The Union health ministry’s latest analysis of adverse events following immunization (AEFI) shows that 61 out of 88 cases that of severe or serious side effects chosen for analysis have a consistent causal association to vaccination, and 37 were vaccine-related reactions. There were five deaths in this clutch of cases but these were not directly linked to the vaccine, according to the government report that HT has accessed.
This is the fifth AEFI report of the government and experts said its findings reinforce the safety of the vaccines. The government has been analysing AEFI instances in batches – this report pertains to 88 cases selected at random between January 16) when coronavirus vaccination was launched in India) and March 30. In this period, 64.3 million doses were administered.
Apart from five deaths, all other severe and serious adverse reaction cases recovered, according to the report, which said that three deaths were coincidental and not linked to vaccination– such cases are when a cause of death other than a vaccine is established upon investigation. The two remaining deaths were classified by experts in the indeterminate category.
Most of the side effects, which were in 22 cases, were related to anxiety following vaccination – which does not directly implicate the product. In two cases, the reactions were related to immunisation error, the report added.
“61 out of 88 cases for which causality assessment has been done found to have consistent causal association to vaccination, of these 61 cases, 37 were vaccine product related reactions 22 cases were immunization anxiety related reactions, and 2 cases were immunization error related reaction. 18 cases have inconsistent causal association to vaccination (coincidental — not linked to vaccination) including 3 death cases. 9 cases were in indeterminate category including 2 death cases,” said the ministry’s AEFI report.
The result of the causality assessment for these 88 cases was completed on June 28, 2021, after a thorough review, deliberation and approval by the national AEFI committee.
Vaccine product related reactions are those that can be attributed based on current scientific evidence. Examples of such reactions are allergies and anaphylaxis.
Indeterminate reactions occur soon after vaccination but there is no definitive evidence in current literature or clinical trial data that this could have been due to the vaccine. Further observations, analysis and studies are required.
Unclassifiable events are events that have been investigated but there is not enough evidence for a diagnosis due to missing information. When this relevant information becomes available, the case may be reconsidered for causality assessment.
A dedicated group has been formed both at the state and central level, to conduct causality assessment of AEFIs following Covid-19 vaccination. The results of causality assessment done by this expert group are discussed in the national AEFI committee meeting for final approval.
The medical specialists include cardiologists, neurologists, pulmonary medicine specialists, and obstetrician-gynaecologists as members of the causality assessment sub-committee at the national level.
“The surveillance happens not just for Covid-19 vaccination; in fact the country has a robust AEFI surveillance system as India vaccinates a large number of children and even pregnant women each year. A well-oiled system is in place for the purpose, and surveillance post Covid-19 vaccination is now a part of that system,” said a senior central government official aware of the matter, on condition of anonymity.
The final analysis of the cases is sent to the Union health ministry’s immunisation division that stores all data related to immunisation in the country at the central level, including Covid-19 immunisation.
Experts also say that the percentage of adverse reactions that have been reported so far is minuscule in comparison.
“It has been well-established that vaccines are safe and should be taken without hesitation. Vaccinating a significant percentage of our population will eventually help in containing the disease transmission,” said Dr Srikant Sharma, senior consultant, department of medicine, Moolchand Hospital.