The crisis that made the government intervene in the production of the BCG vaccine – 06/06/2023 – Health

Fiocruz (Fundação Oswaldo Cruz) announced on Monday (5) that it had signed an agreement to resume national production of the BCG vaccine, which fights tuberculosis, and to intervene in the FAP (Fundação Ataulpho de Paiva), in Rio de Janeiro — an institution philanthropic organization and the only immunizer producer in Brazil.

Since 2016, the production and distribution of the FAP vaccine has been irregular due to prohibitions by Anvisa (National Health Surveillance Agency). Last year, for example, the Ministry of Health asked the states to ration the vaccine, “given the limited availability in the national stock due to difficulties in acquiring this immunobiological.”

According to one of the Anvisa reports that BBC News Brasil had access to, production at the current FAP factory, in the neighborhood of São Cristóvão, in the north of Rio, “presents a risk to the health of the Brazilian population” because it does not comply with good health practices. production of immunobiologicals.

Fiocruz’s intervention in the FAP, assuming part of the entity’s direction and deliberative council, is yet another chapter in a long history of problems in the national production of this, which is one of the first vaccines given to newborns in Brazil. The FAP also manufactured, before the bans, Immuno BCG, used in the treatment of bladder cancer.

The imbroglio also involves a factory under construction for 34 years in Xerém, in the city of Duque de Caxias (RJ) — and which had at least R$ 41.9 million in agreements with the Ministry of Health, as BBC News Brasil revealed. in 2020.

Promised as a solution for supplying BCG in Brazil, construction began on the new factory in 1989 and has never produced a single dose of the vaccine.

Fiocruz stated that it will “provide assistance so that the Xerém factory is finally completed within 2 to 3 years.”

With this delay of more than three decades, the Ministry of Health itself refused at least two accounts from the entity to which the report had access, asking for the full return to the public coffers of at least R$ 24.8 million — part of that money was charged personally by the former president of the FAP, pathologist Germano Gerhardt Filho, and part of the foundation itself.

The amounts would be used for the acquisition and installation of equipment in the new plant. However, the two Ministry of Health reports found a number of problems with FAP’s accountability for how public resources were used in Xerém.

The folder pointed out that, in some cases, the FAP bought only “partially” the equipment for which it received the resources to acquire. In addition, the ministry stated that the rendering of accounts was delivered late by the foundation.

“By analyzing all the documentation presented, as well as the pronouncements of the responsible technical area and the clarifications provided, it was demonstrated the reckless way in which the whole process was conducted, dragging on for years”, concluded the ministry in the document.

With the changes announced by Fiocruz in June, Gerhardt Filho left the presidency of the FAP, but will remain on the deliberative council. Luiz Roberto Castello Branco, who was previously the foundation’s scientific director, assumed the board; and Artur Couto, from Fiocruz.

According to Fiocruz, the new board will start negotiating the FAP’s debts and will present, within 30 days, an institutional and economic-financial recovery plan.

BBC News Brasil questioned the FAP about changes in management and discrepancies in accountability, but did not receive a response until the publication of this report.

The Ministry of Health did not respond whether the amount indicated in its opinion was returned by the foundation and its former president.

“The agreements signed with the Ataulpho de Paiva Foundation are being evaluated by the Ministry of Health, which considers administrative measures that can be applied for the finalization of the instruments”, stated the press office of the folder.

“The Ministry of Health maintains its commitment to the defense of the public interest, the treasury and good service to the population, always with respect for the law and with transparency”, completes the folder.

TEMPORARY PRODUCTION IN SPAIN

While production at the FAP factories in São Cristóvão and Xerém is not resumed, Fiocruz says it has started negotiations for the vaccine to be temporarily manufactured in the city of Vigo, Spain.

The plan is that, from the second half of 2024, the doses produced there will be delivered and used in Brazil. For this to happen, however, Anvisa must first analyze and authorize the doses produced in Spain.

This entire project to resume FAP production involves, in addition to Fiocruz, the Ministry of Health and the IBMP (Instituto de Biologia Molecular do Paraná) — the result of a partnership between Fiocruz and the state government of Paraná.

“It’s not about importing vaccine from another manufacturer. It’s the same FAP BCG vaccine that, instead of being produced at the São Cristóvão plant, would be produced at a contracted factory in Spain. We would just be temporarily transferring production to a new location , until the Xerém plant is completed,” said IBMP’s CEO, Pedro Barbosa, in a press release.

After successive bans on the FAP factory in São Cristóvão, Brazil has been obtaining doses of BCG from the Revolving Fund of the Pan American Health Organization (PAHO), the regional arm of the WHO (World Health Organization). The fund sells vaccines and supplies, such as syringes, to local and national governments that do not have domestic production available.

Sources heard by the report stated that the raw materials for the vaccine had to be rescued by Fiocruz, as they were at risk of being lost in the poor conditions in which they were found at the FAP facilities.

NEWBORN AND CANCER PATIENTS AFFECTED

Since the national manufacture of BCG began to become irregular in the country, the families of newborn babies and patients with bladder cancer have suffered consequences.

In 2019, 12 states reported receiving fewer doses than expected, and some families reported difficulties vaccinating babies.

In April 2022, the Ministry of Health sent a circular to state health departments warning that the doses of BCG sent would be reduced and that states would need to ration them.

Juarez Cunha, director of SBIM (Brazilian Society of Immunizations), celebrated the announcement of the resumption of national production.

“For a long time, we had autonomy in the national production of the BCG vaccine. It is essential that we resume, because it is strategic to have a national production park of immunobiologicals, vaccines”, evaluates the pediatrician, adding that the Covid pandemic -19 opened up the importance of having a national health industry.

The BCG vaccine protects against miliary tuberculosis and meningeal tuberculosis — severe forms of the disease.

“As tuberculosis rates are very important in the country, we have the most complicated cases, so the vaccine is the way to protect the child from these more serious forms.”

Like several other immunizations, BCG vaccination coverage had significant declines from 2016. Before that, between 1995 and 2015, coverage was considered total (100%). In 2021, it reached the lowest level ever recorded, with coverage of 74.9%. In 2022, there was a recovery, with coverage of 90% of the target population. The numbers are from DataSUS.

For Cunha, the irregular supply of BCG in the country is one of the factors that explains the decrease in vaccination coverage — for example, because in the face of rationing, state departments began to offer immunization only by appointment.

“This certainly has an impact on vaccination coverage, because a mother will try to get the vaccine [no filho] that is not available, or you have to make an appointment for another day.”

Bladder cancer patients were also heavily affected. Produced by FAP, Immuno BCG is used in most cases of the disease, when the tumor is said to be superficial — because it has not reached the muscular layers of the organ.

The application of the drug is called an adjuvant procedure, that is, it is after the main intervention, which is the removal of the tumor.

Finding the medicine has become an almost impossible task for cancer patients, both through the Unified Health System (SUS) and in private pharmacies. Without it, the risk of the tumor infiltrating the muscle layers of the bladder increases, which could lead to the removal of the bladder or the need for chemotherapy — procedures considered invasive.

FOUNDATION IS INVESTIGATED

In the 1980s, the Ataulpho de Paiva Foundation was one of the institutions that received investments through Pasni (Program for National Self-sufficiency in Immunobiologicals) — which aimed precisely at guaranteeing national production, without the country having to go through all the procedures to which it is subject. now being submitted on import.

When the operation of the FAP factory in São Cristóvão was regular, the BCG vaccines were purchased by the federal government through the modality “non-requirement of bidding”, since this was the only producer in the country of the immunizer.

In a proposal for an agreement with the Ministry of Health, in 2016, the institution defended that “it has always made Brazil self-sufficient in the production of the BCG Vaccine, never having had the need to import this product”.

According to the foundation’s website, the new unit in Xerém would have the objective of producing BCG in order to “supply the national demand and part of the international one, since the institution receives inquiries from several countries.” But 34 years later, the factory is still not fulfilling its purpose, either nationally or internationally.

Founded in 1900, FAP is one of the most traditional vaccine research and production foundations in the country. But, in addition to the problems already reported, the institution is also experiencing an administrative crisis, with employee layoffs and labor liabilities being discussed in court.

In addition, in February 2022, the MP-RJ (Public Ministry of Rio de Janeiro) opened a civil inquiry to “investigate possible irregularities in the management of the Ataulpho de Paiva Foundation and alleged illegal conduct practiced by the members of its board” from a complaint forwarded to the agency’s ombudsman.

According to Fiocruz, the Foundations Curatorship of the MP-RJ approved the entire FAP recovery process announced this Monday.

This text was originally published here.