Latin America Roundup: PAHO says Latin American countries lagging on routine vaccinations

The Pan American Health Organization (PAHO) warns that national immunization programs across Latin America and the Caribbean have failed to sustain routine vaccination coverage, in part due to the pandemic, leaving as many as 2.7 million children vulnerable to preventable diseases including diphtheria, tetanus, whooping cough and potentially polio. One in five children across the region have not received all their vaccines, according to PAHO data from 2021, and two countries – Brazil and Mexico – account for more than half of children in the region who have never been vaccinated against any disease.

In a news conference on Thursday, PAHO Director Jarbas Barbosa described several reasons for these setbacks, among them inadequate financing and disinformation. He also cited barriers to routine healthcare resulting from the redirection of national health resources during the COVID-19 pandemic. Some countries, such as Nicaragua and St. Kitts and Nevis, were seen as having higher coverage than most. Mexico, Guatemala and Brazil were among those cited at high risk of seeing a resurgence of preventable diseases. These include polio, the PAHO officials acknowledged, noting a confirmed case of vaccine-derived polio type 2 reported in March in Peru. Current polio vaccine coverage for regionwide was 80% in 2021, according to PAHO, below the recommended 95%.
Barbosa said PAHO was “at the ready to support countries to update immunization programs and we will be leading the big catch-up initiative in the Americas,” working with countries to identify communities likely to have high rates of unvaccinated children, including through the use of satellite data.

Most of the unvaccinated children are believed to live in rural areas in marginalized conditions, PAHO officials said, though in some countries, such as Brazil, children from affluent urban families also see high rates of non-coverage. “This may be related to fake news or unfounded information from practitioners,” Barbosa said. Without better information campaigns, “we are leaving people with their own doubts [as to] whether to vaccinate or not.” Several of the PAHO officials who spoke at the press conference spoke of a need to engage local religious leaders.

A further vaccination challenge in the Americas, Barbosa said, is the high number of adults with comorbidities who have not received at least two doses of COVID-19 vaccines. “We have millions of people in that situation,” he said.

In addition to supporting vaccination catch-up campaigns in its 35 member countries, PAHO is promoting the development and production of mRNA vaccines at centers in Brazil and Argentina, an effort that began in 2021. Barbosa called the regional platform for mRNA vaccines “a very important initiative” aimed at reducing the region’s vulnerability in a future pandemic caused by a coronavirus or influenza. Such vaccines might also be developed for use against dengue, chikungunya or Zika, he said. Barbosa also described ongoing efforts by PAHO to certify and improve access to personal protective equipment produced in Central America as a further way to reduce regional vulnerability in a future emergency.

Finally, Barbosa said that PAHO is engaged in negotiations with the Japanese manufacturer Takeda to purchase its new vaccines against dengue, aiming at delivering these “at an affordable price to the countries in the region that want to use them.” Brazil has already approved the Takeda vaccine, along with the European Medicines Agency, and approvals are expected in Argentina and possibly other Latin American countries before the end of the year. “When you have countries with very big populations like Brazil, Colombia, Mexico, when they come together to purchase these vaccines … we can have a very important advantage,” Barbosa said. “And this vaccine will probably have a more affordable price to the countries in the region that want to use them.”

PAHO press briefing (Spanish and English)

Argentina’s ANMAT announces suspension of servers due to cyber threat

Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) announced on 21 April that its servers were not working due to an unspecified cyber threat, and said that the suspension would result in processes being delayed. As of 24 April, ANMAT’s main website was still not working. The incident echoed news from last year in Colombia, where in February and again in October 2022, The National Food and Drug Surveillance Institute (INVIMA) suffered cyberattacks on its website that resulted in suspension of online services and delayed processing for weeks.

ANMAT statement

Mexico’s COFEPRIS proposes plan to ease psychiatric drug shortage

In a public communication issued on 21 April, Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) proposed a regulatory route by which the country’s largest manufacturer of psychiatric medications, Psicofarma, may return to production after its activities were suspended in February over what COFEPRIS called “serious irregularities” in quality and traceability of controlled substances at two of its plants.

Psicofarma’s suspension came amid a dire shortage of psychiatric and neurologic medications in both Mexico’s public and private sectors, and COFEPRIS faced criticism from medical associations and the press for having shut down a major supplier.

COFEPRIS said in its statement that it seeks to prioritize the release of finished Psicofarma products for which need is most urgent, based on satisfactory test results. The company must present further documentation from manufacturing site tests before sanctions can be lifted on production, COFEPRIS said, adding that it was in constant communication with company officials and working with them to solve the issues that had resulted in the suspension.

The previous week, COFEPRIS asserted in a different statement that it was prioritizing psychiatric drugs in general, saying that that there were no lags in processing times related to authorizations of controlled psychiatric medications. Indeed, the agency noted, it had authorized a record seven generic medications for psychiatric conditions in the first quarter of 2023, compared with just nine for all of 2022. The agency also said it had issued 59 new import permits for active pharmaceutical ingredients used in psychiatric drugs during the first quarter of this year.

COFEPRIS said it had authorized the importation of 6,400 kilograms of active pharmaceutical ingredients in 2022. However, the agency said that companies had actually imported less than half of the ingredients they were authorized to receive.

COFEPRIS statement (Spanish)

Neurosurgery Platform approved in Brazil

ClearPoint Neuro, a California company that makes technologies for stereotactic navigation and therapeutic delivery to the brain, announced on 13 April that regulators with the Brazilian Health Regulatory Agency (ANVISA) had approved its Neuro Navigation Portfolio. The approval marks the company’s first for its platform in Latin America.

ClearPoint Neuro press release

Latin America Roundup: PAHO says Latin American countries lagging on routine vaccinations

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