People who are receiving Bharat Biotech's Covaxin will be required to sign a consent form which assures recipients medical care and compensation if any serious adverse event is found linked to the COVID-19 vaccine.
Concerns have been raised from several quarters regarding the efficacy and safety of Covaxin, since phase 3 clinical trials for the vaccine are still ongoing. However, the government has asserted that both the vaccines which have been given restricted approval are safe and have been subjected to adequate scientific scrutiny.
Why exactly are recipients required to sign the consent form? Can you choose to not sign the form? What happens in case of an adverse event?
The Quint breaks it down for you.
What is informed consent? Is this a common practice?
According to the World Health Organisation (WHO), informed consent is the principle of getting the approval or permission from the recipient before starting/administering any healthcare intervention.
Yes, this is a fairly common practice across the world and in India where the permission is sought before medical procedures etc.
In this case, informed consent is sought before administering 'Covaxin,' but not in case of Covishield.
Why are recipients of Covaxin asked to sign a form, but not those being given Covishield?
Covaxin, jointly made by Bharat Biotech, in collaboration with Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), has been given restricted approval by the Drug Controller General of India (DCGI) "in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains.”
The 'clinical trial mode' is because phase-III clinical trials, that are essential to establish efficacy, are still ongoing. Since the vaccine is being given in clinical trial mode,' those being inoculated will be monitored more closely in a type of 'open label' trial. This is the reason why they are being asked to sign a consent form.
In case of Covishield, produced by Serum Institute of India in partnership with Oxford University, phase-III trials were conducted in August 2020 in the UK and Brazil, where the combined efficacy of the two trials was found to be 70 percent effective. While bridge trials for Covishield are still ongoing in India, the regulator looked at international data to establish safety and efficacy. So no informed consent is sought to given the vaccine.
What information is sought from those signing the form?
The informed consent form collects data such as:
- Name, date of birth, gender, marital status
- Recipient's address and phone number
- Name and phone number of vaccinating supervisor
- Vaccination registration number, address of vaccination site
The form also seeks response to the following, from the recipient:
- Are you feeling sick today?
- Have you had a COVID-19 test in the last 14 days or been told by a healthcare provider to isolate or quarantine at home?
- Have you been treated with antibody therapy in the past 90 days. Details, if yes.
- Have you ever had a serious allergic reaction?
- Have you had any vaccines in the past 28 days? Details, if yes
- Are you pregnant or considering becoming pregnant?
- Are you a nursing mother?
- Are you on any medication for a long-standing disease?
- Are you taking radiotherapy?
- Will you be given time to read the form?
What happens in case of an illiterate person? Who will explain it to them?
If vaccine recipient is illiterate, then the vaccinator/supervising officer should explain it to the person and consent should be taken in the presence of an impartial witness. The witness will also be required to sign the informed consent.
What if I have further questions about the vaccine?
In this case, you are entitled to ask the vaccinator or supervising officer about the same.
Can you choose to not take the vaccine?
Yes, in India vaccination is not mandatory. But if you choose to get vaccinated, you cannot choose which vaccine you will get. You will be administered the vaccine that is available at the site.
In case you are choosing not to take Covaxin at the site, you are legally allowed to do so.
What are the expected adverse events after being administered Covaxin?
According to the Centre’s fact sheet, these are the common adverse events after administering Covaxin.
- Injection site pain
- Fatigue
- Fever
- Headache
- Body ache
- Nausea
- Abdominal pain
- Dizziness
- Sweating
- Cold
- Cough
Bharat Biotech has claimed that no serious adverse event has been reported in Phase 1 and 2.
Who pays for my care and treatment in case of adverse event or serious adverse event?
The form states that:
- In case of any serious adverse events, vaccine recipients will be provided medically recognised standard of care in the government designated and authorised centers/hospitals.
- The compensation for the serious adverse event will be paid by sponsor (BBIL) if the SAE is proven to be causally related to the vaccine.
- The compensation will be determined by the ICMR Central Ethics Committee, as appropriate.
Who is liable in case of serious adverse event? Who is responsible for compensation if the event is found to be linked to the vaccine?
The form clearly says that Bharat Biotech will be responsible if compensation is sought in case of serious adverse event that is causally linked to the vaccine.
Does this mean Covaxin is no longer used as a ‘buffer’ vaccine?
On 13 January, Covaxin doses manufactured by Bharat Biotech reached 10 cities across the country – making it formal that this vaccine was no ‘backup.’
The government has inked a deal with the pharma major for nearly 55 lakh doses, at a cost of Rs 295/dose. Of these nearly 17.5 lakh doses will be provided for free.
However, how states use Covaxin is under their discretion and the number of vaccines they receive.
For example, in Karnataka only six of the 243 sites will administer Covaxin. In Delhi, 75 sites will be administering Covishield but six sites, which come under the Centre like AIIMS, will administer Covaxin. In Tamil Nadu too, six centres are administering Covaxin.
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