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  • Raghav Sand

COVID-19 Vaccination in India: Approval and Strategy

Economics and logistics played a pivotal role in India’s approval of the COVID-19 vaccines developed by Bharat Biotech and Serum Institute of India (SII). Covishield by SII, based on the Oxford AstraZeneca vaccine, and Covaxin by Bharat Biotech will be offered to frontline workers and health workers on priority basis. Covishield is a two-dose vaccine. Health Ministry estimates that 3 crore (30 million) personnel will be immunized in the first phase, and the drive shall commence in the second half of this month. The approval to both the vaccine candidates was formally announced by Central Drugs and Standards Committee (CDSCO) on 3rd January, Sunday.

Emergency Use Sanction

Both Covishield and Covaxin have been approved for emergency use in haste, argue noted health experts. “I am completely unaware of any data that suggest that Covaxin has any efficacy against any SARS-CoV-2 strain, let alone the U.K. strain”, Gagandeep Kang, Professor, Christian Medical College, Vellore, said in an interview to CNBC-TV18. Covaxin was referred as a “back-up vaccine” by Randeep Guleria, Director of the All India Institute of Medical Sciences.

Health Ministry seems to be caving in to the pressure for delivering a vaccine; it followed in the footsteps of its U.K. counterpart and may have based its judgement on borrowed wisdom. Covishield has reported an efficacy of 62-90 per cent, which is short of Moderna, at 94.5%, and Pfizer, at 95%

Efficacy and Efficiency: Myriad Misconceptions

Efficacy can be defined as the performance of an intervention under ideal and controlled circumstances, whereas effectiveness refers to its performance under ‘real-world’ conditions. Unfortunately, the distinction between these two types of trials is often poorly understood.

As per JM Fritz and J Cleland in their paper, Effectiveness versus efficacy: more than a debate over language, “the distinction between the two types of trial is a continuum rather than a dichotomy, as it is likely impossible to perform a pure efficacy study or pure effectiveness study”. It is crucial for any study to provide sufficient data regarding the trial’s setting, participants, and intervention.

A trial with an insufficient description regarding the intervention is effectively rendered useless, as external implementation and validation is impossible. The 62% efficacy clears the 50% hurdle set earlier this year for emergency authorization of Covid-19 vaccines by regulators including the U.S. FDA.

Cost to Conquer

AstraZeneca has announced that it will not be making a profit from the vaccine during the pandemic. It has an agreement with SII to provide a billion doses of the vaccine to developing countries. SII is the world’s largest vaccine maker by capacity, making more than a billion doses a year for everything from polio to measles, primarily for export to developing countries. Adar Poonawala, CEO, SII, has announced that Covishield will be sold to at ₹1000 for private buyers – subject to Government approval – and at ₹200 per dose to the Government.

COVID-19 Vaccines Operational Guidelines

The Health Ministry released operational guidelines on 28th December 2020 for the COVID-19 vaccination drive. One of the milestones in this direction has been the constitution of a National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The NEGVAC will guide all aspects of the COVID-19 vaccine introduction in India.

High-level coordination at the national, state and district levels will be key for effective cooperation and collaboration among the key departments. 19 ministries at national level, 23 departments at state/district and numerous developmental partners are involved in planning the COVID-19 vaccine introduction.

COVID-19 vaccine will be offered first to healthcare workers, frontline workers and population above 50 years of age, followed by population below 50 years of age with associated comorbidities based on the evolving pandemic situation, and finally to the remaining population based on the disease epidemiology and vaccine availability.

The priority group of above 50 years may be further subdivided into those above 60 years of age and those between 50 to 60 years of age for the phasing of roll out based on pandemic situation and vaccine availability. The latest electoral roll for the Lok Sabha and Legislative Assembly election will be used to identify the population aged 50 years or more.

The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform will be used to track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis. At the vaccination site, only pre-registered beneficiaries will be vaccinated per the prioritization, and there will be no provision for on-the-spot registrations. The entire vaccination process will be broadly similar to the election process.

Essential and Frontline Workers

COVID-19 Vaccination Communication Strategy

Ministry of Health has released communication strategy for rollout of COVID-19 vaccine in India. It seeks to disseminate timely, accurate and transparent information about the vaccine(s) to alleviate apprehensions about the vaccine, ensure its acceptance, and encourage uptake.

Key Areas of COVID-19 Vaccine Communication Strategy

The strategy will also serve to guide national, state and district level communication activities, so that the information on the COVID-19 vaccines and vaccination process reaches all people, across all states in the country.

Messengers of Vaccine

Now that Covishield and Covaxin have been approved for emergency use in India, it will be essential to create awareness and bust the myths in public domain. Selected religious leaders, influencers, social mobilisers and volunteers shall attend orientation sessions in order to educate the community members; they shall be equipped to answer basic queries and counsel the beneficiaries of vaccine.

Those who are selected as the messengers of vaccination drive shall follow COVID-19 appropriate behaviour, including but not limited to wearing masks, thoroughly and frequently washing hands, and maintaining social distancing guidelines. Keeping track of information about COVID-19 vaccine from credible sources (e.g. Ministry of Health) has also been mandated for messengers of vaccine.

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