A Retrospective Study of the Safety and Immunogenicity of MVC-COV1901 Vaccine for People Living with HIV.

BACKGROUND: This study aimed to assess the safety and immunogenicity of MVC-COV1901, a recombinant COVID-19 protein vaccine, containing S-2P protein adjuvanted with CpG 1018 and aluminum hydroxide, for people living with HIV (PWH). METHODS: A total of 57 PWH of ≥20 years of age who are on stable antiretroviral therapy were compared with 882 HIV-negative participants. Participants received two doses of MVC-COV1901 28 days apart. RESULTS: No vaccine-related serious adverse events (SAEs) were recorded. Seroconversion rates (SCRs) of 100% and 99.8% were achieved in PWH and comparators, respectively, 28 days after the second dose. After adjusting for sex, age, BMI category, and comorbidity, the adjusted GMT ratio of comparator/PWH was 3.2 (95% CI 2.5-4). A higher CD4/CD8 ratio was associated with a higher GMT (R = 0.27, p = 0.039). MVC-COV1901 has shown robust safety but elicited weaker immune responses in PWH. CONCLUSIONS: Further investigations may be needed to determine whether PWH require distinct immunization strategies with improved immunogenicity. The main study is registered at ClinicalTrials.gov (NCT04695652).

Analysis of Imported Cases of COVID-19 in Taiwan: A Nationwide Study.

In the early stages of the 2019 novel coronavirus disease (COVID-19) pandemic, containment of disease importation from epidemic areas was essential for outbreak control. This study is based on publicly accessible data on confirmed COVID-19 cases in Taiwan extracted from the Taiwan Centers for Disease Control website. We analysed the characteristics, infection source, symptom presentation, and route of identification of the 321 imported cases that were identified from 21 January to 6 April 2020. They were mostly returned Taiwanese citizens who had travelled to one or more of 37 countries for tourism, business, work, or study. Half of these cases developed symptoms before arrival, most of the remainder developed symptoms 1-13 days (mean 4.0 days) after arrival, and 3.4% never developed symptoms. Three-quarters of the cases had respiratory symptoms, 44.9% had fever, 13.1% lost smell or taste, and 7.2% had diarrhoea. Body temperature and symptom screening at airports identified 32.7% of the cases. Of the remainder, 27.7% were identified during home quarantining, 16.2% were identified via contact tracing, and 23.4% were reported by hospitals. Under the strict enforcement of these measures, the incidence of locally acquired COVID-19 cases in Taiwan remains sporadic. In conclusion, proactive border control measures are effective for preventing community transmission of this disease.

Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan.

BACKGROUND: MVC-COV1901, a recombinant protein vaccine containing pre-fusion-stabilised spike protein S-2P adjuvanted with CpG 1018 and aluminium hydroxide, has been shown to be well tolerated with a good safety profile in healthy adults aged 20-49 years in a phase 1 trial, and provided a good cellular and humoral immune responses. We present the interim safety, tolerability, and immunogenicity results of a phase 2 clinical trial of the MVC-COV1901 vaccine in Taiwan. METHODS: This is a large-scale, double-blind, randomised, placebo-controlled phase 2 trial done at ten medical centres and one regional hospital in Taiwan. Individuals aged 20 years or older who were generally healthy or had stable pre-existing medical conditions were eligible for enrolment. Exclusion criteria included (but were not limited to) travel overseas within 14 days of screening, intention to travel overseas within 6 months of the screening visit, and the absence of prespecified medical conditions, including immunosuppressive illness, a history of autoimmune disease, malignancy with risk to recur, a bleeding disorder, uncontrolled HIV infection, uncontrolled hepatitis B and C virus infections, SARS-CoV-1 or SARS-CoV-2 infections, an allergy to any vaccine, or a serious medical condition that could interfere with the study. Study participants were randomly assigned (6:1) to receive two doses of either MVC-COV1901 or placebo, administered via intramuscular injection on day 1 and day 29. MVC-COV1901 contained 15 µg of S-2P protein adjuvanted with 750 µg CpG 1018 and 375 µg aluminium hydroxide in a 0·5 mL aqueous solution, and the placebo contained the same volume of saline. Randomisation was done centrally by use of an interactive web response system, stratified by age (≥20 to <65 years and ≥65 years). Participants and investigators were masked to group assignment. The primary outcomes were to evaluate the safety, tolerability, and immunogenicity of MVC-COV1901 from day 1 (the day of the first dose) to day 57 (28 days after the second dose). Safety was assessed in all participants who received at least one dose. Immunogenicity was assessed by measuring geometric mean titres (GMTs) and seroconversion rates of neutralising antibody and antigen-specific IgG in the per-protocol population. This study is registered with ClinicalTrials.gov, NCT04695652. FINDINGS: Of 4173 individuals screened between Dec 30, 2020, and April 2, 2021, 3854 were enrolled and randomly assigned: 3304 to the MVC-COV1901 group and 550 to the placebo group. A total of 3844 participants (3295 in the MVC-COV1901 group and 549 in the placebo group) were included in the safety analysis set, and 1053 participants (903 and 150) had received both doses and were included in the per-protocol immunogenicity analysis set. From the start of this phase 2 trial to the time of interim analysis, no vaccine-related serious adverse events were recorded. The most common solicited adverse events in all study participants were pain at the injection site (2346 [71·2%] of 3295 in the MVC-COV1901 group and 128 [23·3%] of 549 in the placebo group), and malaise or fatigue (1186 [36·0%] and 163 [29·7%]). Fever was rarely reported (23 [0·7%] and two [0·4%]). At 28 days after the second dose of MVC-COV1901, the wild-type SARS-CoV-2 neutralising antibody GMT was 662·3 (95% CI 628·7-697·8; 408·5 IU/mL), the GMT ratio (geometric mean fold increase in titres at day 57 vs baseline) was 163·2 (155·0-171·9), and the seroconversion rate was 99·8% (95% CI 99·2-100·0). INTERPRETATION: MVC-COV1901 has a good safety profile and elicits promising immunogenicity responses. These data support MVC-COV1901 to enter phase 3 efficacy trials. FUNDING: Medigen Vaccine Biologics and Taiwan Centres for Disease Control, Ministry of Health and Welfare.

Varied impacts on outpatient services among departments and divisions in the early phase of the COVID-19 pandemic: Implications for personnel mobilization and preparatory training.

BACKGROUND: Coronavirus disease 2019 (COVID-19) spread all over the world in 2020. In the face of the sudden pandemic, workforce mobilization has been of critical concern to medical institutions. During the pandemic, the public's behaviors of seeking medical assistance have also changed. Using the real-world data of a large medical center in Taiwan, this study aimed to analyze the fluctuations of outpatient visits among various departments and divisions in the early phase of the COVID-19 pandemic and to provide suggestions for staff allocation in similar future events. METHODS: Data of outpatient visits at Taipei Veterans General Hospital were obtained for analysis. The weekly fluctuations of outpatient visits among 36 departments or divisions were computed for 8 weeks from February 3 to March 29, 2020, the early phase of the pandemic. The monthly data of outpatient visits by department and division in March 2020 were also extracted for comparison with those in March 2019. A simple regression equation was used to calculate the weekly trends. RESULTS: Average outpatient visits decreased by 26% in 2 months following the outbreak. Among the 36 departments or divisions, ophthalmology, orthopedics, and cardiology underwent marked declines after the outbreak; the slopes of the simple regression equation were -110.8, -100.7, and -99.2, respectively. By contrast, transfusion medicine, toxicology, transplantation surgery, pediatric surgery, chest surgery, technical aid, and oncology were divisions less influenced. In the year-over-year comparison, infection was the only department or division with positive growth (20.5%), whereas all others exhibited negative growth. CONCLUSION: In the future, we can fulfil the additional personnel needs during a pandemic by redeploying physicians from departments experiencing a reduced workload. Hospitals should also establish preparatory employee training programs to ensure that the reassigned personnel are adequately equipped to serve in their new positions.

In-kind donations to healthcare facilities during COVID-19: Experiences from a large medical center in northern Taiwan.

BACKGROUND: In early 2020, a global outbreak of 2019 novel coronavirus disease (COVID-19) caused high mortality rates and public panic. Worldwide demand for personal protective equipment has risen, with diminishing supplies and shortages reported. During the pandemic, charitable donations have been made by the public, aimed at helping medical staff. Based on the open data, we investigate the charitable in-kind donations received by a large medical center in northern Taiwan (Taipei Veterans General Hospital [TPEVGH]) in Taiwan during the pandemic. METHODS: The period of investigation was the first half of the year 2020. TPEVGH has received various public donations. The list of donations published on the hospital's official website was analyzed. The variables in the analysis were donation category, donation percentage, number of donations, and total donation amount. RESULTS: Most in-kind donations were food and beverages (55.1%), with a monetary value of 3 124 510 New Taiwan Dollars (NTD) (24.3%). Medical equipment accounted for the second-highest number of items (34.8%) but was the highest monetary value (70.6%; 9 275 945 of 12 875 855 NTD). Daily necessities accounted for the lowest number of items (10.1%) and had a total monetary value of 475 400 NTD (3.7%). Over two-thirds were beverages (68.4%), all of which were bottles or cans for easy storage. Despite only five items (13.2%) being juice, the donation size was the largest, accounting for nearly half (47.1%) of the total monetary value. Only one item was fruit, which was high-class organic apples. The monetary value of this item was the highest (7.8%) among all donated food. Most donated snacks were biscuits. CONCLUSION: During the COVID-19 pandemic, most public donations to TPEVGH were food and daily necessities. While every donation should be appreciated, accepting high volumes of donations might incur donation management problems. Further research could be focused on managerial aspects, for example, quality and safety checking, storage, and distribution.

COVID-19 Publications in Family Medicine Journals in 2020: A PubMed-Based Bibliometric Analysis.

Family medicine physicians have been on the front lines of the novel coronavirus disease 2019 (COVID-19) pandemic; however, research and publications in family medicine journals are rarely discussed. In this study, a bibliometric analysis was conducted on COVID-19-related articles published in PubMed-indexed English language family medicine journals in 2020, which recorded the publication date and author's country and collected citations from Google Scholar. Additionally, we used LitCovid (an open database of COVID-19 literature from PubMed) to determine the content categories of each article and total number of global publications. We found that 33 family medicine journals published 5107 articles in 2020, of which 409 (8.0%) were COVID-19-related articles. Among the article categories, 107 were original articles, accounting for only 26.2% of the articles. In terms of content, the main category was prevention, with 177 articles, accounting for 43.3% of the articles. At the beginning of the epidemic, 10 articles were published in family medicine journals in January 2020, accounting for 11% of all COVID-19-related articles worldwide; however, this accounted for <0.5% of all disciplinary studies in the entire year. Therefore, family medicine journals indeed play a sentinel role, and the intensities and timeliness of COVID-19 publications deserve further investigation.

Family Medicine Academic Workforce of Medical Schools in Taiwan: A Nationwide Survey.

Little is known about family medicine academic workforce in Taiwan, and basic data on this may aid healthcare decision-makers and contribute to the limited literature. We analyzed data from 13 medical schools in Taiwan collected by the Taiwan Association of Family Medicine from June to September 2019, regarding characteristics of medical schools, and total staff, gender, age, degree, working title (adjunct/full-time), academic level, and subspecialty of each current family medicine faculty member. Total 13 medical schools in Taiwan with an undergraduate education program in family medicine, but only nine of the 13 medical schools had family medicine departments, while four still do not. A total of 116 family medicine faculty members ranging from 33-69 years. Of these, most were male (n = 85, 73.3%), with a mean age of 43.3 years. Most faculty members possessed a master's degree (n = 49, 42.2%), were academic lecturers (n = 49, 42.2%), were located in northern Taiwan (n = 79, 68.1%), and subspecialize in gerontology and geriatrics (n = 55, 47.4%) and hospice palliative care (n = 53, 45.7%). Additionally, most family medicine faculty in medical schools were adjunct faculty (n = 90, 77.6%), with only about one-fourth (n = 26, 22.4%) working full-time. Our study provides the most holistic census to date on academic family medicine faculty from all medical schools in Taiwan. The novel information can provide educational leaders, health policy managers, and decision-makers about the current developments of the family medicine departments in Taiwan's medical schools. The basic data will help formulate an effective medical school family medicine education plan and improve the establishment and development of the family medicine faculty workforce to help medical education and national health policy development in the future in Taiwan.

Impact of the COVID-19 pandemic on the use of advance care planning services within the veterans administration system in Taiwan.

BACKGROUND: The aim of this study is to investigate the effect of COVID-19 on the outpatient advance care planning (ACP) services provided by veterans hospitals in Taiwan. METHODS: This study adopted a retrospective data analysis. We investigated ACP services provided by 15 veterans hospitals in Taiwan from 2019 to June 2020. We also conducted a statistical analysis on the ACP services provided by the Taipei Veterans General Hospital. RESULTS: From 2019 to June 2020, 15 veterans hospitals in Taiwan provided ACP services to 2493 individuals. The outpatient ACP services declined significantly after January 2020, decreasing from a national average of 206.2 ± 29.2 declarants per month to 106.2 ± 30.8 declarants per month in the 6 months immediately following the COVID-19 pandemic outbreak (p < 0.001). From the official implementation of the ACP in January 2019 to the end of June 2020, a total of 1126 declarants accepted ACP services at the Taipei Veterans General Hospital. When the COVID-19 pandemic was prevalent, the declarants who received ACP services were younger (i.e., 60.1 ± 15.2 vs 65.5 ± 16.3 years; p < 0.001). After the variables had been adjusted, the changes in the characteristics of the declarants receiving ACP services when the COVID-19 pandemic was prevalent were as follows: a significant increase in the percentage of hospital staff receiving ACP services (odds ratio [OR]: 5.460, 95% confidence interval [CI]: 2.378-12.536); An increase in the percentage of declarants who paid for the ACP services received at their own expense (OR: 3.417, 95% CI: 1.591-7.339); and an increase in the percentage of declarants who received the consultations with three or more people (OR: 2.017, 95% CI: 1.278-3.182). CONCLUSION: COVID-19 severely changed outpatient ACP services provided by hospitals. The results obtained by this study offer valuable insight regarding the provision of outpatient ACP services.

Analysis of community-acquired COVID-19 cases in Taiwan.

BACKGROUND: The demographic characteristics and transmission dynamics of the community-acquired coronavirus disease 2019 (COVID-19) cases in Taiwan were analyzed for more effective control and prevention of the community transmission of this novel disease. METHODS: Open-access data and press releases on COVID-19 in Taiwan were collected on the website of the Taiwan Centers for Disease Control. All 55 community-acquired cases of COVID-19 confirmed from January 28 to April 12, 2020, in Taiwan were included. Basic demographic characteristics, symptom presentation, infection source, route of identification, and transmission dynamics were analyzed. RESULTS: Of the 55 cases, 52.7% were female and 74.5% were between 20-59 years of age. One-sixth (16.4%) of community-acquired cases were asymptomatic. More than half (58.2%) of the cases were identified via contact tracing. The median incubation period was 6 days (range 1-13 d) and the median serial interval was 4 days (range -3-24 d). Twenty-six cases (47.3%) were transmitted from presymptomatic cases, 11 cases (20%) from symptomatic cases, and 2 cases (3.6%) from an asymptomatic case. The contagious period of symptomatic cases was from 7 days before to 15 days after the onset of symptoms. CONCLUSION: The high proportion of asymptomatic cases and the transmissibility in the presymptomatic and asymptomatic periods make control of COVID-19 challenging. Protective measures such as social distancing, wearing face masks, and hand washing are mandatory to prevent community transmission.

Visiting Policies of Hospice Wards during the COVID-19 Pandemic: An Environmental Scan in Taiwan.

During an epidemic, almost all healthcare facilities restrict the visiting of patients to prevent disease transmission. For hospices with terminally ill patients, the trade-off between compassion and infection control becomes a difficult decision. This study aimed to survey the changes in visiting policy for all 76 hospice wards in Taiwan during the COVID-19 pandemic in March 2020. The altered visiting policies were assessed by the number of visitors per patient allowed at one time, the daily number of visiting slots, the number of hours open daily, and requisites for hospice ward entry. The differences in visiting policies between hospice wards and ordinary wards were also investigated. Data were collected by reviewing the official website of each hospital and were supplemented by phone calls in cases where no information was posted on the website. One quarter (n = 20) of hospice wards had different visiting policies to those of ordinary wards in the same hospital. Only one hospice ward operated an open policy, and in contrast, nine (11.8%) stopped visits entirely. Among the 67 hospice wards that allowed visiting, at most, two visitors at one time per patient were allowed in 46 (68.6%), one visiting time daily was allowed in 32 (47.8%), one hour of visiting per day was allowed in 29 (43.3%), and checking of identity and travel history was carried out in 12 wards (17.9%). During the COVID-19 pandemic, nearly all hospice wards in Taiwan changed their visiting policies, but the degree of restriction varied. Further studies could measure the impacts of visiting policy changes on patients and healthcare professionals.

Where to buy face masks? Survey of applications using Taiwan's open data in the time of coronavirus disease 2019.

BACKGROUND: The coronavirus disease 2019 (COVID-19) had spread rapidly since late December 2019. Personal protective equipment was essential to prevent transmission. Owing to shortage of face masks, Taiwan government began to implement quasi rationing on February 6, 2020, by allowing each resident to purchase two masks in seven days. Taiwan National Health Insurance Administration offered online data with real-time updates on face mask availability in all contracted pharmacies and selected local health centers. Based on the open data, numerous software applications quickly emerged to assist the public in finding sales locations efficiently. METHODS: Up until March 15, 2020, the Public Digital Innovation Space of Taiwan government had recorded 134 software applications of face mask availability, and 24 software applications were excluded due to defect, duplicate, and unavailability. These applications were analyzed according to platform, developer type, and display mode. RESULTS: Of the 110 valid software applications, 67 (60.9%) applications were deployed on websites, followed by 21 (19.1%) on social networking sites, 19 (17.3%) as mobile applications, and 3 (2.7%) in other modes. Nearly two thirds (n = 70) of applications were developed by individuals, one third (n = 37) by commercial companies, only two applications by central and local governments, and one by a nongovernmental organization. With respect to the display mode, 47 (42.7%) applications adopted map-view only, 41 (37.3%) adopted table-view only, and 19 (17.3%) adopted both modes. Of the remaining three applications, two offered voice user interfaces and one used augmented reality. CONCLUSION: Taiwan's open data strategy facilitated rapid development of software applications for information dissemination to the public during the COVID-19 crisis. The transparency of real-time data could help alleviate the panic of the public. The collaborative contributions from the grassroots in disasters were priceless treasures.

Hospital visiting policies in the time of coronavirus disease 2019: A nationwide website survey in Taiwan.

BACKGROUND: Coronavirus disease 2019 (COVID-19), a novel infectious coronavirus disease, has become a worldwide pandemic. Infection control precautions for hospital visitors are needed to avoid cluster outbreaks, so this study investigated the visiting policies of all the hospitals in Taiwan in the time of COVID-19. METHODS: From March 15, 2020, to March 18, 2020, we searched the official websites of all 472 National Health Insurance-contracted hospitals to determine their visiting policies. For those hospitals that had posted new visiting policies and still allowed visits to ordinary wards, we recorded the relevant details shown on their websites, including the number of visitors allowed at one time, the number of visiting slots per day, the total visiting hours per day, and the rules provided to visitors before visiting. RESULTS: During the study period, 276 (58.5%) hospitals had posted new visiting policies on their websites, with higher proportions of academic medical centers (92.0%, 23/25) and metropolitan hospitals (91.5%, 75/82) than local community hospitals (48.8%, 178/365) doing so. Visits to ordinary wards were forbidden in 83 hospitals among those. Among the 193 hospitals that had new visiting policies and still allowed visits to ordinary wards, 73.1% (n = 141) restricted visitors to two at a time and 54.9% (n = 106) restricted visits to two visiting slots per day. Furthermore, history taking regarding travel, occupation, contacts, and cluster information was mentioned by 82.4% (n = 159) of these 193 hospitals, body temperature monitoring by 78.2% (n = 151), hand hygiene by 63.2% (n = 122), and identity checks by 51.8% (n = 100). CONCLUSION: In the time of COVID-19 covered by this study, about three-fifths of the hospitals in Taiwan had posted their visiting policies for ordinary wards on their websites. Furthermore, the thoroughness with which such visiting policies have been enforced also requires investigation.