SÃO PAULO, BRAZIL – Although it has yet to get approval from Brazil’s federal health regulatory agency ANVISA, Brazilian pharmaceutical firm União Química, the only manufacturer in the country of Russia’s Sputnik V against Covid-19, is already producing doses, stated Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF) on Thursday, January 21st.
“We are doing everything within our reach to bring the (Covid19) vaccine to Brazil,” União Quimica’s International Business Director, Rogerio Rosso, told The Rio Times.
“If approved it will be the first totally, 100% Brazilian vaccine for Covid19,” added Rosso.
The Russian executive said that Brazilian production of the vaccine will increase in February and that he expects Sputnik V’s approval in Brazil to be resolved in the coming weeks.
According to company officials, Sputnik V is the only Covid-19 vaccine being used in the world today that uses two different types of human adenovirus as viral vectors, one in each of the two predicted doses.
On Thursday, União Química executives met with ANVISA (Brazilian National Health Regulator) to discuss the matter.
Although in a press release issued after the meeting, ANVISA stated that União Química had not yet applied for emergency authorization, Rosso said the request was made in December. The regulatory agency later revised its statement.
“During the meeting, representatives of União Química presented information and stated that they are interested in complying with all the regulatory steps required by Anvisa to advance with clinical studies in Brazil and the authorization for emergency use,” read the statement issued by the regulator.
According to the agency, new documents are expected be presented soon. A new technical meeting has been tentatively scheduled for Friday, according to Rosso.
Last Saturday, ANVISA officials said there was not sufficient information supplied by the company to justify an emergency authorization.
Even so, the government of the state of Bahia has filed a lawsuit in the country’s Supreme Court (STF) asking for authorization for independent purchase and application of up to 50 million doses of Sputnik V.
Officials at União Química told the press that the action of the Bahian government is “independent” and distinct from the pharmaceutical company.
With 100% domestic capital and a biotechnology manufacturing complex in the United States, the União Química group is among the largest and most solid companies in the Brazilian pharmaceutical industry.
The company founded in 1936 under the name of Laboratório Prata was acquired in 1970 by João Marques de Paulo, who created União Química, which invoiced approximately R$2.7 million in 2020 and employs 6,349 people. The firm offers drugs such as Ciclo 21 contraceptive, producing 5.5 million boxes per month, or even Lacrifilm artificial tear solution.
It is structured in five business units: Agener (pets, production and reproduction animals), pharmaceutical (generics, similar and OTCs), genom (medical prescription), hospital and outsourcing, and since the 1980s it has been chaired by Fernando de Castro Marques, who explained the details about his interest in the Sputnik V.
The company manufacturers drugs for approximately 30 medical specialties, including anesthesiology, ophthalmology, psychiatry, orthopedics and neurology.
In all, the group produces 31 million units/month and invested more than R$100 million in research and development in 2020.
It is among the eight largest corporations in Brazil’s pharmaceutical market with eight manufacturing plants, two biotechnology factories, including one in the state of Georgia, in the United States.
According to sources, before the pandemic the Brazilian company had sought business relationships with both Chinese and Russian governments, due to its animal division.
“In 2019 I traveled to dozens of countries negotiating our animal division products. Then came Covid19,” explains Rosso. The director says the company’s focus quickly switched from its animal division to its pharmaceutical division.
In August 2020, the pharmaceutical company signed a technology transfer contract with RDIF and the Gamaleya Epidemiology and Microbiology Research Institute, responsible for the development of the Russian vaccine.
According to the international business director, Sputnik V was developed by the renowned Russian government-run Gamaleya Institute.
“(It has) more than 130 years of history in the development of medicines and vaccines,” Russo said in an interview to Brazilian daily Correio Brasiliense on Thursday.
Brazilian technicians were at Gamaleya in September for a 12-day training session, and União Química has been working on preparing its biotechnology unit in Brasilia, called Bthek, to receive the technology for producing the active vaccine ingredient IFA.
Last week, company executives were again in Russia to clarify regulatory questions that will be passed on to ANVISA.
The União Quimica executive said Sputnik V has been proven to be 91.4 percent effective, with two doses in an interval of 21 days.
“The manufacturing of IFA in Brazil guarantees the country more sovereignty; we will become less dependent on foreign raw materials and less dependent on the ‘goodwill’ of foreign companies and foreign governments,” concludes Rosso.
According to the RDIF spokesman, in addition to Brazil, other countries like China, India and South Korea will also produce doses outside of Russia.