Chinese lab requests ANVISA approve emergency use of single-dose Covid-19 vaccine

RIO DE JANEIRO, BRAZIL – The Brazilian Health Regulatory Agency (ANVISA) said on Wednesday, May 19, that it had received a temporary authorization request for the emergency use of a single-dose Covid-19 vaccine developed by Chinese CanSino Biologics laboratory.

In a statement, the Brazilian regulator said it received the application on Tuesday from Belcher Pharmaceuticals, the representative of CanSino Biologics laboratory in Brazil, and that the analysis of the documentation to consider authorizing the vaccine has been initiated.

ANVISA said it should issue an opinion within seven working days, if all legal requirements for the request have been met by the applicant. For now, the agency is conducting a thorough check to ensure that all the information to be assessed by the agency has been submitted.

China’s ambassador to Brazil, Yang Wanming, used his Twitter to comment on the application. “The Cansino vaccine, effective with only one dose, is being administered in China.”

“Chinese CanSino laboratory has been in contact with the Ministry of Health and submitted the request to ANVISA to authorize its emergency use in Brazil. China is committed to continue and expand its vaccine partnership with Brazil,” he said.

If authorized, this will be the second vaccine created in China against Covid-19 in use in Brazil. CoronaVac was previously authorized, from the Sinovac laboratory, which has the Butantan Institute as a partner in Brazil.

Brazil is also using vaccines from AstraZeneca/Oxford and Pfizer/BioNTech in the fight against the pandemic.

Meetings

ANVISA also reported that, before the request was submitted, it had met twice in March with the Chinese laboratory’s representatives.

“CanSino’s vaccine, which is produced from a non-replicating human adenovirus, was developed in partnership with the China Academy of Military Medical Sciences. The vaccine is provided in just one dose,” he said.

“Clinical trials of Convidecia (the name of the vaccine) have been conducted in Pakistan, Russia, Chile, Argentina and Mexico. The data from these trials will be analyzed by ANVISA,” the representative added.