BRASILIA, Jan 16 (Reuters) – Brazil’s health regulator, Anvisa, said on Saturday it was sending back documents submitted by pharmaceutical company Uniao Quimica seeking approval for the emergency use of Russia’s Sputnik V coronavirus vaccine because they did not meet the minimum required criteria.
In a statement on the Ministry of Health’s website, Anvisa said the company’s request failed to provide adequate guarantees on Phase III clinical trials and problems related to vaccine manufacturing.
Anvisa officials previously said that the Sputnik V vaccine must be submitted to Phase III clinical trials in Brazil before its use can be authorized.
In its statement, Anvisa also said that any applicant requesting an emergency use permit must demonstrate the ongoing clinical trials of the vaccine will provide long-term safety and effectiveness.
Uniao Quimica sought approval for the use of 10 million doses of Sputnik V in Brazil in the first quarter of this year.
Anvisa is expected to decide to authorize the emergency use of the vaccine developed by Sinovac China and Britain’s AstraZeneca on Sunday. (Reporting by Jamie McGeever and Eduardo Simoes; Editing by Dan Grebler)