Anvisa relaxes rules to expand access to Covid-19 vaccines
Understand the changes to Guide no. 42/2020 and the supply process for vaccines purchased through the Covax Facility international consortium
The Brazilian Health Regulatory Agency (Anvisa) has adopted two new measures that make the process of acquisition, regularization and availability of vaccines more flexible during the pandemic to expand the access to Covid-19 vaccines for the Brazilian population. The initiatives were disclosed in the midst of controversial changes promoted by the Brazilian National Congress to Provisional Measure No. 1.003/2020, now pending presidential approval.
According to the approved version of the text, Anvisa must grant the emergency use authorizations for the importation, distribution and use of any Covid-19 vaccine that has been temporarily or definitively approved by one of the following authorities within five days:
- Food and Drug Administration (FDA), United States;
- European Medicines Agency (EMA), European Union;
- Pharmaceuticals and Medical Devices Agency (PMDA), Japan;
- National Medical Products Administration (NMPA), China;
- Health Canada (HC), Canada;
- The Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom;
- Korea Disease Control and Prevention Agency (KDCA), South Korea;
- Russian Ministry of Health;
- Administración Nacional De Medicamentos, Alimentos Y Tecnología Médica (ANMAT), Argentina.
Requirements for emergency use and vaccine importation
The first measure refers to the changes promoted in Guide No. 42/2020, which establishes the minimum requirements for submitting the Emergency Use Authorization (EUA), on an experimental basis, of vaccines against Covid-19.
In addition, Anvisa also approved specific rules and procedures for importing and monitoring vaccines purchased by the Ministry of Health under the Covax Facility initiative, an international alliance led by the World Health Organization (WHO), Gavi Alliance and the Coalition for Epidemic Preparedness Innovations (CEPI) to accelerate the development, manufacturing and distribution of Covid-19 vaccines in a fair and equitable manner in various countries around the world.
Check below the main aspects of each initiative.
Cutting red tape of the Emergency Use Authorization submission process
On February 3, 2021, Anvisa published the third version of Guide 42/2020 — which determines the minimum requirements for EUAs — to promote relevant changes in the conditioning criteria for submitting applications by the respective developers.
According to the new Guide, the vaccine under the EUA application should preferably have a Clinical Drug Development Dossier (DDCM) approved by Anvisa and a phase three clinical trial underway in Brazil. If not, the company may still submit the application, provided the following requirements are met:
- Submission of the sponsor’s strategy for conducting clinical trials, to demonstrate the intention to follow the participants for the assessment of efficacy and safety of the pivotal trial participants for at least 1 year, as well as for the assessment of respiratory disease exacerbation (RDE);
- Unrestricted access to Anvisa of the raw clinical trial data;
- Demonstration that the pre-clinical and clinical studies were conducted in accordance with national and international guidelines recognized by Anvisa (e.g. International Council on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH);
- Demonstration that clinical data obtained in other countries applies to the Brazilian population;
- Commitment that the sponsor will conclude the development of the vaccine in all aspects and submit the results to Anvisa in order to apply for definitive registration of the product.
According to the new version of the Guide, EUA applications based on phase three clinical trials which are authorized and ongoing in Brazil will be reviewed within ten days. If there are no phase three clinical studies in Brazil, the review period will be up to 30 days.
Acquisition and importation of Covid-19 vaccines under the Covax Facility
On February 09, 2021, the Anvisa Board of Directors (Dicol) approved ANVISA Resolution RDC No. 465/2021, which establishes a specific regime for the importation and monitoring of the availability of Covid-19 vaccines that are purchased by the Ministry of Health under the Covax Facility initiative.
The new rule waives the need for registration or EUA for imported vaccines in this context, based on the provisions of Law No. 9,782/1999, which expressly provides for the possibility for Anvisa to waive the registration of immunobiological, drugs, and other strategic inputs when purchased through international multilateral organizations (such as WHO), for use in public health programs by the Ministry of Health and its linked entities.
Criteria for evaluation of imported vaccines
According to ANVISA RDC No. 465/2021, Covid-19 vaccines that are imported under this regime must meet the following requirements, subject to the determination for recall of the products by ANVISA in case of non compliance:
- The vaccines must have proven quality, safety and efficacy and be approved through the Emergency Use Listing Procedure/Prequalification process conducted by the WHO;
- Anvisa must participate in the approval of Covid-19 vaccines under the Covax Facility;
- The vaccines must be intended exclusively for the Brazilian National Immunization Program (PNI);
- Batch release for use is conditional on approval by the National Institute for Quality Control in Health (INCQS).
The import request must be submitted by the Ministry of Health and will be analyzed by Anvisa within 48 hours for subsequent approval of the vaccine import license by SISCOMEX. The Ministry of Health will also be responsible for:
- Ensuring and monitoring the conditions of the transportation chain and the expiration date of the vaccines, as well as establishing mechanisms to ensure general conditions and maintenance of quality and adequate storage;
- Ensuring the monitoring of the conservation and transportation temperature of the vaccines during the international transit (from the moment of shipment until the arrival at the importer’s storage place), and notifying Anvisa immediately in case of temperature excursion that may compromise the quality of the product;
- Providing guidance to health services on the use and conservation care of imported vaccines, as well as to patients on how to report technical complaints and adverse events;
- Creating mechanisms to perform post-distribution and post-use monitoring of the vaccines and ensuring that the cases of technical complaints and adverse events identified are reported to Anvisa through the VigiMed or e-SUS Notifica systems;
- Collecting the imported vaccine when determined by Anvisa.
ANVISA RDC No. 465/2021 will be automatically revoked when the Ministry of Health declares the end of the Public Health Emergency of National Importance.
For more information on Covid-19 regulations, please contact Mattos Filho’s Life Sciences and Healthcare specialists.