Results from the preliminary main analysis of the Novavax Covid-19 vaccine trial carried out by Wits VIDA in SA have actually been released.
The New England Journal of Medicine (NEJM) released findings of the Phase 2b scientific trial carried out in South Africa. NEJM is acknowledged as the world’s leading medical journal.
Shabir Madhi, Professor of Vaccinology, co-author of the research study, and the Director of the Vaccines & Infectious Diseases Analytics Research Unit (Wits VIDA), led the Novavax Covid-19 vaccine trial in South Africa.
The released information offer extra information of a preliminary analysis carried out in January, while more robust information from a total analysis of the research study was consequently shared in March 2021.
Publication of preliminary main analysis highlights cross-protection by the Novavax Covid-19 vaccine versus the B.1.351 alternative common in South Africa throughout the research study.
This is the very first released research study to reveal defense versus moderate Covid-19 triggered by the B.1.351 alternative flowing in South Africa.
An upgraded analysis of the research study showed 100% defense versus extreme Covid-19 due to the B.1.351 version.
“An efficacy of 50% is sufficient to meet the World Health Organization criteria for regulatory approval of the vaccine,” states Madhi.
The Novavax Covid-19 vaccine, called NVX-CoV2373, is made by Novavax, Inc., a US-based biotechnology business establishing next-generation vaccines for major transmittable illness.
Gregory M. Glenn, M.D., President of Research and Development, Novavax, states: “This data publication reinforces the encouraging safety profile and cross-protective effect across variants seen in studies of our vaccine to-date.”
About the research study
The Phase 2b randomized, observer-blinded, placebo-controlled trial carried out in South Africa examined effectiveness, security and immunogenicity in healthy grownups, and in a little associate of clinically steady grownups coping with human immunodeficiency infection (HIV).
The research study satisfied its main endpoint – i.e., the Novavax vaccine showed a general effectiveness of 49% in the preliminary analysis (released in NEJM), and 49% in the subsequent total analysis (unpublished).
Among healthy grownups without HIV, the Novavax vaccine showed effectiveness of 60% in the preliminary analysis, and 55% in the subsequent total analysis.
In the preliminary analysis, cases were mainly mild-to-moderate and due to the B.1.351 version that controls in South Africa, and progressively in southern Africa.
In the subsequent total analysis, blood circulation of the B.1.351 alternative continued to control, and all 5 cases of extreme illness observed in the trial happened in the placebo group.
The preliminary analysis, now being released in NEJM, recommended that previous infection with the initial Covid-19 stress did not secure versus subsequent infection by the alternative mainly flowing in South Africa through 60 days of follow-up.
However, with extra follow-up, the total analysis of the South Africa trial suggests that there might be a modest protective impact of previous direct exposure with the initial Covid-19 stress.
Among placebo receivers, at 90 days of follow-up, the disease rate was 8.0% in standard seronegative individuals and 5.9% in standard seropositive individuals.
“The data make a compelling case for use of the Novavax Covid-19 vaccine in settings where the B.1.351 variant dominates – which is most of southern Africa – to reduce the risk of mild disease and also to maximize the opportunity for protection against severe Covid,” states Madhi. “Further work is required for Novavax and all other Covid-19 vaccines, particularly in people living with HIV.”
The Novavax Covid-19 vaccine trial is among 2 Covid-19 vaccine trials in South Africa led by Madhi and Wits VIDA, with the other being the Oxford/AstraZeneca Covid-19 vaccine trial.
Reference: “Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B.1.351 Variant” by Vivek Shinde, M.D., M.P.H., Sutika Bhikha, M.B., B.S., Zaheer Hoosain, M.B., Ch.B., Moherndran Archary, Ph.D., Qasim Bhorat, M.B., B.Ch., Lee Fairlie, M.B., Ch.B., Umesh Lalloo, M.B., Ch.B., Mduduzi S.L. Masilela, M.B., Ch.B., Dhayendre Moodley, Ph.D., Sherika Hanley, M.B., B.S., Leon Fouche, M.B., Ch.B., Cheryl Louw, M.B., Ch.B., Michele Tameris, M.B., Ch.B., Nishanta Singh, M.B., Ch.B., Ameena Goga, M.B., Ch.B., Keertan Dheda, M.B., B.Ch., Coert Grobbelaar, M.B., Ch.B., Gertruida Kruger, M.B., Ch.B., Nazira Carrim-Ganey, M.B., B.Ch., Vicky Baillie, Ph.D., Tulio de Oliveira, Ph.D., Anthonet Lombard Koen, M.B., Ch.B., Johan J. Lombaard, M.B., Ch.B., Rosie Mngqibisa, M.B., Ch.B., As’advertisement E. Bhorat, M.B., B.Ch., Gabriella Benadé, M.B., B.S., M.P.H., Natasha Lalloo, M.B., Ch.B., Annah Pitsi, M.B., Ch.B., Pieter-Louis Vollgraaff, M.B., Ch.B., Angelique Luabeya, M.B., Ch.B., Aliasgar Esmail, M.B., Ch.B., Friedrich G. Petrick, M.B., Ch.B., Aylin Oommen-Jose, M.B., Ch.B., Sharne Foulkes, M.B., Ch.B., Khatija Ahmed, M.B., Ch.B., Asha Thombrayil, M.B., Ch.B., Lou Fries, M.D., Shane Cloney-Clark, B.S., Mingzhu Zhu, Ph.D., Chijioke Bennett, M.D., M.P.H., Gary Albert, M.S., Emmanuel Faust, Ph.D., Joyce S. Plested, Ph.D., Andreana Robertson, M.S., Susan Neal, B.S., Iksung Cho, M.S., Greg M. Glenn, M.D., Filip Dubovsky, M.D., M.P.H., and Shabir A. Madhi and M.B., B.Ch., Ph.D. for the 2019nCoV-501 Study Group, 5 May 2021, New England Journal of Medicine.
In addition to directing Wits VIDA, Madhi is Dean of the Faculty of Health Sciences at the University of the Witwatersrand, Johannesburg (Wits), and co-Director of African Leadership in Vaccinology Expertise (ALIVE).
Funding: Novavax, Bill and Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovations
About the Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit
Formerly called the Respiratory and Meningeal Pathogens Research Unit (RMPRU) and established in 1995, the Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand (Wits) is a globally acknowledged, African-led research study system in the field of public health of vaccine avoidable illness, and scientific advancement of life-saving vaccines.
Under the assistance of Professor Shabir Madhi, a worldwide leader in the field of pediatric transmittable illness and the Dean of the Faculty of Health Sciences at Wits University, Wits VIDA is performing translational research study on vaccine-preventable illness and training the next generation of clinician researchers.
Combining scientific, microbiological, and epidemiological know-how in an African setting, Wits VIDA’s advanced clinical research study notifies regional and international policy suggestions on using next-generation and unique vaccines today.
In addition to numerous other research studies on Covid-19, Wits VIDA promoted and led the very first 2 Covid-19 vaccine trials in Africa in 2020, for the Oxford and Novavax vaccine prospects.
About the Novavax vaccine called NVX-CoV2373
NVX-CoV2373 is a protein-based vaccine prospect crafted from the hereditary series of the very first stress of SARS-CoV-2, the infection that triggers Covid-19 illness.
NVX-CoV2373 was developed utilizing Novavax’ recombinant nanoparticle innovation to produce antigen originated from the coronavirus spike (S) protein and is with Novavax’ trademarked saponin-based Matrix-M™ adjuvant to improve the immune action and promote high levels of reducing the effects of antibodies.
NVX-CoV2373 consists of cleansed protein antigen and can neither reproduce, nor can it trigger Covid-19. In pre-clinical research studies, NVX-CoV2373 caused antibodies that obstructed the binding of spike protein to cellular receptors and offered defense from infection and illness.
It was typically well-tolerated and elicited robust antibody action in Phase 1/2 scientific screening.
NVX-CoV2373 is saved and steady at 2 degrees Celsius to 8 degrees Celsius, permitting the usage of existing vaccine supply chain channels for its circulation. It is packaged in a ready-to-use liquid formula in 10-dosage vials.