Anvisa should advise repeating the vaccine model in the booster dose

Anvisa (National Health Surveillance Agency) should go against the Ministry of Health and guide that the booster dose of Covid’s vaccination is preferably applied with the same model as used in the basic cycle.

The collegiate board of the agency has a meeting this Wednesday (24) to vote on an orientation on the reinforcement of vaccination.

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.

Marcelo Queiroga’s team also suggests that the viral vector vaccine, such as Janssen’s or AstraZeneca’s, can be applied in an “alternative” way in the booster.

Anvisa’s board of directors should suggest the “homologous” reinforcement, that is, with the same immunizing model applied previously. The exception should be Coronavac, for which there should be a recommendation to prioritize other vaccine models.

Photo: Geraldo Bubniak / AEN

The guidance of Anvisa, however, will not have the power to overturn the decisions of the Ministry of Health. The agency, even, should mention that Queiroga’s portfolio is responsible for defining the Covid-19 immunization campaign.

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 on the 18th, but did not receive a response until this Tuesday night (23).

Despite the divergence and questions, Anvisa wants to avoid a dispute with the ministry. The idea is not to feed the anti-vaccination speech.

But agency officials acknowledge that the two different orientations can be confusing.

While the ministry prioritizes Pfizer as a booster dose for those who received any model previously, Anvisa should suggest using AstraZeneca for those who received this product before, for example.

In addition, the ministry set a five-month interval for the application of the booster dose. While some pharmacists ask Anvisa to take a six-month break.

In the case of Janssen’s vaccine, the divergence should be even greater, but the agency should not look into the immunizing agent at this Wednesday’s meeting. The Ministry of Health decided, also in the announcement made on the 16th, to apply this vaccine, before a single dose, in two doses.

But Janssen itself sent a request to Anvisa to maintain the basic single-dose cycle and apply the same product in the reinforcement.

Sought by Folha de S.Paulo, the Ministry of Health did not comment on Anvisa’s questions.

When presenting its guidance, the agency must state that the data taken so far to the regulator suggest the homologous reinforcement of vaccination. That is, the agency does not exclude reviewing its decision later.

When deciding on vaccination, Anvisa analyzes data on safety, quality and efficacy of products, as well as information on manufacturing.

“The requested clarifications are necessary from a sanitary point of view, especially with regard to monitoring the use of new vaccine schemes in Brazil,” said the agency, in a statement released to the press on the 18th.

In the same document sent to Health, the agency stated that it is necessary to demonstrate “minimum” that the safety and efficacy of vaccines are maintained after the changes.

Anvisa also said that it only knows of discussions about Janssen that involve the “possibility of applying a booster dose and not a second dose as part of the primary vaccination schedule.”

In the reading of members of Anvisa, the ministry’s decision overturned the agency’s discussions on the subject. The agency has already opened analysis to insert in the package insert of AstraZeneca, Pfizer and Janssen vaccines the rules on the booster dose.

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.

A point that worries Anvisa is how to organize the monitoring of adverse reactions to vaccines. In the agency’s reading, this is one of the topics that should have been previously discussed with the ministry.

Since the end of September, the ministry started to recommend the booster dose for people aged 60 and over, as well as groups at risk. In this case, Anvisa participated in the decision.

The announcements on the 16th, on the other hand, caught even part of Queiroga’s team by surprise. Decisions about Covid-19 have been made in restricted groups, and the PNI (National Immunization Program) has been without command since the end of June.

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