Hyderabad, January 19
Bharat Biotech’s fact sheet on COVID-19 vaccine Covaxin, has advised pregnant or breastfeeding women, besides people with high fever or bleeding disorders, not to take the antidote.
The vaccine maker in the fact sheet on Covaxin, posted in its website, said the clinical efficacy of the vaccine is yet to be established and is being studied in Phase 3 clinical trial and hence it is important to appreciate that receiving the vaccine does not mean other precautions related to COVID- 19 need not be followed.
“You should not get Bharat Biotech’s COVID-19 vaccine Covaxin if you have any history of allergies. Have high fever. Have bleeding disorder or are a blood thinner. Immune compromised or are a medicine that affects your immune system. Are pregnant. Are breast feeding. Have received another COVID-19 vaccine. Any other serious health related issues, as determined by the vaccinator/ Officer supervising vaccination,” the fact sheet said.
The fact sheet also asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
Bharat Biotech said in an ongoing clinical trial Covaxin has been shown to generate immunity following two doses given four weeks apart.
Covaxin is a vaccine with approval for restricted use in emergency situations that may prevent COVID-19.
The Central Licensing Authority has granted permission for the sale or distribution of the antidote for restricted use in emergency situations in public interest as an abundant precaution, in clinical trial mode, the fact sheet said.
Covaxin is a highly purified and inactivated two-dose SARS-CoV-2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses, the company had said.
Covaxin is India’s totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology.
The inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) biocontainment facility, one of its kind in the world. PTI