Bhubaneswar: The Centre has asserted that both the vaccines for novel Coronavirus – COVISHIELD and COVAXIN, which have been given restricted approval, are safe and have been subjected to adequate scientific scrutiny. So, why exactly are recipients required to sign the consent form? In this article, we take a closer look at the details about this pre-requisite of signing the consent for COVAXIN.
This is a common practice across the world where permission is sought before medical procedures. In this case, informed consent is sought before administering ‘Covaxin,’ but not in the case of Covishield.
Prime Minister Narendra Modi, launching the vaccine drive in the morning, said: “Our scientists and experts were assured about the safety and efficacy of the two Made-in-India vaccines, only then did they allow the emergency use authorization. So stay away from propaganda, rumours, or misinformation.”
Covaxin has been jointly made by Bharat Biotech, in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). This vaccine has secured restricted approval by the Drug Controller General of India (DCGI) which states:
“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, which 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.
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, and Cough. Bharat Biotech has claimed that no serious adverse event has been reported in Phase 1 and 2.
In case of any serious adverse events, vaccine recipients will be provided a 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. 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.