07 January,2021 10:25 AM IST | Mumbai | Vinod Kumar Menon
Experts say all information on vaccine trials and mass vaccination should be made public. Representation pic
Do citizens have the right to choose a COVID-19 vaccine? The FAQs of the Ministry of Health and Family Welfare (MOHFW) are silent on the issue. Ahead of a mass vaccine rollout, ethicists are raising the question: when it's my turn, will I have the choice between products that have variable contents, pedigrees, and efficacy levels? Medical experts and legal brains are of the view that citizens do have the right to choose, especially since data of the trial run of vaccines has not been made public, creating room for ambiguity and uncertainty.
Advocate Tishampati Sen, who practices at the Supreme Court and tribunals including consumer courts, said, "Vaccine invention, production and approval has been achieved at an unbelievable pace. While one hopes that this is a god-sent panacea, from a legal point of view there are grey areas. Two vaccines have been approved by the DCGI (Drugs Controller General of India) - Oxford-Astra Zeneca's âCovishield' and Bharat Biotech's indigenous âCovaxin' - on the basis of information only they are privy to. The deployment of the vaccines, including location-based selection, is up to the government alone at this stage."
"Even otherwise, the common man has no ability/criteria to choose a certain vaccine. Presently, the only choice that can be exercised is whether to get vaccinated or not," Sen said.
"There is widespread, positive recommendation by government and accredited doctors to get vaccinated, based on data provided by vaccine manufacturers to DGCI. But if the vaccine causes significant side effects and/or fails to prevent the disease, a consumer would, presumably, have the legal ability to bring a claim against the manufacturer and perhaps other stakeholders. Sufficient information is not available, yet there is a strong encouragement to get vaccinated," said Sen.
"Only time will tell how such a fast-paced vaccine rollout, at the risk of product liability claims by consumers, works out for the stakeholders," Sen said.
Dr Subhash Hira, Professor of Global Health, University of Washington-Seattle, USA, said, "India is getting to the point of choosing between four vaccines selected by the Vaccine Task Force - Bharat Biotech's containing inactivated Coronavirus; Pfizer vaccine (messenger RNA based); Serum Institute's adeno-virus-based inactivated Coronavirus vaccine in collaboration with Astro-Zaneca/Oxford and the Russian vaccine Sputnik V, also based on adeno-virus vector-based inactivated Coronavirus. While India won't have enough doses to cover all priority groups comprising over 40 crore people before June-September, ethicists are questioning whether people will be able to choose between products that have variable contents, pedigrees, and efficacy levels."
"Initially, there won't be enough vaccines for 40 crore Indians. Most of us will likely take whatever gets delivered from the central supply chain. Later, I assume a policy decision at the ministry of health will prioritise vaccines based on parameters such as efficacy, durability of immunity, adverse effects, made-in-India pedigree, and cost," Dr Hira said.
However, ethics should be balanced, Dr Hira said, "The State has the duty to protect citizens under the National Disaster Management Plan. While citizens have the right to âconsent' or âexercise choice of vaccine' for themselves and their kin, ârefusal' to take the vaccine is not a choice. Public health can trump the rights of individuals."
Dr Ketan Vagholkar, professor of surgery at DY Patil Medical College, has similar views. "The results of vaccine trials in the West and India and results of the first round of mass vaccination in the US, Europe should be made public. Medical experts should analyse these results and issue safety guidelines. Those getting vaccinated should first undergo a preliminary check for underlying allergic disorders by primary health care physicians. Citizens should be able to choose rather than health authorities deciding for them," he said.
Advocate Mithil Sampat, who practises consumer law, said, "Under the Consumer Protection Act, people have the right to variety and choice. Although people should not be picky during a pandemic, they have the right to not be used as guinea pigs."
According to Solicitor Stuti Galiya, "The MOHFW has clarified that getting vaccinated is voluntary. This question of choosing from options becomes important considering that not all vaccines may be right for everyone. Each vaccine can affect a person differently. Age, health, and other factors may need to be considered. It is here that seeking informed consent from potential vaccine candidates becomes crucial.
"Healthcare professionals must provide people with options, educate them, and address fears. To achieve this, they must have proper training, too."
"It is important to have adequate safeguards and detailed guidelines from the MOHFW to prevent misuse, improve vaccine confidence and overall trust in medical science," Galiya concluded.
Detailed Frequently Asked Question (FAQ) on Covid 19 for General Public. Also, a separate FAQ is listed below to answer specific questions from health care workers who will be shortlisted for the vaccine at the first stage (courtesy source- https://www.mohfw.gov.in/pdf/FAQsonCOVID19VaccineDecember2020.pdf )
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S. No. |
Question |
Potential response |
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1 |
Is a COVID vaccine scheduled anytime soon |
Yes, vaccine trials are under different stages of finalization. Government of India is geared to launch a vaccine for COVID 19 soon. For more information and updates visit www.mohfw.gov.in |
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2. |
Will COVID 19 vaccine be given to everyone simultaneously |
Based on the potential availability of vaccines the Government of India has selected the priority groups who will be vaccinated on priority as they are at higher risk. The first group includes healthcare and frontline workers. The second group to receive COVID 19 vaccine will be persons over 50 years of age and persons under 50 years with comorbid conditions |
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3. |
Is it mandatory to take the vaccine? |
Vaccination for COVID-19 is voluntary. However, it is advisable to receive the complete schedule of COVID-19 vaccine for protecting oneself against this disease and also to limit the spread of this disease to the close contacts including family members, friends, relatives and co-workers. |
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4. |
Will the vaccine be safe as it is being tested and introduced in a short span of time? |
Vaccines will be introduced in the country only after the regulatory bodies clear it based on its safety and efficacy. |
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5. |
Can a person presently having COVID-19 (confirmed or suspected) infection be vaccinated? |
Person with confirmed or suspected COVID-19 infection may increase the risk of spreading the same to others at vaccination site. For this reason, infected individuals should defer vaccination for 14 days after symptoms resolution. |
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6. |
Is it necessary for a COVID recovered person to take the vaccine? |
Yes, it is advisable to receive complete schedule of COVID vaccine irrespective of past history of infection with COVID-19. This will help in developing a strong immune response against the disease. |
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7. |
Out of the multiple vaccines available, how is one or more vaccine chosen for administration? |
The safety and efficacy data from clinical trials of vaccine candidates are examined by Drug regulator of our country before granting the license for the same. Hence, all the COVID-19 vaccines that receive license will have comparable safety and efficacy. However, it must be ensured that the entire schedule of vaccination is completed by only one type of vaccine as different COVID-19 vaccines are not interchangeable. |
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8. |
Does India have the capacity to store the COVID vaccine at temperature of +2 to +8 degree Celsius and transport them at required temperature? |
India runs one of the largest Immunization programme in the world, catering to the vaccination needs of more than 26 million newborns and 29 million pregnant women. The programme mechanisms are being strengthened / geared up to effectively cater to the country's large and diverse population. |
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9. |
Will the vaccine introduced in India be as effective as the ones introduced in other countries? |
Yes. The COVID 19 vaccine introduced in India will be as effective as any vaccine developed by other countries. Various phases of vaccine trials are undertaken to ensure its safety and efficacy. |
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10. |
How will I know if I am eligible for vaccination? |
In the initial phase, COVID 19 vaccine will be provided to the priority group- Health Care and Front-line workers. The 50 plus age group may also begin early based on vaccine availability. The eligible beneficiaries will be informed through their registered mobile number regarding the Health Facility where the vaccination will be provided and the scheduled time for the same. This will be done to avoid any inconvenience in registration and vaccination of beneficiaries. |
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11. |
Can a person get the COVID-19 vaccine without registration with Health Department? |
No, registration of beneficiary is mandatory for vaccination for COVID 19. Only after registration the information on the session site to visit and time will be shared with the beneficiary. |
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12. |
What documents are required for registration of eligible beneficiary? |
Any of the below mentioned ID with Photo may be produced at the time of registration: . Aadhar Card . Driving License · Health Insurance Smart Card issued under the scheme of Ministry of Labour · Mahatma Gandhi National Rural Employment Guarantee Act (MGNREGA) Job Card · Official identity cards issued to MPs/MLAs/MLCs · PAN Card · Passbooks issued by Bank/Post Office · Passport · Pension Document · Service Identity Card with photograph issued to employees by Central/ State Govt./ PSUs/Public Limited Companies · Voter ID · Smart card issued by RGI under NPR |
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13. |
Will a Photo / ID be required at the time of registration? |
The Photo ID produced at the time of registration must be produced and verified at the time of vaccination. |
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14. |
If a person is not able to produce Photo ID at the session site, whether s/he be vaccinated or not? |
Photo ID is a must for both registration and verification of beneficiary at session site to ensure that the intended person is vaccinated. |
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15. |
How will the beneficiary receive information about due date of vaccination? |
Following online registration, beneficiary will receive SMS on their registered mobile number on the due date, place and time of vaccination. |
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16. |
Will vaccinated beneficiaries receive information on the status of their vaccination after completion? |
Yes. On getting due dose of COVID 19 vaccine, the beneficiary will receive SMS on their registered mobile number. After all doses of vaccine are administered, a QR code based certificate will also be sent to the registered mobile number of the beneficiary. |
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17. |
If one is taking medicines for illnesses like Cancer, Diabetes, Hypertension etc, can s/he take the COVID- 19 vaccine? |
Yes. Persons with one or more of these comorbid conditions are considered high risk category. They need to get COVID -19 vaccination. |
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18. |
Are there any preventive measures and precautions that one needs to follow at the session site? |
We request you to rest at the vaccination centre for atleast half an hour after taking the COVID-19 vaccine. Inform the nearest health authorities / ANM / ASHA in case you feel any discomfort or uneasiness subsequently. Remember to continue following key COVID Appropriate Behaviours like wearing of mask, maintaining hand sanitization and physical distance (or 6 feet or Do Gaj). |
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19. |
What about the possible side-effects from COVID-19 vaccine? |
COVID Vaccine will be introduced only when the safety is proven. As is true for other vaccines, the common side effects in some individuals could be mild fever, pain, etc. at the site of injection. States have been asked to start making arrangements to deal with any Covid-19 vaccine-related side-effects as one of the measures towards safe vaccine delivery among masses. |
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20. |
How many doses of the vaccine would have to be taken by me and at what interval? |
Two doses of vaccine, 28 days apart, need to be taken by an individual to complete the vaccination schedule. |
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21. |
When would antibodies develop? After taking first dose, after taking second dose, or much later? |
Protective levels of antibodies are generally developed two weeks after receiving the 2nd dose of COVID-19 vaccine. |
Target Group: Healthcare providers / Frontline workers
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|
Question |
Potential response |
|
1. |
Why am I being chosen for COVID 19 vaccine? |
Government of India has prioritised the most at risk/high risk groups which will get the vaccine first. Healthcare providers have led the battle against COVID 19 from the front. The government wantsyou to be able to continue your work, without the fear of risk associated with the virus. Therefore, healthcare and frontline workers are among the first group of people to be vaccinated in the country. |
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2. |
What are the groups to be vaccinated in the first phase? |
Based on the potential availability of vaccines the Government of India has selected the priority groups who will be vaccinated on priority as they are at higher risk. The first group includes healthcare workers because they are at high risk of contracting the infection and protecting them helps to sustain essential health services. The vaccination of frontline workers will help in reducing the societal and economic impact by reducing COVID- 19 mortalities. The next group to receive COVID 19 vaccine will be persons over 50 years of age and persons under 50 years with comorbid conditions because there is high mortality in this category. The reason for including more than 50 years of age group for vaccination is that it will be able to cover 78% of persons having co-morbidities and thereby reduce mortality on account of COVID- 19. More than 50 years of age group is divided into two subgroups. One subgroup is 60 years and above, they will be vaccinated first. Second sub-group is between 50 to 60 years age group, they will be vaccinated after the first subgroup is covered. The vaccination may not be sequential. It can go in parallel for all beneficiaries depending on the availability of the vaccine. |
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3. |
Will my family members also be given the vaccine? |
Due to the limited vaccine supply in the initial phase, it will first be provided to people who are at higher risk of contracting COVID-19. In subsequent phases the COVID-19 vaccine will be made available to all others in need of the same. |
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4. |
Is this vaccine safe? |
Yes. Safety and efficacy of vaccine will be ensured through various phases of vaccine trials and only then a vaccine will be introduced. |
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5. |
Does one need to follow preventive measures such as wearing a mask, hand sanitization, social distancing after receiving the COVID 19 vaccine? |
Even after receiving the COVID 19 vaccine, we must continue taking all precautions like use of face cover or masks, hand sanitization and maintain distancing (6 feet or Do Gaj). These behaviours must be followed both at the session site and in general. |
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6. |
Are there any common side- effects of this vaccine? |
The COVID 19 vaccine will be safe and effective but may have minor side effects like fever, pain, etc. at the injection site. These effects can happen in any vaccine. |
