Anvisa (National Health Surveillance Agency) received a request from the pharmaceutical company AstraZeneca to include in the package insert a booster dose of the immunizing agent against Covid-19.
Currently, the package insert for AstraZeneca’s vaccine, developed in partnership with the University of Oxford and produced in Brazil by Fiocruz, provides for two doses for complete immunization. The proposal involves all age groups currently included in the package insert, that is, people aged 18 or over.
“AstraZeneca’s request provides for homologous vaccination, that is, application of a booster dose to people who received the two initial doses of the same AstraZeneca vaccine for at least 6 months,” he said in a statement.
In order to change the package insert of any drug or vaccine, clinical studies must demonstrate the maintenance of the product’s safety profile and indicate the efficacy achieved with the additional dose.
The clinical study that accompanies the request had the participation of Brazilian volunteers. The clinical protocol was approved by Anvisa on July 19 this year.
The deadline for evaluating the request for inclusion of the booster dose is up to 30 days, provided that there is no need for further clarification.
The Ministry of Health released the booster dose of the Covid vaccine for people aged 18 or over on Tuesday (16).
The application of the new injection will be carried out five months after the basic vaccination schedule for all adults.
Since the end of September, the Ministry of Health has indicated the application of the booster dose to people over 60 years of age, in addition to members of risk groups, such as patients undergoing chemotherapy, immunodeficiency, people living with HIV/AIDS, among others cases.
Although the booster dose is not yet in AstraZeneca’s package insert, the Ministry of Health already uses the immunizing agent for that.
According to Anvisa, it is important to differentiate the vaccination schedule provided for in the package insert and the vaccination and reinforcement strategy.
The scheme provided for in the package insert and approved by Anvisa, with the indication of the amount of doses and intervals, points out how to use the vaccine, which, according to studies, produce the best immunization results.
The vaccination and reinforcement strategy, on the other hand, is a decision by the health authority on how a given immunization agent will be applied to the population in order to obtain the best vaccination coverage, monitoring adverse reactions.
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