Vaccine Safety Research Articles

Stability of closed and needle-punctured vials of Porvac® subunit vaccine against classical swine fever subjected to thermal stress

BackgroundClassical Swine Fever (CSF) is still one of the most economically important viral diseases of pigs. In endemic countries, the disease is controlled mostly through vaccination; hence, the availability of safe and effective vaccines is of utmost importance. Vaccines intended for application in developing countries must also be thermally stable, since the infrastructure needed to maintain a cold chain in those countries is usually lacking. Porvac® is a second-generation subunit marker vaccine against CSF that has demonstrates to be safe and protective. Previous studies have also shown that the vaccine is stable for 1 week at 37 oC and have a shelf life of at least 36 months at 2–8 oC. The aim of this work was to further explore the accelerated stability of Porvac® by assessing the physicochemical properties of the emulsion, and the safety and immunogenicity of the vaccine subjected to more drastic conditions of thermal stress: (1) 25 oC for 12 months; (2) 30oC and 37 oC for one month and (3) 15 days at 37 °C after the cap of the vials had been needle-punctured.ResultsThe vaccine subjected to all these conditions did not show significant changes in the physicochemical properties of the emulsion; did not produce local or systemic adverse reactions in pigs, and the chromatographic profile of the recovered antigen was preserved. All vaccinated swine developed neutralizing antibody titers ≥ 1:1000 at 28 days post vaccination.ConclusionsPorvac® is stable in all the experimental conditions tested, even after cap puncture, and retains the capacity to induce high titers of neutralizing antibodies, well above the threshold of protection. These results reinforce the robustness of the vaccine, and support its use as a very attractive alternative to modified live vaccines in developing countries endemic for CSF.

Challenges and Ongoing Actions to Address the Mpox Emergency in Africa.

This review examines key events, challenges, and responses to the mpox public health emergency following the Africa CDC's declaration of a Public Health Emergency of Continental Concern on August 13, 2024. In response to the crisis, over 3.6 million vaccine doses and more than $150 million in funding have been mobilized globally, with contributions from the United States, European Union, and Japan. However, challenges persist, particularly in the Democratic Republic of Congo, where a humanitarian crisis in Kinshasa has complicated mpox diagnostics and treatment. In response, the Africa CDC has deployed its One Continental Incident Management Support team, with a focus on decentralizing diagnostics and enhancing sample movement through additional PCR equipment, funded by the Pandemic Fund and USAID. To reinforce laboratory diagnostics, surveillance, and case management, the Africa CDC has adopted a comprehensive "One Team, One Plan, One Budget, One M&E" approach and has deployed 72 epidemiologists to improve data integration. Collaborative efforts with WHO, GAVI, and UNICEF aim to expedite vaccine distribution, with a target of 10 million doses by 2025, alongside enhanced vaccine safety monitoring.

Mapping global public perspectives on mRNA vaccines and therapeutics

The development and rollout of mRNA vaccines during COVID-19 marked a significant advancement in vaccinology, yet public hesitation to vaccination was prevalent, indicating the potential risk that future mRNA-based medical innovations will fail to be adopted. Utilizing a combined approach of large language models with manual validation and unsupervised machine learning, we conducted a social listening analysis to assess attitudes towards mRNA vaccines and therapeutics on Twitter from June 2022 to May 2023, contrasting online perspectives with data from the Vaccine Adverse Event Reporting System. Our findings reveal widespread negative sentiment and a global lack of confidence in the safety, effectiveness, and trustworthiness of mRNA vaccines and therapeutics, with frequent discussions of severe vaccine side effects, rumors, and misinformation. This underscores the need for targeted communication strategies to foster acceptance of medical treatments and strengthen public trust in order to enhance societal resilience to future health challenges.

Machine learning algorithms for prediction of measles one vaccination dropout among 12–23 months children in Ethiopia

IntroductionDespite the availability of a safe and effective measles vaccine in Ethiopia, the country has experienced recurrent and significant measles outbreaks, with a nearly fivefold increase in confirmed cases from...

HPV Vaccine Awareness and Uptake Among Sexually Transmitted Infections Clinic Users: A Cross-Sectional Study in Bologna, Italy.

Human Papillomavirus (HPV) infection poses a significant health risk, particularly for high-risk groups such as men who have sex with men (MSM), people living with HIV (PLHIV), and transgender individuals. Despite the availability of effective vaccines, uptake among these groups remains suboptimal due to various social and behavioral barriers (BeSD). A cross-sectional survey was conducted at the Sexually Transmitted Infections (STIs) clinic in Bologna, Italy, from 8 April to 12 April 2024 using a paper questionnaire, investigating HPV vaccine uptake and BeSD factors influencing vaccination decisions. Statistical analyses included descriptive statistics and multivariate logistic regression. Among the 236 respondents, PLHIV and transgender individuals demonstrated lower uptake rates (60.0% and 15.6%) if compared to women under 30 years old (72.7%). Concern about HPV infection varied significantly across groups, with MSM showing the highest worry (48.7%). Perceptions of vaccine safety and access were mixed, influencing vaccination decisions. Multivariate analysis indicated that age inversely correlated with infection worry (OR: 0.94, 95% CI: 0.91-0.98), while being a woman under 30 (OR: 164.0, 95% CI: 17.2-1560.18) or MSM (OR: 3.53, 95% CI: 1.37-9.11) was positively associated with vaccine uptake. The study identifies disparities in HPV vaccine uptake among STI clinic users in Bologna, Italy, emphasizing the need for targeted public health campaigns. These campaigns could engage STI clinics and address awareness, safety perceptions, and access barriers to enhance vaccination coverage among sexual and gender minorities.

Safety and immunogenicity of freeze-dried human rabies vaccines: A phase 3 clinical trial of Zagreb and Essen regimes

ABSTRACT Recently optimized freeze-dried rabies vaccines (Vero cell) are promising for rabies prevention; however, comparisons of Essen 5-dose and Zagreb 4-dose regimens are needed for clinical applications. This phase III clinical trial aimed to assess the safety and immunogenicity of candidate freeze-dried rabies vaccines developed for human use by Shandong Yeedo Biotechnology (Registration No.: CTR20182016, http://www.chinadrugtrials.org.cn/index.html). In total, 40 participants in stage I and 1797 subjects in stage II with an age range of 10–60 years were recruited. Both 4-dose and 5-dose experimental vaccines were well-tolerated in stage 1, with similar overall adverse event (AE) rates. In stage 2, systemic fever (35.39%) and local pain (48.91%) were common, and the rate of Grade 3 AEs was approximately 2.5%. Rates of local reactions and unsolicited AEs differed among groups (p = .045 and 0.011). Immunogenicity analyses showed higher antibody levels, seroconversion rates, and pre-immune seroconversion rates in the 4-dose experimental group versus the 5-dose group (p < .001) on day 7 post-first dose, with similar GMCs (geometric mean concentrations) by day 14. Pre-immune negative subjects had comparable antibody levels in the 4-dose and 5-dose experimental groups, outperforming the 5-dose control group (p = .039). The rate difference (95% CI) for first-dose seroconversion at 14 days post-vaccination among pre-immune antibody-negative subjects indicated non-inferiority between the 5-dose experimental and control groups. Overall, the Shandong Yeedo rabies vaccine demonstrated satisfactory safety and efficacy, offering a new option for rabies prevention.

Host Innate and Adaptive Immunity Against African Swine Fever Virus Infection.

Africa swine fever virus (ASFV) is the causative agent of African swine fever (ASF), a highly contagious hemorrhagic disease that can result in up to 100% lethality in both wild and domestic swine, regardless of breed or age. The ongoing ASF pandemic poses significant threats to the pork industry and food security, with serious implications for the sanitary and socioeconomic system. Due to the limited understanding of ASFV pathogenesis and immune protection mechanisms, there are currently no safe and effective vaccines or specific treatments available, complicating efforts for prevention and control. This review summarizes the current understanding of the intricate interplay between ASFV and the host immune system, encompassing both innate and adaptive immune responses to ASFV infection, as well as insights into ASFV pathogenesis and immunosuppression. We aim to provide comprehensive information to support fundamental research on ASFV, highlighting existing gaps and suggesting future research directions. This work may serve as a theoretical foundation for the rational design of protective vaccines against this devastating viral disease.

Overcoming barriers of cervical cancer elimination in India: A practice to policy level advocacy

India’s ambitious goal of eliminating cervical cancer by 2030 faces significant challenges due to the high burden of disease, low screening rates, and sociocultural barriers. Despite the Government’s focus on vaccination, addressing cervical cancer requires a more comprehensive approach that is multisectoral and consider practice to policy engagement. Addressing not only vaccination but also social barriers, healthcare infrastructure, and research is key to preventing and controlling this preventable disease. Fragmented health policies with limited coverage for cervical cancer, coupled with societal issues like stigma and limited access to healthcare, particularly in rural areas, pose significant challenges. Moreover, limited awareness of HPV and vaccines hinders progress. To effectively combat cervical cancer, India must prioritize a readiness assessment to evaluate past interventions, economic feasibility, and social issues before launching new programs. Improving healthcare infrastructure, training healthcare workers, and utilizing innovative models like mobile clinics can expand access to care. Public-private partnerships with incentives can also play a crucial role in mobilizing resources. Investing in culturally appropriate public awareness campaigns is essential to educate the population about HPV, cervical cancer, and prevention strategies. A robust pharmacovigilance program is necessary to ensure vaccine safety. Additionally, India should invest in science and technology to support long-term research efforts, while increasing understanding of population-specific predisposing factors for broader-spectrum vaccines and personalized approaches. A dedicated national policy with clear objectives, strategies, and accountability mechanisms is crucial for successful cervical cancer control. Learning from the experiences of other countries can inform policy development.

Factors impacting vaccine uptake among adult Medicaid beneficiaries: a systematic literature review.

Vaccine uptake is suboptimal among adult Medicaid beneficiaries. To evaluate factors affecting vaccine uptake among adult Medicaid beneficiaries and/or affecting healthcare providers who vaccinate adult Medicaid beneficiaries, we conducted a systematic literature review in Embase, Medline, Database of Abstracts of Reviews of Effects, and the Cochrane Library for articles published from January 2005 through July 2022 and relevant conferences. For included studies, data were extracted on the study characteristics, patient and provider cost barriers, patient and provider perceived risks/benefits, and other barriers faced by patients and providers. Quality assessments were conducted using a checklist from the Joanna Briggs Institute. Twenty-one studies analyzed patient-related factors (14 studies) and/or provider-related factors (8 studies). Reviewed studies indicate that vaccine uptake is influenced by insurance benefit and cost-coverage policies, including cost-sharing, access to vaccination services, and vaccine education and awareness. Financial factors, including reimbursement for vaccine acquisition and administration, influence providers' vaccination practices for Medicaid beneficiaries. Our findings suggest that reducing or eliminating vaccination cost-sharing, promoting vaccine education and awareness about the importance and safety of vaccines, increasing access, and exploring reimbursement rates equivalent with other public or private insurance plans could mitigate barriers to vaccination for the adult Medicaid population.

The Processuality of ‘Sex’ in Biomedicine: Exploring Stem Cell Research, Cancer Medicine and Vaccine Safety Research

Incorporating sex into biomedical research is envisioned as key to addressing inequalities in health. However, feminist research suggests that it is a complicated task. This is, we argue, especially the case with research that seeks to mobilise sex across different scales involving bodies, samples and populations to provide a basis for personalised biomedical prevention and treatment. Through case studies from stem cell research, cancer medicine and vaccine safety research, we analyse how sex is enacted, foregrounded and sidelined at different stages of research. We argue that sex becomes suspended between individual bodies, samples and population groups, and that this postpones biomedical analysis of sex differences in health. Yet, research on sex differences in complex embodied processes, such as drug metabolism or immunity, appears as a future potentiality. This potentiality shapes research practices that may open biomedicine towards multi-disciplinary study settings that bring together physiological and social dimensions of bodily difference.

Safety observation of COVID-19 inactivated vaccine in immature mice

Objective To investigate the safety of COVID-19 inactivated vaccine in immature mice. Methods We selected 3-week-old immature BALB/c mice, continuously observed until 7 weeks old after continuous immunization with fully inactivated vaccine (initial strengthening), and sacrificed BALB/c mice at 7 weeks old, and used H&E, Masson, mast cells and Ki-67 staining to analyze the changes of heart, liver, spleen, kidney, lung and brain. In addition, RNA was extracted from important organs such as the heart, liver, spleen, kidney, lung, and brain, and to evaluate whether there was any effect after vaccination through bulk-RNA sequencing. Results After H&E, Masson, mast cells and Ki-67 staining analyses, there are no significant differences between tissues and organs in the vaccine group and the PBS group, and RNA-Seq did not show that the vaccine had any effect on immature mice. Conclusion COVID-19 inactivated vaccine is safe in immature mice.

PaedVacCOVID - safety of the BNT162b2 vaccine against the SARS-CoV-2 in children with and without comorbidities aged 5 to 11 years.

Little is known about specific safety aspects in children with significant comorbidities receiving the mRNA vaccine BNT162b2, as approval studies did not address this population. This study's purpose is to evaluate safety and adverse events in these children compared to healthy children. In this prospective, multicentre, industry-independent cohort study, caregivers whose children received BNT162b2 were asked to participate in an online questionnaire. Potential side effects were evaluated in ten organ related categories. Frequency of symptoms was compared in both cohorts by bivariate analysis. From a total of 1,294 responses to the questionnaire, 793 data sets were included into the analysis (179 children with comorbidities and 614 healthy children). Responses were given at a median of 17 days after vaccination. Overall, safety of BNT162b2 was high in both cohorts. Psychological (OR: 3.56, [95% CI: 1.461 to 8.629]), pulmonary (OR: 7.14, [95% CI: 2.039 to 21.48]), gastrointestinal (OR: 2.35, [95% CI: 1.231 to 4.665]), neurological (OR: 1.74, [95% CI: 1.078 to 2.796]) and dermatological (OR: 2.28, [95% CI: 1.220 to 4.172]) side effects were increased in children with comorbidities over healthy controls. The higher rate of reported post-vaccination symptoms could either be due to a higher susceptibility for symptomatic effects following immune stimulation, or due to a trained awareness to health-related symptoms. The data emphasizes the importance to evaluate safety of the new mRNA COVID-19 vaccines not only in healthy children but also in children with comorbidities. To perform such evaluation should be made mandatory for pharmaceutical enterprises.

Assessment of Single-Cycle M-Protein Mutated Vesicular Stomatitis Virus as a Safe and Immunogenic Mucosal Vaccine Platform for SARS-CoV-2 Immunogen Delivery.

The goal of the next-generation COVID-19 vaccine is to provide rapid respiratory tract protection with a single dose. Circulating antibodies do not protect the olfactory mucosa from viral infection, necessitating localized mucosal immunization. Live attenuated vesicular stomatitis virus (VSVMT)-based COVID-19 vaccines effectively stimulate mucosal immunity in animals, though safety concerns remain, particularly in immunocompromised populations. A viral vector capable of single-cycle replication may face less stringent regulatory requirements. A replication-defective VSVMT is developed with its G protein replaced by a SARS-CoV-2 spike protein (S) mutant, where residues K986 and V987 are substituted by prolines (S2P). This studies show that single-cycle VSVMT encoding Omicron subvariant S2P (VSVMT-S2P) is safe in both healthy and immunocompromised animals treated with cyclophosphamide (CP). Significant antibody and T-cell responses against the spike protein are observed in VSVMT-S2P vaccinated healthy animals. Intramuscular VSVMT-S2P administration induces neutralizing antibody responses comparable to those from replication-competent VSVMT-S. In immunocompromised animals, lower and delayed immune responses are observed. Thus, single-cycle M-protein mutated VSV offers a safe and effective platform for SARS-CoV-2 immunogen delivery. Remarkably, replication-competent VSVMT-S caused no pathogenicity and elicited potent mucosal immunity via intranasal administration, highlighting its potential as a mucosal COVID-19 vaccine.

Immunogenicity of intraperitoneal and intranasal liposome adjuvanted VLP vaccines against SARS-CoV-2 infection

Humans get SARS-CoV-2 infection mainly through inhalation; thus, vaccine that induces protective immunity at the virus entry site is important for early control of the infection. In this study, two anionic liposome (L)-adjuvanted VLP vaccines against SARS-CoV-2 were formulated. Baculovirus-Sf21 insect cell system was used for production of VLPs made of full-length S, M and E proteins. S protein of one vaccine (L-SME-VLPs) contained furin cleavage site at the S1/S2 junction, while that of another vaccine (L-S′ME-VLPs) did not. Both vaccines were innocuous and immunogenic when administered IP and IN to mice. Mice immunized IP with L-SME-VLPs/L-S′ME-VLPs (three doses, two-weeks intervals) had serum virus neutralizing (VN) antibodies (in falling order of isotype frequency): IgG3, IgA and IgG2a/IgG3, IgA and IgM, respectively. The L-S′ME VLPs vaccine induced significantly higher serum VN antibody titers than the L-SME-VLPs vaccine. All mice immunized IN with both vaccines had significant rise of VN antibodies in their bronchoalveolar lavage fluids (BALF). The VN antibodies in 67% of immunized mice were Th1- isotypes (IgG2a and/or IgG2b); the immunized mice had also other antibody isotypes in BALF. The intranasal L-S′ME-VLPs should be tested further step-by-step towards the clinical use as effective and safe vaccine against SARS-CoV-2.

Intention to Consume Halal Pharmaceutical Products Influenced by Religiosity and Knowledge through Attitudes in Jember

The Indonesian government did everything it could to stop the virus from spreading during the COVID-19 pandemic, including distributing vaccines. Regarding the immunization campaign, the City of Jember in East Java Province had a variety of reactions, including uncertainty over the vaccine's efficacy, safety, and halal (permitted to consume according to Islamic law). Refusing the vaccination, which is seen as a medicine, is interpreted as a way of expressing a desire to use halal pharmaceuticals. Through the mindset of the Jember community, this study seeks to examine the substantial impact of religiosity and halal awareness on the desire to use halal pharmaceutical items. Purposive sampling procedures were used to choose 100 respondents from the community of Jember drug users. The Path Analysis using SPSS analysis tool version 23 is the analysis technique employed. The study's findings indicate that views are significantly influenced by religion and halal awareness. Then, the desire to consume was strongly influenced by religion, halal knowledge, and attitude. Halal religiosity and knowledge significantly influenced consumption intentions through attitudes, according to the route test results. Therefore, via the mindset of the Jember community, religion, and halal knowledge have a major impact on the desire to use halal pharmaceutical items.

The impact of COVID-19 on routine child immunisation in South Africa

BackgroundThe COVID-19 pandemic disrupted immunisation programs worldwide, reversing gains that had brought vaccine-preventable diseases largely under control. This study explored the impact of COVID-19 on the uptake of routine child immunisation services in South Africa.MethodsWe conducted qualitative research using in-depth interviews with 51 purposively selected parents/caregivers of children below the age of five who missed or delayed one or more scheduled immunisation doses in 2020–2022 and with 12 healthcare providers who provided public immunisation services during the pandemic.ResultsDuring the pandemic lockdowns, most caregivers perceived the risk of their child being infected with COVID-19 during a clinic visit as more salient than the risk of missing immunisation doses. Caregivers reported minimal exposure to routine immunisation communication, as well as shortages of routine vaccines for children at public health facilities, healthcare workers experienced anxiety and burnout. There was a post-pandemic shift to more active decision-making about immunisation, which had previously been an almost automatic behaviour, leading some caregivers to delay vaccinating their children. There was also evidence of a “bad vaccine” mental model among some caregivers regarding COVID vaccinations, which could lead to doubts about the safety of routine childhood vaccinations.DiscussionThe shift from default to active decision-making highlights a risk that routine immunisation will backslide in future pandemics. Governments should build resilient health systems at all levels and communicate clearly about the benefits and availability of RIs and the safety of vaccinations in general, alongside supply-side interventions.ConclusionRoutine immunisation is widely accepted in South Africa, driven by generational norms and provider recommendations. During the COVID-19 pandemic, many caregivers faced the dilemma of balancing COVID-19 exposure risk with the risk of their child developing a deadly VPD, leading to missed RI visits. This shift to active decision-making highlights a future pandemic risk. Governments should build resilient health systems and focus on understanding and engaging procrastinating and doubtful caregivers. Clear communication about RI benefits and vaccine safety is crucial, as misinformation can lead to distrust in new vaccines.

Identifying influential factors using machine learning techniques on the intention to receive a COVID-19 booster dose and vaccine fatigue among partially vaccinated individuals

This study assesses COVID-19 booster intentions and hesitancy in Texas, a state known for its diversity and libertarian values. A survey was conducted with 274 participants residing in Texas between June and July 2022. The analysis examined sociodemographic and health-related factors, trusted information sources, and preventive behaviors. The survey focused on vaccinated participants and their intention to receive the booster dose, which was categorized into three outcomes: yes, no, and not sure. Machine learning techniques were employed to analyze the survey responses of vaccinated participants to identify the most critical factors. Among the participants, 113 expressed their intention to get the booster (41.2%), 107 did not plan to receive the booster (39.1%), and 54 remained undecided (19.7%). Our findings indicate that the perception of vaccine safety significantly influenced the decision to receive the booster dose. Those who reported trust in social media contacts as reliable information sources were more likely to intend to boost. Additionally, among those hospitalized when diagnosed with COVID-19, the largest proportion were unwilling to receive the booster (47.0%) compared to those who intended to receive the booster (33.3%). In contrast, most of those who believed they would be hospitalized if infected with COVID-19 intended to get the booster. Other factors did not demonstrate a significant association. Our findings are highly transferable and can offer valuable insights, particularly for countries where COVID-19 remains prevalent and are pivotal both presently and in the future for developing strategies to improve booster uptake and shape public health initiatives in epidemic and pandemic outbreaks.

Safety of COVID-19 Vaccines; Frequency of Side Effects and Association with Sociodemographic Characteristics among Medical Students

Objective: To find out the side effects of vaccines of COVID-19 and its association with sociodemographic factors among students of medical colleges of Rawalpindi. Study Design: Cross sectional analytic study. Place and Duration of Study: A cross-sectional analytical study was carried out from May to Aug 2022 among medical students of three Medical Colleges (AMC, FUMC, RMC) in Rawalpindi Pakistan. Methodology: There were 200 participants that were conveniently selected with the Rao soft sample size calculator. Avalidated questionnaire was used to collect data. SPSS (v:26) was used to analyze the data. Chi square analysis was used to assess the relationship between side effects and demographic characteristics and a p-value of 0.05 was taken as significant. Results: Majority of the participants were male 126(63%) and unmarried 182(94%). The mean age of the participants was 20 years (SD=1.4). Almost all were vaccinated 197(98.5%) with two doses 195(97.5%). The side effects after the first dose were more profound as compared to the second dose, like normal pain 133(66.5%), tenderness at injection site 69(34.5%), fever 65(32.5%) and fatigue 80(40%). Muscular pains were also documented to be pronounced after the administration of first dose 58(29%). Association analysis showed significant association between first dose side effects, normal pain(p=0.001), tenderness (p=0.004), redness (p=0.02) and fatigue (p=0.02) with gender variable. Whereas age and degree socio demographic variables reported significant association with first dose side effects, normal pain (p=0.04) and muscle pain (p=0.01), respectively. Conclusion: It was conclusive that adverse effects were more common and more severe after the first dose than after the second. The most frequent side effect was normal pain at the injection site, found more frequently in men, with muscular pain being noticeably worse after the first dosage and surprisingly minimal following the second dose of the COVID-19 vaccination.

Exploring vaccine hesitancy in digital public discourse: From tribal polarization to socio-economic disparities.

This study analyzed online public discourse on Twitter (later rebranded as X) during the COVID-19 pandemic to understand key factors associated with vaccine hesitancy by employing deep-learning techniques. Text classification analysis reveals a significant association between attitudes toward vaccination and the unique socio-economic characteristics of US states, such as education, race, income or voting behavior. However, our results indicate that attributing vaccine hesitancy solely to a single social factor is not appropriate. Furthermore, the topic modeling of online discourse identifies two distinct sets of justifications for vaccine hesitancy. The first set pertains to political concerns, including constitutional rights and conspiracy theories. The second pertains to medical concerns about vaccine safety and efficacy. However, vaccine-hesitant social media users pragmatically use broad categories of justification for their beliefs. This behavior may suggest that vaccine hesitancy is influenced by political beliefs, unconscious emotions, and gut-level instinct. Our findings have further implications for the critical role of trust in public institutions in shaping attitudes toward vaccination and the need for tailored communication strategies to restore faith in marginalized communities.

Comparative assessment of a COVID-19 vaccine after technology transfer to Iran from critical quality attributes to clinical and immunogenicity aspects

During COVID-19 pandemic, international pharmaceutical companies put effort to build global manufacturing networks for vaccines. Soberana Plus vaccine, a recombinant protein based vaccine (RBD dimer), with the trade name of PastoCovac Plus in Iran, is based on a protein subunit platform in Cuba and completed preclinical and toxicological assessments. This study aimed at presenting the steps of vaccine technology transfer from Cuba to Iran. This study provides the first practical comparability results in Iran to ensure the quality, safety and efficacy of a protein subunit vaccine against COVID-19 after a successful technology transfer from Cuba. PastoCovac Plus was transferred to Iran at the formulation stage. The assessment of the active ingredient pharmaceutical (API) was achieved through physicochemical and clinical data collection and tests to assure if there was any adverse impact on the vaccination results. In order to assess the quality of the vaccine product after technology transfer, we sought different properties including regulatory features, physicochemical quality, vaccine potency and stability as well as its immunogenicity and safety. Following the evaluation of the clinical quality attributes (CQAs) based on the standard protocols, the results showed that the two vaccines are highly similar and comparable, with no considerable effect on safety or efficacy profiles. The CQAs were all in the acceptance limits in terms of safety and efficacy as well as clinical evaluation results. The immunogenicity evaluation also confirmed no significant differences between the vaccines regarding reinfection (P = 0.199) or vaccine breakthrough (P = 0.176). Furthermore, the level of anti-spike and neutralizing antibodies in the both vaccine groups was not significantly different indicating the equality of performance between the two vaccines. According to the results of the quality and clinical assessment of this study, we achieved an acceptable quality attributes and acceptant limits in terms of safety and efficacy of the vaccines pre and post technology transfer.