BCG vaccine: with national factory stopped, ministry asks states to ration immunization

One of the first vaccines to be given to a child born in Brazil, BCG will have a reduced supply in the coming months due to problems that the Ministry of Health has had to obtain doses of the immunizer, which prevents tuberculosis.

At the end of April, the Ministry of Health sent a circular to the state secretariats stating that, “given the limited availability of the BCG vaccine in the national stock due to difficulties in acquiring this immunobiological”, the ministry’s shipment will decrease by 1.2 million of doses per month (average from January to March 2022) to 500 thousand monthly doses in the next seven months.

In the document, the ministry asked States to “optimize and make rational use of this vaccine for this period” until “the situation of the national stock of the BCG vaccine is regularized”. Ideally, the immunizing agent should be applied while still in the maternity ward — at most, until the end of the first month of life.

BBC News Brasil sent an email to all state departments in the country asking about the availability of the BCG vaccine. Of the 17 who responded, all said that there is currently no shortage of doses, but some mentioned that they are readjusting for the next seven months, in which the ministry’s shipment will be reduced.

The secretariats of Mato Grosso, Paraná, Rio de Janeiro, Rio Grande do Norte and Santa Catarina stated that they sent the municipalities instructions to control the use of bottles, so that there is no waste; and for them to start offering vaccination only in selected places, in some cases by appointment.

The city of Cachoeira do Sul, in Rio Grande do Sul, has already announced to the population a change in the vaccination schedule. Until the notice from the Ministry of Health, the municipality applied the vaccine in ten health units throughout the city. Now, it is given at just three stations — and by appointment.

“In the last shipment of vaccines, we didn’t receive any dose of BCG”, says Marcelo Figueiró, secretary of health of Cachoeira do Sul.

According to him, a batch of BCG arrived in the city with 20 doses.

“Often, you need to open a whole batch to give few vaccines. Those that are left over need to be discarded after six hours of opening. So, we are trying to rationalize and have better control over this use so that we miss the minimum doses possible, since in the coming months there may be a lack of vaccine”, he says.

This is yet another chapter of the problems in the supply of this vaccine in recent years. In 2019, BBC News Brazil showed that 12 states needed to ration the immunizer to guarantee vaccination and that Onco BCG, immunotherapy made with the same base as BCG but used to treat bladder cancer, was in short supply in the country.

Since 2016, the only national factory that produces BCG and Onco BCG, belonging to the Atalpho de Paiva Foundation (FAP), in Rio de Janeiro (RJ), has undergone successive bans by Anvisa (National Health Surveillance Agency) — and, from then on, the supply of the vaccine in the country became intermittent.

Anvisa’s press office informed BBC News Brazil that the factory, in the neighborhood of São Cristóvão, remains closed. Meanwhile, a new factory of the foundation in Duque de Caxias (RJ), under construction since 1989, has not yet been inaugurated (read more below).

The MP-RJ (Rio de Janeiro Public Ministry) opened an inquiry in February to investigate possible irregularities in the management of the foundation.

An Anvisa report that led to the ban in 2016, obtained by BBC News Brasil via the Access to Information Law, stated that “the manufacture of the Vacina BCG and Immuno BCG products [a marca da Onco BCG feita pela instituição] by Fundação Ataulpho de Paiva at the factory located in São Cristóvão (Rio de Janeiro – RJ) presents a risk to the health of the Brazilian population”. something that “may present a latent or immediate health risk”.

According to an email sent by Anvisa to the report on the 16th, “the factory of Fundação Athaulpho de Paiva (FAP) located in the neighborhood of São Cristóvão (RJ) is paralyzed by the company to carry out adjustments and corrections resulting from the last inspection sanitary”.

“Manufacturing cannot resume until the necessary adjustments are completed and again the factory is inspected to verify the effectiveness of the corrections,” he continues.

Since the problems with the national producer began, Brazil has obtained doses of BCG with the Revolving Fund of the Pan American Health Organization (PAHO), the regional arm of the WHO ​(World Health Organization). The fund provides vaccines and supplies, such as syringes, to local and national governments that do not have national production available.

The Ministry of Health did not answer exactly why there will be a reduction in the quantity in the next seven months and if there was any problem with the supply through the Revolving Fund.

In a note, the folder wrote: “This readjustment refers to the entire procedure of the acquisition process, which involves the purchase itself, customs clearance and authorization by Anvisa for the entry of the product into the country, which is later sent for analysis of INCQS quality control before being distributed to vaccine rooms.”

National foundation is investigated

In the 1980s, FAP (Fundação Ataulpho de Paiva) was one of the institutions that received investments through the National Self-Sufficiency Program in Immunobiologicals (Pasni) — which aimed precisely at guaranteeing national production, without the country having to go through all the formalities which you are now being subjected to on import. Born in 1900, FAP is a private, non-profit and philanthropic entity.

When the operation of the FAP factory in São Cristóvão was regular, BCG vaccines were purchased by the federal government through the modality “unenforceability of bidding”, since this was the only producer in the country of the immunizer. In a 2016 proposal for an agreement with the Ministry of Health, the institution argued that it “has made Brazil always self-sufficient in the production of the BCG Vaccine, and there has never been a need to import this product”.

In 1989, FAP started the construction of a new factory in Xerém, Duque de Caxias (RJ). According to the foundation’s website, the new unit aims to produce BCG in order to “supply national demand and part of the international one, since the institution receives consultation from several countries.” But 33 years later, the factory is still not fulfilling its objective. Anvisa told the report that the unit in Xerém still does not have authorization to manufacture vaccines because it has not received a request from the foundation to carry out the inspection, which can only occur after the completion of the works.

Sought, FAP stated, through its president, Germano Gerhartdt Filho, that the factory “has already started its operation, in the areas and activities of storage, packaging and sale of products” and that it is “in the process of regularization before Anvisa” to “continue the marketing and supply of BCG and Onco BCG”. That is, the factory is producing other items but still does not manufacture vaccines.

BBC News Brasil published a report in 2020 about the imbroglios involving the construction of the new factory. At the time, the foundation stated that the unit would be inaugurated in 12 months and attributed the delay to the need to readjust the structure to new Anvisa regulatory standards.

Through the Access to Information Law (LAI) and consultations with the Transparency Portal, BBC News Brasil identified agreements between the Ministry of Health and the entity specifically aimed at the new factory in Xerém, which totaled R$ 41.9 million in funds, from of which more or less half (46.5%) had been released.

In fact, this amount is possibly higher, since it was not possible to locate information on expenditures with the project since the 1980s — only from 2012 onwards. The BNDES (National Bank for Economic and Social Development) also lent R$ 5.9 million to the foundation through a program of the Ministry of Health that aimed to develop and modernize the Brazilian industrial park in the area of ​​health.

In February this year, the MP-RJ 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” based on a complaint sent to the organ’s ombudsman, according to its daily. official.

In a note sent to the report, the president of FAP stated that “there was a false accusation of irregularity in the management of the entity, promoted by a former employee, with a clear interest in blackmailing the foundation, in the vain hope that we will reach an agreement in a labor lawsuit by he moved”.

“We have provided all the information and will continue to be at the disposal of the Public Prosecutor’s Office, to avoid any suspicion about this centenary and important institution for the country”, wrote Gerhartdt Filho, adding that “the accusations of administrative irregularities are not consistent with the truth”.