Safety Monitoring after the BNT162b2 COVID-19 Vaccine among Adults Aged 75 Years or Older

Abstract

Background Older adults are given high priority for coronavirus disease 2019 (COVID-19) vaccination; however, little is known about the safety of vaccines. This study was conducted to examine the safety of the COVID-19 vaccine for people who were ≥ 75 years of age, specifically those who first took two doses of the vaccine at the COVID-19 central vaccination center in South Korea. Methods Safety monitoring after the BNT162b2 vaccine was conducted in three ways for older adults who received the first dose of the vaccine at our center between April 5 and April 23, 2021. For immediate adverse reactions, every person who was vaccinated was observed for 15–30 minutes after injection at the center. For active surveillance, a telephone interview was conducted for stratified randomly sampled people after 7 days of each vaccination to enquire regarding types of adverse reactions they experienced, and its severity and duration. For passive surveillance, reported adverse event data were collected from the COVID-19 vaccine adverse event following immunization (AEFI) surveillance system—run by the Korea Disease Control and Prevention Agency (KDCA). The data were then reviewed. Results In total, 2,123 older adults received at least one vaccine dose during the study period. The frequency of acute adverse reactions that developed during the observed 15–30 minutes after injection was 8.5 cases per 1,000 doses. None of the reactions was assessed as acute allergic reactions to the vaccine and no cases required special treatment or drug administration. Overall, 638 people were followed up at least once by telephone interview 7 days post vaccination. The overall response rate was 82.3%. The rates of local reactions were 50.3% after the first dose and 45.2% after the second dose, and the rates of systemic reactions were 15.2% and 26.0%, respectively. During the study period, 23 medically attended adverse events (5.4 cases per 1,000 administered doses) were reported to the KDCA AEFI surveillance system. The most common symptoms of medically attended cases were nonspecific general weakness (26%) and dizziness (26%), followed by muscle pain (22%), headache (13%), fever (13%), and skin rash or urticaria (13%). Among them, there were five serious adverse events reported, which required hospitalization, including one death. However, most of them were not related to the vaccines. Conclusion BNT162b2 vaccination was tolerable among adults who were ≥ 75 years of age.

Cutaneous adverse reactions following COVID‐19 vaccinations: A systematic review and meta‐analysis

“…The majority of studies were cross‐sectional in design (22 studies), 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 , 19 , 20 , 21 , 22 , 23 , 24 , 25 , 26 , 27 , 28 , 29 , 30 , 31 , 32 followed by cohort (13 studies 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 , 45 ) and case–control (one study 46 ) studies, respectively. Most of the studies were carried out in Europe (14 studies), followed by Eastern Asia (6 studies), Western Asia (5 studies), North America (4 studies), and South America (2 studies), respectively.…”

Roadmap for Sex-Responsive Influenza and COVID-19 Vaccine Research in Older Adults

“…Few studies have provided both sex- and age-disaggregated safety data for the SARS-CoV-2 vaccines. Among older adults, local, systemic, and medically attended AE are more common in females than in males ( Choi et al, 2021 ; Hoffmann et al, 2021 ). Both among females and overall, older individuals report fewer AE than younger individuals ( Choi et al, 2021 ; Hoffmann et al, 2021 ), but the proportion of events classified as serious increases with age ( Xiong et al, 2021 ).…”

“…Among older adults, local, systemic, and medically attended AE are more common in females than in males ( Choi et al, 2021 ; Hoffmann et al, 2021 ). Both among females and overall, older individuals report fewer AE than younger individuals ( Choi et al, 2021 ; Hoffmann et al, 2021 ), but the proportion of events classified as serious increases with age ( Xiong et al, 2021 ). Sex differences have been reported for several serious AE, including a female bias in anaphylaxis ( Blumenthal et al, 2021 ; Shimabukuro et al, 2021 ; Somiya et al, 2021 ) and thrombosis with thrombocytopenia syndrome ( Lai et al, 2021 ), and a male-bias in myocarditis ( Klein et al, 2021 ), but these events predominantly occur in younger age groups.…”

Adverse effects of vaccinations and potential therapies against COVID-19

“…Sama korelacja, nawet jeśli wystąpi, nie daje naukowcom prawa do stwierdzenia, że taka jest przyczyna zjawiska [3]. Niepożądane odczyny poszczepienne muszą być bardzo dokładnie badane [4,5]. W przypadku szcze-pionek wektorowych zaobserwowano, że w nielicznych przypadkach po szczepieniach pojawiają się przeciwciała skierowane przeciwko czynnikowi płytkowemu 4 (PF4), co może prowadzić do powikłań zakrzepowo-zatorowych.…”