New Delhi: Strict follow-up, written informed consent and rigorous reporting of side-effects — these are among the conditions recommended by the government drug watchdog’s expert panel for the two Covid-19 vaccines given conditional approval Sunday, ThePrint has learnt.
On Saturday, the subject expert committee (SEC) of the Drugs Controller General of India (DCGI) recommended the Oxford-AstraZeneca candidate, Covishield, and Bharat Biotech’s Covaxin, for a conditional emergency-use licence. They were cleared for the same by the DCGI Sunday.
“While the conditions for the approval to both the vaccine candidates have remained more or less similar, the one thing that is unique to Covaxin is the condition of stringent and rigorous follow-ups with the recipients of its vaccine product,” said a source who attended the SEC meeting on the vaccines. “It was discussed in the meeting that the follow-up should begin right after the person receives the shot till the decided period.”
The panel, which met Friday, was undecided over approving the indigenous vaccine candidate Covaxin as the company is yet to finish recruitment for its phase 3 trial, sources added.
“The scientific debate was over granting the emergency approval to Bharat Biotech’s vaccine candidate. I agree, there were disagreements but the members convinced each other using the scientific basis,” said a second SEC member.
“The company is yet to complete the phase 3 trial and, hence, some data is still pending. However, on the parameters set by the World Health Organisation and the US Food and Drug Administration (FDA), the company had shared all the relevant information basis on which emergency authorisation can be given. The certain threshold of efficacy and immunogenicity has been established,” added the first source.
The company “argued that Covaxin may work better against the mutated variants”, the second source added.
ThePrint reached DCGI V.G. Somani for comments via email but there was no response till the time of publishing this report.
Conditions for nod similar to those for remdesivir
According to both the sources, the conditions for emergency approval for Covishield and Covaxin would be similar to the terms set for remdesivir, a drug used in Covid treatment.
On 2 June, India had given its nod to remdesivir under the emergency-use authorisation provision.
“We have suggested that written informed consent from each person should be taken prior to administration of the vaccine,” the second source said, adding that “an informed consent form should be used”.
“It must contain language understandable to the person and contain factual detail about the vaccine and its restricted emergency-use approval,” the source said.
According to the sources, the companies have to submit active surveillance data of all people vaccinated to the Central Drugs Standard Control Organisation (CDSCO) on regular intervals.
“Also, as per our suggestions, a risk-management plan, including active post-marketing surveillance and reporting of serious adverse events (SAEs), should be submitted to CDSCO every month,” the second source added.