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SARS-CoV-2 and COVID-19
Published in Patricia G. Melloy, Viruses and Society, 2023
Other prominent vaccines include the Sputnik V (Gam-Covid-Vac) vaccine used in Russia and other countries, Sinopharm (BBIBP-CorV) used in China and other countries, Sinovac (CoronaVac) also used in China and other countries, and Covaxin used in India and other countries (Krammer 2020; Corum and Zimmer 2021b). Novavax (NVX-CoV2373), a recombinant protein-based vaccine also known as Covovax, which was developed in the United States, received an emergency authorization from the WHO and a conditional approval for use in Europe at the end of December 2021 (Corum and Zimmer 2021b; Krammer 2020; Heath et al. 2021; Dunkle et al. 2021; Novavax 2021).
Clinical Trials of COVID-19 Therapeutics and Vaccines
Published in Debmalya Barh, Kenneth Lundstrom, COVID-19, 2022
Candan Hizel Perry, Havva Ö. Kılgöz, Şükrü Tüzmen
In the context of the COVID-19 pandemic, there are 28 PS SARS-CoV-2 vaccine candidates being explored in clinical trials. The Matrix-M1 adjuvanted recombinant S protein nanoparticle vaccine candidate NVX-CoV2373 was produced in the established baculovirus Spodoptera frugiperda (Sf9) insect cell expression system. Phase I results showed robust humoral and cellular immune responses against SARS-CoV-2, with high viral neutralizing activity [27, 39]. Additionally, the NVX-CoV2373 vaccine developed by Novavax, showed 89.3% vaccine efficacy in a Phase III trial [40].
Can Misconduct and Fraud Be Fixed?
Published in Charles E. Dean, The Skeptical Professional's Guide to Rational Prescribing, 2022
Whatever the damage to the population as a whole, the money continues to flow, as found in a brief history of Novavax,36 which 18 months ago was on the brink of delisting by NASDAQ following the failure of a second failed vaccine trial in less than 3 years. (The company had never brought a vaccine to market.) The stock fell to less than $1/share. However, it was one of seven vaccine makers to win funding from Operation Warp Speed—some $2 billion—which sent its stock up to $80.71 in October 2020. Nevertheless, its efforts to make a vaccine based on harvesting the spike protein from moth cells seemed very promising, as noted in detail by an article in Science.36 Yet questions arose when the top managers at Novavax made tens of millions from exercising stock options. Two board members pulled in almost $17 million in August 2020, while in September, four senior managers sold $18.9 million in shares. No one has been charged with misconduct.
Lessons learned from the SARS-CoV-2 pandemic; from nucleic acid nanomedicines, to clinical trials, herd immunity, and the vaccination divide
Published in Expert Opinion on Drug Delivery, 2023
Hiba Hussain, Aishwarya Ganesh, Lara Milane, Mansoor Amiji
Several protein subunit vaccines with adjuvants are in clinical phases for SARS-CoV-2 where each utilizes a different form of S-protein and RBD to bind to ACE2 receptors in host cell, to undergo conformational changes for fusion into the host cell membrane. The Novavax vaccine (NVX-CoV2373) is especially successful with an efficacy of 89.7% [42]. It contains trimeric S-glycoprotein enclosed in a baculovirus as a recombinant protein antigen. The isolated protein nanoclusters are packaged into lipid nanoparticles with Matrix-MTM, a saponin-based adjuvant that increases cell trafficking and overall immune cell activation [43]. Upon injection, APCs engulf the spike proteins from the nanoparticles, presents a fragment easily recognizable by T-helper cells (Th cells) and activates plasma B cells to produce antibodies against SARS-CoV-2 [22]. Exploiting the help of adjuvants may help the other vaccines
COVID-19 and vaccination: myths vs science
Published in Expert Review of Vaccines, 2022
Vivek P. Chavda, Yangmin Chen, Jayant Dave, Zhe-Sheng Chen, Subhash C. Chauhan, Murali M. Yallapu, Vladimir N. Uversky, Rajashri Bezbaruah, Sandip Patel, Vasso Apostolopoulos
Novavax (Nuvaxovid; NVX-CoV2373) and Covovax (Novavax formulation) are the two WHO emergency use listing COVID-19 vaccines using the protein subunit platform. Mild-to-moderate injection site pain and tenderness are the most common local symptoms, while muscle pain, fatigue, and headache are common systemic symptoms among participants which last less than two-three days [132]. In a phase II placebo controlled trial in 9 Australian sites and 8 sites in USA, receiving 5 or 25 μg of novavax vaccine showed mild-moderate short-term reactogenicity (less than 3 days) and was highly immunogenic generating high neutralizing antibody titers [133]. In a phase III randomized observer-blinded placebo controlled trial in the USA and Mexico it showed that the vaccine was safe and effective at preventing COVID-19 in adults over the age of 18, and breakthrough cases being reported only to other VOCs [134]. In a phase III study in the UK showed robust antibody responses (86.3% effective to alpha VOC and 96.4% effective to non-alpha variants) with mild and transient reactogenicity [135]. In those under the age of 18, novavax vaccine was well-tolerated with strong immunogenicity noted [136].
Fluorescent quantum dots enable SARS-CoV-2 antiviral drug discovery and development
Published in Expert Opinion on Drug Discovery, 2022
Kirill Gorshkov, Kimihiro Susumu, Mason Wolak, Eunkeu Oh
The presentation of S on the QD surface mimics the structure of SARS-CoV-2 viral particles. The RBD within the S1 domain has immunogenic epitopes starting at R345, R405, and R465 [16]. In this way, it is feasible that S conjugated to QDs could be a platform for vaccine development, as the QD-S would be recognized by the immune system via antigen-presenting cells and subsequent recognition of S by helper T cells. B cells may also encounter the S protein and work with helper T cells to boost immune cell activation and generate antibodies against S. Lastly, a QD-based nanoparticle vaccine could prime the immune system to respond to infected cells faster with the help of killer T cells that would be activated by antigen presenting cells, preventing the infected cells from being used to replicate virus. The Novavax vaccine candidate [17] is one kind of nanoparticle vaccine that presents S on the surface. The Novavax formulation also includes an adjuvant to help boost the immune response by attracting immune cells toward the nanoparticle. For QDs to be viable vaccine candidates for human inoculation, lower toxicity QDs not containing cadmium would need to be developed for use in humans. QD-S would initially be used to facilitate model studies of in vitro immune system response prior to replacement of the QD carrier with a nontoxic metal NP suitable for in vivo studies.