COVID-19 vaccine development: need for a pre-planned vaccination program

Image: Created by Saurabh Kumar (Created with BioRender.com)

As we begin the new year 2021, we expect to have an effective vaccine to tackle the present COVID-19 virus. The highly infectious single-stranded positive-sense RNA novel coronavirus (nCoV) is known to have affected humans in late 2019, shortly afterwards WHO declared it a pandemic. So far, it has killed 1,449,373 and infected 62,010,669 people worldwide. As of November 24, 2020, FDA has given Emergency Use Authorization (EUA) to 291 tests (225 molecular, 59 antibodies, 7 antigen-based tests). Remdesivir, bamlanivimab, and convalescent plasma (CP) are the only EUA-FDA drugs/therapies approved for hospitalised COVID-19 affected individuals. 

More than 212 vaccines are in the development stage, including 164 in preclinical and 48 in clinical stage. The race towards developing an effective vaccine is quite impressive, especially when we look at  previous experiences that usually took about 10 years. Around 7% of vaccines at the preclinical stage succeed, and reach clinical stages, with only 20% chances of further success. We may need more than one vaccine type for a different population group, like one may not work in the old-age population. Of the 48 vaccines undergoing clinical trials, 11 are in the Phase-III evaluation stage. The platform adopted to develop these vaccine types includes inactivated virus, RNA/DNA vaccines, protein subunits, viral vectors, or live-attenuated virus. 

Table 1: List of potential COVID-19 vaccines undergoing phase-III clinical trials (compiled from WHO (1, 2), RAPS)

Table 1 outlines the potential COVID-19 vaccines undergoing Phase-III clinical trials, which have shown promising results during their early course of development, but it is not necessary that all of them will get final approval. Therefore, it becomes crucial to have the right approach to deliver promising vaccines to protect humankind. In April 2020, WHO launched a collaboration strategy called access to COVID-19 tools (ACT). The primary purpose of launching the ACT was to bring scientists/researchers, governments, civil society, philanthropists, businesses, and health organizations together at one platform to speed up all the possible ways (including testing, treatments, and vaccination) to tackle the pandemic. In a similar way, WHO has launched COVAX, a platform that will ensure that once a safe and effective vaccine is ready, it reaches out to the right people, i.e., the one at higher risk (frontline healthcare workers/vulnerable people). WHO, GAVI, and Coalition for Epidemic Preparedness Innovations (CEPI) look after the COVAX. COVAX aims to support various vaccine candidates’ scientific research and development and further their manufacture and price negotiation. 

While the race for vaccine development is still ON, based on early promising data shown by these 11 vaccines, we can expect to have at least one or two approved for ready-to-use purposes by early 2021. In this situation, a pre-planning strategy can work for countries. At the country level, the government can form a regulatory or monitoring body that can look after all the possible strategies. For this purpose, the WHO developed a Vaccine Introduction Readiness Assessment Tool (VIRAT). Countries can use VIRAT as a directional map. This pre-planning approach includes 1) Adequate planning and coordination: a national committee with various roles and responsibilities. 2) Regulatory pathway and surveillance: to ensure timely approval, prioritisation, and administration of the vaccine 3) Adequate training, supervision and service delivery: to reduce chances of contamination and ensure proper administration during immunisation process. 4) Monitoring and evaluation: a framework for wide distribution and acceptability. 5) Vaccine transportation  and Safety surveillance: a proper standard operating procedure (SOP) for cold chain supply of the vaccine. vaccine pharmacovigilance team will ensure the safety issues during the immunisation session. The policymakers and the governments can use these approaches to develop an initial strategy for vaccinating the population. It will also enable the government to have a speedy and effective vaccination program.