Published on February 27, 2022 07:43
Pharmaceutical companies interested in producing the pentavalent vaccine have until April 7 to submit a proposal, according to public call 03/2021, from the Paraná Institute of Technology (Tecpar). Vaccination given to babies protects against diphtheria, tetanus, whooping cough, hepatitis B and pneumonia/meningitis.
Companies can intervene in three phases: sanitary registration of the product on behalf of Tecpar, supply of the product by the partner during the technology transfer stages and transfer of technical information for the manufacture of the product.
Currently, only six companies worldwide have pre-qualification with the World Health Organization (WHO), a process that guarantees the quality, safety and efficacy of the input for the production of pentavalent .
However, of the six companies prequalified at WHO, five are from countries with unregulated health markets and therefore are not registered with a regulatory body equivalent to the National Agency. health surveillance (Anvisa). The Tecpar public appeal process aims to fill this regulatory void in the country, in addition to contributing to the autonomy of the Brazilian healthcare industrial park.
Tecpar’s planning for the production of vaccines, including pentavalent, includes the project, filed with the Ministry of Health, for the development of a multi-vaccine factory to meet the National Vaccination Program (PNI). Implementation can be made possible by the Ministry of Health, as a way to expand public vaccine providers in the country and give more autonomy in supply.
The pentavalent vaccine is the combination of five individual vaccines into one. The aim is to protect people against several diseases at the same time. The vaccine was introduced in the basic schedule in Brazil from September 2012, following the recommendations of the World Health Organization (WHO) to increase vaccination coverage by combining vaccines in the same application.
Children should be vaccinated at 2, 4 and 6 months. From the age of 1, the PNI recommends that they do booster shots with the tetravalent vaccine.