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In yet another episode in the race for the covid-19 vaccine, yesterday, the government of São Paulo and the Butantan Institute announced that the CoronaVac vaccine, produced in partnership with the SinoVac laboratory, was safe and effective enough for use in Brazil.
Even so, there are still some steps to be taken for the São Paulo government to obtain authorization to start the vaccination campaign against the new coronavirus. Under the Twitter explains the following steps:
1) Dissemination of efficacy data
CoronaVac’s effectiveness rate has not yet been disclosed, although the São Paulo government has guaranteed the vaccine’s efficiency. Without the publication of this rate, it is impossible to advance in the vaccination plan.
This is because it measures the percentage of immunized patients who were able to generate antibodies against Sars-Cov-2.
According to São Paulo authorities, the data has not yet been released at the request of the Chinese laboratory, which will review the figures before sending them to Anvisa (National Health Surveillance Agency) for approval. They must send the studies to the agency within 15 days.
2) Data reviewed and published in a scientific journal
This step is not mandatory, but, according to experts, it is essential for registration with regulatory bodies, such as Anvisa.
The study that supported the CoronaVac tests must be submitted to an internationally credible scientific journal so that the data can be reviewed by other academic scientists and subsequently officially published in a scientific journal.
Ultimately, the reviewers either endorse or disagree with the truth and correct or not the vaccine development process.
3) Regulation with Anvisa
This step is crucial. Anvisa must analyze the results of the CoronaVac tests and issue an opinion on whether or not to authorize the use of the vaccine in Brazil.
There are two types of immunization registration requests: emergency and definitive. The first, as its name implies, considers the global urgency of a vaccine against a virus or bacteria, which forces the regulatory agency to expedite the analysis of the tests – according to a decision of the STF (Federal Supreme Court), in case of emergency requests. , the analysis period is up to five days. The second option, on the other hand, takes longer and gives the agency the opportunity to examine the data in up to two months.
In the case of CoronaVac, the path is usually easier. This is because the São Paulo government must follow the legislation passed in February on drugs and vaccines against covid-19 to speed up the application of the vaccine.
According to the law, if a drug is authorized in the US, Europe, Japan or China, Anvisa must evaluate it within three days for use in Brazil. If it fails on time and does not give a technical justification, it is automatically approved.
Another facilitator of CoronaVac regulation is that vaccine studies have been subject to scrutiny by Anvisa continuously since July, when vaccine trials began in Brazil. With this, the organ can register the immunizer immediately, as soon as it has access to the results of the last phase of tests.
4) Definition of the logistics of the vaccination plan
The government of São Paulo, with the State Immunization Plan, guarantees that it has already developed a system for the application of vaccines, which do not require great complexity of storage and transportation. According to experts, as the state already has a structure for mass vaccination campaigns, this process should be quick and easy to solve.
The state promises to begin vaccination on January 25; In the first phase, approximately 9 million people should be immunized, according to the government’s forecast. Since each person needs two doses, 18 million doses must be used.
If approved by Anvisa, CoronaVac can also enter the PNI (National Immunization Plan) of the Ministry of Health. Other states and countries are also negotiating with the São Paulo government.
* Infectologists Evaldo Stanislau, from the Hospital das Clínicas and professor of medicine at the São Judas Tadeu University, and Renato Kfouri, director of the Brazilian Society of Immunizations (SBI), collaborated for the report.
