ICMR releases detailed plan for Covaxin recipients to dispel safety concerns about vaccine

Indian Council of Medical Research (ICMR) has released a detailed plan in an attempt to dispel safety concerns about the vaccine whose efficacy data isn't publically known. According to the plan, Covaxin recipients will be monitored for 3 months after getting the second dose for any adverse reactions. The plan also said that if any serious adverse event is linked to vaccination, then the recipient will be compensated based on the national drug controller's recommendations after thorough investigation. 

Two COVID-19 vaccines, Bharat Biotech's Covaxin and Serum Institute of India (SII) Covishield is currently being used in India’s nationwide inoculation drive that began on January 16. Covaxin has been developed by Hyderabad-based Bharat Biotech in collaboration with ICMR. 

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ICMR releases detailed plan 

As per the latest plan released by ICMR in regards to Covaxin, the recipients will be actively monitored for the first 35 days after the first dose of the vaccine. Out of these 35 days, for 7 days after taking each dose, the recipient will have to document their health condition in writing and submit the form to health authorities. Meanwhile, the second dose of the vaccine is administered 28 days after the first. 

ICMR's plan said that any report of adverse event following immunization (AEFI), including serious ones, will be submitted to the designated immunisation officer or health care worker, Apart from this, vaccination officers will also help in providing psychological support to recipients. 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.

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So, the side effects reported which Covaxin include injection site pain, redness, itching, stiffness in the upper arm, weakness in injection arm, body ache, headache, fever, malaise, weakness, rashes, nausea and vomiting. Besides all this, there is a chance that the vaccine may cause a severe allergic reaction that includes difficulty in breathing, swelling of face and throat, fast heartbeat, body rash, dizziness and weakness. 

The document released by ICMR said, "These may not be all possible side effects...Serious and unexpected side effects may occur because Covaxin is still being studied in clinical trials. In case of any adverse events or serious adverse events, vaccine recipients will be provided a medically recognized standard of care in the government designated respective state hospitals."

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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. 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.

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