Anvisa (National Health Surveillance Agency) sent a list of questions to the Ministry of Health about the decision to release the booster dose of vaccination against Covid-19 to all adults.
The agency also asks for data on the decision to apply the Janssen vaccine, before a single dose, in two doses.
as showed the sheet, these changes in the vaccination strategy, announced by the Ministry of Health on Tuesday (16), took ANVISA and the vaccine manufacturers by surprise.
“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 note released to the press this Thursday (18th).
Anvisa’s questions were sent on Wednesday night (17) to the Ministry of Health. The agency says that it is necessary to demonstrate “minimum” that the safety and efficacy of vaccines are maintained after the changes.
In the same document, Anvisa states that it only knows 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 six questions about the change in Janssen’s vaccine schedule, the ministry asks Health to ask for data on studies used for the announcement, efficacy demonstrated after the second dose, the application of booster, safety results, among other points.
“The agency also requests that they be informed about the studies, opinions and technical notes, containing scientific evidence and clinical data, which supported the decision of the Ministry of Health to expand the application of the booster dose to the entire adult population”, says Anvisa in the document.
In the reading of Anvisa members, the ministry’s decision runs over the agency’s discussions on the subject. The agency has already opened analysis to insert in the package insert of AstraZeneca and Pfizer 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.
Janssen should also send data in the coming weeks about the application of the booster dose, but there is no forecast that the company will ask for a change in the basic vaccination cycle. Today this vaccine is applied in a single dose.
With pharmaceutical orders in hand, Anvisa can still take different decisions from those announced by the ministry. For example, approving the Janssen booster dose, but without inserting in the package insert the forecast of a second application in the basic cycle.
Despite the discomfort and questions, Anvisa wants to avoid a dispute with the ministry. The idea is not to feed the anti-vaccination speech.
Health prepared a technical note on Wednesday night (16) about the booster dose. Minister Marcelo Queiroga’s team says that “preferably” should be used an immunizing agent from the messenger RNA platform, such as that of Pfizer. It also advises that the viral vector vaccine, such as Janssen or AstraZeneca, can be applied “alternatively”.
Since the end of September, the ministry has already recommended the booster dose for people aged 60 years and over, as well as groups at risk. In this case, Anvisa participated in the decision.
The legislation leaves room for the Ministry of Health to decide on topics that are up to Anvisa, such as how to apply vaccines. But the minister can only take this type of initiative in cases “that imply a risk to the health of the population” or in scenarios of inaction by Anvisa, according to current rules.
In reading the agency’s technicians, the ministry should formalize that it acted in place of the regulatory body, in a publication in the Federal Official Gazette, for example, in addition to explaining the reasons for this initiative.
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.
This Tuesday’s announcements also took part of minister Marcelo 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.
The argument of Queiroga’s assistants is that both the change in the application of the Janssen dose and the expansion of the booster vaccine’s audience follow international experiences.
In a note released on Tuesday (16), however, Anvisa said that initiatives of this type were previously discussed with regulatory agencies in several countries.
“Before incorporating the booster dose of vaccines, countries like the United States, Canada, Indonesia, Great Britain, Israel, members of the European Community and others submitted the strategy for prior evaluation by their regulatory authorities. Primarily, the third or dose of booster was indicated for people with weakened immune systems, the elderly and health professionals,” said the Brazilian agency.
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