Posted on 05/07/2021 8:25:28 AM PDT by Red Badger
The New England Journal of Medicine (NEJM) published 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 provide additional detail of an initial analysis conducted in January, while more robust data from a complete analysis of the study was subsequently shared in March 2021.
Publication of initial primary analysis highlights cross-protection by the Novavax Covid-19 vaccine against the B.1.351 variant prevalent in South Africa during the study.
This is the first published study to show 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 sufficient to meet the World Health Organization criteria for regulatory approval of the vaccine,” says 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, M.D., President of Research and Development, Novavax, says: “This data publication reinforces the encouraging safety profile and cross-protective effect across variants seen in studies of our vaccine to-date.”
About the study The Phase 2b randomized, observer-blinded, placebo-controlled trial conducted in South Africa evaluated efficacy, safety and immunogenicity in healthy adults, and in a small cohort of medically stable adults living with human immunodeficiency virus (HIV).
The study met its primary endpoint – i.e., the Novavax vaccine demonstrated an overall efficacy of 49% in the initial analysis (published in NEJM), and 49% in the subsequent complete analysis (unpublished).
Among healthy adults without HIV, the Novavax vaccine demonstrated efficacy of 60% in the initial analysis, and 55% in the subsequent complete analysis.
In the initial analysis, 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 complete analysis, circulation of the B.1.351 variant continued to dominate, and all five cases of severe disease observed in the trial occurred in the placebo group.
The initial analysis, now being published in NEJM, suggested that prior infection with the original Covid-19 strain did not protect against subsequent infection by the variant predominantly circulating in South Africa through 60 days of follow-up.
However, with additional follow-up, the complete analysis of the South Africa trial indicates that there may be a modest protective effect of prior exposure with the original Covid-19 strain.
Among placebo recipients, at 90 days of follow-up, the illness rate was 8.0% in baseline seronegative participants and 5.9% in baseline seropositive participants.
“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,” says 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 one of two 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’ad 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. DOI: 10.1056/NEJMoa2103055
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 known as the Respiratory and Meningeal Pathogens Research Unit (RMPRU) and founded in 1995, the Vaccines and Infectious Diseases Analytics (VIDA) Research Unit of the University of the Witwatersrand (Wits) is an internationally recognized, African-led research unit in the field of epidemiology of vaccine preventable diseases, and clinical development of life-saving vaccines.
Under the guidance of Professor Shabir Madhi, a global leader in the field of pediatric infectious diseases and the Dean of the Faculty of Health Sciences at Wits University, Wits VIDA is conducting translational research on vaccine-preventable diseases and training the next generation of clinician scientists.
Combining clinical, microbiological, and epidemiological expertise in an African setting, Wits VIDA’s cutting-edge scientific research informs local and global policy recommendations on the use of next-generation and novel vaccines today.
In addition to various other studies on Covid-19, Wits VIDA championed and led the first two Covid-19 vaccine trials in Africa in 2020, for the Oxford and Novavax vaccine candidates.
About the Novavax vaccine known as NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease.
NVX-CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is with Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause Covid-19. In pre-clinical studies, NVX-CoV2373 induced antibodies that blocked the binding of spike protein to cellular receptors and provided protection from infection and disease.
It was generally well-tolerated and elicited robust antibody response in Phase 1/2 clinical testing.
NVX-CoV2373 is stored and stable at two degrees Celsius to eight degrees Celsius, allowing the use of existing vaccine supply chain channels for its distribution. It is packaged in a ready-to-use liquid formulation in 10-dose vials.
100%! Wow! The first 100% effective medical treatment in entire the history of the entire world!
Even a blind squirrel......?
For those worried about adverse vaccine reactions, the Novavax vaccine is likely to be preferable to the others. And it should be available in another month or two.
Yeah can’t wait to not get it...............
This vaccine is different than the others. It is not a an RNA vaccine or DNA vaccine.
True. It was also produced without the use of fetal stem cells in any R&D or internal testing (just like Pfizer and Moderna were). That separates it from the J&J vaccine, which DID use fetal stem cells for R&D and testing.
Anyone who’s pro-life, but concerned about the newness of the mRNA platform should consider the Novavax vaccine as a potential alternative.
Your choice. Yet I will get vaccinated. One relative who got Covid nearly died of it, while another still suffers fatigue and headaches months later.
The Navavax vaccine uses a artificial Spike Protein, that has now being found to cause clotting, strokes, and heart attacks. It is just as dangerous as the mRNA vaccines.
I’ve heard about this one and have been waiting to see how it fares.
Novavax, like Moderna, has never had any vaccine that has been FDA approved in their existence. Take it at your own risk.
False information. There is some evidence of some level of tissue damage from the S protein, but it has nothing to do with being “artificial”. The amount of damage it actually does on its own is an unanswered question. No clotting, strokes, or heart attacks have been linked to Novavax or the S protein by itself.
And if you’re worried about damage from the S protein, worry about it from the self-replicating virus that dumps S proteins all over your body (SARS-CoV-2) rather than a tiny amount of non-replicating S proteins contained in a tiny little vaccine shot.
Gone through full Phase 1, Phase 2, and Phase 3 clinical trials. Just like any other medicine from any other manufacturer.
But keep on banging that fear drum. I’m sure China appreciates it: https://www.pbs.org/wgbh/frontline/article/chinese-spam-network-aims-to-discredit-u-s-covid-vaccine-and-response-report-finds/
Just saying....and I've had the 19
Recombinant spike protein nanoparticle technology. Interesting.
Both companies used the fetal cell line HEK 293 in the confirmation phase to ensure the vaccines work. All HEK 293 cells are descended from tissue taken from a 1973 elective abortion that took place in the Netherlands.
Note: I couldn’t care less how many generations have passed. It got its start from an aborted baby
It’s a miracle, I tell ya!
Confirmatory testing is performed by an independent third party. All confirmatory testing was performed after doses had already been produced, bottled, and in the freezer ready to ship. Neither Moderna nor Pfizer have any say in how the independent third party does their testing, per FDA rules.
Pinning what the independent third party decided to do on the products from Pfizer and Moderna (and Novavax for that matter) would be like saying that if some lab bought Tylenol off the shelf at Walgreens and tested it on fetal stem cells, all Tylenol now and forever is tainted by abortion. That’s a bizarre position to take. The doses were in the freezer ready for use, but the FDA says “send it here and let them confirm what you’re telling us”. And the place it goes uses fetal stem cells to test. The product - which has already been made - is still free from any ethical issues.
They grow S proteins from SARS-CoV-2 in moth cells, then attach them to an inert object. This gives the appearance of a virion, but there’s no replication capability.
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