Anvisa (National Health Surveillance Agency) questioned the Ministry of Health about the reinforcement of Janssen’s vaccine against Covid-19. The pharmacist itself was taken by surprise with the decision to apply the booster dose in Brazil.
According to sources, Janssen only presented the package insert for the vaccine approved in two doses in the US, but did not send documents from the technical base to the folder pointing out the need for this application.
Pharmaceutical sources even say that the recommendation is that the second dose would have a better result if applied 6 months after the first, and not 2 months as recommended by the Ministry of Health.
With the questioning, Anvisa wants to know what was the technical basis of Health to define the time criteria and the need for the booster dose and third application of the Johnson & Johnson vaccine.
The Agency questions whether the folder had access to the full data of the studies conducted and asks to share the information to understand how safe it is to administer three doses of Janssen in a row.
This Tuesday (16), sources from the Ministry of Health said that the decision was taken based on studies and with the international experience of the USA.
A CNN sought a position from Anvisa, the Ministry of Health and Janssen on the matter, but still has not received an answer. The text will be updated as soon as they manifest.
(With information from Kenzô Machida)
Reference: CNN Brasil
