The Wire Science: New Delhi: Tuesday, 19 July 2022.
In a shocking turn, The Wire Science has found that the Central Drug Standards Control Organisation (CDSCO) the country’s nodal drug-regulation agency and an independent body under the Government of India never approved the ‘precautionary doses’ that Prime Minister Narendra Modi flagged for rollout from January 10, 2022.
In fact, the CDSCO is yet to approve of these doses a.k.a. booster doses to this day.
At press conferences in November and December 2021, the top brass of India’s COVID-19 response programme Union health secretary Rajesh Bhushan, Indian Council of Medical Research (ICMR) director-general Balram Bhargava and COVID-19 task force chief Vinod K. Paul were opposed to rolling out booster doses even as many other countries had started to. Their answers were muddling, but in all, their position was clear.
So when Prime Minister Narendra Modi suddenly announced on Christmas Day that “precautionary doses” would be rolled out in the country from January 10, 2022, the whole country and probably the country’s COVID-19 response team was caught off guard.
What changed from December 24 to December 25?
The excuse
To find out, The Wire Science filed six applications under the Right to Information (RTI) Act with the Union health ministry, ICMR, the Central Standard Drugs Control Organisation (CDSCO), and the Prime Minister’s Office (PMO) on April 27, 2022, and subsequent first appeals. As one entity repeatedly forward the applications to another, there were eventually 24 applications in all.
In reply to RTI query CDSCO/R/X/22/00043 on June 7, 2022, the CDSCO said, “CDSCO has not approved precautionary dose of Covishield and Covaxin for those who have taken primary dose of Covishield and Covaxin. As precautionary dose is in vaccination program” (sic).
In other words, the CDSCO said it didn’t approve the booster doses because the vaccines to be used as booster doses were already part of the national vaccination drive.
Even as The Wire Science’s applications wound their way through various government departments, the quality of answers wasn’t very good. For example, in response to a question about what data the Drug Controller of India had perused to clear Covishield and Covaxin as ‘precautionary’ doses, among other things, the CDSCO refused to supply any information.
In a reply designated CDSCO/R/E/22/00142, on May 12, 2022, it said, “The minutes of meetings of the Subject Expert Committee (SEC) are available in the CDSCO website. The link is as follows: https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/.”
The Wire Science subsequently filed a first appeal with the CDSCO. Then, on June 30, the CDSCO replied: “The CDSCO has not received [in the first place] any application for the grant of permission/approval for [the] precautionary dose of Covishield and Covaxin.”
That is, before Prime Minister Modi flagged off India’s booster-dose drive from January 10, the CDSCO hadn’t even received an application for the use of Covaxin and Covishield as booster doses. The vaccines had in effect gone straight from company clinical trials to public use sidestepping both the independent and the publicly appointed CDSCO in between.
The missing minutes
For any drug or vaccine to be approved in India, the company that makes the vaccine/drug has to file an application for approval with the CDSCO. Then begins a chain of events leading up to market rollout.
The CDSCO had told The Wire Science that its ultimate decision-making body had received the recommendations of the subject expert committee (SEC) when it said these recommendations were also available on the CDSCO website.
The SEC is an advisory committee that studies approval applications and makes recommendations to the CDSCO about what it should do. The CDSCO may or may not accept the recommendation.
The Wire Science pored through the section of the CDSCO website that hosts minutes of the SEC’s meetings and found the minutes of almost all decisions vis-à-vis COVID-19 vaccines and drugs since the pandemic began. But the minutes of the meeting where the SEC deliberated the booster doses were notably absent.
The meeting that came closest was one in which the SEC deliberated Serum Institute of India’s application to deliver a third dose of Covishield. The SEC had rejected this application on December 10, 2021. It said:
“The committee noted that the firm has presented immunogenicity data of only 75 subjects from UK study. Further, the firm has not presented any data from Indian population for the requirement of booster dose based on demographical profile and waning immunogenicity, the interval between the first & second dose etc.”
The committee asked Serum Institute to come back after conducting clinical trials in India.
There are no other SEC meeting details in which the committee approved Covishield or Covaxin as ‘precautionary’ or booster doses. This is at odds with the CDSCO’s claim that the corresponding meeting’s minutes are available on its site but in line with the admission that it never approved these two vaccines as ‘precautionary’ doses.
In a shocking turn, The Wire Science has found that the Central Drug Standards Control Organisation (CDSCO) the country’s nodal drug-regulation agency and an independent body under the Government of India never approved the ‘precautionary doses’ that Prime Minister Narendra Modi flagged for rollout from January 10, 2022.
In fact, the CDSCO is yet to approve of these doses a.k.a. booster doses to this day.
At press conferences in November and December 2021, the top brass of India’s COVID-19 response programme Union health secretary Rajesh Bhushan, Indian Council of Medical Research (ICMR) director-general Balram Bhargava and COVID-19 task force chief Vinod K. Paul were opposed to rolling out booster doses even as many other countries had started to. Their answers were muddling, but in all, their position was clear.
So when Prime Minister Narendra Modi suddenly announced on Christmas Day that “precautionary doses” would be rolled out in the country from January 10, 2022, the whole country and probably the country’s COVID-19 response team was caught off guard.
What changed from December 24 to December 25?
To find out, The Wire Science filed six applications under the Right to Information (RTI) Act with the Union health ministry, ICMR, the Central Standard Drugs Control Organisation (CDSCO), and the Prime Minister’s Office (PMO) on April 27, 2022, and subsequent first appeals. As one entity repeatedly forward the applications to another, there were eventually 24 applications in all.
In reply to RTI query CDSCO/R/X/22/00043 on June 7, 2022, the CDSCO said, “CDSCO has not approved precautionary dose of Covishield and Covaxin for those who have taken primary dose of Covishield and Covaxin. As precautionary dose is in vaccination program” (sic).
In other words, the CDSCO said it didn’t approve the booster doses because the vaccines to be used as booster doses were already part of the national vaccination drive.
Even as The Wire Science’s applications wound their way through various government departments, the quality of answers wasn’t very good. For example, in response to a question about what data the Drug Controller of India had perused to clear Covishield and Covaxin as ‘precautionary’ doses, among other things, the CDSCO refused to supply any information.
In a reply designated CDSCO/R/E/22/00142, on May 12, 2022, it said, “The minutes of meetings of the Subject Expert Committee (SEC) are available in the CDSCO website. The link is as follows: https://cdsco.gov.in/opencms/opencms/en/Committees/SEC/.”
The Wire Science subsequently filed a first appeal with the CDSCO. Then, on June 30, the CDSCO replied: “The CDSCO has not received [in the first place] any application for the grant of permission/approval for [the] precautionary dose of Covishield and Covaxin.”
That is, before Prime Minister Modi flagged off India’s booster-dose drive from January 10, the CDSCO hadn’t even received an application for the use of Covaxin and Covishield as booster doses. The vaccines had in effect gone straight from company clinical trials to public use sidestepping both the independent and the publicly appointed CDSCO in between.
The missing minutes
For any drug or vaccine to be approved in India, the company that makes the vaccine/drug has to file an application for approval with the CDSCO. Then begins a chain of events leading up to market rollout.
The CDSCO had told The Wire Science that its ultimate decision-making body had received the recommendations of the subject expert committee (SEC) when it said these recommendations were also available on the CDSCO website.
The SEC is an advisory committee that studies approval applications and makes recommendations to the CDSCO about what it should do. The CDSCO may or may not accept the recommendation.
The Wire Science pored through the section of the CDSCO website that hosts minutes of the SEC’s meetings and found the minutes of almost all decisions vis-à-vis COVID-19 vaccines and drugs since the pandemic began. But the minutes of the meeting where the SEC deliberated the booster doses were notably absent.
The meeting that came closest was one in which the SEC deliberated Serum Institute of India’s application to deliver a third dose of Covishield. The SEC had rejected this application on December 10, 2021. It said:
“The committee noted that the firm has presented immunogenicity data of only 75 subjects from UK study. Further, the firm has not presented any data from Indian population for the requirement of booster dose based on demographical profile and waning immunogenicity, the interval between the first & second dose etc.”
The committee asked Serum Institute to come back after conducting clinical trials in India.
There are no other SEC meeting details in which the committee approved Covishield or Covaxin as ‘precautionary’ or booster doses. This is at odds with the CDSCO’s claim that the corresponding meeting’s minutes are available on its site but in line with the admission that it never approved these two vaccines as ‘precautionary’ doses.
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