Latin America Roundup: PAHO director defends Mexico’s COVID-19 vaccine policy
Mexico’s Commission for the Protection Against Health Risks (COFEPRIS) has delayed its decision on the approval of the new monovalent COVID-19 vaccines from Pfizer and Moderna.Since mid-September, when COFEPRIS opened the door to the full marketing approval of the two newest monovalent mRNA COVID-19 vaccines manufactured by Pfizer and Moderna, the agency has insisted in repeated statements that it was advancing these applications. COFEPRIS even recently announced that a final decision would be made on 29 November. That day came and went, with the agency saying the decision on Moderna’s monovalent SpikeVax and Pfizer’s Comiarty vaccines had been delayed. The manufacturers require more time to resolve “missing elements” in their documentation, COFEPRIS said.
Mexico’s public health system, meanwhile, continues to purchase and administer Russian- and Cuban-manufactured COVID vaccines that have not been fully evaluated by the World Health Organization, and the government plans to add a Mexican-manufactured product – which also lacks WHO recognition -- to its arsenal.
While legislators and medical societies in Mexico have expressed concerns that none of these vaccines is likely effective against currently circulating Omicron variants, the vaccines found a defender in Jarbas Barbosa, director of the Pan American Health Organization (PAHO).
“We have to be careful [distinguishing] what is public health and what is the market, because many times vaccine producers create a lot of propaganda, including involving health professionals to say the new version of a vaccine offers more protection,” Barbosa said in an interview on 29 November with the Mexican news outlet Milenio.
Older vaccines such as those used in Mexico, Barbosa said, “continue to be very effective at preventing serious casas and deaths. So it is important to get the vaccines that are available. That is our recommendation.”
Colombia’s public health ministry has purchased vaccines from different US, European and Chinese makers for use in campaigns in 2023 and 2024, and the country has seen few public arguments about which vaccines should be prioritized.
However, on 28 November, health minister Guillermo Alfonso Jaramillo alleged during a Colombian Senate hearing that all the COVID-19 vaccines used in Colombia, with the exception of the Chinese-made Sinovac, “entered the country without permission, turning us into an experiment. All the Colombians who have been vaccinated have lent themselves to the greatest experiment that has been done in all of human history. We cannot continue experimenting with the Colombian community,” he said.
Jaramillo’s comments were swiftly challenged by Colombian media and medical organizations, which issued statements denouncing them as misleading and irresponsible. Former health minister Fernando Ruiz, in different media interviews, pointed out that all the COVID-19 vaccines available in Colombia have been approved for emergency use by Colombian regulators.
On 30 November, Colombian president Gustavo Petro was forced to defend the health minister against accusations that he harbored anti-vaccine views. Indeed, the president insisted, “it is no secret to anyone that the methods of approval of anti-Covid vaccines [during the pandemic emergency] were different from those used in normal times. It was necessary. The minister did not lie.”
COFEPRIS Announcement (Spanish)
INVIMA will seek institutional ‘redesign’
Colombia’s National Food and Drug Surveillance Institute (INVIMA) has presented the bare outlines of a plan that, if executed, would result in significant changes to its operations. The plan is in response to a judicial action by Columbia’s Attorney General’s office aimed at clarifying INVIMA’s role in the country’s ongoing medication shortages.
In a presentation given 28 November in a Bogota court and reproduced in the Colombian news outlet Semana, Colombia’s Health Ministry described how the agency intends to improve its technical, operational and pharmacovigilance capacity.
In the same presentation, INVIMA offered the court some details about its current large backlog, with delayed responses affecting tens of thousands of active requests. It also cited reasons for the backlog, including cyberattacks, outdated technology and excessively complex processes. As it is currently structured, INVIMA’s financing is highly dependent on processing fees.
INVIMA told the court that it sought an institutional “redesign” aimed at speeding applications, changing its financing and modernizing operations.
In a related discussion in Colombia’s Senate 28 November, INVIMA acting director Juan Carlos Arias commented that the agency’s fee structure was at the heart of its problems. “As long as the agency is living off fees, we are going to see many difficulties in resolving the applications filed,” Arias told senators.
During the same Senate hearing, Health Minister Guillermo Alfonso Jaramillo insisted that Colombia’s medications shortages also resulted from the behavior of pharmaceutical firms and he said the Health Ministry and INVIMA had no choice but to respond.
“No more pressure from laboratories. No more laboratories above the needs of the poorest people and people who suffer. We are going to intervene and make prices drop, according to the Constitution and the law. We are going to intervene in these oligopolistic markets,” Jaramillo said.
No market or price interventions were proposed in INVIMA’s presentation to the court. Industry groups in Colombia noted, in response to Jaramillo’s statements, that robust legal price controls, under an established methodology, have been in place in Colombia since 2013.
Colombia Senate Hearing (Spanish)
Chile announces new safeguards on contraceptives
Chile’s Public Health Institute (ISP) announced 1 December that it had conducted an analysis of 115 hormonal contraceptive products including pills, implants, gels, and injectable agents, and found no inconsistencies or defects. Concern stemmed from incidents in 2020 and 2021 in which a Chilean subsidiary of the German manufacturer Grünenthal produced faulty lots of a contraceptive pill, resulting in more than 200 unwanted pregnancies. The drugs had been distributed in government clinics.
In a related announcement the same day, Antonia Orellana, Chile’s minister of Women and Gender Equity, along with public health subsecretary Andrea Albagli, described new ISP rules that would reclassify contraceptives as higher risk medications and oblige manufacturers to withdraw potentially defective products from the market within five days.
Chile government statement (Spanish)