“It is in the interest of transparency that the information about members of the Subject Expert Committee (SEC) for the COVID-19 vaccine should be in the public domain because it will tell us who are the key experts who have been consulted. Especially, in a pandemic situation, hiding details does not help, rather it raises more doubts and questions in the minds of the people.”Dr Anant Bhan, Researcher, Global Health and Bioethics.
The SEC of the Central Drugs Standard Control Organisation (CDSCO) was tasked with evaluating and recommending the Emergency Use Authorisation (EUA) request of COVID-19 vaccines.
After detailed deliberation in multiple meetings, on 2 January 2021, the SEC recommended the grant of permission for restricted emergency use of two COVID-19 vaccines – Covishield, manufactured by Serum Institute of India (SII), and Bharat Biotech’s Covaxin.
But do we know who are these SEC members?
No, all we know about the SEC, based on the CDSCO’s press release, is that it “consists of domain knowledge experts from the field of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.”
However, being apprised of only their names or designation or experience is not sufficient. Don’t we have the right to know more about SEC experts who are taking such crucial decisions that will affect each one of us?
Are International Regulatory Bodies Transparent?
The COVID-19 pandemic has hit the world and not just India. Now, let’s take a look at how transparent are the regulatory bodies of some of the developed countries.
The Food and Drug Administration (FDA) advisory panel of the United States that recommended the approval of COVID-19 vaccine has not only shared the names of the experts and detailed minutes of the meetings but also the web recording of the meeting on the COVID-19 vaccine. People can see and hear what transpired between the experts and representatives of the vaccine firms.
On the other hand, the United Kingdom’s regulatory authority, Medicines and Healthcare Products Regulatory Agency (MHRA), for COVID-19 vaccine has also shared the names of the experts and detailed minutes of the meetings.
The MHRA has also uploaded separate documents such as ‘Information for Professionals on Pfizer/BioNTech COVID vaccine’, ‘Information for UK recipients on Pfizer/BioNtech COVID-19 vaccine’, ‘Conditions of Authorisation for Pfizer /BioNtech COVID-19 vaccine’, and ‘Public Assessment Report for Pfizer/BioNtech COVID-19 vaccine’.
In March 2020, the CDSCO notified the SEC for approvals of COVID-19 drugs and vaccines. Ever since, experts and NGOs have been demanding transparency in the decisions made by SEC members.
All India Drug Action Network (AIDAN), an independent network of NGOs, working to improve the rational use of essential medicines, has written multiple emails to the head of CDSCO, requesting them to make the minutes of the COVID-19 SEC meeting and the names and designations of the members public.
The CDSCO made the minutes of the meetings of SEC public but not the members’ names and designations.
Are SEC Minutes of Meetings Satisfactory?
The fact is, the SEC minutes of the meetings uploaded on the CDSCO website do not provide satisfactory information to the public.
For instance, on 1 January, the SEC while commenting on Bharat Biotech’s Covaxin approval said that it had the ‘potential’ to target mutated coronavirus strains, but the data provided by the company is not enough. Hence, the SEC turned down the request for restricted emergency use approval.
But the very next day, the SEC recommended approval saying, “(The) firm has presented the safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective.”
The question is:
- What data did the Bharat Biotech provide within 24 hours that they managed to get emergency use approval while Covaxin is still conducting Phase III trials?
- We also do not know if the decision by the SEC was unanimous or did any member express dissent.
- What transpired between the firm and the expert panel?
“To me, it is very important that we have both safety and efficacy data. I have worked with vaccines long enough to know that immunogenicity does not equate to efficacy. So I would really like to see some clinical efficacy data for Bharat Biotech before it is widely used,”Dr Gangandeep Kang, Virologist
Interestingly, not sharing the names of the SEC members is not the practice followed by the CDSCO. For instance, it has uploaded names of technical experts committee members in the minutes of other meetings.
Experts question why is the government holding back the details of SEC members, as it is serving no purpose?
“A detailed minutes of the discussion on what kind of questions were asked by the experts and what were the answers provided by the company representative, what was the nature of data which was sought and provided, etc. We would certainly want to see more details.”Dr Anant Bhan, Researcher, Global Health and Bioethics
Since so many questions have already been raised on the approval of the two vaccines by the SEC, shouldn’t the government work on making the whole process more transparent? Moreover, is it due to the lack of transparency that several people are hesitant to take the vaccine?
We have written to the Ministry of Health & Family Welfare and the CDSCO and will update the article as and when we get a response.
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