Modi’s Booster News Leads to Confusion, and Again Endangers Covaxin Prospects

The government's ham-fisted efforts at 'demand management' and uncertainty over safety and efficacy may once again conspire to disprivilege Covaxin.

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Nearly 12 months ago, on January 3, Drug Controller General V.G. Somani announced that his office had approved the emergency-use of Covaxin and Covishield against infections of the novel coronavirus. Dr Somani read his statement from a piece of paper in four minutes and then rushed out of the venue without answering questions. But in this short time, he said that his office had approved the use of Covaxin in “clinical trial mode”. No one at the time could agree on what it meant.

Prime Minister Narendra Modi’s announcement at 10 pm on December 25 was the country’s next equally significant vaccine-related announcement, and it was even more short on details.

He said India would roll out vaccines for children aged 15-18 years from January 3 and booster doses for the elderly with comorbidities (if they had a “comorbidity certificate”) from January 10, 2022. Like Dr Somani before him, Prime Minister Modi left out a lot of information people need to make informed choices about who should receive doses and when. He also introduced a new term into the immunisation lexicon: “precaution doses”, a term that muddles the meaning of a ‘booster’ shot.

As things stand, there is no official clarity on which vaccines are to be used as boosters when the primary course is Covaxin or Covishield, if recipients will have a choice, how eligibility criteria conflicts (if any) between the two vaccines will be resolved, how severe adverse events after a heterologous boost will be dealt with, and the timing of booster doses in different contexts.

Some reports quote unnamed officials saying the booster dose will be given only to those whose second dose was at least nine months ago; others cite a figure of 9-12 months. The global standard, on the other hand, has been six months.

Earlier this month, Indian Council of Medical Research chief Balram Bhargava had said the council and the Department of Biotechnology are working on culturing copies of the Omicron variant to support lab studies in the country. And at the weekly Union health ministry press conference on December 24, the head of India’s vaccination drive, Vinod K. Paul, had said the government didn’t perceive an imminent need for booster doses, even for the elderly or the immuno-compromised.

He also said there haven’t been any studies examining changes in Covaxin’s response versus the Omicron variant, for the reason that Dr Bhargava had specified.

However, Prime Minister Modi’s announcement negated this part of the government’s caution by implying that Covaxin can be used as booster doses as well. Recall that on January 3, when Dr Somani approved Covaxin for emergency-use in “clinical trial mode” in the eligible population, its phase 3 trials had barely got underway. This absence of trial data seeded hesitancy against Covaxin, and together with poor supply planning, only around 12% of all vaccine recipients in India have received this shot.

Similarly, today, we’re confronted with a situation in which senior health ministry officials say they haven’t been able to study Covaxin against the Omicron variant – and 24 hours later the prime minister says the vaccine is good to go as a booster.

The Economic Times reported on December 27 that the government may in fact “stipulate” a heterologous boosting regimen: for Covishield recipients to receive Covaxin boosters and vice versa. The basis for this potential decision, according to the newspaper, is a “soon to be published” study and a “separate field trial of a small size” – both of which we know little about. The same report also says the drug controller is soon expected to approve Covovax, the Indian equivalent of Novavax, made and sold by Serum Institute.

In fact, the newspaper also reported that the government may have limited booster doses to frontline workers plus those older than 60 years and with comorbidities because of “the relatively low supply of Covaxin and lack of any other alternative to it if the government chooses to mix the jabs”, and that once “more jabs are available, the government will rapidly expand the coverage to those below 60.”

Similarly, in October, India Today had reported that Bharat Biotech had submitted data to the drug controller about the use of Covaxin with people aged 2-18 years. But the government has approved the shot for minors aged 15-18 years, without clarifying whether there were issues with the data of participants aged 2-14 years or because the government didn’t want to confront a vaccine shortage again.

Also read: 10 Questions the Indian Govt Must Answer About Vaccines for Minors and Boosters

These clarifications are important. Even if the actual truth may be banal, the possibilities that Prime Minister Modi is leaving open aren’t helping assuage concerns about the rollout plan’s design. Add to this unnecessary doubts about who is calling the shots on COVID-19 vaccines – the prime minister’s office or the health ministry, considering the former has been speaking as if it knows something the latter doesn’t.

Ultimately, the government’s ham-fisted efforts at ‘demand management’ and uncertainty over safety and efficacy may once again conspire to disprivilege Covaxin among vaccine recipients.

In addition, was the government holding back on rolling out booster doses because Covaxin remains in short supply? Covishield stocks are there in abundance, with Serum Institute CEO Adar Poonawalla quoted earlier this month saying his company may be forced to scale back production as a result. And in November, Serum Institute received a go-ahead from the Indian government to begin exporting Covovax to other countries to the tune of 50 million doses a month.

Considering there have been encouraging studies in the US and Europe of the Covishield and the Covovax counterparts in those countries vis-à-vis the Omicron variant, could the government have approved booster doses then itself, using a heterologous regimen consisting of Covaxin + Covovax and/or Covishield + Covovax?

Another related issue is that in April 2021, Bharat Biotech had proposed a booster dose for Covaxin administered six months after the second dose. This statement had come well before the rise of the Omicron variant (first reported from South Africa on November 22), implying that Covaxin was in need of boosting before Omicron came along. How do experts at the health ministry plan to reconcile these ‘boosters’ with Modi’s “precaution doses”, which Hindustan Times has reported will likely be given 9-12 months after the second dose?

The Indian government’s communication during the COVID-19 epidemic has been wanting on many fronts, but that it appears to have learnt nothing from the mistakes of its ‘first’ vaccine rollout is dispiriting. Covaxin in all likelihood is a good vaccine, but the government has repeatedly compromised India’s chances to make sure by undermining the vaccine’s credibility.

Its actions have also created a situation that it did earlier this year: in which the most vulnerable sections of the population – frontline workers and the elderly, and now also our children – are once again exposed to the most uncertainty.