You will need to sign a consent form for a Covaxin shot
The world's largest Covid-19 vaccination drive is underway. Starting today, two vaccines -- Serum Institute's Covishield and Bharat Biotech's Covaxin -- are being administered to people across the country. But there's a catch.
People who will be taking a shot of the Bharat Biotech vaccine will need to sign a consent form before the vaccination.
The consent form's rollout was approved on January 12 when the Subject Expert Committee of the Central Drugs Standard Control Organisation tweaked the protocol for the release of Covaxin.
Even though health ministry officials said that the consent form is in line with international practices, many on social media are questioning the need for a consent form especially when it's not needed for the Serum Institute vaccine.
The consent form makes it abundantly clear that the Covaxin is being offered under "restricted use in an emergency situation". It also clearly states that the clinical efficacy of Covaxin is yet to be established.
"The Bharat Biotech COVID-19 Vaccine (COVAXINTM) is a vaccine with approval for restricted use in an emergency situation that may prevent COVID-19. In phase 1 and phase 2 clinical trials, COVAXINT has demonstrated the ability to produce antibodies against COVID-19. However, the clinical efficacy of COVAXIN is yet to be established and it is still being studied in phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed," the form states.
"In case of any adverse events or serious adverse events, you will be provided a medically recognized standard of care in the government designated and authorized centres/hospitals. The compensation for the serious adverse event will be paid by the sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine," the consent form adds.
Eleven Indian states are administering Covaxin with each dedicating six vaccination centres for the purpose. To note, five are opposition-ruled states.
Asianet Newsable reached out to medical experts to seek clarification. Here's what Dr Ranjit Mohan, Consultant for Internal Medicine, Infectious Diseases at Manipal Hospitals Old Airport Road said.
Does the presence of a consent form suggest that there are doubts over the efficacy of the vaccine?
"The presence of a consent form certainly does not suggest that the vaccine's efficacy is in doubt. The consent form may be considered as a complete scientific disclosure by the manufacture to the consumer and such a form is being utilised since the vaccine is still very new and the public is still largely unaware about its efficacy and side effects."
Does the consent form come as a curveball for the patients considering that they can't choose between which vaccine they should have?
At the current time, the authorities have not maid vaccination compulsory. Even if the choice of the vaccine may not be available to any individual, the decision whether to get vaccinated or not finally rests with individuals themselves.
The consent form says that the vaccine is for "restricted use under emergency situation". What does this mean?
- The vaccine is being urgently deployed on a large scale only because of the current pandemic. In the normal course, the vaccines would have taken much longer to reach the market after the conclusion of phase 3 trials. Initially, restricted usage mainly targeting the healthcare community and those at higher risk of exposure to the virus is envisaged.
In a related incident, Resident Doctors Association at the Ram Manohar Lohia Hospital have reportedly written to the Medical Superintendent expressing apprehensions about the Bharat Biotech vaccine.
In their letter, the doctors said that they were bringing to notice "apprehensions about the lack on complete trial in the case of Covaxin and might not participate in large numbers, thus defeating the purpose of vaccination".
"We request you to vaccinate us with Covishield which has completed all stages of the trial before rollout," they requested.