The Covaxin vaccine, which was developed by labs in India and given emergency approval on Sunday, will be tested on children as young as two, pending approval from India’s drug regulatory body, according to the developer and manufacturer Bharat Biotech.
Bharat Biotech’s chairman Krishna Ella said at a news conference on Monday that the company was planning to submit a proposal to India’s drug regulatory body soon on its plan to start a clinical trial that would include 2- to 15-year-olds.
Covaxin is currently still in Phase 3 trials and there are questions that remain about how it could have been approved without the release of those trials’ efficacy data.
In a news release Sunday, Bharat Biotech said Covaxin’s Phase 3 trial started in mid-November, with a goal to include 26,000 volunteers.
India’s health minister Dr. Harsh Vardhan tweeted late on Sunday that the emergency use authorization (EUA) for Covaxin is “differently conditional — in clinical trial mode.”
Children above the age of 12 are already a part of the Phase 3 trials but Bharat Biotech hopes to establish the vaccine’s effectiveness among children by testing lower age groups, according to Ella.
Ella explained that this vaccine would be the safest option for babies as it is an inactivated vaccine.
Inactivated vaccines are produced by growing the virus in culture media, then inactivating it with heat and/or chemicals, according to the US Centers for Disease Control and Prevention (CDC). Inactivated vaccines are not alive and can’t replicate, nor can they cause disease from infection, according to the CDC.
Ella explained that inactive polio vaccines are currently given to newborns — and are safe to do so. The Covaxin vaccine, which is also an inactivated vaccine, is working under the same reasoning, he said.
An inactive vaccine is “a proven platform and the safest platform to give to children,” Ella added.
Bharat Biotech said that it intends to sell their vaccine to the United States, and will specifically target it for the vaccination of children there, said Ella.
The company has 20 million doses of the vaccine currently in stock, with the capacity to manufacture hundreds of millions of doses across four manufacturing facilities.
Regarding the timeline of the vaccine’s rollout, Ella said: “I would love to launch it the earliest possible time … but it is not in our hands.”