580 adverse events reported in three days of vaccination

India reported 580 adverse events following immunisation (AEFI) out of 381,305 people vaccinated for Covid-19 till Monday, said data from the Union health ministry, translating to just 0.15% — a rate experts said was key to dispelling hesitancy among recipients that was dogging the inoculation programme.

In Delhi, 26 AEFI were recorded on Monday out of 3,593 shots administered, a rate of 0.72%. Overall, 133 adverse reactions, which can be caused by allergies or underlying medical conditions and are not necessarily causally linked to vaccines, were reported among 148,266 jabs given on Monday, which marked the third day of the nationwide immunization drive.

“So far, cumulative 580 AEFI have been reported, of which seven needed hospitalisation,” said Manohar Agnani, additional secretary, Union health ministry.

Two people died since Saturday, Agnani added. One of them, a hospital employee from Uttar Pradesh’s Moradabad town, suffered a cardiac arrest and his death wasn’t related to the vaccine, the authorities declared. A post-mortem examination would be conducted late on Monday to ascertain the reason for the other death, of a 43-year-old man from Ballari in Karnataka. Of the seven people hospitalised, three were from Delhi, said Agnani.

One was admitted in the intensive care unit (ICU) of the All India Institute of Medical Sciences (AIIMS), Delhi, after complaining of uneasiness, and developed rashes within 15 minutes of getting the shot. The second was admitted for uneasiness to the Northern Railways Hospital. Both were discharged on Sunday. A third person, who fainted, is under observation at a private hospital in east Delhi, said Agnani.

Adverse events are observed with most vaccines and can range from pain, mild swelling at injection site and body ache to breathlessness and hospitalisation. Experts said AEFIs needed to be evaluated in the context of risk-and-benefits associated with immunization.

“Acceptable level of AEFI would ideally be zero, but that is not the case. I think it is around 0.2% and yet we are focusing on that and not the 99.8% benefit,” said Dr Shahid Jameel, former CEO of Wellcome Trust/DBT India Alliance.

In the case of coronavirus vaccines, the government has said that there can be mild AEFIs, such as pain and swelling at the site of injection, mild fever, nausea, giddiness and mild rashes. Serious AEFIs can be a severe allergic reaction, such as an anaphylactic shock, which could potentially require hospitalisation.

India is administering two vaccines as part of the first phase of Covid-19 immunisation covering roughly 30 million health care and other frontline workers. The lead candidate is the Oxford-AstraZeneca vaccine, manufactured by Serum Institute of India and locally known as Covishield, and the second is Bharat Biotech-made Covaxin, which has spurred some controversy because its efficacy data isn’t publicly known.

Uttarakhand reported one case of AEFI, and the health care worker is stable and under observation at AIIMS, Rishikesh. He was admitted to the hospital on Saturday.