Brazil hopes local vaccines to boost Covid vaccinations

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In the grip of a Covid-19 disaster and with a vaccination campaign troubled by shortages, Brazilian scientists hope local vaccines can provide a vital weapon against the pandemic.

A handful of nationally-developed jabs have been submitted to health regulators with requests to start clinical trials in Latin America’s largest country, where the death toll from the respiratory disease has exceeded 400,000.

Brazil is lagging behind in the international race to develop Covid-19 vaccines, but proponents of the projects say they could boost the country’s self-sufficiency during a global rush for vaccinations and even lead to a surplus in the country. ‘export.

“Our duty is to provide vaccines not only for Brazil but for the region,” said Ricardo Palacios, director of clinical medical research at the Butantan Institute in São Paulo.

The biomedical research center started producing one of the most advanced candidates last week. Based on existing influenza vaccine technology and touted as inexpensive, ButanVac uses as a vector a genetically engineered virus that causes Newcastle disease, which affects birds but not humans.

Containing a peak coronavirus protein, which induces an immune response in hosts, the material is grown in chicken eggs and then extracted and inactivated.

“There is one trick that is essential in this process. We need to stabilize the spike protein in order to make more of it. . . relevant, ”said Palacios.

Butantan incorporates knowledge of new coronavirus variants, which include the more contagious P.1 strain that has ravaged Brazil. The institute expects to have 18 million doses ready by mid-June, with a possibility of 100 million before the end of the year – ambitious given that other vaccine delivery schedules in Brazil have experienced setbacks.

While not entirely Brazilian – the underlying technology was created by two US universities and the international consortium includes manufacturing partners in Vietnam and Thailand – production of ButanVac will not require imported materials, Palacios said. .

“It is easy to produce and is more or less plug and play, because we already have the flu [manufacturing] plant.”

The discovery and commercialization of new vaccines in Brazil would mean a break with the “deindustrialisation” of its capacities in this field since the 1980s, according to Julio Croda, infectious disease specialist at the Oswaldo Cruz Foundation (Fiocruz), another biomedical research center.

Latin America’s largest economy has largely outsourced the development and production of active pharmaceutical ingredients (APIs), which give a drug its properties, Croda said.

“We have never made this investment in Brazil to develop a [vaccine] product. In the past, we imported the API and bottled it. “

This model was put to the test during the pandemic. Butantan and Fiocruz have supplied most of the Brazilian vaccines through partnerships to manufacture the Chinese vaccines CoronaVac and Oxford / AstraZeneca, respectively. But both have experienced delays in API shipments from China and aim to start making key entries from scratch.

While 14% of Brazil’s population of 213 million has received at least one vaccine and the government has contracted more than enough for everyone, supply constraints have slowed the pace of injections, with some people having struggling to get a second dose.

Health minister Marcelo Queiroga said last week that the entire nation could be vaccinated by the end of the year, but called on countries with spare supplies to share them with Brazil.

President Jair Bolsonaro has drawn international opprobrium for his handling of the health crisis, decreasing the severity of Covid-19 and failing to ensure adequate vaccine stocks on time.

On the day ButanVac was unveiled in March, the federal government announced that a gunshot it was funding had requested permission to conduct human testing.

Versamune-CoV-2FC was developed by the Brazilian company Farmacore in partnership with the Ribeirão Preto Medical School at the University of São Paulo and PDS in the United States.

It contains an artificially produced recombinant protein, a common basis for many pharmaceuticals, which is derived from the coronavirus. This is combined with microscopic oily droplets called lipid nanoparticles which act as a carrier.

Helena Faccioli, Managing Director of Farmacore, called it “unique in the world”.

“There are other vaccines that use adjuvants with the S1 coronavirus protein, but have no ability to activate T cells,” she said, referring to a type of white blood cell that plays a role. important role in the immune system.

Along with the challenge of increasing manufacturing capacity, Brazilian researchers say the lack of funding is a major obstacle to getting new vaccines on the line. The country has cut spending on scientific research from a peak of nearly R $ 14 billion ($ 2.6 billion) in 2015 to R $ 5 billion last year, according to Senate figures.

“If we had invested, we wouldn’t be in this situation. But at the moment, there is no alternative. Either we buy the API or we buy ready-to-use vials, ”said Soraya Smaili, professor of pharmacology and rector of the Federal University of São Paulo. The facility is collaborating on a nasal spray vaccine that does not require a needle or syringe.

“These [new] the vaccines will not be used immediately, as they have not yet started clinical trials, ”added Smaili. “Everything indicates that this situation will continue next year.”

Another hurdle is the regulatory approval of the Brazilian drug watchdog, Anvisa, which requested more documentation before authorizing clinical testing of ButanVac.

Its decision last week to reject Sputnik V imports over security concerns and a lack of information sparked a furious backlash from Russian developers of the jab, who claimed the move was politically motivated and threatened to prosecute. the agency for defamation.

If approval for human trials of a vaccine were to be granted in May, leading to late Phase 3 trials in a few months, a candidate could potentially be released for emergency use later in the year, a said Peter Hotez, co-director of the Center for Vaccine Development at Texas Children’s Hospital.

“They have a lot of potential [in Brazil]. For me, it’s a little disappointing that they aren’t further along at this point, ”he said. “They’re doing the right thing, but it’s terribly delayed.”

Additional reporting by Carolina Pulice

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