Anvisa (National Health Surveillance Agency) approved a request by Pfizer for the third dose of the vaccine against Covid to be included in the product’s package insert.
Until then, there were two doses in the package insert. Therefore, a booster dose (third dose) administered at least 6 months after full primary immunization in individuals aged 18 years and over is approved.
Approval is for homologous vaccination, that is, application of a booster dose to people who have already received the two initial doses of Comirnaty, the trade name of the American immunizing agent.
Gustavo Mendes, general manager of medicines at Anvisa, informed that it would be a conditional approval, considering that the laboratory still needs to forward more data on the efficacy, immunogenicity and safety of the booster dose. In addition to forwarding the risk management plan including the booster dose.
The clinical study presented to support the claims of efficacy and safety of booster dose application had the participation of Brazilian volunteers. The clinical protocol was approved by Anvisa on June 18, 2021.
The analysis of putting on the package insert a booster dose of AstraZeneca and Janssen is still being carried out by the regulatory agency.
In addition, the board of directors of Anvisa approved the guidance that the booster dose of Covid vaccination is preferably applied with the same model used in the basic cycle in the cases of Pfizer, Janssen and AstraZeneca.
Like sheet he added, the exception should be Coronavac, for which there should be a recommendation to prioritize Pfizer’s vaccine.
“Anvisa is not approving the booster dose for the Janssen and AstraZeneca vaccine, the process is under evaluation. But if the Ministry of Health understands that there is a need to maintain the booster dose, it should consider the elements known so far and adopt the homologous scheme for the vaccine of AstraZeneca and Janssen”, said Meiruze Freitas, director of Anvisa.
On the last 16th, without consulting the agency, the Ministry of Health announced the release of the new application to all adults. Saúde recommends using “preferably” immunizers from the messenger RNA platform, such as Pfizer’s.
Minister Marcelo Queiroga’s team also suggests that the viral vector vaccine, like the one from Janssen or the one from AstraZeneca, can be applied in an “alternative” way in the reinforcement.
The announcement of Health caused discomfort with Anvisa. The agency sent a series of questions to the ministry about the change in the vaccination schedule, receiving the answer this Wednesday (24).
For Anvisa, the Ministry of Health said that the vaccine scheme should be homologous to Pfizer’s vaccines and also to Janssen’s, that until then, the initial recommendation is that the booster would be preferentially with Pfizer’s vaccine.
And he also replied that there should be a heterologous booster dose schedule when the primary vaccine schedule is with AstraZeneca and Coronavac vaccines.
The guidance of Anvisa, however, will not have the power to overturn the decisions of the Ministry of Health.
Agency members recognize that the two different orientations can lead to confusion. While the ministry prioritizes Pfizer as a booster dose for those who received any model previously, Anvisa suggests using AstraZeneca for those who received this product before, for example.
In a previous discussion, technicians from Anvisa advised the ministry to wait for a position from the agency on the application of the booster dose, which did not happen.
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