Bio Farma Research Articles

Comparison of Immunogenicity and Safety of Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants.

Satisfying the needs of the national immunization program requires maintaining diphtheria-tetanus-pertussis (DTP)-hepatitis B (HB)-Haemophilus influenza B (Hib) production. Therefore, new hepatitis B sources are needed. This study aimed to evaluate the immunogenicity of the DTP-HB-Hib vaccine (Bio Farma) that used a different source of hepatitis B. A prospective randomized, double-blind, bridging study was conducted. Subjects were divided into two groups with different batch numbers. Healthy infants 6-11 weeks of age at enrollment were immunized with three doses of the DTP-HB-Hib vaccine after a birth dose of hepatitis B vaccine. Blood samples were obtained prior to vaccination and 28 days after the third dose. Adverse events were recorded until 28 days after each dose. Of the 220 subjects, 205 (93.2%) completed the study protocol. The proportion of infants with anti-diphtheria and anti-tetanus titers ≥ 0.01 IU/mL was 100%, with anti-HBsAg titers ≥ 10 mIU/mL was 100%, and with Polyribosylribitol Phosphate-Tetanus Conjugate (PRP-TT) titers > 0.15 µg/mL was 96.1%. The pertussis response rate was 84.9%. No serious adverse events related to the study vaccine occurred. The three-dose DTP-HB-Hib vaccine (Bio Farma) is immunogenic, well tolerated, and suitable to replace licensed-equivalent vaccines.

The Role of Demand Forecasting Analysis (Case Study: Bio Farma for Papua Area)

Bio Farma as the only vaccine manufacturer in Indonesia, divides its marketing area for vaccine distribution throughout Indonesia, represented by marketing representatives in 34 provinces in Indonesia. Segmentation based on geography for vaccine products is divided into five regions, one of the region is Papua. The forecast method used in Bio Farma for Papua Area is still manual. Marketers order vaccines from central Bio Farma and make forecasts if product stock is empty. If the product is empty, a buffer stock will be created. With the buffer stock system that has been implemented so far, there are often problems with excess product which causes the product to expire. From the data, the total loss due to overstock is Rp. 14,161,693 in 2022. If consumer demand falls short of expectations, it will definitely have an impact on the manufacturing of high inventory value, even leading to lost opportunities for sales. That is the fundamental issue with this research. The goal of this research is to identify the possible causes for the overstock and to identify a suitable solution for those issues. There are five things consist of root causes the problem; (1) fully manual forecasting, (2) low sales forecast accuracy, (3) sales forecasting based on sales of the last one or two months, (4) lack of employee knowledge about sales forecasting, (5) significant gap between target and actual sales. The alternate strategy recommended is to provide a forecasting technique that is suitable for the company. Different forecasting techniques were selected to be compared in order to determine which may be used to improve forecasting accuracy. The forecasting techniques that are employed are the 3-month simple moving average, the 5-month simple moving average, the 3-month weighted moving average, the 5-month weighted moving average, and exponential smoothing. By using the MAD and MAPE measurement tools, exponential smoothing showed the most acceptable accuracy result.

The Role of Demand Forecasting Analysis (Case Study: Bio Farma for Papua Area)

The Role of Demand Forecasting Analysis (Case Study: Bio Farma for Papua Area)

The Creating Share Value communication of PT. Bio Farma in green livestock feed empowerment program

One of the flagship Creating Share Value (CSV) programs by PT Biofarma in 2021 is the Re-Grass & Sustainability Village program. First, this program has been able to meet the demand for fodder for horses, which is one of the input rows in the production process at PT. Biofarma and also for the farming community around PT Biofarma’s operations. Even the fostered community is able to supply the needs of green fodder for several breeders in other areas through fermentation activities (silage) and pellet feed. Second, the CSR program to build animal feed security also received MURI records for productivity and high protein content. Third, the results of the evaluation by calculating the value of Social Return on Investment (SROI) show the value of Rp. 7,37. Based on the indicators, there are questions about what kind of communication was built into the program so that it was able to achieve a high level of success. Research with qualitative methods was conducted to answer the questions. The results of the research show that the communication activities carried out include the integration and coordination of various channels and sources of information, designing and implementing various communication techniques, and utilizing the nature and characteristics of communicators according to their respective positions. Implementation of information diffusion of green fodder is also supported by facilities that can simplify and reduce the risk of loss to the target group in adopting innovations.

Fikih Prioritas dalam Fatwa Kehalalan Vaksin Covid-19 di Indonesia

This study intends to identify the dimensions.of the priority fiqh paradigm(fiqh al-Awlawiyyât) in the formulation of the MUI Fatwa No. 02 of 2021 Regarding Covid-19 Vaccine Products From Sinovac Life Sciences Co. Ltd. China And Pt. Bio Farma (Persero). This qualitative research is in the form of a literature review using a philosophical normative approach. The analytical theory used is the priority fiqh paradigm that was initiated by Yusuf al-Qaradawi. The results showed that there were dimensions of the priority fiqh paradigm in the formulation of the MUI fatwa on the halalness of the Sinovac vaccine. First, the dimension of the fiqh al-maqasid paradigm (fiqh objectives) in the use of a theological foundation that contains a universal legal message about the importance of the orientation to maintain the benefit of the human soul (hifz nafs). Second, the dimension of the fiqh al-muwazanat paradigm (consideration fiqh) in the use of the basic principles of Islamic law (qawaid fiqhiyah) and classical fiqh thinking which emphasizes preventive efforts (saddal-dzari'ah) and universal benefit (maslahah mursalah). Meanwhile, the dimensions of the muwazanah fiqh paradigm can also be seen in the use of various classical fiqh opinions which are the basis for the formulation of the MUI fatwa, dominated by the opinions of the Shafi'i school of jurisprudence, which have acceptability for Muslims in Indonesia. Third, the dimension of the fiqh al-wâqi' paradigm (fiqh of reality) in the involvement of experts in the analysis of vaccines. This shows that MUI emphasizes the importance of integrating the formulation of fatwas with competent and developing scientific thinking, not just based on speculation. The theoretical implication of this research shows that the formulation of the MUI fatwa related to the halalness of the Sinovac vaccine has a paradigmatic priority scale for considering the level of benefit for life safety. The limitation of this research is that it has not examined the concrete role of MUI in disseminating the.fatwa on the halalness of the Sinovac vaccine as a form of synergy with the vaccination program in Indonesia

Latent tuberculosis infection in family members in household contact with active tuberculosis patients in Semarang City, Central Java, Indonesia.

A quarter of the world’s population is infected with Mycobacterium tuberculosis (M.tb), 10% of cases develop active tuberculosis (TB), and 90% have a latent TB infection. Family members of TB patients have the highest potential for latent TB infection. This study aims to identify latent TB infection and risk factors in family members within the household contacts of active TB patients. This study used a crosssectional study design with a contact tracing method. The selected subjects were 138 people from 241 total family members of 112 active TB patients. Subjects underwent a tuberculin skin test (TST), using 2 units of tuberculin (TU) purified protein derivative (PPD) 0.1 mL (PT. Bio Farma Persero, Bandung, Indonesia). Data risk factors were collected during home visits. Data were analyzed using the chi-square test and multiple logistic regression. A total of 63.8% (88/138) of family members of active TB patients’ household contacts had latent TB infection. The type of occupation of laborers/ farmers/fishers is the most dominant risk factor associated with latent TB infection (AOR: 7.04; 95% CI: 1.70–29.02), followed by unqualified bedroom density (<8 m2/2 people) (AOR: 5.33; 95% CI: 2.44– 12.71) and contact duration ≥5 hours/day (AOR: 4.70; 95% CI:1.33–16.66). Latent TB infection in family members of active TB patients’ household contacts was quite high. Occupation type, contact duration, and bedroom density were simultaneously confirmed as the main risk factors related to latent TB infection. Therefore, it is recommended to identify and prevent latent TB infection in family members in household contact with active TB patients.

TINJAUAN HUKUM ISLAM TERHADAP FATWA MUI NO 02 TAHUN 2021 TENTANG KEHALALAN VAKSIN COVID-19 SINOVAC

The determination of various types of Covid-19 vaccine products that have been determined by the Indonesian government as well as promises to provide Covid-19 vaccine products cannot be guaranteed to be halal, thayib and safe to use, especially for Indonesian people who are Muslim. On this basis, there was a debate in Indonesia regarding the halalness of thecovid 19 vaccine. Therefore, in order to organize and be able to successfully distribute the vaccine, as well as the consumption of the vaccines that have been purchased. So the Indonesian government cooperates with the Indonesian Ulema Council (MUI) by referring to the Fatwa of the Indonesian Ulema Council (MUI) NO. 02 of 2021 which issues a fatwa regarding the law that the Covid-19 vaccine produced by Sinovac Life Sciences Co. Ltd. China and PT. Bio Farma (Persero) is legal, holy and halal. This study aims to find out in detail the legal basis for the MUI to issue a fatwa that the Sinovac vaccine is halal and to know and be able to analyze the views of Islamic law on the MUI Fatwa No. 02 of 2021 regarding the halalness of the Sinovac vaccine. This research is legal-normative research, namely research that uses law to justify a legal event. This type of research is descriptive-analytic research using library research. Based on the results of the study, it is known that there are 7 basics used by the MUI in determining the halalness of the Sinovac vaccine, namely: First, the opinion of the Ulama; Second, MUI Fatwa No. 04/2016 on Immunization; Third, MUI Fatwa Number 01 of 2010 concerning the Use of Microbes and Microbial Products in Food Products; Fourth, MUI Fatwa Number 45 of 2018 concerning the Use of Blood Plasma for Medicinal Ingredients; Fifth, the report and explanation of the audit results of the LPPOM MUI Auditor Team together with the MUI Fatwa Commission to Sinovac and PT Bio Farma; Sixth, the opinion of the participants of the Fatwa Commission meeting on January 8, 2021; Seventh, BPOM's decision to give approval for emergency use and guarantee of safety, quality, and efficacy for the Sinovac vaccine, which is one indicator that the vaccine meets thayyib qualifications. In addition, it can be believed that the Covid-19 vaccine produced by Sinovac is holy and halal. Those are the notes on the results of the MUI Fatwa regarding the halal certification of vaccines that were described in the Plenary Session of the MUI Fatwa Commission on January 8, 2020 and the MUI Fatwa No. 2 of 2021 has been issued/decided.

Membangun Orientasi Pelangggan Secara Profesional dengan Dasar Etika Bisnis

This study aims to examine the effect of business ethics and professional competence as independent variables with customer satisfaction as the independent variable. The type of research used is descriptive quantitative with a sample of 90 employees at the company PT. Pharos and Bio Farma. The data analysis technique used hypothesis testing with multiple linear regression. The results of the study partially illustrate that the t-test of business ethics variables has a significant effect on customer satisfaction and professional competence also has an effect on customer satisfaction. based on the simultaneous F-test and R-test produced simultaneously, business ethics and professional competence have an effect on customer satisfaction. and based on the R test, the two variables of business ethics and professional competence were able to give an effect of 54.9 percent on customer satisfaction.

Legal Protection of Inventor Employees through Patent Ownership Agreements in Indonesia

Intellectual property born in the production process in a company is usually a patent produced by inventor employees through research and development activities. However, arrangements regarding the ownership of patents generated by inventor employees in employment or service relations in Article 12 and Article 13 of the Patent Law grant the patent ownership rights automatically to the employer so as not to provide adequate legal protection to the inventor employee. Legal protection for an employed inventor is important to note because it will spur IPR productivity and motivate inventors' creativity to produce intellectual property work. This research used normative juridical methods with analytical descriptive research specifications. Data collection was done through interviews together with company representatives at PT. Martina Berto (Tbk) and PT. Bio Farma (Persero). The results showed that the practice of patent ownership produced by inventor employees at PT. Martina Berto (Tbk) and PT. Bio Farma (Persero) based on Article 12 and Article 13 of the Patent Law is contrary to the principle of alter ego. Inventor employees can negotiate with the company by forming a patent ownership agreement that will clarify the ownership rights and the number of rewards that will be obtained by inventor employees based on Article 12 paragraph (1) and Article 153 of the Patent Law

Protectivity and safety following recombinant hepatitis B vaccine with different source of bulk compared to hepatitis B (Bio Farma) vaccine in Indonesia.

PurposeIndonesia, a high populous and the second-highest country in epidemicity of hepatitis B in South-East Asia require maintaining its capacity of monovalent hepatitis B production to keep up with both the national immunization program and global needs. To keep the sustainability of the vaccine, a new bulk is needed to be made available. This study aims to evaluate the immunogenicity and safety of Bio Farma newly formulated recombinant hepatitis B vaccines, which came from different sources of bulk, compared to the already registered hepatitis B vaccine.Materials and MethodsAn experimental, randomized, double-blind, cohort intervention phase II clinical trial was conducted on three recombinant hepatitis B vaccines from different bulk sources, with Bio Farma registered hepatitis B vaccine as the control group. A total of 536 participants around age 10 to 40 years old were thricely vaccinated with twice serological assessments. The subject’s safety was monitored for 28 days after each vaccination.ResultsOf 536 enrolled participants, 521 finished the vaccination and serology assessments. The investigational products were proven not to be inferior to the control. All vaccines were well tolerated. No differences in rates of local and systemic reactions were seen between the investigational products and control. No serious adverse event was found to be related to the investigational vaccines.ConclusionInvestigational vaccines are shown to be equally immunogenic and safe as the control vaccine.

Immunogenicity and Safety of Three WHO Prequalified (DTwP -HB-Hib) Pentavalent Combination Vaccines Administered As Per Iranian National Immunization Plan in Iranian Infants: A Randomized, Phase III Study

The pentavalent vaccine Pentavac was officially introduced in the Iranian National Immunization Plan in November, 2014. To compare the immunogenicity and safety of Pentavac vaccine (Serum Institute of India Ltd.) with two other pentavalent vaccines available in Iran, i.e., Pentabio (PT Bio Farma (Persero)) and Shan 5 (Shantha Biotechnics Ltd.). Randomized, phase III study. 900 infants attending the study sites to receive the vaccine at 2, 4, and 6 months of age. Infants were randomly assigned to one of the Pentavac, Pentabio, and Shan 5 vaccine groups. The antibody titers were measured against five antigens, diphtheria, tetanus, pertussis, Haemophilus influenzae B, and hepatitis B before receiving the first dose and one month after the last dose. The adverse events following vaccination after each dose were recorded in the adverse events diary. All vaccines showed similar immunogenicity against four of the five antigens except pertussis. While vaccination with Shan 5 resulted in the highest immunogenicity against pertussis, Pentabio was significantly lower than the other two vaccines (P<0.001). The incidence of local adverse events significantly differed among the three vaccine brands (P<0.001), but the incidence of most of the evaluated systemic adverse events was similar (P>0.05). Pentavac and Shan 5 had similar immunogenicity, the former having better immunogenicity against pertussis than Pentabio. Pentavac and Pentabio had a comparable safety profile.

Pengadaan Vaksin Covid-19 Triwulan I Tahun 2021 di Indonesia Persfektif Hukum Ekonomi Syariah

In the first quarter of 2021, Indonesia will purchase vaccines by importing COVID-19 vaccines from COVID-19 vaccine companies. Islamic Economic Law regulates the process of purchasing vaccines by importing Covid-19 vaccines, how transactions are completed, and aspects of the safety and halalness of Covid-19 vaccines. The purpose of this study was to determine the import contract of Indonesia's Covid-19 vaccine with halal guarantees and health aspects in accordance with sharia economic law. This research uses literature study method. The data analysis method used in this research is deductive analysis. The data collection method in this research is documentation. Sources of data used are primary and secondary data sources. The main data sources used in this study are COVID-19 vaccines, vaccine books, import and export of Islamic law and economics, Islamic law, trade law, and documents related to precedents contained in Islamic law. Sources of supporting data used in this research come from scientific studies, articles, and books that support the research topic. From the perspective of Islamic economic law, the purchase of the Covid-19 vaccine in Indonesia is included in the Salam sale and purchase contract. MUI has announced that the Covid-19 vaccine product is halal and multifaceted. In accordance with Presidential Regulation No. 99 regarding vaccine procurement and vaccination implementation in 2020, the current sales contract is in effect. For the Covid-19 pandemic, if there is a mandatory threat, the contract can be extended. Or cancel. The government guarantees the safety, type and quality of halal products as well as the effectiveness of the Covid-19 vaccine (namely the POM and MUI). The type of covid-19 vaccine with guaranteed halal products and an emergency use license is the type of vaccine from PT. Bio Farma (Persero), Sinovach Biontech Ltd, AstraZeneca.Keywords : vaccine procurement, covid-19 vaccine, salam contract

The Epystimology of Islamic Jurisprudence on Covid-19 Vaccine in Indonesia

The Covid-19 vaccination program in Indonesia, practically has received a pro and contra in the society. In this context, the Majelis Ulama Indonesia (MUI) came through its fatwa to respond the contra-productive of the community over the succession of the vaccination program. This study analysis the epistemological basis of Islamic law in the construction of the MUI Fatwa Number. 02 of 2021 about Covid-19 Vaccine Products from Sinovac Life Sciences Co. Ltd. China And Pt. Bio Farma (Persero). This qualitative research used philosophical approach, statute approach and conceptual approach. The results show, the epistemological construction of the MUI fatwa No. 02 of 2021 about the Covid-19 vaccine, Sinovac tends to integrate the paradigm of idealism and realism of Islamic law. The tendency of the integrative paradigm can be seen from the epistemological basis of the MUI fatwa formulation on the halalness of the Sinovac Covid-19 vaccine, which is normative-deductive and empirical-inductive, beside that still use preventive fiqh rules (sad al-dhariah) and benefit (maslahatul mursalah) as the basis for formulating a fatwa. This conclusion can be seen in various elements in the epistemological construction of the MUI Fatwa. First, universal ethical moral values ​​('am) are taken from the texts (al-Qur'an and Hadith). Second, several fiqh rules emphasize the sadd al-zari'ah (preventive action) and maslahah mursalah (public benefit). Third, the opinion of classical scholars. Fourth, the thought of experts regarding the Covid-19 vaccine.

THE INFLUENCE OF WORK MOTIVATION AND SELF MANAGEMENT PRACTICES ON EMPLOYEE JOB SATISFACTION (CASE STUDY OF PT. BIO FARMA IN BANDUNG)

This research aims to determine how the description of work motivation, self-management practices, and employee job satisfaction, as well as to determine how the influence of work motivation and self-management practices on employee job satisfaction PT. Bio Farma. The factors tested in the study were work motivation and self-management practices as independent variables, while job satisfaction was dependent variables. The research methods used in this research are descriptive and verification methods. The population in this study were employees at PT. Bio Farma. The sampling technique used in this study was Purposive Sampling and the size of the sample in this study was calculated with the formula Slovin, so the total number was 200 respondents. The analytical methods used in this study are some linear regression analyses using SPSS25 for Windows. The results of this study show that work motivation and self-management practices affect employee job satisfaction at PT. Bio Farma. The effect of work motivation and self-management practices on employee job satisfaction was 59.3%.

Legal Aspects of Business Competition in the Procurement of Covid-19 Vaccine by Bio Farma Ltd

The purpose of this research is to analyze the exclusion of monopoly by State Owned Enterprises (BUMN) based on the provisions of business competition law in the procurement of the Covid-19 vaccine by Bio Farma (Persero) Ltd. Indonesia is being hit by the Covid-19 outbreak. This condition has had a negative impact in various fields. To overcome this, one of the government's efforts is to bring in vaccines to prevent the spread, and the procurement of vaccines is given to Bio Farma Ltd. There are indications of monopoly actions in the procurement of Covid-19 vaccines by Bio Farma Ltd. This research uses the approach statute approach and conceptual approach. The technique of tracing legal materials uses field study techniques and document studies (library research), as well as study analysis is using qualitative analysis. The results of the research and the discus-sion show that the procurement process for the Covid-19 vaccine is strictly regulated by the government. Even the quantity, procurement, and distribution are coordinated by the government in this case through the assignment of SOEs (BUMN) as regulated in Presidential Regulation Number 99 of 2020 as amended by Presidential Regulation Number 14 of 2021. The results of the study show that the actions taken by SOEs (BUMN) in this case Bio Farma (Persero) Ltd in procuring the Covid-19 vaccine is included in the excluded monopoly category, because it meets the elements of the provisions in Article 50 paragraph a. Law Number 5 of 1999 concerning Prohibition of Monopolistic Practices and Unfair Business Competition.

Safety and immunogenicity of human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, and neonates in Indonesia: Phase I Trial

BackgroundDespite safe and effective WHO prequalified rotavirus vaccines, at least 84 million children remain unvaccinated. A birth dose schedule of the RV3-BB vaccine was reported to be highly efficacious against severe rotavirus disease in Indonesian infants and is under further development at PT Bio Farma, Indonesia. The aim is to develop a rotavirus vaccine starting from birth that could improve the implementation, safety, and effectiveness of vaccines. MethodsA multi-site phase I study of a human neonatal RV3 rotavirus vaccine (Bio Farma) in adults, children, neonates in Indonesia from April 2018 to March 2019. The adult and child cohorts were open-labeled single-dose, while the neonatal cohort was randomized, double-blind, and placebo-controlled three-doses at the age of 0–5 days, 8–10 weeks, and 12–14 weeks. The primary objective was to assess the safety of vaccines with the immunogenicity and vaccine virus fecal shedding as the secondary endpoints in neonates. ResultsTwenty-five adults, 25 children, and 50 neonates were recruited, and all but one in the neonatal cohort completed all study procedures. Three serious adverse events were reported (1 adult & 2 neonates), but none were assessed related to investigational product (IP). The neonatal vaccine group had a significantly higher positive immune response (cumulative seroconverted SNA and IgA) 28 days after three doses than those in the placebo group (72% vs. 16.7%, respectively). The GMT of serum IgA in the vaccine group was significantly higher at post IP dose 1 (p < 0.05) and post IP dose 3 (p < 0.001) compared to the placebo group. ConclusionThe trial results show that the RV3 rotavirus vaccine (Bio Farma) is well tolerated in all participant cohorts (adults, children, and neonates). Three doses of this vaccine administered in a neonatal schedule were immunogenic. These promising results support further clinical development of the RV3 rotavirus vaccine (Bio Farma).

EDUKASI MASYARAKAT PENTINGNYA VAKSIN COVID-19 GUNA MENCEGAH PENYEBARAN COVID-19 DI KECAMATAN BIRU-BIRU

The Covid-19 pandemic has entered a new phase. Efforts to control Covid-19 are carried out by conducting mass vaccinations to all levels of society. Indonesia itself has launched and targeted a vaccination program for all levels of society. This vaccination program aims to achieve herd immunity. Indonesia itself currently uses 6 types of vaccines from several countries, namely vaccines produced by PT Bio Farma (Persero), AstraZeneca, China National Pharmaceutical Group Corporation (Sinopharm), Moderna, Novavax Inc, Pfizer Inc. and BioNTech, Sinovac Life Sciences Co., Ltd. This outreach activity aims to provide understanding and knowledge to the public about the importance of the Covid-19 vaccine. This activity was carried out in Penen village, Biru-Biru District.

Public Communication Strategies on Socialization Covid-19 Vaccine in Indonesia Perspective Sociology of Mass Communication

To hold a Covid-19 event, of course, it requires first socialization to the community. So that people can believe that it has been confirmed to be safe and has gone through the III clinical trial by PT. Bio Farma (Persero). This study aims to determine the public communication strategy for the socialization of the COVID-19 vaccine carried out by the government which is studied in the perspective of the Sociology of Mass Communication. This study uses a library research method that refers to resources available both online and offline such as: scientific journals, books and news sourced from trusted sources. The results of this study conclude that handling and overcoming COVID-19 is still a top priority in Indonesia and still requires serious attention. Especially in the process of socializing the COVID-19 vaccine and the process of educating the public still needs to be done, considering that there are still groups of people who refuse vaccination for unscientific reasons.

Public Communication Strategies on Socialization Covid-19 Vaccine in Indonesia Perspective Sociology of Mass Communication

To hold a Covid-19 event, of course, it requires first socialization to the community. So that people can believe that it has been confirmed to be safe and has gone through the III clinical trial by PT. Bio Farma (Persero). This study aims to determine the public communication strategy for the socialization of the COVID-19 vaccine carried out by the government which is studied in the perspective of the Sociology of Mass Communication. This study uses a library research method that refers to resources available both online and offline such as: scientific journals, books and news sourced from trusted sources. The results of this study conclude that handling and overcoming COVID-19 is still a top priority in Indonesia and still requires serious attention. Especially in the process of socializing the COVID-19 vaccine and the process of educating the public still needs to be done, considering that there are still groups of people who refuse vaccination for unscientific reasons.

Convalescent plasma therapy in patients with moderate-to-severe COVID-19: A study from Indonesia for clinical research in low- and middle-income countries.

BackgroundWe explored the outcome of convalescent plasma (CP) treatment in patients with moderate and severe coronavirus disease 2019 (COVID-19) and investigated variables for the design of further trials in Indonesia.MethodsHospitalised patients with moderate (n = 5) and severe (n = 5) COVID-19 were recruited and transfused with CP from donors who recovered from mild (n = 5), moderate (n = 5), or severe (n = 1) COVID-19. Neutralising antibodies (NAbs) to the virus were measured at the end of the study using a surrogate virus neutralisation test as an alternative to the plaque reduction assay. Clinical improvement was assessed based on the modified World Health Organization Research and Development Blueprint six-point scale, Brixia Chest-X-Ray scoring, and laboratory parameters. The study was registered at ClinicalTrials.gov (NCT04407208).FindingsCP transfusion in three doses of 3 mL/kg of recipient body weight at 2-day intervals was well tolerated. Good clinical improvement was achieved in all patients with moderate disease and in two patients with severe disease. Most patients at baseline had detectable NAbs with median inhibition rates comparable to those of the donors (90·91% vs. 86·31%; p = 0·379). This could be due to the unavailability of pre-donation NAb testing and postponed CP administration that required communal consent.InterpretationThis study highlights the safety of CP therapy. Although improvements were observed, we could not conclude that the outcomes were solely due to CP treatment. Further randomised controlled trials that cover different disease stages with pre-donation NAb measurements using locally applicable strategies are warranted.FundingThe study was supported by PT Bio Farma, Indonesia.