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News Article | May 5, 2017
Site: marketersmedia.com

— Market Highlights A vaccine contains a biological preparation of a weakened or killed microbial agent, its toxins or its surface proteins, which provides active acquired immunity against the disease caused by the microbe. Vaccination stimulates and trains the body immunity to recognize and destroy the microbial threat in later encounters. According to World Health Organization (WHO), out of the total number of children worldwide who did not receive the required three doses of diphtheria-tetanus-pertussis vaccines, more than 40% were from sub-Saharan Africa. Sub Saharan Africa accounts for a bulk share of unimmunized people in Africa. The other African nations with large number of unimmunized people include Nigeria, Iraq, Chad, Niger, Angola, Somalia, Sudan, Democratic Republic of Congo, Ethiopia, Iraq, Nigeria, Uganda and South Africa. The market for vaccines in Middle East and Africa presents immense potential. The market driving factors are unmet needs for vaccination, policies of national Governments and international bodies such as World Health Organization (WHO) which provide huge funding and international aid, increasing funds from philanthropy organizations such as Bill and Melinda Gates Foundation, inclusion of several new vaccines in the national immunization schedule of many countries, development of new vaccines such as for hepatitis; growing awareness, growth of low cost vaccine manufacturing especially in developing countries, the entry of China in the vaccine market etc. Key Players The major participants of this market are: GlaxoSmithKline Plc., Merck & Co. Inc., Pfizer, Inc., Sanofi Pasteur, Inc., AstraZeneca Plc., Bharat Biotech, Shenzhen Kangtai Biological Products, Valeant Pharmaceuticals, Emergent Biosolutions Inc., Astellas Pharma Inc., Panacea Biotec and others. Regional Analysis: Depending on geographic region, human vaccine market is segmented into following countries: UAE, Egypt, Saudi Arabia, Kuwait, Qatar and Oman. UAE is the largest market followed by Egypt. However the future market will be led by the poor developed parts of Africa due to large unmet needs and the favorable government policies. Segmentation: Middle East and Africa human vaccines market has been segmented on the basis of technology commonly mentioned as “by technology” which comprises attenuated, inactivated, toxoid, conjugate, & subunit, recombinant DNA. On the basis of disease indication the market is segmented into pneumococcal, influenza, hepatitis, rotavirus, DTP, polio and others. On the basis of type market is segmented into prophylactic and therapeutic. On the basis of composition the market is again segmented into mono vaccine and combination vaccines. On the basis of route of administration; market is segmented into oral, injectable and other. On the basis of end user; market is segmented into children and adults. Taste the market data and market information presented in more than 60 market data tables and figures spread over 84 pages of the project report. Avail the in-depth table of content (TOC) & market synopsis on “The Middle East and Africa Human Vaccine Market Research Report - Forecast to 2022”. Table of Content 1 Introduction 2 Research Methodology 3 Market Dynamics 4 Market Factor Analysis 4.1 Porter’s Five Forces Model 4.1.1 Bargaining Power of suppliers 4.1.2 Bargaining Power of Customer 4.1.3 Intensity of Competitor’s 4.1.4 Threat of New Entrants 5 Middle East and Africa Human Vaccines Market, by Technology 6 Middle East and Africa Human Vaccines Market, by Disease Indication 7 Middle East and Africa Human Vaccines Market, by Type 7.1 Introduction 7.1.1 Prophylactic 7.1.2 Therapeutic 8 Middle East and Africa Human Vaccines Market, by Composition 8.1 Introduction 8.1.1 Mono vaccine and 8.1.2 Combination vaccines 9 Middle East and Africa Human Vaccines Market, by Route of Administration 9.1 Introduction 9.1.1 Oral 9.1.2 Injectible 9.1.3 Others 10 Middle East and Africa Human Vaccines Market, by End User About Market Research Future: At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. For more information, please visit https://www.marketresearchfuture.com/reports/human-vaccines-market-2671


Chen J.,Peking University | Liang Z.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Lu F.,Peking University | Fang X.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | And 7 more authors.
Vaccine | Year: 2011

It is well documented that 5-10% hepatitis B adult vaccinees are non- and hypo-responders and probably are not adequately protected against hepatitis B virus (HBV) infection. The sequence variations of genes involved in processes such as pathogen recognition, antigen processing and presentation, and differentiation/maturation of lymphocytes may affect the duration and intensity of protective humoral immune response to the hepatitis B vaccine. In this study, frequencies of 53 known SNPs within 21 candidate genes were analyzed among 46 responders and 24 non-responders. Four SNPs (rs2243248, rs1805015, rs1295686 and rs3804100) in IL-4, IL-4RA, IL-13 and TLR2 genes were found significantly associated with the vaccinees' status of serum anti-HBV response triggered by the vaccine (P< 0.05). Two SNPs (rs1295686 and rs1805015) also showed significant association with the vaccine-induced immune response when analyzed together with risk factors such as age and gender, by multivariable logistic regression analysis (P< 0.05). Further, haplotype analysis showed that the AG haplotype defined by SNPs rs1143633 (IL-1B; intron) and rs1143627 (IL-1B; intron) was present more frequently in non-responders than in responders (P=0.035). Thus, specific SNPs in genes of cytokines/cytokine receptors and TLR2 were associated with status of the hepatitis B vaccine-induced protective humoral immune response. © 2010 Elsevier Ltd.


Mao Q.-Y.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Liao X.-Y.,Chinese National Institute for the Control of Pharmaceutical and Biological Products | Yu X.,Hualan Biological Engineering Inc. | Li N.,Hualan Biological Engineering Inc. | And 7 more authors.
Chinese Medical Journal | Year: 2010

Background Enterovirus 71 (EV71) and coxsackievirus A16 (Cox A16) are major causative agents for hand, foot and mouth disease (HFMD). Studies indicate that the frequent HFMD outbreaks result in a few hundreds children's death in China in recent years. The vaccine and other research for HFMD need to be developed urgently. The aims of our study were: to explore dynamic development of mother-source neutralizing antibodies against EV71 and Cox A16 in infants from Jiangsu Province, China, and to provide the fundamental data for further establishing of corresponding immunization course. Methods Peripheral blood samples were collected from 133 of parturient women once immediately before delivery and their infants at two and seven months of age. Method of micro-dose cytopathogenic effect was used to measure neutralizing antibodies against EV71 and Cox A16, respectively. Results Seropositive rates of anti-EV71 and anti-Cox A16 in prenatal women were 79.7% (106/133) and 92.5% (123/133), respectively; geometric mean titers (GMTs) were 29.0 and 61.9; 75.9% (101/133) prenatal women were both positive in anti-EV71 and anti-Cox A16; seropositive rates of anti-EV71 and anti-Cox A16 were 25.6% (34/133) and 38.3% (51/133) in infants at two months of age; GMTs were 12.3 and 18.0, respectively. GMTs of anti-EV71 were significantly higher for infants at seven months (82.6) compared with that at two months (P <0.05), showing infants had inapparently infected by EV71 during two to seven months. Although only one offspring (0.75%) at seven months was found having anti-Cox A16 transfered from maternal, this observation suggested no maternal antibody may remain in infants at seven months. Conclusions The prevalence of EV71 and Cox A16 were relatively high in Jiangsu Province. Bivalent vaccine against both EV71 and Cox A16 should be developed, and the ideal time point for prime immunization for infants is around 2-5 months of age.


Wang Z.-Z.,Peking University | Li M.-Q.,Centers for Disease Control and Prevention | Wang P.,Centers for Disease Control and Prevention | Yang Z.-X.,Centers for Disease Control and Prevention | And 6 more authors.
Vaccine | Year: 2016

Objectives: To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20. μg) and 2-dose with higher-dosage (60. μg) regimens in healthy young adults and evaluate the safety profile. Methods: A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20. μg) and other groups were immunized with regimens of 0-1 or 0-2 month (60. μg) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA). Results: The seroprotection rates in 20. μg (0-1-6 month), 60. μg (0-1 month) and 60. μg (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p >. 0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20. μg (0-1-6 month) group than that in 60. μg (0-1 month) group at month 7/2 (1847.99 vs. 839.27. mIU/ml, p = 0.004), but was similar to that in 60. μg (0-2 month) group at month 7/3 (1847.99 vs. 1244.80. mIU/ml, p = 0.138). At month 12, the GMC in 20. μg (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15. mIU/ml, respectively, p <. 0.001). The total incidence of injection-site or systemic adverse reactions was <3%. Conclusions: A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. Clinicaltrials.gov identifier: NCT02203357. © 2016 Elsevier Ltd.


Zhu F.-C.,Centers for Disease Control and Prevention | Sun K.-X.,Peking University | Pan H.-X.,Centers for Disease Control and Prevention | Yang Z.-H.,Shenzhen Kangtai Biological Products Co. | And 6 more authors.
Vaccine | Year: 2016

Background and Aims: To evaluate immunogenicity and efficacy of a 10 μg recombinant Saccharomyces cerevisiae-derived hepatitis B vaccine (Kangtai Biological Products Co. Ltd, Shenzhen, China) (Hep-KSC) in newborns. Methods: Overall 1197 infants born to mothers negative for HBV markers (NM group) and 534 born to HBsAg-positive mothers (PM Group) were enrolled. Infants in NM group were given 10 μg Hep-KSC, 10 μg Engerix-B or 5 μg Hep-KSC and those in PM group received 10 μg Hep-KSC or 10 μg Engerix-B at 0, 1 and 6 months, with an additional 200 IU HBIG at birth for the latter. Results: For NM Group, 10 μg Hep-KSC paralleled 10 μg Engerix-B but outperformed 5 μg Hep-KSC regarding seroprotective rate (95.06% vs 94.83% vs 89.67%, p = 0.0077) and anti-HBs geometric mean concentration (GMC) (798.87 mIU/ml vs 790.16 mIU/ml vs 242.04 mIU/ml, p < 0.0001) at 7 months. The proportion of infants with anti-HBs greater than 1000 mIU/ml was higher in 10 μg Hep-KSC than 5 μg Hep-KSC group (45.77% vs 11.93%, p < 0.0001) at 7 and 12 months. For PM Group, the HBsAg positivity rate in 10 μg Hep-KSC and 10 μg Engerix-B group was 1.60% and 4.27% at 7 months, respectively. In 10 μg Hep-KSC group, 93.61% and 91.29% achieved seroprotection at 7 and 12 months, respectively, and correspondingly 90.24% and 86.96% in 10 μg Engerix-B group. The anti-HBs GMC was comparable between 10 μg Hep-KSC and 10 μg Engerix-B group at 7 and 12 months (575.31 mIU/ml vs 559.64 mIU/ml; 265.79 mIU/ml vs 264.48 mIU/ml). Conclusions: 10 μg Hep-KSC might be appropriate for neonatal immunization with good immunogenicity and efficacy, especially for infants born to HBsAg-positive mothers. © 2016.


PubMed | Centers for Disease Control and Prevention, Peking University and Shenzhen Kangtai Biological Products Co.
Type: Comparative Study | Journal: Vaccine | Year: 2016

To compare immunogenicity of hepatitis B vaccine between the standard 3-dose (20 g) and 2-dose with higher-dosage (60 g) regimens in healthy young adults and evaluate the safety profile.A randomized, parallel-group clinical trial was conducted among healthy young adults aged 18-25 years. Subjects were randomly assigned to three groups. One group was administered hepatitis B vaccine with the standard regimen of 0-1-6 month (20 g) and other groups were immunized with regimens of 0-1 or 0-2 month (60 g) respectively. Serum samples were collected at 1 month after a series vaccination and 12 months after the first-dose inoculation for anti-HBs antibody measurement with a Chemiluminescent Microparticle ImmunoAssay (CMIA).The seroprotection rates in 20 g (0-1-6 month), 60 g (0-1 month) and 60 g (0-2 month) groups were 100, 93.64 and 99.19% at month 7/2/3, and 100, 96.04 and 95.90% at month 12, respectively. There were no significant differences among three vaccine groups (p>0.05). The geometric mean concentration (GMC) of anti-HBs was significantly higher in 20 g (0-1-6 month) group than that in 60 g (0-1 month) group at month 7/2 (1847.99 vs. 839.27 mIU/ml, p=0.004), but was similar to that in 60g (0-2 month) group at month 7/3 (1847.99 vs. 1244.80 mIU/ml, p=0.138). At month 12, the GMC in 20 g (0-1-6 month) group was significantly higher than those of other groups (1456.63 vs. 256.30, 235.15 mIU/ml, respectively, p<0.001). The total incidence of injection-site or systemic adverse reactions was <3%.A 2-dose with higher-dosage hepatitis B vaccine regimens are comparable to the standard 3-dose regimen in terms of immunogenicity except a relatively rapid decline in GMC levels which are associated with the longevity of protection. All formulations of hepatitis B vaccine were well tolerated. CLINICALTRIALS.GOV IDENTIER: NCT02203357.


PubMed | Centers for Disease Control and Prevention, Peking University, National Institutes for Food and Drug Control and Shenzhen Kangtai Biological Products Co.
Type: Journal Article | Journal: Vaccine | Year: 2016

To evaluate immunogenicity and efficacy of a 10g recombinant Saccharomyces cerevisiae-derived hepatitis B vaccine (Kangtai Biological Products Co. Ltd, Shenzhen, China) (Hep-KSC) in newborns.Overall 1197 infants born to mothers negative for HBV markers (NM group) and 534 born to HBsAg-positive mothers (PM Group) were enrolled. Infants in NM group were given 10g Hep-KSC, 10g Engerix-B or 5g Hep-KSC and those in PM group received 10g Hep-KSC or 10g Engerix-B at 0, 1 and 6 months, with an additional 200IU HBIG at birth for the latter.For NM Group, 10g Hep-KSC paralleled 10g Engerix-B but outperformed 5g Hep-KSC regarding seroprotective rate (95.06% vs 94.83% vs 89.67%, p=0.0077) and anti-HBs geometric mean concentration (GMC) (798.87mIU/ml vs 790.16mIU/ml vs 242.04mIU/ml, p<0.0001) at 7 months. The proportion of infants with anti-HBs greater than 1000mIU/ml was higher in 10g Hep-KSC than 5g Hep-KSC group (45.77% vs 11.93%, p<0.0001) at 7 and 12 months. For PM Group, the HBsAg positivity rate in 10g Hep-KSC and 10g Engerix-B group was 1.60% and 4.27% at 7 months, respectively. In 10g Hep-KSC group, 93.61% and 91.29% achieved seroprotection at 7 and 12 months, respectively, and correspondingly 90.24% and 86.96% in 10g Engerix-B group. The anti-HBs GMC was comparable between 10g Hep-KSC and 10g Engerix-B group at 7 and 12 months (575.31mIU/ml vs 559.64mIU/ml; 265.79mIU/ml vs 264.48mIU/ml).10g Hep-KSC might be appropriate for neonatal immunization with good immunogenicity and efficacy, especially for infants born to HBsAg-positive mothers.


Pan H.-X.,Centers for Disease Control and Prevention | Zeng Y.,Shenzhen Kangtai Biological Products Co. | Song X.-F.,Shenzhen Kangtai Biological Products Co. | Zhang Y.-J.,Centers for Disease Control and Prevention | And 3 more authors.
Vaccine | Year: 2014

Context: Alternative schedules are needed to provide greater immunogenicity in adults who fail to respond to the standard hepatitis B (HB) vaccine regimen. Objective: To evaluate the immunogenicity and safety of high antigen content HB vaccine formulations administered to non-responders after routine primary vaccination. Design setting, and participants: This was a phase III, double-blind, controlled clinical trial in China. We enrolled healthy participants (16-60 years old) seronegative for HB surface (HBs) antigen after primary vaccination, who had HBs antibody (anti-HBs) titres <10. mIU/ml at 28 days following routine vaccination with licensed HB vaccine containing 10. μg of antigen. Participants were randomised (2:2:1) to receive three booster doses of HB vaccine formulations containing 60. μg, 30. μg or 10. μg of antigen per dose 28 days apart. Blood samples were obtained pre-vaccination and 28 days after each dose to assess immunogenicity. Reactogenicity and safety were evaluated up to 28 days after each vaccine dose. Results: Seroconversion rates were ≥92.1% and ≥87.1% as from the second dose of the 60. μg and 30. μg HB vaccine formulations, respectively, with geometric mean concentrations (GMCs) of ≥286.0. mIU/ml and ≥164.0. mIU/ml. In the 10. μg HB vaccine group the seroconversion rates were ≥83.0% and the GMCs ≥110.1. mIU/ml as from the second vaccine dose. All HB vaccine formulations were well tolerated: 352/1091 (32.3%) participants reported at least one injection-site or systemic adverse reaction (145/434 [33.4%] from the 60. μg group; 138/435 [31.7%] from the 30. μg group and 69/222 [31.1%] from the 10. μg group). Most reactions were mild or moderate and resolved within 24. h. No serious adverse events were reported. Conclusion: Booster vaccination with a three-dose schedule of a high antigen content HB vaccine formulation was immunogenic and well tolerated in healthy adults. Clinicaltrials.gov identifier: NCT01203319. © 2014.


Zhu F.-C.,Centers for Disease Control and Prevention | Liang Z.-L.,National Institutes for Food and Drug Control | Meng F.-Y.,Centers for Disease Control and Prevention | Zeng Y.,Shenzhen Kangtai Biological Products Co. | And 15 more authors.
PLoS ONE | Year: 2012

Background: Hand, foot, and mouth disease (HFMD) has been emerging as an important public problem over the past few decades, especially in Asian and Pacific regions. A national program on EV71 vaccine development against HFMD was initiated in China, in 2008, which called for a need for seroepidemiological study for the target population. Methodology/Principal Findings: This was a retrospective study conducted in Jiangsu Province, in October, 2010. We measured the neutralizing antibodies against EV71 and CoxA16 in a cohort of infants aged of 2, 7, 12, and 27-38 months and their mothers just before delivery. Series sera samples from 975 infants and 555 mothers were collected and analyzed. Questionnaires on the history of HFMD were completed in the survey. A total of 143 HFMD cases were collected, but only 11.2% were reported to the National Infectious Disease Information Management System. The level of maternal antibody titers decreased dramatically during the first 7 month and remained at a relatively low level thereafter. But it increased significantly from month 12 to months 27-38. The accumulate incidence density of HFMD demonstrated a significant increase after 14 months of age, resulting in a accumulate incidence density of 50.8/1000 person-years in survey period. Seropositivity of EV71 antibody in infants at the age of 2 months seems to demonstrate a protective effect against HFMD. Conclusions and Significance: High seropositive rate of EV71 and CoxA16 antibody was found in prenatal women in mainland China, and there is a need to enhance the HFMD case management and the current surveillance system. We suggest that infants aged between 6 to 14 months should have the first priority to receive EV71 vaccine. © 2012 Zhu et al.


Zhang G.-M.,Shenzhen Kangtai Biological Products Co.
Chinese Journal of Biologicals | Year: 2016

Objective: To optimize the formula of stabilizer for pentavalent oral rotavirus vaccine (live). Methods: The stabilizers A (consisting of sucrose, sodium succinate, succinic acid, and sodium glutamate), B (consisting of sucrose, sodium citrate, citric acid and sorbitol) and C (consisting of mannitol, disodium hydrogen phosphate, sodium dihydrogen phosphate) were optimized by orthogonal design using the virus titer after storage at 37 °C for one week as an indicator. Results: The optimal formula of stabilizer A consisted of 40% sucrose, 0. 2 mol/L sodium succinate, 0. 01 mol/L succinic acid and 0. 05 mol/L sodium glutamate, while that of stabilizer B consisted for 40% sucrose, 0. 1 mol/L sodium citrate, 0. 005 mol/L citric acid and 1% sorbitol, and that of stabilizer C consisted of 40% sucrose, 0. 1 mol/L disodium hydrogen phosphate, 0. 005 mol/I, sodium dihydrogen phosphate and 0. 5% mannitol. Conclusion: All the three stabilizers showed good protective effect on pentavalent oral rotavirus vaccine (live).

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