Ocugen requests authorization in the US for an anti-COVID vaccine for minors between the ages of 2 and 18

The United States health authorities received an authorization request for a COVID-19 vaccine developed in India, Covaxin, used in children between the ages of 2 and 18, the company Ocugen announced.

However, clinical trials of this vaccine, developed in a small group of children and outside of USA, may not be enough for the demanding Federal Agency for Medicines (FDA) from the United States to grant you an emergency clearance.

This vaccine received emergency approval from the World Health Organization (WHO) on Wednesday to be used from the age of 18.

Licensed in 17 countries, tens of millions of doses have already been administered to adults around the world outside of USA, specially in India.

It is an inactivated virus vaccine, a relatively conventional technology used for other immunizers in children.

The Bharat Biotech company, of which OccugenUS-based partner, has conducted clinical trials on 526 children ages 2 to 18 in India.

The results of those tests were then compared with those collected from more than 28,000 participants in adult clinical trials.

The levels of antibodies against the virus observed after vaccination of people aged 2 to 18 years “were equivalent to those observed in adults over 18 years of age,” Ocugen said in a statement.

“These results suggest similar protection in children”He added.

The vaccine is given in two doses, 28 days apart.

“Having a new type of vaccine will allow people to discuss with their child’s doctor the best approach to reduce the risk of the child contracting COVID-19 ″, said Shankar Musunuri, co-founder of Occugen, quoted in the press release.

The “Inactivated virus technology has been used for decades to vaccinate children and, if licensed, we hope to provide another vaccine option to protect children as young as 2 years old.”He added.

Among the 526 participants, no case of “hospitalization, death, myocarditis, pericarditis, Guillain-Barré syndrome, thrombotic or anaphylactic thrombocytopenic reaction”The press release stated.

But the sample may be too small to detect possible rare side effects.

The FDA had asked Pfizer and Modern, whose COVID vaccines were already licensed in the United States, to conduct their trials in thousands of children to have a better chance of detecting these rare potential side effects.

The vaccine Pfizer is the only one approved for children under 18 years of age in the country, and FDA He extended it last week to children ages 5 to 11.