL procedure,” the researchers wrote.

One limitation is the small number of women reporting the type of tubal ligation, Langton added.

When it came to oral contraceptives, “we saw a significant inverse association – the longer the use of oral contraceptives, the lower the AMH levels were,” Langton said. “That particular finding was a little surprising to us because it didn’t completely align with what we saw when we looked at oral contraceptives and early menopause in the larger cohort” of more than 115,000 women.

Even after adjusting for factors including BMI, smoking, alcohol, number of pregnancies and breastfeeding, the inverse association between oral contraceptive use and AMH levels remained significant.

“We think further research is warranted,” Langton said.

Source: University of Massachusetts

Categories : Mental HealthTags :

Higher Oxytocin Levels in Men with Hypersexual Disorder

On By ModernMedia
Photo by cottonbro from Pexels

Men with hypersexual disorder may have higher levels of oxytocin in their blood compared to men without the disorder, as reported in a small study published in the Journal of Clinical Endocrinology & Metabolism. In some study participants, cognitive behavioural therapy was effective in lowering oxytocin levels.

Hypersexual disorder involves excessive, persistent sexual behaviours related to various mood states, with an impulsivity component and experienced loss of control.

Oxytocin is produced by the hypothalamus and secreted by the pituitary gland. It is a hormone with a key role in sexual behaviour, and abnormal levels of it may contribute to hypersexual disorder.

“We discovered that men with compulsive sexual behavior disorder (CSBD) had higher oxytocin levels compared with healthy men,” said Andreas Chatzittofis, MD, PhD. “Cognitive behavioural therapy led to a reduction in both hypersexual behaviour and oxytocin levels.”

The researchers analysed the blood samples of 64 men with hypersexual disorder and 38 healthy men. The hypersexual men had significantly higher levels of oxytocin in their blood (mean ± SD: 31.0 ± 9.9 pM) compared with healthy volunteers (16.9 ± 3.9 pM; P < 0.001). Thirty men with hypersexual disorder underwent a cognitive behavioural therapy programme and saw a significant reduction in their oxytocin levels after treatment.

“Oxytocin plays an important role in sex addiction and may be a potential drug target for future pharmacological treatment,” Dr Chatzittofis said.

Source: Endocrine Society

Categories : General InterestTags :

Record Numbers of ‘Healthcare Hero’ Entries for Doctors’ Day

On By ModernMedia

“She brings humanity, humility, understanding and – dare I say it – love into her practice.”

Stories of appreciation, like this one, are just the medicine South Africa’s doctors need, over 670 days into the COVID pandemic. Since March 2020, the country’s healthcare workers have been manning the frontline of this global healthcare crisis, regularly putting themselves at risk of exposure in order to help their patients. And now, many patients are giving back.

“This is why we say thank you” is the theme on the Doctors’ Day website. This dedicated website is part of an initiative called Doctors’ Day, created by EthiQal, a division of Constantia Insurance Company Limited. The initiative was launched in 2018 and is celebrated annually on 16 November. This national day is intended to raise awareness about the value that so many of the country’s doctors bring to the lives of their patients and families – and the website is the platform where stories of gratitude can be read.

“This is the fifth year that we’ve run Doctors’ Day and every year the number of stories we receive grows substantially. We’ve far surpassed the responses from last year, as more and more patients take the time to share their healthcare hero stories,” says Alex Brownlee, EthiQal Executive.

Stories of appreciation
Every year, EthiQal calls on the nation to celebrate and recognise South Africa’s doctors. Heading into the third year of the COVID pandemic, the healthcare industry deserves to be recognised more than ever for the critical role they continue to play in meeting the needs of our nation, explains Brownlee.

Of the hundreds of entries from the 2021 Doctors’ Day competition, five of the most moving stories have been selected and are featured on the website, with each winning entrant receiving R1000. EthiQal also donated R10 000 to the Healthcare Workers Care Network – a nationwide healthcare worker support network. The winning entries can be read at www.doctorsday.co.za

“Our firm belief is that doctors are national assets, and so the core of the Doctors’ Day message truly resonates with everyone who works at EthiQal. We love Doctors’ Day because it gives people an opportunity to share their sincere messages of thanks. It’s just one small way that patients can give back to their doctors. We look forward to all the new entries and heart-warming stories that we’ll receive in November,” says Brownlee.