India confirms first death following COVID-19 vaccination

New Delhi, June 15 (PTI): A government panel studying COVID-19 vaccine side effects has confirmed the first death due to anaphylaxis following vaccination.
The causality assessment of 31 reported Serious Adverse Events Following Immunisation (AEFI) cases following COVID-19 vaccination was carried out by the panel.
According to a report by the National AEFI Committee, a 68-year-old man died due to anaphylaxis (severe allergic reaction) after being vaccinated on March 8, 2021.
“It is the first death linked to COVID-19 vaccination due to anaphylaxis. It re-emphasises the need to wait for 30 minutes at the inoculation centre after receiving the jab. Most of the anaphylactic reactions occur during this period and prompt treatment prevents deaths, Dr NK Arora, chairperson, National AEFI committee, told PTI.
The Committee examined five such cases that took place on February 5, eight cases on March 9 and 18 cases on March 31.
As per data in the first week of April, the reporting rate is 2.7 deaths per million vaccine doses administered and 4.8 hospitalisations per million vaccine doses administered, the report stated.
The panel said mere reporting of deaths and hospitalisations as serious adverse events does not automatically imply that the events were caused due to vaccines.
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 for causality assessments, priority has been given to death cases.
Of the 31 causally 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, 1 was anxiety related reaction and two cases were found to be unclassifiable, the government panel report said.
Vaccine product related reactions are expected reactions that can be attributed to vaccination based on current scientific evidence, it said.
Examples of such reactions are allergic reactions and anaphylaxis, etc. Indeterminate reactions are reactions which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that this event could have been caused due to the vaccine, the report said, adding further observations, analysis and studies are required.
In the two other cases of anaphylaxis, two persons were given vaccines on January 19 and 16 and both of them were hospitalised and have since recovered.

Risk of death following vaccination negligible compared to known risk
of dying due to Covid: Govt

New Delhi: The health ministry on Tuesday termed as “incomplete” and of “limited understanding” media reports which stated that 488 deaths between January 16 and June 7 following vaccination were linked to post-Covid complications, and highlighted that the vaccination coverage during this period was 23.5 crore.
The number of deaths reported following COVID-19 vaccination in the country is only 0.0002 per cent of the 23.5 crore doses administered, and this is within the expected death rates in a population, it said. In a population, deaths occur at a certain rate. The crude death rate in 2017, according to sample registration system (SRS) data, was 6.3 per 1,000 persons annually, the ministry said.
It is also important and pertinent to note that the mortality rate for those testing positive for COVID-19 is more than one per cent and vaccination can prevent these deaths, it said.
“Therefore, the risk of dying following vaccination is negligible as compared to the known risk of dying due to COVID-19,” the ministry stated.
The ministry also referred to some media reports suggesting an increase in the cases of severe adverse events following immunisation (AEFI) that have also resulted in “succumbing of patients” post vaccination.