2k serious cases of AEFI, 0.004% of 123 crore of shots given: Government

NEW DELHI: Adverse events following immunisation (AEFI) were recorded after 0.004% of the total around 123 crore Covid jabs administered till November 30. Of the 49,819 reported adverse events, 47,691 were minor, 163 severe and 1,965 were serious cases, the government told the Parliament on Tuesday.

AEFI is any untoward medical occurrence that follows innoculation and does not necessarily have a causal relationship with the Covid-19 vaccine. They are reported through the AEFI surveillance system.

An AEFI is considered serious if it results in death, requires hospitalisation, results in persistent or significant disability or a cluster (two or more cases) of AEFIs in a geographical area. Investigations and causality assessment help in establishing a cause and effect relationship, junior health minister Bharati Pravin Pawar said.

“Total deaths and hospitalisations following use of all three Covid-19 vaccines were 946 (0.00008%) and 1,019 (0.00008%) respectively. The causality assessment of 89 deaths have been completed,” the minister said her reply to a query raised in the Rajya Sabha.

“The number of deaths classified under different causality assessment categories is — vaccine product-related 4, coincidental 58, indeterminate 16 and unclassifiable 11,” she further stated.

In response to a separate question on whether the government has ascertained the efficacy of Covishield and Covaxin, the minister said Covishield, manufactured by the Serum Institute of India, is technology transfer of Oxford/AstraZeneca vaccine developed by Oxford University and AstraZeneca.

The efficacy studies for Oxford/AstraZeneca vaccine were conducted overseas by Oxford University and AstraZeneca. Serum Institute of India has conducted Phase II/III immune-bridging clinical trials in the country, she said.

“The overall interim efficacy of the Oxford/AstraZeneca vaccine at the time of approval of Covishield has been reported to be 63%. Bharat Biotech International has conducted Phase III efficacy trial of Covaxin in the country wherein the efficacy of the vaccine has been reported as 77.8%,” she informed the House.

Covaxin was granted Emergency Use Listing (EUL) by the World Health Organisation (WHO) on November 3, 2021. The WHO EUL is sufficient for travelling to a large number of countries. However, some countries issue specific notifications for the inclusion of vaccines for travel purposes, Pawar said.