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INTRODUCTION: Japan will be transitioning from the free-of-charge COVID-19 vaccination program to annual periodic vaccination under a national immunization program for old adults and high-risk patients from 2024 fall/winter season. The policy transition including out-of-pocket payment requirement may discourage vaccination, leading to a lower vaccination rate. This study aimed to estimate the impact of varying vaccination rates with BNT162b2 COVID-19 mRNA vaccine on economics and public health in an illustrative prefecture which administers and promotes the periodic vaccination program, using budget impact analysis. METHODS: A combined cohort Markov decision tree model estimated the public health outcomes of COVID-19-related symptomatic cases, hospitalizations and deaths; and the economic outcomes including vaccine-related cost, non-vaccine-related medical cost, and productivity loss from the societal perspective. The base case examined the impact on the outcomes when vaccination coverage changed from the reference value of 50% to upper and lower values, respectively. Scenario analyses were performed based on multiple scenarios. RESULTS: Increase in the vaccination rate demonstrated improvement in all public health outcomes. At 50% vaccination, the vaccine-related cost for 3 years in a prefecture was estimated at JPY 7.58 billion (USD 57.67 million), the non-vaccine-related medical cost at JPY 79.22 billion (USD 602.48 million), the productivity loss at JPY 253.11 billion (USD 1.92 billion), and the total cost at JPY 339.92 billion (USD 2.59 billion). When the vaccination rate increased to 90%, the total cost decreased by JPY 4.88 billion (USD 37.11 million) (1.4%). When the vaccination rate decreased to 10%, the total cost increased by JPY 5.73 billion (USD 43.58 million) (1.7%). Results were consistent across almost all scenario analyses. CONCLUSIONS: Maintaining a high vaccination rate with BNT162b2 is important from both public health and economic perspectives in Japan. The findings highlight to local governments the importance of continued effort to promote vaccination.

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The SARS-CoV-2 Omicron variant and its sublineages continue to cause COVID-19-associated pediatric hospitalizations, severe disease, and death globally. BNT162b2 and CoronaVac are the main vaccines used in Chile. Much less is known about the Wuhan-Hu-1 strain-based vaccines in the pediatric population compared to adults. Given the worldwide need for booster vaccinations to stimulate the immune response against new Omicron variants of SARS-CoV-2, we characterized the humoral and cellular immune response against Omicron variant BA.1 in a pediatric cohort aged 10 to 16 years who received heterologous vaccination based on two doses of CoronaVac, two doses of CoronaVac (2x) plus one booster dose of BNT162b2 [CoronaVac(2x) + BNT162b2 (1x)], two doses of CoronaVac plus two booster doses of BNT162b2 [CoronaVac(2x) + BNT162b2 (2x)], and three doses of BNT162b2. We observed that the [CoronaVac(2x) + BNT162b2 (2x)] vaccination showed higher anti-S1 and neutralizing antibody titers and CD4 and CD8 T cell immunity specific to the Omicron variant compared to immunization with two doses of CoronaVac alone. Furthermore, from all groups tested, immunity against Omicron was highest in individuals who received three doses of BNT162b2. We conclude that booster vaccination with BNT162b2, compared to two doses of CoronaVac alone, induces a greater protective immunity.

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The vaccination against Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is an important public health strategy to prevent people from the pandemic. Vaccines are a game-changing tool, it is essential to understand the adverse events after COVID-19 vaccination. This study explored the adverse events of COVID-19 Vaccination Oxford-AstraZeneca, Pfizer-BioNTech, Moderna, Johnson and Johnson on Guillain-Barré Syndrome (GBS). In this study, initially 128 documents were identified from the databases, including Pub-Med, Web of Science-Clarivate Analytics, Scopus, and Google Scholar. The articles on COVID-19 vaccination and GBs were searched using the keywords "SARS-CoV-2, COVID-19, Vaccination, and Guillain Barré Syndrome, GBS", finally, 16 documents were included in the analysis and synthesis. After administering 1,680,042,214 doses of COVID-19 vaccines, 6177 cases were identified with 10.5 cases per million vaccine doses. A significant positive risk was found between COVID-19 vaccine administration and GBS with a risk rate of RR 1.97 (95% CI 1.26-3.08, p = 0.01). The mRNA vaccines were associated with 2076 cases, and 1,237,638,401 vaccine doses were linked with 4.47 GBS events per million vaccine doses. The first dose of the m-RNA vaccine was associated with 8.83 events per million doses compared to the second dose with 02 events per million doses. The viral-vector vaccine doses 193,535,249 were linked to 1630 GBS cases with 11.01 cases per million doses. The incidence of GBS after the first dose was 17.43 compared to 1.47 cases per million in the second dose of the viral-vector vaccine. The adverse events of the Oxford-AstraZeneca vaccine were linked to 1339 cases of GBS following 167,786,902 vaccine doses, with 14.2 cases per million doses. The Oxford-AstraZeneca vaccine significantly increased the risk of GBS RR: 2.96 (95% CI 2.51-3.48, p = 0.01). For the Pfizer-BioNTech vaccine, there were 7.20 cases per million doses of the vaccine, and no significant association was identified between the Pfizer-BioNTech vaccine and GBS incidence RR: 0.99 (95% CI 0.75-1.32, p = 0.96). Moderna vaccine was related with 419 cases of GBS after administering 420,420,909 doses, with 2.26 cases per million doses. However, Johnson and Johnson's vaccination was linked to 235 GBS after 60,256,913 doses of the vaccine with 8.80 cases per million doses. A significant association was seen between the risk of GBS and Ad.26.COV2. S vaccine, RR: 2.47 (95% CI 1.30-4.69, p < 0.01). Overall, a significant association was seen between the COVID-19 vaccines and the risk of GBS. The incidence of GBS was higher after the first dose compared to GBS cases per million in the second dose.

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Thrombosis is a common clinical feature associated with morbidity and mortality in coronavirus disease-2019 (COVID-19) patients. Cytokine storm in COVID-19 increases patients' systemic inflammation, which can cause multiple health consequences. In this work, we aimed to indicate the effect of Pfizer-BioNTech vaccination on the modulation of monocyte chemoattractant protein-3 (MCP-3), matrix metalloproteinase 1 (MMP-1), and tumor necrosis factor-alpha (TNF-α) levels, and other systemic inflammatory biomarkers that associates with COVID-19 severity in patients who suffers from thrombosis consequences. For this purpose, ninety people were collected from Ibn Al-Nafees Hospital and divided into three groups each of which contained 30 people, 15 of them were venous thromboembolism (VTE) positive and the other were VTE negative. The three groups were non-vaccinated COVID-19, vaccinated COVID-19, and control. The levels of MCP-3 and TNF-α were significantly (p < 0.05) increased in vaccinated and non-vaccinated COVID-19 patients regardless of their thrombosis condition, while MMP-1 level was non-significantly (p > 0.05) higher in vaccinated patients compared to control. MCP-3 and TNF-α were correlated positively with D-dimer (r = 0.544 and r = 0.513, respectively) in non-vaccinated patients, while MMP-1 and TNF-α were correlated positively with D-dimer (r = 0.624 and r = 0.575, respectively) in vaccinated patients. The odds ratio of MCP-3 (2.252), MMP-1 (1.062), and TNF-α (1.360) were reduced in vaccinated patients (2.093, 1.022, and 1.301 for MCP-3, MMP-1, and TNF-α respectively). Thus, MCP-3 plays a vital role in COVID-19 pathophysiology, and vaccination can reduce the risk of developing VTE in COVID-19 patients, and improve the inflammatory condition of patients.

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Objectives: This study aimed to report any suspected adverse drug reactions (ADRs) experienced by all vaccinated staff and students in a tertiary teaching hospital following COVID-19 vaccination. Methods: This retrospective study was conducted during the COVID-19 vaccination campaign at Sultan Qaboos University and Hospital in Muscat, Oman, from August to September 2021. An online survey was generated and sent to all staff and students via email and text messages. An announcement was made on the hospital website with a link to the survey. Results: A total of 8,421 individuals reported being vaccinated at least once with a total of 11,468 doses administered from January to July 2021; 8,014 staff and students received the Pfizer-Biotech vaccine while 3,454 staff and students received the Oxford-AstraZeneca vaccine. The survey received a total of 3,275 responses (response rate = 38.8%). Of these, 741 individuals (22.6%) experienced an ADR after vaccination and 67.2% (n = 498) were females (P <0.001). The majority of the ADRs reported were fever and chills (19.7%) followed by localised pain and swelling at the injection site (18.8%). Other ADRs such as hair loss (0.5%) were reported, and one staff/student reported a clot in the right leg. Among the responders, 27.0% considered their ADRs as mild while 25.0% considered them as severe. Conclusions: In the study cohort, mild symptoms of COVID-19 vaccines were reported. Females experienced more ADRs compared to males. Long-term observation of ADRs to the vaccines and follow-up monitoring should be done on subjects to preclude any unwanted effects.

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Coronavirus disease 2019 (COVID-19) caused a global calamity that forced emergency use authorization to Pfizer-BioNTech COVID-19 (BNT162b2) vaccine. It is efficacious in preventing symptomatic severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection in seronegative recipients. The safety profile is still unclear; however, commonly reported symptoms post-vaccination are fatigue, headache, muscle pain, chills, and injection-site pain. COVID-19 disease elicits, to some extent, cutaneous side effects like urticaria, morbilliform rash, and chilblain-like eruption. Vaccination against COVID-19 was reported to induce similar dermatologic manifestations, such as urticarial rash, delayed large-local reaction, local injection-site reaction, and morbilliform eruption. Erythema multiforme (EM) is a rare manifestation post-vaccination, and only a few reports implicate it as a culprit in cutaneous eruptions following the BNT162b2 vaccine. This report delineates the presentation of a healthy 14-year-old girl to a dermatology clinic who developed EM post-vaccination with the first dose of BNT162b2. New-onset EM-eruption post-vaccination with BNT162b2 had been reported previously in 14 cases, and one case reported on the flare of preexisting-EM.

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Introduction: The SARS-CoV-2 pandemic that spread swiftly is now a major global public health issue. Vaccines are currently being distributed in an effort to limit the viral transmission and mortality. The aim of the study was monitoring of both safety and efficacy in determining the overall effectiveness of the vaccine and identifying any potential safety concerns. Material and methods: A retrospective, cross-sectional study employing a validated 13-item structured questionnaire divided into two sections was performed between March 2022 and September 2022. Different post-vaccination side effects (SE) according to symptoms severity in terms of age and sex for participants were reported. Additionally, some pertinent serological assays for participants' post-vaccinations were investigated. Results: A total of 502 participants (male: 262, female: 240) with comorbidity (healthy: 258, morbid: 244) who received two Pfizer/BioNTech mRNA vaccine doses were included. Importantly, second dose (D2) vaccination was associated with significantly more SE than single dose (D1) vaccination (p < 0.0001). In D1 vaccination injection site pain (ISP) (45%), followed by equal proportions of headache and fever (40%) were the most common vaccine SE, while in D2 vaccination, ISP (66%) and nausea (57%) were reported. In all, 97% (p < 0.0001) of participants were IgG antibody positive at D2 vaccination. Similarly, serum CR protein level was elevated significantly (p < 0.0001) corresponding to the severity of SE between D1 and D2. Significant differences in IgG concentration were found between D1 and D2 vaccination in different gender and age groups (p < 0.0001). Conclusions: In light of the extensive data from this study, it is evident that mRNA vaccines, particularly the Pfizer/BioNTech vaccine, have proven to be highly safe and effective in mitigating the impact of the SARS-CoV-2 pandemic.

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To evaluate the development of neutralizing Anti-Spike Protein IgG (Anti-S-IgG) during twin pregnancies before conception vs. during pregnancy. In this prospective study, three blood samples were collected from pregnant women and subjected to anti-S-IgG immunodiagnostics. The patient's medical records, including vaccination and PCR test results, were collected from the hospital's electronic database. Age-matched non-pregnant women were used as a control group. We enrolled 83 women with twin pregnancies. 49 women were vaccinated before conception, 21 women were vaccinated during pregnancy, and 13 were not vaccinated. Of the 13 women who weren't vaccinated, three became positive during pregnancy, and all three were severely ill. By contrast, in women who were vaccinated during or before pregnancy, COVID-19 infection during pregnancy caused only mild symptoms. A ten-fold lower level of neutralizing Anti-S-IgG in the 3rd trimester was observed in healthy women who were vaccinated before conception and remained healthy until discharge from the hospital after delivery 1605 (IQR: 763-2410) compared to the healthy women who were vaccinated during pregnancy 152 AU/mL (IQR: 54-360). This difference was higher among women who were infected by COVID-19 (as verified by a positive PCR test). The third-trimester level of neutralizing Ant-S-IgG in the infected group was 4770 AU/mL (4760-6100) in infected women vaccinated before conception compared to those vaccinated during pregnancy who had 70 AU/mL (IQR: 20-170) (p < 0.001). In women vaccinated at 13-16 weeks gestation, neutralizing Anti-S-IgG at 20-22 weeks went up to 372 AU/mL (IQR: 120-1598) but rapidly dropped to 112 AU/mL (IQR: 54-357) at 28-30 weeks, (p < 0.001), a faster decline than in women vaccinated at a median 22 weeks before conception. Being infected by COVID-19 before conception was linked to having low Anti-S-IgG levels during pregnancy, whereas being infected by COVID-19 during pregnancy led to a very high response in the 3rd trimester. In twin pregnancies, significantly lower neutralizing Anti-S-IgG levels were observed in women vaccinated during pregnancy compared to those vaccinated before conception, whether infected or not infected by COVID-19. A full course of vaccination before conception is recommended.Trial registration. ClinicalTrials.gov Protocol Registration and Results System (PRS) Receipt Release Date: October 4, 2021. https://clinicaltrials.gov/ ID: NCT04595214.

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Background: The aim of the study was to evaluate the humoral and cellular immunity after SARS-CoV-2 infection and/or vaccination according to the type of vaccine, number of doses and combination of vaccines. Methods: Volunteer subjects were sampled between September 2021 and July 2022 in Hospital Clínico San Carlos, Madrid (Spain). Participants had different immunological status against SARS-CoV-2: vaccinated and unvaccinated, with or without previous COVID-19 infection, including healthy and immunocompromised individuals. Determination of IgG against the spike protein S1 subunit receptor-binding domain (RBD) was performed by chemiluminescence microparticle immunoassay (CMIA) using the Architect i10000sr platform (Abbott). The SARS-CoV-2-specific T-cell responses were assessed by quantification of interferon gamma release using QuantiFERON SARS-CoV-2 assay (Qiagen). Results: A total of 181 samples were collected, 170 were from vaccinated individuals and 11 from unvaccinated. Among the participants, 41 were aware of having previously been infected by SARS-CoV-2. Vaccinated people received one or two doses of the following vaccines against SARS-CoV-2: ChAdOx1-S (University of Oxford-AstraZeneca) (AZ) and/orBNT162b2 (Pfizer-BioNTech)(PZ). Subjects immunized with a third-booster dose received PZ or mRNA-1273 (Moderna-NIAID)(MD) vaccines. All vaccinees developed a positive humoral response (>7.1 BAU/ml), but the cellular response varied depending on the vaccination regimen. Only AZ/PZ combination and 3 doses of vaccination elicited a positive cellular response (median concentration of IFN- γ > 0.3 IU/ml). Regarding a two-dose vaccination regimen, AZ/PZ combination induced the highest humoral and cellular immunity. A booster with mRNA vaccine resulted in increases in median levels of IgG-Spike antibodies and IFN-γ as compared to those of two-dose of any vaccine. Humoral and cellular immunity levels were significantly higher in participants with previous infection compared to those without infection. Conclusion: Heterologous vaccination (AZ/PZ) elicited the strongest immunity among the two-dose vaccination regimens. The immunity offered by the third-booster dose of SARS-CoV-2 vaccine depends not only on the type of vaccine administered but also on previous doses and prior infection. Previous exposure to SARS-CoV-2 antigens by infection strongly affect immunity of vaccinated individuals.

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The coronavirus disease 2019 (COVID-19) infection has led to accelerated development and utilization of vaccines to prevent its implications on health. One of these vaccines is a vector-based, Oxford-AstraZeneca Vaccine (AZD1222). Frequently reported side effects are related to host-immune response. While dermatologic manifestation is peculiar in nature and denotes a serious eruption that might defer future vaccination. Herein, we present a case of a medically free 37-year-old female who developed clinical and histological evidence of pityriasis rosea (PR) after administration of a second-dose vaccination of AZD1222. The first dose of vaccination was administered as Pfizer BioNTech COVID-19 mRNA (BNT162b2) vaccine. This case is unique in nature as this patient developed AZD1222-induced PR, while some reports in the literature have linked PR to the BNT162b2 vaccine. This patient continued to receive a booster vaccination with BNT162b2 with no reportable side effects.

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On March 13, 2021, Tunisia started a widespread immunization program against SARS-CoV-2 utilizing different vaccinations that had been given emergency approval. Herein, we followed prospectively a cohort of participant who received COVID-19 vaccine (Pfizer BioNTech and Sputnik-Gameleya V). The goal of this follow-up was to define the humoral and cellular immunological profile after immunization by assessing neutralizing antibodies and IFN- γ release. 26 vaccinated health care workers by Pfizer BioNTech (n=12) and Sputnik-Gameleya V (n=14) were enrolled from June to December 2021 in Military hospital of Tunis. All consenting participants were sampled for peripheral blood after three weeks of vaccination. The humoral response was investigated by the titer of anti-SARS-CoV-2 immunoglobulin G (IgG) antibodies to S1 protein. The CD4 and CD8 T cell responses were evaluated by the QuantiFERON® SARS-CoV-2 (Qiagen® Basel, Switzerland). Regardless the type of vaccine, the assessment of humoral and cellular response following vaccination showed a strong involvement of the later with expression of IFN-γ as compared to antibodies secretion. Moreover, we showed that people with past SARS-CoV-2 infection developed high levels of antibodies than those who are not previously infected. However, no significant difference was detected concerning interferon gamma (IFN-γ) expression by CD4 and CD8 T cells in health care worker (HCW) previously infection or not with COVID-19 infection. Analysis of immune response according to the type of vaccine, we found that Pfizer BioNTech induced high level of humoral response (91.66%) followed by Sputnik-Gameleya V (64.28%). However, adenovirus vaccine gave a better cellular response (57.14%) than mRNA vaccine (41.66%). Regarding the immune response following vaccine doses, we revealed a significant increase of neutralizing antibodies and IFN-γ release by T cells in patients fully vaccinated as compared to those who have received just one vaccine. Collectively, our data revealed a similar immune response between Pfizer BioNTech and Sputnik-Gameleya V vaccine with a slight increase of humoral response by mRNA vaccine and cellular response by adenovirus vaccine. It's evident that past SARS-CoV-2 infection was a factor that contributed to the vaccination's increased immunogenicity. However, the administration of full doses of vaccines (Pfizer BioNTech or Sputnik-Gameleya V) induces better humoral and cellular responses detectable even more than three months following vaccination.

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Background and Objectives: Vaccination is one means of SARS-CoV-2 prevention and control. However, despite the effectiveness of vaccination, adverse reactions continue to require vigilance and monitoring. The researchers emphasize the possibility that some of the reported side effects may be psychological in origin. Based on this hypothesis, the main goal of this study was to evaluate the emotional dispositions of healthcare workers who experienced emotions before vaccination and adverse reactions after vaccination. Materials and Methods: This study was conducted between February and May 2021 in the Kaunas Clinics of the University of Health Sciences. A total of 2117 employees of the clinic departments who were vaccinated with two doses of the Pfizer-BioNTech vaccine participated in this study. Statistical analysis was performed on the data using IBM SPSS Statistics®. Results: Most participants (74.5%) experienced systemic (including local) adverse events; 16.5% experienced only local adverse events, and 9.1% experienced no adverse events. The frequency of systemic (including local) adverse events reduced with increasing age (p < 0.05). The main emotions that participants experienced before vaccination were anxiety (37.88%) and happiness (39.02%). Systemic (including local) adverse events occurred 1.26 times more frequently in women than men (77.44% vs. 61.6%, p < 0.05), while local adverse events occurred 1.4 times more often in male participants than in female participants (21.39% vs. 15.27%, p < 0.05). Among the respondents who did not experience adverse events, the most common emotion felt was happiness (25.5%), and most of the participants who experienced systemic (including local) adverse events felt anxiety (42.6%). Conclusions: The information about vaccination and potential adverse events should be targeted at younger persons. It is recommended that women, more than men, should receive professional counseling from psychologists or psychotherapists. The public dissemination of positive messages about the benefits and safety of vaccines prior to a vaccination campaign may alleviate the tension or anxiety felt regarding potential adverse events. Healthcare specialists-both those who work directly with vaccines and those who do not-should maintain a positive psychological attitude towards vaccination, as this can increase patient satisfaction with the benefits of vaccines.

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Introduction: This study aimed to delineate longitudinal antibody responses to the Pfizer-BioNTech BNT162b2 COVID-19 vaccine within the Ugandan subset of the Sub-Saharan African (SSA) demographic, filling a significant gap in global datasets. Methods: We enrolled 48 participants and collected 320 specimens over 12 months after the primary vaccination dose. A validated enzyme-linked immunosorbent assay (ELISA) was used to quantify SARS-CoV-2-specific IgG, IgM, and IgA antibody concentrations (ng/ml) and optical densities (ODs). Statistical analyses included box plots, diverging bar graphs, and the Wilcoxon test with Bonferroni correction. Results: We noted a robust S-IgG response within 14 days of the primary vaccine dose, which was consistent with global data. There was no significant surge in S-IgG levels after the booster dose, contrasting trends in other global populations. The S-IgM response was transient and predominantly below established thresholds for this population, which reflects its typical early emergence and rapid decline. S-IgA levels rose after the initial dose then decreased after six months, aligning with the temporal patterns of mucosal immunity. Eleven breakthrough infections were noted, and all were asymptomatic, regardless of the participants' initial S-IgG serostatus, which suggests a protective effect from vaccination. Discussion: The Pfizer-BioNTech BNT162b2 COVID-19 vaccine elicited strong S-IgG responses in the SSA demographic. The antibody dynamics distinctly differed from global data highlighting the significance of region-specific research and the necessity for customised vaccination strategies.

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Although ocular complications following COVID-19 vaccination have been reported, particularly retinal vascular occlusion and uveitis, their definitive causal relationships remain uncertain. This report presents a case of central retinal artery occlusion (CRAO) with paracentral acute middle maculopathy (PAMM) developed one day after receiving Pfizer COVID-19 vaccine, with a favorable outcome. The patient experienced sudden vision loss in her left eye, and her vision dropped to hand motion the day after vaccination. The initial examination suggested CRAO, but optical coherence tomography (OCT) revealed PAMM. We administered intravenous d-mannitol and acetazolamide and performed ocular massage. Two days later, her corrected visual acuity improved to 0.4, and further improvement to 1.2 occurred after 16 days. To the best of our knowledge, no reports have documented CRAO with PAMM following mRNA COVID-19 vaccination. The relationship between COVID-19 vaccination and retinal vascular occlusion remains unknown, highlighting the need for further research.

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BACKGROUND AND AIMS: We found a higher incidence of myocarditis in young males who had received at least two Pfizer-BioNTech BNT162b2 vaccinations. The human leukocyte antigens (HLA) are known to play an important role in infectious and autoinflammatory diseases. We hypothesized that certain HLA alleles might be associated with vaccination-induced myocarditis. METHODS: HLA typing was performed using next-generation sequencing technology with the Illumina Iseq100 platform. HLA class I and II loci were genotyped in 29 patients with post-vaccination myocarditis and compared with HLA data from 300 healthy controls. RESULTS: We demonstrate that the DRB1*14:01, DRB1*15:03 alleles and the motifs in HLA-A - Leu62 and Gln63, which are part of binding pocket B and HLA-DR Tyr47, His60, Arg70 and Glu74, which are part of binding pockets P4, P7 and P9, were significantly associated with disease susceptibility. CONCLUSIONS: Our findings suggest that immunogenetic fingerprints in HLA peptide-binding grooves may affect the presentation of peptides derived from the Pfizer-BioNTech BNT162b2 vaccination to T cells and induce an inflammatory process that results in myocarditis.

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OBJECTIVE: COVID-19 immunization was implemented with emergency-use authorization. We had concerns/lack of information on mRNA vaccine side effects in different inborn errors of immunity (IEI) types. METHODS: We enrolled 141 patients (IEIP) and 151 healthy controls(HC) who received SARS-CoV-2 vaccine/s(Sinovac and/or Pfizer-BioNTech(mRNA vaccine), one to five doses), questioned them for side-effects, evaluated in three groups according to the vaccine/s they received; only Sinovac, only Pfizer-BioNTech, and both vaccines. RESULTS: Arm pain, generalized weakness, myalgia, and fever were common side effects in IEI-P and HC groups. Generalized weakness/fatigue, fever, and palpitation were significantly frequent in IEI-P who experienced COVID-19 compared to those who did not (p = 0.021, p = 0.047, and p = 0.024, respectively). Severe symptoms after vaccination, new-onset splenomegaly and pancytopenia, urticaria, herpes simplex virus (HSV), and varicella zoster virus (VZV) reactivation were seen in four IEI-P (2.8%). CONCLUSION: IEI-P mRNA vaccination is relatively safe compared to the conventional vaccine. Individuals who experience uncommon side effects should undergo immunological screening.

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In May 2021, Qatar launched the BNT162b2 COVID-19 vaccine campaign for adolescents aged 12 to 15 years across all 27 health centers. Our study assessed the safety and efficacy of the vaccine among vaccinated and nonvaccinated adolescents in Qatar. Using a retrospective observational study, we analyzed the medical records of 1956 adolescents who were severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) positive from June 17 to December 17, 2021. The mean age for the vaccinated group was 13.89 ± 0.93 years, and for the nonvaccinated group, it was 12.99 ± 0.93 years. In the vaccinated group, 46% were male (n = 185) compared with 53% in the nonvaccinated group (n = 827) and 54% were female in the vaccinated group (n = 217) versus 47% in the nonvaccinated group (n = 727). Our findings demonstrate satisfactory protection provided by the Pfizer-BioNTech COVID-19 vaccine, with only one fifth of the study population contracting SARS-CoV-2 infections after the double-dose regimen. These results highlight the importance of maximizing vaccination coverage and considering booster doses for adolescents to enhance protection.

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This pilot study explores alterations in miRNA profiles among pregnant women and their neonates upon receiving different doses of COVID-19 vaccines. Blood samples, including maternal blood (MB) and neonatal cord blood (CB), collected from five pregnant women were scrutinized using the miRNA PanelChip Analysis System, identifying nine distinct miRNAs, including miR-451a and miR-1972, which exhibited significant downregulation with two vaccine doses in both MB and CB. When compared with women vaccinated with four doses, miR-486-5p, miR-451a, and miR-1972 in the two-dose group also showed notable downregulation. Evaluating recipients of three and four doses, miR-423-5p and miR-1972 expression were significantly reduced in both MB and CB. Further comparative analysis highlighted a decline in miR-223-3p expression with increasing vaccine doses, while miR15a-5p, miR-16-5p, and miR-423-5p showed an upward trend. Notably, miR-451a, miR-1972, and miR-423-5p levels varied across doses and were associated with pathways such as "PI3K-Akt", "neurotrophin signaling", and "cortisol synthesis", suggesting the profound influence of vaccination on diverse molecular mechanisms. Our research has uncovered that escalating vaccine dosages impact miRNA profiles, which may be associated with the immunological response mechanisms in both the mother and fetus, thus indicating a substantial impact of vaccination on various molecular processes.

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COVID-19 vaccines were originally authorized in the United States in December 2020 on the basis of safety, immunogenicity, and clinical efficacy data from randomized controlled trials (RCTs). However, real-world vaccine effectiveness (VE) data are necessary to provide information on how the vaccines work in populations not included in the RCTs (e.g., nursing home residents), against new SARS-CoV-2 variants, with increasing time since vaccination, and in populations with increasing levels of prior infection. The goal of CDC's COVID-19 VE program is to provide timely and robust data to support ongoing policy decisions and implementation of vaccination and includes VE platforms to study the spectrum of illness, from infection to critical illness. Challenges to estimating VE include accurate ascertainment of vaccination history, outcome status, changing rates of prior infection, emergence of new variants, and appropriate interpretation of absolute and relative VE measures. CDC COVID-19 VE platforms have played a pivotal role in numerous vaccine policy decisions since 2021 and will continue to play a key role in future decisions as the vaccine program moves from an emergency response to a routine schedule.

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The vaccines developed to prevent infection and mitigate morbidity and mortality in patients with COVID-19 demonstrated high efficacy in clinical trials but were associated with adverse events, most of which were mild and transient. However, some adverse events were rather serious, with grave prognoses. Of note, a few cases of autoimmune hematological conditions such as thrombotic thrombocytopenic purpura (TTP), immune thrombocytopenic purpura (ITP), and vaccine-induced immune thrombotic thrombocytopenia (VITT) were reported. TTP following Pfizer-BioNTech mRNA vaccination is exceptionally rare, with very scant literature. This case report describes an interesting case of a 61-year-old woman who presented 22 days after receiving the third dose of the Pfizer-BioNTech mRNA COVID-19 vaccine with malaise, bloody stools, and jaundice. Her medical history was significant for multiple myeloma previously treated with autologous bone marrow transplant and in remission with chemotherapy. She also had a history of chronic heart failure with preserved ejection fraction (HFpEF) and neuropathy treated with daily vitamins. The diagnosis was predicted by her classic presentation and was clinched by low ADAMTS13 activity. She was treated with plasmapheresis, steroids, and monoclonal antibodies. Intriguingly, her hospital stay was further complicated by an episode of generalized tonic-clonic seizure requiring intubation and mechanical ventilation for airway protection. Albeit infrequent, COVID-19 vaccine-associated TTP is associated with substantial morbidity and mortality. Hence, early diagnosis and treatment are essential in patients presenting with thrombocytopenia after COVID-19 vaccination.