Hyderabad-based pharmaceutical company Bharat Biotech has put out a fact sheet on its COVID-19 vaccine, Covaxin, which is being administered along with Serum Institute’s Covishield in phase one of the vaccination drive that is being carried out across the country. The fact sheet answers commonly asked questions, but also adds a disclaimer on those who should not be administered the jab at a point when its vaccine is still in the phase-3 clinical trial.
Bharat Biotech has said that Covaxin should not be given to those who have any history of allergies; a fever; a bleeding disorder or are on a blood thinner; if they are immuno-compromised or are on a medicine that affects their immune system; if they are pregnant or breastfeeding; or if they have received another COVID-19 vaccine. The company has also asked people who have any other serious health-related issues, as determined by the Vaccinator/Officer supervising vaccination, to avoid getting vaccinated with Covaxin.
Bharat Biotech added that it is a person’s choice whether they want to take Covaxin or not.
Bharat Biotech also added some side-effects have been reported with Covaxin, which 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 added that there is a remote chance that the Covaxin could cause a severe allergic reaction. “A severe allergic reaction may very rarely occur after getting a dose of the vaccine. For this reason, your vaccination provider will ask you to stay for 30 minutes after each dose of vaccine at the vaccination centre for monitoring. Signs of a severe allergic reaction can include difficulty in breathing, swelling of your face and throat, a fast heartbeat, rash all over your body, dizziness and weakness.”
Bharat Biotech has said that Covaxin has received approval for restricted use in an emergency situation that may prevent COVID-19 and has been granted permission for the sale or distribution for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode.
The company has added that in phase 1 and phase 2 clinical trials, Covaxin has demonstrated the ability to produce antibodies against COVID-19. “However, 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,” the company said.