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 | Mar 31, 2021
The HPV and STIs Training Centre for Africa Home » Search Results for "Scientist" About The HPV and STIs Training Centre for Africa In many African countries there is limited data on the circulating HPV types causing anal, oral and cervical benign...
by Kegorapetse | Jul 23, 2019 | Research, SMU Media
The Health and Welfare SETA, invite applications from registered employed (part-time), and unemployed (full-time) South African students pursuing Postgraduate Diploma/Honours/B-Tech, M-Tech/Masters, D-Tech/Doctoral and Post-Doctoral studies at South African universities and other accredited higher education and training institutions.
While other areas of study within the sector will be considered; preference will be given to majors / streams and research focus that fall within the following priority areas:
- Veterinary Sciences, Marine Aquaculture and Marine biology
- Nursing Sciences focus – Nursing Education, Health Professions Education, Mental Health Nursing, Maternal and Child Health, Community Health Nursing, Rural Health, and Primary Health Care;
- Social Work focus – Social Health Care, Occupational Social Work and Social Work (in Forensic Practice); Clinical Social Work, Child Protection Law and Play Therapy.
- Psychology focus – Counseling, Clinical, Forensic, Educational, and Community,
- Public Health focus – Clinical Epidemiology, Health Economics, Health Systems (Policy, Planning & Management), Medical Informatics, eHealth, Telemedicine, Biostatistics, Bioethics and Health Law (Medical Law);
- Mental Health focus – Forensic Mental health, Child-Adolescent and Adult Psychiatry, Public Mental Health and Community Psychiatry,
- Health sciences focus – Radiography, Audiology, Speech Language Therapy, Pharmacy, Optometry, Dentistry, and Physiotherapy,
- Medical Sociology, Environmental Sociology, Demography and Population studies;
- Environmental Health/Biology/Chemistry and Occupational Health and Safety;
- Social Welfare focus – Child and Youth Care, Social Services and Development, Poverty and Inequality, Disability care – Rehabilitation and Management,
A special consideration will be given to Honours students undertaking programmes, which will lead to scarce skills specializations, professional registration and licensing. Students with disabilities are encouraged to apply.
Application process: Interested students must complete (type text by using Word) and sign an HWSETA postgraduate bursary application form attached, and submit in a pdf format no later than 26 July 2019. The application must include a proof of registration (a university stamped copy), draft research proposal (where applicable), motivation letter (1 page), required proposed budget (itemized) to complete the research project and a clear certified copy of the South African Identify Document.
Applications must be submitted via email to:jadah.matentji@smu.ac.za.
Enquiries may be directed to Ms. Jadah Matentji at jadah.matentji@smu.ac.za
by Kegorapetse | Mar 6, 2019 | SMU Media
Hundreds of first time entering students attended the 2019 orientation ceremony that was held at the Sport Centre, recently. The orientation event serves as a necessary rite of passage that the new students must undergo to be able to part ways with their erstwhile high school habits and begin to embrace the ethos that befit an SMU Student. An impressive array of speakers were lined up to share their wisdom and experiences with the captive audience of starry eyed students and their parents who had accompanied them.
Prof Chris de Beer, the Vice-Chancellor of SMU thanked the first time entering students for choosing SMU as the university that will nurture their dreams to become health and natural science professionals. He called upon them to optimally use the opportunity afforded to them as it may be a once in a lifetime opportunity.
In his words, the VC stated, “Thousands have applied to study at SMU, but they could not make the grade. Being admitted at SMU places a great responsibility on their shoulders to work hard to succeed in your studies. SMU is doing all in its power to foster an enabling institutional culture that would inspire them to succeed in their studies. Use the support systems that are in place to address your emotional, academic and social challenges. Free education gives talented yet lesser fortunate students access to higher education. But it also obliges them to give a satisfactory academic performance.
Boast about SMU and show pride in it because you have this privilege to be admitted to study at the only university in South Africa focusing on the health sciences, “said Prof de Beer.
In the same spirit, Prof. Lekan Ayo-Yusuf, the deputy Vice- Chancellor responsible for the research, postgraduate studies and innovation also gave his remarks to calm anxieties of these students. The DVC encouraged them, not only, to focus on their studies, but also urged them to identify extracurricular activities in which they will invest their positive energies. He called upon them to familiarize themselves with the rules and regulations of the university in the general calendar.
Mr. Innocent Chauke, the President of the Student Representative Council (SRC) also welcomed and advised them to work hard so that they will be able to complete their academic programmes within the prescribed period.
by Kegorapetse | May 25, 2017 | SMU Media
Master of ceremonies, your Excellency’s, the Ambassadors of various African Countries, or their representatives, our guest speaker, special guests, colleagues, students and visitors,
Welcome to the Sefako Makgatho Health Sciences University for the celebration of Africa Day. It is indeed an honour and pleasure to receive you here today.
In modern times, Africa Day is celebrated on 25 May in accordance with a decision of the African Union. This decision of the African Union replaced a decision of the Organisation of African Unity, which determined the date for celebrations as 15 April.
But, ladies and gentlemen, of importance is not so much the date, but the fact that Africa Day presents an opportunity of all of us to reconnect and recommit ourselves in support of all interventions, whether from government, liberation movements or civil organisations, formal or informal, to develop a better Africa and a better world.
When we celebrate Africa day today, we declare openly and with conviction, and as a statement of pride, that we foster inclusivity and that we remain committed to continuous change and transformation for the better of our societies and our continent. The demands for change in South Africa and elsewhere in Africa, manifesting in so many ways and drawing attention to various issues and challenges faced by society, education institutions and governments, are firmly founded on the historical contexts and spirit of Africa Day.
It is about the process of decolonization of the African continent, the agitation for more political rights and independence, the liberation from foreign domination and exploitation, etc. It is also about coming together as the people of Africa, to encourage one another and to forge a common goal. It is about the reality that the national interest of the constituent parts of the African continent is intrinsically linked to the entire continent’s stability, unity and prosperity.
The continent benefitted greatly from the inspirational power of the individual and collective struggle against colonial rule.
The time has come, to draw from this powerful source of inspiration to confront the persisting effect and consequence of colonialism plaguing the continent and South Africa in particular. It is still deeply entrenched in the way things are done, postulating the contexts of what we should learn and how we should behave, dominating social and economic status, experience and aspiration, etc.
The spirit of Africa Day shall continue to inspire until all of us shall not only find our home in Africa, but most importantly, experience a total and overwhelming “feeling at home” in Africa.
Prof Chris de Beer
Interim Vice-Chancellor
25 May 2017
