National production of vaccines strengthens sovereignty and planning

Weeks of waiting for the active pharmaceutical ingredient (API) of the covid-19 vaccine to clear through Chinese customs during the outbreak of the Gamma variant in Brazil set the tone for a dramatic development of the outbreak. National reliance on hygiene products. Affected by the epidemic, even wealthy developed countries are facing supply shortages as they shift their domestic healthcare industries overseas. Therefore, strengthening the strength of local suppliers has entered the sights of these countries.

In the case of Brazil, the National Immunization Program (PNI) will celebrate its 50th anniversary in 2023, one of the hallmarks of which is the presence of a national vaccine manufacturer. The Butantan Institute and the Oswaldo Cruz Foundation (Fiocruz) provided most of the program’s vaccines, sera and other immunobiological agents, which experts say is one reason why PNI was successful.

Luciana Fabo, head of the United Nations Children’s Fund (UNICEF) health sector in Brazil, stressed that it is a privilege in Brazil to have reliable institutions that know how to deal with such serious health problems. For her, the guaranteed supply of vaccines by institutions with the technical capacity of national manufacturers is one of the strengths of the program to ensure its continuity.

“This has added value not only to the country but to the whole world,” he said. “PNI is important not only for Brazil, but for the whole world, and even more so when it comes to viral diseases. Viruses do not have passports and do not recognize the responsibility of one country and another.”

public laboratory

The Butantan Institute, which is linked to the São Paulo government, is part of the rearguard that guarantees supplies from the Nationalist Party. During the pandemic, for example, it produced more than 115 million doses of CoronaVac. The institute also provides 80 million doses of influenza vaccine annually, as well as hepatitis A, hepatitis B, HPV, dTpa and rabies vaccines.

Fernanda Buros, medical director of the Butantan Institute, emphasized that while public laboratories strengthen national autonomy, it is necessary to advance this sovereignty while guaranteeing the necessary supplies at all stages of production.

“It is important to point out that many of the inputs used in the vaccine production process are still imported. It is important to continuously strengthen these institutions so that we can internalize all stages of the production process, including the production of the active pharmaceutical ingredient (API), ensuring local vaccine production capacity,” he said.

In addition to manufacturing, Butantan also researches new vaccine technologies. Currently, the laboratory is conducting Phase 3 clinical trials of new vaccine candidates against dengue, chikungunya and influenza, the last trial before registration. “We are optimistic that we will soon be able to register and commercialize these vaccines,” Fernanda Bloos said.

Likewise, Butantan supplies all regions of Brazil with 100% antivenom distributed by the Ministry of Health for the treatment of snake, spider and scorpion poisoning cases.

Vaccines for Brazil and abroad

Another part of the main PNI vaccine is produced at the Fiocruz Technical Institute of Immunobiology (Bio-Manguinhos). Its product portfolio includes DTP, yellow fever, Haemophilus influenzae type B, meningitis A and C, 10-valent pneumococcus, Covid-19 vaccine (recombinant), inactivated polio, oral polio, human Rotavirus quadrivalent virus, triple virus and measles and rubella (attenuated).

After the crisis that led to the closure of the Ataulfo ​​de Paiva Foundation’s factory, the Institute is also responsible for the production of the BCG vaccine (FAP), in collaboration with the Institute of Molecular Biology (IBMP) of the State of Paraná, the only institution in Brazil that produces it.

Maurício Zuma, director of Bio-Manguinhos, confirmed that in addition to Brazil, 70 other countries have access to the Fiocruz-produced Vaccines Vaccines and Immunization (Gavi). The most exported vaccines are yellow fever vaccine and meningococcal vaccine.

“Bio-Manguinhos currently manufactures 10 different vaccines, all of which make up the National Vaccination Program. In 2022, we delivered more than 120 million doses to the PNI, which is the average of our usual annual deliveries. In 2021 alone In 2010, we delivered more than 120 million doses of vaccine. More than 200 million people died due to the Covid-19 pandemic”, recalls Zuma.

economic complex

Minister Nicea Trindade said in an interview that the restructuring of the Health Economic and Industrial Complex Executive Group is one of the Ministry of Health’s first actions. Brazil agency.

“Our work plan is to ensure that within ten years more than 70 per cent of health products, including vaccines, medicines and supplies, are produced in the country. We saw the importance of this during the covid-19 pandemic, when we had to import active pharmaceutical ingredients and many other necessities such as face masks and gloves.” Brazil has greater autonomy in this sector, as local industry develops, in addition to creating jobs and income, reducing SUS vulnerability and guaranteeing Universal access to health services. “

The recently launched Growth Acceleration Program expects more than R$8.9 billion to be invested in this sector, of which R$6 billion will be used to strengthen the production chain of vaccines, medicines and equipment. Another 2 billion reais will be used to finance the construction and pre-operation of the factory in the new Santa Cruz de Fio Cruz campus, which will become the largest center for the production of biological products in Latin America. An additional R$ 895 million will be invested in the Hemobrás Industrial Park and the accreditation of the country’s Bleeding Network, which will have a direct impact on hemophiliacs, facilitating access to blood products for treatment.

*Contributed by: National Radio reporter Tâmara Freire