The National Adverse Effects Following Immunisation Committee has confirmed India's first death owing to the COVID-19 vaccine. The panel confirmed that a 68-year-old man died in March 2021 due to complications that arose after he took Covishield.
The man suffered an anaphylactic reaction post the vaccine announced the AEFI committee. He received the vaccine on March 8, 2021.
The Ministry of Health and Family Welfare has reported 484 deaths in people who died post-vaccination till June 7, 2021 but has not attributed the others to the vaccine. The deaths and hospitalisations have been classified as unclassified, coincidental, intermediate, or vaccine product related reaction.
Even though the Ministry reported about one vaccine related death, it advocates that the benefits of the vaccine outweigh the risks and such reports should not deter people from registering for and taking the COVID-19 vaccine. India had vaccinated close to 23.4 crore people till June 7 and has crossed 26 crore vaccinations so far. Close to 21.6 crore have received the first dose while 4.19 crore are fully vaccinated.
What Did The National AEFI Committee Find?
The National AEFI Committee analysed 31 cases of which 28 were deaths and three were hospitalisations. Eighteen of the 31 were classified as coincidental - not linked to vaccination, seven were classified as indeterminate, three were linked to the vaccine product, one was anxiety related reaction and two cases were found to be unclassifiable.
The Ministry compared the post-vaccination death rate (0.0002%) to the country's death rate and suggested that these deaths should not hamper the COVID-19 vaccination drive. To ensure that there is less hesitancy, the Ministry was sharing data about each adverse event assessed by the National AEFI committee.
How Are Adverse Events Determined And Classified?
The Ministry emphasised that deaths or hospitalisations post vaccination should be thoroughly studied and not be automatically attributed to vaccination. The district administration is expected to research the causes of side effects and classify if they are adverse.
Adverse events, according to the Ministry, are defined as "any untoward medical occurrence which follows immunisation 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."
Following the first level check by the district officials, the state and central government officials further conduct a causality analysis to find out which classification they fall under.
According to the Ministry, vaccine product related reactions are due to vaccination based on current scientific evidence. Examples of such reactions are allergic reactions and anaphylaxis, etc. The Ministry had pre-released a list of contraindications that could act against the vaccine and had also mandated that people be observed for 30 minutes post receiving the vaccine so as to ensure that there are no sudden allergic reactions.
The Ministry classifies indeterminate reactions as those which have occurred soon after vaccination but there is no definitive evidence in current literature or clinical trial data that the event could be due to the vaccine. These reactions need to be further researched.
Unclassifiable events are those which are under investigation but there is not enough evidence to assign a specific diagnosis due to lack of essential information. As soon as after more information is available, these cases could be considered for causality assessment at the national level.
Coincidental events are those that are reported following immunization but have a clear non-vaccine related diagnosis upon investigation.
Finally, anxiety related reaction are observed wherein the general anxiety a person goes through acts out and leads to the person experiencing sudden breathing issues, sweating, or other reactions not linked to side effects of the vaccine.
