Sinovac, China and Partner Numolux, South Africa Launching Paediatric Covid-19 Vaccine Trial (The Pedcoronavac Study) at Sefako Makgatho Health Sciences University
Numolux Group (Pty) Ltd of Pretoria is the authorized representative in South Africa of SINOVAC Life Sciences Co., Ltd., a subsidiary of the SINOVAC Biotech Ltd. (“SINOVAC”) of Beijing, China. SINOVAC and Numolux announced that they are ready with its partners to launch a Phase III pediatric COVID-19 vaccine study on 10 September with the first child to be vaccinated at the MeCRU Clinical Research Unit, based at the Sefako Makgatho Health Sciences University (SMU), South Africa.
The study is a Multi-center, Randomized, Double-blind, Placebo-controlled Phase Ⅲ Clinical Trial to Evaluate the Efficacy, Immunogenicity and Safety of SINOVAC Inactivated COVID-19 Vaccine (CoronaVac®) in children and adolescents aged 6 months to 17 years. The primary objective of the study is to evaluate the efficacy of two doses of CoronaVac® against confirmed symptomatic COVID-19 cases in children and adolescents aged 6 months to 17 years. Efficacy will also be evaluated against hospitalization and severe COVID-19 cases.
The study worldwide will enroll 14 000 children and adolescents in various pediatric age group cohorts across 5 countries (South Africa, Chile, Philippines, Malaysia and Kenya). Numolux has partnered with 7 clinical research sites across South Africa to enroll 2000 participants from 6 months to 17 years.
Participants in the trial will receive 2 doses of CoronaVac® or placebo 28 days apart. Efficacy assessments to include the surveillance for COVID-19 like symptoms and the laboratory confirmation of SARS-CoV-2 infection by RT-PCR. Any confirmed COVID-19 case will be followed by the investigators until resolution. Whole viral genome sequencing to detect mutations or variants of concern among all the confirmed COVID-19 cases during the trial will be done. Interim analysis will be done when 47 COVID-19 cases have been reported. Safety will be evaluated in terms of solicited local and systemic adverse events during 7 days following vaccination and of unsolicited adverse events during 28 days post-vaccination. Occurrence and relationship of serious adverse events will be monitored from first dose to 12 months after the last dose. Humoral immune response across a subset of all pediatric age group cohorts will be evaluated and cell mediated immune response in a subset of vaccinated participants in Chile will be investigated.
In South Africa, the trial has received South African Health Products Regulatory Authority (SAHPRA), Pharma Ethics and SMUREC approval and is listed on the South African Clinical Trial Registry (Identification number DOH-27-082021-6331).
This study has public health importance globally because a vaccine that prevents COVID-19 disease and transmission in pediatrics would be a crucial tool to assist in curbing the pandemic. Although children and adolescents have a milder form of the disease than adults, they remain susceptible to infection and severe manifestations across all ages.
SINOVAC is committed to the research and development of a safe and effective vaccine that protects people of all ages and comorbidities against COVID-19.
About Sinovac COVID19 Vaccine: CoronaVac®
CoronaVac® is an inactivated SARS-COV-2 vaccine manufactured by SINOVAC Life Sciences Co., Ltd., a subsidiary of the SINOVAC Biotech Ltd., a leading provider of biopharmaceutical products in China.
CoronaVac® received validation from the western science establishment in May 2020 when Science Journal published results of the pre-clinical studies, and in Nov 2020 Lancet published the Phase I/II study results of CoronaVac® in adults followed by a paper in Lancet in July 2021 of the Phase Ⅲ study in conducted in Turkey showing high efficacy (83.5%) against symptomatic PCR confirmed cases with good safety and tolerability, a real-world study from Chile published in the NEJM 02 Sep. 2021 showing 65.9% efficacy of the vaccine in preventing COVID-19 infection in adults and 87.5% in preventing hospitalizations, 90.3% (95% CI, 89.1 to 91.4) for the prevention of ICU admission, and 86.3% (95% CI, 84.5 to 87.9) for the prevention of Covid-19–related death. The Phase I/II study in children has been conducted in China and the results have been published in the Lancet, 28 June 2021.
CoronaVac® is currently approved for emergency use or marketing use with condition in adults in nearly 50 countries worldwide, as well as WHO, and approved for emergency use in children in China on 28 May 2021. CoronaVac® also received EUA/Section 21 approval from SAHPRA on 01 July 2021.
About the Numolux Group (Pty) Ltd
The Numolux group, based in Pretoria, South Africa have been providing advanced and sustainable health solutions to both the public and private sector, locally and internationally, since 2017. Numolux, together with its alliance partners, identifies latent needs with solutions for Hospital Infrastructure, Health Mobile Units, Adaptive Diagnostic Devices, Military Medical Equipment, Rapid Tests, Pharma Products and Vaccines. The CEO of the Numolux Group, Mr Hilton Klein, made the following statement and I quote “The children of Africa are the future of Africa and something must be done to protect the future of Africa against the deadliest pandemic the world has ever seen. Numolux Group has joined Sinovac in the fight against this deadly monster to ensure that the children of Africa have access to a safe and effective children’s vaccine to protect them against COVID-19. Numolux has declared war against this deadly virus and we will do everything in our power to ensure we protect the future of the African children.”
Partners of Numolux Group of companies include Ardent Consulting, providing scientific and technical expertise, and Numolux-Curanto Pharma assisting with regulatory applications. Numolux is the authorized representative of Sinovac Life Sciences in South Africa.
MEDIA
The official launch of the trial , and vaccination of the first participant will take place on: Date: Friday, 10 September 2021
Time: 9am – 11am; MEDIA BRIEFING at 11h30
Venue: MeCRU Research Unit at the Sefako Makgatho Health Sciences University. Tshwane Gauteng
Any media interested in attending the event, please inform us:
Via email: eric.pule@smu.ac.za
For any media enquiries please contact Dr Eric Pule, email address eric.pule@smu.ac.za, Phone 012 521 4563 Cell: 0763723964
END.
Prof Demana appointed Vice President of SAAPI
Professor Patrick Demana appointed as the Vice President of the South African Association for Pharmacists in Industry in 2021.
SAAPI is an association of pharmacists and other professionals who practice in the pharmaceutical industry.
The Sefako Makgatho Health Sciences University hosted a successful 50th International Association of Dental Research Conference
The Sefako Makgatho Health Sciences University hosted the 50th International Association of Dental Research Conference (IADR) from 12 -13 November 2020 at the Fire and Ice Protea Hotel, near Menlyn, in Pretoria.
IADR is a professional body of oral health practitioners with over 10 000 members worldwide. The IADR’s mission is to drive dental, oral, and craniofacial research to advance health and well-being worldwide. Its vision is to provide access to oral health services for the world through discovery and dissemination.
A number of prominent speakers attended and addressed the conference including Deputy Minister of Higher Education Science and Innovation Mr Buti Manamela, Vice Chancellor of the University of Johannesburg Prof Tshilidzi Marwala, Professor Ayo-Yusuf and others.
Go to the 10th Edition 2020 of SMU Newsletter
The Sefako Makgatho Health Sciences University Department of General Surgery first in the country to use a HAST Technique on a patient
Media Statement
01 October 2020
For Immediate Release
The SMU department of general surgery is proud to be the first in South Africa to make use of the Hot Axios Stent Technique (HAST) to relieve a patient suffering from jaundice, due to an obstruction of bile duct. Although this technique has been in use for several years overseas, it was used for the first time to relieve bile duct obstruction in both the private and public sectors, in South Africa by SMU specialists.
The leading light in this pioneering work is Dr Christopher Ziady, a veteran gastro- enterelogist who examined a patient at the Dr George Mukhari Academic Hospital (DGMAH) presenting with a large Pancreatic Cancer, which could not be operated on.
The 58-year-old patient had deep Jaundice, itchy skin, loss of appetite, pain and had lost weight. Having examined this patient, Dr Ziady reckoned that the most appropriate treatment for such a patient was to afford him relief from these debilitating symptoms, to enable him to have appetite and to improve on his nutrition.
The normal treatment for such a condition was to place a stent into the bile obstruction to relieve jaundice, by means of an Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure, which he had attempted previously to the patient. “This resulted in failure because the tumour had spread into the wall of the small intestine and destroyed the opening of the bile duct”, said Dr Ziady.
“We then sought an alternative to this failed treatment. An endoscopic ultrasound examination that was conducted on the patient confirmed the HAST was an appropriate alternative treatment”, Ziady continued.
A suitable size Stent was selected and was placed by means of Endoscopic Ultrasound (EUS) Scope and the entire procedure took only 5 minutes. In most instances, other methods of Stent placement took up to one and half hour.
Not only is the technique efficient and safe, it also cuts down on recovery time spend in the hospital as the patient heals quicker than surgical technique. The patient can also be treated as an outpatient.
The successful general surgery department at SMU is headed by internationally acclaimed surgeon Professor Zach Koto.
Issued by the Marketing & Communication
For more details, please contact Dr Eric Pule, email address eric.pule@smu.ac.za
Phone 012 521 4563 Cell: 0635035587
Website: www.smu.ac.za
Download: Media-Statement-SMU-general-surgery-department-the-first-to-use-HAST-on-patient-final
Sefako Makgatho Health Sciences University tackled issues associated with Obesity
Media Advisory
28 February 2020
Members of the media are hereby invited to cover and be part of the celebration of World Obesity Day to be hosted by the Sefako Makgatho Health Sciences University which will take place on Wednesday 4 March 2020.
The university’s participation in this international event marks its contribution towards the realisation of the UN’s Sustainable Development (SDG) Goal 3 – which seeks to bring about healthy lives and promote well-being for all.
Dr George Mukhari Academic Hospital (DGMAH)/SMU bariatric Surgery Unit has recently been accredited to perform metabolic and bariatric surgeries, making it the first public hospital in Gauteng to do this.
The performance of bariatric and metabolic surgeries represents an important advance in health care delivery in SA because it gives access to those who are poor but also in need of this life changing surgery.
“By hosting an event of this nature, we have a responsibility as a health sciences institution to take the lead in raising awareness and educating communities around obesity, its contribution to lifestyle diseases, how it affects quality of life and to deal with the stigma related to it”, says Dr Eric Pule, Director Marketing and Communication.
There will be free health assessment services on the day such as Body Mass Index (BMI), blood pressure and sugar tests. These tests will help identify those that are at risk of contracting obesity related illnesses and will also identify what should be done about the diagnoses.
Members of the media will also have an opportunity to interview those that were once obese and whose lives were seriously transformed for the better, by undergoing bariatric Surgery. The Unit is headed by Prof Zack Koto – a world renowned weight loss expert who will also interact with the media for more information around obesity.
Details are as follows:
Date 04 March 2020
Venue: Sefako Makgatho Health Sciences University Library lawn (Garankuwa)
Time: 10h00 am
Please RSVP by 03 March 2020 by forwarding your names to Phaladi.Seakgwe@smu.ac.za/ seakgwe@gmail.com/eric.pule@smu.ac.za
Ends
Issued by the Marketing and Communication Department.
For more details and enquiries please contact Dr Eric Pule: Director, Marketing and Communication email: eric.pule@smu.ac.za Cell 0635035587 phone 012 521 4563
Website: www.smu.ac.za
Download: Media-Advisory-world-obesity-day-SMU-28-Feb-2020
The first Bariatric Surgery (or weight loss surgery) Unit of Sefako Makgatho Health Sciences University (SMU) has been recently established at Dr. George Mukhari Academic Hospital (DGMAH). This collaboration between the Gauteng Department of Health and SMU Department of Surgery represents an important advance in bringing this type of surgery within reach of the poor. The surgery also represents the multidisciplinary approach to the management of a patient with morbid obesity where surgeons, physicians, anesthetists, psychologists and other disciplines all contribute to the initial screening, workup and ongoing management and surgery of these patients.
The Bariatric surgery workshop held at SMU provided a real-time information for the numerous attendees including professors, specialists and doctors from both the public and private sectors as well as students. Unit head Professor Zach Koto said, “The surgery includes a variety of procedures performed on people who have morbid obesity. The weight loss is achieved by reducing the size of the stomach making it the size of an egg and re-routing the small intestine to a small stomach pouch. Patients are still advised to eat healthy afterwards because the surgery does the 50% and healthy eating does the rest”.
Prof Koto said the other type of bariatric procedure is reducing the size of the stomach by two-thirds (70%) in a procedure called sleeve gastrectomy. “This works by two mechanisms, Firstly, it reduces the size of the stomach so that the patient eats less. Secondly, it reduces the hunger hormones where the patient does not feel hungry”, he emphasised.
Obesity is a significant public health problem in South Africa with serious potential metabolic complications. “One out of three patients in South Africa is obese and this leads to diseases such as high blood pressure, diabetes, high cholesterol and arthritis, hence it is important for a patient to go through a proper screening process before they can be considered for bariatric surgery which is a complete life style change for the patients. What is intriguing is that bariatric surgery is able to permanently cure diabetes, hypertension, sleep apnea and other obesity related comorbid conditions” added Prof Koto.
SMU through the department of surgery is spearheading the registration and accreditation of a qualification in Bariatric and minimal access surgery in South Africa. Koto said the service would help the government to save money as it could cure diabetes and ensure that there were no more premature deaths. He further said that the procedure had to be looked at, and be made available to the public throughout the country.
Prof Dhaneshwar Bhagwandass, Clinical Head in the Department of Anaesthesiology at SMU and DGMAH, welcomed the opportunity for the team involved in this venture to grow professionally as individuals and as members of a team. “Bringing such initiatives to the public sector, and succeeding, proves that collaborative efforts from clinicians can improve the lives of all South Africans,”emphasised Prof Bhagwandass.
After the presentations at the workshop, the audience was shown live Roux Y gastric bypass procedure on eight patients. This was done using the state-of-the-art 3D laparoscopic camera system in the high-tech room in the department of surgery at SMU. It was transmitted a distance from theatre at DGMAH to the Clinical Pathology Building (SMU). All the patients did well and were discharged two days later.
At this workshop, they also showcased the 4k (ultra-high definition) camera system. This interactive live surgery symposium is a significant education tool which is a growing intervention for learning and professional development. Attendees came from all over the country and some surgeons came all the way from
Namibia. Members of the SMU Surgical Students Society were also in attendance