Safety of Matrix-M–adjuvanted COVID-19, seasonal influenza, combination influenza-COVID-19, and malaria vaccines: a review of the evidence

Effect of seasonal influenza and COVID-19 vaccination on severity and long-term outcomes of patients with heart failure decompensations.

Objective In this study, we aimed to assess the rates of pneumococcal and seasonal influenza vaccinations among elderly and nonelderly diabetes patients andexamine their perceptions and attitudes toward the coronavirus disease 2019 (COVID-19) vaccine. Methods A single-center study was conducted among patients with diabetes, employing a structured survey encompassing sociodemographic data, vaccination records, and the COVID-19 vaccine perception and attitude scale. Results Among the 280 diabetes patients in our study, the vaccination rates for COVID-19, seasonal influenza, and pneumococcal vaccines were 96.1%, 16.8%, and 17.5%, respectively. A higher cumulative dosage of the COVID-19 vaccine was associated with older age (r = 0.463; p<0.001), increased safety score (r = 0.479; p<0.001), and lower conspiracy theory score (r = -0.336; p<0.001). Participants who had received COVID-19 and influenza vaccines were observed to have significantly higher safety scores related to COVID-19 vaccines (p<0.001; d = 2.381and p = 0.008; d = 0.525, respectively).Notably, vaccination rates for influenza and pneumococcus were significantly different between nonelderly and elderly patients (8.7% vs. 29.6%; p<0.001 and 13.4% vs. 24.1%; p = 0.022). Elderly patients with diabetes were 3.3 times more likely to receive the influenza vaccine than nonelderly participants [odds ratio (OR) = 3.319; 95% confidence interval (CI) = 1.592 - 6.920; p = 0.001] and had a higher safety score related to COVID-19 vaccines (OR= 1.076; 95% CI = 1.011 - 1.146; p = 0.021). Conclusions Both influenza and pneumococcal vaccination rates were below the desired targets in this study. The vaccination rates among the nonelderly diabetes population suggest that this group may be more likely to neglect to receive vaccination compared to the elderly diabetes population. The association between vaccination rates and post-pandemic safety perceptions highlights the critical need to implement public health strategies specifically designed to address and improve safety-related information dissemination.

Comparison of constitutional and dermatologic side effects between COVID-19 and non–COVID-19 vaccines: Review of a publicly available database of vaccine side effects

SUMMARYBackgroundPublic reluctance to receive COVID-19 vaccination is due in large part to safety concerns. We compare the safety profile of the BNT162b2 COVID-19 booster vaccine to that of the seasonal influenza vaccine, which has been administered for decades with a solid safety record and a high level of public acceptance.MethodsWe study a prospective cohort of 5,079 participants in Israel (the PerMed study) and a retrospective cohort of 250,000 members of Maccabi Healthcare Services. We examine reactions to BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 booster vaccinations and to influenza vaccination. All prospective cohort participants wore a Garmin Vivosmart 4 smartwatch and completed a daily questionnaire via smartphone. For the prospective cohort, we compare pre-vaccination (baseline) and post-vaccination smartwatch heart rate data and a stress measure based on heart rate variability, and we examine symptom severity from patient self-reports. For the retrospective cohort, we examine electronic health records (EHRs) for the existence of 28 potential adverse events during the 28-day period before and after each vaccination.FindingsIn the prospective cohort, 1,905 participants received COVID-19 vaccination; 899 received influenza vaccination. Focusing on those who received both vaccines yielded a total of 689 participants in the prospective cohort and 31,297 members in the retrospective cohort.Questionnaire analysis: For the COVID-19 vaccine, 39·7% [95% CI 36·4%–42·9%] of individuals reported no systemic reaction vs. 66·9% [95% CI 63·4%–70·3%] for the influenza vaccine. Individuals reporting a more severe reaction after influenza vaccination tended to likewise report a more severe reaction after COVID-19 vaccination (r=0·185, p&lt;0·001).Smartwatch analysis: A statistically significant increase in heart rate and stress measure occurred during the first 3 days after COVID-19 vaccination, peaking 22 hours after vaccination with a mean increase of 4·48 (95% CI 3·94–5·01) beats per minute and 9·34 (95% CI 8·31–10·37) units in the stress measure compared to baseline. For influenza vaccination, we observed no changes in heart rate or stress measures. In paired analysis, the increase in both heart rate and stress measure for each participant was higher (p-value &lt; 0·001) for COVID-19 vaccination than for influenza vaccination in the first 2 days after vaccination. On the second day after vaccination, participants had 1·5 (95% CI 0·68–2·20) more heartbeats per minute and 3·8 (95% CI 2·27–5·22) units higher stress measure, compared to their baseline. These differences disappeared by the third day after vaccination.EHR analysis: We found no elevated risk of non-COVID-19 or - influenza hospitalization following either vaccine. COVID-19 vaccination was not associated with an increased risk of any of the adverse events examined. Influenza vaccination was associated with an increased risk of Bell’s palsy (1·3 [95% CI 0·3–2·6] additional events per 10,000 people).InterpretationThe more pronounced side effects after COVID-19 vaccination compared to influenza vaccination may explain the greater concern regarding COVID-19 vaccines. Nevertheless, our findings support the safety profile of both vaccines, as the reported side effects and physiological reactions measured by the smartwatches faded shortly after inoculation, and no substantial increase in adverse events was detected in the retrospective cohort.FundingThis work was supported by the European Research Council, project #949850, and a Koret Foundation gift for Smart Cities and Digital Living.RESEARCH IN CONTEXTEvidence before this studyThe unprecedented global impact of COVID-19 led to the rapid development and deployment of vaccines against the virus, including vaccines using novel mRNA technology. Despite the promising effectiveness of mRNA vaccines in preventing severe outcomes of COVID-19, concerns have been raised regarding the safety profile of these new vaccines. These concerns led to a notable global public reluctance to become vaccinated. By contrast, the seasonal influenza vaccine has been administered for decades with a well-established safety record and a high level of public acceptance. We searched Google Scholar, PubMed, and preprint services (including medRxiv, bioRrxiv, and SSRN) for studies comparing the safety profile of the two vaccines between March 1, 2023 (our study’s launch) and May 30, 2023, with no language restrictions, using the terms “safety of” AND (“COVID-19” OR “SARS-CoV-2”) AND (“vaccine” OR “BNT162b2 (Pfizer–BioNTech) mRNA vaccine”) AND “compared to” AND (“Influenza” OR “seasonal influenza” OR “flu”) AND “vaccine”. We found a study that compared the safety profile of the mRNA COVID-19 vaccine among 18,755 recipients with 27,895 recipients of the seasonal influenza vaccine using the WHO international database. The authors found a different safety pattern between the two vaccines with more systematic reactions following inoculation of the COVID-19 vaccine. Additionally, COVID-19 vaccines were associated with a higher risk of cardiovascular adverse events, while the influenza vaccine was associated with a higher risk of neurological adverse events. The remaining studies identified in our search compared the simultaneous administration of both vaccines to the administration of only COVID-19 vaccines. None of the studies conducted a paired analysis that compared reactions post-influenza vaccination and post-COVID-19 vaccination for the same individual; none examined the extent of physiological reaction (in terms of heart rate and heart rate variability) following the administration of COVID-19 or seasonal influenza vaccines; and none examined a cohort of individuals with data from before and after vaccination episodes or presented a comprehensive analysis to address concerns regarding the existence of potential rare adverse events following vaccination.Added value of this studyWe studied a prospective cohort of 5,079 participants in Israel (the PerMed study) from October 31, 2020 to September 30, 2022 and a retrospective cohort of 250,000 members of Maccabi Healthcare Services from July 31, 2021 and March 1, 2023. We examined reactions to BNT162b2 (Pfizer-BioNTech) mRNA COVID-19 vaccination (third or fourth shot) and to influenza vaccination. We compared the extent of reactions at the individual level, among individuals who received both vaccines separately. While the self-reported data and the continuous physiological measures from smartwatches revealed a higher rate of reactions following COVID-19 vaccination, these reactions faded soon after inoculation. We found no increase in risk of rare adverse events for either vaccine. We found a weak, albeit significant, correlation in the severity of the symptoms for the two vaccines (r=0·185, p&lt;0·001): individuals who reported a more severe reaction after influenza vaccination tended to likewise report a more severe reaction after COVID-19 vaccination. We found no elevated risk of non-COVID-19 or - influenza hospitalization following the administration of either vaccine. COVID-19 vaccination was not associated with increased risk of any of the adverse events examined. Influenza vaccination was associated with an increased risk of Bell’s palsy (1·3 [95% CI 0·3–2·6] additional events per 10,000 people).Implications of all the available evidenceOur study demonstrates the importance of accounting for continuous and objective surveillance of vaccines in both the clinical trial phase and the post-marketing phase, as it can aid in evaluating the safety profile of clinical trials and reduce vaccine hesitancy. The more pronounced side effects after COVID-19 vaccination compared to influenza vaccination may explain the greater concern regarding COVID-19 vaccines. Nevertheless, our findings support the safety profile of both vaccines, as the reported side effects and physiological reactions measured by the smartwatches faded shortly after inoculation, and no substantial increase in adverse events was detected in the retrospective cohort.

BackgroundCoronavirus disease 2019 (COVID-19) vaccine coverage remains low in Libya compared to other countries in the Eastern Mediterranean Region. This study aimed to evaluate the willingness of the general public in Libya to receive COVID-19 and seasonal influenza vaccines. Additionally, the study aimed to investigate the potential effect of combining the two vaccines to reduce COVID-19 vaccine rejection.MethodsAn anonymous nationwide online cross-sectional survey was carried out from 1st September to 16th October 2022. Libyans aged 18 years or older were recruited using convenience and snowball sampling approaches. The participants were surveyed for sociodemographic information, health status, and vaccination attitude towards COVID-19 and seasonal influenza vaccines.ResultsA total of 2484 participants formed the final study sample: 68.7% were females, 39.4% were aged 18–25 years, 50.4% were single, 32.5% had previous COVID-19 infection, and 47.2% experienced COVID-19 death among relatives. Three-fourths of the respondents showed COVID-19 vaccine rejection: 57.3% did not receive COVID-19 vaccination, 10.1% would not complete the primary vaccination series, and 7.8% refused booster doses. About 55.0% rejected seasonal influenza vaccination, while 1.9% reported influenza vaccine uptake and 21.2% were willing to get the influenza vaccine for the first time. Additionally, 18.8% had already received influenza vaccination in the last year and intended to get the vaccine this season, while 3.3% were unwilling to get influenza vaccination this year despite receiving it in the last influenza season. Age, sex, and occupation were significantly associated with COVID-19 and influenza vaccine rejection. Rejection of COVID-19 vaccination decreased if its combination with influenza vaccine as a single dose was suggested, with 28.2% of the COVID-19 vaccine rejector group accepting the combined vaccine as it would be safer (50.9%), needing fewer injections (24.0%), would be more effective (19.1%), and would be less expensive (3%). Approximately 73.0% of the COVID-19 vaccine rejector group refused this combination due to fear of side effects (48.7%), absence of published studies on this combination (29.8%), and considering this combination as useless (11.2%).ConclusionIn Libya, the prevalence of COVID-19 vaccine rejection was high, while the rejection of seasonal influenza vaccination was relatively lower. If influenza and COVID-19 vaccines are administered simultaneously as a single injection, this may reduce the rejection of the COVID-19 vaccine due to better-perceived vaccine safety and efficacy besides being more convenient in terms of the number of injections and cost.

Transverse myelitis following bivalent <scp>COVID</scp>‐19 booster vaccine and quadrivalent seasonal influenza vaccine

Single-dose influenza vaccination of patients with egg allergy in a multicenter study

Receipt of COVID-19 and seasonal influenza vaccines in California (USA) during the 2021–2022 influenza season

Safety of co-administration of mRNA COVID-19 and seasonal inactivated influenza vaccines in the vaccine adverse event reporting system (VAERS) during July 1, 2021–June 30, 2022

Ovalbumin content of influenza vaccines

The Advisory Committee on Immunization Practices (ACIP) routinely recommends adolescents receive tetanus, diphtheria, and acellular pertussis (Tdap); meningococcal conjugate (MenACWY); and human papillomavirus (HPV) vaccines at age 11-12 years and routinely recommends influenza and COVID-19 vaccines annually for all adolescents, based on recommendations in 2023. We aimed to assess the overall proportion of US teens who are up-to-date (UTD) on receiving Tdap, MenACWY, and HPV vaccines by age 13 and the proportion who received seasonal influenza vaccine, the initial COVID-19 vaccination series and the initial COVID-19 booster. We also aimed to determine the relationship between multiple socio-demographic factors with the following: UTD status, and receipt of seasonal influenza vaccine, and receipt of COVID-19 vaccines. We analyzed the 2022 National Immunization Survey-Teen (NIS-Teen). We estimated the proportion of teens 13-17 years old vaccinated for Tdap, MenACWY, and HPV by age 13, categorizing participants as "fully UTD", "partially UTD" and "not vaccinated" for these three vaccines and we assessed coverage of influenza and COVID-19 vaccines. Logistic regression was used to identify factors associated with the following outcomes: UTD status for these three vaccines, seasonal influenza vaccination, and COVID-19 vaccination. We reported adjusted odds ratios and 95% confidence intervals. Of the 15,971 adolescents eligible for this analysis; 60.6% (95%CI: 59.8-61.3%) were fully UTD for Tdap, MenACWY and HPV by age 13, 29.6% (95%CI: 28.9-30.3%) partially UTD, and 9.8% (95%CI: 9.4-10.3%) were not vaccinated. When compared to fully UTD adolescents, those partially UTD and not vaccinated had significantly lower odds of receiving the seasonal influenza vaccine, initial COVID-19 vaccination series, and initial COVID-19 booster. Nearly 2 out of 5 adolescents aged 13 to 17 years in 2022 were not fully UTD for Tdap, MenACWY, and HPV vaccines by age 13. Being UTD by age 13 for these vaccines was significantly associated with subsequently receiving seasonal influenza and COVID-19 vaccines.

Background The use of vaccination against both SARS-CoV-2 and Influenza is an important tool in preventing healthcare workers (HCW) ill-health and nosocomial patient infection. However, vaccine uptake is highly variable. We utilise a longitudinal HCW study to describe uptake of seasonal Influenza and COVID-19 booster vaccines, as well as factors associated with receipt of vaccine.Figure 1:Vaccine uptakeBreakdown of Influenza and COVID-19 vaccine uptakeTable 1:Characteristics associated with receipt of any seasonal vaccineBetween-group differences assessed using Chi-squared or Wilcoxon ranksum test, as appropriate. Methods All participants in the Prevalence of COVID-19 in Irish HCWs (PRECISE) study, a longitudinal study across two hospital sites in Ireland (St James’s Hospital, Dublin &amp; University Hospital Galway), were included. Participants reported seasonal vaccines received from September 2024 – February 2025, prior vaccine history, and demographic, medical and occupation details. Vaccination history was confirmed using the national immunisation system. Univariate analysis assessed variables associated with both Influenza and COVID-19 vaccine uptake, with multivariable logistic regression including significant univariate variables and relevant variables identified a priori.Table 2:Characteristics associated with COVID-19 booster and seasonal Influenza vaccineBetween-group differences assessed using Chi-squared or Wilcoxon ranksum test, as appropriate.Table 3:Multivariable regression of factors associated with COVID-19 booster and seasonal Influenza vaccineMultivariable models including significant univariate features and variables selected a priori. Time since last vaccine was z-scored prior to analysis. Results There were n=893 participants. Of these, n=549 (61%) did not receive any vaccine, n=189 (21%) received both COVID-19 and Influenza vaccine, n=145 (16%) received Influenza alone and n=10 (1%) received COVID-19 alone (Figure 1). Older age, level of educational attainment, and a shorter interval since most recent vaccination were associated with increased uptake of any vaccine. These variables were associated with both Influenza and COVID-19 vaccine. Additionally, male HCWs were more likely to receive the COVID-booster than females, while there were no sex differences with Influenza vaccine uptake (Table 2). These variables remained significant following multivariable logistic regression (Table 3). Conclusion The overall uptake of vaccination amongst HCWs is low, with 37% receiving Influenza vaccine and fewer than 1 in 4 (22%) receiving a COVID-19 booster. Older age, education status and prior engagement with vaccine programmes influenced vaccine uptake. COVID-19 vaccination was significantly lower in female HCWs. These factors should inform future vaccination information campaigns to improve vaccine coverage. Disclosures All Authors: No reported disclosures

Healthcare workers (HCWs) are a priority group for coronavirus disease 2019 (COVID-19) and influenza vaccination. We evaluated sociodemographic and occupational factors, attitudes, and knowledge associated with the uptake of primary and booster doses of COVID-19 and seasonal influenza vaccines among HCWs. Between February 2022 and February 2023, we administered a structured questionnaire to HCWs in 3 Albanian hospitals who were enrolled in a multiyear cohort study. The questionnaire assessed participants' knowledge, confidence, and attitudes toward COVID-19 and seasonal influenza vaccines, and included questions on COVID-19 and influenza vaccination history, perceptions of vaccine safety and effectiveness, and factors influencing vaccine decision-making. We included 1456 HCWs. Their median age was 44 (interquartile range: 33-53) and 77.3% were female. Overall, 20.7% were physicians, 47.0% nurses or midwives, and 21.5% support staff. In all, 93.6% received a COVID-19 primary vaccine series, 20% a COVID-19 booster, and 23.7% received an influenza vaccine in the 2022-2023 season. In the multivariable analysis, male HCWs were more likely to receive COVID-19 boosters (adjusted odds ratio [aOR] 2.08; 95% confidence interval [CI]: 1.55-2.80). However, they were less likely to receive influenza vaccines (aOR 0.69; 95% CI: .51-.95). Medical doctors were more likely to receive COVID-19 vaccine doses, while nurses had higher uptake of the influenza vaccine (aOR 1.87; 95% CI: 1.30-2.68). Confidence in the safety and effectivity of both vaccines was positively associated with vaccine uptake. Among HCWs, primary series COVID-19 vaccine coverage was high, but COVID-19 booster doses and seasonal influenza vaccines were low. Findings related to age and sex differences among HCW groups with low vaccine uptake, as well as their knowledge and attitudes toward vaccines, should inform targeted strategies to improve COVID-19 and influenza vaccine uptake, particularly among younger HCWs, female HCWs, and nonphysicians.

Conspiracies regarding vaccines are widely prevalent, with negative consequences on health-seeking behaviors. The current study aimed to investigate the possible association between the embrace of vaccine conspiracies and the attitude to booster COVID-19, seasonal influenza, and monkeypox (mpox) vaccinations as well as the perceived side effects following COVID-19 vaccination. The target population involved academic staff and university students in health colleges in the Kingdom of Saudi Arabia. A self-administered questionnaire was distributed in January 2023 to collect data on participants’ demographics, self-reported side effects following each dose, willingness to get booster COVID-19, seasonal influenza, and mpox vaccinations, as well as an evaluation of vaccine conspiracies and attitude to mandatory vaccination. Among the 273 participants, the willingness to receive yearly booster COVID-19 vaccination was observed among 26.0% of the participants, while it was 46.9% and 34.1% for seasonal influenza and mpox vaccinations, respectively. Multinomial logistic regression analyses demonstrated a significant correlation between endorsing vaccine conspiracies and higher frequency of self-reported side effects following uptake of the second and third doses of COVID-19 vaccines. Vaccine conspiracies were also correlated with attitude toward booster COVID-19, influenza, mpox, and mandatory vaccination. The findings of this pilot study highlighted the potential adverse impact of the preexisting notions and negative attitudes toward vaccines, which could have contributed to heightened perceived side effects following COVID-19 vaccination. The study also highlighted the ongoing divisions concerning mandatory vaccination policies, emphasizing the need for cautious implementation of this strategy as a last resort for public health benefit.

Mycophenolate and lower graft function reduce the seroresponse of kidney transplant recipients to pandemic H1N1 vaccination