COVID-19 vaccine: Roll-out plan in India

In a historic turning point, the US Food and Drug Administration (FDA) cleared Pfizer’s Covid-19 vaccine for emergency use, and this makes America the sixth country after Britain, Bahrain, Canada, Saudi Arabia, and Mexico to breeze in for COVID-19 vaccination. This decision is not only a ray of hope to the American citizens but for millions of highly vulnerable people around the world.

According to WHO, as of November 12, 2020, there are 48 vaccines in Clinical Trials and 164 candidate vaccines in Pre-clinical evaluations. The development of immune memory by vaccines is what will protect the person against subsequent COVID-19 infection.

Role of the World Health Organisation (WHO)

Began on April 7, 1948, as the directing and coordinating authority on international health within the United Nations system, the WHO states its primary objective as ‘the attainment by all peoples of the highest possible level of health.' Apart from tracking the pandemic, publishing rolling updates, advising on critical interventions, distributing medical supplies to those in need, WHO is racing to find an affordable vaccine for every nation. WHO has launched the ‘Access to COVID-19 Tools (ACT) Accelerator’ to accelerate the development, production, and equal access to diagnostics tools, therapeutics, and vaccines. This is in close collaboration with scientists, business, and global health organizations such as the Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovation (CEPI), the Foundation for Innovative New Diagnostics (FIND), Global Alliance for Vaccines and Immunisation (GAVI)-the Vaccine Alliance, the Global Fund, Unitaid, Wellcome Trust, and the World Bank.

COVAX, one of four pillars of the ACT Accelerator will ensure the equal distribution of vaccine to the entire world. The first round of 2 million safe and effective vaccine doses will be available to high risk and vulnerable people, as well as frontline workers by the end of 2021. At present, 78 higher-income countries and economies have now confirmed their interest in participating in the COVAX Facility, with more possibly to follow where nine vaccines are already in the development phase, and the other nine are under evaluation.

Status of the COVID-19 vaccine in India

India's Bharat Biotech International Limited, Serum Institute of India (SII), Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax, and Biological E are among the major domestic players that have already joined the global efforts to find a preventive measure against the COVID-19. The Government of India is proactive and providing all necessary support for the development of the vaccine against the COVID-19. The recent visit of the Hon’ble Prime minister has encouraged the vaccine manufacturers and scientists. The Vaccine Task Force was constituted on April 14, 2020, co-chaired by Principal Scientific Advisor to Govt. of India and Member (Health), NITI Aayog, representatives from the relevant Ministries of Government of India and technical experts for guiding focused research on Corona vaccines and other science and technology issues.

India is actively considering three vaccine candidates - BioNTech/ Pfizer's coronavirus vaccine; one being developed by the SII in partnership with AstraZeneca and Oxford University, and the last one is the indigenous inactivated vaccine based on the SARS-CoV 2 virus in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune by Hyderabad-based Bharat Biotech.

The Indian arm of the US drug firm Pfizer had sought an Emergency Use Authorisation (EUA) for their Covid-19 vaccine from the Central Drug Regulator of India (CDRI) days back after the firm secured such clearance in Britain, Bahrain, and Singapore. The SII plans to make up to 10 crore doses of Oxford University-AstraZeneca vaccine (dubbed as Covishield in India) each month, starting next year.

Table 1: Types of Vaccines: on India’s roadmap   

Roll-out Plan

National Expert Group on Vaccine Administration for COVID 19 was constituted on August 7, 2020, under the chairmanship of member (Health)from NITI Aayog and Secretary, Health and Family Welfare (H&FW) as Co-chair to provide the guidance on the roll-out plan of COVID-19 vaccine. This committee is planning for the prioritization of population groups, procurement and inventory management, vaccine selection, and vaccine delivery and tracking mechanism. The representatives from the relevant ministries of Government of India, five State governments’ viz. Assam, Madhya Pradesh, Maharashtra, Tamil Nadu, and Uttar Pradesh and technical experts are also a part of this committee.

The Indian government has started the preparatory activities to roll out a huge vaccination drive through Co-WIN: Digital Platform. Based on the electoral experience and universal immunization programme, the multi-level coordinating mechanism will be used in collaboration with states/UTs at the level of states, districts, and blocks.

As per the strategy shared by the H&FW, 60 crore doses will be administered to the 30 crore Indians in the first phase. It will include one (01) crore healthcare workers (HCWs), about two (02) crores frontline workers including personnel from state and the central police department, armed forces, home guard, and civil defense organization including disaster management volunteers and municipal workers (excluding HCWs), and about twenty-seven (27) crore people above the age of 50 years. After this, vaccines will be given to those below 50 years of age suffering from a chronic critical illness. Data collection, uploading on Co-WIN software, monitoring, and verifying process is already going on.  The concern authorities planned and executed state steering committee meetings and state task force meetings from state to block level.

A draft SOP issued by the H&FW to all states and union territories stated that 100 people should be vaccinated per day at a site in a timespan of no more than 13-14 per hour. 200 people can be vaccinated if sufficient resources are available at that site. The schools, community halls, or tents with drinking water and toilet facility can be used as a vaccination site. Only 1.54 lakh vaccinators (ANMs) out of a total available around 2.39 lakh ANMs across the country will be used for the COVID Vaccination. It may have minimal impact on routine Universal Immunization Programme (UIP).

Another challenge is to maintain the cold chain of the vaccine. Vaccines are temperature sensitive and required an optimum facility to store them. At present, there are 85,634 pieces of equipment for the storage of vaccines at about 28,947 cold chain points across the country. The current cold chain capacity may store an additional quantity of Covid-19 vaccine required for the first 3 Crore, i.e., Health Care Workers and Front Line Workers. The ministry is in consultation with States/UT to explore the additional requirement like walk-in coolers, freezers, deep freezers, ice-lined refrigerators, etc. Additional procurement for syringes, needles, and other logistics like Vaccine Vial Monitor (VVM) is also on track. 

Conclusion

Many COVID-19 vaccines are ready for administration, and others are in the pipeline. These vaccines have been developed in a short span of time compared to the regular vaccine's development process. Vaccine development moves through the established pipelines from pre-clinical studies, phase 1, phase 2, phase 3 to the phase 4 trials. These steps are required for rigorous safety and efficacy testing of the vaccine. The vaccine is safe and effective in most cases. However, there is a need to address the doubts of the common men against the vaccine quality, efficacy & safety and subsequently prepare people to accept some adverse effects as happen with all vaccines. A transparent, effective, and sustained communication is required for a successful roll-out plan of the COVID-19 vaccine in India.

References

1. https://www.who.int/emergencies/diseases/novel-coronavirus-2019/covid-19-vaccines

2. https://static.pib.gov.in/WriteReadData/userfiles/Press%20Briefing%208th%20Dec%202020.pdf

Jyoti Sharma¹ and Sanjeev Kumar Varshney²

Senior Scientist¹, Head & Advisor², International Cooperation Division (ICD), Department of Science and Technology, Ministry of Science and Technology, Govt. of India

Disclaimer: This work has been submitted by the author. Any opinions, findings, conclusions or recommendations expressed in this article are those of the authors only.