India says its safety study of Sputnik V vaccine comparable to Russian trial
Coronavirus chronicle
13 April, 2021, 04:05 pm
Last modified: 13 April, 2021, 04:14 pm
The vaccine has now been “recommended for grant of permission for restricted use in emergency situations subject to various regulatory provisions”
FILE PHOTO: A medical specialist holds a vial of Sputnik V vaccine against the coronavirus in a department store in Moscow, Russia, January 18, 2021 REUTERS/Shamil Zhumatov
India's health ministry said on 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.
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