COVID: How is India vetting its vaccines for children?

A COVID-19 vaccine developed in India will soon be available to adults and children over 12 years old. The Drug Controller General of India (DCGI) recently approved Zydus Cadila’s needleless, three-dose vaccine for emergency use.

The shot, known as ZyCoV-D, will be the first vaccine to be administered to adolescents in India. It is also the world’s first vaccine built on a DNA platform to be handed authorization for emergency use.

The National Technical Advisory Group on Immunization (NTAGI) will also soon give scientific recommendations for the vaccine to the National Expert Group on Vaccine Administration for COVID-19.

NTAGI chief NK Arora told DW that guidelines and a timeline for the phased vaccine rollout will be released in the near future. “We will have good news soon,” said Arora.

The NTAGI is the nation’s top advisory body on immunization. The agency has examined the scientific data on comorbidities among children and the size of this vulnerable group.

According to the country’s census figures, 41% of its 1.3-billion-plus population is comprised of people under the age of 18. In the month of June, a serological survey found that seroprevalence was 55.7% in the age group below 18 years old and 63.5% in adults.

‘Cautious but optimistic’

Although children have a low risk of experiencing significant effects of the virus, fewer overall infections will create less of a chance for dangerous variants to spread. Pediatricians in India maintain a cautious but optimistic stance on inoculating children.

A number of states reopened schools last month for certain age groups. Life in India has slowly started returning to normal, following the devastation caused by a catastrophic second wave in April and May, which sickened tens of millions and left hundreds of thousands dead.

“I think vaccinating this cohort of children is a good idea. The candidate vaccine has shown it is effective and will give them protection. We know kids can be carriers of the virus to infect the adults and the elderly,” pediatric pulmonologist Shally Awasthi of Lucknow’s King George’s Medical University told DW.

Doctors point out that hospitals in India saw many cases of multisystem inflammatory syndrome (MIS-C) during the second wave. MIS-C is a condition in which different body parts become inflamed, including the heart, lungs, kidneys, brain, skin, eyes and gastrointestinal organs.

Children found to have MIS-C also had the coronavirus, or had been around someone with it.

“It is good to vaccinate children but you need to conduct good research on vaccines, especially for those under 10 and more so for children under the age of 5. There is a possibility that we can give them half or even a quarter of a dose,” top pediatrician Promila Bhutani told DW.

‘Look at the common good’

“No vaccine or drug is ever 100% safe, and data from the US shows that the number of children affected is very small. But we must look at the wider common good that vaccination can do in preventing complications,” a senior doctor from the NTAGI task force told DW.

Apart from Zydus Cadila’s DNA vaccine, India is also preparing other pediatric vaccines so that it can immunize the rest of the child population.

The Pune-based Serum Institute of India (SII) recently received permission to conduct phase II and III clinical trials of Covovax, the Indian version of the US biotechnology firm Novavax’s vaccine, in children between the ages of seven and 11.

The second and third phases of the trials, which kicked off in August, include a total of 920 children, 40 in the 12-17 age range, 230 in the 7-11 range and 230 from two to six years old.

Bharat Biotech, meanwhile, has completed Phase II and III clinical trials of the inoculation, Covaxin, for use in kids between the ages of two and 18 years old.

The Hyderabad-based vaccine maker has already submitted the trial data to the DCGI. The study was conducted at six different sites across the country.

“We will have two or three options for our child population and that is a good sign,” said Arora.

Currently, only adults over 18 are eligible to receive the vaccination under the national immunization drive. The situation in India has been steadily improving since the second wave. The country reported just 18,833 new infections over the last 24 hours, taking its overall COVID-19 tally to over 33.8 million, according to data from the Health Ministry.

Over 915 million single doses of the vaccine have been administered so far, with at least 70% of the country’s adult population partially vaccinated. Over 240 million people have received both doses of the vaccine.