Creation of the Institute of Technology on Immunobiologicals (Bio-Manguinhos), on May 4th. The Institute becomes an independent technical-scientific unit focused on the promotion, development and production of immunobiologicals of interest to public health. Since its creation, Bio-Manguinhos has evolved from a set of small laboratories for typhoid, cholera, meningitis and yellow fever, designed for research, to an industrial and technological complex for immunobiologicals, one of the most important in South America.

Signing of the technology transfer contract for the production of the meningococcal AC vaccine between Fiocruz and the Mérieux Institute.

In September, we obtained the national certification of Good Manufacturing Practices (GMP) for the yellow fever vaccine, issued by the National Health Surveillance Agency (Anvisa), a fundamental step towards international qualification. In October, the unit achieves pre-qualification of the World Health Organization to act as an international supplier of this product, an unprecedented event in the area of vaccine production in Brazil.

Start of production of the combined DTP&Hib vaccine (50 doses per cartridge) in partnership with the Butantan Institute. Start of construction of the Viral Antigen Production Center and the Bacterial Antigen Production Center in Bio-Manguinhos.

The unit breaks a record for exporting yellow fever vaccines: more than 26 million doses against about eight million the previous year.

Bio-Manguinhos closes an agreement with Cuba for the technology transfer for the production of the biopharmaceuticals epoetin alfa and interferon alfa 2b.

Inauguration of the Center for the Production of Bacterial Antigens, responsible for the national production of the Haemophilus influenzae b (Hib) conjugate vaccine. Rapid HIV diagnostic test technology transfer agreement with Chembio Diagnostic Inc.

In May, the national production cycle of the Hib vaccine is completed — the technology transfer of which was signed in 1999 with GlaxoSmithKline: three batches of product consistency were produced, used for non-inferiority clinical studies.

The new rapid tests for the diagnosis of HIV 1 and 2 are made available to the Department of STD, AIDS and Viral Hepatitis.

Bio-Manguinhos celebrates 30 years and holds the 1st International Symposium on Immunobiologicals and Human Health.

The works on the Konosuke Fukai Center are completed, which brings together the new facilities of the Viral Antigen Production Center and the Quality Center.

Start of operation: a level 3 biosafety area (at the beginning of the year) and an area for experimental lyophilization (at the end of the year).

Taking advantage of the experience with the formulation of the yellow fever vaccine in 5 doses, Bio-Manguinhos develops a new presentation in 10 doses and submits an application for registration with the National Health Surveillance Agency (Anvisa).

Beginning of Phase I of clinical studies of the serogroup B and serogroup C conjugate meningococcal meningitis vaccines.

On May 4, Bio celebrates its 31st birthday and implements its Social and Environmental Responsibility Commission.

Starts to industrially produce, at the end of April, the concentrated vaccine of the Haemophilus influenzae b vaccine.

In response to the World Health Organization demand, the Institute signs an agreement with Cuba to supply the meningococcal AC vaccine, with the aim of combating the risk of epidemics in African countries.

On October 1st inauguration of Bio-Manguinhos Viral Antigen Production Center, with the capacity to produce about 100 million doses of the MMR vaccine.

Between November 11 and 14, Bio-Manguinhos organizes the 8th Annual Meeting of the Network of Vaccine Producers in Developing Countries (DCVMN). The largest vaccine manufacturers from developing countries gathered.

On July 11, the Konosuke Fukai Technological Center is inaugurated in honor of the Japanese researcher of the same name, who contributed to the strengthening of technological training in the production of viral vaccines, such as those for measles and poliomyelitis in Bio-Manguinhos.

In August, Bio-Manguinhos and GlaxoSmithKline signed two agreements. The first for the introduction of the pneumococcal vaccine in the National Imunization Program; while the second aims to accelerate the research of new products, stimulating the exchange of scientific and technological experiences to develop dengue, yellow fever and malaria vaccines.

As part of the commemorative agenda of the 35th anniversary of its foundation, Bio-Manguinhos promotes the II International Symposium on Immunobiologicals.

In December, an agreement was signed with the company Sanofi Pasteur, which made it possible for the unit to supply and, later, produce the inactivated polio vaccine.

Five POCs were introduced with Dual Path Platform (DPP®) technology, ensuring faster and more accurate results: syphilis, canine visceral leishmaniasis, HIV-1/2 immunoblot, leptospirosis and HIV-1/2 screen.

As of the second semester, the Institute begins to supply the Measles, Mumps, Rubella and Varicella (MMRV), introduced in the basic vaccination schedule in the second semester of 2013.

Phase II of the clinical trial of meningococcal B vaccine was completed. Protection in children aged 4 to 11 years was evaluated with the three-dose schedule.

The HIV/HCV NAT kit, which detects the AIDS and hepatitis C virus in blood bags, was implemented in six more laboratories, totaling 13 of the 14 planned blood centers.

The construction of the two new Bio-Manguinhos campi, in Santa Cruz (RJ) and Eusébio (CE) is gaining ground. The executive project for the Health Biotechnology Industrial Complex is contracted.

Through a technology transfer with the Israeli company Protalix, Bio will produce the biopharmaceutical taliglucerase alfa, which fights Gaucher's disease. In addition, the Institute has signed 10 partnership intentions for productive development (PDP), in addition to an agreement with the Bill and Melinda Gates Foundation, for the first phase of clinical studies of the Measles and Rubella vaccine (MR).

The Heitor Beltão Coordinating Center for Clinical Research was inaugurated, where Bio will conduct its clinical research.

The unit receives a visit from the PAHO director, Carissa Etienne.

Renovation of the Lyophilization and Bacterial Technology labs at the Rockefeller Pavilion.

Bio-Manguinhos signs a partnership for the technology transfer of the biopharmaceutical infliximab with the companies Janssen and Bionovis.

The Institute was able to obtain registrations for the biopharmaceutical taliglucerase alfa and the DPP® Syphilis DUO rapid test.

The DPP® HIV-1/2 diagnostic test, which used to be performed using a drop of blood, serum or plasma, is now also performed using oral fluid.

The NAT/HIV/HCV kit incorporated a new target, HBV (hepatitis B virus).

The partnership between Bio and the Bill and Melinda Gates Foundation competed for the Vaccination Organization's Vaccination Industry Excellence Award, in the best partnership category.

Akira Homma is voted one of the most influential people in the vaccine industry, taking the 20th position.

Registration of three products: DPP® HIV/Syphilis rapid test, infliximab biopharmaceutical and Measles Mumps Rubella and Varicella vaccine (MMRV).

Signing of a technology transfer agreement for the biopharmaceutical beta interferon 1a, indicated in the treatment of multiple sclerosis, with Merck and Bionovis.

Start of the phase I clinical trial of the Measles and Rubella vaccine (MR).

Health Biotechnology Industrial Complex in Santa Cruz: start of planting 30 thousand tree seedlings. Preparation for the piling stage and beginning of the 2nd earthwork phase.

With the expansion of Final Processing Center, vaccine formulation capacity grew by 200%.

On May 4, Bio turned 40 and promoted the III International Symposium on Immunobiologicals.

The Henrique Penna Center - Prototypes, Biopharmaceuticals and Diagnostic Reagents was inaugurated on December 9th.

In December, Bio obtained the registration of the ZDC Kit, a test that detects the zika, dengue and chikungunya viruses.

Faced with the yellow fever outbreak in Angola and the Democratic Republic of Congo, Bio was contacted by WHO and exported 5,074,600 of the immunobiological product. The unit also sent 160,000 doses of the meningococcal ACW vaccine to African countries.

In February, the following were in Bio-Manguinhos: the director general of the World Health Organization (WHO), Margareth Chan and the director of the Pan American Health Organization (PAHO), Carissa Etienne, the director of the Department of Outbreaks and Emergencies from the WHO, Bruce Aylward, and the coordinator of the Brazilian National Imunization Program, Carla Domingues.

The Joaquim Venâncio Polytechnic School of Health (EPSJV/Fiocruz) offered 32 places free of charge for the mid-level technical course in Biotechnology as of 2017, in partnership with Bio and the Center for Technological Development in Health.

The last stage of the clinical study of the Measles Mumps and Rubella vaccine (MMR) was completed.

In May, the production of two batches of DPP® Quick Imunoblot started operations at the Henrique Penna Center, which opened in December 2016.

In June, there was the launch of the book "Innovation in public management - the construction of the Bio-Manguinhos company".

To support applied research, development and product innovation, Bio-Manguinhos launched the InovaBio Program. Twenty projects from different Fiocruz units were approved to receive funding.

The unit participated in two WHO events: the first, in Denmark, was the WHO-Unicef-Unfpa Meeting with Pharmaceutical and Diagnostics Manufacturers and Suppliers, and the second was the 14th Annual Meeting on Surveillance and Response to Meningitis Outbreaks, in Africa.

In view of the yellow fever outbreaks in 2017 and 2018 and the large number of doses demanded by the Ministry of Health, Bio presented the Dose-Response Study of the Yellow Fever Vaccine 17DD. The study started in 2009 with 900 volunteers and demonstrated that the yellow fever vaccine, administered with up to 1/10 of the standard dose, provides the same immunity as the full dose. Thus, the Ministry adopted the fractional dose (1/5 of the dose) to expand vaccination coverage. In 2018, 30 million doses of this vaccine were delivered to the National Imunization Program.

In November, the Lincoln de Freitas Filho Clinical Research Center and Biological Sample Processing Laboratory was inaugurated. The unit is the Institute's second clinical research center outside the Fiocruz campus.

A public consultation was carried out to present the built to suit project of the Health Biotechnology Industrial Complex, which will be in Santa Cruz. In addition to giving wide publicity to the bidding process, those interested in participating were able to clarify doubts and contribute to the improvement of the economic-financial, technical and legal modeling of the enterprise. Also in 2018, environmental compensation was made with the planting of 29,000 seedlings of Atlantic Forest species, in addition to the construction of blocks and straps.

In December, Bio-Manguinhos signed an agreement with the South Korean company Samsung Bioepis to absorb the technology for the production of the biopharmaceutical etanercept, which joins infliximab in the portfolio of drugs used in the treatment of rheumatoid arthritis.

Four diagnostic kits were registered with Anvisa in 2018: DPP® Dengue, DPP® Chikungunya, DPP® ZDC and ZDC Molecular.

Bio-Manguinhos hosts the 20th Annual General Meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN). The meeting was part of the commemorations of the 120th anniversary of the Oswaldo Cruz Foundation.

Bio-Manguinhos developed and evaluated, in partnership with Instituto Oswaldo Cruz (IOC/Fiocruz) and IBMP, a molecular diagnostic test for the new coronavirus. As a complementary action to surveillance actions, a molecular diagnostic test was also developed for Influenza A and B. Bio-Manguinhos also started the acquisition of a new rapid test modality, which provides the result in up to 20 minutes, for use at the point of care of suspected patients.

Registry of the Rapid Test for Chagas Disease, developed at the Institute.

Start of supply of Somatropina, in PDP with Cristália.

Agreement with AstraZeneca for the supply and transfer of COVID-19 vaccine technology under development by the University of Oxford.

Start of supply of Rituximab, in PDP with Sandoz and Bionovis.

Start of supply of Trastuzumab, in PDP with Samsung Bioepis and Bionovis.

Start of supply of Golimumab, in PDP with Janssen and Bionovis.

On January 23, Bio-Manguinhos delivers the first 2 million doses of the COVID-19 vaccine (recombinant) to the National Immunization Program (PNI).

Agreement with Chembio for the supply and incorporation of TR DPP® Covid19 - AG (antigen) technology.

Agreement with IBMP to supply the Yellow Fever Molecular Diagnostic Kit.

Agreement with Humasis for the supply and incorporation of TR Covid-19 - AG technology (antigen).

Agreement with GenBody to supply and incorporate technology from TR TR SARS-CoV-2 - Ag.

Launch of the project Retake of High Vaccination Coverages.

Bio-Manguinhos is selected as a hub by the World Health Organization for the technological development, production and transfer of vaccine technology with RNA technology for COVID-19.

In January, ANVISA defers Bio-Manguinhos as the production site of the bulk for the COVID-19 vaccine, representing the full incorporation of the technology and the self-sufficiency in the production of a 100% nationalized immunobiological.

Technology transfer of the COVID-19 vaccine (recombinant) is completed in February, with the availability of the first doses with national bulk to National Imunization Program.

Start of supply of Adalimumab, in PDP with Frenesius and Bionovis.

MR (measles & rubella) vaccine, developed by Bio-Manguinhos, take part in Institute's portfolio.