Fiocruz: Brazilian Covid-19 Vaccine Could Advance to Clinical Trials in 2021

RIO DE JANEIRO, BRAZIL – While preparing to produce the Covid-19 vaccine developed by AstraZeneca Pharmaceutical Company and Oxford University, the Oswaldo Cruz Foundation (Fiocruz) is working on its own immunizing projects that may reach human trials in 2021.

Should these studies produce positive results over the next year, one of these vaccines is expected to be available in 2022.

The two initiatives are being developed by the Institute of Technology in Immunobiology (Bio-Manguinhos) and employ groundbreaking technology platforms. According to the vice-director of Bio-Manguinhos/Fiocruz Technological Development, Sotiris Missailidis, both are in pre-clinical trials, in the laboratory, and should undergo a new stage of animal testing known as “challenge study”.

The vaccines have already been approved in the immunogenicity and toxicity phase in animals, which means they have produced an immune response without harming the health of the test subjects. In the next step, researchers will check how vaccinated test subjects will react to exposure to SARS-CoV-2.

Because it involves the virus under conditions to cause an infection, the trial was awaiting a high biosafety (NB3) laboratory availability and is scheduled to take place later this month.

“These two approaches that we are using do not compete with the production lines we will use for AstraZeneca. So, we could potentially offer both at the same time, which provides national sovereignty,” says Missailidis. He explains that Bio-Manguinhos will choose which of the two vaccine proposals is the most promising to proceed to clinical trials next year.

The deputy director of Bio-Manguinhos points out that it is important to proceed with the research, regardless of the success of the AstraZeneca/Oxford vaccine trials, the total offer of which in 2021 should reach 210 million doses, in a vaccination scheme that initially includes two doses per person.

All these projections still hinge on the confirmation of the vaccine’s safety and efficacy, with the results of Phase 3 clinical trials and the registration of the National Health Regulatory Agency (ANVISA).

“I realize that we have guaranteed a significant amount [of doses], but the efficacy of the vaccines ahead is not yet known. We still do not know if vaccination will be enough or if we will have to be immunized every year, as is the case with the Influenza vaccine. Having your own vaccine which you can supply to the national market, with the same efficacy of vaccines of large pharmaceutical companies, is very important for public institutions, for health and for Brazilian science”, says the researcher. According to Missailidis, Brazil could even export its own vaccine to help fight the pandemic internationally.

New technologies

One of the vaccine proposals under development used the production of SARS-CoV-2 S and N proteins that Bio-Manguinhos already conducted for the production of Covid-19 diagnostic tests.

Classified as a subunit vaccine, the technology used includes the injection of these proteins into the human body so that its defenses recognize them and prepare for when the coronavirus actually starts to invade. The S protein is the one that forms the crown of thorns that gave the coronavirus its name, and the N protein composes the core of the virus.

The second proposal developed at Fiocruz is a synthetic vaccine, which uses peptides of the S and N proteins produced in the laboratory by chemical synthesis and coupled to nanoparticles. These peptides were identified by means of a computer model and trigger both the production of antibodies and cellular immunity, in which the organism eliminates the infected cells and prevents the development of symptoms.

One of these proposals should reach Phase 1 human clinical trials as early as 2021, and the agility of such trials, particularly in Phase 3, will also hinge on external factors such as virus circulation. If the number of new infections drops, the research time may need to be extended since Phase 3 trials depend on thousands of volunteers being exposed to the virus in their daily lives to test the vaccine’s efficacy.

In addition to the vaccines developed entirely in Bio-Manguinhos, two projects are currently underway in partnership with other research institutes: a synthetic vaccine with Oxford University and a recombinant protein vaccine with Fiocruz’s Center for Technological Development in Health (CDTS).

Modernization

The dozens of Covid-19 vaccines that have already made it to clinical trials should reach the market with unprecedented technological platforms, such as synthetic vaccines, viral vector vaccines, and RNA vaccines.

In the case of the work in Bio-Manguinhos, Missailidis stresses that the ongoing research may lead to the modernization of other immunizers available in the country, such as vaccines that use live attenuated virus technologies and therefore have greater public limitations.

“These platforms are new technologies. There was a worldwide investment in these new technologies before the pandemic, specifically to prepare humanity to react faster than was traditionally the case. After the consolidation of these technologies, of course, this will change our approach to vaccinology somewhat, depending on the cost of these vaccines and their safety.”

Source: Agência Brasil

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