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Who Will Get The First Shot In A Child's Arm?

Serum Institute of India Pvt. Ltd. will soon join the ranks of Pfizer Inc. and Moderna, Inc. in beginning pediatric trials for COVID-19 vaccines.

However, Bharat Biotech has already included children aged 12 years and above in its Phase III clinical trials which began in November and could steal a march over the others as it also plans studies in children between two and 15 soon.

Serum Institute of India intends to begin clinical trials of an indigenously developed vaccine in Indian children, an industry source told Scrip. Currently in Phase II trials in Australia, the vaccine candidate is believed to have generated good safety and immunogenicity data, though details are not available in India yet.

The company was recently granted conditional accelerated approval for Covishield, which it developed with AstraZeneca PLC/University of Oxford; however, this has been approved in India for those 18 years of age and above. The indigenous vaccine is expected to be trialed among children in the four to 18 age group.

During a virtual press conference on 4 December, Bharat Biotech chairman and managing director Krishna Ella announced his company’s plans to begin exclusively pediatric trials of the COVID-19 vaccine, Covaxin, on children between the ages of two and 15 years of age.

 

Covaxin has already been granted conditional accelerated approval in India and Ella said children above the age of 12 had been recruited for ongoing Phase III trials. With more than 25,000 participants, the third phase is the largest for any Indian vaccine and while the trials are not complete, several volunteers have already received the second dose of the two-dose regimen. 

“We are confident of the vaccine’s safety and will seek permission to begin trials of our vaccine in children,” said Ella, claiming that Covaxin is also capable of preventing transmission of SARS-CoV-2, apart from protecting vaccine recipients from the disease.

Who Will Get Ahead In The Race?

While Ella has said the company can complete pediatric trials in three to four months after receiving the regulator Drugs Controller General of India (DCGI)’s nod, it could be difficult to predict exact timelines.

Outside India, Pfizer and Moderna have also begun pediatric trials, including children as young as 12 years of age. Whether and when they will trial their vaccines in even younger children is not clear yet. For now, Pfizer’s vaccine is approved in the US for ages 16 and up, while Moderna’s vaccine is authorized for ages 18 and up.

In India, Pfizer has sought accelerated approval for its vaccine, but hasn’t presented its data to the regulator for approval yet. ()

Immune systems and responses of children are different compared to those of adults, even varying at different ages, from infancy through the teenage years. After completing studies in adults, companies will need to examine the dosages, interval between doses, and the number of doses that work best in children.

“Age de-escalation studies will have to be done meaning that after Phase I and II trials among adults, the trials are conducted in older children, and finally, if relevant, in small children. Epidemiology of the disease, the risks and benefits of the vaccine for each age group and safety profile will have to be factored during de-escalation,” said an industry expert.

 

Children Need To Be Vaccinated Too

Meanwhile, as immunization programs for adults roll out in countries like the US and UK, parents are wondering when their children would be afforded protection by a COVID-19 vaccine. While fewer and milder cases of the disease have been reported in children in comparison to adults, they are at risk too. ()

In November, the American Academy of Pediatrics published a statement calling for drug manufacturers to include children in their trials soon.

Apart from reducing the strain on already stretched healthcare systems and reducing the parental stress of having to look after sick kids, the pediatric vaccine could also ensure re-opening of schools.

Once children get back to school, it would also mean that vaccinated adults could resume full-time professional duties.

Bharat Says Vaccine Can Tackle UK Strain

However, there is a worry that mutant strains can derail the recovery process. A more contagious coronavirus variant first identified in UK has cropped up across the globe and at least 33 countries have identified the new variant, known as B117.

Several nations have also identified an additional variant, 501Y.V2, first identified in South Africa, which also appears to infect people, including children, more easily. 

At the press conference, Krishna Ella said Covaxin has had success against the UK strain and that some confirmatory data could be provided in around a week. When the Indian regulator’s subject expert committee (SEC) recommended an accelerated approval, it took into consideration that Covaxin is an “inactivated whole virion, coronavirus vaccine having potential to target mutated corona virus strains.”

The SEC said data generated so far demonstrate a strong immune response (both antibody as well as T cell) and in-vitro viral neutralization, adding that already 22,500 subjects had been enrolled in Bharat Biotech’s Phase III trials, including those with comorbidities, and the vaccine has demonstrated safety so far. Moreover, the company presented safety and efficacy data from a non-human primate challenge study where the vaccine was found to be safe and effective. 

A great furor erupted in India recently when Serum Institute’s AstraZeneca-partnered vaccine Covishield and Bharat Biotech’s Covaxin were approved for “restricted use in emergency situation” as both companies had not presented efficacy data from Phase III human trials conducted in India.

Earlier Pediatric Trials In India

Like elsewhere around the world, pediatric trials have been conducted in India for other vaccines and drugs. “An Analysis of Clinical Trials.gov 2006-2015” by Giulia Lorenzoni,, Rosanna Irene Comoretto and Ileana Baldi in the Indian Journal of Pediatrics identified 9,648 pediatric clinical trials from the database of clinicaltrials.gov from January 2006 through December 2015.

Of these, 193 had at least one enrolling site in India with participants aged 0 to 18. The primary purpose of these trials was treatment (n=92), and prevention (n=65) coupled with an efficacy and/or safety endpoint (n=158). ()

Infants and toddlers were eligible for enrolment in the majority of trials (97%), while neonates only in 22% of trials. The rate of early termination or withdrawal was 5%. The most studied conditions were bacterial infections, viruses, digestive and mental diseases. Overall, communicable diseases (n=75) and major non-communicable diseases (n=72) were equally investigated.

It concluded that the commonly studied therapeutic areas in trials enrolling from India and registered in clinicaltrials.gov were appropriate for India’s public health needs and patients were not enrolled into studies inappropriately from this perspective.

 

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