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Who shouldn’t take jab? Vaccine makers issue fact sheet

Amid reports of side effects of COVID-19 vaccines, Bharat Biotech and Serum Institute of India have issued fact sheets for who should avoid getting vaccinated.

Bharat Biotech’s Covaxin

 

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.

Serum Institute’s Covishield

Serum Institute of India said that people who are severely allergic to any ingredient of COVID-19 vaccine ‘Covishield’ are advised not to take it,

According to the fact sheet for the vaccine recipient by the Serum Institute of India, one should not get the Covishield vaccine if the person had a severe allergic reaction after a previous dose of this vaccine.

The ingredients of Covishield vaccine are “L-Histidine, L-Histidine hydrochloride monohydrate, Magnesium chloride hexahydrate, Polysorbate 80, Ethanol, Sucrose, Sodium chloride, Disodium edetate dihydrate (EDTA), Water for injection,” Serum Institute said.

The fact sheet for the vaccine recipient on the website of the vaccine major is to help the recipient understand the risks and benefits of the Covishield vaccine.

The vaccine maker also said that the vaccine recipient should also tell the healthcare provider about all the medical conditions before getting the Covishield vaccine including, “if you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of Covishield vaccine”.

The recipients should also mention to the healthcare provider, if they have fever, if they have a bleeding disorder or are on a blood thinner and also if they are immuno-compromised or are on a medicine that affects your immune system, it added.

The fact sheet also says that if a person is pregnant or plans to become pregnant or is breastfeeding she should tell the healthcare provider before taking the jab.

The vaccine recipient should also mention to the healthcare provider if “you have received another COVID-19 vaccine,” Serum Institute said.