Myanmar Health Sciences Research Journal
Original Articles :
Myanamr Health Research Registration 2023; 35(1-3): 1-9.

Assessment of Safety and Immunogenicity of BBIBP-CorV (Myancopharm) COVID-19 Vaccine as a Third Dose (Booster) among Workers of Pharmaceutical Factory (Insein) in Yangon, Myanmar

Mo Mo Win1#, Aung Kyaw Kyaw1#, Han Win1*, Thae Mg Mg1, Kyaw Lwin Show1, Wah Wah Aung1, Mu Mu Shwe1 Hlaing Myat Thu1 and Zaw Than Htun1

Myanmar Health Sciences Research Journal, 2023; 35(1-3): 1-9


Vaccination is an important strategy to stop the pandemic situation of COVID-19 infection. This study was conducted to determine the
safety and immunogenicity of BBIBP-CorV (Myancopharm) as a third dose (booster) among factory workers in Yangon. A single group prospective cohort study was conducted in Pharmaceutical Factory (Insein), Yangon, 2022. A total of 306 workers who had received two doses of any kind of COVID-19 vaccine before 6 months of the screening were enrolled. Adverse Events (AEs) were assessed and recorded by phone interviewing using Kobo Collect software. Safety hematological and biochemical parameters were also assessed. Immunogenicity was assessed by antibody (Ab) to SARS-CoV-2 spike antigen by Enzyme Linked Fluorescent Assay (VIDAS® SARS-COV-2 IgG assay, Biomerieux, France). Among 306 participants, the mean age was 45.8±8.1 years and male to female ratio was 1:2.73.
During the seven days after vaccination, solicited local and systematic AEs were reported by 46(47.7%) and 97(31.7%) participants, respectively.



A novel coronavirus disease, caused by SARS-CoV-2, has emerged and started from a family cluster in China to an international outbreak in 2019. It was named COVID-19 by World Health Organization (WHO) and due to the rapid spread and the nature of the disease, the WHO declared a pandemic on 11 March 2020.1 Vaccines play an important role in increasing population immunity, preventing severe disease, and reducing the ongoing health crisis.2 All countries tried to get the vaccines as early as possible and vaccinate the people according to the priority list for stopping the pandemic situation. There are various types of vaccines and policy makers need to choose the effective vaccines which are suitable for storage and transportation within the country.


An observational study (Single group prospective cohort study) was conducted among factory workers of Pharmaceutical Factory (Insein), Yangon, Myanmar during June-July, 2022. A total of 306 factory workers (18-59 years old) with stable medical conditions who received two doses of any kind of COVID-19 vaccine as a primary series vaccination before 6 months of the screening period were enrolled. The exclu-sion criteria were subjects with signs of active COVID-19 infection at the screening visit, history of COVID-19 infection within one month, pregnancy or lactation or willingness to become pregnant within 30 days after study vaccine, subjects who receive immuno-suppressive or cytotoxic medications, history of severe allergic reactions after previous vaccinations or hypersensitivity to any components of the study vaccine and subjects who have any known bleeding disorders or, in the investi-gator’s opinion, have any contraindications for an intramuscular injection. (Fig. 1)


Many variants of SARS-CoV-2 virus have emerged and with the recommendation of the WHO, booster immunization among high risk people began worldwide including Myanmar. Now, Ministry of Health, Myanmar is giving COVID-19 booster vaccination to all adults (more than 12 years old) who have completed two doses of primary vaccination.

During the seven days after vaccination, solicited local and systematic adverse reactions were reported by 146(47.7%) and 97(31.7%) participants, respectively. These results were comparable with a safety and immunogenicity study of a third-dose homo-logus BBIBP-CorV boosting vaccination by Ai J, et al, 2022 which described that 44.4% of participants had injection site adverse reactions and 22.2% had systemic adverse reactions.10 A double-blind placebo control trial of BBIBP-CorV vaccine for primary series vaccination in China during 2020, 46% had solicited adverse events in Phase-1 and 37% in Phase-2.11 The safety and immuno-genicity of BBIBP-CorV (Sino-pharm) among Thai adolescents aged 12-17 years revealed  that the vaccine was safe and effective.12


This study was conducted using research grants supported by Ministry of Health and Ministry of Industry. The authors would like to thank the staff of the Department of Medical Research who took part in data collection team and blood collection team. We are also grateful to General Manager and the staff of Pharmaceutical Factory (Insein) for their administrative support throughout the study period. Last but not the least, we are thankful to all the study participants.


There were no competing interests.


1.       Chan JFW, Yuan S, Kok KH, To KKW,
Chu H, Yang J, et al. A familial cluster of pneumonia associated with the 2019 novel coronavirus indicating person-to-person transmission: a study of a family cluster. The Lancet 2020; 395: 514-523.
https:// 1016/S0140-6736(20) 3015 4-9.

2.       Wang H, Zhang Y, Huang B, Deng W, Quan Y, Wang W, et al. Development of an inactivated vaccine candidate, BBIBP-CorV,1.       with potent protection against SARS-CoV-2. Cell 2020; 182: 713-721. https://doi. org/10.1016/j.cell.2020.06.008. with potent protection against SARS-CoV-2. Cell 2020; 182: 713-721. https://doi. org/10.1016/j.cell.2020.06.008.

3.       AlQahtani M, Bhattacharyya S, Alawadi A, Mahmeed H Al, Sayed J Al, Justman J, et al. Morbidity and mortality from COVID-19 post-vaccination breakthrough infections in association with vaccines and the emergence of variants in Bahrain. Research Square 2021.