70,102 adverse events after vaccination reported in India: Govt data

As of January 30, 2022, India has reported at least 70,102 cases of Adverse Events Following Immunization (AEFI), and 1,013 fatalities following the COVID-19 vaccines, the Ministry of Health and Family Welfare informed the Parliament. 

Out of the total reported adverse events, Covishield comprised 63,315 cases, followed by Covaxin at 6,757 and Sputnik at 30.

Further, out of 1,013 deaths reported following the COVID-19 vaccines, 921 were after Covishield, 92 after Covaxin, and Sputnik reported zero such incidents, the ministry said.

According to the World Health Organization, although vaccines are safe and effective, adverse events can occasionally result after immunisation and range from minor side-effects to more severe reactions that could be a cause of concern for vaccine safety. The government needs to study "what caused the reaction, was it related to the vaccine, or how it was administered, and if the reactions are minor or severe."

The National AEFI Committee determines the type of AEFI, arranges for compensation for the affected parties, vaccine regulation and recommends improving AEFI surveillance. In its written reply to the Parliament, the government has said that "there is no recommendation to make reporting of AEFIs mandatory for healthcare service providers."

Last year, on January 16 2021, NITI Aayog member (Health) V.K. Paul said in a press conference that concerns about adverse effects are unfounded, negligible and insignificant and emphasised that both the vaccines – Covishield and Covaxin – are safe.

As of March 29, 2021, 617 serious AEFIs had been reported from around the country, according to the National AEFI Committee.

The government in its reply also said that AEFI reported in developed countries is self-reporting of adverse drug reactions and using the internet for reporting AEFI online is well established in other countries. 

Further, the ministry noted that "frequent communication to states in letters, advisories have been issued to improve reporting of minor, severe and serious AEFI."

In addition, states have been asked to regularly sensitise health care service providers, including private health care providers, to report AEFI following vaccination.

In March 2021, the government had said there were only 0.18 per cent adverse events following immunisation, while 0.002 per cent had to be hospitalised, which is fairly low.