ABSTRACT
The safety of measles vaccination is of great interest and importance to public health practice and the general society. We have analyzed the adverse events following immunization (AEFIs) of currently used measles-containing vaccines (including live attenuated measles vaccine, live attenuated measles and rubella combined vaccine, live attenuated measles and mumps combined vaccine, live attenuated Measles, Mumps and Rubella Combined Vaccine) in Anhui Province, China. From 2009 to 2014, 9.9 million doses of measles-containing vaccines were administrated and 1893 AEFIs were found (191.4 per million doses), of which, 33 serious AEFIs (3.3 per million vaccine doses) were reported. 59.4% (1124 cases) were male cases, and 85.1% (1611 cases) occurred in persons aged < 1 year. 93.3% (1766 cases) occurred at the first dose of vaccination and 95.9% (1815 cases) were found within 3 days after vaccination. This study presents up-to-date data and suggests that the measles-containing vaccines used in Anhui Province of China are safe.
Subject(s)
Immunization/methods , Measles Vaccine/immunology , Measles/immunology , Product Surveillance, Postmarketing/methods , Adverse Drug Reaction Reporting Systems/statistics & numerical data , Anaphylaxis/etiology , Asian People , China , Drug-Related Side Effects and Adverse Reactions/classification , Drug-Related Side Effects and Adverse Reactions/ethnology , Drug-Related Side Effects and Adverse Reactions/etiology , Encephalitis/etiology , Humans , Immunization/adverse effects , Measles/ethnology , Measles/prevention & control , Measles Vaccine/administration & dosage , Measles Vaccine/standards , Measles-Mumps-Rubella Vaccine/immunology , Measles-Mumps-Rubella Vaccine/standards , Product Surveillance, Postmarketing/standards , Seizures/etiology , Thrombocytopenia/etiology , Vaccines, Attenuated/immunology , Vaccines, Attenuated/standards , Vaccines, Combined/immunology , Vaccines, Combined/standardsABSTRACT
Anflu® is a seasonal trivalent inactivated split-virion influenza vaccine manufactured by Sinovac Biotech Co., Ltd. The objectives of this study were to evaluate the safety of Anflu® (2013-14 formulation: H1N1, H3N2 and BYAM) in infants and adults and its immunogenicity and cross-reactivity against mismatched influenza B lineage and avian influenza A(H7N9) viruses (hereafter BVIC and H7N9, respectively) in adults. In this phase IV open label trial, infants 6-35 months old (n=61) each received two injections with 28 days apart; adults 18-60 yrs old (n=60) and elderly >60 yrs old (n=61) each received one injection. Information of adverse events was collected through safety observation and follow-up visits. Pre- and post-immune blood samples (day 0 and 21) were collected from subjects ≥18 yrs old to detect hemagglutination inhibition antibody titers and calculate seroprotection rates (SPRs) and seroconversion rates (SCRs). The overall adverse reaction incidence was 1.6% (3/182), and no serious adverse event was reported during the study period. For subjects ≥18 yrs old, the SCRs, SPRs, and the geometric mean titers (GMTs) met the European criteria for all three strains. In addition, the point estimations of SCR, SPR and GMT for BVIC also met the European criteria. Six subjects were seroconverted against H7N9; however the serological results did not meet the European criteria. In conclusion, the results showed a satisfactory safety and immunogenicity profile of Anflu® and cross-reactivity against BVIC, but did not demonstrate cross-reactivity against H7N9 (Clinicaltrials.gov ID: NCT02269852).
Subject(s)
Immunogenicity, Vaccine , Influenza A Virus, H1N1 Subtype/immunology , Influenza A Virus, H3N2 Subtype/immunology , Influenza B virus/immunology , Influenza Vaccines/adverse effects , Influenza Vaccines/immunology , Influenza, Human/prevention & control , Adolescent , Adult , Antibodies, Viral/blood , Child, Preschool , Cross Reactions , Female , Hemagglutination Inhibition Tests , Humans , Incidence , Infant , Influenza A Virus, H7N9 Subtype/immunology , Influenza Vaccines/administration & dosage , Influenza, Human/immunology , Influenza, Human/virology , Male , Middle Aged , Seasons , Vaccines, Inactivated/administration & dosage , Vaccines, Inactivated/immunology , Young AdultABSTRACT
Due to immune abnormalities and the use of steroids and immunosuppressant treatment, patients with rheumatic diseases are susceptible to infections. Vaccination is one of the most important prevention tools in modern medicine. A discussion on risk-benefit or cost-benefit analysis, and advisory on individual vaccines or vaccination programs falls outside the scope of this review. In particularly, this review summarizes the knowledge about the effectiveness and safety vaccinations in patients with autoimmune inflammatory rheumatic diseases (AIIRD) treated with biologics. Finally, we aim to provide vaccination plans basis for clinical management of rheumatic patients depending upon prevaccination antibody titers, drug treatments and immunological potential.
