Articles Perspectives

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)

Sl.No.

Name/ /manufacturer Country of Origin Platform Dose Efficacy demonstrated (based on published data)

Status

1.

CoronaVac, Sinovac China Inactivated (formalin-inactivated and alum-adjuvanted) 2 (0, 14 days) demonstrated safety and immunogenicity -Emergency approval in China. -Undergoing Phase 3 in Brazil.

2. 

Wuhan Institute of Biological Products/Sinopharm

China Inactivated virus 2 (0, 21 days) demonstrated strong neutralizing antibody response

-Emergency approval in UAE

-Undergoing Phase 3 in UAE, Peru, and Morocco

3.

Beijing Institute of Biological Products / Sinopharm China Inactivated virus 2 (0, 21 days) safe and tolerable

-Undergoing Phase 3 in China

4.

AZD1222, University of Oxford / AstraZeneca UK Non-Replicating Viral Vector (ChAdOx1-S) 1 demonstrated humoral and cellular immune response.

-Undergoing Phase 3 in USA, India, Brazil

5.

mRNA-1273, Moderna/ NIAID USA RNA Vaccine 2 (0, 28 days) demonstrated neutralizing antibody response

-Undergoing Phase 3 trial in the USA

6.

Sputnik V, Gamaleya Research Institute Russia Non-replicating viral vector (Adeno- rAd26 and rAd5) 2 (0, 21 days) demonstrated strong humoral and cellular response

-Approved for early use in Russia

-Undergoing Phase 3 in Russia, UAE, Belarus, and phase 2/3 in India

7.

Ad5-nCoV, CanSino Biological Inc. / Beijing Institute of Biotechnology China Non-Replicating Viral Vector (Adenovirus- Ad5) 1 safe and induced strong immune response

-Approved for limited use in China

-Undergoing Phase 3 trial in China, Pakistan, Saudi Arabia, and Russia

8.

JNJ-78436735, Johnson & Johnson USA Non-replicating viral vector 2 (0, 56 days) demonstrated safety and immunogenicity

-Phase 3 trials in the USA, Brazil, Colombia, Peru, Mexico, Philippines, South Africa

9.

NVX-CoV2373, Novavax USA Protein Subunit (nanoparticle vaccine) 2 (0, 21 days) safe and participants developed antibody response -Phase 3 trials in the UK

10.

BNT162, Pfizer/BioNTech/ Fosun Pharma Germany/

USA

RNA Vaccine 2 (0, 28 days) induced antibody and TH1 cell responses

-Phase 3 in USA, Argentina, Brazil

11. Covaxin, Bharat Biotech/National Institute of Virology/ICMR India Inactivated vaccine (Whole-Virion) 2 (0, 28 days) demonstrated safety and immunogenicity

-Phase 3 trials in India

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.  

About the author

Saurabh Kumar

Saurabh Kumar

Saurabh Kumar is a Young Policy Professional affiliated with DST-Centre for Policy Research at the Indian Institute of Science (IISc), Bengaluru. Presently he is hosted at the Department of Science & Technology (DST), Government of India, New Delhi. He completed his B.Sc in Zoology (Hons) from Shivaji College, University of Delhi, followed by Masters in Life Sciences from the Central University of Punjab. He has more than four years of research experience from the National Institute of Immunology (NII), New Delhi, and the Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh. He has 17 international publications in peer-reviewed journals and is also acting as a reviewer for many international journals. Innovation in herbal medicine and its wide use for humankind through Indian technology are his primary research interests and he aims to improve the Indian education system.

About the author

Madhu Chopra

Madhu Chopra

Ms. Madhu Chopra is presently in her final year of Ph.D., PGIMER, Chandigarh. She completed her Master's degree in Biochemistry from Panjab University, Chandigarh. Her area of research focuses on Hepatic Encephalopathy in patients with liver cirrhosis. She also has experience in the psychometric analysis (psychometric hepatic encephalopathy score) in Hepatic Encephalopathy patients. She has clinical research experience of more than 9 years. She has presented her work in several national and international conferences and workshops, and her research papers have been published in many peer-reviewed international journals. Her RG score is 22.49.

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