India is studying various vaccines from Russia’s Sputnik V and Covishield to Covaxin from the Serum Institute of India (SII) in Oxford and Pune, which is being developed by Bharat Biotech in association with the Indian Council for Medical Research (ICMR). Not many of these vaccine manufacturers have shared much about adverse reactions and thus far they have not addressed concerns about the safety of these vaccines. Is there a lack of transparency regarding covid-19 vaccines globally, as several clinical trials were previously stopped for safety concerns and then resumed?
Safety is always paramount for all vaccines and especially for new platforms such as in the pandemic. The usual process for safety monitoring is that if there is a serious adverse event, usually hospitalization or death, the principal investigator leading the study on site will follow up to obtain as much information as possible and report it to the board. institutional review. or ethics committee. It does not matter whether the serious adverse event is obviously related to vaccination or not, it must be reported.
Therefore, 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 that makes the vaccine, the Controller General of Medicines of India (DCGI) and the independent committee of the Data Safety and Monitoring Board (DSMB) should also be reported. . The principal investigator must ensure that no matter what has happened, the participant receives appropriate medical care and is closely followed. All information about the follow-up will be sent to the ethics committee and the DSMB, who will then work with the investigator to find out if what happened to the participant is definitely not related to vaccination, could possibly be related to vaccination. or probably related to vaccination. This determination should be sent to the sponsor, DCGI, and the ethics committee, who will work together to determine whether the participant has sustained a serious or permanent injury and what must be done to ensure that they are cared for. including the question of compensation, and secondly, what does this mean for vaccine safety. Is this related? How common is it? How bad is it? What does this mean for risk versus benefit? Should the vaccine development program continue?
Generally, for one or two cases it is very difficult to determine whether vaccination is related to the serious adverse event. When you vaccinate apparently healthy people and follow up on them, you will discover after a while that they are not all as healthy as they seemed. New diagnoses of diabetes, kidney disorders, or neurological disorders can occur and determining whether these are vaccine-related requires an understanding of the background rates of such diseases in the population to see if the condition is seen in people vaccinated more frequently than the expected. for that population. This is very difficult unless there is a clustering of cases or a very large increase in cases.
Since vaccines are administered to healthy people, absolute transparency about the process followed is essential. I think in the event that trials are stopped for 1-2 cases and then resumed, that’s really good news, that the process is being followed and trial participants are being protected as we hope. It is important to emphasize that trials do not stop for every serious adverse event and only for those where there is a reasonable inference of a potential relationship to ensure that all research is reviewed. If a decision is not possible even after this, the trial consent can be modified to ensure that such events are reported quickly and early.
Normally, each serious adverse event will have a reporting system and all information about a participant will not be published in the newspapers, but will be available to researchers, institutional review boards / ethics committees, sponsors, DSMB and regulators, who determine what is best for the participants. However, given the current situation with greater concerns, perhaps more information should be available in the public domain. However, it is up to regulators to decide whether that should be the case, how much information should be shared, and in what format.
How long do you see from now on in real availability of a safe and effective covid-19, which is ready to be implemented in the country?
I think we will likely have a licensed vaccine in the first quarter of 2021, probably from the Serum Institute of India (SII), after Bharat Biotech and then from Gamaleya, Bio E and Zydus, all in 2021. Increasing distribution will take time And it will continue from the first quarter until well into 2022. My optimistic schedule for the entire Indian population to be covered with vaccination against covid-19 is late 2022, early 2023.
The government has not decided on the price of the covid-19 vaccine. How can the price of the vaccine be reduced so that it is equitably available to all?
The government has a responsibility not to differentiate between vaccines for SARS-CoV2 and any other vaccines recommended in national immunization programs, and therefore any vaccine provided by the government must be free. That said, in the current vaccination schedule, many people do not get their vaccines from the government and purchase 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 there is for all other vaccines at this time? I think it is feasible, but I hope there is no diversion of vaccines that are intended for priority populations as defined by the government. Those most in need should be vaccinated first, not just in India but around the world.
What about the covid-19 vaccine to be delivered through India’s universal immunization program? Do you agree with the government’s strategy of implementing the vaccine in order of priority?
So far, all government-recommended vaccines have been delivered by the government and in parallel for segments of the population seeking private health care, by other providers. For SARS-CoV2, we are likely to have a limited supply and the government clearly intends to implement the vaccine that it purchases or has supplied through Covax facilities. That is appropriate and the broadly defined priorities appear to be aligned with WHO. The only suggestion I have is that the government develop and deliver a targeted communication on the value of vaccination and the processes to follow as soon as possible, given that we have never taken on such a challenging task before.
A mass vaccination program for Covid-19 will come with more demands ranging from more manpower and people trained to administer the vaccines. What challenges do you see facing the government in this exercise and how do you think they can be overcome?
The provision of public health services is an opportunity not only to improve health but also for the employment and training of new and old health workers. With good planning, I hope that this vaccination campaign will be the foundation for a sustainable improvement in primary health care in India.
Vaccine nationalism is a huge concern. This is a global problem and it is important to understand that even if we vaccinate our entire population the first time, with global trade and travel, we are continually vulnerable as long as there is an infection somewhere in the world. It is better to be citizens of the world to support the uniform synchronized distribution of vaccines to priority populations around the world.
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