Question

Topic: BioNTech working on COVID Vaccine.

Question: Please explain the technology readiness level? Please write at least 5 lines of explanation.

Answer 1

BioNTech with collabration with another company are working together on a messenger RNA- vaccine, based on m-RNA-based immuno therapy, which will help in prevention from contracting COVID-19. Vaccine development is a long process consisting of various phases like collecting research data, forming proof of concept, pre-clinical & clinical trials (animals, humans), manufacturing process, market availability and finally its usage.

Technology Rreadiness Level (TRL): The standard of measurement which is used to estimate the progression of its technology, is called as TRL. The TRL scale can be divided into 9 technology readiness levels- From TRL-1 to TRL-9. This term was coined by NASA. This includes various phases of development of particular technology.

The phases in VACCINE development are explained in short:

TRL-1- Identification of need, scientific research applied into research and development

TRL-2- Epidemiologic study, hypothesis and protocols formulated, in vitro studies

TRL-3- Hypothesis testing, demonstrating invitro models, developing in vivo models for efficacy studies

TRL-4- Animal model defined for demonstration of efficacy & toxicity studies of the vaccine candidate

TRL-5- Pre-clinical trials, chronic toxicity studies, Repeat dose toxicity studies for clinical trials in humans

TRL-6- Phase-I clinical trials results reviewed by DCGI, approval for Phase-II trials

TRL-7- Phase II Clinical trials results reviewed by DCGI, approval for Phase-III trials

TRL-8-Phase III Clinical trials completion, DCGI approval for the vaccine along with manufacturing license for market entry

TRL-9- Vaccine launched in market, Post studies,Scale up,Observation and keeping track of the same.(Phase IV clinical trial)