Bharat Biotech trial nod a turning point for paediatric Covid-19 vaccine

With Bharat Biotech’s inactivated virus-based Covid19 vaccine Covaxin now set for phase 2 and 3 clinical trials on children in the 2-12 years age group, the stage is set for a paediatric range to hit the market.
 
Experts believe this is a critical step to ensure break in transmission.
 
Apart from Covaxin, two more vaccine candidates would be available for paediatric use in India. Zydus Cadila’s ZyCoV-D has been tested on children above 12 years and on Monday the USFDA authorized use of Pfizer’s mRNA vaccine on kids as young as 12 years.
 
Bharat Biotech has already conducted trials on children 12 years and above. Bharat Biotech Chairman and Managing Director Krishna Ella had said last year: “Our vaccine is safe, and built on time-tested and proven technology. It can be given to a six-month-old or a 60-year-old.”
 
T Jacob John, senior virologist and former head of the departments of clinical virology and microbiology at Christian Medical College, Vellore, said, “Covaxin is an inactivated virus based vaccine. It is the same technology as the injectable polio vaccine and the hepatitis A vaccine. These vaccines are given to infants and have proven to trigger immunogenic response in children. Covaxin should also work on children above 2 years. However, this needs to be backed up by data and hence trials are necessary.”
 
John added that if the world wanted to get rid of the coronavirus, vaccinating children was an important step as they are a link in the transmission process.
 
Ahmedabad-based Zydus Cadila too is prepping up with data on adolescents. Clinical trials of ZyCoV-D have included children 12 years and above.
 
“We would have sufficient data on the safety and efficacy of the vaccine on children by the time we seek approval from the regulator. Moreover, this is a needle-free vaccine, which may make it more acceptable to children,” Sharvil Patel, managing director of Cadila Healthcare, said.
 
Cadila Healthcare’s ZyCoV-D would be administered through a needle-free injection system (NFIS). Typically, in an NFIS, a jet of fluid is accelerated to high speed, providing it significant penetrating power through a fine-diameter nozzle when placed against the skin.
 
Patel thus said the vaccine might have higher acceptance among children scared of needles. ZyCoV-D is stable at room temperatures, making the logistics of the vaccine easier.
 
Pfizer too got the nod on Monday to use the vaccine on children as young as 12. Bill Gruber, senior vice president of Pfizer, has told agencies that this was a ‘watershed moment’ in our ability to fight back the Covid19 pandemic.

 
Pfizer is now in discussion with the Indian government for bringing its vaccine to India. India has adopted a more liberal policy to allow foreign vaccines that are approved by regulators like the USFDA, UK-MHRA etc to come to India without conducting bridging clinical trials. Companies can simultaneously conduct bridging studies when the vaccine is available here, and then submit the data.
 
This paves way for Pfizer’s vaccine to be used on adolescents here too. Pfizer did not comment till the time of going to press.
 
Paediatric vaccine is also a sizeable market. A Mumbai-based analyst said, ‘’It is estimated that 350-400 million in India are below 18-years of age. Considering two doses Covid vaccine regimen, this would translate into 700-800 million doses potential demand easily.”
 
According to an estimate by Unesco, around 321 million Indian children were asked to stay home when the lockdown began end of March last year.