Overview:
On Friday, January 8th , two requests for vaccines were submitted to Anivsa from the Butantan Institute (CoronaVac vaccine) and Fiocruz (Oxford vaccine). This Blog will focus on how Brazil’s Health Authority, Anvisa, analyzes requests for vaccine submissions.
ANVISA’S ANALYSIS
Anvisa has already started the analysis of two requests for emergency use of vaccines for Covid-19. The requests were presented on Friday (January 8th) by Instituto Butantan, for the CoronaVac vaccine, and by Fiocruz, for the Oxford vaccine.
Anvisa’s goal is to analyze the emergency use within 10 days, discounting any period that the process is in a status of demand, known as company/institution time.
In the evaluation, the Agency will analyze:
“The data presented, the target population, product characteristics, results of pre-clinical and clinical studies and all available scientific evidence relevant to the vaccines, i.e. whether the provisional results of one or more clinical trials met the efficacy and safety criteria for the intended use, the benefits of the vaccine must clearly and convincingly outweigh its risks”, as well as the commitment of laboratories to “continuously evaluate its benefits and risks in maintaining the use of the vaccine under the condition of a temporary and emergency authorization” and to have “an adequate plan for the collection of safety data among individuals vaccinated under that authorization”.
At Anvisa, the analysis is made by a multidisciplinary team (biologist, biomedical, statistician, pharmacist and physician), career-serving specialists, who work in the areas of registration, monitoring and inspection.
- For this analysis, the Agency will use all the information already available, which includes data that have already been submitted in continuous submission, information from other authorities and the results of inspections made by Anvisa.
- Each one of the areas involved in the analysis will produce a technical opinion on the aspects of quality, safety, efficacy, risk minimization plan, monitoring and compliance with good manufacturing practices and control of the vaccine for Covid-19.
- The authorization of emergency use of the vaccine at the clinical/experimental development stage is considered a regulatory strategy to allow, at this time, that two vaccines, if approved, can be made available for the prevention of Covid-19.
- The decision on the emergency use will occur through Anvisa’s scientific and transparent review process and decided by the Agency’s Board of Directors with the subsidies of the technical opinions.
- Anvisa will disseminate the results of the decisions, through a public report with the opinions of the analyses of each vaccine, containing information of the technical and scientific aspects evaluated by the Agency.
- The public report will be available on Anvisa’s website after the results of the analysis are released.
- The indications of use and efficacy will be part of the vaccine package leaflet.
- The analysis of each application takes place independently.
UNDERSTAND THE WHOLE PROCESS:
What is emergency use?
It is an application made before the final registration to apply the vaccine in a specific population group. It needs to be sent to Anvisa by the manufacturer or importer of the vaccine that is conducting the research in the Brazilian territory. It can be requested with phase 3 of the clinical research in progress.
Emergency use is defined by resolution RDC 444/2020.
What is evaluated in emergency use?
The evaluation of emergency use involves aspects such as:
- Efficacy and safety data already available from clinical studies, i.e. with human beings, including provisional results.
- Quality, stability and storage data.
- Projects for monitoring adverse reactions.
- Evaluations of Good Manufacturing Practices focused on the production line where the drug comes from.
- Authorizations and licensing of imports.
What is continuous submission?
It is the advance presentation of data and information already consolidated by the laboratories, at the same time that other stages of the study are still under development.
The objective of this process is to allow the anticipated evaluation of the companies’ data and to give agility to Anvisa from the moment that the laboratories formalize their requests.
The continuous submission was instituted by the Normative Instruction 77/2020.
More Resources:
Fast-Track Registration of COVID-19 Vaccines in Brazil
On 03/18/2020, Anvisa published a new regulation (RDC 348/2020), that defines the conditions of the priority review for the registration of covid-19 Vaccines .
About Global Regulatory Partners
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.