A vaccine is difficult this year
24
Aug
There are three phases for a vaccine to be released, in Brazil the 
body responsible for evaluating and approving requests for conducting clinical research for the purpose of registration and requests for registration of immunobiological products developed in the pharmaceutical industry is made by Anvisa (Agência Nacional de Health Surveillance), there are ethics committees that monitor the stages of the studies, the Research Ethics Committees (CEPs) and / or the National Research Ethics Commission (CONEP), so there are criteria and care.
In phase 1, small groups of volunteers are selected, normally healthy adults, are evaluated to verify the safety and determine the type of immune response caused by the vaccine, in phase 2, a greater number of individuals are included and the product is administered to individuals representative of the population with lower immunological protections (children, adolescents, the elderly and people with compromised immunology), already in the third phase it is necessary to apply to a large number of individuals and ensure the minimum possible adverse reactions and contraindications, in this stage the number of volunteers must be large.
The company will only request the registration of products with studies in phase 3 in progress, so the data from steps 1 and 2 must be consolidated and their efficiency demonstrated with high therapeutic and / or preventive efficiency, and there is no alternative therapy comparable to that stage of disease, here comes the play of economic interests that can be taken to the political field and even to dispute markets, however it is to be expected that in the case of Covid-19 there is some ethics in this process.
There are 26 vaccines in an advanced stage, but the four vaccines with potential use in Brazil are based on four different techniques: the viral vector is the technique of Oxford and AstraZeneca, which has the collaboration of FioCruz Brazilian Lab, the one from the Chinese laboratory Sinovac has participation from the Butantan Institute USP-Brazilian, BioNTech – Wytech / Pfizer has private laboratories in Brazil and announced that it could be ready in October, and Janssen Pharmaceuticals (Johnson & Johnson) adopts the adenovirus vector technique (see techniques and collaborations in the figure).
Sinovac with the virus inactivated technique may be ready for next year, Janssen has not made big announcements yet, but it is known that it will go to the third phase, and the most promising one is that of Oxford is in phase 3, but it should not be available until at best in December.
According to Anvisa, the deadline for the manifestation on the vaccine is up to 60 days, although Anvisa has accelerated the ordering process for medicines and vaccines in the case of Covid-19, it instituted a Committee for the Evaluation of Clinical Studies, Registration and Post-registration of Medicines, which includes vaccines.
Thus, even if the request is sent in October, the probable approval is for December, until production begins and the health agencies must make it available, they should be ready to start the vaccination in mid-January, before this care, prevention and maintaining hopes.
Meanwhile, in Brazil, we are paralyzed at a level of a thousand daily deaths.
