Covovax denied trials on children; no nod needed for Sputnik Light

The vaccine expert panel denied permission to Serum Institute of India (SII) to conduct clinical trials on children for Novavax, on Thursday. In addition, it felt there was no need to conduct a separate Indian clinical trial of Sputnik Light, as adequate safety and immunogenicity data is already available.

The decision comes as a setback to SII, which had sought permission to start a pediatric clinical trial of Covovax. The Subject Expert Committee’s (SEC) decision means DRL does not require separate safety and immunogenicity trials on Indians for getting approval for Sputnik Light. As for SII, the permission was denied as the adult vaccine was not approved in neither US nor India. 

Sputnik Light is the first dose of the two-dose Sputnik vaccine. This uses two different components based on two different human adenovirus vectors — Ad26 and Ad5 — for its two-dose vaccine. 

The two components are thus different. Sputnik Light is a single-dose vaccine that uses Ad26, the same vector as used in J&J’s single-dose Covid vaccine. 

A DRL spokesperson said “DRL has already generated safety and immunogenicity data on the first dose component in India through its clinical trial and and a phase III efficacy trial is currently underway in Russian on Sputnik Light, the SEC recommended that DRL should submit safety, immunogenicity and efficacy data from the phase-III clinical trial of Sputnik V in Russia to the SEC for its consideration of Marketing Authorisation of Sputnik Light in India.”

The spokesperson added that the SEC had also observed, that in view of the safety and immunogenicity data generated by Dr. Reddy’s in India on the first dose component of Sputnik V (in other words, Sputnik Light), there was no need for a separate Phase-III Sputnik Light trials in India. 

Meanwhile, for Covovax, the SEC felt that the Novavax nanoparticle vaccine is not approved in any country. “We thus felt that SII should submit safety and immunogenicity data from the ongoing clinical trials in the US in adults, for considering an approval to conduct trials on children,” said an expert in the SEC. 

After such data is generated, the SEC will again review the proposal for children trials of Covovax in India, the person quoted above said. 

Sources in Serum Institute have said that they have not received any official communication from the SEC on the matter so far.