SII not allowed to conduct phase 2 & 3 clinical trials of Covavax vaccine on children

Pune's Serum Institute, which has come under a lot of discussion due to Covishield, has suffered a major setback. The government panel has recommended against allowing Serum Institute of India to conduct phase 2 & 3 clinical trials of Covavax COVID-19 vaccine on children of age 2-17 years. The government panel has asked Serum Institute of India to complete trials of Covavax COVID-19 vaccine on adults first. Serum had sought permission from the Drug Controller General of India to test the vaccine on children.

The third wave of corona is said to affect children the most. This has led to speeding up work on vaccines for young children.

“The Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO), which deliberated on the application, noted that the vaccine has not been approved in any country," a source said. “It also recommended that the Pune-based company should submit the safety and immunogenicity data (of Covovax) from the ongoing clinical trial in adults for considering the conduct of a clinical trial in children," the source said.

The committee said that before the Serum sought permission to test the Covavax vaccine on children, it was necessary to present the effects of the vaccine on adults and test data. DCGI has approved testing of this vaccine on adults.

However, this objection has been raised as the Serum has sought permission to test on young children without submitting data on the results of this vaccine. Zydus Cadila, on the other hand, who passed the third test stage, has asked the DCGI for permission to use the DNA vaccine for children over 12 years of age.

The government panel has asked Serum Institute of India to complete trials of Covavax #COVID19 vaccine on adults first: Sources

— ANI (@ANI) July 1, 2021