No other product currently serves this preventive purpose for people who cannot generate an adequate immune response
Em meio à pandemia que testou os limites da medicina moderna, o Brasil deu um passo silencioso mas significativo em favor daqueles que a vacinação em massa não conseguiu alcançar. A Anvisa aprovou na quinta-feira o uso emergencial do Evusheld, um tratamento com anticorpos monoclonais da AstraZeneca destinado a pacientes imunocomprometidos que não desenvolvem resposta imune adequada às vacinas disponíveis. É um reconhecimento de que a proteção coletiva, por mais abrangente que seja, sempre deixa à margem os mais vulneráveis — e de que a ciência tem a obrigação de voltar seu olhar para eles.
- Milhares de brasileiros imunocomprometidos enfrentaram a pandemia sem proteção efetiva, pois suas condições — cânceres, transplantes, HIV avançado — os impediam de responder adequadamente às vacinas.
- O Evusheld chega como resposta direta a essa lacuna crítica: dois anticorpos sintéticos, cilgavimabe e tixagevimabe, que imitam as defesas naturais do organismo e neutralizam o vírus antes que ele se replique.
- A aprovação é emergencial e restrita a perfis clínicos específicos, o que reflete tanto a urgência da necessidade quanto a cautela regulatória diante de um medicamento ainda em avaliação contínua.
- A Anvisa comprometeu-se a monitorar a segurança de longo prazo e a eficácia contra novas variantes, reconhecendo que a aprovação de hoje é um ponto de partida, não uma certeza definitiva.
- Para a diretoria da agência, o Evusheld não substitui vacinas — ele preenche um espaço que nenhum outro produto disponível no país conseguia ocupar, oferecendo uma camada adicional de defesa a quem mais precisa.
A Anvisa aprovou na quinta-feira o uso emergencial do Evusheld, medicamento da AstraZeneca que representa a primeira opção preventiva contra a COVID-19 voltada especificamente a pacientes com sistemas imunológicos gravemente comprometidos. O tratamento não é uma vacina nem pretende substituí-la — seu propósito é proteger aqueles cujos corpos simplesmente não conseguem responder à imunização convencional.
O Evusheld é composto por dois anticorpos produzidos em laboratório, cilgavimabe e tixagevimabe, aplicados por injeção intramuscular. Eles atuam ligando-se à proteína spike do vírus e impedindo sua replicação, tendo demonstrado eficácia contra múltiplas variantes do SARS-CoV-2, incluindo a Ômicron. Os efeitos colaterais mais comuns nos ensaios clínicos foram dor de cabeça, fadiga e tosse, com perfil de segurança considerado aceitável pelos reguladores, que mantiveram atenção especial a possíveis complicações cardíacas.
O público elegível é amplo em sua especificidade: pacientes com tumores sólidos ou cânceres hematológicos, transplantados, pessoas com imunodeficiências primárias graves como as síndromes de DiGeorge ou Wiskott-Aldrich, receptores de transplante de células-tronco nos últimos dois anos, e indivíduos em uso de corticoides em altas doses, quimioterápicos ou imunossupressores biológicos. O tratamento se aplica a maiores de 12 anos ou com peso acima de 40 quilogramas que não tenham tido contato recente com casos confirmados de COVID-19.
A presidente em exercício da Anvisa, Meiruze Sousa Freitas, destacou que nenhum outro produto disponível no Brasil cumpria essa função preventiva para quem não responde às vacinas ou é alérgico a seus componentes. A agência comprometeu-se a acompanhar os dados de segurança a longo prazo — com atenção especial ao uso em adolescentes — e a reavaliar a eficácia do medicamento conforme novas variantes surjam. Para os milhares de brasileiros imunocomprometidos que permaneceram desprotegidos ao longo da pandemia, o Evusheld representa, finalmente, uma resposta à altura de sua vulnerabilidade.
Brazil's health regulator gave the green light on Thursday to a new preventive treatment for people whose immune systems are too compromised to benefit from standard COVID-19 vaccines. The drug, called Evusheld, is made by AstraZeneca and represents the first medicine of its kind available in the country designed specifically to shield vulnerable patients from coronavirus infection.
Evusheld is not a vaccine replacement and was never intended to be. Instead, it targets a narrow but critical population: people whose bodies cannot mount an adequate immune response to vaccination because of cancer, organ transplants, advanced HIV, or medications that suppress immunity. The treatment consists of two laboratory-engineered antibodies—cilgavimab and tixagevimab—that are injected into muscle tissue. These synthetic antibodies work by mimicking the body's natural defenses, binding to the spike protein on the virus surface and preventing it from replicating inside human cells. In laboratory tests, both antibodies proved capable of neutralizing multiple variants of the coronavirus, including Omicron.
The approval applies to patients aged 12 and older, or weighing at least 40 kilograms, who have not recently been exposed to someone with COVID-19. Anvisa's pharmaceutical director, Gustavo Mendes Lima Santos, explained that the two monoclonal antibodies are engineered to latch onto the virus's spike protein and render it inert. Clinical trials showed that the most common side effects were headache, fatigue, and cough—none occurring at particularly high rates. Regulators paid special attention to potential heart complications, a concern across all COVID-19 treatments, and found the safety profile acceptable, though they acknowledged the need for continued monitoring.
The list of eligible patients is specific and extensive. They include people undergoing treatment for solid tumors or blood cancers; those recovering from organ transplants or receiving immunosuppressive therapy; individuals with moderate to severe primary immunodeficiency disorders such as DiGeorge or Wiskott-Aldrich syndrome; people who received stem cell transplants within the past two years; and those taking high-dose steroids, chemotherapy agents, or biological drugs that suppress immune function. The treatment can also be given to patients with untreated advanced HIV or those on certain cancer medications classified as severely immunosuppressive.
Meiruze Sousa Freitas, Anvisa's acting president, voted in favor of the approval, noting that while Brazil has access to innovative vaccines, no other product currently available serves this specific preventive purpose for people who cannot generate an adequate immune response to vaccination or who are allergic to vaccine components. She framed Evusheld as an additional tool in the pandemic response—one that could reduce individual risk, prevent outbreaks, and slow viral spread in a population that has been largely left unprotected by existing interventions.
The regulator has committed to monitoring the drug's long-term safety profile, with particular attention to adolescents, and will reassess its effectiveness as new virus variants emerge. Ongoing clinical trials are expected to resolve remaining questions about the treatment's performance. For now, Evusheld fills a gap that has left thousands of severely immunocompromised Brazilians vulnerable to a virus that poses an outsized threat to their survival.
Citas Notables
We are talking about two human IgG1 monoclonal antibodies—antibodies modified and used to bind to the spike protein of the virus to prevent it from replicating, neutralizing it.— Gustavo Mendes Lima Santos, Anvisa's pharmaceutical director
In the context of a pandemic, the use of a new product in COVID-19 prophylaxis can provide one more strategy for population protection, serving as an additional tool to minimize individual risks, reduce outbreaks, and control virus spread.— Meiruze Sousa Freitas, Anvisa's acting president
La Conversación del Hearth Otra perspectiva de la historia
Why does this drug matter if we already have vaccines?
Because vaccines don't work for everyone. For severely immunocompromised people—those with cancer, on transplant medications, with advanced HIV—their bodies simply can't generate the immune response a vaccine requires. They're left unprotected.
So this is a substitute for vaccination?
No, it's something entirely different. It's a preventive injection of ready-made antibodies. You're not training the immune system; you're giving it the tools it needs right away.
How long does it last?
The source doesn't specify duration, but it's given as a single intramuscular injection. Whether it needs repeating isn't yet clear.
What about side effects?
Mostly mild—headache, fatigue, cough. Regulators were especially careful about heart complications, which is a known concern with COVID treatments. The safety profile looked acceptable, but they're watching closely.
Who exactly can get it?
People 12 and up with specific conditions: cancer patients, organ transplant recipients, people with primary immunodeficiency, those with advanced untreated HIV, or anyone on medications that suppress immunity. You also can't have recently been exposed to someone with COVID.
What happens now?
Anvisa will monitor how it performs in the real world, especially in teenagers, and watch whether it still works against new variants. Clinical trials are still ongoing to answer remaining questions.