The announcement comes amid concerns over the lack of transparency and insufficient disclosure about the neurological complications suffered by a 40-year-old trial participant from Chennai.
“The adverse event will not affect the timelines in any manner whatsoever," said Union health secretary Rajesh Bhushan on Tuesday.
The serious adverse event during the Covishield trial was the second such incident within a week. Bharat Biotech International Ltd said it had seen an adverse event in August during clinical trials of its experimental vaccine, Covaxin.
Despite hospitalization of the two volunteers, the trials were not temporarily stopped to determine the cause and whether the administration of the vaccine had anything to do with it. However, after similar adverse events, UK’s AstraZeneca Plc and US’s Johnson and Johnson had paused their respective clinical trials.
“Initial causality assessment (of the serious adverse events) did not necessitate stoppage of these trials," said Balram Bhargava, director-general, Indian Council of Medical Research, ICMR is the co-sponsor of both Serum Institute and Bharat Biotech trials.
The Centre is soon expected to share the guidelines on vaccine safety with states so that people can be made aware of the benefits of a vaccine before the mass immunization programme gets underway, because “there was an inherent issue of vaccine hesitancy among a certain section of people", the government said.
“It is the collective responsibility of the Union government, state governments, media, NGOs, vaccine manufacturers, pharma companies and other stakeholders to educate people and create awareness about the effectiveness and safety of vaccines," said Bhushan.
“The Union health ministry is preparing detailed guidelines...and one of the chapters in it deals with communication addressing issues of vaccine safety," he added.
Serum Institute’s Covishield is widely expected to be available for the immunization programme for frontline health workers starting January.