People living with HIV (PLWH) tend to have high COVID-19 related morbidity and mortality [1].UNAIDS suggested that PLWH should be given priority in COVID-19 vaccinationsregardless of CD4+ T lymphocyte count (CD4 count) and HIV viral load (HIV-VL) levels [2]. The Chinese guideline also suggested that PLWH be given the inactivated vaccine or the recombinant subunit vaccine[3]. However, the safety of COVID-19 vaccines among PLWH in China is unknown. This study aims to estimate the adverse events (AEs) rateafter COVID-19 vaccination among PLWH.
Between April and July 2021, PLWH from the Wuchang district of Wuhan, China, aged between 18 and 59 years, were enrolled in this study. All participants received inactivated COVID-19 vaccine (Sinopharm, Wuhan Institute of Biological Products Co. Ltd) on day 0 and day 28 by intramuscular injection. Post-vaccination adverse events were evaluated seven days after each dose of vaccination. These adverse events include injection site pain, swelling, redness, fever, headache, fatigue, drowsiness, and cough.
In total, 91.1% of the PLWH (236/259) have taken both doses, while the remaining 8.9% have only taken the first dose of inactivated vaccine. Of all participants, 99.2% were on antiretroviral therapy (ART), 80.3% had virus suppressed (208/259), and 81.1% had CD4 count>350 cells/μl (210/259) at enrollment (Table).
The overall AE rate was 22.8% after dose one (D1) of the vaccination, which was higher than that after dose two(10.17%)(P<0.001). Local injection-site reactions were reported in 17.0% of the participants after D1 and 7.6% after D2. The most common systemicreactions included Fatigue (3.5% after D1, and 0.8% after D2, drowsiness (2.3% after D1, and 1.7% after D2), fever (1.9% after D1, and 0.0% after D2).
The majority of AEs were non-severe. The most common severe symptom after D1 included fatigue (3.1%), drowsiness (2.3%), anddizziness (1.9%).The most common severe symptom after D2 had drowsiness (1.7%). No other extremeadverseeventswere observed.Comparing with participants with different ART regimens (7.6%), participants receivingprotein inhibitor (PI) based antiretroviral regimen(all PI is lopinavir/ritonavir) had more AEs (38.5%) after D2regimens (P<0.05). No significant differences in any AE rateswere observed in other subgroups of PLWH (P>0.05). After adjusted for age, sex, CD4 count, and HIV viral load, receiving LPV/r based regimen were still associated with increased AE risk in D2 (OR=11.26, 95% CI 2.54–50.01; p=0.001). We also found no difference in AE rates after each dose between participants with CD4>350/μL and ≤350/μL (P>0.05).
Concerns for AEs significantly impact persistent vaccine hesitancyamong PLWH. A subsequent national survey found that about 37.1% of PLWH are concerned that COVID-19 vaccination may have severe side effects [4].Our study extended the existing literature by reporting the AE after COVID-19 vaccination among PLWH [5,6]. We conclude the adverse events afterthetwo-doseof inactivated COVID-19 vaccination among PLWH are minimal and mild. In addition, we also found that participants who were receiving LPV/r based regimenwere more likely to experience AE after D2.
Our results have direct and immediate clinical implications. The data in this analysis arereassuring, finding no severeadverse event or vaccine safety concern among PLWH. There is an urgent need to disseminate this information to the vulnerable group of PLWH to minimize vaccine hesitancy and eliminate its refusal.