Latin America Roundup: Argentina approves first locally produced COVID vaccine
Argentine regulators have approved the first locally produced vaccine against COVID-19, culminating a years-long effort to reduce reliance on foreign-produced vaccines. Dubbed “ARVAC-Cecelia Grierson” in honor of the country’s first female physician, the vaccine uses recombinant protein technology against SARS-CoV-2 variants. Approved for use as a booster in adults 18 and older, it was developed through a private-public consortium that included the country’s National Council of Scientific and Technical Investigation (CONICET), investigators with San Martin National University (UNSAM), and Laboratorio Pablo Cassará, a pharmaceutical firm.It is uncertain when ARVAC-CR vaccine will become available in clinics or exported to other countries in the region. Argentina is now the third country in Latin America to have produced its own COVID vaccine, following Cuba and Mexico; the ARVAC-CG vaccine, unlike the Mexican and Cuban products, has been shown to produce a robust antibody response against recently circulating variants.
Approval was based on results from a Phase 2/3 clinical trial enrolling more than 2,000 subjects. During an 18 October press conference, Carla Vizzotti, Argentina’s minister of health, called the approval “historic,” saying the new vaccine offered “the possibility of having a secure, effective, and high-quality tool” that will allow for a reduction in vaccine importations and may also prove suitable for export in the region.
In 2021, research institutions and vaccine manufacturers in Argentina and Brazil were tapped by the World Health Organization to participate in a technology transfer program aimed at launching mRNA vaccine production in low- and middle-income countries. That work is ongoing, though no licensed products have yet resulted.
Announcement (Spanish)
COFEPRIS greenlights two COVID vaccines
On 16-17 October, the new molecules committee of Mexico’s Federal Commission for the Protection Against Health Risks (COFEPRIS) evaluated four COVID-19 vaccines under non-emergency protocols, and granted favorable opinions to two, paving the way to their commercialization. The decisions, made during sessions that were open to the public and broadcast live, in a gesture of transparency, mark the first time since the onset of the pandemic that COVID vaccines have been evaluated for full health registry in Mexico.
On 16 October, the committee issued a negative opinion on AstraZeneca’s recombinant vaccine Vaxzevria ChAdOx-1-S, claiming that while the company had presented enough data to establish its safety, it “did not present data on the variants currently circulating in Mexico and globally,” COFEPRIS said in a news release. The vaccine maintains its emergency use authorization in Mexico, and the company was invited to submit updated efficacy and immunogenicity data to the agency. Also, on 16 October, the committee voted in favor of Pfizer’s monovalent mRNA vaccine Comirnaty.
The following day, the committee voted against Moderna’s bivalent Spikevax vaccine BA.4-5, while allowing its monovalent Spikevax XBB.1.5 vaccine to proceed. “Based on the recommendations of the World Health Organization (WHO) … the role of monovalent vaccines is of greater relevance, since they are more effective against the strains that currently circulate,” COFEPRIS said in a statement.
COFEPRIS Announcement Vaxzevria
COFEPRIS Announcement Comirnaty
COFEPRIS Announcement Spikevax
COFEPRIS proposes harmonization on devices; meets with US agencies on supply chain, nearshoring goals
Mexico’s COFEPRIS is developing, along with representatives from Mexican industry, a new four-year strategy for the regulation of medical devices “aligned with the highest international standards,” according to a statement issued 20 October. Mexico exported nearly $11 billion worth of medical devices in 2020, according to the Mexican Association of Innovative Industries of Medical Devices (AMID), and the country’s analysts have long argued that greater regulatory certainty in this sector would afford Mexican device makers better access to US markets.
COFEPRIS’s interest in boosting nearshoring – the practice of moving production and distribution closer to the consumer – is not limited to medical devices. On 18 October, Mexico’s economic secretary, Raquel Buenrostro Sánchez; COFEPRIS commissioner Alejandro Svarch Pérez; and Jose W. Fernandez, US Under Secretary of State for Economic Growth, Energy, and the Environment; met in Mexico City with representatives of US Pharmacopeia and other organizations for a seminar titled: “Constructing a high-quality pharmaceutical supply chain between Mexico and the United States.”
During the seminar , Ms. Buenrosto stressed the need for the creation of a national pharmaceutical industry in Mexico focused on generics of greatest importance to the Mexican population, and “emphasized the importance of establishing commercial bridges,” to the US, according to a COFEPRIS statement. Svarch Pérez added that “million-dollar investments on both sides of the border,” require “applying increasingly effective and agile [regulatory] strategies.”
COFEPRIS statement
COFEPRIS statement
Top Chilean regulator forced to resign
Rubén Verdugo, resigned as head of the Chile Public Health Institute (ISP) on 18 October, according to media reports. In late September, ISP announced an immediate withdrawal of all medical products from one national manufacturer, citing bacterial contamination. The announcement resulted in cessation of surgeries and procedures across the country. The notice was later restricted to apply only to certain lots of a saline solution from the same manufacturer. Chile’s health minister, Ximena Aguilera, demanded that Verdugo resign over the debacle, though he resisted the move for weeks. Officials with the country’s National Medicines Agency (ANAMED) registered their objections to Aguilera’s action in a joint letter that cited a “lack of transparency” surrounding it.
Article in biobio Chile (Spanish)
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