Covid-19 vaccination drive begins today; all you need to know about it

Under the emergency use authorisation, the vaccine is only for those above 18 years of age

With the country all set to roll out two Covid vaccines —Covishield and Covaxin — on Saturday, the health ministry has come out with directions for programme managers on handling the two jabs and detailing the precautions that need to taken. And, giving them a heads-up about the adverse events that may occur after a person receives the shot. 

What are the basic check points? 

Under the emergency use authorisation (EUA), the vaccine is only for those above 18 years of age. If required, Covid vaccine and any other vaccination has to be done at an interval of at least 14 days. The second dose should be of the same Covid vaccine as the first dose. 

Who should not be given the vaccine?

Those who have anaphylactic or allergic reaction to a previous dose of Covid vaccine, and also if there is immediate or delayed onset of such reactions to vaccine or injectable therapies or food items. Besides, pregnant and lactating women should not receive the vaccine yet since such a group has not been part of the trials. 

Who can use the deferred vaccination for Covid? 

Patients who are among active cases; those who received plasma therapy and were given antibodies; and those who are acutely ill and hospitalised due to any illness can be given the vaccine four to six weeks after they have recovered. 

Special precaution has to be taken in persons with a history of bleeding or coagulation disorder. 

What are the adverse events following immunisation to watch out for?

The health ministry has prepared a comparative fact-sheet that lists the adverse events that may occur for both vaccines individually. For Covishield, made by the Serum Institute of India, the common and mild adverse events mentioned are injection site tenderness and pain, headache, fatigue, myalgia (pain in muscle), malaise (general feeling of discomfort), pyrexia (fever), chills and nausea. For Bharat Biotech’s Covaxin too similar events have been listed along with abdominal pain, tremor, sweating, bodyache, dizziness or giddiness. 

The government has listed rare adverse events for Covishield, but there are no such effects reported for Covaxin. The list says that “very rare demyelinating disorders (nerve tissue damage) have been reported following vaccination using Covishield without causal relationship establishment”. 

A detailed investigation into the adverse event in Serum’s trial did not find any causal link between the illness and the investigational candidate. In the wake of reports of a serious adverse event in one 40-year-old Chennai volunteer in the Serum Institute-AstraZeneca vaccine trial, the Indian drug regulator had reassured that all processes and protocols were being followed for clinical trials.  

How will the regulator review any future adverse events? 

While the vaccine makers are unlikely to have any indemnity from the government in case of an adverse event, the Central Drugs Standards Control Organisation (CDSCO) will investigate if there are any causal links between the adverse event and the vaccine.

The approval for the vaccines is according to the provisions of the New Drugs and Clinical Trials Rules, 2019, which fall the the Drugs and Cosmetics Act of 1940. The Act has a provision of "compensation to the subject in case there is any serious adverse event in a trial subject which is linked to the investigational product". 

Serum Institute would have to submit an India-specific risk management plan, and also provide safety data on adverse events with due analysis every 15 days for the first two months to the regulator. 

Thereafter, the monthly submission of data on adverse events is allowed. 

The Indian situation is different from countries such as the US where the Public Readiness and Emergency Preparedness Act was invoked to give legal protection to companies making or distributing the vaccines unless there is "willful misconduct" by the company.