National production strengthens sovereignty and planning in the PNI

The weeks of waiting for shipments of active pharmaceutical ingredient (IFA) to clear at Chinese customs for vaccines against covid-19, amid the explosive expansion of the Gamma variant in Brazil, set the tone of how dramatic dependence on inputs can be health for a country. With the pandemic, even rich and developed countries suffered from a lack of inputs, as they transferred their national health industry beyond their borders, and strengthening local suppliers entered the radar of these nations.

In the case of Brazil, the National Immunization Program (PNI), which turns 50 in 2023, has among its hallmarks the presence of national producers of the vaccines used. The Butantan Institute and the Oswaldo Cruz Foundation (Fiocruz) supply most of the vaccines, sera and other immunobiologicals that are part of the program, and this is one of the reasons attributed by specialists to its success.

The head of health at the United Nations Children’s Fund (Unicef) in Brazil, Luciana Phebo, points out that having robust institutions that know how to respond to such serious health problems is a privilege that Brazil has. For her, guaranteeing the supply of vaccines by institutions with the technical capacity of national manufacturers is one of the trump cards of the program to guarantee its continuity.

“It is an added value not only for the country, but for the whole world”, he says. “The PNI is not only important for Brazil, it is important for the whole world. And even more so dealing with viral diseases. Viruses do not have passports and do not recognize the duty of one country and another.”

public laboratories

The Butantan Institute, linked to the government of São Paulo, is part of this rear guard that guarantees supply to the PNI. In the pandemic, for example, there were more than 115 million doses of CoronaVac. Every year, the institute still supplies 80 million doses of the flu vaccine, in addition to producing vaccines against hepatitis A, hepatitis B, HPV, dTpa and rabies.

The medical director of the Butantan Institute, Fernanda Boulos, points out that, although public laboratories strengthen national autonomy, it is necessary to advance in this sovereignty, also guaranteeing the necessary inputs for all stages of production.

“It is necessary to point out that many inputs used during the vaccine production process are still imported. It is important to increasingly strengthen these institutions so that we can internalize various stages of the production process, including the production of active pharmaceutical ingredient (API), guaranteeing this local capacity for vaccine production”,

she argues.

In addition to manufacturing, Butantan also researches new vaccine technologies. At the moment, the São Paulo laboratory is carrying out phase 3 clinical trials, the last phase before registration, of new candidate vaccines against dengue, chikungunya and influenza being tested. “We are optimistic that we will be able to register and make these vaccines available soon”,

says Fernanda Boulos.

In addition to vaccines, Butantan also supplies 100% of the antivenom serums distributed by the Ministry of Health to all regions of Brazil, to treat cases of poisoning by snakes, spiders and scorpions.

“Antivenom serums are extremely important for public health, as we live in a country with high rates of accidents with venomous animals. These serums save lives every day,”

remembers the director of Butantan.

Vaccines for Brazil and abroad

Fiocruz’s Institute of Technology in Immunobiologicals (Bio-Manguinhos) brings together the other part of the main PNI vaccines. Its portfolio includes DTP, Yellow Fever, Haemophilus influenzae B, Meningitis A and C, Pneumococcal 10-valent, Covid-19 Vaccine (recombinant), Inactivated Poliomyelitis, Oral Poliomyelitis, Tetravalent Viral Human Rotavirus, Triple Virus and Measles and rubella (attenuated).

The institute is also supporting the resumption of production of the BCG vaccine, in a partnership with the Institute of Molecular Biology of Paraná (IBMP), after a crisis that led to the closure of the Ataulfo ​​de Paiva Foundation (FAP) factory, the only institution that produces the BCG vaccine in Brazil since the sample of the attenuated bacillus arrived from France, almost a century ago.

The director of Bio-Manguinhos, Maurício Zuma, says that, in addition to Brazil, 70 other countries receive vaccines produced at Fiocruz, through the foundation’s supply to international organizations such as the Pan-American Health Organization, the United Nations Fund for Childhood and the International Alliance for Vaccines and Immunization (GAVI). The most exported are the vaccine against yellow fever and immunizers against meningococcal disease.

“Bio-Manguinhos today produces ten different vaccines, all of which make up the national vaccination schedule. In 2022, we delivered more than 120 million doses to the PNI, this is the average number we usually deliver every year. In 2021 alone, there were more than 200 million due to the covid-19 pandemic”, recalls Zuma.

more autonomy

Member of the Epidemiology Coordination of the Brazilian Collective Health Association (Abrasco), Maria Rita Donalisio argues that investments are needed to strengthen production capacity and the nationalization of supply production, and that it is already a consensus in science that the money spent on vaccines saves much higher costs in care.

“We have two large laboratories that guarantee the national production of the most important vaccines in the program, and we need reinforcement to guarantee these supplies, to renew and adapt these laboratories. People always need investments. This strengthening is strategic for the country, for us to have autonomy and more strength to meet national needs”,

affirm.

Local supply gives planning predictability, lower prices, guarantees regularity in the arrival of doses and greater safety for frontline professionals in the municipalities where the vaccine rooms are located.

“SUS has an immense capillarity, with basic units all over Brazil, with teams that need this certainty that the immunobiologicals will arrive on time, guaranteeing their quality and the cold chain. This whole system starts with purchases from the Ministry of Health.”

economic complex

The recreation of the Executive Group of the Economic and Industrial Health Complex was one of the first actions of the Ministry of Health, highlighted minister Nísia Trindade.

“Our work plan is to ensure that, in ten years, more than 70% of health goods are produced in the country, including vaccines, medicines and inputs. We saw how essential this is during the covid-19 pandemic, when we had to import a pharmaceutical ingredient active for vaccines and so many other essential inputs, such as masks and gloves, for example. Brazil’s greater autonomy in the sector with the development of local industry reduces the vulnerability of the SUS and ensures universal access to health, in addition to generating employment and income”, he said.

The Growth Acceleration Program foresees more than R$ 8.9 billion for this area, BRL 6 billion for strengthening the production chain for vaccines, medicines and equipment. Another R$ 2 billion will fund the construction and pre-operation of the factories in campus Santa Cruz da Fiocruz, which will be the largest production center for biological products in Latin America. The other BRL 895 million will be invested in the Hemobrás industrial park and in the qualification of the blood network in the country, which will directly impact patients with hemophilia, facilitating access to treatment with blood products.

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