BENGALURU (Reuters) – India on Tuesday recommended emergency use of Bharat Biotech’s COVID-19 shot in the 2 to 18 age-group, as the world’s second-most populous nation expands its vaccination drive to include children.
The country has so far fully vaccinated around 29% of about 944 million eligible adults, as per government data, which includes administration of more than 110 million doses of Bharat Biotech’s Covaxin.
The company, however, is still in the process of securing an emergency use listing from the World Health Organization, a decision that is expected later this month.
Without the WHO nod, the two-dose shot is unlikely to be accepted as a valid vaccine around the world.
Several countries have been working to authorise vaccines for children, with the United States clearing Pfizer’s shot for children aged 12 and above.
The advisory panel to the U.S. regulator will meet later this month to discuss the shot for children between 5 and 11 years of age.
While COVID-19 is known to usually cause mild disease in children, there is a risk of rare post-disease complications.
“Children with comorbidities should be vaccinated as soon as possible now that a vaccine with immunogenicity in children and a large safety database in adults is available,” said Dr Gagandeep Kang, professor at Christian Medical College, Vellore.
“For healthy children, given low risk and low virus circulation at the moment, it is safe to wait until more adults are covered,” Kang, who is also a board member of Coalition for Epidemic Preparedness Innovations, said.
CEPI is an international body that funds development of vaccines against epidemic disease, including COVID-19.
Bharat Biotech began a trial of Covaxin in children in June following a devastating second wave led by the Delta variant that brought the country’s healthcare system to its knees.
The data for the 2 to 18 age-group “has been thoroughly reviewed by the Central Drugs Standard Control Organisation and Subject Expert Committee and (they) have provided their positive recommendations,” the company told Reuters.
But Bharat Biotech has not publicly shared the efficacy and safety data for children.
The vaccine is based on inactivated whole-virions with a novel adjuvant, Alhydroxiquim-II, developed with support from the U.S. National Institute of Allergy and Infectious Diseases (https://bit.ly/3Dq6TSq).
If approved by India’s drugs regulator, Covaxin would be the first shot to be available for kids aged between 2 and 12, while those in the 12-18 years age-group can choose between Covaxin and Zydus Cadila’s DNA-based vaccine.
Two other companies, Serum Institute of India and homegrown drugmaker Biological E., have also been allowed to test their shots on children.
Serum is enrolling children aged 7-11 years for its trial of U.S. drugmaker Novavax’s COVID-19 vaccine, while Biological E. has been allowed to begin mid-stage studies of its shot in children above 5 years.
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