by Kegorapetse | Sep 23, 2021 | Accolades and Achievements, All News, statements
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.
by Kegorapetse | Aug 17, 2021 | Media Statements, statements
Media Statement
Date: 21 July 2021
For Immediate Release
The Sefako Makgatho Health Sciences University will host Open Days virtually from 22 to 23 July 2021 due to the unusual challenges of Covid-19. Prospective students are encouraged to follow the Open Days broadcasts by logging in to the university website www.smu.ac.za and also download the SMU prospectus to see all available qualifications offered by the University.
SMU boasts top academics and researchers who are rated by the National Research Foundation and respected in their various fields of expertise. These dedicated men and women go out of their way to help the students through their journey as they develop to be full professionals that are expected to make a meaningful contribution in addressing the health challenges and needs of the country upon completion of their studies.
SMU offers a variety of qualifications in the following five schools:
- School of Medicine
- School of Science and Technology
- School of Health Care Sciences
- School of Oral Health sciences
- School of Pharmacy
The university has already received over 30 000 applications from prospective students and would like to encourage others not to waste time and apply. The applications for 2022 will close on 30 July 2021 after they were extended previously.
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.
Download Media Statement – 2021 Open Days
by Kegorapetse | Mar 4, 2021 | All News, statements
Media Advisory
Date: 04 March 2021
Obesity is a serious issue worldwide; it has occurred as a serious risk factor for severe diseases in the current epidemic disease of Covid-19.
Sefako Makgatho Health Sciences 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.
Members of the media are hereby notified of the planned activities for World Obesity Day at Sefako Makgatho Health Sciences University, which will take place today 4 March 2021.
This year’s activities will be held virtually due to the conditions presented by Covid-19.
World renowned weight loss expert and SMU Head of Department of Surgery Professor Zach Koto will share his expertise on obesity and Covid-19. Other speakers will focus on obesity and diet, obesity and Covid-19 effects on mental health as well as metabolic surgery. There will also be testimonials from those whose lives were changed by the programme.
Dr George Mukhari Academic Hospital (DGMAH)/SMU bariatric Surgery Unit is accredited to perform metabolic and bariatric surgeries, making it the first public hospital in Gauteng to do this.
“SMU as a Health Sciences University is on a mission to educate people about health related matters and make a meaningful contribution especially during these difficult times of Covid-19. We are taking a lead in ensuring that we engage with our communities, raise awareness and offer them life-changing health care services and advice through programmes such as this one focusing on Obesity, which is a very serious health hazard”, says Dr Eric Pule, SMU spokesperson.
Details of the virtual proceedings are as follows:
Date 04 March 2021
Time: 16h00 – 18h00
Link : https://tinyurl.com/smuworldbobesityday
Members of the media can make arrangements for post event interviews with the experts for more in-depth perspectives on Obesity and Bariatric surgery and other alternative ways of treating Obesity.
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 Advisory World Obesity Day 2021
by Kegorapetse | Mar 1, 2021 | All News, statements
Media Statement
01 March 2021
For Immediate Release
Sefako Makgatho Health Sciences University (SMU) congratulates Professor Joshua Olowoyo for attaining a C2 Rating from the National Research Foundation. The rating is given to researchers as a recognition for having recently produced a body of quality work recognized by their peers. Prof Olowoyo was able to identify activities that are introducing trace metals in the environment including vehicular emissions and various industries, especially mining industries, which are responsible for introducing numerous hazardous metals into the environment.
“My research has also been able to demonstrate that humans are affected by the levels of trace metals in the environment. For instance, one of my research findings revealed elevated concentrations of toxic metals such as Pb, Cd and As in blood not only in occupationally exposed individuals but also in their immediate family members”, said Prof Olowoyo.
Interestingly, the research has also demonstrated that certain plants such as lichens and other higher plants have applications in biomonitoring the levels of these toxic metals in the environment.
Prof Olowoyo has vowed to continue working on emerging pollutants in the environment and their impact on human health with particular focus on women and children living within the vicinity of polluted or urban environments.
The number of NRF rated researchers and scientists at SMU is growing. Prof Olowoyo is attached to the SMU Biology department.
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 Prof Joshua Olowoyo attains a C2 rating from NRF
by Kegorapetse | Feb 28, 2021 | Accolades and Achievements, All News, statements
Media Statement
28 February 2021
For Immediate Release
The South African Vaccination and Immunisation Centre at Sefako Makgatho Health Sciences University (SMU) is set to have a new head. Prof Hannelie Meyer takes over the reins from Prof Rose Burnett who is retiring at the end of 2021. However, to ensure a smooth transition, the newly appointed head is expected to take over her role with effect from 01 March 2021.
Since joining SAVIC in 2013, Prof Meyer has dedicated her time to immunisation related activities including serving as part of two ministerial advisory committees while also serving in the division of Public Health Pharmacy at SMU. Currently, she also serves as the Chair of the National Immunisation Safety Expert Committee (NISEC).
She has made a significant contribution since joining SAVIC as Scientific Advisor for pharmacovigilance, cold chain management and logistics and this saw SAVIC grow enormously. Furthermore, Prof Meyer was very instrumental in the development and introduction of the Higher Certificate in Vaccinology offered by the School of Pharmacy at SMU as well as a series of short courses.
Her contribution is felt across the nation as she is also part of the team of experts from the nine schools of Pharmacy in the country working with the South African Pharmacy Council to develop a generic short course on vaccination techniques for pharmacists to build capacity for future vaccination, as well as the administration of vaccines as part of the national Covid-19 vaccine roll-out.
Professor Meyer assumes this new role at the time when the country is rolling out a massive vaccination programme to cushion people against the debilitating effects of Covid-19. Her knowledge and expertise in the field of Vaccines and Immunisation will certainly continue to contribute to the national efforts on the fight against Covid-19.
SMU wishes the outgoing head of SAVIC Prof Rose Burnett well and thank her for the immense contribution she made while serving as the head of SAVIC.
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 Statement Prof Hannelie Meyer takes over the reins of SAVIC
by Kegorapetse | Feb 21, 2021 | All News, statements
Media Statement 21 February 2021 For Immediate Release As the Coronavirus continues to spread around the globe, Sefako Makgatho Health Sciences University together with the South African Vaccination and Immunisation Centre will tomorrow Monday 22 February 2021 hold a panel discussion and presentation to share scientific information on Vaccines and various aspects of tackling Covid-19. An assortment of distinguished academics and experts from the SMU and SAVIC are lined up to separate science from fiction by sharing their insights on the current debates taking place in South Africa and across the globe. The discussions are an integral part of the University’s community engagement efforts to help address bigger challenges facing Africa and the World. Furthermore, it is expected that the debates and diverse views shared by the experts will help engender awareness and debunk myths around vaccines and Covid-19 in public. The panel will comprise of the following leading experts and academics:
- Professor Rose Burnett, Head of SAVIC and a member of the National Advisory Group on Immunisation
- Professor Hannelie Meyer from the Public Health Pharmacy and Management division at SMU and Chair of NISEC
- Dr Lufuno Razwiedani from Community Health and member of the Provincial and District outbreak response team and member of SAVIC
- DR Temitayo Famoroti, a clinical virologist and member of SAVIC
The session will be presented by Dr Andrew Musyoki from the SMU department of microbiology and Deputy Head of SAVIC and Professor Dini Mawela, the Deputy Dean of SMU School of Medicine will chair the session. To be part of the virtual discussions please use the following details: To join the meeting: https://eu.bbcollab.com/guest/fb4cae47ef6d4535b0b4d0eec68bab2d For registration: https://forms.gle/rViB3AnZfMyZtSbQ6 Date: 22 February 2021 Time: 12h00 – 14h00 The Sefako Makgatho Health Sciences University is home to leading health experts and boasts NRF rated researchers, scientists and academics. 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 21 February 2021 SMU Health Experts to hold a panel discussion on Covid and Vaccines
