A poses for photographs in a selfie booth at a vaccination center for COVID-19 booster doses, Bikaner, July 15, 2022. Photo: PTI
New Delhi: In a shocking twist, The Wire Science found that the Central Drug Standards Control Organization (CDSCO), the country’s nodal drug regulatory firm and an independent framework reporting to the Indian government, has never approved the “precautionary doses” that Prime Minister Narendra Modi has reported a launch from January 10, 2022.
In fact, CDSCO has still approved those doses, also known as booster doses, to date.
At press meetings in November and December 2021, senior officials from India’s COVID-19 Response Programme – Union Health Secretary Rajesh Bhushan, Director General of the Indian Council of Medical Research (ICMR) Balram Bhargava and Head of the COVID-19 Working Group Vinod K. Paul – opposed the deployment of booster doses even though many other countries had started to do so. His answers were confusing, but overall, his position was clear.
So when Prime Minister Narendra Modi suddenly announced on Christmas Day that “precautionary doses” would be implemented in the country from January 10, 2022, the entire country, and probably the country’s COVID-19 reaction team, took it by surprise.
What from December 24 to 25?
The excuse
To find out, The Wire Science introduced six right-to-data (RTI) programmes under the Union Ministry of Health, the ICMR, the Central Standard Medicines Control Organisation (CDSCO) and the Prime Minister’s Office (PMO) on 27 April 2022. and upcoming first appeals. As one entity continuously sent requests to another, in the end there were 24 requests in total.
In response to RTI’s application CDSCO/R/X/22/00043 of June 7, 2022, CDSCO stated, “CDSCO has not approved the precautionary dose of Covishield and Covaxin for those who have taken the number one dose of Covishield and Covaxin. As a precautionary dose is in the vaccination program” (sic).
In other words, CDSCO said it did approve booster doses because the vaccines that would be used as booster doses were already part of the national vaccination campaign.
While The Wire Science applications ran across departments, the quality of the reactions was not very good. For example, in response to a query about the knowledge accessed by the Indian drug controller to authorise Covishield and Covaxin as “precautionary” doses, among others, CDSCO refused to provide information.
In a reaction designated as CDSCO/R/E/22/00142, on May 12, 2022, he stated: “The minutes of the meetings of the Committee of Experts on the Subject Matter (SEC) are on the CDSCO website. The link is: https://cdsco. gov. in/opencms/opencms/en/Committees/SEC/.
The Wire Science filed an initial appeal with CDSCO. Then, on June 30, CDSCO responded, “CDSCO has not won [first] any authorization/approval application for [the] preventive dose of Covishield and Covaxin. “
That is, before Prime Minister Modi reported on India’s January 10 withdrawal campaign, CDSCO had not even won an application for the use of Covaxin and Covishield as booster doses. The vaccines had moved from the company’s clinical trials to public use, avoiding the independent, publicly-named CDSCO in the medium.
Minutes missing
In order for a drug or vaccine to be approved in India, the company that manufactures the vaccine or drug must submit an application for approval to the CDSCO. Then, a chain of events begins that lead to implementation in the market.
CDSCO had told The Wire Science that its final decision-making framework had won over the recommendations of the Committee of Experts on the Subject Matter (SEC), when it said those recommendations were also on CDSCO’s website.
The SEC is an advisory committee that reviews programs for approval and makes recommendations to CDSCO on what to do. CDSCO may or may not agree with the recommendation.
The Wire Science reviewed the segment of CDSCO’s online page that houses the minutes of the SEC assembly, and discovered the minutes of nearly any and every resolution related to COVID-19 vaccines and drugs since the pandemic began. But the minutes of the assembly where the SEC deliberated on the doses of remembrance were noticeably absent.
The closest assembly when the SEC deliberated on the Serum Institute of India’s request to deliver a third dose of Covishield. The SEC had rejected this request on December 10, 2021. Said:
The committee asked the Serum Institute to return after conducting clinical trials in India.
There are no other major points of the SEC assembly where the committee approved Covishield or Covaxin as “precautionary” or withdrawn doses. This contradicts CDSCO’s statement that the minutes of the corresponding assembly are on its online page, but in line with the admission that it has never approved those two vaccines as “precautionary” doses.
Private trials, public health
India has two legal tools to regulate drug regulation: the Drugs and Cosmetics Act of 1940 and the New Drugs and Clinical Trials Rules of 2019. According to its terms, any new vaccine or drug must discharge CDSCO approval before it is eligible for marketing authorization. , according to those rules.
None of the tools specify the criteria for booster doses in the adult population because there was never a universal vaccination program for adults in India before the pandemic. approve vaccines on time.
But this is not the case with booster doses.
“If you’ve replaced the dose of a drug or vaccine [from two to three], it’s a new drug for the purposes of the Drug Act,” Murali Neelakantan, former global general manager of Cipla and Glenmark, told The Wire. And therefore, it will have to be approved through the CDSCO [even if it is an existing vaccine], after a clinical trial. “
CDSCO wants to take a look at the clinical trial data and tell others in the country why it recommends a dose change, he added. Who takes office in this case: the government, hospitals, or doctors administering off-label booster shots?
(Off-label use means the handling of a drug or vaccine in an environment where it has been tested. )
The protective bar for vaccines is higher because they are given to other healthy people, while the drugs are given to other people with health problems.
Where is NTAGI?
In a Supreme Court case on May 2, the Union government claimed that India’s COVID-19 vaccine approval procedure bore the hallmark of a vital clinical framework: the National Technical Advisory Group on Immunization (NTAGI).
The NTAGI is composed of independent experts in the fund as government officials.
The government also told the Supreme Court that all minutes of all NTAGI meetings could be obtained on the websites of the Union Ministry of Health and the ICMR.
The Wire Science verified in April: there were no minutes similar to the withdrawal dose sets. On May 6, in response to a request from RTI, the Union Ministry of Health refused percentage of the minutes (MOHFW/R/E/22/01529/1): “The minutes of the assembly requested are exempt from Article 8 (1) (a) of the RTI Law of 2005, the disclosure of which would harm the clinical and strategic interests of the State. “
This statement, however, contradicts what the Union government had stated before the Supreme Court, namely that the minutes of the NTAGI meetings should be available on the website of the Ministry of Health.
Reacting to the first call, on July 14, the Ministry of Health said the minutes of the 17th NTAGI assembly held a year ago, in June, were still approved by the “competent authority. “
Many NTAGI meetings have since taken a stand and none of their minutes are also not in the public domain.
The Wire Science had asked in particular about the minutes of the NTAGI assembly that deliberated on “caution” ahead of its deployment in January. The Ministry stated in its May 6 reaction (MOHFW/R/E/22/01529/1) that the assembly took a position in December but refused to share the minutes.
The first appeal reaction included a link to the minutes of the 16th NTAGI assembly, which was held in May and had nothing to do with booster doses. However, the link did not work; The Wire Science still discovered the minutes of the 16th assembly on the Department of Biotechnology’s online page.
It seems that the Union government has misled the Supreme Court. Specifically, the Department stated in its response:
While the Supreme Court was informed that minutes of all NTAGI meetings would be posted on the ministry’s website. The ministry added that minutes are missing from meetings held since May, adding a very important six-month meeting.
Again, it’s worth considering whether NTAGI approved the booster doses or whether, like CDSCO, this is not part of the approval process. The reaction the Wire Science won on May 6 from the Ministry of Health read:
But it is not distinguished when the NTAGI STSC approved “precautionary” doses.
The ministry’s reaction to the first call indicated that “the contributions/suggestions of the NTAGI COVID-19 Working Group, as well as the NTAGI STSC” informed the government’s resolution to approve the booster doses.
But he didn’t say what those inputs were.
Two NTAGI members categorically told The Wire Science that none of the members of the NTAGI execution group, STSC or the main NTAGI framework had approved the “precautionary” doses.
The two members also said government officials within NTAGI had tried to get the company to approve the “precautionary” doses. first I needed the knowledge [of clinical trials] to perceive the efficacy and need for booster doses,” they said.
“If we had told government officials what the appropriate time period was, the government would have presented it as ‘NTAGI approving booster doses,’ which never happened. “
Where does peer drive come from?
One of the two members also said that since there was no knowledge of clinical trials on “precautionary” doses and the government sought to implement Covaxin and Covishield despite this absence, the Comptroller General of Drugs of India (DCGI), who is also a member of the NTAGI Working Group – homologous booster doses.
Homologous booster means that the vaccine used for doses number one is also used as a booster dose: A-A-A. Heterologous reinforcement is also known as mixing and combining: A-A-B.
According to the NTAGI member, the DCGI’s resolution was motivated by the desirability of legal compensation. “If there is no knowledge and something is wrong with vaccination, then having 3 doses of the same corporate vaccine would make it less difficult to identify day-to-day jobs than having two other corporations and wonder which corporations deserve to be blamed,” the member said.
The member added that there is no other justification at work.
The member also said that to date, none of NTAGI’s independent experts have gained any knowledge from the government or the corporations that manufacture the vaccines, Serum Institute and Bharat Biotech, regarding their functionality as opposed to the dominant omicron variant lately.
AstraZeneca has manufactured its COVID-19 vaccine in India through serum the Institute. The vaccine is known in India as Covishield. La University of Oxford and AstraZeneca developed together.
However, the UK’s drug regulator has not been in favour of Covishield as a recall. A pre-printed article from the UK’s Health Safety Agency said an mRNA vaccine should be used to stimulate instead. The WHO has also stated that mRNA vaccines are suitable booster applicants after vaccination number one with AstraZeneca’s vaccine.
Regarding the use of Covaxin as a reminder: scientists at ICMR and Bharat Biotech published a preprinted paper online on June 14, 2022, five months after the start of the “precautionary” dosage campaign. Here, they wrote that the third dose presented coverage contrary to the delta and omicron variants, but was based on a study only on hamsters. That is, preclinical data.
The effects of a clinical trial with human participants related to the use of Covaxin as a “precautionary” dose were published in a pre-printed article in January 2022. The effects here were limited to the delta variant, which is a major disadvantage since the omicron circle of variant relatives is lately very dominant.
It wasn’t until July 14 that scientists from ICMR and Bharat Biotech published a paper on the effects of a clinical trial conducted in India. They wrote in the article that Covaxin is also effective as a booster dose unlike the omicron variant.
That said, the consultation of the DCGI resolution to approve peer reinforcement is still raised. A trial conducted at the Christian Medical College in Vellore has exposed evidence of the use of Covishield as a booster after vaccination number one with one of the available vaccines. in India. (mRNA vaccines are not available in India. )
More importantly, the trial found that two doses of Covaxin followed by a Covishield booster elicited an immune reaction than 3 doses of Covaxin, highlighting DCGI’s resolution to approve homologous withdrawal in the absence of any of the required data.
The effects of the trial have been in CDSCO for review for more than two months. “After being ignored for so long, we sent our article to a foreign magazine. It will be published soon,” a member of the school told The Wire Science.
Secrecy and ignorance
The Wire Science asked the Union Ministry of Health, either in its RTI application and in its first call, for minutes of meetings in which the National Group of Experts on COVID-19 Vaccine Management (NEGVAC) approved “precautionary” doses.
This framework is co-chaired by the Chair of the National COVID-19 Working Group, Vinod K. Paul, and the Secretary of the Union Ministry of Health, Rajesh Bhushan.
On either occasion, the Ministry invoked segment 8(a) of the ITR Act. “Disclosure would harm the state’s strategic and clinical interests,” the reaction reads. In reaction to a consultation based on the approval of “precautionary” doses. , the ministry only said it was based on “clinical evidence and more productive global practices. “
T. Prashant Reddy, a lawyer and pharmaceutical expert, laughed at the explanation. He and Neelakantan asked whether a practice can be simply “global” and should already be taken as clinical evidence and at the same time be a matter of secrecy.
The ministry’s reaction added: “These minutes come with discussions about other issues besides [doses of caution], there would possibly be a threat of misuse of information. “
Neelakantan said this piece is also unsustainable. ” I’m surprised that expert bureaucrats don’t write quick minutes on every topic, which is the norm,” he said.
“Assuming this is done, it is common, for example, in corporate law. . . extract only the applicable data from the minutes and percentages if necessary. What prevents the government from doing this and providing you with this data? »
Wire Science’s call also asked the ministry to explain what practice it was referring to, to which the ministry responded: component of the internal discussion. Again, it is not transparent how a “global practice” can be only the prerogative of internal discussion.
The Wire Science also filed an ITR on April 27 asking the ICMR if it made any recommendations to the ministry regarding the deployment of “precautionary” doses. In its reaction of 17 May (INCMR/R/E/22/00228), the Medical Studies Organization stated that it had never issued an opinion on the matter. Were you aware of any clinical trials in this regard?
Doses that no one has approved
The Wire Science had also filed an ITR application with the PMO on April 27 asking it to be aware of all the knowledge applicable to the approval of “precautionary” doses. Remember that Prime Minister Modi was the first person to announce that India would implement booster doses. , even though those responsible for the country’s reaction to COVID-19 had in the past refuted the idea.
The request also asked whether the PMO was involved in the approval of the “precautionary” doses and whether it had corresponded with the Ministry of Health in this regard. The PMO, however, said The Wire Science’s questions are not considered “information” under the RTI Act. A first appeal challenging this response met the same fate.
So who approved India’s “precautionary” doses?More than six months after other people in the country received the third dose of Covaxin and Covishield, the answer turns out to be: no one.
The Indian government is suffering lately to encourage more people: the policy in the eligible population, that of 18-59 years, is less than 1%.
On July 17, the government announced with wonderful fanfare that loose precautionary doses will be administered for 75 days to mark the 75th anniversary of India’s independence. been vaccinated against COVID-19 in India (including number one and precautionary doses).
Instead of that optics, the Indian government may have made greater progress in explaining where the approval of COVID-19 booster doses came from, or whether the country’s leaders simply continued despite medical expertise, legislation, and public accountability.
Some anecdotes to finish: At the time Prime Minister Modi announced the deployment of “precautionary” doses, reports were circulating of COVID-19 vaccine brands in the country facing a stockpile buildup.