09/10/2025 | Natasha Pinelli | Butantan Portal

https://butantan.gov.br/noticias/cada-segundo-conta-os-bastidores-de-como-o-butantan-traz-a-cepa-atualizada-da-vacina-da-gripe-para-o-brasil-apos-anuncio-da-oms 

From import authorization in just 48 hours to careful transport in dry ice, learn about the process that ensures the population is protected against the disease

Just like in a professional kitchen, where every movement must be carefully timed so that a dish is served perfectly, the production of Butantan's flu vaccine requires precision and synchronization to reach Brazilians' arms at the right time.

This pace intensifies at the end of September, when the World Health Organization (WHO) announces the three strains that will make up the next season's vaccine in the Southern Hemisphere, after a detailed analysis of the types of influenza viruses that are circulating in the region and have the greatest potential for causing serious illness. 

If any of these strains (a version of the virus modified in the laboratory for safe vaccine production) are not available in the Institute's stock, dozens of professionals work in a coordinated manner to ensure that, in about 48 hours, the material is duly authorized to continue its journey to the institution.

Part of this process begins even before the agency's official announcement, with the scheduling of deliveries of special pathogen-free eggs, which will serve as the basis for the multiplication of the strains indicated for the vaccine. But it is when the WHO releases its recommendations that a real race against time begins. 

Below, learn about the decisive moments in this journey with no room for error, which is essential for the annual production of more than 80 million doses of flu vaccine that are distributed annually by the federal government to the Brazilian population. Check it out:

Announcement and first moments after the update: maximum alert
The WHO meeting to announce the new strains takes place in a hybrid format—in person and remotely—with all influenza vaccine producers in the Southern Hemisphere. 

“On that day, the atmosphere here at Butantan is very similar to a World Cup final. We, in production, watch everything live to follow the guidelines and pass on crucial information as quickly as possible to the other areas involved in the process,” says Priscila Comone, manager of Influenza Bank Production (PBI) at Butantan. 

During the meeting, the technical production team decides which of the announced strains available in stock will be used to begin development of the flu vaccine. In addition, it is necessary to identify which international laboratories have the possible “new” strain available. Everything is passed on in real time to Butantan’s Purchasing department, which immediately begins contacting those responsible for shipping the biological material.

“As we cannot depend on just one supplier, because any problem could jeopardize our production, the strategy is to activate and import strains from all those who have the material. We usually deal with two different laboratories,” explains Butantan's Purchasing and Bidding Manager, Luciane Vieira de Jesus.

1 hour after the announcement: opening of change control
Immediately after the meeting with the WHO ended, a task force was set up to open and approve the so-called Change Control (CC), an internal Butantan protocol that formalizes the need to change the vaccine and import a new strain of the influenza virus. This step is crucial to signal all areas that will be impacted by this update and ensure compliance with Good Manufacturing Practices.

The process triggers a series of cascading approvals, involving about ten areas of the institution. In normal situations, the process between the opening and validation of this change can take several days. However, as this is an emergency procedure, the areas impacted are notified one week in advance of the change that will be recorded in the system on the day of the WHO meeting.

The tension is constant, as any pending issues or delays can delay a sequence of tasks that can only be performed after the Change Control has been duly approved, such as the request to purchase and import the strain.

Seven hours after the WHO announcement: the formal request
The CM is fully approved about six hours after opening in the system. The next step is to generate the identification in the system for the updated strain. "To avoid wasting time, we adopted a war strategy: we locked ourselves in a room and only left after completing the registration. At each new stage, we called the employee responsible for giving the next approval, so that the process would not get stuck with anyone," says PBI coordinator Hugo Jemesom.

This is important so that the new strain can actually “exist” in Butantan’s systems, thus allowing requests related to it to be made—such as the request to import the material, which is consolidated by Butantan’s Production Planning and Control (PCP) area. 

24 hours after the WHO announcement: negotiations with laboratories
Although the Purchasing department has already contacted suppliers in parallel to understand the availability of the strain, an “official” request must be received from the PCP department to continue the process.

At this stage, laboratories must send two documents to Butantan's Purchasing team: the invoice, a type of invoice with a description of the material to be supplied; and the packing list, with information on the packaging in which the strain will be shipped, such as dimensions, weight, and temperature. One detail: the material must travel at an average temperature of -60 °C and, therefore, must be wrapped in dry ice. 

“The problem with this stage is that suppliers are not always quick to respond, and the answer can take much longer than we would like,” emphasizes Luciane Vieira de Jesus. When this happens, the Purchasing team springs into action again to pressure suppliers on several fronts, whether by email, phone, or WhatsApp.

48 hours after the WHO announcement: import approved
Once these documents are sent by the supplier, the logistics of transporting the strain are handled by Butantan's Foreign Trade department, which is also responsible for obtaining the so-called Import License—an electronic document that authorizes the entry of controlled goods into the country, ensuring compliance with safety and quality standards. 

With the license in hand, Foreign Trade and Purchasing begin to follow up daily with the supplier. The goal is to understand when the material will be shipped, estimating its arrival at the Butantan vaccine factory. 

One week after the announcement: shipment approved
Transporting the strain is another tense moment. Before shipment, all documentation is thoroughly checked to minimize potential setbacks. And although the volume is small—only two vials, each containing 1 ml of the product, are shipped—the cargo must travel under constant temperature monitoring. To this end, a small device called a data logger is included in the shipment, capable of recording temperature variations minute by minute. 

“There are many strategic decisions to be made. We cannot allow the strain to be shipped on a flight arriving in Brazil on Friday, for example. Otherwise, we run the risk of not having a team available at the airport to replace the dry ice, thus compromising the integrity of the material,” points out Foreign Trade Analyst Katia Rejane Ferreira.

Last leg: from customs to the Butantan ultrafreezer
As soon as the flight carrying the strain lands in Brazil, the process of clearing and releasing the cargo begins immediately. The process is conducted with maximum priority and speed to minimize the time spent at the airport, ensuring that the material maintains its integrity and quality until it is transported to its final destination.

After authorization from the Federal Revenue Service, the imported strain is finally cleared to begin the last leg of its journey to Butantan. On the ground, transportation takes place in a refrigerated car. Although some of the anxiety ends when the material is finally cleared at the airport, the arrival of the strain at the Institute's premises also represents a decisive moment for production.

Before being delivered to the PBI, where the new strain will be inspected and finally stored in an ultra-freezer, the strain ends up passing through other areas, such as the Receiving and Inventory departments. “When the car is on its way, we already put everyone involved in the operation on alert. It's a matter of receiving, checking, and dispatching. We can't mess around, because we're dealing with the heart of the flu vaccine," notes Foreign Trade analyst Karin Yuri Kawazu.

To give you an idea of how fast this process is, in 2024, the strain arrived at the Butantan Institute just 15 days after the WHO announcement—thanks to the coordinated and efficient actions of the various areas involved in the operation. It's a short and intense period that guarantees months of work at the Butantan flu vaccine factory, in addition to strengthening the protection of the Brazilian population against the disease for more than a year.