The ministry says nothing, but what we're seeing in the Northern Hemisphere is precisely this update
Enquanto países como Estados Unidos, Canadá e Chile já distribuem doses bivalentes contra a Covid-19 — formuladas para enfrentar o Ômicron —, o Brasil permanece à espera de uma aprovação regulatória que a Anvisa ainda não concedeu, meses após o pedido da Pfizer. É uma pausa que carrega peso: novas subvariantes circulam no país, uma idosa já morreu em São Paulo, e o Ministério da Saúde não apresentou estratégia clara para 2023. Na história longa das epidemias, a demora burocrática e a ausência de planejamento raramente poupam os mais vulneráveis.
- A Pfizer protocolou o pedido de autorização da vacina bivalente na Anvisa em 19 de agosto, mas novembro chegou sem resposta — enquanto outros países já vacinavam suas populações.
- A subvariante BQ.1.1 do Ômicron já circula em São Paulo, no Amazonas, no Rio de Janeiro e no Rio Grande do Sul, e uma mulher de 72 anos morreu após contrair a cepa em São Paulo.
- Especialistas da Fiocruz e de outras instituições alertam que idosos acima de 80 anos enfrentam risco desproporcionalmente alto de hospitalização e morte, mesmo com os reforços atuais.
- O Ministério da Saúde não definiu estratégia de vacinação para 2023, e pesquisadores divergem sobre o ritmo ideal de reforços — a cada quatro a seis meses ou anualmente, como a gripe.
- Enquanto alguns especialistas defendem iniciar já a vacinação bivalente priorizando grupos de risco, outros recomendam completar primeiro as séries primárias e vacinar crianças menores de cinco anos ainda sem imunização.
A Pfizer pediu à Anvisa, em agosto, autorização para a vacina bivalente contra a Covid-19 — um imunizante de reforço desenvolvido para combater tanto a cepa original do coronavírus quanto as subvariantes do Ômicron. Meses depois, a aprovação ainda não veio. Enquanto isso, Estados Unidos, Canadá, Europa e Chile já administram essas doses atualizadas em suas populações. No Brasil, a subvariante BQ.1.1 já foi detectada em São Paulo, no Amazonas, no Rio de Janeiro e no Rio Grande do Sul. Uma mulher de 72 anos com comorbidades morreu após contrair a cepa em São Paulo.
Especialistas ouvidos pela reportagem apontam para uma lacuna preocupante: o Ministério da Saúde, sob o governo Bolsonaro, não apresentou nenhuma estratégia de vacinação para 2023. Julio Croda, infectologista e pesquisador da Fiocruz, defende que o debate precisa começar agora, dentro do Programa Nacional de Imunizações, e que, caso a bivalente chegue ao Brasil, os idosos — especialmente os acima de 80 anos — devem ser priorizados, como ocorreu ao longo de toda a pandemia.
A questão do ritmo dos reforços também permanece em aberto. Marco Aurélio Sáfadi, da Sociedade Brasileira de Pediatria, explica que o coronavírus perde eficácia vacinal mais rapidamente do que outros patógenos, especialmente contra casos leves. A comparação com a gripe é tentadora, mas imperfeita: a influenza tem pico sazonal previsível; a Covid pode exigir um calendário próprio. Já Marcelo Gomes, da Fiocruz, pede cautela — é impossível saber qual variante dominará o outono e o inverno brasileiros de 2023, e completar séries primárias e vacinar crianças pequenas pode ser prioridade mais urgente do que reforços bivalentes.
Rosana Richtmann, do Instituto Emílio Ribas, propõe unir as campanhas de vacinação contra Covid e gripe para reduzir a sobrecarga sobre profissionais de saúde e pacientes. Ela argumenta que, independentemente da incerteza sobre variantes futuras, três anos é tempo demais para depender exclusivamente da vacina original. A Anvisa confirmou que o pedido da Pfizer segue em análise e que sociedades médicas foram consultadas. O Ministério da Saúde disse que a estratégia para 2023 ainda está sendo discutida. Por ora, o Brasil espera enquanto o mundo avança.
Pfizer filed its request to bring a new COVID-19 vaccine to Brazil on August 19th. It is now November, and the country's health regulator, Anvisa, has not yet said yes. Meanwhile, the rest of the world has moved on.
The vaccine in question is bivalent—a booster shot designed to protect against both the original coronavirus strain and the Omicron variant, specifically its BA.1 and BA.5 subvariants, which are currently the most common forms circulating globally. The original vaccines, formulated in the pandemic's first year, were built to fight a virus that no longer dominates. They still work, but their effectiveness against mild and moderate illness has eroded. The United States, Canada, Europe, and Chile have already begun administering these updated boosters. In Brazil, a newer Omicron subvariant called BQ.1.1 has appeared in São Paulo, the Amazon region, Rio de Janeiro, and Rio Grande do Sul. A 72-year-old woman with underlying health conditions died after contracting it in São Paulo.
Infectologists and public health researchers say Brazil should follow the path other nations have taken. Julio Croda, an infectious disease specialist and researcher at Fiocruz, the country's leading research institute, notes that the Health Ministry under President Jair Bolsonaro has offered no clear strategy for vaccination in 2023. "The ministry says nothing, but what we're seeing in the Northern Hemisphere is precisely this update with the bivalent vaccine," Croda said. "It would be worthwhile to begin this discussion now within the National Immunization Program for next year." The elderly face the greatest risk—people over 80 have a substantially higher chance of hospitalization and death even with current boosters compared to younger, unvaccinated people. Croda argues that if the bivalent vaccine does arrive in Brazil, it should prioritize these groups first, as they have been prioritized throughout the pandemic.
But questions remain unresolved. No one yet knows whether these updated vaccines will need to be administered every four to six months—the typical window before protection against symptomatic COVID drops—or whether an annual schedule, like the flu shot, will suffice. Marco Aurélio Sáfadi, an infectious disease specialist and head of the immunization department at the Brazilian Pediatric Society, explains that the coronavirus behaves differently from other pathogens. Protection wanes faster than with most vaccines, and it wanes even faster against mild illness. "The vaccine did its job of drastically reducing severe cases, hospitalizations, and deaths," Sáfadi said. "It was always expected that new applications would be necessary to keep pace with the virus's mutations." Flu vaccines typically protect for about six months, but because influenza peaks in winter, one annual shot usually covers the season. COVID may demand a different rhythm—possibly seasonal boosters once the virus becomes endemic rather than pandemic.
Marcelo Gomes, a researcher and coordinator of Fiocruz's InfoGripe surveillance system, cautions against rushing. It is impossible to predict which variants will dominate Brazil's autumn and winter in 2023. "It will probably be a descendant of Omicron, but we can't know which one," Gomes said. He suggests that starting bivalent vaccination now may be premature. The real priority, he argues, should be completing primary vaccination series for those who have not finished them and reaching children under five, who remain largely unvaccinated. "Analyzing benefits against costs, giving a booster to recover immunity is better, but it's not essential right now," he said.
Rosana Richtmann, an infectious disease specialist at the Emílio Ribas Institute of Infectious Diseases, proposes a different approach: combine COVID and flu vaccination into a single campaign. This would reduce the burden on health workers and patients, who would not need to visit clinics twice. Even if the coronavirus's future behavior remains uncertain—the past two and a half years have been atypical for a respiratory virus—she believes Brazil should plan for updated vaccines. "We're already seeing an increase in cases in Brazil, but even if the next dominant virus isn't the same one circulating now, three years is too long to rely on the original vaccine alone," Richtmann said. "We need to think about the bivalent booster strategy."
The Health Ministry responded to inquiries with a statement saying that vaccination strategy for next year remains under discussion by the National Immunization Program, as does the number of doses needed to maintain COVID protection. The ministry emphasized the importance of completing primary vaccination and receiving boosters for maximum protection. Anvisa, for its part, confirmed that Pfizer's application is still under review and that the agency has asked medical societies to evaluate the data and provide recommendations. The regulator also noted that it considers assessments from international health agencies and that any emergency authorization would still require approval from its board of directors. For now, Brazil waits while the world moves ahead.
Citações Notáveis
The ministry says nothing, but what we're seeing in the Northern Hemisphere is precisely this update with the bivalent vaccine. It would be worthwhile to begin this discussion now within the National Immunization Program for next year.— Julio Croda, infectious disease specialist and researcher at Fiocruz
Three years is too long to rely on the original vaccine alone. We need to think about the bivalent booster strategy.— Rosana Richtmann, infectious disease specialist at Emílio Ribas Institute
A Conversa do Hearth Outra perspectiva sobre a história
Why is Brazil moving so slowly on this vaccine when other countries have already started?
Anvisa, the regulatory agency, received Pfizer's request in August and hasn't approved it yet. They're asking medical societies for input, which takes time. But there's also a deeper question—some experts think Brazil shouldn't rush at all.
What do you mean, shouldn't rush? People are dying from new variants.
One death has been reported from the BQ.1.1 subvariant. That's serious, especially for elderly people. But some researchers argue that the real priority right now is getting people who haven't finished their primary series vaccinated at all, including children under five. The bivalent booster is important, but it's not the emergency.
So it's a question of resources and priorities?
Partly. But it's also about uncertainty. We don't know which variant will dominate next winter. If you're going to update the vaccine, you want to be targeting the right threat. Waiting until early 2023 might actually be smarter than rushing now.
What about the elderly? They're clearly at risk.
Absolutely. People over 80 face much higher hospitalization and death rates even with current boosters. If the bivalent vaccine does arrive, it should go to them first. But the question is whether that happens in December or January—and whether it matters.
And the ministry just... hasn't decided anything yet?
Not publicly. They say the strategy is still under discussion. Which is frustrating for doctors and researchers who want a clear plan, but it also reflects the real difficulty of predicting how an evolving virus will behave.