Only half India's population has received the first shot of Covishield and Covaxin and the government's immediate task is to first vaccinate its adult population before placing its focus on children.
Rashme Sehgal reports.
Should children above the ages of twelve be vaccinated?
The medical community remains divided on this crucial question even as India's central drugs regulatory authority approved the ZyCoV-D vaccine with its 66 per cent efficacy rating developed and manufactured by Zydus Cadila.
The Phase 3 trials of this vaccine were tested across 28,000 participants including 1000 adolescents between the ages of 12-18. But the results of this trial have not been made public.
UK-based NGO Transparency International Global Health expressed concern that a vaccine developed for a new platform has not gone public on its findings pointing out that a similar lack of transparency occurred when Covaxin had been given emergency approval.
The vaccine, the manufacturers claim, is an innovative leap for India which is the first country to approve a DNA platform shot for COVID-19 in the world. But Dr Jammi Nagaraj Rao, an epidemiologist and public health physician in the UK, believes that ZyCoV-D may well be a remarkable innovation story for Indian science but that does not mean it does not place the result of its trials in the public domain.
The response of the medical fraternity to this vaccine has been mixed given that India has around 340 million children and adolescents in that age group.
Dr Chandrakant Lahariya, an epidemiologist, points out that current evidence does not suggest that all kids need a vaccine especially with current evidence pointing to the fact that the COVID-19 vaccination has not proved efficacious in reducing transmission of this virus.
Also, it is clear that kids do not suffer from severe cases of COVID-19 Dr K Srinath Reddy, director, Public Health Foundation of India, believes it is too early to judge the efficacy of the ZyCov-D vaccine, but it has not reported any adverse results.
"We are all waiting to see what the published results are. We have been provided with the overall results and have not been given the actual breakup on its safety, efficacy and immunogenicity We do not know what level of detail they have provided," says Dr Reddy who agreed with Dr Lahariya that administering the vaccine does not stop transmission of the virus.
"Vaccines do not prevent infections. Transmission has not been curtailed as has been shown in Israel but it does protect people from getting severe illness," says Dr Reddy.
Nevertheless, there are several COVID-19 vaccine trials being conducted on children around the world with Bharat Biotech planning to come up with a vaccine for six-month-old babies and above. A lot of these trials are being conducted using the mRNA vaccine.
This again remains a contentious area. Several pediatricians insist that vaccines should be given to younger and younger children and others in the medical fraternity are equally vociferous in claiming that we need to adopt a more cautious approach.
Dr Lahariya emphasises that current research does not indicate that all children should be vaccinated. Other public health experts believe children must get vaccinated because they carry and transmit the virus even if they don't show any symptoms.
The homegrown ZyCov-D vaccine is a plasmid DNA which uses the plasmid -- the small ring-like part of the DNA molecule --to deliver key information to the immune system in order to fight the infection. This information helps train the body to fight an infection. This is not a new platform as it has been used to fight other infectious diseases including the HIV virus.
This platform is different from the mRNA vaccine because it does not need the immune signal to reach inside the nucleus of the cell. Unlike the Pfizer and Moderna vaccines which need to be stored at below freezing temperatures, the ZyCoV-D can be stored between 2º and 8º Celsius.
Its other advantage is that it is a needle free vaccine which can be applied with an interdermal application thereby making it more children friendly.
Vaccinologist Dr Gagandeep Kang has issued a word of caution to point out that in the past DNA vaccines have been successful in animal studies but have often failed to produce desirable and long-lasting immunity in humans.
Dr N K Arora, who heads the National Technical Advisory Group on Immunisation, stated recently that children with comorbidities makes them more vulnerable to serious illness and so they will be given this vaccination on a priority basis.
The ZyCov-D vaccine will be available in the market by October.
Dr Arora also believes for the present, an emergency use authorisation of one vaccine for kids above the age of 12 suffering from co-morbidities must be given. Children without co-morbidities will have to wait till 2022 to be able to get a jab.
Regarding, Covaxin, he pointed out that it was presently being tested on children above the age of 2, but its actual rollout was likely to happen later this year.
Bharat Biotech's inactivated virus-based COVID-19 vaccine Covaxin is set for phase 2 and 3 clinical trials on children in the 2-12 years age group.
Bharat Biotech Managing Director Dr Krishna Ella had asserted that the vaccine was built on time-tested and proven technology and could be given to both a six month old or a 60 year old. This is because it is based on the same technology as has been used in the polio vaccine and the hepatitis A vaccine.
These vaccines have been found to be safe with infants. But Covaxin claims need to be backed up by data and hence trials are necessary.
India has around 10 million co-morbid children between the ages of 12 and 17. Children between the ages of two and twelve number around 440 million.
Virologist Dr Shahid Jameel believes that ZyCov-D had conducted one of the largest trials in India with 28,000 people from which 3.5 per cent were 12-17 year olds.
"With only about 50 million doses of this vaccine being available this year," says Dr Jameel, "this will be sufficient to vaccinate about 16 million people."
But issues remain around children being vaccinated. The UK had given approval to the use of the Pfizer/BioNTech jab in over-12s in early June. But they withdrew this order when scientists pointed out that some kids had developed an inflammatory heart condition after being given the vaccine shot.
Countries such as the US, Israel, France and Germany have all recommended over-12s be universally vaccinated.
In the US, the vaccine is being administered to children between the age of 12 and 15 years. Pfizer, which is testing its shot in the younger children, said it expects to have data and request authorisation by September.
According to data released in the US, up to late March this year, more than 3.4 million children had been infected with COVID-19, according to the American Academy of Pediatrics. There had been nearly 14,000 hospitalizations and 279 deaths of children so far.
The problem is that a large number of parents across the world want their children to be vaccinated before sending them to school.
The office for national statistics in the UK on the basis of a survey found that almost 90% of parents in England favoured their children being given the vaccine before schools re-opened in September.
In India, an overwhelming number of parents also want their children to be vaccinated before they send them to school. The fear of a Third Wave adds to their apprehensions.
But here the reality is more complex, For one, the results of the Zydus Cadila's anti coronavirus vaccine are not in the public domain.
The other problem is that only half India's population has received the first shot of Covishield and Covaxin and the government's immediate task is to first vaccinate its adult population before placing its focus on children.
Do children need to be vaccinated at all?
This is a debate which has no easy answers.
Several infectious disease experts believe that the emergence of more-contagious variants including the Delta vaccine which has emerged as the dominant vaccine has seen several adolescents getting infected in Western countries.
The problem is that this is an evolving situation.
Some specialists believe vaccines alone can turn the tide on this pandemic making it necessary to include children and teens in this overall strategy.
On the entire issue of vaccines posing risks to children? There is no sure shot answer since a great deal of research is going on in this area.
Vaccines can cause adverse reactions though researchers believe they have not found evidence that these pose any additional risks to children versus adults.
There is clear evidence that points to the fact that paediatric vaccine is expected to get an enormous market share with around 350-400 million children and adolescents below 18 years of age.
If we consider only a two dose Covid vaccine regimen, this alone would translate into 700-800 million doses.
Feature Presentation: Ashish Narsale/Rediff.com