Regulators are not taking any short cuts to ensure the safety of the COVID-19 vaccine, says NTF member NK Arora.

Dr NK Arora, The New Delhi-based INCLEN Trust Executive Director and Head of the ICMR National Working Group COVID-19 Operational Research Group said all safety related information will be shared with the public as they will emerge with the use of the COVID-19 vaccine.

This is the first time that the government will vaccinate adults. Does this require special preparation?

Yes. India has a vaccine safety monitoring mechanism called AEFI (Adverse Events Following Vaccination) surveillance. It is made up of a national secretariat under the Universal Immunization Program (UIP), comprising doctors, data specialists and public health specialists. The vaccine safety surveillance network spans all districts where a group of doctors and health workers monitor events of concern after receiving a vaccine, investigate and report to states and nationally.

COVID-19 required immunization of the adult population. The government has now involved cardiologists, neurologists, general practitioners and pulmonologists in AEFI committees at the national, state and district levels.

At present, we are predicting – in theory – some worrying events that could eventually occur after the vaccination campaign. Members of the AEFI will be trained to look for any adverse events before starting the vaccination process. Adverse event surveillance is being established to actively seek out these events in designated health facilities across the country. In addition, there are approximately 300 medical schools and tertiary care hospitals across the country that have Adverse Drug Reaction Monitoring Centers that also report adverse events after vaccines with the drugs.

What kind of awareness programs do we need before we roll out the COVID vaccination?

We need to educate people and make them aware of lesser known facts about vaccines. For example, some people may face mild symptoms such as pain or swelling, mild fever, among others. It’s a normal immune response.

Next, it is important for people to know that the vulnerable population – the elderly, people with associated diseases, such as diabetes, chronic lung disease, high blood pressure, kidney disease, cancer and others can, if not too, suffer from sudden health problems. like a heart attack. We cannot and should not link it to the vaccine in all cases. I think we need to practice “exceptional transparency” in this case. I assure that all safety related information will be shared with the general population as it emerges from the use of the COVID-19 vaccine (s) in our country or any other part of the world with the same vaccine.

Indian regulators gave Covaxin clearance even before the results of its Phase III trial were released. How do we explain this?

We are going through troubled times. COVID-19 has caused social disruption, an economic downturn and a significant number of deaths. To control this pandemic, society as well as the system may need to take actions that can also be described as drastic. The preclinical and clinical data (complete data for phases I and II and partial data for phase III) of Covaxin have been carefully reviewed by regulators. These data show that the vaccine is safe and induces a robust antibody response. However, to what extent the vaccine will protect recipients against the disease is not yet known. Therefore, regulators have allowed its use in test mode.

What would the test mode mean for a vaccine recipient?

The way we do in a clinical trial phase: First, the recipient will be asked to give written consent. Then he / she will have blood tests before and after taking the vaccine. In addition, the recipient will be actively monitored to see if the vaccine has caused any side effects. In short, it will be an extension of the Phase III trial. But in this, the person would know that they received the vaccine and not the placebo. It will be entirely up to the person whether or not to try the vaccine.

Developing a vaccine takes years. But this time, our scientists have developed a vaccine against the coronavirus in such a short time. How was this possible?

Developing a vaccine usually involves years of research. First, we need a vaccine candidate whose safety and efficacy are evaluated in animals. Once a vaccine candidate has passed a preclinical trial, it enters the clinical trial phase. While scientists worked around the clock in the lab, even regulatory approvals that took several months were pretty quick. It has helped eliminate all time intervals between the stages of preclinical and clinical trials. Previously, vaccine development involved a series of steps, but in the case of the coronavirus vaccine, scientists and regulators worked in tandem, speeding up the whole process without compromising on protocols and steps.

What is your opinion on the safety and effectiveness of the vaccine?

To make sure a vaccine is safe, we have to try it on a large number of people. Vaccine developers have not reduced the sample size at any stage of clinical trials, but rather larger than what we usually test a vaccine on.

When a vaccine is tested, most side effects or side effects, if any, occur within the first four to six weeks of its administration. So in order to make sure it’s safe, we keep a close eye on who it’s been in for the first two to three months. This data helps us decide whether a vaccine is safe. All parties involved in vaccine development, testing and evaluation have followed these procedures through to completion. Both Indian vaccines are considered safe in this regard.

As for the effectiveness of the vaccine, we need time to say how effective a vaccine is. All global agencies have set the benchmark that only candidate vaccines that show at least 50-60% efficacy will be considered. Interestingly, most vaccines showed 70-90% efficacy within the short 2-3 month observation period, much more than we expected. Additionally, when a vaccine receives emergency use authorization, as in the case of the COVID-19 vaccine, trial follow-ups continue for one to two years to assess the total duration of protection that the vaccine has. will offer.

What is emergency use authorization. Does this mean shortcuts on the part of our regulators?

Not at all. In fact, our regulators are taking extra precautions. Some candidate vaccines have not been reviewed by our regulatory bodies because the data was inadequate; some companies have been asked to increase their sample size so that our regulators can have sufficient evidence to support the safety and efficacy of the vaccine before approving it.

Likewise, Indian regulators wanted the UK regulator to approve the Oxford vaccine first before even considering it for the Indian population. An important prerequisite for the authorization of the COVID-19 vaccine for our country is – the vaccine should have been evaluated on subjects in India. Regulators are not taking any short cuts to ensure the safety of COVID-19 vaccines.