Covid: 2 years after announcement, Butanvac does not complete tests – 03/25/2023 – Health

Two years after the former governor of São Paulo, João Doria (then in the PSDB), announced the Butanvac vaccine against the coronavirus, the vaccine has not yet completed the initial testing phase on humans.

The immunizing potential, which was announced as the first “100% Brazilian”, has technology produced at Mount Sinai Hospital, in New York, as revealed by Sheet.

At the time, Doria said that Butanvac would be ready to vaccinate Brazilians in September 2021, just six months after the announcement of the start of studies. At the time, the then governor said that he had also ordered the manufacture of 18 million doses from the São Paulo institute.

Without being used, the doses are at risk of having expired.

Currently, the vaccine has started phase 2 of human trials in the country, when the vaccine under study is applied to hundreds of healthy people to assess its safety and ability to generate an immune response.

The expectation now is to use the immunizing potential as a vaccine booster, since there are almost no more volunteers who can be included in the study who have not currently vaccinated against Covid. In phase 2, 400 people will be tested.

In a note, the Butantan Institute said that Butanvac is in the clinical studies phase, when the vaccine is tested in humans for evaluation and dose definition, in addition to safety and immunogenicity evaluation. The current stage, phase 2, has an estimated period of 12 months, but in six months the preliminary results may be presented to Anvisa (National Health Surveillance Agency).

Testing is now taking place on 400 participants, aged between 18 and 59 years who received up to four doses of any Covid vaccine, with the last dose received 120 to 240 days before the date of entry into the study.

He also informed that, once stage 2 is finished, phase 3 will begin – but that depends on the progress and results, as well as on the evolution of Sars-CoV-2 variants.

Finally, he said that the API (active pharmaceutical ingredient) produced so far is being used in the development of the vaccine candidate, and that there was no disposal of immunizers.

According to the director of Butantan, infectologist Esper Kallás, the first individual was vaccinated in early March, and the delay was due to the difficulty in finding participants. “No more ‘virgins’ [também chamados de “naïves”] of vaccine. Virtually everyone has either had Covid or been vaccinated,” she said.

The immunizer is produced with the Newcastle disease virus, a type of virus that affects birds, modified to present the Spike S protein (or spike, the molecular hook used by the coronavirus to infect cells). In addition to Brazil, the vaccine is also tested in the United States, Mexico, Thailand and Vietnam. Mount Sinai said it owns the technology and is responsible for preclinical testing on animals.

There are two formulations currently being tested: the attenuated one, in which the Newcastle virus has its infectivity reduced until it can no longer cause infection, currently being tested in the US and Vietnam, and the inactivated vaccine, in other countries.

In Brazil, the clinical trial and production of the immunizer focus on the inactivated formulation, which could be easily manufactured in embryonated eggs, in the same way that the flu vaccine is made at the institute today.

However, the deadline for completion of phase 2 is still open. After this phase, a third stage, with over 4,000 people, will assess the effectiveness of the immunizer to, only then, present the final results of the vaccine and, depending on them, request approval from Anvisa.

Phase 1 result has not been announced.

The phase 1 clinical trial, also carried out in Brazil by Butantan, has not yet released its results. Findings from combined phase 1/2 studies in Thailand published last month in Science Translational Medicine showed that the vaccine, actually called NDV-HXP-S (which stands for Newcastle disease virus-hexapro-protein S) induced the production of neutralizing antibodies and anti-RBD antibodies (receptor binding domain, in English, which is the area where the virus binds to cells) comparable to the Pfizer vaccine 14 days after application.

According to the authors, the vaccine had a good immunogenicity profile with two doses at the highest dosage (10 micrograms, the same as the dose used in Pfizer), thus being a good option for low- and middle-income countries due to its ease of production (in eggs, not using mRNA technology) and storage (refrigerated).

For the director of vaccine production at the institute, Ricardo Oliveira, the institute now “bets” on the immunization candidate as a future booster option because it is produced from embryonated eggs, a technology already mastered by the institute for the manufacture of immunization against flu .

With a scenario of annual reinforcements, as has been the case since the emergence of new variants, the production of a national vaccine for the annual campaigns against Covid can be an important advantage, and in this case Butantan places itself as a protagonist with Butanvac , since the agreement with the Chinese pharmaceutical Sinovac for another vaccine produced by the institute (Coronavac) does not provide for the transfer of technology.

Also two years after the announcement of the preliminary results of effectiveness, Coronavac still has not had the complete data published in a scientific journal with peer review and scientific recognition. Currently, contracts with the Ministry of Health for the supply of immunization only provide for vaccination in children aged 3 to 5 years.

---

How are other vaccines against Covid being studied in Brazil

SpiN-Tech
Developer: CT Vacinas (National Vaccine Center) of UFMG (Federal University of Minas Gerais)
Phase: trials 1 and 2 already started
Amount of people: 432 in this stage + 4,000 to 5,000 in the next stage
Technology: virus-like proteins (VLPs), which mimic the S protein of Sars-CoV-2
Partners: MCTI (Ministry of Science, Technology and Innovation)

versamune
Developer: Farmacore, PDS Biotechnology (USA) and USP Ribeirão Preto Medical School
Phase: trials 1 and 2 recruiting volunteers
Amount of people: 90 (phase 1) + 300 (phase 2)
Technology: virus-like proteins (VLPs)
Partners: MCTI (Ministry of Science, Technology and Innovation)

nasal spray
Developer: Laboratory of Immunology at InCor (Heart Institute) at USP
Phase: Approved for testing, awaiting start of human trials
Amount of people: not yet defined
Technology: nanoparticles containing virus proteins
Partners: Fapesp, Unifesp (Federal University of São Paulo) and different units of USP: the Faculty of Medicine, the Institute of Biomedical Sciences and the Faculty of Pharmaceutical Sciences