On February 9, the Collegiate Board Resolution (RDC) No. 465, which dispenses with the registration and authorization for emergency use and also establishes the procedures for importing and monitoring Covid-19 vaccines acquired by the Ministry of Health, within the scope of the Covid-19 Global Vaccine Access Instrument (Covax Facility), came into force.
The Covax Facility initiative is a global alliance led by the World Health Organization (WHO), which aims to accelerate the development and manufacture of Covid-19 vaccines. Through global resource allocation, countries adhering to the initiative have equal access to immunization.
Brazil joined the program in September 2020, becoming one of the more than 150 countries that are part of the initiative.
In this sense, in addition to the portfolio of vaccines under development that Brazil will have access to, RDC No. 465 has numerous procedures that will certainly speed up the use of vaccines under the Covax Facility program.
The exemption from registration and emergency use authorization was possible due to the equivalence of the regulatory assessment, since the international consortium has the participation of specialists, including Anvisa, who are responsible for the analysis of the studies required for approval.
It is important to note that, according to the text, imported Covid-19 vaccines should be destined exclusively to the National Immunization Program (PNI). It is the responsibility of the Ministry of Health to inform Anvisa about the import of the immunizers, describing the country of origin, the vaccine identification and the intended schedule for the import. The agency must also petition the import process with Anvisa in advance.
In addition, the Ministry of Health will be in charge of checking the conditions of the transport chain, expiration date, maintaining the quality of imported vaccines and storage, as well as post-distribution and post-use monitoring.
In this sense, the agency assumes an important role from import to distribution.
Anvisa must monitor technical complaints and adverse events associated with imported vaccines under the terms of the new Resolution, adopt the appropriate control, monitoring and health inspection actions, and carry out the operational procedures that allow customs clearance within 48 hours.
Anvisa is also authorized to suspend the import, distribution and use of vaccines, in addition to the application of other necessary measures, based on information from control and monitoring.
Imported Covid-19 vaccines must have quality, safety and efficacy guaranteed and proven upon approval by Covax Facility, through the WHO Emergency Use Listing Procedure / Prequalification.
It is important to note that vaccine batches can only be used after being released by the National Institute for Quality Control in Health (INCQS), ensuring the safety of these immunizers for use in the population.
Exemption from registration and authorization for emergency use of vaccines purchased via the Covax Facility will automatically cease as of the end of the Public Health Emergency situation of national importance.