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 profile of inactivated COVID-19 in healthy adults aged ≥ 18 years: A passive surveillance in Indonesia

“…We also found drowsiness (unsolicited systemic reaction) as the most occurred symptom in the AEs group. Benjamanukul et al also found similar symptoms following the injection of Sinovac/CoronaVac, such as nausea, diarrhea, hypersomnia, fatigue, hunger, rash, and dizziness, which aligned with our study [ 26 ]. These results have proven the importance of continuous vaccine safety surveillance to substantiate and justify the previous results from the clinical phase trial with real-world data.…”

“…Therefore, young adults are more prone to experience AE compared to the elderly, proving that inactivated COVID-19 vaccine is also safe for the elderly. In the trial phases 1, 2, and 3 done in several countries, the data also showed the adverse events reactions were considered safe and well tolerated in the child and adults in the immunocompromised group (HIV, autoimmune and elderly) [26][27][28][29][30][31][32][33][34].…”

Pharmacovigilance in Vaccines: Importance, Main Aspects, Perspectives, and Challenges—A Narrative Review

“…[ [248][249][250] Obesity Patients with body mass index (BMI) ≥40 kg/m 2 as a high-risk condition for severe COVID-19 (obesity was associated with an increased risk of intubation or death). [251,252] Diabetes mellitus The risk of mortality was higher with glycated hemoglobin (A1C) levels of 7.6 to 8.9 percent compared to 6.5 to 7 percent.…”