| Revue: | Revista do Instituto de Medicina Tropical de Sao Paulo |
| Base de datos: | |
| Número de sistema: | 000547883 |
| ISSN: | 0036-4665 |
| Autores: | Miyaji, Karina Takesaki1 Itto, Lucas Yuji Umesaki1 Jacintho, Lucas Caue1 Sales, Amanda Caroline Ribeiro1 Hiratsuka, Marcel1 Leonel, Fabio Campos1 Higa Taniguchi, Keila Tomoko1 Picone, Camila Melo1 Lara, Amanda Nazareth1 Rodrigues, Camila Cristina Martini1 Lopes, Marta Heloisa1 Sartori, Ana Marli Christovam1 |
| Instituciones: | 1Universidade de São Paulo, Faculdade de Medicina, São Paulo, São Paulo. Brasil |
| Año: | 2022 |
| Volumen: | 64 |
| País: | Brasil |
| Idioma: | Inglés |
| Resumen en inglés | 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. |
| Keyword: | COVID-19 vaccine, Inactivated vaccine, Safety, Adverse events, Elderly, Post-marketing product surveillance |
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