The company Zodiac Produtos Farmacêuticos submitted a request for registration with the National Health Surveillance Agency (Anvisa) of the vaccine against Covid-19 manufactured by the company Moderna.
The request includes Moderna’s messenger RNA vaccine authorized for use in several countries. In the United States and Europe, the administration of the immunizer in children from 6 months of age, adolescents and adults, under the trade name Spikevax, has been approved.
According to Anvisa, the request was filed on Friday (20th) and proceeds to analyze the relationship between the benefits and potential risks of the product. The review requires submission of clinical studies and other data to substantiate the quality, safety and efficacy of the product.
The analysis of vaccines by Anvisa is done jointly by three different areas:
- Biological Products, which evaluates aspects of quality, safety and efficacy
- Pharmacovigilance, responsible for monitoring and follow-up plans for the vaccine after it has been used in the country
- Inspection and Supervision, responsible for evaluating Good Manufacturing Practices
After the initial analysis, requests may be made for clarification or supplementation of information throughout the process.
If approved, the registration is the green light for the vaccine to be commercialized, distributed and used by the population, in accordance with the indication established in its leaflet.
Source: CNN Brasil
I am an experienced journalist and writer with a career in the news industry. My focus is on covering Top News stories for World Stock Market, where I provide comprehensive analysis and commentary on markets around the world. I have expertise in writing both long-form articles and shorter pieces that deliver timely, relevant updates to readers.
