Clicky

Novavax Vaccine Trial Indicates 100% Protection Against Severe COVID-19 Due to South African Variant

Novavax Vaccine Trial Indicates 100% Protection Against Severe COVID-19 Due to South African Variant

0 View

Publish Date:
6 May, 2021
Category:
Covid
Video License
Standard License
Imported From:
Youtube

The results of the first primary analysis of the Novavax Covid-19 vaccine trial conducted by Wits VIDA in SA have been published.

The New England Journal of Medicine (NEJM) published the findings of the Phase 2b clinical trial conducted in South Africa. NEJM is recognized as the world’s leading medical journal.

Shabir Madhi, professor of vaccinology, co-author of the 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 published data provides additional details from an initial analysis conducted in January, while more robust data from a full analysis of the study was subsequently shared in March 2021.

Shabir Madhi, Professor of Vaccinology, is Director of the Wits Vaccines & Infectious Diseases Analytics (VIDA) Research Unit, Dean of the Faculty of Health Sciences at University of the Witwatersrand, Johannesburg, and Co-Director of African Leadership in Vaccinology Expertise (ALIVE). Credit: Wits University

Publication of the first primary analysis emphasizes cross-protection by the Novavax Covid-19 vaccine against the B.1.351 variant found in South Africa during the study.

This is the first published study to demonstrate protection against mild Covid-19 caused by the B.1.351 variant circulating in South Africa.

An updated analysis of the study indicated 100% protection against severe Covid-19 due to the B.1.351 variant.

“An efficacy of 50% is enough to meet the World Health Organization criteria for regulatory approval of the vaccine,” said Madhi.

The Novavax Covid-19 vaccine, known as NVX-CoV2373, is made by Novavax, Inc., a US-based biotechnology company developing next-generation vaccines for serious infectious diseases.

Gregory M. Glenn, MD, President of Research and Development, Novavax, says, “This data publication reinforces the encouraging safety profile and cross-protective effect of variants seen in studies of our vaccine to date.”

About the study

The phase 2b randomized, observer-blind, placebo-controlled study conducted in South Africa evaluated efficacy, safety and immunogenicity in healthy adults and a small cohort of medically stable adults living with the human immunodeficiency virus (HIV).

The study met the primary endpoint: the Novavax vaccine showed an overall efficacy of 49% in the first analysis (published in NEJM) and 49% in the subsequent full analysis (unpublished).

In healthy adults without HIV, the Novavax vaccine showed efficacy of 60% at the first analysis and 55% at the subsequent full analysis.

In the first analysis, the cases were predominantly mild to moderate and due to the B.1.351 variant that dominates in South Africa, and increasingly in Southern Africa.

In the subsequent full analysis, circulation of the B.1.351 variant continued to dominate and all five cases of serious illness observed in the study occurred in the placebo group.

The first analysis, now published in NEJM, suggested that previous infection with the original Covid-19 strain did not protect against subsequent infection by the variant mainly circulating in South Africa during 60 days of follow-up.

However, with additional follow-up, the full analysis of the study in South Africa indicates that there may be a modest protective effect from previous exposure to the original Covid-19 strain.

Among placebo recipients, after 90 days of follow-up, the disease rate was 8.0% in seronegative subjects at baseline and 5.9% in seropositive subjects at baseline.

“The data is a compelling case for using the Novavax Covid-19 vaccine in environments where the B.1.351 variant dominates – most of southern Africa – to reduce the risk of mild diseases and also to reduce the risk of developing maximize protection against serious diseases. Covid, ”says Madhi. “More work is needed on Novavax and all other Covid-19 vaccines, especially in people with HIV.”

The Novavax Covid-19 vaccine study is one of two Covid-19 vaccine studies in South Africa led by Madhi and Wits VIDA, and the other is the Oxford / AstraZeneca Covid-19 vaccine study.

Reference: “Efficacy of NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 Variant” by Vivek Shinde, MD, MPH, Sutika Bhikha, MB, BS, Zaheer Hoosain, MB, Ch.B., Moherndran Archary, Ph .D., Qasim Bhorat, MB, B.Ch., Lee Fairlie, MB, Ch.B., Umesh Lalloo, MB, Ch.B., Mduduzi SL Masilela, MB, Ch.B., Dhayendre Moodley, Ph. D. , Sherika Hanley, MB, BS, Leon Fouche, MB, Ch.B., Cheryl Louw, MB, Ch.B., Michele Tameris, MB, Ch.B., Nishanta Singh, MB, Ch.B., Ameena Goga , MB, Ch.B., Keertan Dheda, MB, B.Ch., Coert Grobbelaar, MB, Ch.B., Gertruida Kruger, MB, Ch.B., Nazira Carrim-Ganey, MB, B.Ch., Vicky Baillie, Ph.D., Tulio de Oliveira, Ph.D., Anthonet Lombard Koen, MB, Ch.B., Johan J. Lombaard, MB, Ch.B., Rosie Mngqibisa, MB, Ch.B., As’ad E. Bhorat, MB, B.Ch., Gabriella Benadé, MB, BS, MPH, Natasha Lalloo, MB, Ch.B., Annah Pitsi, MB, Ch.B., Pieter-Louis Vollgraaff, MB, Ch.B., Angelique Luabeya, MB, Ch.B., Aliasgar Esmail, MB, Ch.B., Friedrich G. Petrick, MB, Ch.B., Aylin Oommen-Jose, MB, Ch.B., Sharne Folkes, MB, Ch.B., Khatija Ahmed, MB, Ch.B., Asha Thombrayil, MB, Ch.B., Lou Fries, MD, Shane Cloney-Clark, BS, Mingzhu Zhu, Ph.D., Chijioke Bennett, MD, MPH, Gary Albert, MS, Emmanuel Faust, Ph.D., Joyce S. Plested, Ph.D., Andreana Robertson, MS, Susan Neal, BS, Iksung Cho, MS, Greg M. Glenn, MD, Filip Dubovsky , MD, MPH, and Shabir A. Madhi and MB, B.Ch., Ph.D. for the 2019nCoV-501 Study Group, May 5, 2021, New England Journal of Medicine.
DOI: 10.1056 / NEJMoa2103055

In addition to leading 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 research unit Wits Vaccines & Infectious Diseases Analytics (VIDA)

Formerly known as the Respiratory and Meningeal Pathogens Research Unit (RMPRU) and established in 1995, the Vaccines and Infectious Diseases Analytics (VIDA) Research Unit at the University of the Witwatersrand (Wits) is an internationally recognized African-led research unit in the area epidemiology of vaccine-preventable diseases, and clinical development of life-saving vaccines.

Led by Professor Shabir Madhi, a world leader in infectious pediatric diseases and the Dean of the Faculty of Health Sciences at Wits University, Wits VIDA conducts translational research into vaccine-preventable diseases and trains the next generation of clinician scientists. .

Combining clinical, microbiological and epidemiological expertise in an African environment, Wits VIDA’s groundbreaking scientific research provides information on local and global policy recommendations on the use of new and new vaccines today.

In addition to several other studies on Covid-19, Wits VIDA defended and led the first two Covid-19 vaccine studies in Africa in 2020 for the vaccine candidates for Oxford and Novavax.

About the Novavax vaccine known as NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease.

NVX-CoV2373 is made using Novavax ‘recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is combined with Novavax’ proprietary saponin-based Matrix-M ™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

NVX-CoV2373 contains purified protein antigen and cannot replicate nor cause Covid-19. In preclinical studies, NVX-CoV2373 induced antibodies that blocked spike protein binding to cellular receptors and protected against infection and disease.

It was generally well tolerated and elicited a robust antibody response during phase 1/2 clinical testing.

NVX-CoV2373 is stored and stable at two degrees Celsius to eight degrees Celsius, allowing the existing vaccine distribution channels to be utilized. It is packaged in a ready-to-use liquid formulation in 10-dose vials.