Since vaccines are given to healthy trial participants, absolute transparency about the procedure followed is essential, says Gagandeep Kang
No vaccine has ever been developed as rapidly as the covid-19 vaccine, the World Health Organization (WHO) has said. India is at the forefront of global vaccine development and manufacture. However, making the covid-19 vaccines available to the poorest and most vulnerable will be a real challenge for the government, though plans for the roll out are underway. Noted Indian scientist Dr Gagandeep Kang, the vice chair, Coalition for Epidemic Preparedness Innovations (CEPI), a global non-profit aiding vaccine development platform for the covid-19 pandemic, and professor at the Christian Medical College (CMC), Vellore, Tamil Nadu, spoke about covid-19 vaccine development in India, immunization roll-out plans, challenges and the way forward. Edited excerpts from an interview:
India is looking at various vaccines from Russia’s Sputnik V and Oxford and Pune-based Serum Institute of India (SII)’s Covishield to Covaxin, which is being developed by Bharat Biotech in association with the Indian Council of Medical Research (ICMR). Not many of these vaccine manufacturers have shared much about adverse reactions and have not addressed concerns about the safety of these vaccines so far. Is there a lack of transparency regarding covid-19 vaccines globally as several clinical trials were earlier stopped over safety issues and then resumed?
Safety is always paramount for all vaccines and especially for new platforms as in the pandemic. The usual process for safety monitoring is that if there is any serious adverse event, usually a hospitalization or death, the principal investigator who leads the study at the site will follow up to obtain as much information as possible and report it to the institutional review board or ethics committee. It does not matter whether the serious adverse event is obviously related to the vaccination or not, it must be reported.
So, it is possible that a trial participant was hit by a car and had fractures, or a participant had sudden seizures. All serious adverse events must be reported. After reporting to the ethics committee, the sponsor, usually the company making the vaccine, the Drugs Controller General of India (DCGI), and the independent Data Safety and Monitoring Board (DSMB) committee must also be informed. The principal investigator must ensure that no matter what has happened, the participant is provided the right medical care and followed up carefully. All the information about the follow up will be submitted to the ethics committee and the DSMB, which will then work with the investigator to figure out whether what happened to the participant is definitely not related to the vaccination, could possibly be related to the vaccination, or is probably related to the vaccination. This determination needs to be submitted to the sponsor, the DCGI, and the ethics committee, which will work together to determine whether any serious or permanent injury has resulted for the participant and what should be done to ensure that he/she is looked after, including the question of compensation and second, what this means for vaccine safety. Is this related? How common is it? How serious is it? What does this mean for risk versus benefit? Should the vaccine development programme continue?
Usually, for one or two cases it is very difficult to make a determination of whether vaccination is related to the serious adverse event. When you vaccinate apparently healthy people and follow them up, you will find after a while that they are not all as healthy as they appeared. New diagnoses of diabetes, kidney disorder, or neurological disorders can happen and to determine whether these are vaccine related requires some understanding of the background rates of such illnesses in the population to see whether the condition is being seen in the vaccinated people more often than expected for that population. This is very challenging unless there is a clustering of cases or a very large increase in cases.
As vaccines are given to healthy people, absolute transparency about the process followed is essential. I think that in the case of the trials being stopped for 1-2 cases and then resumed, that is actually good news, that the process is being followed and trial participants are being protected as we expect. It is important to emphasize that trials are not stopped for every serious adverse event and only for those where there is reasonable inference of a potential for relatedness to make sure that all investigations are reviewed. If it is not possible to decide even after this, the trial consent may be modified to ensure that any such events are reported quickly and early.
Ordinarily, every serious adverse event will have a system of reporting and all information about a participant will not be published in the newspapers, but will be available to the investigators, the institutional review boards/ethics committees, sponsors, DSMB and regulators, who will determine what is in the best interest of participants. However, given the current situation with heightened concerns, perhaps there should be more information available in the public domain. However, it is up to the regulators to decide whether that should be the case, how much information should be shared and in what format.
How much time do you see from now on in actual availability of a safe and effective covid-19, which is ready to roll out in the country?
I think it is likely that we will have a licensed vaccine in first quarter of 2021, most likely from Serum Institute of India (SII), after that from Bharat Biotech and then from Gamaleya, Bio E and Zydus, all in 2021. Ramping up distribution will take time and will continue from the first quarter well into 2022. My optimistic timeline for all the Indian population to be covered with vaccination for covid-19 is the end of 2022, beginning of 2023.
The government has not decided about pricing of the covid-19 vaccine. How can the price of the vaccine be reduced so that it can be made equitably available for all?
The government has a responsibility to not differentiate between vaccines for SARS-CoV2 and any other vaccines that are recommended in the national immunization programmes and hence any vaccine provided by the government should be free. That said, in the current immunization schedule, many people do not get their vaccines from the government and buy their vaccines at a very high cost from private providers and hospitals. Will there ultimately be a two tier system for SARS-CoV2 vaccines as exists for all other vaccines at the moment? I think that is feasible, but I hope that there will no diversion of vaccines that are intended for priority populations as defined by the government. Those most in need should get vaccines first, not just in India but around the world.
What about the covid-19 vaccination to be delivered through India’s universal immunization program? Do you agree with the government strategy of rolling out the vaccine in order of priority?
So far, all vaccines recommended by the government have been delivered by the government and in parallel for segments of the population that seek private healthcare, by other providers. For SARS-CoV2 we are likely to have limited supply and the government clearly intends to roll out the vaccine that it purchases or has supplied through the Covax facility. That is appropriate and the broadly defined priorities seems aligned to WHO. The only suggestion I have is for the government to develop and deliver targeted communication about the value of vaccination and the processes to be followed as early as possible, given that we have never taken on such a challenging task before.
A mass vaccination programme for covid-19 will come with more demands ranging from more manpower and trained people to administer the vaccines. What challenges do you see before the government in this exercise and how do you think these can be overcome?
Delivery of public health services is an opportunity for not just improving health but for employment and skilling of old and new health workers. With good planning, I hope that this vaccination campaign will be the foundation of sustainable improvement in primary healthcare in India.
Vaccine nationalism is a huge worry. This is a global problem and it is important to understand that even if we vaccinate our entire population the first time around, with global trade and travel, we are continually vulnerable as long as there is infection somewhere in the world. It is better to be global citizens to support synchronized uniform distribution of vaccines to prioritized populations around the world.
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