The eradication of poliomyelitis is a landmark achievement in the history of public health, providing strong protection for children's health. The introduction of the Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine is a prerequisite and safeguard for the large-scale production and use of domestically produced live poliovirus vaccines, serving as an indispensable component of vaccine safety. This article, based on archival documents, letters, collections of essays, and oral interviews, examines the historical experience of the development of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine. It contends that the emphasis on localization and the active engagement in international cooperation are critical factors in the swift introduction of Chinese Regulations for the Manufacture and Control of Live Poliovirus Vaccine.
Child ; Humans ; Poliovirus Vaccine, Inactivated ; Poliomyelitis/epidemiology* ; Disease Outbreaks ; China

Poliomyelitis, or polio, is a highly infectious disease and can result in permanent flaccid paralysis of the limbs. Singapore was certified polio-free by the World Health Organization (WHO) on 29 October 2000, together with 36 other countries in the Western Pacific Region. The last imported case of polio in Singapore was in 2006. Fortunately, polio is vaccine-preventable-the world saw the global eradication of wild poliovirus types 2 and 3 achieved in 2015 and 2019, respectively. However, in late 2022, a resurgence of paralytic polio cases from vaccine-derived poliovirus (VDPV) was detected in countries like Israel and the US (specifically, New York); VDPV was also detected during routine sewage water surveillance with no paralysis cases in London, UK. Without global eradication, there is a risk of re-infection from importation and spread of wild poliovirus or VDPV, or new emergence and circulation of VDPV. During the COVID-19 pandemic, worldwide routine childhood vaccination coverage fell by 5% to 81% in 2020-2021. Fortunately, Singapore has maintained a constantly high vaccination coverage of 96% among 1-year-old children as recorded in 2021. All countries must ensure high poliovirus vaccination coverage in their population to eradicate poliovirus globally, and appropriate interventions must be taken to rectify this if the coverage falters. In 2020, WHO approved the emergency use listing of a novel oral polio vaccine type 2 for countries experiencing circulating VDPV type 2 outbreaks. Environmental and wastewater surveillance should be implemented to allow early detection of "silent" poliovirus transmission in the population, instead of relying on clinical surveillance of acute flaccid paralysis based on case definition alone.
Child ; Humans ; Infant ; Public Health Surveillance ; Pandemics ; Wastewater ; Wastewater-Based Epidemiological Monitoring ; COVID-19/epidemiology* ; Poliomyelitis/prevention & control* ; Poliovirus ; Poliovirus Vaccine, Oral ; Vaccination ; Global Health

Objective: To compare the immunogenicity of three kinds immunization programs with poliovirus vaccine. Methods: Healthy infants aged 2 months or over were selected and divided into three groups by complete randomization method. Basic immunization with Sabin inactivated poliovirus vaccine(sIPV) and bivalent oral poliovirus vaccine(bOPV) were completed. Three kinds of basic immunization procedures were 1sIPV+2bOPV,2sIPV+1bOPV and 3sIPV, respectively.Two qualified serums that before basic immunization and 28-42 days later were collected, and measured the poliovirus neutralizing antibody with microcell neutralization method. To compare the difference by analysis of variance, rank test and χ² test. Results: After the basic immunization, 205 subjects of the positive conversion rate of poliovirus neutralizing antibodies of types Ⅰ, Ⅱ and Ⅲwere all higher than 97.00%, and the positive rates were all higher than 98.00%, the geometric mean titer (GMT) of neutralizing antibody was significantly higher than that before basic immunization in three groups.There were significant differences in the positive rate and GMT before and after basic immunization of typeⅠ, Ⅱand Ⅲ in the three (P<0.05). The highest GMT in three groups after basic immunization were all typeⅠ, followed by type Ⅲ, and the lowest in type Ⅱ. The GMT of type Ⅱin 2sIPV+1bOPV and 3sIPV groups were both higher than that in sIPV+2bOPV group. Conclution: After three kinds of basic immunization, the poliovirus neutralizing antibodies of serum were all at high levels in three groups, which could form an effective immune barrier against poliovirus. The immunogenicity of three kinds of basic immunization programs were all well, but there were certain differences of neutralizing antibodies among three kinds basic immunization programs. The immunogenicity in 2sIPV+1bOPV and 3sIPV groups against typeⅡpoliovirus were better than that in 1sIPV+2bOPV group.
Antibodies, Neutralizing ; Antibodies, Viral ; Humans ; Immunization Schedule ; Infant ; Poliovirus ; Poliovirus Vaccine, Inactivated ; Poliovirus Vaccine, Oral

Since the Global Polio Eradication Initiative was launched by the World Health Assembly in 1988, significant progress has been made in global polio prevention and control. But the occurrence of vaccine-associated paralytic poliomyelitis cases and vaccine-derived poliovirus related cases have become a major challenge during the post-polio era. While coronavirus disease 2019(COVID-19) has brought serious disease burden and economic burden to all countries in the world, prevention and control of vaccine-preventable infectious diseases such as polio should not be neglected under the background of the global common fight against COVID-19. Taking the type Ⅲ VDPV cycle event in Shanghai as an example, the paper discussed how to do a good job of routine inoculation under the prevention and control of COVID-19 to strictly prevent the outbreak of vaccine-preventable infectious diseases.
COVID-19 ; China ; Humans ; Poliovirus ; Poliovirus Vaccine, Oral ; SARS-CoV-2 ; Vaccination

History, 20th Century ; Humans ; Philately ; Poliomyelitis ; history ; prevention & control ; Poliovirus Vaccine, Inactivated ; history ; United States

OBJECTIVETo analyze the polio immunity level of persistent population in Beijing, 2012.

METHODSA total of 1 676 subjects residing more than 6 months in Beijing were selected by stratified random cluster sampling design in 2012. Demographic characteristics, history of oral poliovirus vaccine (OPV) immunization were investigated by questionnaire. All 5 ml blood sample were collected for testing of polio neutralizing antibody using the method of microcell neutralization. The positive rate and the geometric mean titer (GMT) of polio neutralizing antibody type I, II and III were analyzed in different groups.

RESULTSThe positive rate of type I, II and III were 98.2% (1 645/1 676), 98.1% (1 644/1 676), 97.6% (1 635/1 676); The GMT were 1:130.2, 1: 113.4 and 1: 79.7. Three types of positive rates in<15 years group (99.7% (664/666), 99.8% (665/666), 99.5% (663/666)) were higher than those of ≥ 15 years group (97.1% (981/1 010), 96.9% (979/1 010), 96.2% (972/1 010)), the differences were significant (all the values of P < 0.01); The GMT in<15 years group (1:325.9, 1:250.5, 1:190.7) were higher than that of ≥ 15 years group (1: 71.1, 1: 67.2, 1: 44.8), the difference was significant (all the values of P < 0.01). The positive rate (99.0%-100%) and GMT (1: 128.8-1: 300.7) in vaccination information confirmed population were higher. The highest positive rate (all were 100%) and GMT(1: 409.7-1: 636.7) were observed in children who vaccinated three times.

CONCLUSIONThe polio antibody of healthy population was at a high level in Beijing in 2012; Especially the age groups of < 15 years which were covered by vaccines.Immunization barrier had been formed firmly to interrupt the transmission of wild poliovirus and vaccine-derived poliovirus.

Adaptive Immunity ; Adolescent ; Antibodies, Neutralizing ; Antibodies, Viral ; Child ; Humans ; Poliomyelitis ; Poliovirus ; Poliovirus Vaccine, Oral ; Vaccination ; statistics & numerical data

OBJECTIVETo evaluate safety of different sequential immunization schedules of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV) primary vaccination.

METHODSInfants of 2 months old (60-89 days) selected in Beijing, were assigned to four groups, 1 dose IPV plus 2 doses OPV (I-O-O), 2 doses IPV plus 1 dose OPV(I-I-O), 3 doses IPV (I-I-I), and 3 doses OPV (O-O-O), and were vaccinated at the age of 2, 3, 4 months, from 2009 to 2011. The frequencies of systemic as well as local injection site reactions after every dose were recorded and calculated. A total of 553 infants were enrolled in the study and 89 infants were quit, 1492 diseases were observed.

RESULTSThe incidence of adverse events in I-O-O, I-I-O, I-I-I, O-O-O were 22.9% (94/410), 18.4% (60/327), 22.0% (78/354) and 17.7% (71/401) with no statistical differences (χ(2) = 4.84, P = 0.184). Dose 1 (22.7% (32/141)-35.3% (54/153) ) was more frequently than dose 2 and dose 3. No serious adverse events (SAE) were reported during the study. The incidence of systemic adverse reactions in I-O-O, I-I-O, I-I-I, O-O-O were 21.5% (88/410), 17.7% (58/327) , 20.1% (71/354) and 17.7% (71/401) with no statistical differences (χ(2) = 2.53, P = 0.472). Abnormal crying were the most frequency reactions (7.2% (29/401)-11.3% (37/327) ) in 4 groups. Rarely severe reactions were observed of abnormal crying, somnolence, irritability and mild or medium reactions occurred in other symptoms. Local adverse reactions such as injection site pain, scleroma and swelling were reported by 2.2% (5/229)-5.6% (22/393) ,0-0.9% (2/229) and 0-1.0% (4/393) in I-O-O,I-I-O and I-I-I, and most reactions were mild.

CONCLUSIONThree IPV immunization and IPV/OPV sequential immunization as well as three OPV immunization demonstrated safe.

Humans ; Immunization Schedule ; Infant ; Poliovirus Vaccine, Inactivated ; administration & dosage ; adverse effects ; Vaccines, Attenuated ; administration & dosage ; adverse effects

OBJECTIVETo evaluate the immunogenicity and safety of a boost dose of inactivated polio vaccine (IPV) among children aged 18 months who had been administered with primary doses of IPV.

METHODSForm 2011 to 2012, a total of 97 children were enrolled in the present study who were vaccinated with IPV at 2, 3, 4 months of age and boosted with the same vaccine at 18 months of age. Anti-poliovirus neutralizing antibody titers in serum were measured before and after booster vaccination, geometric mean titers (GMT) and seroprotection rate were calculated. Adverse events occurring within 30 days after booster vaccination were observed, including pain, redness/swelling and induration at the injection site, fever, vomit, abnormal crying, drowsiness, loss of appetite, irritability, and all other physical discomfort and related medications were also recorded. A descriptive analysis was performed for the safety assessment.

RESULTSImmunogenicity was assessed in 84 subjects. The pre-booster seropositivity rates of neutralizing antibody against poliovirus type 1, 2, 3 before booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 148.5 (116.49-189.29) , 1: 237.68 (178.39-316.67) and 1: 231.87 (181.27-296.58) , respectively. The seropositivity rates of neutralizing antibody against the three types of poliovirus after booster were all 100% (84/84) and the corresponding GMT (95% CI) was 1: 1612.14 (1470.57-1767.34) , 1: 1854.92 (1715.83-2005.29) and 1: 1625.50 (1452.12-1819.58) , respectively. The pre-booster titer of neutralizing antibody against poliovirus type 1, 2, 3 mainly ranged 1: 128-1: 512, which accounted for 65% (55/84) , 55% (46/84) , 74% (62/84) in each type. After the booster immunization, titers of neutralizing antibody against type 1, 2, 3 were increased as subjects with titer ≥ 1: 1024 accounted for 94% (78/84) , 95% (80/84) , 92% (77/84) , respectively.Safety was evaluated in 96 subjects, of which 16 subjects reported adverse events with the rate of 17%. The observed local events were mainly tenderness 3% (3/96) , redness/swelling and induration were not reported. The systemic adverse events included loss of appetite (8%, 8/96) , irritability (8%, 8/96) , fever (7%, 7/96) , abnormal crying (6%, 6/96) , drowsiness (6%, 6/96) and vomit (1%, 1/96) . All reported adverse events were mild or moderate. All of the local events occurred in the day of vaccination and lasted for 1-2 days, while systemic events almost developed within 2 days after vaccination and last less than 3 days.

CONCLUSIONIPV booster dose has good immunogenicity and safety profile, which provides effective protection against poliovirus.

Antibodies, Neutralizing ; blood ; Antibodies, Viral ; blood ; China ; Female ; Humans ; Immunization, Secondary ; adverse effects ; Infant ; Male ; Poliomyelitis ; prevention & control ; Poliovirus Vaccine, Inactivated ; adverse effects ; immunology ; therapeutic use

OBJECTIVETo evaluate immunogenicity after primary vaccination by different sequential program of inactivated poliovirus vaccine (IPV) and oral poliovirus vaccine (OPV).

METHODSChildren of 2 months old (60-89 days) selected in Beijing were assigned to 4 groups, 1 dose IPV plus 2 doses OPV (I-O-O, 122 children), 2 doses IPV plus 1 dose OPV(I-I-O, 103 children), 3 doses IPV (I-I-I, 114 children), and 3 doses OPV (O-O-O, 106 children), and were vaccinated at the age of 2, 3, 4 months. Polio neutralizing antibody titers against poliovirus types 1, 2, and 3 were tested and protective rates were calculated before the 1st dose, after the last dose, and after the 1st and 2nd dose of IPV.

RESULTSAfter the primary immunization, geometric mean titers (GMT) of polio neutralizing antibody titers against poliovirus types 1, 2, and 3 were 788.32, 738.42 and 631.17 in O-O-O group, 212.02, 262.30 and 537.52 in I-I-I group, 940.35, 929.72 and 940.35 in I-O-O group and 901.09, 1102.68 and 1110.12 in I-I-O group (F values were 47.71, 53.84, and 9.81 respectively, all P values<0.01). The protective rate of three types among each group was 98.1% (104/106)-100.0% and the difference was not statistically significant (P>0.05). After the 1(st) dose of IPV, the GMT were 18.88, 37.77, 24.64 and the protective rate was 82.6% (122/138)-96.4% (133/138); after the 2nd dose of IPV, GMT were 177.03, 168.25, 321.86 and the protective rate was 99.1% (108/109)-100.0% (109/109) in antibody types 1, 2 and 3, respectively.

CONCLUSIONGMT of polio neutralizing antibody titers against poliovirus is higher after vaccination by sequential program of IPV and OPV than that by IPV or OPV 3-doses program. High level of protective rate after 2 doses of IPV in I-I-O group may lead to better protection from vaccine associated paralytic poliomyelitis (VAPP). Sequential program of IPV and OPV can be used to maintain high level of herd immunity and to prevent VAPP, and the I-I-O sequential program should be the first choice.

Humans ; Immunization Schedule ; Infant ; Poliovirus Vaccine, Inactivated ; administration & dosage ; immunology ; Poliovirus Vaccine, Oral ; administration & dosage ; immunology ; Vaccines, Attenuated ; immunology

Objectives. As part of the global initiative to eradicate poliovirus infections this study aims to: (1) estimate the prevalence of vaccine-derived poliovirus excretion among persons diagnosed with primary immune (B-cell or combined B/T-cell) deficiency disorders (PIDD) in the Philippines; (2) describe clinical features of these PIDD patients excreting poliovirus; (3) genetically characterize vaccine-derived polioviruses isolated from persons with PIDDs; and (4) determine the duration of poliovirus excretion among subjects who tested positive for vaccine-derived poliovirus excretion. Methods. Seventy-one (71) Filipino patients (ages 0-35 years of age) with PIDD were recruited retrospectively and prospectively over a period of 16 months. The study participants, after informed consent and administration of a questionnaire for baseline data, underwent further testing of quantitative immunoglobulin levels (IgG, IgA, and IgM) and stool poliovirus isolation using two stool samples. Stool specimens which tested positive for the poliovirus were sent to the Regional Reference Laboratory in Australia for further characterization by Intratypic Differentiation (ITD) and Vaccine-derived polioviruses (VDPV) real-time PCR. These participants were then monitored on a monthly basis until laboratory tests identified two sequential months of negative poliovirus stool specimens. Results. Seventy-one (71) patients underwent interview and quantitative serum immunoglobulin testing. However, one patient expired prior to stool isolate collection. This study, then, documented that none of the remaining 70 Filipino individuals (0-35 years old) with confirmed or suspected PIDDs chronically excreted immunodeficiency-associated vaccine-derived poliovirus (IVDPV). One patient who was a recent OPV-recipient excreted poliovirus Sabin-like 1 transiently (less than 1 month) and two patients excreted non polio-enteroviruses. Conclusions. Chronic and prolonged poliovirus excretion appears to be uncommon among Filipino patients with diagnosed Primary Immunodeficiency Disease Disorders. However, as part of the continuing global initiative for poliovirus eradication, vigilance is still necessary in patients with primary immunodeficiency diseases. Adequate identification of these patients followed by monitoring their capacity for viral excretion and environmental contamination may be necessary to achieve this goal.
Human ; Male ; Female ; POLIOVIRUS VACCINE, ORAL