Pune, October 2, 2020: The most awaited vaccine ‘Covishield’ is one of the highly watched events in the country. With the human clinical trials by Serum Institute of India (SII) entering its third phase, the Oxford University and AstraZeneca have collaborated to give the world a new ray of hope by manufacturing a vaccine for eradicating the novel Coronavirus disease (COVID-19) that has gripped the world. Citizens have been curious and have several queries about the vaccine and its side effects.
To bust all the myths and fears about the trial, Punekar News journalist Mehab Qureshi spoke to IT professional Sandip Chakrabarti (47) of Baner, who is a volunteer in the third phase trial of Corona vaccine. He got the first dose on September 25. He lives with his wife and his 18-year-old son. Chakrabarti discussed what it’s like to participate in a COVID19 vaccine trial and busted misconceptions about the vaccine.
Mehab: How is this vaccine study process which you have volunteered for? How much time will you have to commit?
Sandip: This is the Phase 3 trial of the Covishield, which is being conducted under the guidelines of the Indian Council of Medical Research (ICMR) and being done for Serum Institute, who is manufacturing this in the Pune factory. Volunteers are committed for 187 days, which is almost six months.
Mehab: Are you allowed to do your regular chores?
Sandip: Volunteers can do regular work. But there are certain clinical aspects like pregnancy, childbearing, etc. are considered separately depending on the individual’s specific health conditions.
Mehab: Are you permitted to move out of town for a few days?
Sandip: Volunteers need to attend monthly scheduled visits at the hospital. Hence, traveling needs to be planned accordingly.
Mehab: What were the medical parameters checked before considering you for the study?
Sandip: Detailed examination was carried out like the COVID test ( must be negative) -RTpcr, Antibody test, BP, pulse, height, weight, medication habit, if any.
Mehab: What motivated you to join this program despite having a family?
Sandip: The whole planet is going through a pandemic; all normal activities have come to a halt. Humanity is in a crisis. Only an effective vaccine can get us rid of this pandemic. When that vaccine trial is happening in my city, it is our duty to come forward to help in whatever way possible. This made me volunteer for the Human Trial of Covishield.
Mehab: How was the consent process? Were you explained in detail?
Sandip: The consent process is very detailed because it is based on the global testing standard and ICMR protocol. Standard format explains everything to the volunteers and informed consent is taken by signing the forms in the doctor’s presence. I was explained the impact and risks, whatever unlikely it is, before signing the consent document.
Mehab: Could you please explain to us about the trial process?
Sandip: Phase 3 human trial is going on at four Pune hospitals. I volunteered at Jehangir Clinical Development Center (JCDC). On Day 1- a detailed clinical examination and the vitals of the volunteer are measured. Once these are accepted, then consent will be signed. When the tests’ results are received and found to be favorable, the trial dose is injected. The primary condition is that the volunteer must not have been COVID positive in the past or present. Injection of the vaccine is not even felt. It is quickly given.
Mehab: Tell us about the side effects that you’re observing in your body.
Sandip: There is detailed information about the possible side effects of the trial on the body. After all, it is a trial for a new vaccine, so there is an unknown element. For me, so far, it has been mild fever and headache, which is not a surprise in this type of experiment—no other effects till now.
Mehab: Do you have any symptoms of COVID?
Sandip: No symptoms of COVID19. It is just mild symptoms of post vaccine sickness.
Mehab: In the future, if there is a need, will you be able to donate blood? Because after taking a few vaccine shots, one is not allowed to donate blood for a period of 6-12 months.
Sandip: Yes, in this case, also, there is a restriction. We shall be communicated as the study progresses. It is advisable not to donate blood for a certain period, as this is a trial phase.
Mehab: Are there any restrictions on your diet? Food which you are allowed or not allowed to eat?
Sandip: There are no restrictions whatsoever on the diet.
Mehab: What changes have to notice pre and post-vaccine shots on your health?
Sandip: Initial days of light fever and body ache is experienced.
Mehab: If you notice some side effects, what will be the doctors’ approach towards solving it?
Sandip: Yes, we are connected to doctors and given phone numbers to contact for any problems.
Mehab: The most important question, any misconception that you would like to clear?
Sandip: Any trial is part of new experiments. So, there is naturally an element of fear amongst common people. But we need to remember that there have already been 2 phases of trial in different parts of the world. This is the 3rd and the last phase, which involves a much bigger sample size and longer duration. And it is done very carefully and with caution, so I don’t see a reason to be afraid. Healthy citizens should come forward to help the medical science fraternity.
Mehab: Any advice you would want to give people who wish to consider participating in the trial process?
Sandip: Volunteers must be clear to themselves about the noble cause they will help and discuss with the family members. All medical conditions to be revealed during a fitness test. Discipline is the key to any strenuous activity; hence, we must adhere to all the successful trial process guidelines.