Coronavirus Vaccine: Why Brazil is Considered the “Perfect Laboratory” to Test Immunization Against Covid-19 | Coronavirus

The country, which has more than 4 million confirmed cases of Covid-19, is considered by scientists studying immunization as a “golden opportunity.”

Two of the most promising and advanced vaccines against the coronavirus are being tested in the country: the one from the University of Oxford in partnership with the pharmaceutical company AstraZeneca and the one from the Chinese company Sinovac.

And two others, from the North American pharmaceutical companies Johnson & Johnson and Pfizer, recently received authorization from the Brazilian authorities to start clinical trials in the country.

This week, tests with the Oxford vaccine were suspended after the illness of a patient who had been receiving the study vaccine; Details of the adversities were not released. This Saturday, the pharmaceutical company AstraZeneca, which develops the vaccine at the university, announced the resumption of tests. In a statement, the company said the UK Health Authority (MHRA) reportedly said it was safe to continue the experiments.

Faced with tests with different vaccines, the authorities hope that Brazilians will be among the first to be immunized against the coronavirus.

They are even considering the possibility of producing these vaccines nationally and exporting them to the rest of Latin America.

But why is Brazil considered an “ideal laboratory” for clinical trials of vaccines?

The specialist in epidemiology and immunization at George Washington University in the United States, Jon Andrus, who was deputy director of the Pan American Health Organization (PAHO), says that the high rates of community transmission of the virus, as in Brazil, are among the main criteria to be able to test a vaccine.

He explains to BBC News Mundo (the BBC’s Spanish service) that there are also other reasons why Brazil is considered a perfect setting for research on immunization.

“Certainly you need a situation in which there is a strong prevalence of a disease to be able to test the effectiveness of a vaccine. But I think that in Brazil there is an almost perfect storm for trials, because in addition to the high prevalence of Covid-19, the country has a long history of excellence in public health, with research institutions recognized worldwide, such as Fiocruz (Fundação Oswaldo Cruz) in Rio de Janeiro, which has been conducting research and trials for decades ”, says the expert.

Fiocruz has been actively involved in the research and production of the Oxford vaccine.

Another world-renowned Brazilian institution is the Butantan Institute in São Paulo, which participates in the research and production of the Chinese vaccine Sinovac.

One point in which Brazil stands out is the Experience and strength of its national immunization programs and its tradition in vaccine production..

The Bio-Manguinhos factory in Fiocruz is one of the largest vaccine production centers in Latin America. Millions of doses of vaccines against yellow fever, tuberculosis, measles, among other diseases are processed there.

The Butantan Institute is currently the leading producer of vaccines against influenza or flu in the southern hemisphere, with the capacity to produce 100 million doses.

“It is important to highlight that Brazil has a strategic approach to become self-sufficient in the production of vaccines,” says Cristiana Toscano, a member of the expert group for consultation of the World Health Organization (WHO) on vaccines against Covid-19.

“For three decades, the different Brazilian governments have strengthened and invested in national public capacity, so that almost all vaccine laboratories are financed with public money,” adds Toscano, a professor at the Federal University of Goiás, in an interview with BBC News World. .

Most of the vaccines in Brazil, says the researcher, are produced locally or specialists try to establish technology transfer mechanisms with large pharmaceutical companies.

And that is exactly what is being negotiated now with the Oxford and Sinovac vaccines: transferring the technology to the country so that these vaccines are produced locally.

Both the Oxford and Sinovac vaccines are in phase 3 of clinical trials.

The first trials are being carried out with 5,000 Brazilian volunteers. The second has 9 thousand volunteers.

After the suspension of tests with the vaccine this week, the Federal University of São Paulo (Unifesp), one of the entities responsible for the tests in the country, issued a note to communicate that no one had serious reactions in Brazil.

“Many have already received the second dose and so far there has been no record of serious health complications,” Unifesp reported.

According to AstraZeneca’s note, the suspension of tests is a “routine pause” in the production of vaccines in case a patient has had “unexplained disease”, so that the case is investigated and to guarantee the “integrity of the experiments” . .

“We are working to accelerate the review of this specific event, in order to minimize any impact on the testing schedule,” the company said in a note released before the resumption of studies, which took place this Saturday.

Recent data published by Sinovac indicated that the vaccine is safe and has produced good results among adults. It also brought an immune response to the elderly, but it was lower than among people up to 59 years old. The finding was made after researchers evaluated the responses to the early stages of immunization of 421 volunteers aged 60 and over.

Since vaccines are still being tested, researchers are studying the best immunization strategies to get the best possible responses.

As part of the vaccine under test agreements in Brazil, the country will initially receive the raw material to carry out the final stages of production.

The two agreements include the transfer of technology so that Brazil can then produce vaccines from the first stage.

The agreement with Oxford-AstraZeneca establishes that the Brazilian government will invest US $ 127 million (almost R $ 700 million) in exchange for technology and equipment so that Fiocruz can initially produce 30 million doses during the test phase. If the vaccine is effective, Brazil could produce an additional 70 million doses.

The agreement between Sinovac and Butantan will offer 120 million doses to Brazilians.

Authorities have even said that vaccinations for some people may begin in the first half of 2021 in Brazil.

Some academics, however, do not believe that the country will be able, by the end of the first half of next year, to produce a large number of vaccines.

Former Health Minister José Gomes Temporão said in a recent interview with Reuters that technology transfer could take between five and 10 years. Therefore, he believes that it is impossible for Brazilian laboratories to be ready to start producing vaccines next year.

“This transfer takes a long time. They can even speed up this process, but not so much,” Temporão said.

The specialist Cristiana Toscano believes that Brazil can receive the technology and start the production of vaccines.

“But it all depends on the technology we are talking about,” he says. According to her, there are new technologies that have not been used and, therefore, the transfer process can take a long time, even a decade.

“But Butantan, for example, really has experience in producing many vaccines that have not yet been used, such as Sinovac. There is a safety laboratory that is capable of doing everything necessary to produce an inactivated vaccine,” says Toscano. .

The challenge of immunization

But there is another great challenge that Brazil will have to overcome: how to vaccinate its 212 million inhabitants and its immunization programs have recently suffered a setback, due to disinformation campaigns.

In 2019, for the first time in 25 years, Brazil did not meet its vaccination goals in any of the campaigns that, in previous periods, were concluded without difficulties.

This is a trend that has been registered in all countries, due to anti-vaccine campaigns, which has caused many people not to want to be vaccinated.

“I think the main challenge will be how to keep the vaccination program updated, because it had already been affected before the Covid-19 pandemic, and how to incorporate new vaccines into that program,” says Cristiana Toscano.

“There will be logistical and operational challenges, which require mobilization, training, combating the renunciation of vaccination, in addition to the entire organization distributing and managing the 35,000 vaccination units in the country,” adds the specialist.

All of the above is based on the idea that there will really be an effective and safe vaccine.

But it is not yet known whether any of those being tested in Brazil or anywhere else in the world will show positive results at the end of clinical trials.

What will happen, then, if the vaccines tested in Brazil fail?

Brazilian authorities are trying to diversify options and have expressed interest in joining the WHO COVAX initiative, which aims to ensure rapid and equal global access to Covid-19 vaccines.

Experts agree that, for now, any bet on a vaccine is risky until the results of clinical trials are known.

To say that a vaccine will be ready in 2021 can be a very optimistic statement. “It is important to remember that we should not wait for a magic solution,” says former PAHO Deputy Director Jon Andrus.

“We must be humble and remember that we have not always been successful, that we have many diseases for which we have not found a vaccine, although we have been working on it for decades, such as AIDS (caused by the HIV virus),” he said. to BBC News. World.

“That is why it is so important that we do what we can now and we must embrace all public health interventions: how to maintain social distance, wear masks, test and track cases, and follow hygiene practices,” Andrus adds.

Cristiana Toscano agrees. “Our goal (to have a vaccine in the first half of 2021) seems optimistic. It depends on the approval of clinical trials, if they give good results, and the approval of the regulatory authorities,” he tells BBC News Mundo .

“And while that does not happen, it is necessary to minimize expectations and be more realistic,” says the expert.