RIO DE JANEIRO, BRAZIL – On Wednesday, January 13th, União Química pharmaceutical company and the Russian Direct Investment Fund (RDIF) announced they will apply for emergency use authorization of the Russian Sputnik V vaccine to the National Health Regulatory Agency (ANVISA) later this week, according to a statement released by the RDIF.
However, the vaccine’s clinical trials need to be in phase 3 for the application to be possible. Last Friday, January 8th, ANVISA published a note explaining that União Química “requested authorization to conduct phase 3 clinical trials in Brazil” on December 29th, 2020, but authorization for this phase to begin has not yet been granted.
“ANVISA began the analysis, but identified the need for additional data, which were requested to the laboratory. To date, União Química has not submitted such data to ANVISA. The current status of the application is awaiting the submission of the data requested in the technical requirement,” reads the agency’s text.
It will therefore be necessary to surmount this deadlock before requesting an emergency use. According to the pharmaceutical company, in addition to Russia, the vaccine has been approved for emergency use in countries such as Argentina, Bolivia, Algeria, Serbia and Palestine.
Agreement for sending of doses
União Química and RDIF have also announced an agreement that provides for the sending of ten million ready doses of the Sputnik V vaccine to Brazil by March, with a first delivery in January.
Last Sunday, January 10th, the pharmaceutical company announced it would initiate the production of more doses of the vaccine “still in January”, through the Bthek Plant in Brasília. A total of eight million doses per month are expected to be supplied in the first quarter of this year.
The Sputnik V was the first Covid-19 vaccine to be registered worldwide, in August, amid controversies. Later, in December, Russia announced the vaccine’s efficacy, which stood at 91.4%. However, the study details have not been published nor peer-reviewed.
Situation in Brazil
Should the Russian vaccine be approved and endorsed by ANVISA to be administered to the population, it could be another option within the federal government’s immunization program. However, there are no agreements in place yet for the purchase of the immunizer once it is ready.
According to the Ministry of Health, Brazil currently has 354 million doses of vaccines against Covid-19 guaranteed for 2021 – 254 million doses of which refer to the Oxford/AstraZeneca vaccine, which will be produced domestically by the Oswaldo Cruz Foundation (Fiocruz) and 100 million doses of the CoronaVac, the Chinese Sinovac vaccine in partnership with the Butantan.
The Ministry plans to have at least eight million doses available for immunization as early as January. Of this total, six million would be CoronaVac doses, which are currently stored at the Butantan Institute. The other two million would be the Oxford/AstraZeneca’s vaccine, which according to Minister of Health Eduardo Pazuello are being shipped from India this Wednesday.