12/29/2020
On December 10, the Brazil’s national sanitary regulator Anvisa approved a resolution which allows laboratories to request the authorization for experimental, emergency use of vaccines against COVID-19.
The decision formalizes the announcement made on December 2, being the regulatory instrument that must be observed by the companies that develop the vaccines together with the mentioned Guide.
The agency explains that the request for emergency and temporary must be is limited to a public previously specified and submitted by the company developing the vaccine against COVID-19.
The conditions for approval will be defined taking into account opinions and technical data presented to Anvisa. The maximum period is up to 10 days for analysis of the authorization request, since the companies have already submitted data to the Agency and have phase III clinical trials underway in Brazil.
According to Anvisa, for the vaccination of Brazilians, the following issues should be evaluated:
- Is this vaccine the same as that evaluated in clinical studies, which demonstrated efficacy and safety? Is it the same place and method of manufacture, formulation, packaging material, quality of inputs and other characteristics that can interfere with its performance?
- What is the proposed target population to be vaccinated in Brazil? Is it the same profile as abroad? The evaluation must be carried out considering the Brazilian reality.
- As vaccines are still being studied, adverse reactions in volunteers who will be vaccinated must be monitored closely. What are the monitoring strategies in Brazil? How will the company ensure that all reactions will be properly collected, treated and notified to Anvisa?
It is worth clarifying that the temporary authorization for emergency use is valid only as long as the state of emergency of public health is declared, and can be modified, suspended or revoked by Anvisa at any time.
After the period granted for emergency use, the product will be required to be registered, under penalty of apprehension determined by Anvisa.
Companies holding emergency use authorization, on a temporary basis, must commit to conclude the development of the vaccine, present and discuss the results with Anvisa and request their health registration, provided that the current regulatory requirements are met.
Finally, in the event of serious adverse events related to the vaccine for emergency use, these must be reported to Anvisa within 24 hours of their occurrence. They are good pharmacovigilance practices, in order to guarantee the authenticity of the data collected for the assessment, at each moment, of the associated risks.
Coauthors: Raissa Pinati do Nascimento and Sueli de Freitas Verissimo Vieira
