A year after Doria’s announcement, Butanvac is stuck in tests

A year after the announcement of the “100% Brazilian” vaccine produced by Butantan against Covid, Butanvac encountered obstacles in the initial human trials and has about ten million ready doses stopped at the institute.

According to the director of Butantan, Dimas Covas, the clinical trial of the vaccine had to be remodeled due to the advance of vaccination against the coronavirus in Brazil. Now the immunizer is evaluated as a booster, that is, to stimulate again the immune response against Covid in already vaccinated individuals.

Such a mishap was not expected by the São Paulo government, which ordered the production of ten million doses in April 2021. Now the stock runs the risk of having its expiration date.

When contacted, Butantan did not respond until when the product would be valid. Sources heard by the report say that the period for this type of immunobiological is normally one year. THE sheet, Anvisa said that if the units win, they will have to be discarded.​

On March 26, 2021, the governor of São Paulo, João Doria (PSDB), presented what would be the first “100% Brazilian” vaccine against Covid. The ad, however, did not say that the vaccine had actually been developed by researchers at the Icahn School of Medicine at Mount Sinai Hospital in New York, as revealed by sheet.

Mount Sinai said it owns the technology and is responsible for pre-clinical testing on animals. The institution stated that it was testing the immunizing agent in a consortium with several middle and low-income countries with large-scale production capacity, including Brazil.

Unlike other immunizers, Butanvac uses the Newcastle disease virus as a vector, which normally affects birds. The production is done in embryonated eggs, which has advantages, since it is based on a technology already mastered for the manufacture of the influenza vaccine, which is cheaper and does not depend on imported API (active pharmaceutical ingredient).

On the same day as the announcement, Butantan sent Anvisa (National Health Surveillance Agency) a request to start human trials — hours after another vaccine candidate, Versamune, with support from the federal government, made the same request.

After revealing the origin of the immunizing agent by the sheetDoria said that he was not aware of the American origin of the vaccine, but assured that it would be available to Brazilians until July 2021, a month in which, in reality, it was only able to start being tested.

Anvisa authorized the Butanvac clinical trial on June 9 and, a month later, the first tests on Brazilian volunteers began.

In the initial study plan, Butantan hoped to evaluate the safety and immunogenicity (ability to generate an immune response) of Butanvac in comparison with other vaccines already in use, such as Coronavac itself, produced at the same institute.

With the delay in the beginning of clinical trials, however, the advance of immunization of the Brazilian population, especially in the state of São Paulo, made it more difficult at that time to find volunteers who had not yet received any vaccine, to compose the control group of the studies. .

The institute then expanded the testing centers, including participants from other states, such as Minas Gerais, but even so it had difficulties in finding the approximately 400 initial volunteers.

After nine months since the authorization of the tests, the first data released by Butanvac were from a phase 1 trial carried out in Thailand. The results indicate that the vaccine proved to be safe and induced an immune response similar to that of Pfizer.

According to Covas, the phase 1 tests in Brazil, with 320 volunteers, were concluded with “satisfactory results” at the end of January. Such results, however, have not yet been officially released.

According to Anvisa, the institute requested, on November 5, an amendment to the test order, adapting the phases of the study and changing the placebo test (when a product with no effect is given) for one with individuals immunized with Coronavac. .

The agency also stated that no results of this study were presented or new phases of the research evaluated until this Friday (25).

Earlier this Friday afternoon, in an interview with journalists at Butantan’s new vaccine factory, the CMPV (Multipurpose Center for Vaccine Production), Covas said that, as it is an international consortium, Butanvac’s clinical studies in other countries can provide data for vaccine approval in Brazil.

“The final set of these studies will allow this vaccine to be used worldwide. It is a vaccine with great hope for the participating countries and the WHO itself. [Organização Mundial da Saúde]who has already expressed that this will be an excellent option for reinforcement”, he said.

In a note, Butantan also said that the development of Butanvac is moving towards phase 2, with completion expected in 2022.

“Phase 1 has ended and the data are still under analysis, but the preliminary results are positive. (…) There is the potential to produce approximately ten million doses, depending on the final data of phase 1”, he said.

Death Valey

In Brazil, despite advances in pharmaceutical and immunobiological research in recent years, only about one in 20 vaccine candidates manages to cross the so-called “death valley”. The expression is used when pre-clinical research has satisfactory results, but the research institution or developer is unable to advance in tests involving hundreds to thousands of people.

As in several countries around the world during the pandemic, it is common for the technology or platform for a new vaccine candidate to be developed in a research institute or university, but to be successful and enter the market, it needs the interest of a big pharmaceutical. This was the case, for example, with the Oxford vaccine in partnership with AstraZeneca (in Brazil, produced at Fiocruz).

To reduce the number of projects that fall into the “valley of death”, experts defend that countries, especially low and middle income countries, should have autonomy for the production of the necessary drugs.

Recently, the Ministry of Science, Technology and Innovation announced an agreement with UFMG (Federal University of Minas Gerais) for a new vaccine production center, which will also develop immunizations against Chagas disease, chikungunya and malaria.

In the capital of São Paulo, in addition to the existing plant, the new Butantan factory will produce, in addition to Coronavac with national API, three other vaccines: rabies, zika and hepatitis A.

According to Covas, the factory’s scale production should only start in 2023. The next steps to be carried out are the installation of equipment and the certification of the place and the products to be produced with Anvisa, before the start of the mass manufacturing.