Those who have weaker immunity or are on a medicine that affects their immune system and people with allergies must not take the Covaxin shot, vaccine-makers Bharat Biotech warned on Monday in a fact-sheet, two days after India began mass vaccinations against Covid.
Earlier, the government had said that patients who are on immuno-suppressants or suffer from immune deficiency could take the vaccine but the response would be less effective in such individuals. Usually, cancer patients who are on chemotherapy, HIV-positive people and those who are on steroids are immune-suppressed.
Beginning Saturday, India has started vaccinating lakhs using two Covid vaccines - the home-made Covaxin and the Oxford-Astrazeneca vaccine Covishield produced by Serum Institute of India.
Some 580 adverse reactions have been reported, the government said yesterday, and two deaths - in Uttar Pradesh and Karnataka -- that are unrelated to the vaccine.
Bharat Biotech's fact-sheet says those with a history of allergies, 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.
Neither can those who have received another COVID-19 vaccine.
Bharat Biotech has released a fact-sheet on who can get vaccinated with Covaxin
Recipients are warned 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.
Those receiving jabs are urged to disclose their medical conditions, medicines they are taking and allergies.
The factsheet lists side effects that include pain, swelling or itching where the recipient has been injected, body ache, headache, fever, malaise, weakness, rashes, nausea and vomiting.
"Additionally, there is a remote chance that the Covaxin could cause a severe allergic reaction. For this reason, your vaccination provider will ask you to stay for 30 minutes after each dose of vaccination at the place where you received your vaccine for monitoring after vaccination," says Bharat Biotech.
The pharma giant also said all recipients would be part of follow-ups for a period of three months after the second dose of vaccination.
"In case of any serious adverse events, vaccine recipients will be provided with a medically recognised standard of care in the government designated and authorised centres/hospital. The compensation for the serious adverse event will also be provided," read the factsheet.
The document says in an underlined para that the "clinical efficacy of Covaxin is yet to be established and it is still being studied in Phase 3 clinical trial. Hence, it is important to appreciate that receiving the vaccine does not mean that other precautions related to Covid-19 need not be followed."
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