Covaxin recipients to be monitored for three months after 2nd dose

New Delhi

Covaxin recipients will be monitored for three months after getting the 2nd dose for any adverse reactions, according to a detailed plan released by the Indian Council of Medical Research (ICMR) in an attempt to dispel safety concerns about the vaccine whose efficacy data isn’t publicly known.

If a serious adverse event is linked to vaccination, then the recipient will be compensated based on the national drug controller’s recommendations after thorough investigation, said the plan. Covaxin is one of two vaccines – the other being the OxfordAstraZeneca vaccine known locally as Covishield – being used in India’s Covid-19 immunisation programme that kicked off on Saturday. It was developed by Hyderabad-based Bharat Biotech in collaboration with ICMR, which released the plan on January 18.

For the first 35 days after the first dose of the vaccine, the recipients will be actively monitored, said the document. For seven days after taking each dose, the recipient will have to will have to document their health condition in writing, and submit the form to health authorities. The second dose of the vaccine is administered 28 days after the first.

A district-level team will contact and enquire about any adverse events over phone, added the document.

“Day 1-7: The vaccine recipients will be given an adverse event form to record the adverse events. Day 8-27: The vaccine recipients will inform the vaccination site, if they have encountered any health-related issues or adverse events. The vaccine recipients will return the adverse event form during the visit for the administration of the second dose of vaccine (Day 28),” said the plan.

“Visit 2 (Day 28): The vaccine recipients will be administered the second dose… Day 28-35: The vaccine recipients will be given an adverse event form to record the adverse events... The vaccine recipients will inform the site, if they have encountered any health-related issues or adverse events. Vaccine recipients will return the filled-in adverse event reporting form after completion of 7 days post-vaccination,” it added. “All the vaccine recipients will be followed-up for a period of 3 months after the second dose of vaccination,” the document added.

According to the plan, any report of adverse event following immunisation (AEFI), including serious ones, will be submitted to the designated immunisation officer or health care worker. Vaccination officers will also help in providing psychological support to recipients.

Causality assessment of all severe adverse events, medical management and compensation will be determined by the existing practices under the government immunisation program and central ethics committee as appropriate.

“In case of any adverse events or serious adverse events, vaccine recipients will be provided medically recognized standard of care in the government designated respective state hospitals,” the plan said.

Experts say safety is not a concern with Covaxin, which is currently in late-stage clinical trials. “The studies are done in a robust manner, and the data that has so far been generated has already established Covaxin’s safety profile. So, safety isn’t a concern,” said Dr MC Misra, former director, All India Institute of Medical Sciences, Delhi.

Bharat Biotech developed Covaxin in collaboration with the Indian Council of Medical Research.

Individuals with the following conditions will not be eligible for vaccination: Those with a history of allergies; those with fever, bleeding disorder or those who are on blood thinners; those who are immunocompromised or are on a medicine that affects their immune system; are pregnant; are breastfeeding; have received another Covid-19 vaccine; any other serious health related.

Side effects reported with Covaxin include injection site pain, swelling, redness, itching, stiffness in the upper arm, weakness in injection arm, body ache, headache, fever, malaise, weakness, rashes, nausea and vomiting. There is a chance that the vaccine may cause a severe allergic reaction that includes difficulty in breathing, swelling of face and throat, fast heart beat, body rash, dizziness, and weakness.

“These may not be all the possible side effects… Serious and unexpected side effects may occur... Covaxin is still being studied in clinical trials,” the document said.