In a historic turning point, the Food and Drug Administration (FDA) cleared Pfizer’s Covid 19 vaccine for emergency use and becomes the sixth country after Britain, Bahrain, Canada, Saudi Arabia, and Mexico. This decision not only has shown a ray of hope to the American citizens but for millions of highly vulnerable people around the world……
By Jyoti Sharma/ Sanjeev Kumar Varshney
According to WHO (World Health Organisation), there are more than 50 vaccines in clinical trials and 164 candidate vaccines in preclinical evaluations. 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 with close collaboration with scientists, business, and global health organizations [the Bill & Melinda Gates Foundation, Coalition for Epidemic Preparedness Innovation (CEPI), the Foundation for Innovative New Diagnostics (FIND), Global Alliance for Vaccines and Immunization (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 9 vaccines are already in the development phase and the other 9 are under evaluation.
Mission COVID Suraksha
In India, 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.
‘Mission COVID Suraksha- the Indian COVID-19 Vaccine Development Mission’, has been launched by the Government of India, ‘to accelerate the development of at least 5-6 COVID 19 vaccine candidates and ensure that some of these are brought closer to licensure and introduction in public health systems to combat further spread of Covid infection’, stated by the Department of Biotechnology (DBT).
The Mission was announced as part of the third stimulus package with a provision of Rs. 900 crores to DBT. It aims to provide support from the developmental stage to manufacturing. DBT has already supported the development of approximate ten vaccine candidates in collaboration with academia and industries. This fund is used to support the up-gradation of the existing immunoassay laboratories, and the development of the Good Manufacturing Practices for animal toxicology studies and clinical trials. Eleven Good Clinical Laboratory Practice (GCLP) compliant clinical trial sites in a PAN-India manner are being prepared for the quick initiation of population-based clinical trials for COVID-19 vaccines. The immunoassay laboratory of the Translational Health Science and Technology Institute (THSTI) has become one of the six global networks of laboratories for centralized assessment of COVID- 19 Vaccines, recognized by the Coalition for Epidemic Preparedness Innovations (CEPI).
Currently, 05 vaccines are in different clinical trials of development. India’s Bharat Biotech International Limited, Serum Institute of India (SII), Zydus Cadila, Panacea Biotec, Indian Immunologicals, Mynvax, and Biological E are among the domestic pharma firms which have already joined the global efforts to find a preventive measure against the COVID-19. The three vaccine candidates are indigenous, and the other two vaccine candidates have been in-licensed to India. On one hand, SII is partnering with AstraZeneca and Oxford University and US-based biotech firm Codagenix; on another side the Bharat Biotech is developing 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.
Apart from these, nearly 03 vaccine candidates are in the advanced pre-clinical stage of development, and many are in the early stages of development.
Roll out Plan
National Expert Group on Vaccine Administration for COVID 19 was constituted on August 7, 2020, under the chairmanship of member (Health) NITI Aayog and Secretary, Health and Family Welfare (H&FW) as Co-chair to guide 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 defence 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 who are 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 to have 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 tahat 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). Additional procurement for syringes, needles, other logistics is also on track.
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 is 85,634 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.
Training Programme for the Vaccine administration
The WHO in close collaboration with UNICEF, Gavi, and partners has prepared the Vaccine Readiness Assessment Tool (VIRAT) tool to provide the adaptable guidance, procedures, training, and advocacy materials for the COVID-19 vaccination. A per the standard guidelines, all health workers need to have adequate knowledge and skills to ensure safety during the Covid-19 vaccine administration. The VIRAT may be used by the Ministry of Health of the respective countries to prepare the roadmap for the COVID-19 vaccination program and identifying the gap areas. The free online courses are available on the WHO website for health workers. In India, 2,360 training sessions including 7,000 medical officers, vaccinators, alternate vaccinators, cold chain handlers, supervisors, data managers, and coordinators of accredited social health activists (ASHA) have been trained so far.
Dry run for the COVID vaccination
The COVID-19 vaccines are waiting to receive the emergency use authorization in India. The government has already announced the dry run for vaccine administration in Andhra Pradesh, Assam, Gujarat, and Punjab to identify the gap areas in the preparatory process. This exercise will not only check the end-to-end mobilization but will also test the usage of ‘Co-WIN’.
The vaccines developed by Bharat Biotech, Serum Institute, and Pfizer are under process to get emergency-use approval by the Drug Controller General of India (DCGI). Other candidates are also in the pipeline at different stages. These vaccines have been developed in a short period as 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 mutation in the existing strain has become a matter of concern throughout the world. However, as per the statement issued by the Director of the All India Institute of Medical Sciences (AIIMS) and member of the national task force Delhi AIIMS director and member of the on COVID management that ‘the mutations have not led to any change in symptoms and treatment strategy. According to current data, the vaccines in the trial phase (which are up for emergency authorization) should also be effective against the new (UK) strain. There have been many mutations during the last 10 months, and it is quite common’, the available 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.
(The authors are Senior Scientist/ Head & Advisor, International Cooperation Division (ICD), Department of Science and Technology, Ministry of Science and Technology, Govt. of India)