Bottleneck infrastructure in the race for the national vaccine against COVID-19 – General

Santuza Teixeira explains that CTVacinas is suitable for testing in guinea pigs. For clinical testing, another certified structure will be needed, explains

(photo: Alexandre Guzanshe / EM / DA Press% u2013 12/1/21)

The scarcity of infrastructure laboratorial he can delay the entry of one of the candidates for vaccine produced by the Vaccine Technology Center (CTVacinas) of the Federal University of Minas Gerais (UFMG) in the clinical trial, when human testing is performed. To start this phase, it is necessary to develop a pilot dose. However, Brazil has only three laboratories authorized by the National Health Surveillance Agency (Anvisa) to produce vaccines for human use. The process of producing an immunizer includes the initial stage of manufacturing the active pharmaceutical ingredient (IFA), proceeding to formulation and packaging. And exactly the bottleneck of research on the vaccine in Brazil.

The certified laboratories for this production are Bio-Manguinhos, from Fundao Os- waldo Cruz (Fiocruz), in Rio de Janeiro, and the Butantan Institute, in So Paulo. The third is Fundao Ataulpho de Paiva, also in Rio de Janeiro, but which is authorized only to produce BCG, a vaccine against tuberculosis.

In the last few days, two vaccine candidates were announced to be able to pass to the clinical trial phase with 100% national technology, developed by the Butantan Institute and by the Faculty of Medicine of Ribeiro Preto, of the University of So Paulo. However, there is a lag in Brazil in relation to infrastructure for the manufacture of immunizers. The infrastructure problem does not only affect the UFMG, but all centers that develop research for the production of vaccines against COVID-19 with national technology.

“UFMG does not have this structure to prepare the formulation with the conditions required by Anvisa to be tested in humans. Neither do Ribeiro Preto’s staff. It seems to me that, in this case, the formulation was done abroad”, says the professor Santuza Teixeira, one of the researchers at CTVacinas. She points out that everything is being done within the time necessary to ensure the safety and effectiveness of the immunizer. He also says that CTVacinas scientists do not consider that research for a national immunizer should be politicized or seen as a dispute between the proponents. Despite the caveat, he considers that if UFMG had a laboratory authorized by Anvisa for the production of the IFA, it would be better and the research could move forward faster.

“The bottleneck is the production of the pilot batch of vaccine, which needs to be done under conditions that allow it to be used in humans. We produce under conditions to do tests on guinea pigs. We will have to make another structure of a certified laboratory for this type of test ”, reveals the researcher.

The manufacturing stage of the IFA is the most critical for the quality of the vaccines. In this phase, scientists guarantee the characteristics of the antigens used in the formulation of the immunizers. It is a very sensitive process and is subject to the risk of variability because it is a production that involves biological organisms, which are more difficult to control.

Race

One of the three laboratories certified for the production of IFA in Brazil, the Butantan Institute intends to use the flu vaccine line to produce ButanVac (photo: Government of SP / Instituto Butantan – 3/26/19)

On March 26, the Butantan Institute announced an application for authorization for the clinical trials of ButanVac, presented as a vaccine with 100% national technology, but, soon after, the information was contested, since it used technology from an American university in development. On the same day, the Ministry of Science and Technology presented Versamune, developed by the Faculty of Medicine of Ribeiro Preto, from USP, in partnership with Farmacore and PDS Biotechnology, from the United States. Currently, there are 22 requests for clinical studies of vaccines and drugs against COVID-19 under analysis at Anvisa, 17 of which are immunizing.

In the next few days, CTVacinas should submit an Anvisa request to carry out clinical trials for a protein chimera-like substance, candidate for the most advanced vaccine at UFMG. As researcher Flvio Fonseca recalls, of the five ongoing researches at CTVacinas, the protein chimera has shown better results in animals so far.

Candidates for bivalent vaccine (Influenza + COVID-19) and (BCG COVID-19), RNA Messenger, MVA SARS-CoV2 and Ad5 SARS-CoV are still being studied by UFMG. There are also four other immunization studies carried out by universities in Minas Gerais: Universidade Federal de Viosa in partnership with Fiocruz (virus particles and beer yeast; yellow fever), Universidade Federal de Juiz de Fora (drops with probiotic bacteria). Until March 31, none of the mining institutions had applied to Anvisa for clinical trials.

Tropeos

Despite the advertisements from Instituto Butantan and USP from Ribeiro Preto, the country is far behind, in the world scenario, in the production of vaccines against COVID-19. Anvisa admits that if there were a better laboratory structure, Brazil would be better positioned in the ranking. “The expansion of the industrial park of active vaccine inputs would be very important to reduce the need for imports, minimizing the risks resulting from the breakdown of the supply chain, as was evidenced in this pandemic”, reported the report.

The bottleneck delays vaccine research in the country at this time of fighting time to defeat the new coronavirus. “We do the proof of concept, but when it comes to clinical tests, we don’t have a structure prepared for that”, reveals the researcher. This is not a deficiency of UFMG, but a problem faced by scientists across Brazil. “On a large scale, we have vaccine factories. What is missing this half way ”. However, the researcher informed that UFMG is in negotiations with the government of Minas and MCT for the construction of laboratories for the production of the IFA. According to her, the structure should be installed in two years.

Line redirection

The Butantan Institute said that, for the production of ButanVac, it must use technology already available in its flu vaccine factory – from the cultivation of strains in chicken eggs -, which generates inactivated doses of vaccines, made with virus fragments. dead. Butantan’s CEO, Dimas Covas, at a press conference, assured that it will be possible to deliver the Brazilian vaccine later this year.

Dimas Covas stressed that the production put Brazil on another level in the production of vaccines. “We understand the need to expand the capacity to produce vaccines against coronavirus and the urgency of Brazil and other developing countries to receive the product from an institution with the credibility of Butantan. In view of the global scenario, we have opened the range of options to offer governments one more way to contribute to the control of the pandemic in the country and in the world, ”he said.

In test

Candidates for vaccine against COVID-19 developed in Brazilian institutions en route to clinical trial

Butantan Institute

»ButanVac

»Active: recombinant / inactivated

»Stage: clinical trial request sent to Anvisa

Faculty of Medicine of Ribeiro Preto / USP

»R-Dotap vaccine

»Active: recombinant S1 protein

»Stage: clinical trial request sent to Anvisa

CTVacinas / UFMG

»Protein chimera

»Active: subunit vaccine

»Stage: pre-clinical trials in monkeys. The request for a clinical trial should be made soon

Study projects 562 thousand deaths by July 1

A projection made by the University of Washington, in the United States, points out that, until July 1, Brazil may reach the mark of 562.8 thousand deaths due to COVID-19. Until yesterday, the pandemic had already caused 331,433 deaths in the country, according to the Ministry of Health. The total number of confirmed cases reached 12,984,956. If the projection is confirmed, it will be an increase of 70.4% in just under three months.

The study, carried out by the Institute for Health Metrics and Evaluation (IHME), linked to the university, provides three scenarios. The number of 562,800 deaths refers to the most likely scenario, in which vaccines are distributed without delay, governments determine new restrictive measures lasting six weeks whenever the number of daily deaths exceeds 8 cases per million inhabitants ( today, this index reaches 13), vaccinated people stop using masks only three months after the second dose, among other variables.

In a more positive scenario, which considers the same points as the previous one, but with the difference that 95% of the population would be wearing masks, the estimated number of deaths drops to 507.7 thousand, which would still represent an expressive jump of 53, 7% in the number of victims, but also 55 thousand lives saved by the simple use of facial protection. However, changing behavior should not be easy, since the IHME estimate that today only 69% of Brazilians wear a mask whenever they leave home.

In the worst case scenario, in which more transmissible variants spread to places with no new strains registered and vaccinated people stop using masks one month after the second dose and increase their mobility at pre-pandemic levels, the estimated number of deaths is 597.7 thousand. The IHME model has been based on the health policies of the White House. Today, Brazil has the second largest number of victims in the world, behind the USA, with 554,500 deaths.

Or what or coronavrus

Coronaviruses are a large family of viruses that cause respiratory infections. The new coronavirus agent (COVID-19) was discovered in December 2019 in China. The disease can cause infections with symptoms initially similar to colds or flu, but with the risk of getting worse, which can result in death.
Video: Why you should not spread everything you receive on Whatsapp

How to COVID-19 transmitted?

The transmission of coronaviruses usually occurs by air or by personal contact with contaminated secretions, such as saliva droplets, sneezing, coughing, phlegm, close personal contact, such as touching or shaking hands, contact with contaminated objects or surfaces, followed by contact with mouth, nose or eyes.

Video: People without symptoms transmit the coronavirus?

How to prevent?

The recommendation is to avoid crowding, stay away from those with symptoms of respiratory infection, wash your hands frequently, cough with your forearm in front of your mouth and often use soap and water to wash your hands or gel alcohol after contact with surfaces and people. At home, take extra precautions against COVID-19.
Video: Flexibility of the isolation not ‘released general’; know why

What are the symptoms of coronavirus?

Check out the main symptoms of people infected with COVID-19:

  • Fever
  • Cough
  • Shortness of breath and difficulty breathing
  • Gastric problems
  • Diarrhea

In severe cases, victims have:

  • Pneumonia
  • Severe acute respiratory syndrome
  • Kidney failure

The types of symptoms for COVID-19 increase each week as the researchers move forward in identifying the behavior of the virus.

Video explains why you should ‘learn to cough’


Myths and truths about the virus

On social media, the spread of COVID-19 also spread rumors about how the vrus Sars-CoV-2 transmitted. And other doubts arose: Is alcohol gel capable of killing the virus? Is the coronavirus lethal at a worrying level? Can an infected person infect several others? Will the epidemic kill thousands of Brazilians, since SUS would not be able to serve everyone? We did a report with a doctor specializing in infectology and he explains all the myths and truths about the coronavirus.

Coronavirus and outdoor activities: video shows what science says

To learn more about the coronavirus, read also:

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