RIO DE JANEIRO, BRAZIL - Brazil’s health regulator is seeking further data on Russia’s Sputnik V coronavirus vaccine before considering its approval for emergency use.
Documents supporting drugmaker União Química’s application for emergency use of the vaccine have been returned to the company because they did not meet its minimum criteria, the watchdog said on Saturday, January 16th.
In a statement on the Health Ministry’s website, regulator ANVISA said the request failed to provide adequate assurances on Phase III clinical trials and issues related to the manufacture of the vaccine.
União Quimíca is . . .
To read the full NEWS and much more, Subscribe to our Premium Membership Plan. Already Subscribed? Login Here