Who should not take Covaxin jab? Bharat Biotech explains in fact sheet on COVID-19 vaccine
Bharat Biotech, in the fact sheet, asked people to inform the vaccinator or a supervising official about their medical condition before taking the vaccine.
Amid reports of side effects, COVID-19 vaccine-maker Bharat Biotech on Tuesday issued a set of cautionary guidelines for people with certain conditions who, it said, should consult with their doctor or vaccine provider and preferably avoid getting the Covaxin shot.
Bharat Biotech, in a fact sheet posted on its website, said those with a history of allergies, weaker immunity, those who have fever, those who have a bleeding disorder or are on a blood thinner, those pregnant or breastfeeding, and those with any other serious health-related issues must not be injected with Covaxin.
India on last Saturday started vaccinating lakhs using two COVID-19 vaccines - the home-made Covaxin and the Oxford-Astrazeneca vaccine Covishield produced by Serum Institute of India. According to the government, some 580 adverse reactions have been reported so far, and two deaths - in Uttar Pradesh and Karnataka -- that are unrelated to the vaccine.
In the fact-sheet on Covaxin, the vaccine maker stated that 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.
According to the fact sheet, "one should not get Bharat Biotech's COVID-19 vaccine Covaxin in below conditions":
-- If you have any history of allergies. Have high fever.
-- Have bleeding disorder or are a blood thinner.
-- Immune compromised or are on 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 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, reported PTI. 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.