January 18 (IndiaToday) – Two out of seven Covid-19 vaccine beneficiaries who had developed severe adverse symptoms after being immunized have died. So far, India has immunized over 3.81 lakh health care workers, out of which 580 people developed adverse event following immunization (AEFI).
According to senior officials the Union health ministry, most adverse events reported were minor including fever, headache and nausea. Seven out of these 580 cases of AEFI required hospitalization.
Of the three cases reported from Delhi, two have been discharged whereas one case is under observation at Max Hospital, Patparganj. The reported case of AEFI in Uttarakhand is stable and under observation at AIIMS, Rishikesh.
In Chhattisgarh, one person is under observation at the Government Medical College, Rajnandgaon.
Karnataka has two cases of AEFI, one is under observation at District Hospital, Chitradurga and the second person is under observation at General Hospital, Challakere, Chitradurga.
Of the two deaths reported, the authorities have said that the death of Moradabad man who was vaccinated on Saturday and died on Sunday was not related to vaccination. The post-mortem report is awaited in the second death case, reported on Monday from Bellary, Karnataka.
On Sunday night, a ward staff in a hospital in Moradabad, Uttar Pradesh died a day after being vaccinated against Covid-19. Even as his family blamed the death on the vaccine, the UP government said that man died due to septic shock and cardiac arrest and the death was “not related to the Covid-19 vaccination”.
“An adverse event following immunization (AEFI) committee probed the death of the man in Moradabad. The cause of death was septicemic shock and cardiac arrest and it has nothing to do with the vaccination,” the state’s Additional Chief Secretary (Health) Amit Mohan Prasad told reporters in Lucknow.
A case of death after vaccination has also been reported from Bellary in Karnataka. The deceased was a male aged 43 years. He was vaccinated on Saturday and died on Monday. According to a government statement, the cause of his death was anterior wall infarction with cardiopulmonary failure. The post mortem is scheduled for Monday at Vijayanagar Institute of Medical Sciences, Bellary, Karnataka.
WHAT IS AEFI – ADVERSE EVENTS POST IMMUNIZATION?
Adverse Event Post Immunization or AEFI is any unexpected medical occurrence which follows immunisation. It may or may not be related to the vaccine or vaccination process.
#Majority of the AEFIs are minor in nature: pain, mild swelling at the injection site, mild fever, body ache, nausea, giddiness and mild allergic reactions like rashes, etc.
#Only a few AEFIs may require hospitalization. These cases are classified under serious AEFIs.
#Protocols are in place for reporting, immediate case management at vaccination session site, transportation and hospitalisation and further care of such cases.
#Protocols are also in place for systematic investigation and causality assessment of serious AEFIs.
CSIR chief Dr Shekhar Mande said that most AEFIs are identifiable with 45 minutes but a recipients are advised to monitor their health for 15 days.
“Any adverse event needs to be monitored for 45 minutes, generally any serious adverse event is known in less than half an hour. Every few days, normally for 15 days, beneficiaries are given a form to track their health after vaccination,” he said.
“In case of any adverse event, the onus is on vaccine companies. In such cases, it is very important to know and there are ways to find out is it an independent event, or is it correlated with the vaccine,” Dr Shekhar Mande said.
Ethical expert of health and police Anant Bhan furthered stressed on the need to catalogue all AEFIs.
“All AEFI events should be catalogued, and looked into in detail, including for any causality. Established norms for AEFI in the country should be followed as set up by Union health ministry and WHO looking at the special situation of the pandemic,” he said.
Anant Bhan also said, “An adverse event could happen up to a few days after vaccination. Even in the clinical trials for the vaccines, clinical trial participants are I think being proactively followed up for a week post-vaccination. Both vaccines are still undergoing local trials hence this event needs to be taken seriously and looked into rather than dismissing it outright.”
A body called Indian pharmacopoeia commission under health ministry also looks at adverse events post-vaccination. However, largely the onus lies on vaccine-makers.