A government panel studying COVID-19 vaccine side effects has confirmed the first death, due to anaphylaxis, following COVID-19 vaccination here on Tuesday. According to a report submitted by the national Adverse Events Following Immunisation (AEFI) Committee, a 68-year-old man died due to anaphylaxis (severe allergic reaction) after being vaccinated on March 8. The death is reported as “vaccine product related reaction” in the report.
The deceased had taken Covishield.
The causality assessment of 31 reported adverse events following immunisation (AEFI) cases was carried out by the panel. N.K. Arora, advisor, National AEFI committee told The Hindu: “It is the first death linked to COVID-19 vaccination due to anaphylaxis. But compared to the overall numbers, only a small number had a severe reaction. Those getting their vaccination need to wait for 30 minutes at the inoculation centre after vaccination as most of the anaphylactic reactions occur during this period and prompt treatment prevents deaths.”
Reacting to the report NITI Aayog, member, (Health), V.K. Paul said: “This incident should not create fear in the minds of people and there should be no apprehension about the safety of the vaccines approved for Indian population. Whenever decisions about public health are taken we discuss the benefits and risks involved and in this case the risk involved is miniscule as opposed to the gains.”
The report meanwhile noted that of the 31 assessed cases, 18 were classified as having inconsistent causal association to vaccination (coincidental – not linked to vaccination), 7 were classified as indeterminate, 3 cases were found to be vaccine product related, one was anxiety related reaction and two cases were found to be unclassifiable. It added that mere reporting of deaths and hospitalisations as serious adverse events does not automatically imply that the events were caused due to vaccines.
The report said that the results of the causality assessment of 31 cases approved by the national AEFI Committee on February 5 (five cases), March 9 (eight cases) and March 31 (18 cases) has been released after thorough review and deliberations.
“Only properly conducted investigations and causality assessments can help in understanding if any causal relationship exists between the event and the vaccine,” the report said, adding that for causality assessments, priority has been given to death cases. The panel said benefits of vaccination are overwhelmingly greater than the small risk of harm and as a measure of utmost precaution, all emerging signals of harm are being constantly tracked and reviewed periodically.
The Health Ministry on Tuesday said that the number of deaths reported following COVID-19 vaccination in the country is only 0.0002% of 23.5 crore doses administered which is within the expected death rates in a population. It is also important and pertinent to note that the mortality rates for those testing positive for COVID-19 disease is more than 1% and COVID-19 vaccination can prevent these deaths. Therefore, the risk of dying following vaccination is negligible as compared to the known risk of dying due to COVID-19 disease, it said.
The Health Ministry added that AEFI is defined as ‘any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine.
“It can be any unfavourable or unintended sign, abnormal laboratory finding, symptom or disease’. Healthcare workers, doctors and vaccine recipients have been always encouraged to report all deaths, hospitalizations and events resulting in disability as well as any minor and adverse events following immunization at any point of time after vaccination,” said the release.
Charu Goyal Sachdeva, HOD, Internal Medicine, HCMCT Manipal Hospitals added that there should be no fear or apprehension about COVID vaccines. “Taking vaccines is advisable even for people who have had the COVID-19 infection. Vaccination should be done after the government prescribed window period following COVID. Reliability and duration of the effectiveness of the antibodies produced by a natural infection varies from person to person. Studies have shown that 9% of people do not have detectable antibodies after a natural infection and 7% of people may not have T-cells that are present in the body to recognise the virus.”
She added that a vaccine would provide a more reliable, durable, and protective source of protection. “Therefore, it is advisable for them to go for the shot. Apart from this, there is a lot of concern about variants – how natural immunity gained by the infection could be against the variant and how much it can help us get protected from getting the new strains. So, the vaccine is reliable protection also because they generate a robust response,” she added.
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