Is it time to administer acellular pertussis vaccine to childbearing age/pregnant women in all areas using whole-cell pertussis vaccination schedule?

Background: Whole-cell pertussis (wP) vaccine administration is still advocated for children under 7 years of age in Iran. However, there is no recommendation for the administration of a dose of tetanus, diphtheria, and acellular pertussis (Tdap) vaccine to childbearing age/pregnant women in the Iranian vaccination program and it has increased the risk of infection through waning immunity during women’s childbearing age life. The study aimed to assess the levels of anti- Bordetella pertussis antibodies in childbearing age women of different ages in Iran. Methods: A cross-sectional study was conducted on a total number of 360 childbearing age women divided into six age groups, with 5-year intervals from 15 to 45 years old, in 2018–2019. Then, the levels of immunoglobulin A (IgA), immunoglobulin M (IgM), and immunoglobulin G (IgG) antibodies against B. pertussis were evaluated using enzyme-linked immunosorbent assay (ELISA). The IBM SPSS Statistics software (version 16.0) (SPSS Inc., Chicago, IL, USA) was used for data analysis. Results: The mean age of the participants was 30.01 ± 8.35 years (range 14–45 years). All the cases were IgM negative, but two IgA-positive individuals (in the age groups of 14–19 and 30–34 years) were reported. Overall, 239 (66.4%) cases were IgG positive. The mean age of IgG-positive cases was 30.37 ± 8.37 years. The IgG-positive cases were mostly in the age groups of 30–34 and 35–39 years [43 (71.1%)]. The odds of IgG positivity were 1.97. The highest odds of IgG positivity were seen in 30–34 and 35–39 years groups (2.52) and the lowest odds were seen in the 20–24 and 25–29 years groups (1.60). Using the Jonckheere–Terpstra test, the increasing trend of IgG changes in different age groups was not statistically significant (Tπ=5.78, p = 0.09). Conclusion: The infants of women of childbearing age might be prone to pertussis in countries using the wP vaccination schedule. It is suggested to administer a dose of Tdap to women before or during pregnancy to increase the immunity of their infants against this disease during early infancy.

Safety and reactogenicity of the adjuvanted recombinant zoster vaccine: experience from clinical trials and post-marketing surveillance

An adjuvanted recombinant zoster vaccine (RZV) is licensed for the prevention of herpes zoster. This paper reviews its safety and reactogenicity. A pooled analysis of two pivotal randomized Phase-3 trials (NCT01165177, NCT01165229) in adults ⩾50 years found that more solicited adverse events (AEs) were reported with RZV than placebo. Injection site pain was the most common solicited AE (RZV: 78.0% participants; placebo: 10.9%). Grade-3 pain occurred in 6.4% of RZV and 0.3% of placebo recipients. Myalgia, fatigue, and headache were the most commonly reported general solicited AEs (RZV: 44.7%, 44.5%, and 37.7%, respectively; placebo: 11.7%, 16.5%, and 15.5%, respectively). Most symptoms were mild to moderate in intensity with a median duration of 2–3 days. The intensity of reactogenicity symptoms did not differ substantially after the first and second vaccine doses. The pooled analysis of the pivotal Phase-3 trials did not identify any clinically relevant differences in the overall incidence of serious adverse events (SAEs), fatal AEs or potential immune-mediated diseases (pIMDs) between RZV and placebo. Reactogenicity in five studies of immunocompromised patients ⩾18 years (autologous stem cell transplant, human immunodeficiency virus, solid tumors, hematological malignancies, and renal transplant; NCT01610414, NCT01165203, NCT01798056, NCT01767467, and NCT02058589) was consistent with that observed in the pivotal Phase-3 trials. There were no clinically relevant differences between RZV and placebo in the immunocompromised populations with regard to overall incidence of SAEs, fatal AEs, pIMDs, or AEs related to patients’ underlying condition. Post-marketing surveillance found that the most commonly reported AEs were consistent with the reactogenicity profile of the vaccine in clinical trials. Overall, the clinical safety data for RZV are reassuring. [Formula: see text]

Comprehensive literature review on COVID-19 vaccines and role of SARS-CoV-2 variants in the pandemic

Since the outbreak of the COVID-19 pandemic, there has been a rapid expansion in vaccine research focusing on exploiting the novel discoveries on the pathophysiology, genomics, and molecular biology of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Although the current preventive measures are primarily socially distancing by maintaining a 1 m distance, it is supplemented using facial masks and other personal hygiene measures. However, the induction of vaccines as primary prevention is crucial to eradicating the disease to attempt restoration to normalcy. This literature review aims to describe the physiology of the vaccines and how the spike protein is used as a target to elicit an antibody-dependent immune response in humans. Furthermore, the overview, dosing strategies, efficacy, and side effects will be discussed for the notable vaccines: BioNTech/Pfizer, Moderna, AstraZeneca, Janssen, Gamaleya, and SinoVac. In addition, the development of other prominent COVID-19 vaccines will be highlighted alongside the sustainability of the vaccine-mediated immune response and current contraindications. As the research is rapidly expanding, we have looked at the association between pregnancy and COVID-19 vaccinations, in addition to the current reviews on the mixing of vaccines. Finally, the prominent emerging variants of concern are described, and the efficacy of the notable vaccines toward these variants has been summarized.

Impact of indirect education on knowledge and perception on cervical cancer and its prevention among the parents of adolescent girls: an interventional school-based study

Background: India has almost 225 million adolescent girls and they seem to be at a disadvantage, both economically and by their lack of knowledge on human papilloma virus (HPV) vaccine, when compared to adolescent girls of other Asian countries. Aim: To assess the prevalence of HPV vaccination and to identify the impact of education in improving the knowledge and perception about the HPV infection and vaccination among the parents of adolescent girls. Methodology: The prospective interventional study was conducted in four schools within a South Indian City, Mysuru. The informed consent form and the questionnaire were sent home with the identified adolescent girls during the pre-interventional phase. Educational sessions were conducted for the students in their school and an education leaflet was distributed to their parents. Three weeks later, questionnaires were re-administered to the parents via the enrolled girls and their responses were collected. Results: The prevalence of HPV vaccination in the study population was 4.4%. There was a statistically significant improvement in knowledge in the post-interventional phase of the study ( p = 0.001), but could not identify a significant change in their perception ( p = 0.479). Parents belonging to the socioeconomic class of upper middle and upper lower showed better improvement at the end of the study, with a percentage improvement of 58.93% and 48.44%, respectively. Conclusion: The study proved that the healt care professional can target school children to communicate effectively to their parents on the importance of HPV vaccine as the study clearly observed a positive behavioral change among the study population.

Transdermal approaches to vaccinations in the COVID-19 pandemic era

The COVID-19 pandemic has necessitated rapid vaccine development for the control of the disease. Most vaccinations, including those currently approved for COVID-19 are administered intramuscularly and subcutaneously using hypodermic needles. However, there are several disadvantages including pain and fear of needlesticks, the need for two doses, the need for trained health care professionals for vaccine administration, and barriers to global distribution given the need for cold supply chain. Recently, transdermal techniques have been under investigation for vaccines including COVID-19. Microneedle array technology utilizes multiple microscopic projections from a plate which delivers a vaccine in the form of a patch placed on the skin, allowing for painless antigen delivery with improved immune response. In this review, we discuss challenges of existing vaccines and review the literature on the science behind transdermal vaccines including microneedles, current evidence of application in infectious diseases including COVID-19, and considerations for implementation and global access.

Impact of educational intervention on the best immunization practices among practicing health care professionals in a south Indian city

Background and Aims: Maintaining the quality and safety of immunization is as important as the efficacy of vaccines in vaccine-preventable diseases (VPD) programs. The aim of this study was to determine the problems associated with different stages of vaccine use and to assess the outcome of an educational intervention on safety and quality use of vaccines among health care providers. Methods: A pilot prospective interventional study was conducted over a period of 2 years at 271 sites in Mysuru, India. The study population was health care professionals (HCPs) involved in immunization and a sample of parents (one per site). A validated questionnaire was used as a study tool. An educational intervention on best immunization practice was conducted for the enrolled HCPs and the impact of the educational intervention was assessed using the study tool after 3 weeks. Results: The total number of the study population was 594 (323 HCPs and 271 parents). Of these, 41.49% were working at community health care facility and 33.13% were enrolled from primary care centers. There were statistically significant improvements in post interventional assessment of all stages of the immunization process including storage ( p −0.001), transportation ( p −0.001), administration ( p 0.001), monitoring and reporting of adverse events following immunization (AEFIs) ( p −0.001), knowledge of AEFIs ( p 0.001), and HCP-parent communication ( p 0.001). AEFI reporting improved by 30% in the post education phase. Conclusion: Continuous education and motivation can result in positive behavioral changes on best immunization practices amongst HCPs involved in immunization, which may help to improve and maintain the safety and quality use of vaccines in immunization centers irrespective of the type of facility.

Adverse events following COVID-19 vaccination: first 90 days of experience from a tertiary care teaching hospital in South India

Background: The COVID-19 vaccination program was introduced in India on 16 January 2021. The Government-issued fact sheet was the only source of information regarding Adverse Events Following Immunizations (AEFIs) for these vaccines. The objective of this study was to assess the AEFIs reported following COVID-19 vaccination in a tertiary care teaching hospital. Materials and methods: The spontaneous reporting method was used for data collection for a period of 3 months. A data collection form was designed to collect the data from the study population who reported adverse events. Collected data were analyzed and categorized by severity and seriousness. The causality assessment team performed causality assessment of the AEFIs using the World Health Organization’s causality assessment algorithm. Results: A total of 11,656 doses of COVID-19 vaccine were administered at the study site during the study period, of which 9292 doses were COVISHIELD™ and 2364 doses were COVAXIN™. In all, 445 AEFIs were reported from 269 subjects with an incidence rate of 3.48%. The majority of the subjects with AEFIs belonged to the age group of 18–45 years. Out of the total 445 AEFIs, 418 AEFIs were expected as per the fact sheets, 409 with COVISHIELD™ and 9 with COVAXIN™. Most of the AEFIs [62.02% ( n = 276)] were observed at the system organ class of ‘General disorders and administration site conditions’. After the causality assessment, out of 433 AEFIs to COVISHIELDTM vaccine, 94.22% ( n = 408) of events were categorized to have ‘consistent causal association with immunization’. Out of 12 adverse events following COVAXIN™, 8 (66.66%) events were categorized as ‘consistent causal association with immunization’. All of them recovered from their adverse events without any sequelae. Conclusion: Spontaneous reporting is one of the cheapest methods that can be used for the reporting of AEFI. This method helps health care professionals to identify rare events and potential signals.

Pregnant women’s hepatitis B vaccination coverage in Nigeria: a national pilot cross-sectional study

Objective: To determine the hepatitis B vaccination coverage, full-dose (⩾3) coverage and the associated factors affecting uptake among pregnant women. Methods: This was a cross-sectional study among pregnant women attending antenatal care in six tertiary hospitals across all the geopolitical zones of Nigeria. Pregnant women who consented to the study completed screening questions about their hepatitis B vaccination status and coverage. The main outcome measures were hepatitis B vaccination coverage rate, dose, and factors affecting uptake. Bivariate analysis was performed by the chi-square test and conditional logistic regression analysis was used to determine variables associated with uptake of the vaccination. Odds ratios (ORs) and adjusted odds ratios (aORs) were calculated and statistical significance was accepted when p-value was < 0.05. Results: Of 159 pregnant women who completed the interview questions, 21 [13.2%, 95% confidence interval (CI) 7.9–18.5%] were vaccinated for hepatitis B for one to three doses. The numbers of doses received were: three doses (8/159, 5.0%), two doses (5/159, 3.1%), and one dose (8/159, 5.0%). The reasons for non-uptake of vaccination included: lack of awareness of the vaccine 83/138 (60.1%), inadequate access to vaccine 11/138 (8.0%), and positivity to hepatitis B virus 10/138 (7.2%). The uptake of hepatitis B vaccination was significantly affected by the level of education (OR 0.284, 95% CI 0.08–1.01, p = 0.041), but in multivariable logistic regression, adjusted for confounders, the association between hepatitis B vaccination and participants’ level of education (aOR 3.09; 95% CI 0.95–10.16; p = 0.061) did not remain significant. Conclusions: In Nigeria, the national hepatitis B vaccination coverage among pregnant women appears poor, with the full-dose coverage even poorer. The level of education was not positively associated with uptake of hepatitis B vaccination, while lack of awareness of the vaccine was the commonest reason for non-uptake. Funding: TETFund National Research Fund 2019 (grant number TETFund/DR&D/CE/NRF/STI/33).