India says its safety study of Sputnik V jab comparable to Russian trial

India says its safety study of Sputnik V jab comparable to Russian trial

A medical specialist holds a vial of Sputnik V (Gam-COVID-Vac) vaccine against the coronavirus disease (COVID-19) at a vaccination center in the State Department Store, GUM, in central Moscow, Russia, on January 18, 2021. REUTERS/Shamil Zhumatov

NEW DELHI — India’s health ministry said Tuesday its drug regulator had found that safety and immunogenicity data from a local trial of Russia’s Sputnik V coronavirus vaccine was comparable to that of a late-stage trial done in Russia.

The vaccine has now been “recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions,” the ministry said, commenting on the approval earlier confirmed by the drug’s marketing agencies.

The vaccine can now be imported, it said.

Read more...