BRASILIA, Jan. 16 (Reuters) – Brazilian health regulator Anvisa said on Saturday it had returned documents submitted by pharmaceutical company Uniao Quimica requesting approval for emergency use of Russia’s Sputnik V coronavirus vaccine because they did not meet the minimum criteria required.
In a statement published on the site Department of Health web Anvisa said the company’s request did not provide adequate assurances about its Phase III clinical trials and issues related to the manufacture of the vaccine.
Anvisa officials had previously said the Sputnik V vaccine would need to go through phase III clinical trials in Brazil before its use could be approved.
In its statement, Anvisa also said that any applicant seeking emergency use authorization must show that its ongoing clinical trials on the vaccine will provide long-term safety and efficacy.
Uniao Quimica has requested approval for the use of 10 million doses of Sputnik V in Brazil in the first quarter of this year.
Anvisa is expected to …
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