India has commenced paediatric trials for Covaxin, its indigenously-manufactured vaccine against COVID-19.
Covaxin, manufactured by Hyderabad-based firm Bharat Biotech, is one of four vaccines authorised for use in India alongside Covishield (produced by the Serum Institute of India on license from AstraZeneca), the Russian-manufactured Sputnik-V, and the Moderna vaccine. Bharat Biotech announced last month that paediatric trials of the vaccine would begin.
Now, more than 500 children are enlisted for the trials. The cohorts of minors are spread across three age demographics: those aged two to six, those aged six to twelve, and those aged twelve to eighteen. According to Dr Sanjay Rai, who heads the trials at the All India Institute of Medical Sciences (AIIMS) in Delhi, “most of the children have received the first dose of Covaxin – India’s indigenously developed COVID-19 vaccine – and are being closely monitored for complications, if any, as well as the immune response generated after the vaccine.”
AIIMS in Delhi is one of six centres where paediatric trials for Covaxin are underway. The others include AIIMS in Patna, Bihar; the ESI Hospital in Basaidarapur, Delhi; the Meditrina Institute of Medical Sciences in Nagpur, Maharashtra; the Mysore Medical College And Research Institute in Mysore, Karnataka; the Prakhar Hospital in Kanpur, Uttar Pradesh; and the Pranaam Hospital in the Madeenaguda neighbourhood of Hyderabad, Telangana.
India has yet to approve any vaccine for minors, but regulators granted Bharat Biotech permission to conduct clinical trials of Covaxin in May. “I enrolled both my kids in Covaxin trials because the third wave is imminent and people are saying it will disproportionately affect children,” said Kapil Nema, quoted by The Print. “Getting a vaccine for my kid then grants them safety against the virus. mRNA vaccines have been given to kids above twelve years in other countries and have proven to be safe. Compared to them, Covaxin’s conventional formula is much more safe.” Nema has a six-year-old daughter and a twelve-year-old son, both of whom are trial subjects.
Consent is being taken from all trial participants aged twelve and above. Consent has been solicited from the parents of all children enrolled in the trials.
“The vaccine has been successfully tested on adults and in all likelihood will be safe on kids as well,” Rai said. “Mind you, most vaccines in the world are administered to small kids only. We follow [the] ICMR’s [Indian Council of Medical Research] ethical guidelines while testing on kids, and are giving them the same dose that we give to adults.”
As for side-effects, Rai emphasises “Covaxin in general is not resulting in severe side effects. Also, kids are the population that are most used to vaccinations. We haven’t observed any severe side effects yet, just normal fever, which after a vaccination isn’t an anomaly.”