From concept to delivery: a yeast-expressed recombinant protein-based COVID-19 vaccine technology suitable for global access.

INTRODUCTION: The development of a yeast-expressed recombinant protein-based vaccine technology co-developed with LMIC vaccine producers and suitable as a COVID-19 vaccine for global access is described. The proof-of-concept for developing a SARS-CoV-2 spike protein receptor-binding domain (RBD) antigen as a yeast-derived recombinant protein vaccine technology is described. AREAS COVERED: Genetic Engineering: The strategy is presented for the design and genetic modification used during cloning and expression in the yeast system. Process and Assay Development: A summary is presented of how a scalable, reproducible, and robust production process for the recombinant protein COVID-19 vaccine antigen was developed. Formulation and Pre-clinical Strategy: We report on the pre-clinical and formulation strategy used for the proof-of-concept evaluation of the SARS-CoV-2 RBD vaccine antigen. Technology Transfer and Partnerships: The process used for the technology transfer and co-development with LMIC vaccine producers is described. Clinical Development and Delivery: The approach used by LMIC developers to establish the industrial process, clinical development, and deployment is described. EXPERT OPINION: Highlighted is an alternative model for developing new vaccines for emerging infectious diseases of pandemic importance starting with an academic institution directly transferring their technology to LMIC vaccine producers without the involvement of multinational pharma companies.

COVID-19 Vaccination in Paediatric Population of India: Current Status, Trends, Challenges and Recommendations

Paediatric population is the high-risk segment for the infection of COVID-19 due to weak immune status and low compliance to COVID-19 prevention protocols. The first dose of vaccination for the paediatric population is started in the fifth phase of vaccination, after the vaccination was administered to health workers, elderly individuals, and young adults. Present article aims to analyse the status, trends, and challenges in the implementation of the paediatric vaccination for COVID-19 and provide recommendations that could be taken under consideration by healthcare authorities while designing the second and third vaccination protocols for the paediatric population. Relevant articles published by various journals related to paediatric COVID-19 vaccination were searched from the different databases and analysed for the current status of vaccination, trends, challenges, compliance level, implementation hurdles, and other relevant information. Limited research is available in the paediatric domain for the COVID-19 vaccination. Few vaccines are approved for the paediatric population in India, including the Covaxin, ZyCoV-D, Corbevax and Covovax. It is recommended that the vaccination trials should be accelerated by the government agencies to make COVID vaccines available from other indigenous manufacturers. It is also recommended that the COVID-19 prevention protocol should be made in such a manner that children find that interesting and like to follow them.Copyright © The Author(s) 2023.

Covid 19 Vaccine - A Magical Bullet for Corona

Vaccination is an effective, simple, safeway of providing protection against harmful diseases, before contact with public. Vaccination develops immunity to particular infections and makes our immune system stronger to produce antibodies. Most of the vaccines are administered by parenteral route, but few are given by mouth or sprayed into the nose.We should believe fair and equitable access to safe and effective vaccines is only weapon to end the pandemic, so WHO is hugely working with an effort to encourage the partners to develop and manufacture safe and effective vaccines, a challenging game tool, but in the future we must continue wearing masks, sanitizing our hands, with good ventilation indoors, physical distancing and avoid crowding. Being vaccinated does not mean that we can throw caution to the wind and put ourselves and others at risk, particularly because research is still ongoing on how much vaccines gives protection against disease, infection and transmission.Vaccines may not guarantee protection from infection, they are still doing an amazing job of substantially reducing hospitalization and death related to Covid 19.Copyright © RJPT. All right reserved.

Recombinant protein subunit COVID-19 vaccine-induced Guillain-Barré Syndrome in an adolescent: A case report.

Guillain-Barré Syndrome (GBS), an autoimmune neurological disease of peripheral nerves, has been causally associated with COVID-19 vaccination in adults. However, no such report has been published so far in children. We describe a 13-year-old female child who presented to the emergency department with complaints of bilateral upper limb, lower limb and truncal weakness over 3 days following first dose of recombinant protein subunit COVID-19 vaccine (Corbevax). Clinical examination and nerve conduction studies showed pure motor axonal polyneuropathy with absent compound muscle action potential (CMAP) in all sampled nerves of upper and lower limbs which was consistent with the diagnosis of GBS after ruling out possible alternative aetiologies. A temporal association between first dose of protein subunit COVID-19 vaccine administered a day prior and symptom onset was noted. The causality assessment using the World Health Organization (WHO) tool for adverse event following immunization (AEFI) assessment indicated vaccine product-related reaction categorized as A1. The patient's clinical condition improved after seven sessions of plasmapheresis. The purpose of this report is to create awareness among health care professionals about COVID-19 vaccine-induced GBS in children as early diagnosis and management can be critical in avoiding complications and improving patient outcomes.

Heterologous Booster Dose with CORBEVAX following Primary Vaccination with COVISHIELD Enhances Protection against SARS-CoV-2.

Despite effective vaccination programs, waning immunity in the vaccinated populations and the emergence of variants of concern posed a risk of breakthrough infections. A booster dose was demonstrated to provide substantially increased protection against symptomatic disease and hospitalization. We aimed to evaluate immune memory and the efficacy of reducing the rate of SARS-CoV-2 infection post heterologous booster with CORBEVAX after primary vaccination with two doses of COVISHIELD. SARS-CoV-2 S1/S2 spike IgG and RBD-specific antibody responses were elicited with both booster vaccines, with a greater response in individuals receiving heterologous booster. T and B memory responses were increased with booster dose, whereas B memory needed a longer duration to develop in individuals who received a homologous booster (90 days) in comparison to a heterologous booster (30 days). RBD-specific B memory and antibody-secreting (non-memory) B lymphocytes were enhanced with both boosters; however, the duration of response was longer with the heterologous booster compared to the homologous, indicating greater protection with the heterologous booster. The rate of infection 14 days after administration of the heterologous booster was comparatively lower than that of the homologous booster, with the symptoms being much less or asymptomatic.

Retinal venous occlusion in a child following Corbevax COVID-19 vaccination.

A 13-year-old boy developed painless diminution of vision in left eye 15 days after taking first dose of coronavirus disease 2019 (COVID-19) vaccine (Corbevax). Fundus and fluorescein angiography revealed central retinal vein occlusion in the left eye. Blood investigations were noncontributory. He was administered three doses of pulse corticosteroids followed by a tapering dose of oral corticosteroids. Retinal vascular occlusion can occur following COVID-19 vaccination in children, and early and aggressive systemic anti-inflammatory therapy can be helpful.

Receptor-binding domain recombinant protein on alum-CpG induces broad protection against SARS-CoV-2 variants of concern.

We conducted preclinical studies in mice using a yeast-produced SARS-CoV-2 RBD subunit vaccine candidate formulated with aluminum hydroxide (alum) and CpG deoxynucleotides. This formulation is equivalent to the CorbevaxTM vaccine that recently received emergency use authorization by the Drugs Controller General ofIndia. We compared the immune response of mice vaccinated with RBD/alum to mice vaccinated with RBD/alum + CpG. We also evaluated mice immunized with RBD/alum + CpG and boosted with RBD/alum. Mice were immunized twice intramuscularly at a 21-day interval. Compared to two doses of the /alum formulation, the RBD/alum + CpG vaccine induced a stronger and more balanced Th1/Th2 cellular immune response, with high levels of neutralizing antibodies against the original Wuhan isolate of SARS-CoV-2 as well as the B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 and (Delta) variants. Neutralizing antibody titers against the B.1.1.529 (BA.1, Omicron) variant exceeded those in human convalescent plasma after Wuhan infection but were lower than against the other variants. Interestingly, the second dose did not benefit from the addition of CpG, possibly allowing dose-sparing of the adjuvant in the future. The data reported here reinforces that the RBD/alum + CpG vaccine formulation is suitable for inducing broadly neutralizing antibodies against SARS-CoV-2, including variants of concern.