ABSTRACT
Background: Given the paucity of data on safety and effectiveness of mRNA COVID-19 booster vaccinations in lower income settings with high HIV prevalence, we evaluated a heterologous mRNA-1273 (Moderna) boost after priming with 1 or 2 doses of Ad26.COV2.S (Janssen, Johnson & Johnson) vaccine among health care workers (HCWs) in South Africa. Method(s): SHERPA is an open-label, phase 3 mRNA-1273 booster study, nested in the Sisonke Phase 3b implementation trial, that vaccinated ~500000 HCWs with 1 or 2 doses of Ad26.COV2.S from Feb and Dec 2021. Sisonke participants were offered mRNA-1273 boosters between 23 May and 12 Nov 2022 (median 17 and 8 months after 1 and 2 Ad26.COV2.S, respectively), with data cut-off on 12 Dec 2022. Reactogenicity and adverse events (AEs) were self-reported via an online data entry link shared by SMS with participants 1, 7 and 28 days after boosting. Using national databases analyses are underway to compare effectiveness against COVID-19 infections and severe disease with Sisonke participants who did not receive the booster. Result(s): 12188 HCWs (79.5% female, 28.6% with self-reported previous COVID-19 diagnosis) received a mRNA-1273 booster, of whom 44.6% and 55.4% had received 1 and 2 prior Ad26.COV2.S vaccines in Sisonke, respectively. 3056 (25.2%) reported being HIV positive, more among those receiving only 1 previous Ad26.COV2.S (26.8% vs 23.9%), and 1.4% reported not being on antiretroviral therapy. 17.0% of participants reported hypertension and 6.4% diabetes mellitus. 262 participants (2.1% of women, 2.5% of men) reported 234 reactogenicity events and 95 AEs post-vaccination, with more reported by those with prior COVID-19 infection (3.5% vs 1.6%), HIV negative status (2.5% vs 1.2%) and those who received 2 prior doses of Ad26.COV2.S (2.4% vs 1.8%) (Table). Among 159 (1.3%) reporting injection site reactions the commonest were pain (59.7%), swelling (42.1%) and induration (20.1%). Of 177 (1.5%) systemic reactogenicity events (all grade 1 or 2 severity), the commonest were myalgia (69.5%), headache (67.8%) and fever (37.9%). 14 participants had AEs of special interest or serious AEs, of which 4 (all AESIs of ageusia or anosmia) were deemed related to the booster. 13 COVID-19 infections occurred a median of 125 days post booster vaccination (IQR 90-154) after 3477 person-years of follow up. Conclusion(s): A mRNA-1273 booster administered after 1 or 2 doses of Ad26. COV2.S was well tolerated regardless of HIV status, other chronic conditions or prior COVID-19 infection.
ABSTRACT
Background. Understanding the pattern of deaths from COVID-19 in South Africa (SA) is critical to identifying individuals at high risk of dying from the disease. The Minister of Health set up a daily reporting mechanism to obtain timeous details of COVID-19 deaths from the provinces to track mortality patterns. Objectives. To provide an epidemiological analysis of the first COVID-19 deaths in SA. Methods. Provincial deaths data from 28 March to 3 July 2020 were cleaned, information on comorbidities was standardised, and data were aggregated into a single data set. Analysis was performed by age, sex, province, date of death and comorbidities. Results. SA reported 3 088 deaths from COVID-19, i.e. an age-standardised death rate of 64.5 (95% confidence interval (CI) 62.3 - 66.8) deaths per million population. Most deaths occurred in Western Cape (65.5%) followed by Eastern Cape (16.8%) and Gauteng (11.3%). The median age of death was 61 years (interquartile range 52 - 71). Males had a 1.5 times higher death rate compared with females. Individuals with two or more comorbidities accounted for 58.6% (95% CI 56.6 - 60.5) of deaths. Hypertension and diabetes were the most common comorbidities reported, and HIV and tuberculosis were more common in individuals aged <50 years. Conclusions. Data collection for COVID-19 deaths in provinces must be standardised. Even though the data had limitations, these findings can be used by the SA government to manage the pandemic and identify individuals who are at high risk of dying from COVID-19.