The new vaccine introduced for children, Corbevax, “cannot be effective”

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By Dr Amitav Banerjee*
Contrary to all scientific principles, childhood vaccines against Covid-19 are deployed in emergency mode without any urgency. The latest to join the ranks is Corbevax. It is a Covid-19 protein subunit vaccine. The vaccine was developed at Baylor College of Medicine, Houston, in collaboration with Dynavax Technologies, California, USA. It is licensed to Indian company Biological E. Ltd (BioE) for development and production.
The vaccine consists of the receptor-binding domain portion of the virus’s “spike protein”, along with an adjuvant aluminum 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 the end of 2022.
Kostoff et al, in a peer-reviewed article titled “Why do we vaccinate children against Covid-19?” state that deaths from Covid-19 are negligible in children. On the other hand, post-vaccination deaths when they are small are not negligible in children. Clinical trials for the safety and effectiveness of these vaccines in children involve very small sample sizes and short durations.
Additionally, clinical trials have not addressed changes in “biomarkers” that could serve as early warning indicators of side effects. More importantly, clinical trial data did not address long-term effects which, if severe, would be felt by children and young people for perhaps decades.

Phase 1 clinical trials were undertaken to evaluate safety and immunogenicity in 360 adult participants. Phase 2 was completed in April 2021. The Drug Controller General of India has authorized Phase 3 trials in 1,268 adult participants.
In December 2021, BioE announced positive results but some experts complained about the lack of data in the public domain. On December 28, 2021, India licensed the vaccine for emergency use. After Phase 2/3 trials in just 624 children aged 5-18, Corbevax was granted emergency use authorization for children in February 2022.

Lack of logic

Where is the urgency? In children, the survival rate after infection with the coronavirus is 99.9973%. We have many other neglected endemic diseases which kill many more children in India. Every day, more than 2,000 children die from various causes unrelated to covid. Approximately 10,000 children die each year from the 100% fatal rabies infection. About 300 children die every day from accidents.
Tuberculosis kills more than 1,000 people every day, mostly young people, in our country. Typhoid and dengue also take a heavy toll on the lives of young people. We have an effective typhoid vaccine in which the mortality 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 determined by our own disease profile rather than Western models.
Whatever sparse data is available, it indicates that all diseases prevalent among children and young people kill far more than Covid-19, in which deaths are negligible among children. Hard data and evidence indicate that all non-Covid related illnesses are a far greater cause of emergency than the self-limiting coronavirus in healthy children!

In addition, in our country, most adults and children under the age of 18 have acquired robust immunity after recovering from natural infection with the virus. More than 80% of children in most cities where serological surveys have been undertaken showed IgG antibodies.
Studies in various parts of the world have established that natural herd immunity obtained in this way confers immunity 13 times more robust than vaccine-induced immunity. Vaccination in these populations would provide no additional benefit, but could cause harm due to unknown short-term and, more concerning, long-term adverse effects.

Elephants in the bedroom?

The long-awaited “third pediatric wave” has not hit anywhere in the world or in India. Meanwhile, schools across the country started offline lessons more than a month ago. There has been no increase in cases or cluster outbreaks despite physical classes during this period, even though the majority of school children are unvaccinated so far.
Aggregated data from seven European countries during deadliest first wave, study finds did not reveal any appreciable deaths from Covid-19 in children. The study compared child deaths from Covid-19 in children and compared it to deaths from all causes. It found 44 deaths out of 42,846 confirmed cases of pediatric Covid-19, a case fatality rate of 0.1%.

If we adjust for asymptomatic cases, which can vary between 20 and 30 for each confirmed case, the infection fatality rate would be much lower. A British study estimated at 2 deaths per 1 million children affected. In contrast, deaths from conditions other than Covid-19 during the same period were much larger – 13,200 child deaths during the same period.
The main causes of infant mortality were – accidents 1056; other respiratory infections 308; influenza 107. The study authors concluded that even at the height of the pandemic, 99.67% of all child deaths were due to other causes.
In addition to being at negligible risk from Covid-19, studies found that schoolchildren do not transmit infections to elders or initiate community transmissions.
Also, do we have Indian data on child deaths from Covid-19 as well as their health profiles? Without this data, how can we do a risk-benefit analysis of a vaccine whose long-term adverse effects are unknown?

There has been no increase in cases or cluster outbreaks despite physical lessons, even though the majority of schoolchildren are unvaccinated

Apart from the unknown side effects, the cost-benefit analysis also does not come out in favor of a Covid-19 vaccine for children when in our country more than 2000 children die of other preventable diseases every day.

Diverting resources to mass vaccination of children without any benefit in reducing the non-existent burden of disease and death in children from Covid-19 will deprive resources for more pressing public health issues in children such as child malnutrition, dengue fever, Japanese encephalitis, typhoid, tuberculosis, etc.

Sweden vs India

Has school closure curbed transmission or flattened education? Sweden was an exception being perhaps the only country not to have closed schools during the pandemic. With this strategy, only 1 in 1,30,000 children required admission to intensive care, with no child deaths. There was no excess deaths nor among school teachers.

India, on the other hand, has had one of the longest durations of school closures. This did not verify transmission among school children. However, serological surveys of children under 18 revealed that more than 80% had IgG antibodies.

As these surveys were carried out before the vaccine was deployed in children, this herd immunity is due to a natural infection and not induced by the vaccine. It also calls into question the rationale and science for rolling out the Covid-19 vaccination in this group. This indicates that we were unable to control 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 on excess admissions and deaths, if any, from Covid-19 in children should be put in the public domain and debated. Without this basic information, it is impossible to undertake a risk-benefit or cost-benefit analysis of childhood vaccination.
During the third wave of omicron, there were no excessive admissions of children to hospitals or intensive care units. The continued spread of this mutant would have increased the level of natural immunity even further in schoolchildren and the general population.
An open scientific debate is urgently needed before proceeding with the vaccination of children.

*MD, post-doctoral fellow in epidemiology, currently professor at Dr. DY Patil Medical College, Pune; former Field Epidemiologist for 20 years in the Indian Armed Forces and led the Outbreak Investigation Mobile Team at the Armed Forces Medical College from 2000 to 2004

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