Anvisa approves definitive registration of Janssen vaccine against Covid

Anvisa (National Health Surveillance Agency) published this Tuesday (5) the definitive record of Janssen’s vaccine against Covid-19. The vaccine has been approved for emergency use since March 31, 2021.

Unlike other immunizers, it only needs one dose in the primary cycle. The Ministry of Health adopted the booster dose for those who took the vaccine, which is indicated for people aged 18 or over.

In addition to contemplating primary immunization, registration with the regulatory agency includes the approval of the booster dose.

“The vaccine can also be administered as a heterologous booster dose (of a different vaccine) to people who have completed their primary vaccination with an mRNA technology vaccine. Currently, the only mRNA vaccine approved in Brazil is the Pfizer vaccine. In this case, the interval for the booster dose is the same as that authorized for the vaccine used in the primary vaccination”, said Anvisa, in a note.

Anvisa said that the requirements for granting the registration are more complex than those required for authorization for emergency use, as this modality was created exceptionally, to meet the urgency imposed by the outbreak of the new coronavirus.

For the record, for example, data from complete stability studies are necessary, which allow establishing the expiration date and models of package inserts and labeling capable of favoring the rational use of the vaccine.

Complementary data on quality, transport chain and the results of phase 3 clinical studies are also required, that is, carried out with a greater number of volunteers to evaluate the safety and efficacy of the vaccine.

Another important difference between the authorization modalities is that the release for emergency use is restricted to a predefined target audience. In addition, immunizers subjected to exceptional use can only be applied in the Unified Health System. In the case of the sanitary registry, the manufacturer receives authorization for the vaccines to be widely used in the country, in the public and private systems.

In Brazil, the only vaccine against Covid that still only has an emergency use record is Coronavac.

Anvisa received a request from the Butantan Institute to expand the use of the Coronavac vaccine in children aged 3 to 5 years, but the regulatory agency asked for more data.

The agency has already approved the immunizer for children and adolescents aged 6 to 17 years in January this year.

At the time, Anvisa vetoed the application of the vaccine to the public from 3 to 5 years old, understanding that there was not enough data to authorize the immunizer in this age group.