Adverse event in Serum's trial won't affect vaccine timelines: Health secy

Health ministry to come out with guidelines that will address the issues around vaccine safety to create awareness and dispel misinformation

The initial assessment of the adverse event in the ‘Covishield’ vaccine trials being conducted by the Serum Institute of India (SII) did not necessitate the stoppage of the trial and it has in no way impacted the timelines of the vaccine’s roll out plans, the government officials said on Tuesday. 

“Due processes were followed in reporting the adverse event... We have been given to understand that there is a court case so we cannot comment on the specifics of the case,” said Rajesh Bhushan, secretary, health and family welfare ministry while addressing a press conference on the Covid-19 situation in India.

Indian Council of Medical Research chief, Balram Bhargava, also said that adverse events do occur in trials for drugs, vaccines or any other health intervention. However, based on the scientific data the regulator has to ascertain or refute whether there is a one-to-one correlation between the vaccination and the adverse event. 

The health ministry is planning to come out with guidelines that will address the issues around vaccine safety to create awareness and dispel any misinformation. 

Bhushan said that there are set procedures for human trials to ensure safety of volunteers. Subjects are supposed to sign a prior informed consent form that tells the subject of the possible adverse events in case they decide to participate in the clinical trial. 

Besides this, the institutional ethics committee and the data safety monitoring board which are independent of the company and the government monitor the trials and keep an eye on any adverse event. 

They submit their report to the drug controller general of India who takes the final decision on the matter based on the data presented.

The government does not plan to vaccinate the entire population of the country for Covid, but just enough to stop the chain of transmission as of now. 

“If we are able to vaccinate a critical mass of people and break the transmission...we may not have to vaccinate the entire population,” Bhargava said. 

Health ministry has also said that it is the collective responsibility of the centre and the state governments along with the vaccine makers to educate the people and make them aware of the safety and effectiveness of the vaccine. 

A Chennai-based man had demanded compensation of Rs 5 crore from Pune-based drugmaker SII as his health allegedly worsened after volunteering to take part in the clinical trials for the Covid-19 vaccine developed by the UK’s Oxford university and AstraZeneca. The company has refuted the allegations and said that its vaccine was safe and immunogenic. 

Bharat Biotech, which is developing the covid-19 vaccine Covaxin, also had an adverse event in August during the phase 1 trial when a volunteer had to be hospitalised after being given the vaccine. The company had found the incident as not vaccine-related.