|Year : 2022 | Volume
| Issue : 4 | Page : 246-251
Short-term side effects of sinopharm Coronavirus Disease 2019 vaccine in adolescents aged 12-18 years vaccinated in Dr. Masih Daneshvari Hospital
Parisa Honarpisheh1, Zahra Nematollahi2, Mojgan Palizdar3, Azade Zeinab Mirzaee1, Elham Askari4, Vahab Rekabi5, Zahra Daneshmandi1, Parsa Jamilian6, Maryam Hassanzad1, Mahsa Rekabi1
1 Pediatric Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 Dental Research Center, Research Institute of Dental Science, Shahid Beheshti University of Medical Science, Tehran, Iran
3 MASIH Daneshvari Hospital, Tehran, Iran
4 Chronic Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
5 Anatomical and Clinical Pathologist, AP CP Fellowship of Molecular Pathology and Cytogenetics, Shiraz University of Medical Sciences, Pathology Medical Education Research Center, Tehran, Iran
6 Keele Medical School, Keele University, Keele, UK
|Date of Submission||10-Aug-2022|
|Date of Decision||17-Sep-2022|
|Date of Acceptance||18-Oct-2022|
|Date of Web Publication||5-Dec-2022|
Pediatric Department, Pediatric Respiratory Diseases Research Center, National Research Institute of Tuberculosis and Lung Diseases (NRITLD), Shahid Beheshti University of Medical Sciences, Tehran
Source of Support: None, Conflict of Interest: None
BACKGROUND: Vaccination is known as one of the best approaches for overcoming the coronavirus disease 2019 (COVID-19) pandemic. Many COVID-19 vaccines were authorized for emergency use, and the knowledge about efficacy, safety, and adverse effects of COVID-19 vaccines is based only on data published from clinical trials and is not reliable. Therefore, a report of the side effects in the real world and among different populations is very helpful. The purpose of this research is to study and describe the side effects of the Sinopharm vaccine in adolescents aged 12–18 years.
MATERIALS AND METHODS: A descriptive retrospective study was conducted on 502 Iranian populations aged 12–18 years who received the first dose of the Sinopharm vaccine. Information was collected based-on telephonic interviews. In this survey, participants and their parents were asked about the underlying disease, side effects developed after receiving the vaccine, the time of beginning the reactions, and the time of resolving them.
RESULTS: Out of 502 vaccinated participants with a mean age of 14.2 ± 0.6 years, about 10% (n = 50) reported side effects after the Sinopharm COVID-19 vaccine. The most common side effects were injection site reactions (5.97%), and pain at the injection site (70%) was the most common of them. Systemic reactions were 2.19%, and fatigue/malaise was the most common of them (22%). The mean time to begin the side effects after injection was 42 ± 8.6 min, and the mean time of resolving developed adverse effects was 38 ± 5.3 min.
CONCLUSION: About 10% of the population aged 12 to18 years developed adverse effects following the Sinopharm vaccine. These adverse reactions were often mild in severity and were developed mostly during 2 h of vaccination and resolved in <1 h and required no or home-based treatment. It seems that the Sinopharm vaccines are safe in the population aged 12–18 years and are not associated with significant complications. The exact mechanisms of these adverse reactions are not clear, but according to the time of occurrence of the vaccine side effects, it seems that type 1 hypersensitivity allergic reactions are mainly involved.
Keywords: BBIBP-CorV, coronavirus disease 2019 vaccines, severe acute respiratory syndrome coronavirus 2, Side effects, Sinopharm
|How to cite this article:|
Honarpisheh P, Nematollahi Z, Palizdar M, Mirzaee AZ, Askari E, Rekabi V, Daneshmandi Z, Jamilian P, Hassanzad M, Rekabi M. Short-term side effects of sinopharm Coronavirus Disease 2019 vaccine in adolescents aged 12-18 years vaccinated in Dr. Masih Daneshvari Hospital. J Prev Diagn Treat Strategies Med 2022;1:246-51
|How to cite this URL:|
Honarpisheh P, Nematollahi Z, Palizdar M, Mirzaee AZ, Askari E, Rekabi V, Daneshmandi Z, Jamilian P, Hassanzad M, Rekabi M. Short-term side effects of sinopharm Coronavirus Disease 2019 vaccine in adolescents aged 12-18 years vaccinated in Dr. Masih Daneshvari Hospital. J Prev Diagn Treat Strategies Med [serial online] 2022 [cited 2023 Jan 29];1:246-51. Available from: http://www.jpdtsm.com/text.asp?2022/1/4/246/362825
| Introduction|| |
After the coronavirus disease 2019 (COVID-19) first emerged in Wuhan, China, in late 2019 and quickly spread around the world, the governments used different strategies to protect against this virus. One of the most effective of these strategies was global vaccination. A lot of vaccines with different platforms were produced; from the direct use of pathogens (live/attenuated) to the application of antigenic epitopes of the virus such as viral spike protein. Some of these vaccines were authorized for emergency use. In Iran, the first case of coronavirus was identified in Qom city in February 2019, and vaccination against coronavirus in Iran began on February 2021 with Gam-COVID-Vac (Sputnik V) and followed by the other COVID-19 vaccines including Sinopharm. Iran issued a permit for emergency use of Sinopharm in March 2021. The Chinese Sinopharm Beijing Bio-Institute of Biological Products (BIBP) COVID-19 vaccine is an inactivated vaccine that was produced by Beijing Bio-Institute and got the World Health Organization's approval in May 2021. Sinopharm based on the used technology platform is categorized as an inactivated COVID-19 vaccine. Elderly people and people with underlying diseases are highly prone to get infected and are vulnerable to complications of the disease, Despite the coronavirus disease tends to have a milder course in children and adolescents, for the following reasons, vaccination may be logical in these age groups: risk of disease transmission from children to adult, higher risk of severe COVID-19 or death in children with preexisting risk factor (such as heart and pulmonary disease, diabetes mellitus, neurologic disorders, and immunodeficiency conditions), and the probability of post-COVID-19 sequelae and long COVID-19 in this age groups. Whereas children and adolescents can play a significant role in the burden of COVID-19 disease, vaccination of these age groups was considered. However, the net advantage of vaccinating children is not completely clear. Due to the significant result of vaccination in terms of a high level of antibody production among adults, the same is expected in the younger population. Experiencing some side effects is expected after COVID-19 vaccines like any other vaccines; however, most adverse effects can be preventable or treatable.
Potential adverse effects and low trust toward manufacturer companies have been reported as some reasons for lower vaccine compliance rates in some populations. These concerns reveal the necessity of studies about the adverse effects of the COVID-19 vaccine. There are few studies about Sinopharm vaccine adverse reactions,, Although BBIBP-CorV is reported to have an acceptable safety profile and immunogenicity in a population older than 18 years, up to now, no published study has focused on the side effects of the Sinopharm vaccine in adolescents.
In this study, our purpose was to evaluate the side effects of the Sinopharm vaccine in Iranian adolescents which is of high importance because clarifying the safety of the vaccine in children and adolescents helps to excel the global vaccination program, and as the result, it reduces transmission of infection from these age groups to adults, mortality rate, and health-care costs.
| Materials and Methods|| |
In this descriptive retrospective study, 502 Iranian adolescents aged 12–18 years were enrolled. Exclusion criteria included individuals above 18 years old or under 12 years old and who received other types of COVID-19 vaccines. The study was performed between October 10, 2021, and December 10, 2021, and participants had received the first dose of the Sinopharm COVID-19 vaccine. The study was conducted via telephonic interview, and participants were enrolled in the study after orally informed consent.
All procedures performed in this study were according to the ethical standards of the Shahid Beheshti University of Medical Sciences Research Committee (approval number: IR.SBMU.NRITLD.REC.1401.004, approval date: 1401.02.01) and with the 1964 Helsinki Declaration and its later amendments or comparable ethical standards. Participants and their parents consented orally before enrollment in this survey and only individuals who consented entered the study.
The interviews were performed by calling the participants and their parents using their registered phone numbers and filling out the prepared questionnaires including three major parts; demographic data (age, gender, weight, and height), clinical profile (medical history/underlying disease, allergy history, and previous history of COVID-19 infection), vaccination data (date of injection, developed side effects, the time interval from the vaccine injection to the onset of side effects, continuity of experienced vaccine-related side effects, and used treatment including sedatives) were recorded.
| Results|| |
Five hundred and two patients were enrolled in this study, and demographic data and underlying diseases of the participants were recorded [Table 1]. The mean age of participants was 14.2 ± 0.6 years with a minimum of 12 years and a maximum of 18 years. Out of 502 participants, 90% had no symptoms while 50 (9.9%) reported adverse reactions after the first dose of the Sinopharm vaccine. Among the ones who developed side effects, the most commonly described adverse reactions were injection site reactions (60%). Systemic adverse reactions were found in 40% of adolescents, and the most common of them were fatigue/malaise (22%), fever/chills (18%), and headache/dizziness (12%), respectively. Among symptomatic patients, 33 individuals used over-the-counter (OTC) analgesics (15: acetaminophen, 8: ibuprofen), and three of them consumed antibiotics (2: azithromycin, 1: cephalexin), and 14 subjects preferred to rest at home. One death was reported among participants. The symptoms expressed by participants are summarized in [Table 2].
|Table 2: Prevalence of side effects among 502 participants after Sinopharm vaccine injection|
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The findings of our study also showed that most Sinopharm vaccine-associated side effects started within 2 h after the vaccination (46%) and often resolved in <1 h (40.8%). The times of onset and duration for individual side effects are presented in [Figure 1] and [Figure 2], respectively.
|Figure 1: Time to onset the side effects after receiving the Sinopharm vaccine|
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|Figure 2: The duration of the side effects after the first dose of the Sinopharm COVID-19 vaccine|
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| Discussion|| |
Phase III trials for the Sinopharm vaccine were completed in 10 countries globally in September 2020. China and some other countries, including Iran, have issued an emergency permit to use the Sinopharm vaccine. The most reported side effects during clinical trials phase 1 and 2 of the Sinopharm COVID-19 vaccine were fever and pain at the injection site, but some of the vaccine-related reactions may appear only during mass immunization programs. There are several studies about experienced side effects after Pfizer-BioNTech, AstraZeneca, and Moderna COVID-19 vaccines,,,, and after the Sinopharm COVID-19 vaccine,,,, but, to the author's knowledge, there is no published study which has focused on the Sinopharm vaccine complications among adolescents.
In this study, we evaluated the side effects of the first dose of the Sinopharm vaccine among the population 12–18 years old. Out of 502 participants in our study, 452 (90%) persons were asymptomatic and 50 (9.96%) individuals were symptomatic. The most frequent side effects of this vaccine in the participants were local side effects (5.97%), and pain at the injection site was the most common of them (70%) followed by erythema at the injection site (23.3%), local rigors (10%), and itching at the injection site (6.6%). Systemic reactions among Sinopharm recipients were 3.98%, and fatigue/malaise (22%), fever/chills (18%), and headache/dizziness (12%) were the most common of them. Our results regarding the most common side effects were similar to some previous studies on the adult population.,
A cross-sectional survey by Jayadevan et al. on a total of 5396 participants assessed the adverse reactions of four types of COVID 19 vaccines; Covishield (Astra Oxford vaccine manufactured by Serum Institute, India), Covaxin (Bharat Biotech, India), Pfizer Biotech, and Sinopharm vaccine. They indicated that 65.9% of participants had at least one symptom after vaccination. Fatigue (45%), myalgia (44%), fever (34%), headache (28%), local pain at the injection site (27%), arthralgia (12%), nausea (8%), and diarrhea (3%) were the most prevalent side effects. Unfortunately, they did not report the side effects of the four types of COVID-19 vaccines; therefore, the exact side effects related to the Sinopharm vaccine were not clear.
In a study by Abu-Halaweh et al., among 513 participants who received the Sinopharm vaccine, 158 (30.8%) reported adverse effects following vaccination. Pain and swelling at the injection site were 17.2% and 1%, respectively. The most common systemic reactions were general weakness (8.4%), headache (5.7%), fever (3.1%), flu-like symptoms (2.3%), and others including muscle pain, nausea/vomiting, arthralgia, rigors at the injection site, abdominal pain/diarrhea, allergic reactions, and skin rash.
Among 114 adults who received the first dose of the Sinopharm vaccine, Zahid reported 19% pain at the injection site, 13.1% fever, 13% fatigue, 8% headache, and 1% myalgia. None of them suffered from cough or nausea.
In our study, one person (0.19%) showed systemic urticarial skin rash spreading on the trunk, arms, legs, and back. The lesions were red, raised, and itchy of different sizes and appear after 3 h of vaccination and were resolved by antihistamine after 24 h. Systemic cutaneous adverse reactions after COVID-19 vaccines seem to be infrequent, and among COVID-19 vaccines, Moderna and Pfizer have more skin reactions. In a systematic review about COVID-19 vaccine-related cutaneous manifestations, urticaria was reported 11% of skin reactions and mainly occurred following Pfizer and Moderna and AstraZeneca COVID-19 vaccine. However, systemic and severe skin reactions have also been reported after the Sinopharm COVID-19 vaccine.,
We observed one death among our participants: a 14-year-old boy, with a body mass index of 27 kg/m2 and a history of diabetes mellitus from 8 months ago and with good glycemic control with diet, exercise, and metformin, without any history of allergy or another underlying disease. He was brought to the emergency room with symptoms of deep and fast breathing, vomiting, and decreased alertness. In clinical examination, he has severe dehydration and was confused, pulse rate: 180/min, respiratory rate: 32/min, and systolic blood pressure: 90 mmHg. His extremities were cold and cyanotic. In early laboratory tests, he had severe metabolic acidosis, prerenal azotemia, blood sugar of 650 mg/dl, sodium: 130 meq/l, potassium: 3.3 meq/l, and a negative nasopharyngeal polymerase chain reaction. The patient was diagnosed with diabetic ketoacidosis (DKA), and treatment was started. After a few hours, the patient's condition deteriorated and cardiopulmonary status became unstable and his resuscitation was unsuccessful. His parents do not consent to the autopsy. We speculate DKA might be induced after the COVID-19 vaccine. Several studies have demonstrated the relationship between diabetes and COVID-19 and a high prevalence of diabetes among patients with COVID-19. Mishra et al. reported exacerbation of hyperglycemia in three cases with diabetes type 2 after COVID-19 vaccination. The pathogenesis of this condition may be the induction of the inflammatory response by the vaccine. Therefore, some of the COVID-19 vaccines may be a trigger for revealing the subclinical diseases.
In our study, 90% of vaccinated individuals showed no adverse effects, either local or systemic reactions, while the percentage of individuals who had no signs or symptoms in Al Khames et al. was represented by 40% for those who received the Sinopharm vaccine. Additionally, they concluded that the Sinopharm vaccine had a lower prevalence of local reactions at the injection site or systemic events in comparison with Pfizer and AstraZeneca. Zahid reported that recipients of the Sinopharm vaccine had the mildest side effects than AstraZeneca, Pfizer, and Sputnik COVID-19 vaccines among populations above 18 years old. In a comparative study by Hatmal et al., they observed that “no symptoms” were mostly reported by Sinopharm vaccine recipients. Our findings confirmed the results of previous studies on the mild side effects of the Sinopharm vaccine.
In our study, the time of appearance of the side effects after the Sinopharm vaccine was 42 ± 8.6 min among our participants. The exact mechanisms of these reactions are unclear, but according to the time of occurrence of the vaccine side effects, it seems that type 1 hypersensitivity allergic reactions are mainly involved; however, in a clinical trial by Kaur et al., the average cumulative side effects occurred after 7 days of Sinopharm vaccine in 29% out of 144 participants in the phase 1 trial and 23% out of 336 individuals.
The mean duration of adverse effects in our study was 38 ± 5.3 min, which was reported to be 20 h in the Jayadevan et al. evaluation. Al Khames et al. reported that the duration of signs and symptoms in the population aged 18–35 years was 1.733 ± 1.258 days. The duration of symptoms in Abu-Halaweh et al. evaluation was between 13 ± 0.6 h for skin rashes and 216 ± 203.7 h for allergic reactions.
| Conclusion|| |
Adverse reactions after Sinopharm vaccination in adolescents were mainly mild and self-limited. Pain at the injection site was the most common of them. Overall, according to the reports of the participants in our evaluation, the side effects of Sinopharm were mild in severity and had a short duration; therefore, Sinopharm seems to be safe in adolescence. The findings of our study are similar to the results of the previous studies on the safety and adverse reactions of the Sinopharm COVID-19 vaccine in children and adults.
Limitations of the study
It was better to the comparison between the different platforms of the COVID-19 vaccines in terms of safety and efficacy and between the different age populations and with a larger sample size to give us an insight into the selectivity of the appropriate vaccine. On the other hand, due to the type of study design (telephonic interview), we could not investigate the severity of the vaccine's side effects.
The authors wish to thank all individuals who participated in this study.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2]
[Table 1], [Table 2]