BRASILIA: Brazilian health regulator Anvisa said on Saturday it sent back documents submitted by pharmaceutical company Uniao Quimica seeking approval for emergency use of the Russian Sputnik V coronavirus vaccine because they did not meet the minimum criteria required.
In a statement on the Health Ministry website, Anvisa said the firm’s request failed to provide adequate assurances on its Phase III clinical trials and issues related to the manufacture of the vaccine.
Anvisa officials had said previously that the Sputnik V vaccine would have to 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 emergency use authorization must show its ongoing clinical trials of the vaccine will deliver 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 on…