The All India Drug Action Network (AIDAN), an alliance of advocacy groups, has written a letter to the Health Ministry, Niti Aayog and Drug Controller General of India, seeking transparency and clarification on the regulatory approval processes being followed by the country to clear the emergency use of coronavirus vaccines.
The letter came in the backdrop of the US drugmaker Pfizer, Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech International Limited’s recent request for the emergency use authorization (EUA) of their vaccine candidates from the Drug Controller General of India.
Emergency Use Authorization is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. Such an approval was given to Covid-19 drugs — remdesivir and favipiravir in June and itolizumab in July.
While posing scores of questions to Health Ministry Secretary Rajesh Bhushan, Niti Aayog Member Dr. V.K. Paul and DCGI Dr. V.G. Somani, AIDAN emphasized that it is the responsibility of the government to assure that there is no pressure on the authorities to give quick approvals without considering the safety and efficacy of the vaccine candidates.
“Clarify the exact processes and parameters for REU (regulatory approval processes) approval of Covid-19 vaccine candidates in India and whether and under what conditions interim results can be sufficient for seeking such an approval,” the civil society group sought.
It also asked the health ministry to make public the basis of approval, including evidence reviewed, the restrictions and conditions linked to the approval and at what point full market authorization may be given if the regulatory approval processes for a vaccine is granted.
AIDAN also sought for details of the protocol, process and timelines followed in investigating any reported serious adverse events. “Clarify if the government has or is planning to put in place a mechanism to compensate individuals who suffer serious adverse events post-licensure.”
Most importantly, it requested the government to make public all relevant documents and details related to Covid-19 vaccine trials, including details of the composition of the Covid-19 serious adverse events and the redacted documents placed before the committees for analysis of such events reported from the trial sites.
In the interest of transparency and with a view to building public confidence, the All India Drug Action Network, through their letter, also demanded more information on the emergency use authorization request sought by Serum Institute of India for its vaccine — Covishield.
The society also sought all information that will form the basis of scrutinizing Serum Institute’s emergency approval application for its vaccine.
The society wants the disclosure of detailed clinical trial protocol for the Phase 2/3 bridging trial for Covishield along with all amendments made to the protocol, clarification on whether SII’s application will be considered prior to the grant of an EUA in the UK to AstraZeneca-Oxford’s vaccine candidate.
“Disclose information about which interim data from each of the clinical trials will be considered and reviewed by the SEC. Require SII and ICMR to make public any interim data from the Indian trial on the basis of which SII is seeking emergency approval,” the drug action network requested.
While preserving the privacy and confidentiality of the participant, it also asked to be provided with the conclusions of the Data and Safety Monitoring Board and DCGI regarding relatedness of the serious adverse events with the vaccine candidate and the reasoning behind the decisions.
The clarification was sought after a participant from Chennai had reported ill during participation in Serum Institute of India’s trial. He had then sent a legal notice to the Serum, seeking Rs five crore in damages. The company had, however, termed his allegations as malicious and misconceived.
On Tuesday, the Union Health Ministry informed that as many as eight Covid-19 vaccine candidates are under different stages of clinical trials which could be ready for authorization in near future.