Anvisa sends back request for EUA of Sputnik V vaccine
Anvisa said that Uniao Quimica, the pharma firm applying for EUA of Sputnik V vaccine, failed to provide adequate assurances on its Phase III clinical trials and issues related to the manufacture of the vaccine
Anvisa, Brazilian health regulator, said it sent back documents submitted by pharma 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 authorised.
In its statement, Anvisa also said that any applicant requesting emergency use authorisation 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 soon decide on authorising emergency use of the vaccines developed by China’s Sinovac and Britain’s AstraZeneca.
(Edits by EP News Bureau)