Bharat Biotech, the manufacturer of Covaxin, has issued a fact sheet on who should avoid taking the drug to avoid possible side effects. According to the company's website, those with a history of allergies, suffering from fever, bleeding disorder, pregnant or breastfeeding, serious health-related issues should not be injected with Covaxin among other conditions.
The company said that beneficiaries should first take advice from their doctor or vaccine provider before taking Covaxin. It warned recipients of severe allergic reaction that may include difficulty in breathing, swelling of the face and throat, fast heart-beat, rashes all over the body, dizziness and weakness.
"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.
Those receiving jabs, Bharat Biotech said, are urged to disclose their medical conditions, medicines they are taking and allergies.
Covaxin is one of the two drugs approved for emergency use in India. It is India's totally indigenous COVID-19 vaccine developed in collaboration with the Indian Council of Medical Research and National Institute of Virology. The other being Covishield which is developed by the University of Oxford along with British pharmaceutical major AstraZeneca. The Serum Institute of India (SII), Pune has partnered with the Oxford University to manufacture their Covid-19 vaccine in India. The SII is the world’s largest vaccine manufacturer in terms of numbers.
Who should avoid Covaxin?
India on Saturday started vaccinating its healthwaorkers using two Covid vaccines . According to the government data, over 3.8 lakh people have been inoculated and more than 500 adverse events following immunisation were reported. The Union Health Ministry also informed about two deaths in Uttar Pradesh and Karnataka post the vaccination. But the deaths are unrelated to the vaccine.
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.
It said that an ongoing clinical trial of Covaxin has shown to generate immunity following two doses given four weeks apart.
The company added that 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 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.
Meanwhile, the SII also 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.