Brazil delays bivalent Covid booster rollout to 2023 amid expert debate

One death reported in a 72-year-old woman with comorbidities infected with BQ.1.1 subvariant in São Paulo.
The ministry says nothing, but what we're seeing in the Northern Hemisphere is exactly this update.
Julio Croda, a Fiocruz researcher, on Brazil's delayed response to bivalent vaccine rollout.

Pfizer and Moderna's bivalent vaccines targeting omicron BA.1 and BA.5 subvariants are already deployed in US, Canada, Europe, and Chile, but Brazil's Health Ministry has not approved rollout. New BQ.1.1 omicron subvariant detected in Brazil caused death of 72-year-old woman; experts warn cases will rise, prioritizing elderly and immunocompromised populations for updated vaccines.

  • Pfizer and Moderna bivalent vaccines targeting BA.1 and BA.5 omicron subvariants already deployed in US, Canada, Europe, and Chile
  • BQ.1.1 omicron subvariant identified in Brazil; caused death of 72-year-old woman with comorbidities in São Paulo
  • Pfizer submitted authorization request to Anvisa on August 19; no decision by mid-September
  • Brazil's Health Ministry has not defined vaccination strategy or dose quantities for 2023

Brazil lags behind global vaccination efforts as bivalent COVID-19 boosters targeting omicron variants remain unavailable, with health authorities still debating strategy while new subvariants circulate domestically.

By September 2022, much of the world had already moved on to a new chapter in the pandemic's vaccination story. Pfizer and Moderna had licensed updated boosters—vaccines reformulated to target the omicron variant's most prevalent subvariants, BA.1 and BA.5—and these shots were already in arms across the United States, Canada, Europe, and Chile. The original vaccines, designed around the ancestral coronavirus strain from Wuhan, were losing their edge against the newer forms of the virus, particularly when it came to preventing mild and moderate illness. Brazil, however, was not yet among them.

Inside Brazil's borders, a new omicron subvariant called BQ.1.1 had already appeared. It was identified in São Paulo, where it killed a 72-year-old woman with underlying health conditions. The same strain had surfaced in the Amazon region, Rio de Janeiro, and Rio Grande do Sul. Infectious disease specialists were warning that cases would climb in the coming weeks. Yet the Health Ministry, operating under President Jair Bolsonaro's administration, had offered no clear timeline for deploying the updated vaccines. The strategy for next year remained undefined, they said, as did the number of doses Brazil would need.

Julio Croda, an infectious disease researcher at Fiocruz, the country's leading public health institute, expressed frustration with the silence. "The ministry says nothing, but what we're seeing in the Northern Hemisphere is exactly this update with the bivalent vaccine," he said. "It would be valuable if this discussion had already started within the National Immunization Program for next year." Croda emphasized that the elderly—those over 80 in particular—faced the greatest risk of hospitalization and death even with existing boosters, and that any new vaccine rollout should prioritize these vulnerable groups first, as had been done before.

But the debate ran deeper than timing. Experts disagreed on fundamental questions about how often Brazilians would need these updated shots. Would they require boosters every four to six months, the typical window before protection against symptomatic COVID-19 began to wane? Or would an annual schedule, modeled on flu vaccination, suffice? Marco Aurélio Sáfadi, an infectious disease specialist and head of the immunization department at the Brazilian Pediatric Society, acknowledged that the original vaccines had done their job—they had dramatically reduced severe cases, hospitalizations, and deaths. But he also accepted that the virus's constant mutations meant new doses would be necessary. "The time until protection drops is relatively shorter for coronavirus vaccines than for other immunizations," he explained. "It's even shorter for mild cases, but even for severe disease, protection deteriorates over time. That's why booster doses become necessary."

Marcelo Gomes, a researcher and coordinator of Fiocruz's InfoGripe surveillance system, introduced another layer of uncertainty. It was impossible to predict which variants would dominate Brazil's autumn and winter in 2023, he said. "It will probably be a descendant of omicron, but we can't know which one." That uncertainty led him to argue that rolling out the bivalent vaccine now might be premature. The real priority, he contended, should be completing primary vaccination for those who had never finished their initial series—including children under five. "Weighing benefits against costs, a booster to restore 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, proposed a different angle: combine COVID and flu vaccination into a single campaign. One coordinated effort would spare people from making two separate trips to health clinics and would mobilize resources more efficiently. She also pushed back against the wait-and-see approach. "Even if we can't predict how the coronavirus will behave—and the last two and a half years have been atypical for a respiratory virus—three years is too long to rely on the original monovalent vaccine alone," she said. "We need to think about a bivalent booster strategy."

Meanwhile, the regulatory machinery moved slowly. Pfizer had submitted its request for authorization of the bivalent vaccine to Anvisa, Brazil's health surveillance agency, on August 19. By mid-September, there was still no decision. Anvisa said the application was under review and that it had asked medical societies to evaluate the data and provide recommendations. The agency noted it would also consider assessments from international regulators, and that any emergency authorization would still need approval from its board of directors. The Health Ministry, for its part, issued a statement saying the vaccination strategy for the coming year was still being discussed, without committing to any timeline. The country that had once led Latin America in vaccination speed now found itself waiting—while the virus continued to circulate and evolve.

The ministry says nothing, but what we're seeing in the Northern Hemisphere is exactly this update with the bivalent vaccine. It would be valuable if this discussion had already started within the National Immunization Program for next year.
— Julio Croda, infectious disease researcher, Fiocruz
Three years is too long to rely on the original monovalent vaccine alone. We need to think about a bivalent booster strategy.
— Rosana Richtmann, infectious disease specialist, Emílio Ribas Institute
The Hearth Conversation Another angle on the story
Inventor

Why is Brazil moving slower than other countries on this booster?

Model

The Health Ministry hasn't publicly explained their reasoning. But part of it seems to be genuine uncertainty—they're not sure if these boosters should be given every few months or once a year, and they're waiting to see which variants will actually dominate next winter.

Inventor

But people are already dying from the new variants.

Model

Yes. A 72-year-old woman in São Paulo died from BQ.1.1. But the experts are split on whether that means Brazil should rush the rollout now or wait until they have a clearer strategy. Some say the priority should be getting people their first two doses first.

Inventor

What would a smart strategy look like?

Model

Most of the doctors quoted seem to think combining COVID and flu shots into one annual campaign makes sense—it's efficient, and it mirrors how we handle influenza. But they also want to make sure the elderly and immunocompromised get priority.

Inventor

Is there a risk in waiting?

Model

There's always a risk in waiting during a pandemic. But there's also a risk in deploying a vaccine without knowing if you'll need to update it every four months or every year. That's partly why Anvisa is still reviewing the application.

Inventor

What happens if Brazil waits until 2023?

Model

By then, new variants may have emerged. But the experts seem to think that's manageable—as long as the strategy is clear and the vaccines are updated to match whatever's circulating. The real problem right now is the silence from the Health Ministry.

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