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Butantan flu vaccine trial will have participation of babies; understand

The Butantan Institute is advancing in the development of a tetravalent flu vaccine. The National Health Surveillance Agency (Anvisa) approved, on Thursday (16), the phase 3 clinical trial of the vaccine in children aged 6 to 35 months. According to Anvisa, the approval considers the safety and knowledge that already exists based on the wide use of the trivalent vaccine.

According to Butantan, the study aims to evaluate the ability to induce an immune response against the influenza virus and the safety profile in the population of this age group.

1,412 children will be recruited, including babies born at term (37 weeks of gestation) and with birth weight greater than or equal to 2.5 kg, in ten centers distributed among the states of São Paulo, Roraima, Sergipe and Pernambuco. The time of participation in the study will be approximately six months after the complete vaccination schedule and 12 months in total.

The vice-president of the Brazilian Society of Immunizations (SBIM), Renato Kfouri, explains that clinical trials with the participation of babies and children are a common step in the process of developing new immunizers.

“For the licensing of new influenza vaccines, safety and immune response studies are necessary. So, you compare the vaccine produced by this new laboratory with the existing trivalent vaccines and the immune response must not be inferior to the three common strains and, of course, it must present a superior response to the fourth virus that is included in the tetravalent”, says Kfouri .

Criteria for participating in the study

To participate, the child must not have been vaccinated in the current vaccination campaign and/or in the six months prior to the first vaccination in the study. According to Butantan, all participating babies and children will be protected against the flu, as they will all receive a vaccine – either the trivalent one, the institute’s current vaccine, or the tetravalent vaccine being evaluated.

Those with chronic medical conditions, immunosuppressed, with a history of allergy to egg proteins or any of the components of the vaccine, or who have a history of adverse reaction to any influenza vaccine, cannot participate in the clinical trial.

“Evaluating immunizers in young children is very important for two reasons: the flu causes more hospitalizations and complications in this public, such as pneumonia; in addition, the child is a great transmitter of the virus”, explains the medical manager of clinical development at Butantan, Carolina Barbieri, in a statement.

In February, Anvisa had already authorized the resumption of the previous clinical trial that includes participants from 3 years of age. Started in 2021, the trial was postponed due to the Covid-19 pandemic, which hampered recruitment. In the previous stage, 5,822 volunteers were included and only the group of adults aged 18 to 59 reached the expected number.

About the tetravalent vaccine

Butantan’s tetravalent flu vaccine is made up of two strains of type A influenza virus (H1N1 and H3N2) and two strains of type B (Victoria and Yamagata lineages).

The institute’s objective with the new immunizer is to expand the protection of the population against the disease, since the inclusion of another B strain aims to increase the effectiveness of the vaccine. The product has already been shown to be highly safe in adults in the previous study.

By using the same production process as the trivalent influenza vaccine, with only one addition of the monovalent B strain, the tetravalent vaccine was able to go straight into phase 3 of clinical trials, in a non-inferiority study – that is, the immunizer studied needs to be as effective as trivalent or higher.

Understand what clinical trials are

Clinical trials are studies of a new drug or vaccine carried out with the participation of human beings. The clinical phase allows the evaluation of the safety and efficacy of the experimental product for the proposed indication.

If there is proof that the benefits outweigh the risks, the drug or experimental immunizer may be registered by Anvisa and made available in the Brazilian market, provided there is a request by the company developing the clinical development.

In order to carry out any clinical research involving human beings, the approval of the Research Ethics Committees (CEPs) or the National Research Ethics Committee (Conep) is mandatory.

The approval of a clinical trial by Anvisa applies only to clinical research that has the purpose of registration and post-registration of drugs, at the request of sponsoring companies or their representatives.

The deadline for starting clinical research after ethical and regulatory approval is defined by the study sponsor.

Source: CNN Brasil

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