Anvisa analysis becomes mandatory – Portuguese (Brazil)

After considering the medical societies and evaluating the studies sent by the Butantan Institute, UNVISA experts have concluded that the data presented are inadequate in concluding the use of the coronavacc vaccine for children aged 3 to 5 years.

The agency considers it necessary to submit complementary data from the progressive study in order to identify the benefits of the vaccine in light of the current epidemic situation.

To that end, Anvisa sent a letter to the Butantan Institute this Thursday (4/14) detailing all the data needed to comply with the scientific and regulatory requirements for a final approval.

The information requested includes the following items:

1. In a scenario of predominance of the Ômicron variant, data showing the protection provided by the coronavac vaccine in the pediatric population at least two months after the full immunization with the two-dose primary method, ideally three months later.

2. Study protocol for the efficacy of the coronavac vaccine in the pediatric population of Brazil, including assessment of the protection period provided by the vaccine in the pediatric population.

3. Clinical study protocol for evaluating the immunity and safety of the third or booster dose of the coronavac vaccine in pediatric populations (all age groups).

4. Integrated safety data is presented in support of this extended use request, in a single report format, including the Coronavac Vaccine Safety Overview for children 3-5 years of age.

5. Clinical report with updated data from Phase III Clinical Trials (PRO-nCOV-3002-1) conducted in China for comparative assessment of immunogenicity in children and adults.

6. Clinical report with updated efficacy, safety, and immunogenicity data from Multicenter Phase III studies conducted in South Africa, Chile, Malaysia, and the Philippines. 6) In children and adolescents from 6 months to 17 years.

The justification for requesting the above information and the complete documentation issued by Anvisa can be accessed here.

About deadlines for analysis

The Collegiate Board (RDC) Resolution 475 of March 10, 2021 sets the following deadline for the Emergency Use Authorization (AUE) analysis:

Art. 15. Anvisa will evaluate within 30 (thirty) days of AUE request for a vaccine against Covid-19 in the following cases:

I – when there is no clinical development of the vaccine in Brazil; Or

II – When reports and / or technical opinions issued by foreign health authorities are not able to prove that the vaccine meets the standards, efficacy and safety standards established by WHO or ICH and PIC / S.

Art. 17. For the purpose of issuing an opinion on AUE, Anvisa may request that steps be taken to complete and clarify data on the quality, efficacy and safety of drugs or vaccines against Covid-19.

Single paragraph. The persistent issuance of supplementary data and clarifications postpones the deadline for final decision of Anvisa.

With the issuance of today’s letter, the evaluation period has been postponed until the requested data is presented.

Quickly committed without sacrificing efficiency and safety standards

The use of a vaccine in children requires evaluation of unequivocal information, meaning that there is no doubt about its effectiveness and safety.

Anvisa has brought together its full team of vaccine experts full-time to evaluate and discuss the evidence presented and committed to its analysis.

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