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Exclusive: Nobody Approved India’s COVID-19 ‘Precautionary’ Doses

A woman poses for pictures in a selfie stand at a vaccination centre for COVID-19 booster doses, Bikaner, July 15, 2022. Photo: PTI

  • Neither the CDSCO nor the national advisory group on immunisation was taken into confidence before Prime Minister Modi announced the rollout of booster doses.
  • In reply to a series of RTI applications by The Wire Science, the PMO and the health ministry refused to divulge details of the government’s decision-making.
  • One reply indicated that the government had misled the Supreme Court about the availability of the minutes of an NTAGI meeting in December 2021 deliberating ‘precautionary’ doses.
  • It also appears that the DCGI approved homologous boosting in the absence of data and allegedly because it was the legally safer choice.

NTAGI COVID-19 Working Group chief N.K. Arora’s statement issued after the following article appeared is appended at the end together with The Wire Science‘s response.

New Delhi: 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 forwarded 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:”

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.

Private trials, public health

(L-R) Rajesh Bhushan, Vinod K. Paul and Balram Bhargava. Source: PTI, PTI and YouTube

India has two legal instruments to govern drug regulation: the Drugs and Cosmetics Act 1940 and the New Drugs and Clinical Trial Rules 2019. Under their terms, any new vaccine or drug has to have the CDSCO’s approval before it becomes eligible for market authorisation, according to these rules.

Neither instrument specifies standards for booster doses in the adult population simply because there has never been a universal adult immunisation programme in India before the pandemic. But as the pandemic began, it became clear the CDSCO’s office would have to work extra shifts to approve the vaccines on time.

But it didn’t for booster doses.

“If you have changed the dosage of a drug or vaccine [from two to three], it is a new drug for the purposes of the Drugs Act,” Murali Neelakantan, a former global general counsel at Cipla and at Glenmark, told The Wire Science. “And therefore, it has to be approved by CDSCO [even if it is an existing vaccine], after a clinical trial.”

The CDSCO has to examine the clinical trial data and tell the country’s people why it is recommending a dose change, he added. “If the CDSCO has not approved it, then who has? Who takes the responsibility in that case – the government, the hospitals or the doctors administering the booster vaccines in off-label mode?”

(Off-label use means administering a drug or a vaccine in a context in which it hasn’t been tested.)

The safety bar for vaccines is higher because they’re given to healthy people – whereas drugs are given to sick people.

Where is NTAGI?

In a Supreme Court case that it disposed of on May 2, the Union government claimed that India’s approval process for COVID-19 vaccines had the stamp of an important scientific body – the National Technical Advisory Group on Immunisation (NTAGI).

The NTAGI is composed of independent domain experts as well as officials of the government.

The government also claimed in the apex court that all the minutes of all NTAGI meetings were available on the websites of the Union health ministry and ICMR.

The Wire Science checked in April: there were no minutes related to meetings about booster doses. On May 6, in response to an RTI query, the Union health ministry refused to share the minutes (MOHFW/R/E/22/01529/1): “Minutes of meeting as sought is exempted under section 8(1)(a) of RTI Act, 2005 as disclosure of which would pre-judicially affect the scientific and strategic interests of the State.”

This statement, however, contradicted what the Union government had said in the Supreme Court – that the minutes of NTAGI’s meetings were available on the health ministry website.

In response to the first appeal, on July 14, the health ministry said the minutes of the 17th NTAGI meeting held a year ago, in June, had yet to be approved by the “competent authority”.

Many NTAGI meetings have taken place since and none of their minutes are available in the public domain either.

The Wire Science had specifically asked about the minutes of the NTAGI meeting that deliberated on ‘precautionary’, before their rollout in January. The ministry claimed in its May 6 reply (MOHFW/R/E/22/01529/1) that the meeting did happen in December but refused to share the minutes.

The first appeal reply included a link to the minutes of the 16th NTAGI meeting – which was held in May and had nothing to do with booster doses. The link didn’t work, however; The Wire Science eventually found the minutes of the 16th meeting on the Department of Biotechnology website.

So it appears the Union government had misled the Supreme Court. Specifically, the ministry said in its reply:

“As of date, minutes of last meeting of NTAGI held on May 28th, 2021 are available on the above given link. The minutes of 17th NTAGI minute can be seen from the above link as soon as it approved by the competent authority.”

Whereas the Supreme Court had been told that the minutes of all the NTAGI meetings were available on the ministry’s website. The ministry should have added that the minutes of meetings held since May, including one crucial six-month-old meeting, are missing.

Then again, it bears considering if NTAGI approved the booster doses at all or whether, like the CDSCO, it wasn’t part of the approval process. The reply The Wire Science received on May 6 from the health ministry said,

“Issue of precaution/booster dose/additional dose (third dose) of COVID-19 vaccine was discussed in the National Technical Advisory Group on Immunisation’s (NTAGI) Standing Technical Scientific Committee (STSC) meetings held in December 2021.”

But it was vague about when the STSC of NTAGI had approved the ‘precautionary’ doses.

The ministry’s given response in the first appeal nonetheless claimed that “inputs/suggestions of COVID-19 working group of NTAGI as well as STSC of NTAGI” informed the government’s decision to approve booster doses.

But it didn’t say what those inputs were.

Two members of NTAGI categorically told The Wire Science that none of the NTAGI working group, the STSC or the main body of NTAGI had approved ‘precautionary’ doses. (They wished to remain anonymous because their membership of NTAGI requires them to remain confidential.)

Both members also said government representatives in NTAGI tried repeatedly to have the body approve the ‘precautionary’ doses. “They would ask us what is the correct time gap between the second dose and the third. We used to say we need the [clinical trial] data first to understand the efficacy and the need of booster doses,” they said.

“Had we told the government reps what the correct time gap was, the government would have indirectly presented it as ‘NTAGI approving the booster doses’, which actually never happened.”

Whence homologous boosting?

A healthcare worker administers a booster dose of a COVID-19 vaccine to a woman, Guwahati, July 15, 2022. Photo: PTI

One of the two members also said that since there was no clinical trial data on ‘precautionary’ doses and the government wanted to roll Covaxin and Covishield out despite this absence, the Drug Controller General of India (DCGI) – who is also a member of NTAGI’s working group – recommended homologous booster doses.

Homologous boosting means the vaccine used for the primary doses is also used as the booster dose: A-A-A. Heterologous boosting is also colloquially known as mix-and-match: A-A-B.

According to the NTAGI member, the DCGI’s decision was motivated by the convenience of legal indemnification. “If there is no data and something goes wrong with vaccination, then having three doses of the same vaccine company would make it easier to pin responsibility than to have two different companies and wonder on which company the blame is to be shifted,” the member said.

The member added that there was no other rationale at work.

The member also said that to date, none of the NTAGI’s independent experts have  received data either from the government or the companies that are manufacturing the vaccines – Serum Institute and Bharat Biotech –vis-à-vis their performance against the currently dominant omicron variant.

AstraZeneca has licensed its COVID-19 vaccine to be manufactured in India by Serum Institute. The vaccine is known in India as Covishield. The University of Oxford and AstraZeneca developed it together.

However, the UK drug regulator has not been in favour of using Covishield as a booster. A UK Health Security Agency preprint paper said that an mRNA vaccine should be used to boost instead. The WHO has also said that mRNA vaccines are suitable booster candidates after primary vaccination with AstraZeneca’s shot.

As for Covaxin’s use as a booster: ICMR and Bharat Biotech scientists uploaded a preprint paper on June 14, 2022 – five months after the ‘precautionary’ dose campaign began. Here, they wrote that the third dose provided protection against the delta and the omicron variants but based on a study of hamsters only. That is, it was preclinical data.

The results of a clinical trial with human participants and pertaining to Covaxin’s use as a ‘precautionary’ dose were published in a preprint paper in January 2022. The results here were limited to the delta variant, which is a big drawback because the omicron ‘family’ of variants are currently dominant by far.

It was only on July 14 that ICMR and Bharat Biotech scientists published a paper on the results of a clinical trial conducted in India. They wrote in the paper that Covaxin is efficacious as a booster dose against the omicron variant as well.

All this said, the question of the DCGI’s decision to approve homologous boosting still remains. A trial conducted at the Christian Medical College, Vellore, has unearthed evidence for Covishield to be used as a booster after primary vaccination by any of the shots available in India. (mRNA vaccines aren’t available in India.)

More importantly, the trial found that two doses of Covaxin followed by a Covishield booster elicited a better immune response than three doses of Covaxin – putting the spotlight on the DCGI’s decision to approve homologous boosting in the absence of any of the requisite data.

The trial’s results have been with the CDSCO for consideration for more than two months now. “After being ignored for so long, we sent our paper to an international journal. It will be out soon,” a faculty member at the college told The Wire Science.

Secrecy and ignorance

The Wire Science asked the Union health ministry – both in its RTI query and in its first appeal – for the minutes of meetings in which the National Expert Group on Vaccine Administration for COVID-19 (NEGVAC) approved ‘precautionary’ doses.

This body is co-chaired by national COVID-19 task force chairman Vinod K. Paul and Union health ministry secretary Rajesh Bhushan.

On both occasions, the ministry stonewalled by invoking Section 8 (a) of the RTI Act. “The disclosure would pre-judicially affect the strategic and scientific interests of the State,” its reply read. In response to a question about the basis for approval of ‘precautionary’ doses, the ministry only said that it relied on “scientific evidence and global best practices”.

T. Prashant Reddy, a lawyer and an expert on pharmaceutical matters, laughed off the explanation. Both he and Neelakantan asked if a practice could be ‘global’ and already be available as scientific evidence and at the same time be a matter of a secret.

The ministry’s reply added: “These minutes include discussion on various other matters in addition to [precautionary doses], there may be a chance of misuse of information.”

Neelakantan said this bit was also untenable. “I am surprised that the expert bureaucrats don’t draft minutes specific to each subject, which is the norm,” he said.

“Assuming this is not being done, it is common practice, for example, in corporate law … to extract only the relevant information from minutes and share when necessary. What prevents the government from doing this and giving this information to you?”

The Wire Science’s appeal also asked the ministry to specify what practice it was referring to, to which the ministry replied: “With regard to sharing of scientific and global best practices as sought in the RTI appeal is concerned, it is informed that these things are part of internal discussion.” Again, it wasn’t clear how a ‘global practice’ could be the preserve of internal discussion.

The Wire Science also filed an RTI on April 27 asking ICMR if it made any recommendations to the ministry vis-à-vis rolling out ‘precautionary’ doses. In its reply, dated May 17 (INCMR/R/E/22/00228), the medical research body said it never gave any advice on this front. Was it aware of any clinical trial data in this regard?

“This information is not available with ICMR and may be available [with] DCGI. All issues related to introduction of new vaccines or additional doses of existing vaccines are reviewed and approved in various committees of the NTAGI.”

The doses that no one approved

Prime Minister Narendra Modi addresses the media on the first day of the monsoon session of Parliament, New Delhi, July 18, 2022. Photo: PTI

The Wire Science had also filed an RTI application with the PMO on April 27 asking it was aware of any data relevant to the approval for ‘precautionary’ doses. Recall that Prime Minister Modi was the first individual to announce that India would roll out booster doses, even as the people in charge of the country’s COVID-19 response had until then refuted the idea.

The application also asked if the PMO was involved in the approval for ‘precautionary’ doses and whether it had corresponded with the health ministry in this regard. The PMO, however, said The Wire Science’s questions don’t qualify as “information” under the RTI Act. A first appeal challenging this reply met the same fate.

So who approved India’s ‘precautionary’ doses? More than six months since the country’s people started receiving third doses of Covaxin and Covishield, the answer appears to be – no one.

The Indian government is currently struggling with getting more people to be boosted: the coverage in the eligible population, of those aged 18-59 years, is less than 1%.

On July 17, the government announced with much fanfare that precautionary doses will be administered free of cost for 75 days to mark the 75th anniversary of India’s independence. The next day, government officials embarked on a media blitz after reporting that 2 billion people had been vaccinated against COVID-19 in India (including primary and precautionary doses).

Instead of these optics, the Indian government could have taken greater strides by explaining where the approval for COVID-19 booster doses originated – or if the country’s leaders just went ahead in spite of scientific expertise, laws and public accountability.

Some trivia to finish: At the time Prime Minister Modi announced the rollout of ‘precautionary’ doses, reports were doing the rounds of COVID-19 vaccine manufacturers in the country facing a big stock pile-up.

This article was first published on July 19 and was republished on July 22, 2022.

N.K. Arora’s statement to ANI + The Wire Science‘s response (10:10 am, July 20, 2022):

Responding to The Wire Science’s report on the lack of approval for ‘precautionary’ doses, on July 19, NTAGI COVID-19 Working Group chief N.K. Arora told news agency ANI that “right from the beginning of October-November 2021″, government officials had been deliberating the matter.

But in so doing, Arora has contradicted his own stance in these months.

The key word in this statement was “discussed” – that is, Arora failed to explicitly state that the ‘precautionary’ doses had been “approved”  by NTAGI. The Wire Science found, as described in the article above, that NTAGI had not approved ‘precautionary’ doses.

Arora had told NDTV on October 22, 2021, that it was highly “unlikely” that India would roll out booster doses due to naturally high infection rates. Together with primary vaccination coverage, he had reasoned then that India had “double-barrel advantage” that precluded the need for boosters.

On November 30, he changed his position a little and told NDTV that the government was mulling a policy on “additional doses”, and not booster doses per se. But he also limited the “additional doses” to immunocompromised people. This is vastly different from the phase-wise but general population rollout that Prime Minister Narendra Modi announced on December 25, 2021.

Thus far, neither the Press Information Bureau nor any government entity has formally responded to The Wire Science’s report.

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