Anvisa defines the requirements to order the emergency use of the Covid-19 vaccine | Vaccine

• Second to regulatory, each case will be analyzed independently. The decision will be made by the Collegiate Board;
• Will be considered clinical and non-clinical studies (in humans);
• the quality, good manufacturing practices, monitoring and control strategies, interim clinical trial results, among other scientific evidence;
• The interested company must present information that proves that the manufacture and stability of the product guarantee the quality of the vaccine;
• It is also necessary that the vaccine be accompanied by a Dossier for Clinical Drug Development (DDCM) approved by the agency;
• The clinical study in phase 3, the last stage of the trial, must be ongoing and carried out in Brazil.

The agency makes the reservation that the The emergency use of a product will be released only to the public previously defined and tested in the studies. In addition, he says that the authorization will not replace the sanitary registration in Brazil, which will be necessary to expand the product to the entire population.

Until now, Anvisa did not have the “emergency use” modality for vaccination. The criteria had to be established due to the urgency of the pandemic.

4 vaccines in final tests

Four vaccines are in phase 3 of human trials in Brazil and, if they meet the other criteria, they can request emergency use. They are:

1. AstraZeneca + University of Oxford: 70% efficacy, with a range of 62% to 90% depending on the applied dose.
2. CoronaVac: still without the effectiveness rate disclosed.
3. Pfizer + BioNTech: 95% effective and more than 94% effective in elderly people over 65 years of age, according to preliminary data from phase 3.
4. Janssen: still without the effectiveness rate disclosed.

All of these immunizers are intended for people over 18 years of age, except Pfizer, which can be applied to patients 16 years and older. Responsible pharmacists have already requested continuous presentation with Anvisa: process used by the regulator to gradually receive documents and ensure faster approval.

According to Carla Domingues, former coordinator of the National Immunization Program (PNI) of the Ministry of Health, “children and adolescents will not be vaccinated in the short term because no clinical studies have been carried out in these groups.”

“There have been no clinical studies in this population. We will have to wait for the studies to continue. Although this is not the population most at risk, this is the least affected population. This is the policy of the Ministry of Health and the whole world, “he said.

The Ministry of Health announced on Tuesday (1) the first points of the “preliminary” strategy for the vaccination of the population. According to the portfolio, the plan will be divided into four stages.