With the world coming to a standstill after the genesis of the Covid-19 pandemic, search for Covid-19 Vaccine of the virus has become a crucial objective of thousands of research bodies, health organizations and national and international regulatory bodies. Billions of dollars have already been dedicated towards finding a cure for the virus. For instance, Chinese bio-pharmaceutical company Sinovac Biotech has received $15m in funding to advance the development of its Covid-19 vaccine candidate, CoronaVac.
Recently, Globe Biotech Limited has announced to be the first company from Bangladesh to have a Covid-19 Vaccine under development, as they claim success in preliminary animal modelling trial on rabbits for Covid-19 Vaccine. But does it mean the Covid-19 Vaccine will be available in Bangladesh anytime soon?
According to Centres for Disease Control and Prevention, the general stages of the development cycle of a vaccine include:
- Exploratory stage
- Pre-clinical stage
- Clinical development
- Regulatory review and approval
- Manufacturing and Quality control
Before a new vaccine is ever given to people, extensive lab testing is done that can take several months or even years. Once testing in people begins, it can take several more months or years before clinical studies are complete and the vaccine is licensed.
According to CDCP, even in stage 3 which is the Clinical Development stage, there are 3 phases:
- PHASE 1: Here the safety and side effects of the vaccine is determined by applying on typically 20-100 healthy volunteers.
- PHASE 2: The short-term side effects and response of the immune system is determined by applying the vaccine on several hundred volunteers.
- PHASE 3: The safety, effectiveness and side-effects of the volunteers who get the vaccine is compared with those who did not by applying the test on hundreds or thousands of volunteers.
Only after that, the vaccine goes through to Stage 4 for Regulatory Review and Approval.
According to WHO, as of 2 July 2020, there are 18 candidate vaccines in clinical evaluation and 129 vaccine candidates in pre-clinical evaluation. Of the primary 18 candidates, only a vaccine developed by University of Oxford is in Phase 3 and close to regulatory review and approval while the rest 17 are in either Phase 1 or 2 of Clinical Development Stage (Stage 3).
The vaccine of Globe Biotech Limited which is under development is in Stage 2 as of now. Consequently, the vaccine has to go through several more stages to become available in Bangladeshi market.
According to Dr Asif Mahmud, assistant manager and in-charge, Research and Development, Globe Biotech Limited, it would take another six months for the vaccine to be marketed. Although it remains a wishful thinking, we shall hope for the best and pray for the vaccine to be available in Bangladesh as soon as possible.
The writer is a bright sophomore in Institute of Business Administration (IBA), University of Dhaka.
You can reach him: [email protected]
Draft landscape of COVID-19 candidate vaccines. (2020, July).. World Health Organization (WHO)
Tirumalaraju, D. (2020, May 25). China’s Sinovac Biotech gets funding for Covid-19 vaccine development. Pharmaceutical Technology. Pharmaceuticals Technology
Vaccine Testing and Approval Process | CDC. (2020). Centre for Disease Control and Prevention. CDC.GOV