Sputnik V Studies Should Begin Shortly After ANVISA Approval

RIO DE JANEIRO, BRAZIL – The Russian Sputnik V vaccine for Covid-19 is already registered in its country of origin, as well as authorized for emergency use in other countries, including Argentina, Bolivia, Venezuela and Hungary.

União Química chairman Fernando Marques announced on Monday, January 25th that he plans to immediately start phase 3 trials of the Sputnik V vaccine in Brazil after ANVISA (National Health Regulatory Agency) clearance.

The laboratory has an agreement with the developers of the Russian vaccine against Covid-19 for importation and production of the immunizer in the country. There was a meeting on Monday with the regulatory agency to discuss the matter, according to Marques.

The conducting of phase 3 trials in Brazil is a prerequisite to apply for emergency use authorization in Brazil. The procedure was introduced in the pandemic context to expedite the approval of vaccines still being tested against Covid and only valid during the health emergency.

The pharmaceutical company said it is waiting for ANVISA approval to determine how many subjects will take part in this phase and the cities where trials will be conducted in the country.

Marques added that União Química’s goal is for the vaccine to be part of the PNI (National Immunization Plan). As such, it would be offered by the Ministry of Health to all states. A total of 150 million doses would be available by December, but no agreement has been signed with the Ministry as yet.

Moreover, the company intends to export the vaccine to Latin America, which is part of the agreement signed with the Russian sovereign fund, the sponsor of the development of the vaccine in the country.

Marques said that the embassies of Argentina, Uruguay and Paraguay have already made contact with the laboratory and are interested in purchasing the immunizer.

However, União Química’s chairman was unable to say whether this export would occur in parallel to the production made available to Brazil or after supplying the country. “The moment we have authorization to produce it, I believe the federal government will be interested. We are interested in taking part in the PNI rather than serving states separately.”

The pharmaceutical company applied for emergency use authorization at ANVISA on January 15th. One day later, the regulatory agency rejected the request because it failed to meet basic criteria for approval, such as conducting phase 3 clinical trials in Brazil.

Marques adds that the aim is to start offering the doses produced in the country as of April, which would amount to approximately eight million per month. The Active Pharmaceutical Ingredient production would be performed in Brasília and the filling process would be conducted in Guarulhos, São Paulo.

União Química has started to produce the active ingredient in its plant in Brasília for pilot tests, which will be later discarded. In fact, the production, at industrial and commercial scale, will only occur after authorization by ANVISA.

“The regulatory area staff is having meetings almost daily with ANVISA to meet all the necessary requirements for emergency use, since Russia has already provided ten million doses for the first quarter.”

The Sputnik V has already been registered in its country of origin, as well as authorized for emergency use in other countries, including Argentina, Bolivia and Venezuela, and now in Hungary, the first European Union country to approve the immunizer.

The conversation with the União Química chairman occurred after a ceremony attended by Federal District Governor Ibaneis Rocha and the Health Secretary Osnei Okumoto. The local officials visited the plant where the active ingredient will be produced.

According to the governor, the Federal District has no interest in marketing the vaccine directly with the laboratory, it will follow the National Immunization Plan. “I have been following the National Immunization Plan in the Federal District, the vaccines are distributed rationally, and proportionally by the Ministry of Health. I believe that the states should not race to purchase vaccines,” Ibaneis Rocha said.