Panaji: The manufacturer of the indigenous COVID-19 vaccine ‘Covaxin’ Bharat Biotech has warned against the use of the vaccine in people, who have a history of allergy, fever, bleeding disorder or people who are on a blood thinner.
In a statement issued on its website, the company has said that those with compromised immunity or people who are on a medicine that affects their immune system should not take Covaxin.
Bharat Biotech has also advised pregnant women and lactating mothers to avoid the vaccine, as the effects of the vaccine have not been studied in pregnant women and nursing mothers.
The company has said that people having any other serious health-related issues, as determined by the vaccinator/officer supervising vaccination should also refrain from receiving the Covaxin jab.
It is pertinent to note that the Bharat Biotech’s COVID-19 vaccine is still being studied in clinical trials and it is permitted for restricted use in emergency situation under clinical trial mode and is being offered to
the restricted prioritised groups only. The company has said there is a remote chance that Covaxin could cause a severe allergic reaction. “A severe allergic reaction may rarely occur after receiving a dose of Bharat Biotech COVID-19 vaccine Covaxin. Signs of severe allergic reactions can include difficulty in breathing, swelling of your face and throat, a fast heart beat, rash all over your body, dizziness and weakness. These may not be all the possible side effects of the Bharat Biotech COVID-19 vaccine Covaxin. Serious and unexpected side effects may occur,” the manufacturer said.
Side effects that have been reported with Covaxin include injection site pain, injection site swelling, injection site redness, injection site itching, stiffness in the upper arm, weakness in injection arm, body ache, headache, fever, malaise, weakness, rashes, nausea and vomiting.
The company has said that all the vaccine recipients will be followed up for a period of three months after the second dose of the vaccine. In case of any serious adverse events, the vaccine recipients will be provided medically recognised standard of care in the government designated/authorised centres or hospitals.
The company further said compensation for serious adverse events (SAE) will be paid by the sponsor (Bharat Biotech International Limited) if the SAE is proven to be casually related to the vaccine. The compensation will be determined by the Indian Council of Medical Research’s central ethics committee, as appropriate.
“If any vaccine recipient develops symptoms of COVID-19, he or she will be provided medically recognised standard of care in the government designated/authorised centres or hospitals. COVID-19 positive outcomes must be documented in adverse event form. Proof of positive RT-PCR (tests conducted under existing government programme and from approved laboratories) should be provided to establish the diagnosis of COVID-19. Vaccine recipient’s verbal recall will not confirm the diagnosis,” Bharat Biotech said.