Bharat Biotech, the manufacturer of COVID-19 vaccine, Covaxin has said that the company will pay compensation to recipients in case of any serious adverse effects experienced after receiving the antidote. Bharat Biotech, has received a government purchase order for the supply of 55 lakh doses of Covaxin.

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In the consent form to be signed by the vaccine recipients, Bharat Biotech said, "In case of any adverse events or serious adverse events, you will be provided medically recognised standard of care in the government designated and authorised centres/hospitals."

"The compensation for the serious adverse event will be paid by the sponsor (BBIL) in case if the SAE is proven to be causally related to the vaccine," the consent form said.

In phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antidotes against COVID- 19.

However the clinical efficacy of the vaccine is yet to be established and it is still being studied in phase 3 clinical trials, the vaccine maker said.

"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 consent form said.

Meanwhile, RTI activist Saket Gokhale on Saturday moved a writ plea before the Bombay High Court seeking direction to the Drug Controller General of India (DCGI) to bring in public domain all information pertaining to the safety and efficacy trial results of Bharat Biotech's COVID-19 vaccine 'Covaxin', The Indian Express reported.

"A trial vaccine that has not completed Phase III trials as in the case of M/s Bharat Biotech's 'Covaxin', there remains a great possibility of harm to the life of members of the general public that are being administered this vaccine," the plea said.

The petitioner went on to say, "The approval granted to M/s Bharat Biotech's Covaxin is not a full approval and is merely a green signal to provide its vaccine to the Govt of India while treating every recipient of a vaccine as a participant in its Phase III human clinical trials."

Covaxin has been approved for 'restricted use in an emergency situation' and that Phase I and Phase II clinical trials demonstrated that vaccine was safe, Phase III trials are still ongoing.