Step up measures to report vaccine side-effects, Centre tells states 

The communique comes as at least two vaccine makers are planning to apply for emergency use authorisation for the vaccines, developed abroad but planned to be produced in India.
A nurse prepares to inoculate a volunteer with Russia's Sputnik-V COVID vaccine at a clinic in Moscow. (File photo| AFP)
A nurse prepares to inoculate a volunteer with Russia's Sputnik-V COVID vaccine at a clinic in Moscow. (File photo| AFP)

NEW DELHI:  In anticipation that Covid-19 vaccination could lead to side-effects in some people, the Centre has asked states to step up the ‘Adverse Event Following Immunisation’ (AEFI) surveillance in districts.

The communique comes as at least two vaccine makers are planning to apply for emergency use authorisation for the vaccines, developed abroad but planned to be produced in India.

“You may be aware that preparations are underway for conducting Covid-19 vaccinations in states and districts, starting with certain priority groups,” said the letter by an additional secretary in Union health ministry to state health secretaries. It added that steps need to be taken for AEFI surveillance to maintain confidence in the safety of vaccines.

The letter also listed out initiatives, which it said, are essential to further strengthen the existing AEFI Surveillance System of India so that “timely and complete AEFI reporting for Covid-19 vaccination is possible”.

The Centre has asked states to involve 300 medical colleges and other tertiary care hospitals across the country to handle adverse events or cases of side-effects on people post-vaccination.

In addition, states have been told to keep ready neurologists, cardiologists, respiratory medicine experts, obstetrics, gynaecologists and paediatricians to deal with post-vaccination side-effects, officials said.

The Union government has instructed that each state must choose a medical college to function as a state’s AEFI technical collaborating centre.

“The clinical specialists of the medical college and experts from the department of community medicine will assist the state AEFI committee in conducting rapid causality assessments, case investigations in districts, laboratory tests in certain cases to find the cause of AEFIs, etc.,” said the letter.

“These specialists may be invited to attend AEFI committee meetings.”

“Events due to pre-existing co-morbidities may be reported as AEFIs following Covid-19 vaccinations,” it said.

The Centre has specified that states should also keep enough stock of adrenaline injections used to control immediate life-threatening allergic reactions and specific staff trained to use these injections. India has been running AEFI surveillance since 1988 but according to officials, new requirements are being anticipated for Covid-19 vaccines. 

The Centre has already hinted that emergency use authorisation may be granted to some vaccine makers and two vaccines — by Oxford University-AstraZeneca and Sputnik V by Russian government agencies — may be the first ones to apply for the permission to the Drug Controller General of India.

The government vaccination programme could first target the priority groups including healthcare workers.

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