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After at least three requests for clarification from the STF (Supreme Federal Court) amid the advancement of a action of the vaccine against covid-19, the federal government released on Wednesday (12/16) a national vaccination plan as part of the fight against the pandemic.
The first version had been sent to the Supreme Court on Saturday, but in the face of legal loopholes, the Court asked the Ministry of Health to better explain its planning.
When launching the plan, the Minister of Health, General Eduardo Pazuello, questioned the expectations of the population regarding vaccination. “What is the meaning of this anxiety, this anguish?” He said.
“The Brazilian people are capable of having the largest single health system in the world, of having the largest national immunization program in the world, we are the largest vaccine manufacturers in Latin America,” he said.
To date, the coronavirus has caused more than 182,000 deaths in the country and has infected more than 6.9 million people.
Understand how, according to the government, the national vaccination campaign against covid-19.
What vaccine will be used?
There are several candidate vaccines in phase 3 testing, but the government has not specified which vaccine will be used because it has not yet closed a final contract with any specific pharmaceutical company.
But negotiations are already underway that, according to the government, add up to around 350 million doses.
Among the negotiations is the Oxford / AstraZeneca vaccine, produced in Brazil by Fiocruz. There is an order for 100.4 million doses of this vaccine for July 2021 and a domestic production order for 110 million additional doses for December 2021.
There is also an order for vaccines (42.5 million doses) from the international Covax consortium, no date yet. The vaccine from this source can be from any of the several pharmaceutical companies that are part of the consortium.
In addition, the government has spoken with several other pharmaceutical companies: Pfizer / BioNTech, Janssen, the Butantan / Sinovac Institute, Bharat Biotech, Moderna, Russia’s Gamaleya, and Moderna.
The Health Ministry says that information on prices, estimates and schedules for the supply of doses and scientific data from studies with these vaccines was requested.
Any of the vaccines mentioned, or even more than one of them, can be chosen for the national immunization program against coronavirus.
Despite the government’s previous reluctance with Coronavac, produced by the Butantan Institute in association with the Chinese company Sinovac, the vaccine is mentioned in the document.
Minister Pazuello said that all vaccines will have the same treatment, that is, all will be considered without prejudice to any of them.
“All the vaccines produced in Brazil, whether by Butantan or Fiocruz, by any industry, will have priority for SUS. This is pacified, discussed, treated very well and monitored,” he said.
When will the vaccination start?
The government has not set a date for the start of vaccination: it said it should start after the approval of one or more vaccines by Anvisa (National Health Surveillance Agency).
But there is still no date for the approval of the vaccination registry in Anvisa; in fact, no application for registration has been filed with Anvisa.
As the São Paulo government indicated that the vaccination should start on January 25, the expectation is that the Butantan Institute will send the Coronavac registration application (to be used in the state) soon.
The government also says it expects priority groups to be vaccinated by the end of the first half of 2021. For this to happen, according to project estimates, vaccination would have to start in February.
How long until everyone is vaccinated?
Once the vaccination has started, the government expects the vaccination to be completed in 16 months.
Of that time, the first four months will be used to immunize all priority groups and the other 12 months will be used to vaccinate the general population. In other words, the vaccination campaign should last until at least the first quarter of 2022.
The Ministry of Health estimates that, to stop the circulation of the virus, around 60% to 70% of the population needs to be immune.
Therefore, it would be necessary to vaccinate 70% or more of the population (depending on the efficacy of the vaccine in preventing transmissibility) to eliminate the disease, ”says the vaccination plan.
As the vaccine is not widely available at first, “the main goal of vaccination is to focus on reducing morbidity and mortality from covid-19,” which should happen with vaccination of priority groups, says the government.
When will I get the vaccine?
Since there are no stipulated dates, what you can tell is who are the groups that will receive the vaccine first from the moment the vaccination begins.
The first to be vaccinated will be healthcare workers: healthcare professionals, such as doctors, nurses, nursing technicians and also support professionals, such as hospital cooks and cleaning staff, ambulance drivers, caregivers, etc.
Indigenous peoples living on demarcated lands, institutionalized people aged 60 and over, and people aged 75 and over should also receive the vaccine in this first phase.
The next to be immunized, in a second phase, will be the elderly between 60 and 74 years.
Phase three will be aimed at people with comorbidities, that is, with diseases that can worsen the person’s health situation in case of contamination with Sars-Cov-2, the virus that causes covid-19.
Priority morbidities are considered: diabetes mellitus, severe arterial hypertension, chronic obstructive pulmonary disease, kidney disease, cardiovascular and cerebrovascular diseases, solid organ transplants, sickle cell anemia, cancer, grade III obesity. During this phase, people with severe permanent disabilities will also be vaccinated.
The fourth phase will focus on the immunization of education workers, the homeless, members of the security and rescue forces, public transport workers and road freight carriers and prison staff and the prison population. .
These four phases correspond to the first four months of vaccination.
“For the initial stages of vaccination, according to the delivery schedule and availability of doses known to date, it is estimated that the groups with the highest risk of exacerbation and greater exposure to the virus would be vaccinated in the first half of 2021,” he says. The document.
The choice of the vaccine can change this situation, however, “depending on the indications for the vaccine after approval from Anvisa. [Agência de Vigilância Sanitária], as well as possible contraindications ”, says the government in the project.
If you are not in any of these priority groups, you should receive the vaccine after the first four months of vaccination; that is, you may be vaccinated shortly after or have to wait almost a year.
How will the vaccination work?
Vaccination will follow the same pattern as the existing immunization program, that is, free of charge and with application of doses in municipal and state health units.
Most of the vaccines being considered require two doses, which means everyone will have to come back for a second dose a few weeks after the first.
“The vaccination period for each dose of the vaccine in each phase is approximately thirty days, considering the interval of about 4 weeks between doses (interval that is variable for each vaccine)”, says the document.
At the government level, however, there is a requirement that currently does not exist in any type of immunization offered in the country: that people sign a consent form before receiving the vaccine.
“When patients are vaccinated with vaccines approved for emergency use, they must complete a free and informed consent form, which must be complemented with the specific data of the vaccine subject to authorization for emergency use,” says the program of government.
What will distribution logistics be like?
The government plan says that the Health Ministry is planning distribution logistics in conjunction with state immunization programs.
After their release from the ministry, the lots will be distributed to the States and the Federal District by air or land, reaching the States within 5 days. There are no details in the plan on who will do it or what the layout will look like.
Thereafter, the responsibility for distributing the vaccine to municipalities rests with the states, the government says.
What can go wrong?
The government itself admits in the document that the terms depend on “the amount of immunobiological available for use”, that is, on the amount of vaccine that the government receives.
Several concerns have already been raised in this regard. Brazil did not negotiate the vaccine with Pfizer (the first to be available, which is already distributed in the UK) at the beginning, for example, and will now have to enter the bottom of the line.
Other inputs and tools may also be missing. From simple things such as syringe, cotton, thermal box, plastic bag, disposable glove to more complex ones, such as refrigerator, freezer, computer systems and logistics for distribution and batch transport.
The challenge of a campaign like this in Brazil is enormous, because the country has continental dimensions, with regions of difficult access and a lot of inequality.
However, the country has long experience with this type of project.
“The National Immunization Program (PNI) has existed for 47 years. We have the capacity, organization and structure. We are used to mass vaccinations and we have great examples of this in our history, such as the campaigns against smallpox, polio and influenza. “Nurse Mayra Moura, director of the Brazilian Society for Immunizations (SBIm), told the BBC earlier this month.
In response to questions about the logistics of the plan, Minister Pazuello said that “the logistics are simple.”
“Although our country is of this size, we have structure, we have airlines, the Brazilian Air Force, we have all the structure already planned and ready,” he said.
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