Anvisa denies authorization to the ministry to import 20 million doses of the Covaxin vaccine | Vaccine

According to Anvisa, the decision does not prevent the ministry from making a new request with more information to solve the problems pointed out by the agency.

The federal government’s request was made based on Law 14,124, which facilitated the purchase of vaccines by the Union, states and municipalities. The law opens the possibility for Anvisa to authorize the import and distribution in view of the approvals for use already granted by other health authorities around the world.

In this case, the ministry applied for permission based on a decision by the Indian health agency, which has already released the immunizer in an emergency.

• Anvisa unanimously approves the emergency use of Johnson’s single-dose vaccine

Director Alex Machado Campos, rapporteur of the order in Anvisa, clarified that the import order was received on March 22, and since then the agency has been analyzing data and documents, but the ministry has not been able to resolve the lack of essential documents indicated. . in charge of the organ’s technicians.

“The import request did not show that it met the requirement,” said the rapporteur.

Among the documents, Anvisa noted the absence of “batch release certification”, “import license” and “technical report from the authority that granted emergency use.” In his vote, the speaker also raised doubts on other points in addition to the documentation.

“From the data presented, there is uncertainty about the efficacy and safety of the vaccine, since the data necessary for the analysis were not presented” – Alex Machado, director of Anvisa

Thus, in a preventive manner, the technical area identifies risks and uncertainties in the use of the Covaxin vaccine under current conditions. (…) From the use of vaccines that cannot fail to deliver the necessary amount of antigens with the appropriate amount The potency to induce a protective immune response against Sars-CoV can aggravate the epidemic situation of the country, which entails a relaxation of other measures to contain the pandemic and the appearance of more variants of the virus, although this aspect can, for any reason, be overcome “, the rapporteur evaluated.

No certificate of good manufacturing practices

On Tuesday (30), Anvisa denied the certification of good manufacturing practices to Bharat Biotech, an Indian biotechnology company that developed Covaxin, a candidate vaccine for Covid-19. The inspection at the Indian factory was carried out by a team of Anvisa inspectors in early March.

In Brazil, Covaxin is represented by Precis Medicamentos.

Anvisa’s refusal affects the dose schedule provided by the Health Ministry, which signed an agreement to buy 20 million doses of the immunizer in February.

In the latest schedule, March 19, the ministry had eight million doses of Covaxin still in March, another eight million doses in April, and four million doses in May, even without emergency use approval from the regulatory agency.

Covaxin has also been the subject of negotiations between private clinics and Bharat Biotech. In January, the Brazilian Association of Vaccine Clinics (ABCVAC) sent a delegation to India to negotiate the possible purchase of doses of Covaxin to be sold by private clinics.