Vaccine transparency

The clarification by the Indian Council of Medical Research (ICMR) that Bharat Biotech's Covid-19 vaccine has been cleared in clinical trial mode means efficacy trials of indigenously developed Covaxin are not over and prior consent of the participants will be needed before vaccination.
Vaccine transparency

The clarification by the Indian Council of Medical Research (ICMR) that Bharat Biotech's Covid-19 vaccine has been cleared in clinical trial mode means efficacy trials of indigenously developed Covaxin are not over and prior consent of the participants will be needed before vaccination. This also means that there has to be regular follow-up of the participants. The ICMR clarification confirms that the approval to Covaxin vaccine was abrupt and the need for efficacy data as the condition of the approval was discounted. The Drug Controller General of India (DGCI) on January 3 approved AstraZeneca-Oxford University's Covid-19 vaccine Covishield, manufactured by the Serum Institute, and Covaxin for restricted emergency use in the country. Bharat Biotech's Covaxin has been developed jointly with ICMR labs. The Central government has indicated that much-awaited vaccination programme is set to be rolled out next week. The ICMR authorities have, however, allayed apprehension over the safety of the vaccine. "The phase I and II human trials showed there is very low adverse events and strong neutralizing antibody response, very similar to human convalescent plasma. Even though the phase III efficacy trials are not over, the vaccine's safety was clearly established in the 24,000 volunteers who received it, said ICMR Director General Balram Bhargava. About the Covishield, the ICMR chief said that the vaccine has "an acceptable safety profile and good vaccine efficacy" and in the studies carried out in 1,600 people in India, the vaccine was seen to be non-inferior to the UK vaccine.

The Central and the State governments will have to ensure that the participants are informed about the trial status of both the vaccines so that lack of scientific data does not cast a shadow over the vaccination programme. Indian scientists have proved their excellence in every field including medicine and therefore there can be no room for any doubt over their excellence to develop COVID-19 vaccine. However, sidestepping the due scientific process for granting abrupt approval to Covaxin has triggered the allegation of a command performance. The ICMR has said that the Indian rules allow the DGCI to give restricted approval for vaccine which has been proven safe and immunogenic in phase II trials in an emergency situation like the prevailing pandemic. The vaccination programme will be carried out across the country for simultaneous immunization of three crore healthcare and frontline workers. Altogether 37 state vaccine stores will receive the supplies of vaccines to be dispatched from four primary depots at Mumbai, Karnal, Chennai and Kolkata in refrigerated vans. The vaccines will then travel to district stores and down to the primary health centres and sub-centres along the cold chain. There will be 29,000 cold chain point for vaccinations of the frontline workers and health workers. Their data have already been uploaded on an IT platform and there is no need for them to self-register for vaccination. The system should invariably incorporate dissemination of information as to which of the two vaccines they are going to receive so that prior consent is taken from frontline worker and health workers before administering Covaxin on them. It should also have a built-in mechanism for the follow up of those agreeing to be given Covaxin to boost their confidence level.

Apart from the frontline and health workers, people above 50 years and people with comorbidities will be the priority groups for initial vaccination programmes in the country. The World Health Organization has lauded India's decision to go ahead with the vaccination drive and expressed confidence that as the largest vaccine producer in the world it is well placed to do so. The country's vaccination drive against COVID-19 will be the largest in the world when it if finally taken up to cover the entire population. It is going to be a gigantic exercise and will require meticulous planning and execution. Successful completion of the dry runs in various states including Assam show that the country is well prepared for the exercise. Even though pandemic curve is flattening, the guards must not be lowered till the successful completion of the vaccination programme. A fresh spike will have ruin the country's economy. Lessons must be learnt from the nightmarish experience of the United Kingdom where the new variant of COVID-19 has created havoc. The new UK variant of the virus has also reached India. The COVID-safety protocols of wearing facemask, hand sanitizing and maintaining physical distance in public places must be continued to stay safe. It is hoped that first round vaccination programme in India is going to be carried out successfully which is critical to boost confidence among the people that the pandemic will soon be over by united efforts by the world community. Transparency will be the key in mobilizing consent for participation in the vaccination programme and the lack of it will be counterproductive.

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