Brazil Health Regulator Delays Sputnik V Vaccine Approval Due To Missing Data
Brazil's health regulator, Brazilian National Health Surveillance Agency (Anvisa), has declined to approve the Russia-developed Sputnik V for emergency use because of some missing data.
Russian News Agency TASS reported that the application filed in Brazil did not comply with the country's minimum criteria for emergency approval and was missing data.
Brazil's Anvisa wanted to see more safety data about the Sputnik V vaccine before considering it for emergency use.
Documents about drug maker Uniao Quimica's application for emergency use of Sputnik V had missing data particularly, the lack of "permission for third phase of clinical trials" and "dealing with the advanced production methods," Anvisa said.
Decision on Sputnik V Could Have Been Given in 3 Days
The Russian Direct Investment Fund (RDIF) first contacted Anvisa in December requesting permission to conduct the third stage of the clinical trials in Brazil, said a report from ANI News.
Based on its previous experience in reviewing applications, Anvisa said the process could have taken three days, or 72 hours if there had been enough information on the vaccine.
Related Story: Brazil OKs 2 Million AstraZeneca Vaccine Imports from India, Not Yet Approved for Use
The RDIF assured that it could provide the additional information demanded by Anvisa, said a report from Reuters.
"Such requests from regulators were standard procedure and do not mean the registration bid has been rejected," RDIF said in a statement obtained by Mint.
The RDIF also said a form of legislation, which is going through the Brazilian Senate, could allow the use of vaccines approved by other countries once approved.
Anvisa has already mentioned that any application for emergency use authorizations in vaccines must show that the shot can deliver long-term safety and had high efficacy levels among recipients.
Uniao Quimica, RDIF to Supply 10 Million Doses of Sputnik V in First Quarter
On Wednesday, vaccine developers said Uniao Quimica and the RDIF agreed with the Brazilian government to provide 10 million doses of the vaccine in the first quarter of 2021.
By Friday, it would put forward its request for emergency use of the said number of vaccines with the hope to get first deliveries going this month.
TASS quoted a statement from Uniao Quimica, saying it believes with more cases of the virus rising in Brazil and the rest of the world, "the state and business must take all efforts to fight it."
This includes "taking measures of emergency and exceptional nature" as the pandemic gave rise to an urgent need and high level of importance. The company has already received cellular material to be used in the production of the vaccine.
The Sputnik V vaccine has been approved in Russia for domestic use, even though the trials have yet to be completed there.
It has already been registered in other countries such as Serbia, Belarus, Argentina, Bolivia, Algeria, Venezuela, Paraguay, and by the Palestinian authorities. Two more countries are expected to register the vaccine next week.
Read also: Brazil's Fiocruz to Seek Regulatory Approval for Oxford/AstraZeneca Vaccine
In Brazil, two vaccines had been given emergency use approval so far: the Chinese vaccine CoronaVac and the AstraZeneca/Oxford's coronavirus vaccine, reported the Wall Street Journal.
The rollout of the said shots started on Sunday, minutes after approval from regulators.
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