Ensuring vaccine safety: Case studies of falsified influenza vaccines detected in Brazil.

Falsifications related to health technologies-including vaccines-are a growing threat to patient safety and health systems on a global scale and can cause serious harm to the population (especially vulnerable groups). In Brazil, the manufacturing and spread of counterfeit medicines are prevented through joint actions between different government agencies. In this study, we analyzed three cases of influenza vaccines suspected of counterfeiting. The samples were seized by officials and received by the National Institute for Quality Control in Health (INCQS), the national quality control reference laboratory of the Ministry of Health of Brazil, in 2010, 2017, and 2020. We report the results of our analytical investigations and emphasize the importance of strengthening the partnerships between various national agencies. The seized samples were visually inspected, and their information was compared with that of genuine vaccines (as recorded in the INCQS database). The specific analytical tests were based on quality control tests for biological products. Our results confirmed that all seized samples were falsified. We emphasize the importance of fostering international and intra-national collaborations between various national agencies (such as drug regulatory authorities, official laboratories, customs departments, police forces, and civil society). As demonstrated here, such collaborative actions are essential for combating the release of falsified medical products, safeguarding public health, and strengthening health systems.

Characterization of strains of Neisseria meningitidis causing meningococcal meningitis in Mozambique, 2014: Implications for vaccination against meningococcal meningitis.

INTRODUCTION: In sub Saharan Africa, the epidemiology, including the distribution of serogroups of strains of N. meningitidis is poorly investigated in countries outside "the meningitis belt". This study was conducted with the aim to determine the distribution of serogroups of strains of N. meningitidis causing meningococcal meningitis in children and adults in Mozambique. METHODS: A total of 106 PCR confirmed Neisseria meningitidis Cerebrospinal Fluid (CSF) samples or isolates were obtained from the biobank of acute bacterial meningitis (ABM) surveillance being implemented by the National Institute of Health, at three central hospitals in Mozambique, from January to December 2014. Serogroups of N. meningitidis were determined using conventional PCR, targeting siaD gene for Neisseria meningitidis. Outer Membrane Proteins (OMP) Genotyping was performed by amplifying porA gene in nine samples. RESULTS: Of the 106 PCR confirmed Neisseria meningitidis samples, the most frequent serotype was A (50.0%, 53/106), followed by W/Y (18.9%, 20/106), C (8.5%, 9/106), X (7.5%, 8/106) and B (0.9%, 1/106). We found non-groupable strains in a total of 15 (14.2%) samples. PorA genotypes from nine strains showed expected patterns with the exception of two serogroup C strains with P1.19,15,36 and P1.19-36,15 and one serogroup X with P1.19,15,36, variants frequently associated to serogroup B. CONCLUSION: Our data shows that the number of cases of meningococcal meningitis routinely reported in central hospitals in Mozambique is significant and the most dominant serogroup is A. In conclusion, although serogroup A has almost been eliminated from the "meningitis belt", this serogroup remains a major concern in countries outside the belt such as Mozambique.

Antimicrobial susceptibility of Haemophilus influenzae isolates collected from 4 centers in Brazil (1990-2003).

Antimicrobial susceptibility was determined for 174 Haemophilus influenzae strains collected from patients with infection before and after vaccination against Hib (1990-1999 and 2000-2003, respectively) from 4 public health -laboratories in 3 Brazilian states. All strains were characterized for serotype and beta-lactamase production and in vitro activity of the following antimicrobial agents: -ampicillin, amoxicillin/clavulanate, ceftriaxone, rifampin, chloramphenicol, and trimethoprim/sulfamethoxazole (TMP-SMX). Minimum inhibitory concentrations were determined according to the guidelines of the National Committee for Clinical Laboratory Standards. Overall, ampicillin resistance was observed in 29 strains (17%), all beta-lactamase producers. All isolates were susceptible to amoxicillin/clavulanate and ceftriaxone. The prevalence of TMP-SMX-resistant isolates increased from 32.6% in the period 1990-1999 to 65.8% during the period 2000-2003. Among these isolates, 10.0% and 12.5% were resistant to ampicillin and chloramphenicol, respectively. Resistance to rifampin was detected in 8.2% and 9.7% of the strains, in 2 periods, respectively. Continued surveillance is necessary to monitor trends with the H. influenzae disease in Brazil.