While the US health authorities have just authorized vaccination against the coronavirus for 5-11 year olds, a laboratory has applied for the authorization of its vaccine for children aged 2 to 18 years.
In the United States, children were due to start being vaccinated soon, because the government has already acquired doses of Pfizer-BioNTech to generalize the vaccination to children aged 5-11.
But on Friday, the Ocugen company, which produces Covaxin, developed in India, re-applied for its vaccine so that it can be given to children aged 2 to 18.
“Having a new type of vaccine available will allow people to discuss with their child’s doctor the best approach for them to decrease their child’s risk of contracting Covid-19,” said Shankar Musunuri, co-founder of Ocugen, cited in the press release.
The vaccine has just been approved by the World Health Organization (WHO) to be administered from the age of 18. And already millions of doses have been administered worldwide, especially in 17 countries, but not in the United States.
The Ocugen company, which produces Covaxin, has communicated to the United States Medicines Agency (FDA) the results of its study, clinical trials conducted outside the United States, in India specifically, on 526 children aged 2 to 18 and has compared the results to a larger adult trial of over 28,000 people.
The vaccine was made in the classic way, that is, with a deactivated virus that allows the body to create an immune response without being harmful to health, and it is the type of vaccine most used for the children.
The “inactivated virus technology has been used for decades for childhood vaccines and, if allowed, we hope to provide another vaccine option to protect children as young as 2 years old,” he added.
But for the FDA, this trial may not be important enough to give an authorization especially since it concerns young children, which requires even more caution, even if the results are more than satisfactory. .
Among the 526 participants, no “hospitalization, death, myocarditis, pericarditis, Guillain-Barré syndrome, thrombotic thrombocytopenic, or anaphylactic reaction, was observed”, according to the press release.