Primary Series and Booster Coronavirus Disease 2019 Vaccine Effectiveness in a Cohort of Healthcare Workers in Albania During a BA.1 and BA.2 Variant Period, January-May 2022.

Background: Healthcare workers (HCWs) have experienced high rates of coronavirus disease 2019 (COVID-19) morbidity and mortality. We estimated COVID-19 2-dose primary series and monovalent booster vaccine effectiveness (VE) against symptomatic severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Omicron (BA.1 and BA.2) infection among HCWs in 3 Albanian hospitals during January-May 2022. Methods: Study participants completed weekly symptom questionnaires, underwent polymerase chain reaction (PCR) testing when symptomatic, and provided quarterly blood samples for serology. We estimated VE using Cox regression models (1 - hazard ratio), with vaccination status as the time-varying exposure and unvaccinated HCWs as the reference group, adjusting for potential confounders: age, sex, prior SARS-CoV-2 infection (detected by PCR, rapid antigen test, or serology), and household size. Results: At the start of the analysis period, 76% of 1462 HCWs had received a primary series, 10% had received a booster dose, and 9% were unvaccinated; 1307 (89%) HCWs had evidence of prior infection. Overall, 86% of primary series and 98% of booster doses received were BNT162b2. The median time interval from the second dose and the booster dose to the start of the analysis period was 289 (interquartile range [IQR], 210-292) days and 30 (IQR, 22-46) days, respectively. VE against symptomatic PCR-confirmed infection was 34% (95% confidence interval [CI], -36% to 68%) for the primary series and 88% (95% CI, 39%-98%) for the booster. Conclusions: Among Albanian HCWs, most of whom had been previously infected, COVID-19 booster dose offered improved VE during a period of Omicron BA.1 and BA.2 circulation. Our findings support promoting booster dose uptake among Albanian HCWs, which, as of January 2023, was only 20%. Clinical Trials Registration. NCT04811391.

Primary series COVID-19 vaccine effectiveness among healthcare workers in Albania, February-December 2021.

Background: Healthcare workers have experienced high rates of morbidity and mortality from coronavirus disease 2019 (COVID-19). Methods: A prospective cohort study was conducted in three Albanian hospitals between 19 February and 14 December 2021. All participants underwent polymerase chain reaction (PCR) and serological testing at enrolment, regular serology throughout, and PCR testing when symptomatic.Vaccine effectiveness (VE) against COVID-19 and against all severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infections (symptomatic or asymptomatic) was estimated. VE was estimated using a Cox regression model, with vaccination status as a time-varying variable. Findings: In total, 1504 HCWs were enrolled in this study; 70% had evidence of prior SARS-CoV-2 infection. VE was 65.1% [95% confidence interval (CI) 37.7-80.5] against COVID-19, 58.2% (95% CI 15.7-79.3) among participants without prior SARS-CoV-2 infection, and 73.6% (95% CI 24.3-90.8) among participants with prior SARS-CoV-2 infection. For BNT162b2 alone, VE was 69.5% (95% CI 44.5-83.2). During the period when the Delta variant was predominant, VE was 67.1% (95% CI 38.3-82.5). VE against SARS-CoV-2 infection for the full study period was 36.9% (95% CI 15.8-52.7). Interpretation: This study found moderate primary series VE against COVID-19 among healthcare workers in Albania. These results support the continued promotion of COVID-19 vaccination in Albania, and highlight the benefits of vaccination in populations with high levels of prior infection.

Factors associated with receipt of COVID-19 vaccination and SARS-CoV-2 seropositivity among healthcare workers in Albania (February 2021-June 2022): secondary analysis of a prospective cohort study.

Background: Healthcare workers (HCWs) have been disproportionally affected by COVID-19. We investigated factors associated with two- and three-dose COVID-19 vaccine uptake and SARS-CoV-2 seropositivity among 1504 HCWs enrolled (19 February-7 May 2021) in a prospective COVID-19 vaccine effectiveness cohort in Albania through a secondary analysis. Methods: We collected sociodemographic, occupational, health, prior SARS-CoV-2 infection, and COVID-19 vaccination data from all HCWs at enrollment. Vaccination status was assessed weekly through June 2022. A serum sample was collected from all participants at enrollment and tested for anti-spike SARS-CoV-2 antibodies. We analyzed HCWs characteristics and outcomes using multivariable logistic regression. Findings: By 11 June 2022, 1337 (88.9%) HCWs had received two COVID-19 vaccine doses, of whom 255 (19.1%) received a booster. Factors significantly associated with receiving three doses (adjusted odds ratio (aOR), 95% CIs) were being ≥35 years (35-44 years: 1.76 (1.05-2.97); 45-54 years: 3.11 (1.92-5.05); ≥55 years: 3.38 (2.04-5.59)) and vaccinated against influenza (1.78; 1.20-2.64). Booster dose receipt was lower among females (0.58; 0.41-0.81), previously infected (0.67; 0.48-0.93), nurses and midwives (0.31; 0.22-0.45), and support staff (0.19; 0.11-0.32). Overall 1076 (72%) were SARS-CoV-2 seropositive at enrollment. Nurses and midwifes (1.45; 1.05-2.02), support staff (1.57; 1.03-2.41), and HCWs performing aerosol-generating procedures (AGPs) (1.40; 1.01-1.94) had higher odds of being seropositive, while smokers had reduced odds (0.55; 0.40-0.75). Interpretation: In a large cohort of Albanian HCWs, COVID-19 vaccine booster dose uptake was very low, particularly among younger, female, and non-physician HCWs, despite evidence demonstrating the added benefit of boosters in preventing infection and severe disease. Reasons behind these disparities should be explored to develop targeted strategies in order to promote uptake in this critical population. SARS-CoV-2 seroprevalence was higher among non-physicians and HCWs performing APGs. A better understanding of the factors contributing to these differences is needed to inform interventions that could reduce infections in the future. Funding: This study was funded by the Task Force for Global Health (US Centers for Disease Control (CDC) cooperative agreement # NU51IP000873) and the World Health Organization, Regional Office for Europe.

COVID-19 vaccine effectiveness among healthcare workers in Albania (COVE-AL): protocol for a prospective cohort study and cohort baseline data.

INTRODUCTION: Critical questions remain about COVID-19 vaccine effectiveness (VE) in real-world settings, particularly in middle-income countries. We describe a study protocol to evaluate COVID-19 VE in preventing laboratory-confirmed SARS-CoV-2 infection in health workers (HWs) in Albania, an upper-middle-income country. METHODS AND ANALYSIS: In this 12-month prospective cohort study, we enrolled HWs at three hospitals in Albania. HWs are vaccinated through the routine COVID-19 vaccine campaign. Participants completed a baseline survey about demographics, clinical comorbidities, and infection risk behaviours. Baseline serology samples were also collected and tested against the SARS-CoV-2 spike protein, and respiratory swabs were collected and tested for SARS-CoV-2 by RT-PCR. Participants complete weekly symptom questionnaires and symptomatic participants have a respiratory swab collected, which is tested for SARS-CoV-2. At 3, 6, 9 months and 12 months of the study, serology will be collected and tested for antibodies against the SARS-CoV-2 nucleocapsid protein and spike protein. VE will be estimated using a piecewise proportional hazards model (VE=1-HR). BASELINE DATA: From February to May 2021, 1504 HWs were enrolled. The median age was 44 (range: 22-71) and 78% were female. At enrolment, 72% of participants were seropositive for SARS-CoV-2. 56% of participants were vaccinated with one dose, of whom 98% received their first shot within 4 days of enrolment. All HWs received the Pfizer BNT162b2 mRNA COVID-19 vaccine. ETHICS AND DISSEMINATION: The study protocol and procedures were reviewed and approved by the WHO Ethical Review Board, reference number CERC.0097A, and the Albanian Institute of Public Health Ethical Review Board, reference number 156. All participants have provided written informed consent to participate in this study. The primary results of this study will be published in a peer-reviewed journal at the time of completion. TRIAL REGISTRATION NUMBER: NCT04811391.

Program cost analysis of influenza vaccination of health care workers in Albania.

BACKGROUND: Since 2012, WHO has recommended influenza vaccination for health care workers (HCWs), which has different costs than routine infant immunization; however, few cost estimates exist from low- and middle-income countries. Albania, a middle-income country, has self-procured influenza vaccine for some HCWs since 2014, supplemented by vaccine donations since 2016 through the Partnership for Influenza Vaccine Introduction (PIVI). We conducted a cost analysis of HCW influenza vaccination in Albania to inform scale-up and sustainability decisions. METHODS: We used the WHO's Seasonal Influenza Immunization Costing Tool (SIICT) micro-costing approach to estimate incremental costs from the government perspective of facility-based vaccination of HCWs in Albania with trivalent inactivated influenza vaccine for the 2018-19 season based on 2016-17 season data from administrative records, key informant consultations, and a convenience sample of site visits. Scenario analyses varied coverage, vaccine presentation, and vaccine prices. RESULTS: In the baseline scenario, 13,377 HCWs (70% of eligible HCWs) would be vaccinated at an incremental financial cost of US$61,296 and economic cost of US$161,639. Vaccine and vaccination supplies represented the largest share of financial (89%) and economic costs (44%). Per vaccinated HCW financial cost was US$4.58 and economic cost was US$12.08 including vaccine and vaccination supplies (US$0.49 and US$6.76 respectively without vaccine and vaccination supplies). Scenarios with higher coverage, pre-filled syringes, and higher vaccine prices increased total economic and financial costs, although the economic cost per HCW vaccinated decreased with higher coverage as some costs were spread over more HCWs. Across all scenarios, economic costs were <0.07% of Albania's estimated government health expenditure, and <5.07% of Albania's estimated immunization program economic costs. CONCLUSIONS: Cost estimates can help inform decisions about scaling up influenza vaccination for HCWs and other risk groups.

Acceptance of the Administration of Multiple Injectable Vaccines in a Single Immunization Visit in Albania.

Background: Albania introduced inactivated polio vaccine (IPV) into its immunization system in May 2014, increasing the maximum recommended number of injectable vaccines given in a single visit from 2 to 3. Methods: Health-care providers and caregivers were interviewed at 42 health facilities in Albania to assess knowledge, attitudes, and practices regarding injectable vaccine administration. Immunization register data were abstracted from December 2014 to July 2015 at the same facilities to explore the number of injectable vaccines children received during their 2- and 4-month visits. Results: The majority of children (87%) identified in the record review at either their 2- or 4-month immunization visit received all 3 injectable vaccines in a single visit. Almost all children who did not receive the vaccines in a single visit were subsequently fully immunized, most within a 2-week period. Over half of caregivers whose children got 3 or more injectable vaccines in a single visit reported being only comfortable with 1 or 2 injectable vaccines in a single visit. Conclusions: Despite most caregivers expressing hesitation regarding children receiving multiple injectable vaccines in a single visit, most children received vaccines according to the recommended schedule. Almost all children eventually received all recommended vaccines.

Cost-effectiveness of rotavirus vaccination in Albania.

BACKGROUND: Rotavirus vaccines have been introduced in several European countries but can represent a considerable cost, particularly for countries that do not qualify for any external financial support. This study aimed to evaluate the cost-effectiveness of introducing rotavirus vaccination into Albania's national immunization program and to inform national decision-making by improving national capacity to conduct economic evaluations of new vaccines. METHODS: The TRIVAC model was used to assess vaccine impact and cost-effectiveness. The model estimated health and economic outcomes attributed to 10 successive vaccinated birth cohorts (2013-2022) from a government and societal perspective. Epidemiological and economic data used in the model were based on national cost studies, and surveillance data, as well as estimates from the scientific literature. Cost-effectiveness was estimated for both the monovalent (RV1) and pentavalent vaccines (RV5). A multivariate scenario analysis (SA) was performed to evaluate the uncertainty around the incremental cost-effectiveness ratios (ICERs). RESULTS: With 3% discounting of costs and health benefits over the period 2013-2022, rotavirus vaccination in Albania could avert 51,172 outpatient visits, 14,200 hospitalizations, 27 deaths, 950 disability-adjusted life-years (DALYs), and gain 801 life-years. When both vaccines were compared to no vaccination, the discounted cost per DALY averted was US$ 2008 for RV1 and US$ 5047 for RV5 from a government perspective. From the societal perspective the values were US$ 517 and US$ 3556, respectively. CONCLUSION: From both the perspectives, the introduction of rotavirus vaccine to the Albanian immunization schedule is either cost-effective or highly cost-effective for a range of plausible scenarios. In most scenarios, including the base-case scenario, the discounted cost per DALY averted was less than three times the gross domestic product (GDP) per capita. However, rotavirus vaccination was not cost-effective when rotavirus cases and deaths were based on plausible minimum estimates. Introduction of RV1 would yield similar benefits at lower cost.