People wait to receive a dose of Covishield at a hospital in Noida, August 30, 2021. Photo: Reuters/Adnan Abidi
- Inconsistencies between independent experts, government officials and the PM dog the Union health ministry’s decision to expand India’s COVID-19 booster-dose drive.
- The decision once again sidesteps the NTAGI’s expertise as well as appears to not have factored in India’s high seroprevalence – 67% in July 2021 itself.
- There is also no India-specific consensus on whether the current crop of vaccines can improve protection against severe disease and whether they should be mixed-and-matched.
On April 8, the Ministry of Health and Family Welfare announced that all eligible adults – i.e. people older than 18 years – will be able to receive booster doses for COVID-19 from April 10. The move is the latest expansion of the country’s COVID-19 vaccination drive, which commenced on January 16, 2021, and has since fully vaccinated 83 crore people as well as has delivered booster doses to 2.28 crore people.
Prime Minister Narendra Modi had announced on December 25, 2021, that the drive would be expanded from January 3, 2022, to include young adults (15-18 years) and from January 10 to avail booster doses to those older than 60 years and to frontline and healthcare workers. The announcement was unexpected, in part because questions on the need for booster doses in a country with very high seroprevalence (i.e. presence of antibodies owing to exposure to the virus) have never been settled.
Modi’s words were also unexpected because just a week earlier, on December 17, Vinod K. Paul, the man in charge of India’s COVID-19 vaccination drive, had said the country would focus first on fully vaccinating all eligible adults before rolling out booster doses. That hadn’t happened by December 25 – and hasn’t even until now. Additionally, 24 hours before the announcement, health ministry officials had said they hadn’t had a chance to finish studying Covaxin’s response against the omicron variant.
Indeed, inconsistencies like this between independent experts, government officials and the prime minister himself dog the Union health ministry’s decision yesterday to render India’s entire adult population to be eligible for booster doses.
NTAGI sidestepped again
The first, and perhaps foremost, such issue is that the decision to expand the booster dose programme is the second instance of a prime-ministerial announcement sidestepping the view of a government body he set up, to determine which vaccines should be included in the vaccination and booster drives.
A source at the National Technical Advisory Group on Immunisation (NTAGI) told The Wire Science that the body never discussed the need for booster doses in India, among various population groups, because the item was never listed in its internal agenda. So the question of whether it approved or rejected the idea is moot.
Thus far, all vaccine-manufacturers have had to have their vaccines approved by the Drug Controller General, by law, and subsequently by NTAGI, as a matter of the government’s process during the pandemic, before it could become part of the vaccination drive – with one exception.
On March 14, the Union health ministry announced its approval for the use of Corbevax, a COVID-19 vaccine manufactured in India by Biological E, among young adults aged 12-14 years without NTAGI’s clearance.
Jayaprakash Muliyil, a former professor of community medicine at the Christian Medical College, Vellore, and a member of NTAGI, also told The Wire Science at the time that the nodal decision-making group within NTAGI hadn’t yet developed a final view on Corbevax because it lacked “post-omicron data”.
The Wire Science wrote at the time, “The Centre’s decision to skip NTAGI’s approval for Corbevax deprives the vetting process of three levels of checks, including by subject experts.” The new decision to expand the availability of booster doses inherits the same problem – as well as another form of expertise neglect.
Who are the recipients?
Mulilyil has said before that booster doses are not required for entire populations – as have the WHO, the Indian Medical Association and virologist Gagandeep Kang. The last three have said booster doses can be rolled out to those older than 60 years, those whose jobs entail high exposure to the virus (frontline and healthcare workers) and to people with compromised immune systems.
On the other hand, Virologist Shahid Jameel has noted the omicron variant’s ability to reinfect people – i.e. after they have been naturally infected before – and has stressed on the need for booster doses in this context.
However, Jameel has also advocated for the use of an heterologous booster regimen, also known as ‘mix-and-match’ boosting. In this regime, a person who has been fully vaccinated with Covaxin will receive Covishield, and vice versa. On December 27, 2021, Economic Times had also quoted an unnamed government official saying the government might recommend a heterologous booster regimen based on a “soon to be released” study. It is yet to be released.
India’s policy is homologous, however: those who have received Covaxin will also be boosted by Covaxin, and similarly for Covishield.
(Fewer than 1% of recipients in India have received the Russia-made Sputnik V vaccine. Also, as of 9 am on April 9, 2022, the CoWIN dashboard didn’t display the number of vaccines administered by name.)
Need for booster doses
The need for booster doses has been shaped by two forces: science and politics. On the science front: two studies conducted in August and September 2021 reported that booster doses increased the immune responses of people with weakened immune systems. However, neither study assessed whether this improvement translated to lower chance of developing severe COVID-19.
Some data on this count came from Israel, which authorised booster doses for its elderly population from July 30, 2021. A month later, researchers who had tracked the health of one million booster-dose recipients in the country said their risk of developing severe COVID-19 had dropped by an order of magnitude as a result of the doses. Johnson & Johnson reported a similar result based on tests of its vaccine as a booster shot.
As S. Swaminathan, a retired professor of infectious diseases and biotechnology, wrote for The Wire Science in October 2021:
Most studies on boosters are preliminary and suffer from confounding and selective reporting. Also, the efficacy of all vaccines approved thus far against severe COVID-19 is significantly greater than against infection itself. …
The decision [to roll out booster doses] should take into account the durability of boosting, number of severe COVID-19 cases that it can prevent, its efficacy against prevalent variants and potential safety risks. …
The perception that vaccine-induced immunity wanes over time is being driven by observations that suggest antibody levels drop with time. This is a natural process and happens with any vaccine.
But antibody decline is not necessarily synonymous with decline in protection – as protection can also be mediated by memory B cells and T cells. In fact, no study so far has shown that protection against severe COVID-19 declines significantly with time.
Then there is the fact of Indians’ extant exposure to the virus.
On December 10, 2021, scientists from the National Institute of Epidemiology (NIE), a government institute in Chennai, reported the results of a nationwide sample-based study to estimate the number of people across India who already had antibodies to the virus in their blood. The study was conducted in 70 districts in 20 states and one Union territory in June and July 2021. The team reported in their paper:
Nearly two-thirds of individuals aged 6 years [and above] from the general population and 85% of [healthcare workers] had antibodies against SARS-CoV-2 by June-July 2021 in India. As one-third of the population is still seronegative, it is necessary to accelerate the coverage of COVID-19 vaccination among adults and continue adherence to non-pharmaceutical interventions.
According to a reply in Parliament by Bharati Pravin Pawar, minister of state at the health ministry, on July 27, 2021, “The projected population of 18+ year persons in the country is 94 crore”. By August 2021, India had fully vaccinated 5.96 crore persons – which is 6.3% of the eligible population. Today, the coverage stands at 88.29%.
It is not known what a fifth seroprevalence survey of the sort led by NIE will conclude, but two things have happened since July 2021 to suggest the prevalence of antibodies today is far higher: the rise of the omicron variant and the substantially higher vaccination coverage.
“Given the high seroprevalence of COVID-19 in the country, surely a significant amount of natural boosting, through viral exposure, must be happening,” to quote Swaminathan. “We need to investigate and understand this phenomenon and factor in such knowledge into any decisions on the feasibility of boosting.” There is no evidence thus far that such studies have been conducted.
Pricing and access
Finally, the big affordability question. According to minister of state Pawar, 94 crore people in India will be eligible to avail booster doses – at various times – from April 10. Some media reports (such as this), corroborated by sources within the health ministry, indicated that about six crore people are older than 60 years or are frontline and healthcare workers.
The latter group will receive booster doses for free, according to the government’s standing policy. But the health ministry’s announcement on April 8 noted that booster doses will only be available at private vaccination centres. This means, unless the policy changes, the remaining 88 crore people will have to pay out of their pockets for boosters.
At private hospitals, a dose of the Covishield vaccine currently costs Rs 780 and Covaxin, Rs 1,200 – both inclusive of service charge. These figures and the government’s policy together add salt to the the wounds of poorer people for whom the cost of a single dose (at private hospitals) amounts to a day’s wages or more – and who will now be further excluded from a programme that can at least help immune-compromised individuals.
Update, 4:04 pm: Between 3:25 and 3:35, Adar Poonawalla of the Serum Institute of India (maker of Covishield) and Suchitra Ella, joint managing director of Bharat Biotech (Covaxin), announced that they had consulted with the Indian government and that the price of both vaccines had been revised to Rs 225 per booster dose.
We are pleased to announce that after discussion with the Central Government, SII has decided to revise the price of COVISHIELD vaccine for private hospitals from Rs.600 to Rs 225 per dose. We once again commend this decision from the Centre to open precautionary dose to all 18+.
— Adar Poonawalla (@adarpoonawalla) April 9, 2022
Announcing #CovaxinPricing .
We welcome the decision to make available precautionary dose for all adults. In consultation with the Central Government, we have decided to revise the price of #COVAXIN from Rs 1200 to Rs 225 per dose, for #privatehospitals.🇮🇳💉💉💉😷— Suchitra Ella (@SuchitraElla) April 9, 2022
The government has also said that private hospitals can levy a service charge of Rs 150 at best, bringing the cost to recipient to Rs 375. Even this absolute reduction is commendable – but it’s still unclear why the booster-dose drive has been restricted to private hospitals and whether the government will avail free doses from government facilities, as it did in early 2021.
Is this a supply issue? If so, why not vouchsafe the doses already available to government centres, where they can be dispensed for free, and later expand to private facilities? Or is it to use up unused stock before an imminent expiry date? In that case why not push harder into the ‘main’ vaccination drive? Or is this a payment issue? If so, why not heed the absence of consensus and the high seroprevalence to postpone the booster-dose drive? Or is this a political issue?
One way or another, the Union government must answer: whom will this prematurely expanded booster shots drive really benefit?