Covid-19 Vaccine India update: Bharat Biotech, SII issue factsheets for Covaxin, Covishield; experts question Centre’s role

Covid 19 vaccines in India: The Indian government has started rolling out Covid-19 vaccine under emergency use for the healthcare professionals and the frontline workers in the first phase with Bharat Biotech’s Covaxin and Serum Institute of India’s Covishield. Both Bharat Biotech and Serum Institute have recently issued guidelines and precautions under which the vaccines need to be taken and when to be avoided. They have been claiming that they have put out the fact sheets in public domain since the time the products were shipped out after the regulatory approval. However, not many seem to have noticed, and some experts even unable to recall seeing it.

“It is quite a standard practice when a drug or a vaccine is not fully evaluated and has obtained only an emergency use approval. Companies will, therefore, want to be cautious and also because the government has said that public liability of adverse events will be for the vaccine companies to take upon and compensate,” says K V Balasubramaniam, an independent consultant and the former Managing Director of Indian Immunologicals Ltd.

But then, experts in the sector also feel that much of the anxiety around vaccines and their safety could have been put to rest or avoided, had the government been more vocal and publicised the concerns around the vaccines and their use rather than have the companies put these out into public domain.

Who should not receive Covaxin, Covishield Covid-19 vaccines?

In its factsheet for Covid-19 vaccine recipients and caregivers, Bharat Biotech has mentioned that Covaxin must not be administered to individuals having any history of allergies, who have a fever, bleeding disorder or are on a blood thinner, immumne compromised, or are on a medicine that affects your immune system, anyone who is pregnant, breastfeeding, who have received another Covid-19 vaccine, and any other serious health-related issues, as determined by the vaccinator/officer supervising vaccination.

Serum of Institute of India has said that one should not get the Covishield vaccine if the person had a severe allergic reaction after a previous dose of this vaccine. “If you have ever had a severe allergic reaction (anaphylaxis) after any drug, food, any vaccine or any ingredients of Covishield vaccine,” the Serum of Institute of India said.

Side effects of Covaxin, Covishield

Bharat Biotech has stated that “side effects that have been reported with the Bharat Biotech Covid-19 vaccine” Covaxin are – injection site pain, injection site swelling, injection site redness, injection site itching, stiffness in the upper arm, weakness in the upper arm, body ache, headache, fever, malaise, weakness, rashes, nausea, and vomiting.

Bharat Biotech has also stated that there is a remote chance that the Covaxin could cause a severe allergic reaction after vaccination. The company has listed the signs of severe allergic reactions. These are difficulty in breathing, swelling of face and throat, a fast heartbeat, rash all over the body, and dizziness and weakness.

Bharat Biotech has also stated that one can report any side effects after vaccination if there is any, to toll-free number of 18001022245 or can send email at pvg@bharatbiotech.com.

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. 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, the Serum Institute of India said.