NEW DELHI, Jan 16: Amidst some apprehensions expressed from various quarters over the efficacy of the indigenous Covaxin vaccine, its manufacturer Hyderabad-based Bharat Biotech has agreed to pay compensation if it caused serious side effects to the recipient.
The assurance is given in the consent form the government has made it mandatory for all recipients of Covaxin to sign before administered the shot. It says that the beneficiary is aware of the vaccine and its probable side effects and has given his or her consent for the vaccination.
No such consent form would be required to be signed if the beneficiary was administered Covishield, the vaccine developed by Oxford University – AstraZeneca and being manufactured under license by the Pune-based Serum Institute of India (SII).
The official sources said the reason for differentiating between the two vaccines even when the recipients had not been given the choice to decide was because the Drug Controller General of India (DCGI) had allowed Covaxin to be used in “clinical trial mode.”
The screening and consent form adds that compensation for serious adverse events will be paid by the company if it is proven to be causally related to the vaccine.
“The clinical efficiency of Covaxin is yet to be established and it is still being studied in phase 3 clinical trials. 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 Central Licensing Authority has granted permission for the sale or distribution of COVAXIN for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode,’’ notes the form.
“In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in government-designated and authorised centres or hospitals,” the form said. If there is any serious adverse event which can be proved to be causally related to the vaccine, then Bharat Biotech will compensate, it says.
The consent form, however, informed the recipients that in phase 1 and phase 2 clinical trials, COVAXINTM has demonstrated the ability to produce antibodies against COVID-19.
The recipients are handed over a fact sheet and a form to report adverse effects, in which they have to note down symptoms like fever, pain within seven days.
The central government has made it abundantly clear that it was in position to offer choice to the states and the beneficiaries between Covishield and Covaxin and the supply of the vaccines to various centres would depend on various factors including availability and various other logistics. Despite some serious apprehensions expressed even by some of the junior doctors in several Delhi hospitals, several Central government hospitals in Delhi — AIIMS, Safdarjung, Ram Manohar Lohia hospital, Kalawati Saran Children Hospital — administered Covaxin to its staff under the first round of vaccination which began on Saturday.
(Manas Dasgupta)
