Recipients of Bharat Biotech's COVAXIN vaccine to fill THIS screening & consent form

As India launched its COVID-19 vaccination drive, People receiving Bharat Biotech's Covaxin will have to sign a consent form handed by the Central government and agree to certain terms and conditions. The recipients have to sign the form because the vaccine has been allowed by the Centre in "clinical trial mode".

'Covaxin has demonstrated the ability to produce antibodies' 

"The Bharat Biotech COVID-19 Vaccine (COVAXIN) 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, COVAXIN 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 says.

"In case of any adverse events or serious adverse events, you will be provided medically recognized standard of care in the government designated and authorized centres/hospitals. The compensation for a serious adverse event will be paid by the sponsor (BBIL) if the (adverse effect) is proven to be causally related to the vaccine," it says. 

"I further emphasize that any information provided by me prior to taking the vaccine will be archived in the database maintained by the immunization program of the government and privacy as well as the confidentiality of the information provided by you will be maintained," the declaration says. Covaxin recipients will also be handed over a fact-sheet and an adverse effect reporting form where they have to note down symptoms such as fever, pain and redness suffered within the seven days of getting the shot.

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The Drugs Controller General of India (DCGI) had earlier this month approved Oxford COVID-19 vaccine Covishield, manufactured by the Serum Institute, and indigenously developed Covaxin of Bharat Biotech for restricted emergency use in the country. The government on Tuesday hinted that vaccine recipients, for now, will not have the option to choose from the two vaccines. According to the Health Ministry, getting vaccinated for COVID-19 will be voluntary.  

All 1.65 crore doses of COVID-19 vaccines -- 1.1 crores of Covishield and 55 lakh of Covaxin -- procured by the Centre have been allocated to all states and UTs in proportion to their healthcare workers database, according to the government. There has been some amount of opposition to the government approving COVAXIN which hasn't yet completed phase 3 trials.

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