Comparison of in-vial exhaust method versus conventional exhaust method in the injection of COVlD-19 vaccine

Jingjin XU ,Hui ZHI ,Ye LI ,Jinjing LIU ,Wen ZHENG ,Ling TANG

1School of Nursing,Beijing University of Chinese Medicine,Beijing,China;2Peripheral Vascular Department,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing,China;3Department of Nursing,Dongfang Hospital,Beijing University of Chinese Medicine,Beijing,China

ABSTRACT Objective:The objective of the study was to compare the application effects of in-vial exhaust method and conventional exhaust method in the process of coronavirus disease 2019 vaccine injection.Materials and Methods:Using convenient sampling method,102 vaccines were selected as experiment group during the process of vaccine injection,and the in-vial exhaust method was used.One hundred and five vaccines were selected as the control group and the conventional exhaust method was adopted.The incidence of vaccine solution spillage and exhausting time in the two groups during exhaust were observed.Results:The incidence of solution spillage in the experiment group was lower than that in the control group (0 vs.6.67%, P ＜ 0.05).The exhausting time of the experiment group was shorter than that of the control group ([15.12 ± 4.43] s vs.[22.74 ± 6.53] s, P ＜ 0.05).Conclusion:Implementing the in-vial exhaust method in the vaccine injection can effectively reduce the incidence of solution spillage,reduce nucleic acid contamination,and ensure that the vaccine is injected at the prescribed dose.Moreover,the operation is simple and easy,which improves the nurse’s vaccination efficiency,and has a higher promotion and application value.

Keywords:Coronavirus disease 2019,intramuscular injection,preventive inoculation,vaccine

INTRODUCTION

Coronavirus disease 2019 (COVID-19) is a new infectious disease caused by severe acute respiratory syndrome (SARS) coronavirus 2,with respiratory droplets and close contact as the main transmission routes.[1]People are generally susceptible to the virus.Since the outbreak of the epidemic,it has posed a serious threat to the life and health of the global people and brought great impact to the world economic development.[2,3]At present,vaccination is a powerful measure to control the further spread of COVID-19.[4,5]At present,all countries in the world are stepping up the pace of vaccine development and inoculation.The China Food and Drug Administration has approved several vaccines in COVID-19.Among them,two inactivated vaccines developed by China Biotech and Sinovac Corporation have been widely inoculated nationwide.[6,7]At the same time,as one of the participating countries of the multilateral mechanism“COVID-19 Vaccine Global Access”(COVAX),China has provided inactivated vaccine to many countries such as Turkey,Peru,Morocco,Senegal,Hungary,and the United Arab Emirates.Although the inactivated vaccine has lost its pathogenicity and infectivity,it retains a relatively complete viral nucleic acid fragment.[8]Hence,vaccine solution that is spilled when opening the vial,drawing the vaccine solution,and exhausting air before injection,or liquid residues in the injection syringe after injection may contaminate the inoculation table,wall,door handle,corridor,inoculation personnel,and clothing and other object surfaces in the forms of aerosol and liquid.In such situation,if the nucleic acid fragments are sampled before degradation and tested by high sensitivity the polymerase chain reaction,the nucleic acid test result is likely to be positive.[9]

To avoid nucleic acid pollution,Beijing Center for Disease Control and Prevention (CDC) has given relevant technical suggestions,one of which is that the whole exhaust process should be completed on the treatment tray,in which process to avoid the spillage of vaccine solution,if any,it must be dripped onto the treatment tray.However,in practice,this suggestion is hard to be fully realized.[10,11]Therefore,we explored the effect of in-vial exhaust method versus the conventional exhaust method in solution spillage and exhausting time during vaccine injection from the exhaust method,with a view to provide reference for reducing nucleic acid pollution in vaccine injection.

MATERIALS AND METHODS

General information

The study participants were the COVID-19 vaccine (Sinovac Life Sciences,Beijing,China).The specification is 0.5 mL per vial and 0.5 mL per human dose.All nurses who participated in the vaccination work have received unified training.The intramuscular injection method was adopted,and the injection site was the deltoid muscle of upper arm.

Methods

Using convenience sampling method,102 vaccines were selected as experiment group and 105 vaccines were selected as control group.The control group was treated with conventional exhaust technique,as shown in Figure 1,that is,after the solution was absorbed,the needle was pulled out of the vial and exhaust in the air.The experiment group adopted the in-vial exhaust technique,as shown in Figure 2,that is,after the solution was absorbed,the needle was not pulled out,and the exhaust was performed in the vial.

Figure 2:In-vial exhaust method

Observational indexes

The primary outcome is the incidence of spillage of vaccine solution in the exhaust operation of two groups.The definition of solution spillage was that the number of solution discharged exceeded one drop or the range exceeded the treatment tray.The secondary outcome is the time required to exhaust.

Statistical analysis

SPSS 17.0 software (SPSS Inc.,Chicago,IL,USA) was used for data analysis.The measurement data were shown as mean ± standard deviation;the data conforming to normal distribution were analyzed using independent samplet-test;otherwise,nonparametric test was used.Enumeration data were expressed as number and percentage and analyzed using Chi-square test.Test level α=0.05.

RESULTS

In the control group,seven doses of vaccine solution were spilling out,with an incidence of solution spillage 6.67%,while in the experiment group,there was no spill;the difference was statistically significant between two groups (P＜ 0.05).The exhausting time of the experiment group was less than that of the control group,and the difference was statistically significant (P＜ 0.05) [Table 1].

Table 1:Vaccine spilling situation and exhausting time of two exhaust methods

DISCUSSION

Vaccines play an important role in the prevention and treatment of human diseases

Vaccine is a biological product used to prevent and control the occurrence and prevalence of an infectious disease.Vaccination can induce specific humoral and/or cellular immunity so that the body can obtain immunity to prevent the disease.[12,13]Human’s empirical cognition on immunity and vaccine directly comes from the early medical practice,which can be traced back toHandbookofPrescriptionsforEmergencieswritten by Ge Hong,a medical scientist in the Eastern Jin Dynasty of China,and Wang Su’s invention of vaccination against smallpox in the Song Zhenzong era (998-1002).In the human struggle against infectious diseases,the production and extensive inoculation of vaccines are one of the most effective,economic,and life-saving health measures.[14]

With the development of science and technology,the preparation process of vaccines is increasingly improved,and the types of vaccines are more diverse.At present,there are mainly three types of vaccines:traditional vaccines (the first generation of vaccines),genetic engineering vaccines (the second generation of vaccines),and nucleic acid vaccines (the third generation of vaccines).[15]Vaccines are effective against diseases with high mortality rates and no specific treatments including HIV/AIDS,SARS,and avian influenza.Moreover,vaccine research and development has always maintained a strong trend,and its indications have gradually expanded from infectious diseases to noncommunicable diseases such as tumors.In future,there will be better vaccines to further reduce the global morbidity and mortality of diseases ranging from infectious diseases to tumors.[16]

Advantages of the in-vial exhaust method

This study was found that the use of the in-vial exhaust method has multiple advantages.First of all,the in-vial exhaust method reduces the spillage rate of the solution and largely avoids the occurrence of nucleic acid contamination.Although the spillage of the vaccine solution will certainly not spread the disease,the resulting positive nucleic acid test will bring some interference to the epidemic monitoring and early warning,causing panic to people.In addition,determining whether viral nucleic acid is derived from vaccine fluid requires simultaneous whole-genome sequencing of the positive sample,and the residual fluid in the vaccine vial,which takes a certain amount of manpower,material resources,and time.

Second,the in-vial exhaust method can avoid insufficient dose of vaccine injection.The specification of COVID-19-inactivated vaccine (Vero cell) is 0.5 mL per vial and 0.5 mL for human use.Clinical trial data show that different doses of the vaccine will affect the neutralizing antibody titer and specific IgG binding antibody response produced after injection.[17]This suggests that the vaccine should be injected according to the prescribed dose.However,in the vaccination process,the discharge of too much vaccine solution cannot be completely avoided using traditional exhaust method,but the in-vial exhaust method provides an opportunity to save the exhaust error.At present,the manufacturing process of vials has been relatively mature,and the tightness of vial is good.[18,19]Even if the vaccine solution is discharged during in-vial exhaust,the solution is still aseptic in the vial,and it can be sucked again and exhaust again until the exhaust is successful.

Third,exhaust technology innovation can improve the efficiency of nurses on vaccine injection.Innovation is an important factor to improve the quality of medical service and drive the sustainable development of medical level.[20]This study showed that the time-consuming of in-vial exhaust method was significantly less than that of conventional exhaust method (P＜ 0.05),which greatly saved the time of inoculation and was beneficial to the acquisition of nurses’ sense of professional value.[21-23]In addition,theGuidelinesforPreventiveDisinfectioninVaccinationClinics(third Edition) issued by the Beijing CDC points out that if the vaccine is damaged and sprinkled on the ground or other objects,it is necessary to wipe the contaminated areas with 1000 mg/L chlorine-containing disinfectant,and after 30 min,wipe them thoroughly with clear water.[10]Whereas,the in-vial exhaust method reduces the external spillage rate of the vaccine solution and thus reduces the burden of additional sterilization for nurses.

CONCLUSION

In the context of global promotion of vaccination,having enough health-care workers who know how to vaccinate safely in each country is one of the important tasks to realize the COVAX program.This study provides a new solution to the difficult problem in the process of COVID-19 vaccine injection from the actual operation of vaccination,which effectively reduces the incidence of liquid spillage,avoids viral nucleic acid contamination in the vaccination environment,as well as ensures that the vaccine is injected at the prescribed dose and reduces vaccine waste.The operation is simple and easy to implement,worth promoting,and applying.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.