Brazil proposed procedures related to the commercialization and utilization of influenza vaccines in 2019

Brazilian Health Regulatory Agency (Anvisa) proposed Resolution-RE, 4 October 2018, regarding procedures related to the commercialization and usage of influenza vaccines in 2019.

This Resolution establishes that the trivalent influenza vaccines used in Brazil from February 2019 on must contain, necessarily, a combination of three types of virus strains, and must be in accordance with the specifications below:

- one virus similar to influenza virus A/Michigan/45/2015 (H1N1) pdm09;

- one virus similar to influenza virus A/Switzerland/8060/2017 (H3N2);

- one virus similar to influenza virus B/Colorado/06/2017 (strain B/Victoria/2/87).

It is recommended that the component A (H3N2) of non-based on eggs vaccines for usage on influenza period of 2019 be one type of A/Singapore/INFIMH-16- 0019/2016 virus in addition to the others vaccines components described above.

This Resolution also establishes that the tetravalent influenza vaccines containing two types of virus strains influenza B must contain one virus similar to influenza B/Phuket/3073/2013 (strain B/Yamagata/16/88), additionally to the three strains types specified above.

Products covered: Vaccines

HS code: 300220

Proposed date of adoption: NA

Proposed date of entry into force: NA

Final date for comments: NA

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