Bharat Biotech factsheet advises people with allergies, medical conditions to not take Covaxin

Bharat Biotech has issued a fact sheet on Covaxin, its COVID-19 vaccine. It advises pregnant or breastfeeding women, besides people with high fever or bleeding disorders, to not take the vaccine. The company 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 breastfeeding. 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 that 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.