Ministry of Health announces the first part of the vaccination plan against COVID-19

If you are also looking forward to the arrival of the COVID-19 vaccine, you can be cautiously optimistic: institutions and private companies around the world are joining forces to develop an immunizer that can help us in this pandemic. And in the middle of that, last Thursday (19), the Ministry of Health released the first part of the Vaccine Operationalization Plan against COVID-19. The campaign to publicize the process of production and approval of immunizations, as well as the country’s capacity to distribute supplies, is scheduled to launch between December 2020 and January 2021.

The first part of the plan indicates ten priority axes with the aim of guiding the vaccination campaign of Brazilians, in order to reduce morbidity and mortality from the disease and reduce the transmission of the virus between people. According to the announcement of the Ministry of Health, the objective is to immunize, as soon as a safe vaccine is available, the groups with the highest risk of developing complications and deaths from the disease and the populations most exposed to the virus.

According to the Secretary of Health Surveillance, Arnaldo Medeiros, the target audience will be detailed only after the completion of phase 3 studies of the tested immunizers. “Only then can we evaluate which groups (the vaccine) were most effective,” he said during a news conference. The document was prepared by the Technical Advisory Chamber for Immunizations and Communicable Diseases, in alliance with institutions that assisted in the definition of risk groups, vaccination strategy and updating of studies on the disease.

The National Health Surveillance Agency (Anvisa), the National Institute for Health Control and Quality (INCQS), Fiocruz, the Butantan Institute, the Technological Institute of Paraná (Tecpar), medical societies, federal health councils, Doctors Without Borders and members of the National Councils of State and Municipal Health Secretariats (Conass and Conasems) are part of this, side by side with the Ministry of Health.

Arnaldo Medeiros stressed that the strategy is to give transparency to the campaign development process, so that the population feels safe in the process. “This ministry has a serious commitment to the Brazilian population to vaccinate only when we are sure that we are dealing with a registered vaccine with guaranteed effectiveness,” said the secretary during the press conference.

The announcement of the Ministry of Health indicates ten priority axes: epidemiological situation; update of study vaccines; monitoring and budget; operationalization of the campaign; pharmacovigilance; post-marketing follow-up studies; Information system; surveillance; monitoring and evaluation; communication and campaign closure. Check the details of each one:

Axis 1 – Epidemiological situation

The objective behind this first axis is the identification of groups with a higher risk of disease, aggravation and death from COVID-19. Priority groups include the elderly and people with comorbidities (Diabetes, SAH, Heart / Cerebrovascular Disease, COPD, Kidney, Obesity, Cancer, Transplantation, and Sickle Cell Anemia).

The axis in question also assesses the storage conditions and the duration of the vaccine and safety data. Regarding the storage of immunizers, the specifications will be guided by the supplying laboratory. The entire cold chain in Brazil has equipment for the storage of vaccines at -20 ° C, with the exception of the local instance, which are the vaccine rooms and where the storage is carried out in the control range of + 2 ° C to +8. ° C. Currently, the standard vaccine in the world follows the guidelines for storage between + 2 ° C and + 8 ° C.

Axis 2 – Update of the vaccines under study

There are more than 400 projects in development. Of these, half are registered by the World Health Organization (WHO). In total, 154 are in the preclinical research stage and there are 44 projects in clinical studies, of which 10 are in phase 3. With this in mind, the idea of ​​the second step is basically to monitor the platforms under study, the big picture of vaccines in development and the description of Brazilian vaccines.

Axis 3 – Monitoring and budget

The Ministry of Health announced that the third axis involved in this plan fits into the evaluation of the vaccine itself, that is, whether it will enter as a routine or annual campaign, and what the costs of this operation are.

Axis 4 – Operationalization of the campaign

For its part, axis number 4 consists, ultimately, of the vaccination strategy, distribution of doses by federated unit, target audience, goal, phases and priorities.

Axis 5 – Pharmacovigilance

Axis 5 has this difficult name, which means the monitoring of adverse events after vaccination in the period after the vaccine license (mass administration of the vaccine).

Axis 6 – Monitoring and post-marketing studies

According to the announcement of the Ministry of Health, the sixth axis includes a follow-up that will take into account effectiveness and safety studies such as the inadvertent vaccination of pregnant women, for example.

Axis 7 – Information system

The seventh axis is based on the fact that vaccines must be traceable. Through systems such as DataSUS, the idea will be to obtain the nominal population registry to evaluate vaccination coverage and follow-up of adverse events after vaccination.

Axis 8 – Monitoring, supervision and evaluation

The eighth axis consists of defining indicators to evaluate the vaccination strategy from its execution to the results.

Axis 9 – Communication

At this stage, the communication plan for the vaccination campaign will be defined, with information on the production process and approval of the vaccine, information on vaccination, priority audiences, doses, etc.

Axis 10 – End of the campaign

Finally, it is on this axis where the results of the campaign will be evaluated.

Source: Ministry of Health.