Adverse events following immunization of elderly with COVID-19 inactivated virus vaccine (CoronaVac) in Southeastern Brazil: an active surveillance study

ABSTRACT Healthcare workers, the elderly and other vulnerable populations were the first to receive COVID-19 vaccines in public health programs. There were few vaccine safety data available on the elderly. This observational study aimed to evaluate the inactivated vaccine (CoronaVac) safety in the elderly, at the beginning of the vaccination program, in Sao Paulo city, Brazil. The elderly people that received CoronaVac at the Reference Center for Special Immunobiologicals (CRIE) or at home, administered by the Interdisciplinary Home Care Team (NADI) of the Hospital das Clinicas were invited to participate in this phase 4 observational study. The vaccination schedule included two CoronaVac doses 28 days apart. The information on solicited and unsolicited adverse events following immunization were collected by phone calls on days 4 and 8 after each vaccine dose. We enrolled 158 adults aged 65 to 101 years (mean of 84.1 years); 63.9% were females and 95.6% had chronic conditions, 21.5% had moderate or severe impairment in daily living activities; 34.2% were pre-frail and 19.6% were frail. We were able to contact 95.6% and 91.6% of the vaccinated people, after the first and second doses, respectively; 31.8% and 23.4% of the contacted participants reported some adverse events (AE) following the first and second doses, respectively. Pain at the injection site, fatigue, myalgia and headaches were the most frequent solicited AE. Most AE were mild to moderate. There were eight severe adverse events, but none of them were considered related to the vaccine. The CoronaVac was safe and well tolerated by these adults of advanced age with frailty and comorbidities.

Safety and effectiveness of a biosimilar biphasic insulin in the management of diabetes mellitus during routine clinical practice in Asian patients

@#Introduction: Biosimilar insulins have the potential to increase access to treatment among patients with diabetes mellitus (DM), reduce treatment costs, and expand market competition. There are no published studies evaluating the performance of biosimilar insulins in routine clinical practice in Asia. This study assessed the safety and effectiveness of biphasic isophane insulin injection in Malaysian DM patients. Materials and Methods: In this open label, single-arm, observational, post marketing study, patients received biphasic isophane insulin injection as per the Prescribing Information; and were assessed for safety (adverse events including hypoglycaemia), effectiveness (glycosylated haemoglobin [HbA1c]; fasting blood sugar, [FBS]; and patient’s condition by patient and physician) over a period of 24 weeks. Results: Adult male and female diabetes patients (N=119; type 2 DM, n=117) with a mean (SD) diabetes duration of 13 years were included. No new safety signals have been identified. Significant reduction in HbA1c was observed at weeks 12 and 24 (mean [SD] - baseline: 9.6% [1.9]; Week 12: 9.0% [1.7] and at Week 24: 9.1% [1.7]; p < 0.001). There were 10 serious and 9 non-serious adverse events reported in the study. Expected mild events included hypoglycaemia and injection site pruritus. However, the majority of the adverse events were non-study drug related events. No deaths were reported during the study. Discussion: Biphasic isophane insulin injection was well tolerated with no new safety concerns. It was found effective in post- marketing studies conducted in routine clinical settings when administered in DM patients in this study.

Description of Important Potential Risks of Japanese Risk Management Plan on Each Package Insert / 医薬品情報学

<b>Objective: </b>The Japanese risk management plan (RMP) contains the risk minimization action plans for important potential risks of drugs.  One of the basic risk minimization action plans is reminding on package insert; however, we found that some potential risks were not described in package inserts.  In this study, we investigated the description of potential risks on package inserts.<br><b>Design: </b>Document analysis.<br><b>Methods: </b>We collected all posted RMP documents and the package inserts of corresponding products from the Pharmaceutical and Medical Devices Agency website on January 31, 2015 and investigated the risk minimization action plans of important potential risk items and whether the items had been described in each package insert.<br><b>Results: </b>Of 268 important potential risk items in 81 products, 56 items were not described on package insert.  The major reason for not including the risk items on the package insert was “causality was not indicated sufficiently” and some items had no written reason.<br><b>Conclusion: </b>About 20% of important potential risks are not described in package inserts.  Because most post-marketing pharmacovigilance plans depend on spontaneous reporting by healthcare personnel, description on package insert, the most frequently referred drug information resource, should be considered.

Notificação de eventos adversos em vigilância sanitária: incompletitude das variáveis do NOTIVISA em 2007 E 2008. / Notification of adverse events in Sanitary Surveillance: variables incompleteness in Notivisa from 2007 to 2008.

A informação é instrumento fundamental para o processo decisório na vigilância póscomercialização/ uso, que tem por finalidade promover a identificação precoce de eventos adversos (EAs) relacionados com o uso de produtos sob vigilância sanitária. Este estudo avaliou aqualidade da informação, utilizando o indicador incompletitude das variáveis dos formulários das notificações de EA de uso de sangue e componentes (10), vacinas e imunoglobulinas (39), equipamentos (31) e artigos (30) médico-hospitalares recebidos pelo Notivisa em 2007 e2008. Trata-se de estudo transversal e descritivo. No ano de 2007, apenas 3 (30,0%); 6 (15,4%); 6 (19,4%) e 6 (20%) variáveis apresentaram taxa de incompletitude com classificação bom ouexcelente, respectivamente. Já em 2008, foram 4 (40,0%); 7 (17,9%); 7 (22,9%) e 7 (23,3%), porém as variáveis não foram as mesmas. Os resultados indicam que houve elevada incompletitude para a maior parte das variáveis estudadas. A instrumentalização para subsidiara vigilância pós-comercialização/uso está em construção no âmbito do Sistema Nacional de Vigilância Sanitária. Estratégias com melhoria do preenchimento das variáveis devem ser implementadas para contribuir com informações robustas na tomada decisão.

Information is essential to support the decision making process in post marketing surveillance. It aims to promote the early identification of adverse events (AE) related to the use of products under surveillance. This study aimed to evaluate information quality, using variables incompleteness of the notification forms of AE related to blood and its components use (10), vaccines and immunoglobulin (39), health care equipments (31) and medical devices (30) received by Notivisain 2007 and 2008. This is a transversal and descriptive study. In the year of 2007, only 3 (30%); 6 (15.4%); 6 (19.4%) and 6 (20%) variables presented incompleteness ratio with good or excellent classification, respectively. In 2008, there were 4 (40%), 7 (17.9%), 7 (22.9%) and 7 (23.3%), although the variables were not the same. The results indicate that the incompleteness for most of the studied variables increased. The instrumentation to subside the post marketing surveillance is still being constructed under the Sistema Nacional de Vigilância Sanitária (Brazilian national sanitary surveillance system). Strategies to improve the data s filling out must be implemented in order to provide relevant information to decision makers.