Fiocruz and Sanofi sign memorandum for new collaborations in immunization

The Institute of Technology on Immunobiologicals (Bio-Manguinhos/Fiocruz) and the pharmaceutical company Sanofi signed a Memorandum of Understanding last Wednesday (3/27) that reaffirms their mutual interest in establishing further collaborations in the field of immunization. In January this year, the institutions signed a technology transfer agreement for the domestic production of the acellular hexavalent vaccine. The immunizer offers protection against six diseases that can become serious: diphtheria, tetanus, pertussis, diseases caused by the Haemophilus influenzae type b bacterium, hepatitis B and polio.

Memorandum of Understanding reaffirms mutual interest in establishing more collaborations in favor of immunization (photo: Disclosure)

"The partnership with Sanofi reiterates Fiocruz's historic commitment to universal access to vaccination, to strengthening the National Immunization Program [PNI] and to expanding access to health, promoting a better quality of life for the population. This is another step in the partnership signed aimed at the hexavalent vaccine, now also with a view to innovating cooperation models. These are solid steps towards strengthening our role as a major producer of health supplies for the SUS, for the Brazilian population," says Fiocruz's president Mario Moreira.

The agreement offers a domestic solution for the production and supply of the PNI with the hexavalent vaccine, integrating the capabilities of Sanofi, which already has expertise in the immunizer. With the agreement, Bio-Manguinhos/Fiocruz will now produce and supply the PNI with the acellular hexavalent vaccine.

Head of Commercial Operations for the International Vaccines Region at Sanofi, Stephen Alix highlighted the importance of the technology transfer and the signing of the memorandum. "We are committed to protecting children all over the world and have been present in Brazil for over 100 years. We are very proud of this new collaboration project and partnership, which will bring a positive impact on Brazilian public health and the country's technological development. I am also looking forward to developing new collaborations that will benefit the Brazilian population," he said.

Director of Bio-Manguinhos/Fiocruz, Mauricio Zuma emphasizes the Institute's commitment to producing immunobiologicals that increase the population's access to strategic products aimed at preventing diseases. "This process will bring domestic production of the immunizer to Brazil and contribute to the development of the Health Economic-Industrial Complex, an initiative that encompasses a series of structuring programs aimed at expanding domestic production of inputs, medicines and other health products."

Currently, the hexavalent vaccine is available in the Unified Health System (SUS), through the Reference Centers for Special Immunobiologicals (CRIEs), for babies born with a gestational age of less than 33 weeks or birth weight lower than 1.5kg, with a recommended vaccination schedule at 2, 4 and 6 months and a booster dose between 15 and 18 months. Combination vaccines are an important pillar for advancing vaccination coverage, as they enable simplifying the vaccination schedule with fewer applications and, consequently, help to increase vaccination coverage rates against infectious diseases. They also represent gains in the cold chain and logistics, optimizing the work of health professionals at the front line and providing greater savings for the SUS. As it is a completely liquid, ready-to-use vaccine presented in a filled syringe, the risks of manipulation and dosage errors are less likely than when reconstitution is required.

The acellular hexavalent vaccine is even more important for premature babies, who already undergo an intense health care routine. The immunizer technology has the acellular Pertussis component, which uses specific and purified antigens of the pertussis bacterium and not the whole bacterium, like cell vaccines, ensuring greater reproducibility of the batches produced and higher quality, significantly reducing the occurrence of adverse events. 1 Hexavalent acellular vaccine technology is better tolerated than combined vaccines based on whole cells 6.

History of partnerships between Sanofi and Bio-Manguinhos/Fiocruz

Sanofi and Bio-Manguinhos/Fiocruz have a partnership underway for the transfer of technology for the Inactivated Poliomyelitis Vaccine (IPV), which has been available on the SUS since August 2012. Polio is a serious infectious disease that has caused epidemics all over the world.

In Brazil, the National Poliomyelitis Control Plan, created in 1971, and the actions taken contributed to the elimination of the disease in the country, the last case of which occurring in 1989.