Covaxin recipients under stricter watch, says Centre

The central government on Monday spelt out a detailed policy of monitoring Covid-19 vaccine recipients for adverse responses and assured people that the immunisation programme, which has been dogged by fears of side-effects and hesitancy, is safe.

Union health secretary Rajesh Bhushan said the government had opted for a passive monitoring approach for the Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India and known locally as Covishield. Bharat Biotech’s Covaxin vaccine recipients are being actively followed for any adverse reactions, he added.

“In Covishield vaccine, the monitoring is passive monitoring. The recipient is observed for initial 30 minutes; if he is fine, he is sent home. However, if they develop symptoms later, then the onus is on the recipient to report it to the hospital. Whereas in case of Covaxin, it is active followed up, which means a doctor rings you up on a daily basis and you are given a form that you fill for seven days. That’s the difference,” said Bhushan.

He also pointed out that the number of mild Adverse Events Following Immunisation (AEFI) –pain, nausea, mild fever – were reported in 0.18% of people vaccinated till Monday night. Severe AEFIs, which require hospitalization or high fever, accounted for 0.002% of the shots administered.

This was one of the lowest in the world, he added.

“And there it is clearly mentioned that if there is a causal relationship between immunisation and the adverse event, whether it is severe or serious, the cost of hospitalisation would be borne by the authorities,” he added.

Director general of Indian Council of Medical Research (ICMR), Dr Balram Bhargava, said Covaxin recipients were being closely monitored. “As we cross the half a million number mark in the past three days, it is very clear that both these Covid-19 vaccines are very safe. Also, vaccine does not cause Covid-19; vaccine prevents Covid-19; vaccine prevents Covid-19 deaths. So, the time to take the vaccine is now, and we can break the chain of virus transmission,” he added.

The officials also drew a distinction between Covishield, which finished late-stage trials abroad and whose efficacy data is publicly known, and Covaxin, which is currently in phase 3 trials.

“There are two vaccines; one has been given emergency use authorisation, and there is another vaccine which has been given emergency use authorisation under clinical trial mode.”

He added that the vaccine given emergency approval under clinical trial mode – Covaxin — is accompanied by three documents: a fact-sheet and a consent form that are read out and explained to beneficiaries. “It is in regional languages depending on the state...; and third is the adverse event reporting form where the recipient has to report it for the first seven days.”

He said that states were in charge of deciding which vaccine is allotted to a particular immunisation site.

“The Union government got the supplies, but which vaccine will go to which vaccination session was a decision which has been a decision left entirely to the states. What vaccine will be used in AIIMS, Delhi, was a decision of the state government, and local government in other states...,” he added.

Adverse reactions can be caused by allergies or underlying medical conditions and are not necessarily causally linked to vaccines.

But reports of adverse reactions to immunization have fuelled rumours and vaccine hesitancy, forcing authorities to fall short of inoculation targets.

“Adverse reactions that have been seen so far are negligible. The side effects are practically nil,” added VK Paul, member (health), Niti Aayog.

The ministry said nine AEFIs have required hospitalization until Tuesday. In Delhi, three cases have been discharged and one case is under observation.

An AEFI case in Uttarakhand has been discharged. In Karnataka, one person is discharged and other person is stable. In Chhattisgarh, one person was discharged.

In Rajasthan, one case is of suspected anaphylaxis is under observation.