Cost-ineffective: New vaccine introduced for children, Corbevax, 'can't be efficacious'

By Dr Amitav Banerjee* 
Contrary to all scientific principles, childhood vaccines against Covid-19 are being rolled out in emergency mode without any emergency. The latest to join the ranks is Corbevax. This is a protein sub-unit Covid-19 vaccine. The vaccine has been developed in the Baylor College of Medicine, Houston, in collaboration with Dynavax Technologies, California, USA. It is licensed to Indian firm Biological E. Ltd (BioE) for development and production.
The vaccine consists of the part of the receptor binding domain of the "spike protein" of the virus, along with adjuvant aluminium hydroxide gel. In April 2021, the US International Development Finance Corporation announced that it would fund the expansion of BioE’s, the Indian company's manufacturing capacity so that it could produce 1 billion doses by end of 2022.
Kostoff et al, in a peer reviewed paper titled, "Why we are vaccinating children against Covid-19?" state that Covid-19 deaths are negligible in children. On the other hand, post vaccination deaths while small are not negligible in children. Clinical trials for safety and efficacy of these vaccines among children are on very small sample sizes and short durations.
Further the clinical trials did not address the changes in the “biomarkers” that could serve as early warning indicators of side effects. Most importantly, the clinical trial data did not address long term effects that, if serious, would be faced by children and young people for perhaps decades.

Phase 1 clinical trials were undertaken to evaluate the safety and immunogenicity in 360 adult participants. The Phase 2 concluded in April 2021. The Drug Controller General of India permitted the Phase 3 trials in 1,268 adult participants.
In December 2021, BioE announced positive results but some experts complained about lack of data in the public domain. On December 28, 2021, India cleared the vaccine for emergency use. After the Phase 2/3 trials on just 624 children in the age group 5 to 18 years, Corbevax got emergency use authorization for children in February 2022.

 Lack of logic

Where is the emergency? In children, the survival rate after infection with the coronavirus is 99.9973%. We have a whole lot of other neglected endemic diseases which kill many more children in India. Every day more than 2,000 children die from various non-covid causes. About 10,000 children die from the 100% fatal rabies infection every year. Around 300 children die from accidents every day.
Tuberculosis takes a daily toll of over 1,000 people, most of them young, in our country. Typhoid and dengue also take a heavy toll of young lives. We have an effective vaccine against typhoid in which death rate is 3% (compared to 0.0037% from Covid-19) even after treatment due to emerging drug resistant strains.
Our public health priorities should, therefore, be decided by our own disease profile instead Western models.
Whatever scarce data is available indicate that all prevalent diseases of children and young people kill many times more than Covid-19 in which deaths are negligible in children. Hard data and evidence indicate that all non-Covid diseases are a cause of far bigger emergency than the coronavirus which is self limiting in healthy children!

Moreover, in our country most of adults and children below 18 years have acquired robust immunity after recovery from natural infection with the virus. Over 80% of children in most cities where serosurveys were undertaken have shown IgG antibodies.
Studies from various parts of the world have established that natural herd immunity obtained in this way confers 13 times more robust immunity compared to vaccine induced immunity. Vaccination in such populations would not achieve any extra benefit, but has potential to cause harm due to short term and of more concern, long term unknown adverse effects.

Elephants in the room?

The much awaited “paediatric third wave” did not strike anywhere in the world or in India. Meanwhile, schools in the country have started offline classes since more than a month. There has been no increase of cases or cluster outbreaks in spite of physical classes over this period, even though majority of the school children are unvaccinated so far.
According to a study, pooled data from seven European countries during the deadlier first wave did not reveal any appreciable deaths from Covid-19 in children.  The study compared child deaths from Covid-19 in children and compared it with death from all causes. It found 44 deaths out of 42,846 confirmed cases of paediatric Covid-19 giving a case fatality rate of 0.1%. 

If we make an adjustment for asymptomatic cases, which can range between 20 and 30 for every confirmed case, the infection fatality rate would be much lower. A British study estimated 2 deaths in 1 million children affected. On the other hand, deaths from non-Covid-19 conditions in the same period was much more – 13,200 deaths among children in the same period. 

The main causes of child mortality were – accidents 1056; other respiratory infections 308; influenza 107. The authors of the study concluded that even during the height of the pandemic, 99.67% of all deaths in children were from other causes.
Besides being at negligible risk from Covid-19, studies found that school children do not spread infections to elders nor trigger community transmissions.
Besides, do we have Indian data on deaths of children from Covid-19 along with their health profiles? Without such data how can we make a risk benefit analysis of a vaccine whose long term adverse effects are unknown?

There has been no increase of cases or cluster outbreaks in spite of physical classes, even though majority of school children are unvaccinated

Apart from the unknown adverse effects, the cost benefit analysis also does not work out in favour of a Covid-19 vaccine for children when in our country every day over 2000 children die of other preventable diseases. 

Diverting resources towards achieving mass vaccination of children with no benefit in reducing non-existent burden of illness and deaths in children from Covid-19 will deprive resources for more urgent public health problems among children such as childhood malnutrition, dengue, Japanese encephalitis, typhoid, tuberculosis, and so on.

Sweden vs India

Did closure of schools check transmission or flatten education? Sweden was an outlier being perhaps the only nation which did not close schools during the pandemic. With this strategy only 1 child in 1,30, 000 required ICU admission, with no child death. There were no excess deaths among school teachers either.

India on the other hand had one of the longest duration of school closures. This did not check the transmission among school children. However, serosurveys among children  below 18 years revealed that over 80% had IgG antibodies.

 As these surveys were done before vaccine rollout of children, this herd immunity is due to natural infection and not vaccine induced. This also questions the rationale and science of rolling out vaccination against Covid-19 in this group. It indicates that we could not check transmission among children and unnecessarily caused huge, educational and social setbacks by closing schools and educational institutions.
If vaccination is to be justified in children, then data of excess admissions and deaths, if any, from Covid-19 in children should be put up in the public domain and debated. Without this basic information, risk-benefit or cost-benefit analysis of vaccination of children cannot be undertaken.
During the omicron third wave, there were no excess admission of children in hospitals or ICUs. The further spread of this mutant would have raised the natural immunity level still higher among school children and the general population.
Open scientific debate is urgently needed before proceeding for child vaccination.
---
*MD, Post Doctoral in Epidemiology, presently Professor at Dr DY Patil Medical College, Pune; formerly field epidemiologist for 20 years in the Indian Armed Forces and headed the Mobile Epidemic Investigation Team at the Armed Forces Medical College from 2000 to 2004