Municipalities seek to adapt after a reduction in the transfer of doses of the BCG vaccine

States and municipalities are adopting strategies to adapt to the reduction in the transfer of doses of the BCG vaccine, ideally applied in the first days of life and fundamental in the prevention of severe cases of tuberculosis in children.

The Ministry of Health says that the readjustment of the number of doses transferred to local governments occurred because of the processing of the acquisition process before distribution to the states.

This process involves purchase, customs clearance, authorization from Anvisa (National Health Surveillance Agency) for the entry of the product into the country and submission for analysis by the INCQS (National Institute for Quality Control in Health).

The folder states that there is no shortage, that the doses distributed monthly vary according to the demand of the health departments and that the situation should be normalized by September.

In Cuiabá, where immunization was interrupted from June 19 to August 7 due to lack of doses, vaccination was resumed with limited days and times. The city received 40 vials, equivalent to 800 doses, and distributed the immunizations in four basic health units. Last Tuesday (16), one of the posts no longer had the vaccine and other places had two, five and seven vials, a very different scenario from a few months ago.

Until the end of June, children born at the General Hospital and Maternity Hospital of Cuiabá received BCG before discharge, according to the scheme suggested in Ordinance No. Now, the institution guides parents to seek health centers. The same recommendation is given at Hospital Santa Helena. Together, the two hospitals carry out about a thousand deliveries per month, a number higher than the doses received by the municipality.

In Rio de Janeiro, the State Department of Health has reinforced the request for municipalities to organize the logistics in order to avoid the loss of doses.

In Espírito Santo, where the quota was reduced to 60% (8,630 monthly doses), one of the guidelines passed on to cities is the vaccination of newborns on alternate days in maternity hospitals.

Cities in Bahia also felt the reduction. According to the state Department of Health, since May the monthly transfer is 45,000 doses, below the need for 150,000 to 200,000 doses.

“On April 29, the Ministry of Health issued, by letter, the information that as of May, and for 9 months, it would reduce the number of doses of BCG vaccine to the states and that they should make rational use of the quantities sent. “, says the folder.

To manage the situation, the secretariat has guided municipalities to optimize the opening of ampoules, since each bottle of BCG is valid for six hours after opening.

This is also the suggestion that the National Council of Municipal Health Departments (Conasems) gives to managers. “Of course, with that we ended up losing some windows of opportunity to vaccinate. If at one time I had this vaccine at ease, without risk of shortages, I would open the bottle when the mother looked for it. When there is that risk, I don’t do it anymore. I start to organize by day, make appointments and it may be that on the scheduled day the population does not look”, says Hisham Hamida, director of the entity.

The risk of parents giving up vaccinating their children after going to the health centers and not finding the immunizer is a concern shared by doctors interviewed by the report, especially considering the general drop in vaccination coverage.

“My biggest fear is losing the opportunity to vaccinate and not being able to go after these children later, not having an activated search strategy for those who did not receive the vaccine”, says Mônica Levi, director of SBIm (Brazilian Society of Immunizations).

She and pediatrician Renato Kfouri, also director of SBIm, explain that the purpose of the vaccine is to protect children before exposure to Koch’s bacillus, preventing serious types such as miliary tuberculosis, in which the disease spreads throughout the body, and meningeal , with brain involvement.

“Without vaccination, we can go back to having cases that we haven’t seen in clinics for years”, says Kfouri.

Therefore, the two recommend parents to seek health facilities for the application of BCG as soon as possible.

“If you haven’t vaccinated yet, you need to go to the clinic and ask about opening the next bottle. There is no effective communication from the Ministry of Health, so parents have to inform themselves,” says Kfouri.

BCG production

Until 2016, the doses of BCG distributed by the Ministry of Health came from the FAP (Fundação Ataulpho de Paiva), in Rio de Janeiro. Since then, however, production at the São Cristóvão unit has been interrupted a few times after inspections by Anvisa (National Health Surveillance Agency), and the new factory, in Duque de Caxias, continued to be delayed.

Because of this, the government resorted to the Revolving Fund of PAHO/WHO (Pan American Health Organization) to acquire the immunizing agent, being subject to variations in the international supply.

“We went through this in the pandemic with other inputs, with medicines, and now we are experiencing it with vaccines. As long as we do not structure the health industrial complex, strengthening national production, we will always run the risk of shortages”, argues the director of Conasems.

The instability in the supply of BCG is also felt by patients with bladder cancer, who use Onco BCG in their treatment. The NGO Oncoguia, which supports cancer patients, says that it began to receive reports of shortages of the product in February, two months after a new inspection by Anvisa at FAP determined the suspension of production. The entity sought the Public Ministry of São Paulo to inform about the problem and awaits the processing of the process.

In its position on the shortage of BCG, the SBOC (Brazilian Society of Clinical Oncology) offers some alternatives, such as direct importation from countries such as India and Germany, but emphasizes the high cost of this option.

Asked whether it is investing in FAP or in opening a new factory to return to national production of the vaccine, the Ministry of Health did not take a position. Sought by telephone and email, the Ataulpho de Paiva Foundation did not respond to the contacts in the report.