Vaccination remains the best strategy to prevent severe COVID
Em um momento em que o mundo busca equilibrar prevenção e tratamento na longa luta contra a COVID-19, o Brasil autorizou em 4 de maio de 2022 o uso emergencial do Molnupiravir, antiviral oral desenvolvido pela Merck Sharp & Dohme. A Anvisa aprovou o medicamento para adultos não hospitalizados com risco elevado de agravamento da doença, reconhecendo nele uma ferramenta adicional — mas não substituta — diante de uma pandemia que ainda exige vigilância coletiva. A vacina permanece, nas palavras dos próprios reguladores, o pilar insubstituível da proteção; o Molnupiravir chega para amparar aqueles que, mesmo assim, adoecem.
- Populações vulneráveis — idosos, imunossuprimidos, portadores de comorbidades — seguiam expostas a um risco desproporcional de hospitalização e morte mesmo após anos de pandemia, e o Brasil ainda não dispunha de um antiviral oral aprovado para uso domiciliar.
- A aprovação gerou atenção imediata por sinalizar uma mudança de paradigma: pela primeira vez, um paciente em casa, nos primeiros dias de sintomas, poderia ter acesso a um medicamento capaz de interromper a progressão da doença antes da internação.
- Reguladores foram enfáticos ao delimitar o que o medicamento não é — não é vacina, não é prevenção, não é tratamento para casos graves — evitando que a aprovação alimentasse hesitação vacinal ou uso indiscriminado.
- O caminho até o acesso público ainda é longo: o Molnupiravir precisa passar pela avaliação da Conitec antes de integrar o sistema público de saúde, deixando sua disponibilidade imediata restrita a quem pode arcar com o custo privado.
No dia 4 de maio de 2022, durante sua sétima reunião pública extraordinária, a Anvisa aprovou o uso emergencial do Molnupiravir, cápsula antiviral da Merck Sharp & Dohme destinada a adultos com COVID-19 leve a moderada e alto risco de agravamento. O medicamento atua interrompendo a replicação do vírus no organismo e, em ensaios clínicos, demonstrou reduzir hospitalizações e mortes entre os grupos mais vulneráveis.
A diretora responsável pela avaliação, Meiruze Freitas, votou pela aprovação, mas fez questão de situar o medicamento em seu lugar correto: um recurso terapêutico para quem já está doente, não uma alternativa à vacinação. Pessoas sem esquema vacinal completo ou sem dose de reforço, alertou ela, continuam significativamente mais expostas às formas graves da doença.
O Molnupiravir não é novidade no cenário global — já estava aprovado em mais de vinte países, incluindo Estados Unidos, Reino Unido e nações da União Europeia, e recebeu recomendação condicional da Organização Mundial da Saúde em março de 2022, com monitoramento contínuo de segurança. As restrições de uso são rigorosas: apenas adultos, com prescrição médica, iniciando o tratamento em até cinco dias após o início dos sintomas, por exatamente cinco dias, na dose de 800 mg a cada doze horas. O medicamento é contraindicado na gravidez, na amamentação e para mulheres em idade fértil sem contracepção eficaz, dado o risco ao desenvolvimento fetal observado em altas doses.
Antes de chegar ao sistema público de saúde, o antiviral ainda precisará ser avaliado pela Comissão Nacional de Incorporação de Tecnologias no SUS. Até lá, permanece disponível apenas pela via privada — um detalhe que define, por ora, quem de fato poderá acessá-lo.
Brazil's health regulator gave the green light on May 4th to Molnupiravir, an antiviral capsule made by American pharmaceutical company Merck Sharp & Dohme. The approval came during the agency's seventh extraordinary public meeting, and it marks another tool in the country's arsenal against COVID-19—though regulators were careful to emphasize what it is not.
The drug is designed for adults who are sick enough to need treatment but not so sick they require supplemental oxygen. More specifically, it targets people at high risk of developing severe disease: those with underlying conditions, advanced age, or other factors that make them vulnerable to the worst outcomes. The medication comes as a capsule and works by interfering with the virus's ability to replicate inside the body. Clinical trials showed it could reduce hospitalizations and deaths among this population.
Meiruze Freitas, the director who led the evaluation, voted for approval but made a point of clarifying the drug's place in the broader pandemic response. Vaccination, she stressed, remains the most effective way to prevent severe COVID-19, hospitalization, and death. People who have not completed their full vaccination course, or who lack booster shots, face significantly higher risks of moderate to severe illness compared to those who are fully protected—especially the most vulnerable. The message was clear: Molnupiravir is a treatment option for people who are already sick, not a substitute for prevention.
The medication is not new to the world. It has already been approved in the United States, United Kingdom, Europe, Japan, and Australia, and is currently in use across at least twenty countries. The World Health Organization issued a conditional recommendation for it in early March, meaning the drug's safety continues to be monitored as it circulates more widely. Regulatory agencies are still conducting additional studies and tracking potential side effects, even as the drug moves into broader use.
There are strict rules around how and when it can be used. The drug is for adults only and requires a doctor's prescription. It cannot be used during pregnancy or breastfeeding, and women of childbearing age who are not using effective contraception should not take it—studies showed that high doses can affect fetal development. The treatment window is narrow: patients must start taking it within five days of symptom onset, and the course lasts exactly five days. The dosage is 800 milligrams every twelve hours, taken by mouth, with or without food. The five-day limit exists partly to prevent the virus from developing resistance to the drug.
The medication is not approved for children under eighteen, for people already hospitalized with severe COVID-19, or for preventing infection in people who have been exposed. It is meant for people at home, in the early stages of illness, who meet the risk criteria. Pharmacists dispensing the drug must counsel patients on its importance, how to take it correctly, and the fact that it is for individual use only—it cannot be shared with others without a doctor's evaluation and new prescription.
Before Molnupiravir can be added to Brazil's public healthcare system, it must now go through another evaluation process by the National Commission for Health Technology Incorporation. That step will determine whether the government will make it available to patients who cannot afford to buy it privately. In the meantime, it is available through emergency authorization, which means patients and doctors can access it, but its long-term role in the country's COVID response remains to be decided.
Notable Quotes
It is important to have therapeutic options for certain clinical conditions, especially for individuals who have high risk of developing severe forms of the disease— Meiruze Freitas, Anvisa director and rapporteur on the approval
Vaccination continues to be the best strategy to prevent severe COVID, hospitalizations and deaths— Meiruze Freitas, Anvisa director
The Hearth Conversation Another angle on the story
Why does this drug need emergency approval if it's already been used in twenty countries?
Emergency approval is a pathway that lets a country move faster than the standard review process. Brazil's regulator can authorize use while continuing to gather safety data. It's not that the drug is unproven—it's that the formal, lengthy approval process would take longer than the public health situation allows.
The article mentions that vaccination is still the best prevention. Does that mean this drug is a second choice?
Not exactly. This drug is for people who are already sick. Vaccination prevents infection or severe disease in the first place. They're different tools for different moments. If you're vaccinated and still get sick, Molnupiravir might help you avoid hospitalization. If you're unvaccinated and get sick, you're at much higher risk of needing it.
Why the five-day limit? Why can't people take it longer?
Two reasons. First, the clinical trials only showed benefit when started early—within five days of symptoms. After that window, the virus has already established itself and the drug doesn't help as much. Second, longer use could encourage the virus to mutate and become resistant to the drug. You want to use it strategically, not indefinitely.
The restrictions on pregnancy seem serious. How serious?
Serious enough that the regulator is explicit about it. Animal studies showed the drug can affect fetal development at high doses. There's not enough human data yet to say it's safe in pregnancy, so the agency is taking the precautionary approach. That's why women of childbearing age who aren't using contraception can't use it.
What happens next? Is this drug going to be available to everyone in Brazil?
Not automatically. It has emergency authorization now, which means it can be prescribed and used. But for it to be included in the public healthcare system—where the government pays for it—it has to go through another evaluation. That commission will look at cost, effectiveness, and whether it makes sense to fund it publicly. Until then, it's available mainly to people who can pay for it.