COVID-19 management landscape: A need for an affordable platform to manufacture safe and efficacious biotherapeutics and prophylactics for the developing countries.

To gain world-wide control over COVID-19 pandemic, it is necessary to have affordable and accessible vaccine and monoclonal antibody technologies across the globe. In comparison to the western countries, Asian and African countries have less percentage of vaccination done which warrants urgent attention. Global manufacturer production capacities, dependency on advanced nations for the supply of vaccines or the raw material, national economy, limited research facilities, and logistics could be the factors. This review article elaborates the existing therapeutic and prophylactic strategies available for COVID-19, currently adopted vaccine and monoclonal antibody platforms for SARS-CoV-2 along with the approaches to bridge the gap prevailing in the challenges faced by low- and middle-income countries. We believe adoption of yeast-derived P. pastoris technology can help in developing safe, proven, easy to scale-up, and affordable recombinant vaccine or monoclonal antibodies against SARS-CoV-2. This platform has the advantage of not requiring a dedicated or specialized facility making it an affordable option using existing manufacturing facilities, without significant additional capital investments. Besides, the technology platform of multiantigen vaccine approach and monoclonal antibody cocktail will serve as effective weapons to combat the threat posed by the SARS-CoV-2 variants. Successful development of vaccines and monoclonal antibodies using such a technology will lead to self-sufficiency of these nations in terms of availability of vaccines and monoclonal antibodies.

Capacity Building for Vaccine Manufacturing Across Developing Countries: The Way Forward.

Approved vaccines prevent 2 to 3 million deaths per year. There is a lack of equitable access to vaccines in the low- and middle-income developing nations. Challenges in the life cycle of vaccine production include process development, lead time, intellectual property, and local vaccine production. A robust and stable manufacturing process and constant raw material supplies over decades is critical. In a continuously evolving vaccine landscape, the need of the hour for developing nations is to manufacture their own vaccines besides having supply security, control over production scheduling and sustainability, control of costs, socio-economic development, and rapid response to local epidemics. There is a need for capacity building of workforce development, technology transfer, and financial support. Technology transfer has improved vaccine access and reduced prices of vaccines. Capacity building for the manufacturing of vaccines in developing countries has always been an area of paramount importance and more so in a pandemic situation.

Evaluation of efficacy and safety of recombinant sperm-specific contraceptive vaccine in albino mice.

PROBLEM: This study was undertaken to evaluate the efficacy and safety of recombinant SP-10 protein for male contraception. METHODS OF STUDY: Adult male mice were divided into five groups. Group I was placebo-treated control while Groups II-V were immunized with recombinant SP-10 protein on day 0 and 21 with different doses (range 25-100 µg). From each Group, animals were put for mating fertility test. Histological and hematological parameters, sperm characteristics, serum clinical biochemistry and testosterone levels were investigated. RESULTS: Group I showed normal fertility. Group II-V showed dose dependent reduction in fertility. In contrast, at higher dose (75 and 100 µg), all animals were sterile for three months. Further, all parameters under investigation in experimental groups were comparable to those of control animals. CONCLUSION: Our study has put forth a proof of concept for male contraception for the first time, which may be considered suitable for contraceptive vaccine development.