Coronavirus Explainer: What Are Adverse Events Post COVID-19 Immunisation

New Delhi: On Saturday (January 16), India launched COVID-19 vaccination drive, a process to immunise 1.3 billion people in the country, which according to the government is being called as the largest vaccination programme. On day 1 of the drive, 1.91 lakh people were administered the shots with over 3,000 sites active across India, the government says it is the highest any country has achieved in the world so far. Over 17,000 people were vaccinated across 553 sites in six states on Day 2 of India’s coronavirus vaccination drive, taking the number who had received at least one shot to around 2.24 lakh, according to the Health Ministry. Of the people who have been vaccinated, 447 suffered adverse event following immunisation (AEFI) in India, according to the data released by Health Ministry of India on Sunday (January 17).

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What Is AEFI or Adverse Event Following Immunisation?

World Health Organisation defines Adverse Event Following Immunization as any untoward medical occurrence which follows immunization and which does not necessarily have a causal relationship with the usage of the vaccine. WHO says, “if it is not rapidly and effectively dealt with, it can undermine confidence in a vaccine and ultimately have dramatic consequences for immunization coverage and disease incidence.”

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Classification Of Adverse Event Following Immunisation

Adverse reactions to a vaccine are broadly categorised based on their cause, severity, and frequency. The categories based on severity and frequency are:

a. Common minor reactions: This is basically defined as an event that is not serious and does not pose a potential risk to the health of the recipient. However, even non-serious AEFIs should also be carefully monitored because they may signal a potentially larger problem with the vaccine or vaccination or have an impact on the vaccination acceptability, in general
b. Serious and severe vaccine reactions: An event that results in death, is life-threatening, requires in-patient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Any medical event that requires intervention to prevent one of the outcomes above may also be considered as serious
c. Cause-specific reactions: Vaccine product-related reaction and vaccine quality defect-related reaction

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A Look At How India Has Prepared Itself For Managing Adverse Event Following Immunisation

The government of India had already kept the adverse events post-immunisation in mind and had established protocols for the management of adverse reactions – minor, severe or serious – to the coronavirus vaccine.

Some of the rules in the guidelines included limiting vaccinations per session and 30 minutes of on-site monitoring post-injection. As part of the adverse event mechanisms, state governments had also set up at least one AEFI centre (Adverse Event Following Immunisation) in each block. In addition, primary health care facilities, community health centres and private medical facilities are also functioning as AEFI Management Centres, with vaccination data from each session getting uploaded on government’s Co-WIN (Covid Vaccine Intelligence Network) digital platform.

Health Secretary Rajesh Bhushan added,

Adverse events post-immunisation is a critical aspect. Even during universal immunisation, which have been going on for decades, some adverse effects are seen in children and pregnant women. The key is always how the states and union territories prepare for this.

Dr NK Arora, Head of the Operations Research Unit, Indian Council Of Medical Research’s (ICMR) National Task Force for COVID-19 , said,

The monitoring of any adverse events is being carried out based on the country’s existing vaccine safety surveillance mechanism under the Universal Immunisation Programme (UIP). The AEFI framework under UIP includes doctors, data and public health specialists. The vaccine safety surveillance network extends up to every district, where a panel of doctors and health workers monitor events of concern after getting any vaccine, investigate and report to state and national level.

What Are The Types Of Adverse Events Reported In India After COVID-19 Vaccine?

Of 447 adverse events, three patients had to be hospitalised, two of these three have been discharged after treatment (from Delhi’s AIIMS and Railway Hospital), while the third was under observation at the AIIMS in Rishikesh. According to the health ministry of India, “Majority of the AEFIs are minor in nature, which were reported after immunisation during the weekend. The types included – pain, mild swelling at injection site, mild fever, body ache, nausea, giddiness and mild allergic reactions like rashes, etc.”

On Saturday, a 22-year-old security guard at All India Institute of Medical Sciences (AIIMS), New Delhi, was admitted in the intensive care unit (ICU) after he developed an allergic reaction. The guard had suffered headache, rash, respiratory distress, and tachycardia. According to AIIMS Director Randeep Guleria, the security guard, in his 20s, at AIIMS who received the jab after 4 pm, complained of palpitations and developed an allergic skin rash within 15-20 minutes after being inoculated and was admitted to the facility. He said, “He was immediately managed with appropriate treatment and he improved. He is stable. As a precautionary measure he has been admitted for overnight observation and his condition is being monitored. He is likely to be discharged soon.”

NDTV – Dettol Banega Swasth India campaign is an extension of the five-year-old Banega Swachh India initiative helmed by Campaign Ambassador Amitabh Bachchan. It aims to spread awareness about critical health issues facing the country. In wake of the current COVID-19 pandemic, the need for WASH (Water, Sanitation and Hygiene) is reaffirmed as handwashing is one of the ways to prevent Coronavirus infection and other diseases. The campaign highlights the importance of nutrition and healthcare for women and children to prevent maternal and child mortality, fight malnutrition, stunting, wasting, anaemia and disease prevention through vaccines. Importance of programmes like Public Distribution System (PDS), Mid-day Meal Scheme, POSHAN Abhiyan and the role of Aganwadis and ASHA workers are also covered. Only a Swachh or clean India where toilets are used and open defecation free (ODF) status achieved as part of the Swachh Bharat Abhiyan launched by Prime Minister Narendra Modi in 2014, can eradicate diseases like diahorrea and become a Swasth or healthy India. The campaign will continue to cover issues like air pollution, waste management, plastic ban, manual scavenging and sanitation workers and menstrual hygiene.