We are open to discussions, we have shared all requirements
Em meio à maior crise sanitária do século, o Brasil deu passos regulatórios significativos na sexta-feira, 12 de março de 2021, quando a Anvisa aprovou o antiviral remdesivir para pacientes hospitalizados e concedeu registro definitivo à vacina Oxford-AstraZeneca. A decisão reflete a tensão permanente entre a urgência de respostas terapêuticas e a cautela científica — afinal, a própria Organização Mundial da Saúde havia desaconselhado o remdesivir meses antes por falta de evidências robustas. O país navega, assim, entre a necessidade imediata de ferramentas contra a pandemia e a responsabilidade de garantir que essas ferramentas sejam seguras e eficazes.
- A Anvisa aprovou o remdesivir mesmo após a OMS ter emitido, em novembro de 2020, uma advertência contra seu uso clínico por insuficiência de evidências — uma tensão regulatória que expõe os limites do conhecimento científico em tempo real.
- O acesso ao medicamento será restrito: apenas pacientes hospitalizados com suporte de oxigênio, com 12 anos ou mais e peso mínimo de 40 kg, ficando fora do alcance de casos menos graves.
- A vacina Oxford-AstraZeneca, já em uso emergencial pelo instituto Fiocruz, recebeu registro definitivo — um sinal de normalização institucional em meio ao caos ainda presente.
- A Sputnik V permanece em compasso de espera: a Anvisa exige dados de segurança que a União Química e os russos ainda não forneceram, deixando a aprovação suspensa por omissão do fabricante.
- No horizonte, duas universidades federais — em Minas Gerais e no Rio de Janeiro — desenvolvem vacinas nacionais em estágio pré-clínico, com apoio científico da Anvisa, sinalizando que a soberania sanitária do Brasil pode depender de sua própria capacidade de inovar.
Na sexta-feira, 12 de março de 2021, a Anvisa anunciou duas decisões que marcaram o esforço brasileiro de enfrentamento à pandemia. O chefe da divisão de medicamentos da agência, Gustavo Mendes, comunicou a aprovação do remdesivir — um antiviral originalmente desenvolvido contra o Ebola — para o tratamento de pacientes com COVID-19 internados e dependentes de suporte de oxigênio. O medicamento não estará disponível em farmácias: seu uso ficará restrito a pacientes com 12 anos ou mais e peso mínimo de 40 quilogramas. Estudos indicaram recuperação em cerca de dez dias, embora com efeitos colaterais gastrointestinais relatados. A aprovação ocorre apesar de a OMS ter desaconselhado o remdesivir em novembro de 2020, alegando que as evidências clínicas disponíveis eram insuficientes para confirmar seu papel no tratamento.
No mesmo dia, a vacina Oxford-AstraZeneca recebeu registro definitivo da Anvisa, consolidando o que já era uma realidade prática: o imunizante vinha sendo produzido pela Fiocruz e aplicado em caráter emergencial em todo o país. Mendes também mapeou o cenário das demais vacinas. A Janssen concluiu os testes de fase três com aval da agência e aguarda apenas o pedido formal de registro. Moderna e Covaxin, embora sem solicitações formais no Brasil, não encontrariam obstáculos caso as empresas decidissem avançar, dado o reconhecimento internacional já obtido.
A Sputnik V, por outro lado, permanece em impasse. A Anvisa fez exigências específicas sobre os estudos realizados e aguarda respostas da União Química e dos parceiros russos. Mendes foi claro: a responsabilidade de fornecer os dados de segurança é da empresa. Enquanto isso, duas universidades federais — uma em Minas Gerais, outra no Rio de Janeiro — desenvolvem vacinas próprias em estágio pré-clínico, com orientação científica da Anvisa. Para Mendes, é justamente nessa capacidade de desenvolver soluções domésticas que reside parte do caminho de saída da crise.
Brazil's health regulator moved on two fronts against the pandemic on Friday, March 12th. The National Health Surveillance Agency, known as Anvisa, granted approval for remdesivir, an antiviral drug, to treat COVID-19 patients. On the same day, the agency finalized its registration of the Oxford-AstraZeneca vaccine, which had already been circulating through the state-run Fiocruz institute and administered under emergency protocols across the country.
Gustavo Mendes, the head of Anvisa's medication division, made the announcements. Remdesivir will not be sold in pharmacies. Instead, it will be reserved for patients who require oxygen support—those aged 12 and older and weighing at least 40 kilograms. The specifics of how the drug would be administered had not yet been detailed.
Remdesivir began as a treatment for Ebola but showed promise in early laboratory tests against the new coronavirus. Studies indicated that infected patients recovered quickly, typically within about ten days of viral exposure, though some experienced gastrointestinal side effects. Brazil had been studying the drug since June 2020. There was, however, a complication: in November 2020, the World Health Organization issued a cautionary statement against using remdesivir, citing insufficient robust evidence from clinical trials. The WHO said at the time that the drug's role in actual clinical practice remained uncertain.
Mendes also surveyed the landscape of other vaccines seeking approval in Brazil. The Janssen vaccine had passed its phase three testing with Anvisa's approval; the company now needed only to formally request registration or emergency use authorization. Moderna's manufacturer had made no request for import authorization, emergency use, or registration, yet Mendes indicated Anvisa would not obstruct the vaccine's use, given that international health agencies had already approved it elsewhere. Covaxin faced a similar situation.
The Sputnik V vaccine, manufactured by União Química in the Federal District, presented a different problem. Anvisa had made specific demands regarding the studies conducted and had not yet received responses. Mendes emphasized that it was União Química's responsibility to provide safety information. "Our status today is: we are open to discussions with União Química, we have shared all necessary requirements, and the expectation is that the next steps will be taken by the company and the Russians so we can continue our evaluation and ensure that the data on quality, safety, and efficacy are approvable," he said.
Beyond these established pharmaceutical efforts, Mendes noted that Anvisa had been in contact with other companies, though negotiations remained stalled on the manufacturers' side. Two federal universities—one in Minas Gerais and one in Rio de Janeiro—were developing their own vaccines in preclinical stages. Mendes described Anvisa's role as providing scientific support and guidance to help these domestic efforts advance. "It is through this kind of strategy that we will get out of this kind of situation," he said, suggesting that Brazil's path forward depended not only on international pharmaceutical approvals but also on homegrown vaccine development.
Notable Quotes
Its role in clinical practice remains uncertain— World Health Organization, November 2020, on remdesivir
It is through this kind of strategy that we will get out of this kind of situation— Gustavo Mendes, Anvisa, on supporting domestic vaccine development
The Hearth Conversation Another angle on the story
Why restrict remdesivir only to patients needing oxygen? Doesn't that leave milder cases without options?
The approval was based on where the drug showed its clearest benefit—in people sick enough to require oxygen support. That's where the evidence was strongest. But you're right: it means people with moderate illness fall into a gap.
And the WHO said not to use it. How does Anvisa approve something the WHO cautioned against?
The WHO was saying the evidence wasn't robust enough. Anvisa looked at the same data and decided it was sufficient for approval under these specific conditions. Different regulators, different thresholds. Both are being cautious, just in different ways.
The Oxford vaccine was already being used. What does "final registration" actually change?
It moves it from emergency authorization to permanent approval. Legally and administratively, it's a different status—more stable, more official. But on the ground, people were already getting it.
What about Sputnik V? Why is that one stuck?
União Química needs to submit more safety data. Anvisa has been clear about what they need. It's not a refusal—it's a waiting game. The Russians and the manufacturer have to move next.
These university vaccines—are they realistic?
They're in very early stages. But Anvisa is supporting them, which matters. If Brazil can develop its own vaccine, it changes the entire dependency equation. That's why Mendes emphasized it.