Effectiveness of COVID-19 vaccines among children 6-11 years against hospitalization during Omicron predominance in Malaysia.

There is currently limited data on the effectiveness of COVID-19 vaccines for children aged 6-11 years in Malaysia. This study aims to determine vaccine effectiveness (VE) against COVID-19-related hospitalization after receipt of one- and two-doses of BNT162b2 mRNA (Comirnaty-Pfizer/BioNTech) vaccine over a duration of almost 1 year in the predominantly Omicron period of BA.4/BA.5 and X.B.B sub lineages. This study linked administrative databases between May 2022 and March 2023 to evaluate real-world vaccine effectiveness (VE) for the BNT162b2 mRNA (Comirnaty-Pfizer/BioNTech) vaccine against COVID-19-related hospitalization in the Omicron pre-dominant period with BA.4/BA.5 and X.B.B sub lineages. During the Omicron-predominant period, the cumulative hospitalization rate was almost two times higher for unvaccinated children (9.6 per million population) compared to vaccinated children (6 per million population). The estimated VE against COVID-19 hospitalization for one dose of BNT162b2 was 27% (95% CI - 1%, 47%) and 38% (95% CI 27%, 48%) for two doses. The estimated VE against hospitalization remained stable when stratified by time. VE for the first 90 days was estimated to be 45% (95% CI 33, 55%), followed by 47% (95% CI 34, 56%) between 90 and 180 days, and 36% (95% CI 22, 45%) between 180 and 360 days. Recent infection within 6 months does not appear to modify the impact of vaccination on the risk of hospitalization, subject to the caveat of potential underestimation. In our pediatric population, BNT162b2 provided moderate-non-diminishing protection against COVID-19 hospitalization over almost 1 year of Omicron predominance.

Post COVID-19 condition among adults in Malaysia following the Omicron wave: A prospective cohort study.

Post COVID-19 condition is an important public health problem as we emerge from the COVID-19 pandemic. In this prospective cohort study, we aimed to determine the prevalence of this condition and assess its associated factors and impact on health-related quality of life in a population setting in Malaysia. Study was conducted from April to June 2022 when the Omicron variant predominated. All individuals testing positive for SARS-CoV-2 infection (RT-PCR, RTK-Ag) were invited for participation. Study questionnaires were delivered via the MySejahtera platform (mobile application). From the total of 44,386 participants who provided responses up to 3-months interval, 1,510 participants (3.4%) fulfilled the post COVID-19 condition criteria. Majority of the affected participants (83.8%, n = 1,265) experienced either cough, fatigue or forgetfulness-the three most common symptoms. Being females, having existing comorbidities, presence of symptoms and requiring hospital admission during the acute illness were associated with higher likelihoods of developing the post COVID-19 condition at 3-months interval. Amongst the 1,510 individuals, one in five had limitations in performing their usual daily activities while at least one in three expressed that their work was affected. Understanding this condition better is essential to guide strategic and responsive plans of action, which may require coordinated multidisciplinary interventions.

Identifying factors in the provision of intravenous stroke thrombolysis in Malaysia: a multiple case study from the healthcare providers' perspective.

BACKGROUND: Translation into clinical practice for use of intravenous thrombolysis (IVT) for the management of ischemic stroke remains a challenge especially across low- and middle-income countries, with regional inconsistencies in its rate. This study aimed at identifying factors that influenced the provision of IVT and the variation in its rates in Malaysia. METHODS: A multiple case study underpinning the Tailored Implementation for Chronic Diseases framework was carried out in three public hospitals with differing rates of IVT using a multiple method design. Twenty-five in-depth interviews and 12 focus groups discussions were conducted among 89 healthcare providers, along with a survey on hospital resources and a medical records review to identify reasons for not receiving IVT. Qualitative data were analysed using reflective thematic method, before triangulated with quantitative findings. RESULTS: Of five factors identified, three factors that distinctively influenced the variation of IVT across the hospitals were: 1) leadership through quality stroke champions, 2) team cohesiveness which entailed team dynamics and its degree of alignment and, 3) facilitative work process which included workflow simplification and familiarity with IVT. Two other factors that were consistently identified as barriers in these hospitals included patient factors which largely encompassed delayed presentation, and resource constraints. About 50.0 - 67.6% of ischemic stroke patients missed the opportunity to receive IVT due to delayed presentation. CONCLUSIONS: In addition to the global effort to explore sustainable measures to improve patients' emergency response for stroke, attempts to improve the provision of IVT for stroke care should also consider the inclusion of interventions targeting on health systems perspectives such as promoting quality leadership, team cohesiveness and workflow optimisation.

A comparison between antibiotic utilisation in public and private community healthcare in Malaysia.

BACKGROUND: There are two parallel systems in Malaysian primary healthcare services: government funded public primary care and privately-owned practices. While there have been several studies evaluating antibiotic utilisation in Malaysian public healthcare, there is a lack of literature on the use of antibiotics in the private sector. There is a dire need to evaluate the more recent performance of public vs. private community healthcare in Malaysia. As such, this study aimed at measuring and comparing the utilisation of antibiotics in the public and private community healthcare sectors of Malaysia in 2018-2021. METHODS: This study was a retrospective analysis of antibiotic utilisation in Malaysian primary care for the period of 1 January 2018 until 31 December 2021 using the nationwide pharmaceutical procurement and sales data from public and private health sectors. Rates of antibiotic utilisation were reported as Defined Daily Doses per 1000 inhabitants per day (DID) and stratified by antibiotic classes. The secondary analysis included proportions of AWaRe antibiotic category use for each sector and proportion of antibiotic utilisation for both sectors. RESULTS: The overall national antibiotic utilisation for 2018 was 6.14 DID, increasing slightly to 6.56 DID in 2019, before decreasing to 4.54 DID in 2020 and 4.17 DID in 2021. Private primary care antibiotic utilisation was almost ten times higher than in public primary care in 2021. The public sector had fewer (four) antibiotic molecules constituting 90% of the total antibiotic utilisation as compared to the private sector (eight). Use of Access antibiotics in the public sector was consistently above 90%, while use of Access category antibiotics by the private sector ranged from 64.2 to 68.3%. Although use of Watch antibiotics in the private sector decreased over the years, the use of Reserve and 'Not Recommended' antibiotics increased slightly over the years. CONCLUSION: Antibiotic consumption in the private community healthcare sector in Malaysia is much higher than in the public sector. These findings highlight the need for more rigorous interventions targeting both private prescribers and the public with improvement strategies focusing on reducing inappropriate and unnecessary prescribing.

Thrombocytopenia and venous thromboembolic events after BNT162b2, CoronaVac, ChAdOx1 vaccines and SARS-CoV-2 infection: a self-controlled case series study.

This study assessed the association between COVID-19 vaccines, SARS-CoV-2 infection and the risk of thrombocytopenia and venous thromboembolism (VTE). This self-controlled case series study used hospital records between 1st February 2021 and 28th February 2022 linked to the national immunisation registry and COVID-19 surveillance data in Malaysia. Conditional Poisson regression was used to estimate incidence rate ratios (IRR) of events in the risk period (day 1-21 post-exposure) relative to control period with the corresponding 95% confidence interval (CI) adjusted for calendar period. We found no significant increased risk of thrombocytopenia in 1-21 days following BNT162b2, CoronaVac and ChAdOx1 vaccines while the risk was increased following SARS-CoV-2 infection (IRR 15.52, 95% CI 13.38-18.00). Similarly, vaccination with BNT162b2, CoronaVac, or ChAdOx1 was not associated with an increased risk of VTE during the 1-21 days risk period. SARS-CoV-2 infection was associated with increased risk of VTE (IRR 39.84, 95% CI 27.45-32.44). Our findings showed low event rates of thrombocytopenia and VTE following booster vaccination with comparable safety profiles between those who received homologous and heterologous booster combinations. Our findings showed the risk of thrombocytopenia and VTE was not increased after COVID-19 vaccination while the risks were substantially higher after SARS-CoV-2 infection.

A systematic review of the relationship between household food insecurity and childhood undernutrition.

BACKGROUND: This systematic review aims to investigate the association between household food insecurity (HFIS) and undernutrition in children under 5 years old, thereby informing policymakers on the vital factors needed to be considered in tailoring an effective strategy to tackle childhood undernutrition and ultimately HFIS. METHODS: We performed a systematic review that examined household food insecurity among the undernourished under-five children. PubMed, Cochrane, EBSCO Host, Web of Science and Cumulative Index to Nursing and Allied Health Literature were searched from 1 January 2012 to 1 April 2022, for relevant articles. Outcome measures were stunting, underweight or wasting. Of the 2779 abstracts screened, 36 studies that fulfilled the inclusion and exclusion criteria were included. A range of tools had been used to measure HFIS, the most common being Household Food Insecurity Access Scale. HFIS has been found to be significantly associated with undernutrition, particularly stunting and underweight. This is observed proportionately across all national income levels. CONCLUSIONS: Sustainable and inclusive economic growth, which aims to reduce income, education and gender inequality, should be a key policy goal in the minimizing food insecurity and childhood undernutrition. Multisectoral interventions are needed to address these issues.

Myocarditis/pericarditis following vaccination with BNT162b2, CoronaVac, and ChAdOx1 among adolescent and adult in Malaysia.

This study evaluates 21-day risk of myocarditis/pericarditis following COVID-19 vaccination among those aged 12 years and older in Malaysia. We used data from nationwide COVID-19 vaccine registry linked to hospital episode database to identify individuals vaccinated with BNT162b2, CoronaVac, or ChAdOx1 and hospitalised for myocarditis/pericarditis between 1 February 2021 and 28 February 2022. There were 87 myocarditis/pericarditis cases identified within 1-21 days after vaccination. Most cases were reported following BNT16262 vaccination (77.0%) with absolute risk of 0.33 cases/100,000 vaccinated persons or 1.73 per million doses administered. Highest risk was observed following second dose and in younger, male individuals. The risk of myocarditis/pericarditis following CoronaVac and ChAdOx1 were much lower compared to BNT162b2. The findings on higher risk observed among younger following mRNA vaccine were consistent with literature and important for targeted surveillance.

Impact of COVID-19 Pandemic on Antibiotic Utilisation in Malaysian Primary Care Clinics: An Interrupted Time Series Analysis.

The COVID-19 pandemic has resulted in a dramatic change in the delivery of primary healthcare across the world, presumably changing trends in consultations for infectious diseases and antibiotic use. This study aimed at describing and evaluating the impact of COVID-19 on antibiotic use in public primary care clinics in Malaysia between 2018 and 2021. Data from the nationwide procurement database of systemic antibiotics from public primary care clinics in Malaysia between January 2018 and December 2021 were analysed using interrupted time series analysis. The monthly number of defined daily doses per 1000 inhabitants per day (DID) was calculated and grouped by antibiotic class. The trend of antibiotic utilisation rates had been decreasing by 0.007 DID monthly before March 2020 (p = 0.659). With the introduction of national lockdown due to COVID-19 beginning March 2020, there was a significant reduction in the level of antibiotic utilisation rates of 0.707 (p = 0.022). Subsequently, the monthly trend showed a slight upward change until the end of the study period (p = 0.583). Our findings indicate that there was a significant decrease in antibiotic utilisation for systemic use in primary care following the COVID-19 pandemic compared with the preceding years (January 2018-March 2020).

The Effectiveness of Enhanced Primary Healthcare (EnPHC) interventions on Type 2 diabetes management in Malaysia: Difference-in-differences (DID) analysis.

AIMS: To evaluate the effectiveness of the Enhanced Primary Healthcare (EnPHC) interventions on process of care and intermediate clinical outcomes among type 2 diabetes patients. METHODS: This was a quasi-experimental controlled study conducted in 20 intervention and 20 control public primary care clinics in Malaysia from November 2016 to June 2019. Type 2 diabetes patients aged 30 years and above were selected via systematic random sampling. Outcomes include process of care and intermediate clinical outcomes. Difference-in-differences analyses was conducted. RESULTS: We reviewed 12,017 medical records of patients with type 2 diabetes. Seven process of care measures improved: HbA1c tests (odds ratio (OR) 3.31, 95% CI 2.13, 5.13); lipid test (OR 4.59, 95% CI 2.64, 7.97), LDL (OR 4.33, 95% CI 2.16, 8.70), and urine albumin (OR 1.99, 95% CI 1.12, 3.55) tests; BMI measured (OR 15.80, 95% CI 4.78, 52.24); cardiovascular risk assessment (OR 174.65, 95% CI 16.84, 1810.80); and exercise counselling (OR 1.18, 95% CI 1.04, 1.33). We found no statistically significant changes in intermediate clinical outcomes (i.e. HbA1c, LDL, HDL and BP control). CONCLUSIONS: EnPHC interventions was successful in enhancing the quality of care, in terms of process of care, by changing healthcare providers behaviour.

Stroke thrombolysis in a middle-income country: A case study exploring the determinants of its implementation.

Introduction: Translation of evidence into clinical practice for use of intravenous thrombolysis in acute stroke care has been slow, especially across low- and middle-income countries. In Malaysia where the average national uptake was poor among the public hospitals in 2018, one hospital intriguingly showed comparable thrombolysis rates to high-income countries. This study aimed to explore and provide in-depth understanding of factors and explanations for the high rates of intravenous stroke thrombolysis in this hospital. Methods: This single case study sourced data using a multimethod approach: (1) semi-structured in-depth interviews and focus group discussions, (2) surveys, and (3) review of medical records. The Tailored Implementation of Chronic Diseases (TICD) framework was used as a guide to understand the determinants of implementation. Twenty-nine participants comprising the Hospital Director, neurologists, emergency physicians, radiologists, pharmacists, nurses and medical assistants (MAs) were included. Thematic analyses were conducted inductively before triangulated with quantitative analyses and document reviews. Results: Favorable factors contributing to the uptake included: (1) cohesiveness of team members which comprised of positive interprofessional team dynamics, shared personal beliefs and values, and passionate leadership, and (2) facilitative work process through simplification of workflow and understanding the rationale of the sense of urgency. Patient factors was a limiting factor. Almost two third of ischemic stroke patients arrived at the hospital outside the therapeutic window time, attributing patients' delayed presentation as a main barrier to the uptake of intravenous stroke thrombolysis. One other barrier was the availability of resources, although this was innovatively optimized to minimize its impact on the uptake of the therapy. As such, potential in-hospital delays accounted for only 3.8% of patients who missed the opportunity to receive thrombolysis. Conclusions: Despite the ongoing challenges, the success in implementing intravenous stroke thrombolysis as standard of care was attributed to the cohesiveness of team members and having facilitative work processes. For countries of similar settings, plans to improve the uptake of intravenous stroke thrombolysis should consider the inclusion of interventions targeting on these modifiable factors.

Comparative performance of public and private primary care service delivery in Malaysia: An analysis of findings from QUALICOPC.

INTRODUCTION: Primary care services are essential in achieving universal health coverage and Malaysia is looking into public-private partnership to overcome resource constraints. The study aims to compare the performance of primary care service delivery dimensions between public and private sector. METHODS: This cross-sectional study used the data from the Malaysian International Quality and Costs of Primary Care (QUALICOPC) study conducted in 2015-2016. The relative performance of each sector in four dimensions was compared using multi-level linear regression by incorporating a dummy variable indicating public sector in the model. RESULTS: The public sector was shown to have higher performance in comprehensiveness and coordination, while the private sector was better in continuity. There was no significant difference in accessibility. The public primary care services were better in serving primary care sensitive conditions, better informational continuity, and with better skill-mix and inter- and intra- professional relationship. Meanwhile, the private sector was stronger in referral decision making process, specialist feedback and greater out of hours facilities access. CONCLUSIONS: The public and private sectors differ in their strengths, which the government may tap into to strengthen primary care services. Other areas for improvement include seamless care strategies that promote good referral, feedback, and information continuity.

Conjoint analyses of patients' preferences for primary care: a systematic review.

BACKGROUND: While patients' preferences in primary care have been examined in numerous conjoint analyses, there has been little systematic effort to synthesise the findings. This review aimed to identify, to organise and to assess the strength of evidence for the attributes and factors associated with preference heterogeneity in conjoint analyses for primary care outpatient visits. METHODS: We searched five bibliographic databases (PubMed, Embase, PsycINFO, Econlit and Scopus) from inception until 15 December 2021, complemented by hand-searching. We included conjoint analyses for primary care outpatient visits. Two reviewers independently screened papers for inclusion and assessed the quality of all included studies using the checklist by ISPOR Task Force for Conjoint Analysis. We categorized the attributes of primary care based on Primary Care Monitoring System framework and factors based on Andersen's Behavioural Model of Health Services Use. We then assessed the strength of evidence and direction of preference for the attributes of primary care, and factors affecting preference heterogeneity based on study quality and consistency in findings. RESULTS: Of 35 included studies, most (82.4%) were performed in high-income countries. Each study examined 3-8 attributes, mainly identified through literature reviews (n = 25). Only six examined visits for chronic conditions, with the rest on acute or non-specific / other conditions. Process attributes were more commonly examined than structure or outcome attributes. The three most commonly examined attributes were waiting time for appointment, out-of-pocket costs and ability to choose the providers they see. We identified 24/58 attributes with strong or moderate evidence of association with primary care uptake (e.g., various waiting times, out-of-pocket costs) and 4/43 factors with strong evidence of affecting preference heterogeneity (e.g., age, gender). CONCLUSIONS: We found 35 conjoint analyses examining 58 attributes of primary care and 43 factors that potentially affect the preference of these attributes. The attributes and factors, stratified into evidence levels based on study quality and consistency, can guide the design of research or policies to improve patients' uptake of primary care. We recommend future conjoint analyses to specify the types of visits and to define their attributes clearly, to facilitate consistent understanding among respondents and the design of interventions targeting them. Word Count: 346/350 words. TRIAL REGISTRATION: On Open Science Framework: https://osf.io/m7ts9.

A Case-Based Monitoring Approach to Evaluate Safety of COVID-19 Vaccines in a Partially Integrated Health Information System: A Study Protocol.

In response to Coronavirus disease 2019 (COVID-19) global pandemic, various COVID-19 vaccines were rapidly administered under emergency use authorization. Rare outcomes associated with COVID-19 vaccines might be less likely to be captured in clinical trials, leading to a knowledge gap in real-world vaccine safety. In contrast with high-income countries, many low-to-middle income countries have limited capacity to conduct active surveillance, owing to the absence of large and fully-integrated health information databases. This paper describes the study protocol, which aims to investigate risk of prespecified adverse events of special interests following COVID-19 vaccination in a partially integrated health information system with non-shareable electronic health records. The SAFECOVAC study is a longitudinal, observational retrospective study of active safety surveillance using case-based monitoring approach. This involves linkage of several administrative databases and hospitalization data monitoring to identify adverse events of special interests following administration of COVID-19 vaccines in Malaysia. The source population comprises of all individuals who received at least one dose of COVID-19 vaccine. Self-controlled design and vaccinated case-coverage design will be employed to assess risk of adverse events of special interests and determine the association with vaccine exposure. Data on vaccination records will be obtained from the national COVID-19 vaccination register to identify the vaccination platforms, doses and the timing of vaccinations. The outcome of this study is hospitalization for the adverse events of special interests between March 2021 and June 2022. The outcomes will be obtained through linkage with hospital admission database and national pharmacovigilance database. Findings will provide analysis of real-world data which can inform deliberations by government and public health decision makers relative to the refinement of COVID-19 vaccination recommendations.

Assessment of Heterologous and Homologous Boosting With Inactivated COVID-19 Vaccine at 3 Months Compared With Homologous Boosting of BNT162b2 at 6 Months.

Importance: Evidence for the timing of booster vaccination after completion of BNT162b2 and CoronaVac primary vaccination is crucial to guide policy recommendations. Objective: To compare the odds of symptomatic SARS-CoV-2 infection and COVID-19-related outcomes after heterologous and homologous boosting of CoronaVac at 3-month intervals and homologous boosting of BNT162b2 at 6-month intervals, with BNT162b2 primary series (2 doses) as the reference group. Design, Setting, and Participants: This population-based retrospective cohort study used national data for Malaysia. Participants included all individuals aged 18 years and older who received a complete primary series of CoronaVac or BNT162b2 vaccine and were eligible for a booster dose between November 21, 2021, and December 28, 2021. Data were analyzed from November 21, 2021, to January 7, 2022. Exposures: Receipt of a booster vs no booster and categorized into primary series BNT162b2 (2 doses of BNT162b2), primary series CoronaVac (2 doses of CoronaVac), 3 doses of BNT162b2, primary series CoronaVac plus a BNT162b2 booster, and 3 doses of CoronaVac. Main Outcomes and Measures: The primary outcome was symptomatic SARS-CoV-2 infection. The secondary outcomes were COVID-19-related intensive care unit admission and death. All outcomes were observed from the day an individual was considered fully boosted (≥14 days after booster dose). Results: Our cohort included 13 840 240 individuals (mean [SD] age, 39.9 [15.5] years; 7 040 298 [50.9%] men; 4 451 180 individuals [32.2%] with ≥1 comorbidities), of whom 5 081 641 individuals (36.7%) had received a booster dose. Using the primary series BNT162b2 recipients as reference, the adjusted odds against symptomatic SAR-CoV-2 infection were lower for individuals who received the primary series CoronaVac plus a BNT162b2 (adjusted odds ratio [aOR], 0.06 [95% CI, 0.05-0.06]), 3 doses of CoronaVac (aOR, 0.08 [95% CI, 0.06-0.10]), or 3 doses of BNT162b2 (aOR, 0.01 [95% CI, 0.00-0.01]). Receipt of heterologous booster (primary series of CoronaVac plus a BNT162b2 booster) was associated with lower odds of SARS-CoV-2 infection (aOR, 0.17 [95% CI, 0.17-0.18]) compared with homologous booster (3 doses of CoronaVac) for individuals aged 60 years and older (aOR, 0.19 [95% CI, 0.19-0.20]). Conclusions and Relevance: In this cohort study, for individuals who received the CoronaVac primary series and a booster dose of BNT162b2 or CoronaVac at 3 months, the observed odds of symptomatic SARS-CoV-2 infection were similar to individuals who received the BNT162b2 primary series plus a third dose of BNT162b2 at 6 months. Heterologous booster is recommended for individuals aged 60 years or older who received the CoronaVac primary series, given the lower observed odds against symptomatic SARS-CoV-2 infection among those who received a BNT1612b2 booster.

Evaluation of BNT162b2 vaccine effectiveness in Malaysia: test negative case-control study.

There is a notable lack of vaccine effectiveness studies using test-negative case-controlled approach in low- and middle-income countries which have different logistic, demographic and socio-economic conditions from high-income countries. We aimed to estimate the effectiveness of BNT162b2 vaccine against COVID-19 infection over time, intensive care unit admission, severe or critical disease and death due to COVID-19. This study was conducted in the resident population of Labuan aged ≥18 years who had been tested for SARS-CoV-2 by Reverse-Transcriptase Polymerase Chain Reaction between 1 March 2021 and 31 October 2021. We used a test-negative case-control design where 2644 pairs of cases and controls were matched by age, sex, testing date, nationality and testing reason. Analysis was stratified by age group to estimate age effect (<60 years and ≥60 years). Of 22217 individuals tested by Reverse-Transcriptase Polymerase Chain Reaction, 5100 were positive for SARS-CoV-2 and aged 18 years and above. Overall vaccine effectiveness ≥ 14 days after the second dose was 65.2% (95% CI: 59.8-69.9%) against COVID-19 infection, 92.5% (95% CI: 72.3-98.8%) against intensive care unit admission, and 96.5% (95% CI: 82.3-99.8%) against COVID-19 deaths. Among infected individuals, vaccine effectiveness was 79.2% (95% CI: 42.3-94.1%) in preventing severe or critical disease due to COVID-19. Vaccine effectiveness for ≥60 years was 72.3% (95% CI: 53.4-83.9%) in fully vaccinated individuals, higher than 64.8% (95% CI: 49.3-59.1%) for those <60 years. Two doses of BNT162b2 were highly effective against COVID-19 infection, severe or critical disease, intensive care unit admission and death due to COVID-19. This study addresses a gap in literature on BNT162b2 vaccine effectiveness in low- and middle-income populations and demonstrates the feasibility of such a study design in a resource limited setting while supporting evidence of waning immunity.

Expert review on global real-world vaccine effectiveness against SARS-CoV-2.

INTRODUCTION: COVID-19 vaccines have been highly effective in reducing morbidity and mortality during the pandemic. While primary series vaccination rates are generally high in Southeast Asian (SEA) countries, various factors have limited the rollout and impact of booster doses. AREAS COVERED: We reviewed 79 studies in the International Vaccine Access Center (IVAC) VIEW-hub platform on vaccine effectiveness (VE) after primary immunizations with two-dose schedules. VE data were reported for SARS-CoV-2 infection, COVID-19-related hospitalizations and deaths, and stratified across variants of concern, age, study design and prior SARS-CoV-2 infection for mRNA vaccines (BNT162b2, mRNA-1273, and combinations of both), vector vaccines (AstraZeneca, AZD1222 [ChAdOx1 nCoV-19] 'Vaxzevria'), and inactivated virus vaccines (CoronaVac). EXPERT OPINION: The most-studied COVID-19 vaccines provide consistently high (>90%) protection against serious clinical outcomes like hospitalizations and deaths, regardless of variant. Additionally, this protection appears equivalent for mRNA vaccines and vector vaccines like AZD1222, as supported by our analysis of Asian and relevant international data, and by insights from SEA experts. Given the continued impact of COVID-19 hospitalizations and deaths on health-care systems worldwide, encouraging vaccination strategies that reduce this burden is more relevant than attempting to prevent broader but milder infections with specific variants, including Omicron.

Risk of serious adverse events after the BNT162b2, CoronaVac, and ChAdOx1 vaccines in Malaysia: A self-controlled case series study.

BACKGROUND: Rapid deployment of COVID-19 vaccines is challenging for safety surveillance, especially on adverse events of special interest (AESIs) that were not identified during the pre-licensure studies. This study evaluated the risk of hospitalisations for predefined diagnoses among the vaccinated population in Malaysia. METHODS: Hospital admissions for selected diagnoses between 1 February 2021 and 30 September 2021 were linked to the national COVID-19 immunisation register. We conducted self-controlled case-series study by identifying individuals who received COVID-19 vaccine and diagnosis of thrombocytopenia, venous thromboembolism, myocardial infarction, myocarditis/pericarditis, arrhythmia, stroke, Bell's Palsy, and convulsion/seizure. The incidence of events was assessed in risk period of 21 days postvaccination relative to the control period. We used conditional Poisson regression to calculate the incidence rate ratio (IRR) and 95% confidence interval (CI) with adjustment for calendar period. RESULTS: There was no increase in the risk for myocarditis/pericarditis, Bell's Palsy, stroke, and myocardial infarction in the 21 days following either dose of BNT162b2, CoronaVac, and ChAdOx1 vaccines. A small increased risk of venous thromboembolism (IRR 1.24; 95% CI 1.02, 1.49), arrhythmia (IRR 1.16, 95% CI 1.07, 1.26), and convulsion/seizure (IRR 1.26; 95% CI 1.07, 1.48) was observed among BNT162b2 recipients. No association between CoronaVac vaccine was found with all events except arrhythmia (IRR 1.15; 95% CI 1.01, 1.30). ChAdOx1 vaccine was associated with an increased risk of thrombocytopenia (IRR 2.67; 95% CI 1.21, 5.89) and venous thromboembolism (IRR 2.22; 95% CI 1.17, 4.21). CONCLUSION: This study shows acceptable safety profiles of COVID-19 vaccines among recipients of BNT162b2, CoronaVac, and ChAdOx1 vaccines. This information can be used together with effectiveness data for risk-benefit analysis of the vaccination program. Further surveillance with more data is required to assess AESIs following COVID-19 vaccination in short- and long-term.

Real-world effectiveness of homologous and heterologous BNT162b2, CoronaVac, and AZD1222 booster vaccination against Delta and Omicron SARS-CoV-2 infection.

Given emerging evidence of immune escape in the SARS-CoV-2 Omicron viral variant, and its dominance, effectiveness of heterologous and homologous boosting schedules commonly used in low-to-middle income countries needs to be re-evaluated. We conducted a test-negative design using consolidated national administrative data in Malaysia to compare the effectiveness of homologous and heterologous BNT162b2, CoronaVac, and AZD1222 booster vaccination against SARS-CoV-2 infection in predominant-Delta and predominant-Omicron periods. Across both periods, homologous CoronaVac and AZD1222 boosting demonstrated lower effectiveness than heterologous boosting for CoronaVac and AZD1222 primary vaccination recipients and homologous BNT162b2 boosting. Broadly, marginal effectiveness was smaller by 40-50 percentage points in the Omicron period than the Delta period. Without effective and accessible second-generation vaccines, heterologous boosting using BNT162b2 for inactivated and vectored primary vaccination recipients is preferred.

Assessing the Availability of Teleconsultation and the Extent of Its Use in Malaysian Public Primary Care Clinics: Cross-sectional Study.

BACKGROUND: The integration of teleconsultation into health care systems as a complement to existing approaches to care is growing rapidly. There is, however, limited information on the extent of its implementation across low- and middle-income countries. OBJECTIVE: The aim of this study was to determine the availability and the extent of teleconsultation in Malaysian primary care clinics. METHODS: A cross-sectional study of public primary care clinics in Malaysia was conducted between November 2020 and December 2020. All clinics in Malaysia that see more than 300 daily patients were recruited. A web-based, self-administered questionnaire including questions on availability of the service, whether it uses video or telephone, and the types of services it provides was distributed to the medical officer in charge of each clinic. RESULTS: In total, 97.6% (249/255) of the clinics responded. Out of these clinics, 45.8% (114/249) provided teleconsultation. A majority of the clinics providing consultation (69/114, 60.5%) provided only telephone consultation, while 24.6% (28/114) of the clinics offered video and telephone consultation, and 14.9% (17/114) offered only video consultation. Eighty percent (92/114) of the clinics were located in urban areas. A breakdown by state showed that 17.5% (20/114) and 16.7% (19/114) of the clinics were from two larger states; other states comprised less than 10% each (range 7-9/114). For the clinics providing video consultation, funding for the service came mostly (42/45, 93%) from the Ministry of Health. Conversely, nearly 1 out of 4 (23/97) clinics that provided telephone consultation funded the service either from donations or through self-funding. Most of the clinics provided teleconsultation for diabetes and hypertension. Less than 50% of the clinics with teleconsultation used it for follow up with allied health care providers or pharmacists (video consultation, 20/45; telephone consultation, 36/97). CONCLUSIONS: Our findings show that telephone consultation is more widely used than video consultation, despite a quarter of its funding being self-subsidized or obtained through donations. Also, teleconsultation was less utilized by allied health care providers and pharmacists. Plans for the expansion of teleconsultation in Malaysian primary health care should take into consideration these findings to ensure a better and more cost-effective implementation of the service.

Real-world effectiveness of BNT162b2 vaccine against SARS-CoV-2 infection among adolescents (12 to 17-year-olds) in Malaysia.

OBJECTIVES: In this study, we aimed to investigate vaccine effectiveness (VE) against SARS-CoV-2 infections among adolescents aged 12 to 17 years in Malaysia and examine potential VE differences after full vaccination. METHODS: We consolidated data on COVID-19 testing, vaccination, and outcomes for all public school-going adolescents in Malaysia from September 1, 2021, to December 31, 2021, and estimated the VE against SARS-CoV-2 infections during this period. Cases were defined as positive tests, either by reverse transcriptase- PCR (RT-PCR) or rapid antigen (RTK-Ag) testing, while controls were negative tests. Secondarily, we restricted the analysis to all tests performed in December 2021 and compared VE by month of full vaccination. RESULTS: A total of 175,880 eligible tests (53.4% or 93,995 RT-PCR tests) were included. After full vaccination with BNT162b2, VE against SARS-CoV-2 infections was 65.7% (95% confidence interval [CI] 64.4, 66.9) over the study period. When restricted to tests in December 2021, VEs for those fully vaccinated in September 2021, October 2021, and November 2021 were comparable (60.6% [95% CI 23.7, 81.5], 56.9% [95% CI 51.1, 62.0], and 65.7% [95% CI 59.8, 70.7] respectively). CONCLUSIONS: Among adolescents, full vaccination with BNT162b2 offered considerable protection against SARS-CoV-2 infections over at least three months without substantial evidence of waning.