Pfizer-BioNTech Vaccine Research Articles

Effects of Sinovac-Coronavac and Pfizer-BioNTech mRNA vaccines on choroidal and retinal vascular system

PurposeTo evaluate the effects of Sinovac-Coronavac and Pfizer-BioNTech mRNA vaccines on choroidal and retinal vascular system using enhanced depth imaging optical coherence tomography (EDI-OCT) and optical coherence tomography angiography (OCTA). MethodsIn this prospective cross-sectional study, 63 healthy participants (29 with Pfizer-BioNTech, 34 with Sinovac-CoronaVac) were evaluated after the first dose of vaccination. Vessel density (VD) of the superficial (SCP), deep capillary plexus (DCP) and choriocapillaris (CC) were measured with OCTA. Choroidal thickness (CT) were measured with EDI-OCT. Measurements were performed at the 2nd week and the 4th week after vaccinations and compared to pre-vaccination values. ResultsRegarding Pfizer-BioNTech vaccination, CT in the subfoveal and nasal region significantly increased between the pre-vaccination and post-vaccination 2nd week and then significantly decreased to pre-vaccine values at 4th week. The SCP-VD (whole image, fovea, parafovea, perifovea temporal) variables showed a significant decrease at 2nd week. The DCP-VD inferior hemi, parafovea inferior hemi, parafovea inferior variables demonstrated a significant decrease at 2nd week. The perifovea DCP-VD variables also showed a significant decrease at 2nd week, and these variables returned to pre-vaccination values after 4 weeks. The CC-VD variables showed a significant decrease between pre-vaccine and 2nd week post-vaccination. Regarding the Sinovac-CoronaVac vaccination, there was no statistically significant difference in CT and VD values before and after vaccination (p> 0.05). ConclusionOur study showed significant alterations in retinal vascular density and CT for the Pfizer-BioNTech vaccine at the 2nd week, and these parameters became compatible with pre-vaccination values at the 4th week. In contrast, no differences were observed after the Sinovac-Coronovac vaccination.

The Effect of COVID-19 Vaccines on Hospital Admission and Severity of Symptoms Among COVID-19 Patients in Saudi Arabia, 2021.

Introduction Following the World Health Organization (WHO) declaration of coronavirus disease 2019 (COVID-19) as a pandemic, Saudi Arabia took unpreceded precautions to prevent and control the spread of the severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) infection. It is one of the first countries in the world to grant the authorization to use the Pfizer-BioNTech vaccine. This study aimed to assess the effect of one dose of COVID-19 vaccines (Pfizer-BioNTech,Manhattan, New York City, and Oxford-AstraZeneca, Cambridge, United Kingdom) among the Saudi population regarding symptom severity, hospital admission rate, and death. Methods An observational retrospective cohort study was conducted using data from COVID-19 surveillance records at King Abdulaziz Medical City (KAMC), Saudi Arabia, from January to May 2021. All confirmed COVID-19 patients who had positive tests by reverse transcription polymerase chain reaction (RT-PCR) assay of a nasopharyngeal swab were included in the study. Patients diagnosed outside KAMC and cases below 18 years old were excluded from the study. The research was approved by King Abdullah International Medical Research Center (NRJ21J/303/12). Multivariable logistic regression was conducted to estimate the odds of hospitalization among vaccinated and unvaccinated patients. Results A total of 1058 cases were included in the analysis. Two hundred sixty-five (265; 25%) patients were vaccinated with one dose of either Pfizer-BioNTech or Oxford Astra-Zeneca, and 793 (75%) were unvaccinated. The median age was 34 (IQR 25-51), primarily Saudi (94.6%) and male (59.5%). The odds of being vaccinated (CI: 1.284-2.882, P 0.002) were 1.924 times greater for males than females. Young patients below 40 had 1.997 times higher odds (CI: 1.238-3.222, P 0.004) of being vaccinated than patients above 60. The hospital admission rate was low among both groups (12.9%); however, it was significantly lower among the vaccinated group (2.3%) as compared to the unvaccinated (16.5%). The results showed significant differences in symptom severity among the groups. For vaccinated, only one patient (0.4%) died, one patient was admitted to the ICU, and one patient (0.4%) was admitted to the hospital isolation ward. On the contrary, among the unvaccinated group, 19 patients (2.4%) died, 17 patients (2.1%) were admitted to the ICU, and 114 patients (14.4%) were admitted to the hospital isolation ward. Conclusion This study demonstrates that one dose of COVID-19 vaccines, either Pfizer-BioNTech or Oxford-AstraZeneca, reduced the probability of death by 2% and hospital admission by 15% before the spread of the Delta variant (B.1.617). For generalizable results, nationwide studies using national surveillance data are recommended to assess multiple doses efficacy on different variants of the SARS-CoV-2 infection.

Common Side Effects of Pfizer COVID-19 Vaccine: An Experience From Pakistan.

Introduction The severe acute respiratory syndrome coronavirus 2 (SARS‑CoV‑2) epidemic spread quickly. Vaccines are now being distributed to stop the infectious spread and halt fatalities. The Pfizer-BioNTech vaccine was the first mRNA-based vaccine introduced to boostimmunity against COVID-19; however, it could lead to various adverse reactions. Therefore, the aim of this study was to assess the prevalence of Pfizer vaccine side effects among participants. Methods This was a multicenter cross-sectional study that was performed using a non-probability sampling method. The study period was about six months from March 1, 2022, to August 31, 2022. A total of 1000 participants who received two doses of the Pfizer vaccine met the inclusion criteria. Demographic details of participants, for example, gender, age, comorbidities, Pfizer vaccine with both doses along with booster dose, previous exposure to coronavirus disease 2019 (COVID-19) infection, and the incidence of any local and systemic side effects following the first and second doses of vaccine, were reported. Results The study findings showed that out of 1000 participants, 644 (64.4%) were males and 356 (35.6%) were females; their mean age was 43.06±14.98 years. Among them, 280 (28.0%) had hypertension and 356 (35.6%) had diabetes. Following the first dose of the Pfizer vaccine, burning at the injection site and fever were the most commonly reported side effects in 704 (70.4%) and 700 (70.0%) participants, respectively. Following the second dose of the Pfizer vaccine, muscle pain was the most commonly reported side effect in 628 (62.8%) participants. Conclusion This study concluded that the most frequent adverse effects of the Pfizer vaccine were burning at the injection site, fever, pain at the injection site, muscle pain, swelling at the injection site, and joint pain. Moreover, the first dose was associated with more side effects than the second dose.

The Effect of Vaccination with Pfizer-BioNTech or CoronaVac on Disease Prognosis Among Hospitalized COVID-19 Patients.

The Turkish Ministry of Health offered two types of vaccines by January 13, 2021, which are CoronaVac (Sinovac Biotech, China) and Pfizer-BioNTech. We aimed to describe the impact of the CoronaVac and Pfizer-BioNTech vaccines on clinical outcomes among hospitalized patients during a six-month period. We included patients older than 18 years old and hospitalized because of COVID-19 when the vaccines were available. We conducted the study at Koç University Hospital and American Hospital between June 2021, six months after the vaccination started, and December 2021. In total, 444 RT-PCR confirmed hospitalized patients were included. The mean age of the patients was 59 (standard deviation [SD]=18), and 42.8% were female. The most common comorbidity was hypertension (39%), followed by diabetes mellitus (27%), cardiovascular diseases (18.4%), chronic lung diseases (14.6%), cancer (9.2%), and chronic renal diseases (8%). In multivariate analysis, no vaccination (OR=4.7, CI=2.25-10.06; p<0.001), age >65 (OR=5.2, CI=2.25-11.98; p<0.001), cancer (OR=7.6, CI=3.04-19.31; p<0.001), and chronic kidney disease (OR=3.1, CI=1.14-8.74; p=0.026) significantly increased mortality in COVID-19 patients. Eighteen percent of patients were in the intensive care unit (ICU). One hundred eighty-one patients (40.8%) were non-vaccinated before their admission, and their mortality (17.6%) was higher compared to the patients who were vaccinated with at least one type of vaccine (p=0.002). None of the patients who received two doses of Pfizer-BioNTech vaccines died. Among the inpatients with COVID-19, the predictors for mortality were being unvaccinated, older age, cancer, chronic kidney disease, and cardiovascular diseases. Among the vaccinated inpatients, having two doses of the Pfizer-BioNTech vaccine was the only effective protective measure against mortality, and two doses of the CoronaVac vaccine had no significant effect in preventing fatality.

COVID-19 Vaccine Impacts in Saudi Arabia: A Cross-Sectional Study.

Background and purpose Vaccinations provide disease protection through a variety of mechanisms; however, vaccines can occasionally cause adverse effects. Therefore, the objective of this investigation was to assess the short- and long-term adverse effects of COVID-19 vaccinations in Saudi Arabia. Methods In Saudi Arabia, between October 2021 and October 2022, a cross-sectional study was conducted. A validated Arabic and English dual-language online questionnaire were utilized to collect data. Results This investigation included 492 participants who were all immunized against the COVID-19 virus. There were 152 (30.9%) male participants and 340 (69.1%) female participants, with a mean age of 35±10.7 years. About 72.2% of study participants received three doses of vaccine, with 75.6% receiving the Pfizer-BioNTech vaccine, 22.2% receiving the Oxford-AstraZeneca vaccine, and 2.2% receiving the Moderna vaccine. Fever was observed in 66.3% (326/492) of the participants following vaccination, headache in 57.3% (282/492) of the participants, fatigue in 54.7% (269/492) of the participants, and influenza-like symptoms in 51% (251/492) of the participants. Younger participants (18-29 years old) exhibited influenza-like symptoms and fever after vaccination in comparison to older participants (P=0.03, P=0.02, respectively). In contrast, older participants reported more immobilization of the hands or legs, difficulty breathing, and chest pain than younger participants (P=0.04, P=0.02, and P=0.03, respectively). There was a significant correlation between gender and injection-site pain, headache, lethargy or convulsions, and flu-like symptoms. In addition, the participants' clinical history of chronic diseases was significantly associated with the occurrence of post-vaccination adverse effects. Conclusion The majority of the documented adverse reactions are of a temporary and minimal nature. Additional research is required to assess the enduring adverse reactions and efficacy of the vaccines in preventing SARS-CoV-2 reoccurrence.

Effectiveness of the Pfizer-BioNTech Vaccine against COVID-19-Associated Hospitalizations among Lebanese Adults ≥75 Years Old-Lebanon, April-May 2021.

In Lebanon, the nationwide vaccination against COVID-19 was launched in February 2021 using the Pfizer-BioNTech vaccine and prioritizing elderly people, persons with comorbidities, and healthcare workers. Our study aims to estimate the post-introduction vaccine effectiveness (VE) of the Pfizer-BioNTech vaccine in preventing COVID-19 hospitalizations among elderly people ≥75 years old in Lebanon. A case-control study design was used. Case patients were Lebanese, ≥75 years old, and hospitalized with positive PCR results during April-May 2021, and randomly selected from the database of the Epidemiological Surveillance Unit at the Ministry of Public Health (MOPH). Each case patient was matched by age and locality to two controls. The controls were hospitalized, non-COVID-19 patients, randomly selected from the MOPH hospital admission database. VE was calculated for fully (2 doses ≥14 days) and partially vaccinated (≥14 days of the first or within 14 days of the second dose) participants using multivariate logistic regression. A total of 345 case patients and 814 controls were recruited. Half were females, with a mean age of 83 years. A total of 14 case patients (5%) and 143 controls (22%) were fully vaccinated. A bivariate analysis showed a significant association with gender, month of confirmation/hospital admission, general health, chronic medical conditions, main income source, and living arrangement. After adjusting for a month of hospital admission and gender, the multivariate analysis yielded a VE of 82% (95% CI = 69-90%) against COVID-19-associated hospitalizations for those fully vaccinated and 53% (95% CI = 23-71%) for those partially vaccinated. Our study shows that the Pfizer-BioNTech vaccine is effective in reducing the risk for COVID-19-associated hospitalizations of Lebanese elderly people (≥75 years old). Additional studies are warranted to explore VE in reducing hospitalizations for younger age groups, as well as reducing COVID-19 infections.

Safety Monitoring of mRNA COVID-19 Vaccine Third Doses Among Children Aged 6 Months–5 Years — United States, June 17, 2022–May 7, 2023

As of May 7, 2023, CDC's Advisory Committee on Immunization Practices (ACIP) recommends that all children aged 6 months-5 years receive at least 1 age-appropriate bivalent mRNA COVID-19 vaccine dose. Depending on their COVID-19 vaccination history and history of immunocompromise, these children might also need additional doses* (1-3). Initial vaccine safety findings after primary series vaccination among children aged 6 months-5 years showed that transient local and systemic reactions were common whereas serious adverse events were rare (4). To characterize the safety of a third mRNA COVID-19 vaccine dose among children aged 6 months-5 years, CDC reviewed adverse events and health surveys reported to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor health after COVID-19 vaccination (https://vsafe.cdc.gov/en/) and the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and the Food and Drug Administration (FDA) (https://vaers.hhs.gov/) (5). During June 17, 2022-May 7, 2023, approximately 495,576 children aged 6 months-4 years received a third dose (monovalent or bivalent) of Pfizer-BioNTech vaccine and 63,919 children aged 6 months-5 years received a third dose of Moderna vaccine.† A third mRNA COVID-19 vaccination was recorded for 2,969 children in v-safe; approximately 37.7% had no reported reactions, and among those for whom reactions were reported, most reactions were mild and transient. VAERS received 536 reports after a third dose of mRNA COVID-19 vaccine for children in these age groups; 98.5% of reports were nonserious and most (78.4%) were classified as a vaccination error.§ No new safety concerns were identified. Preliminary safety findings after a third dose of COVID-19 vaccine for children aged 6 months-5 years are similar to those after other doses. Health care providers can counsel parents and guardians of young children that most reactions reported after vaccination with Pfizer-BioNTech or Moderna vaccine were mild and transient and that serious adverse events are rare.

EPH47 Active Surveillance for Safety Monitoring of COVID-19 Vaccines in Saudi Arabia

It is generally accepted that the world will not return to the pre-pandemic normally situation until safe and effective vaccines become available. However, the rare and unknown adverse events following immunization (AEFIs) are not usually detected in the clinical trials. Thus, monitoring the safety of coronavirus disease of 2019 (COVID-19) vaccines in real-world population is essential. Therefore, the Saudi Food and Drug Authority (SFDA) performed a post-marketing safety surveillance of AEFIs following administration of COVID-19 vaccines. A prospective cohort study conducted and followed subjects who received COVID-19 vaccines from the first day of vaccination for seven days after the first and second doses, then biweekly for three months. All information from the vaccinee (demographic information, vaccine type and AEFIs) were collected by phone through a standardized online questionnaire. Baseline characteristics and AEFIs were analyzed descriptively by SPSS software. AEFIs classified according to medical Dictionary for Regulatory Activities (MedDRA). 544 subjects of 8867 agreed to be part of the study. Among them, 218 subjects completed the study. Out of 218, 87 (39.91%) individual received Pfizer-BioNTech vaccine, 45(20.64%) received Oxford/AstraZeneca vaccine, 5(2.3%) individual received Moderna vaccine, and 81 (37.2%) received two different COVID-19 vaccines. The reported events were categorized to system organ class (SOC) according to MedDRA. The most reported SOCs were skin and subcutaneous tissue disorders (n=66 with Pfizer-BioNTech vaccine, n=34 with Oxford/AstraZeneca vaccine, n=5 with Moderna vaccine), nervous system disorder(n=20with Pfizer-BioNTech vaccine, n=18with Oxford/AstraZeneca vaccine, n=3with Moderna vaccine) infections and infestations (n=23 with Pfizer-BioNTech vaccine, n=33 with Oxford/AstraZeneca vaccine, n=4 with Moderna vaccine), musculoskeletal and connective tissue disorders (n=53with Pfizer-BioNTech vaccine, n=46 with Oxford/AstraZeneca vaccine, n=7 with Moderna vaccine). Only 10 (4.6%) cases were serious and required medical intervention. The preliminary results shows the short-term safety profiles of included COVID-19 vaccines are acceptable in Saudi Arabia.

The impacts of the COVID-19 pandemic on patients with viral hepatitis B infection: follow-up, compliance with antiviral treatment, and vaccine preferences.

Elimination programs and interventions for patients with viral hepatitis B (HBV) have been disrupted during the COVID-19 pandemic. This study aimed to evaluate the effects of the COVID-19 pandemic on patients with HBV infection in terms of COVID-19 vaccine preferences, follow-up visits, and antiviral treatment compliance. In this retrospective single-center cross-sectional study, 129 patients with viral hepatitis B infection were evaluated. The patients were surveyed at the time of admission. A special form was created for patients with viral hepatitis B infection, and the form contained information about the patients at admission to collect the study data. A total of 129 participants were included in the study. Of the participants, 49.6% were males and the median age was 50 years. In total, 73 (56.6%) patients had their follow-up visits disrupted because of the COVID-19 pandemic. No newly diagnosed case of HBV infection was detected. Among the 129 patients, 46 had inactive hepatitis B, and 83 had chronic hepatitis B infection and were receiving antiviral treatment. None of the patients had trouble reaching antiviral treatments during the COVID-19 pandemic. A liver biopsy was recommended for 8 patients. Half of these 8 patients did not have follow-up visits during the COVID-19 pandemic. Most of the patients (123/129, 95.3%) received the COVID-19 vaccine and the most frequent vaccine that was used was the Pfizer-BioNTech (n: 92, 71.3%) vaccine. Serious side effects of the COVID-19 vaccines were not detected. Mild side effects were found in 41.9% (13/31) of the patients. The COVID antibody level was found to be statistically and significantly higher in the patients who received the Pfizer-BioNTech vaccine than in those that received the CoronoVac vaccine. It was reported that elimination programs and interventions for HBV infection decreased or stopped because of the COVID-19 pandemic. In the present study, no newly diagnosed case of HBV infection was detected. Most of the patients had their follow-up visits disrupted. There were no patients who could not receive antiviral treatment, the vaccination rate of the patients was high, and the vaccines were well tolerated.

Increasing Levels of Serum Anti-Spike S1-RBD IgG after 120 Days of the Pfizer-BioNTech-mRNA Second Dose Vaccination.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA vaccines, such as Pfizer-BioNTech, have demonstrated high efficacy; however, there is limited data on the duration of immune responses besides their relationships with age, gender, body mass index (BMI), and the presence of previous coronavirus disease-2019 (COVID-19) infection. This study aimed to evaluate SARS-COVID-19 Anti-Spike IgG levels after 30 days (one month) and 120 days (four months) of the 2nd dose of Pfizer-BioNTech vaccine given to medical students at Al-Iraqi University, Baghdad, Iraq. This study was performed after the obtainment of the acceptance and approval of the Medical College of Al-Iraqi University and the Iraqi Ministry of Health. Two groups of students were randomly picked up from the Medical College of Al-Iraqi University. They were completely vaccinated by administering two doses of Pfizer-BioNTech/0.5 ml for each dose. After taking their permission, 5 ml of their blood (one group after one month and the second group after four months of vaccination) was drawn in the Higher Education lab inside the Medical College of Al-Iraqi University. It took approximately four months to collect the samples (from October 2021 until February 2022). Following that, serological analysis was done for measuring the SARS-CoV-2 spike protein IgG by using Elabscience/SARS-CoV-2 spike protein IgG ELISA Kit (USA) (+ve <0.06) that was performed in the Higher Education lab of Medical College of Al-Iraqi University. Demographic data were also collected from participants, including age, gender, BMI, blood group, and the presence of previous COVID-19 infection. For statistical analysis, SPSS (version 26) and STATISTICA (version 12) were used to input, check, and analyze data. Standard approaches of frequencies and percentages were used for qualitative variables, while for quantitative variables, mean±standard deviation was used. A P-value of <0.05 was considered a significant plasma level of the SARS-COVID-19 Anti-Spike IgG. The study results showed that in group 1 (after one month of the 2nd dose), the male-female ratio was 62.2: 37.8, the mean age of the vaccinated students was 28.2000 years old, and the BMI was 25.5454 kg/m2 with 33.3% previously COVID-19 infected individuals. In group 2 (after four months of the 2nd dose), the male-female ratio was 44.4: 55.6, the mean age of the vaccinated students was 25.8444 years old , and the BMI was 24.7584 kg/m2 with 24.4% previously COVID-19 infected individuals. The plasma levels of SARS-COVID-19 Anti-Spike IgG after the 2nd dose of the Pfizer-BioNTech vaccine in group 1 (one month) and group 2 (four months) were statistically non-parametric. Once the independent two samples Mann-Whitney test was used, a significant difference (P<0.05) was observed in SARS-COVID-19 Anti-Spike IgG plasma levels after 30 days of the 2nd dose of the Pfizer-BioNTech vaccine administration, compared to the 120 days of administration. In conclusion, SARS-COVID-19 Anti-Spike IgG levels significantly increased in group 2 (four months after the 2nd dose of the Pfizer-BioNTech vaccine), compared to group 1 (one month after the 2nd dose of the Pfizer-BioNTech vaccine).

EPH99 Janssen COVID-19 Vaccine Safety in a Real-World Setting: A Pharmacovigilance Study

The development of COVID-19 vaccines is a global priority aiming to mitigate the spread of SARS-CoV-2. Although vaccination has been proved to be effective in reducing the rate and severity of COVID-19, it is also associated with the ocurrence of serious adverse events (AEs). Jcovden, previously Janssen (Ad26.COV2.S) COVID-19 vaccine, have shown to be safe in phase 3 trials. We aimed to compare its safety to Pfizer-BioNTech (BNT162b2) and Oxford-AstraZeneca (ChAdOx1) vaccines in a real-world setting. Data about serious adverse events of special interest following vaccination were obtained from EudraVigilance, a large spontaneous-reporting database operated by the European Medicines Agency (EMA). Analysis included all reports until 22nd August 2022. Vaccines were compared by means of the Proportional Reporting Ratios (PRRs) regarding selected AEs. PRR was calculated as the ratio between the proportion of spontaneous reports about a specific AE for Jcovden to the same proportion obtaind for the comparators. A PRR >2 indicates a possible association between Jcovden and the selected AE. We found possible association (PRR>2) between Jcovden vaccine and different AEs of special interest. The probability of reporting of Thrombosis with thrombocytopenia syndrome, cerebral venus sinus thrombosis, myelitis transverse, Guillain Barret Syndrome, pulmonary embolism and capillary leak syndrome was 3 to 9 times greater (PRR value between 3 and 9) for Jcovden compared to Pfizer-BioNTech vaccine. Also, reporting probability of myocartidis/pericarditis and Guillain Barret Syndrome was 3 and 2.5 times greater for Jcovden than Oxford-AstraZeneca ChAdOx1, respectively. Overall, most COVID-19 vaccine-associated AEs occur very rarely. Jcovden is possibly associated with a greater rate of some serious AE compared to other covid-19 vaccines. The ocurrence of serious AE in the real-word setting that were not previously observed in clinical trials reassure the importance of continuous monitoring of vaccine safety.

Immunoglobulin G follow-up and immune response longevity analysis in SARS-CoV-2 convalescent patients and vaccinated individuals: A longitudinal analysis.

Although the detection of immunoglobulin G (IgG) molecules has long been considered to be crucial for successful humoral immune defence against infections and harmful metabolites, it has become increasingly important in relation to SARS-CoV-2 research. To compare longitudinal changes in IgG titres in post-infection and post-vaccination Iraqi participants, and to estimate the protective benefits of the two principal vaccines used in Iraq. This quantitative study used samples from SARS-CoV-2 recovered patients (n= 75), those vaccinated with two doses of Pfizer or Sinopharm vaccine (n= 75), and healthy unvaccinated individuals (n= 50) who formed a control group. Participant ages (range 20-80 years) and sex (52.7% men, 47.3% females). An enzyme-linked immunosorbent assay was used to measure IgG. IgG antibody levels peaked in the first month and tapered off in the following three months in both convalescent and vaccinated groups. The latter showed a significant decrease in IgG titres than in the convalescent group. Samples from the group given the mRNA vaccination that targeted spike (S) proteins might have a cross-reactivity between nucleocapsid (N) and spike (S) proteins. Participants who had recovered from or who were vaccinated against SARS-CoV-2 exhibited a protective, persistent and durable humoral immune response for at least a month. This was more potent in the SARS-CoV-2 convalescent group compared to the vaccinated cohort. The IgG titres decayed faster after vaccination with Sinopharm than following the Pfizer-BioNTech vaccine.

COVID-19 Vaccination Acceptance among Healthcare Staff in the West of Libya

Healthcare workers (HCWs) are vital in providing guidance and recommendations to patients and the wider community about vaccination, which includes giving correct information on the risks and benefits of the vaccine. As they are crucial players in vaccine delivery and have a large impact on vaccine acceptability in the community, it is important to know their attitudes towards vaccination. In this study we aimed to assess acceptance rate and identify factors associated with vaccine hesitancy among Libyan healthcare staff in west region cities. We use questionnaire to the healthcare staff workers in the western district in Libya. A total of 150 respondents completed the questionnaire. This study showed that 60.66% of healthcare workers accepted the COVID-19 vaccine, 39.33% workers were hesitant. 42% of respondents were believed that origin of corona is man-made virus. 38.66 % stated that Pfizer-Biontech vaccine is the most accepted vaccine. 82% of participants in this current study were willing to encourage people for vaccination and only 18% were not encouraged.

Spontaneous reporting of adverse reactions associated with the COVID-19 vaccine in health care professionals: A descriptive observational study conducted in a Portuguese hospital.

The coronavirus disease 2019 (COVID-19) was classified as a pandemic in March 2020 by the World Health Organization. The Pfizer-BioNTech COVID-19 vaccine was the first to be authorized in the European Union, based on data from phase 1, 2, and 3 clinical trials of limited duration. Concerns have been raised regarding the vaccine's safety profile. Some of the adverse drug reactions (ADRs) associated with vaccines may not have been identified during clinical trials. This study aimed to identify ADRs associated with the Pfizer-BioNTech vaccine in health care professionals at a Portuguese tertiary university hospital. The data used in this analysis consist of ADRs reported through a spontaneous notification system from vaccines administered between December 27, 2020, and January 31, 2021. ADRs were categorized according to the MedDRA terminology. A total of 8,605 Pfizer-BioNTech vaccines were administered to 4568 health care professionals. ADRs were reported among 520 of the vaccines, with an incidence of 13.56% in women and 5.31% in men. The mean age of the population reporting ADRs was 41.52 years, with a standard deviation of 9.83 years. The most frequent ADRs were myalgia (n = 274), headache (n = 199), pyrexia (n = 164), injection site pain (n = 160), fatigue (n = 84), nausea (n = 81), chills (n = 65), lymphadenopathy (n = 64), and arthralgia (n = 53). Hypersensitivity reactions occurred in 15 health care professionals, with no anaphylactic reactions observed. A total of four Important Medical Events were observed, which consisted of two cases of syncope, one case of sudden hearing loss, and one case of transverse myelitis. The vaccine was well-tolerated among the study participants. Reactogenicity was greater after the second dose. The incidence of ADRs was higher in women and individuals aged between 40 to 49 years. Systemic adverse reactions were most frequently reported. Systematic monitoring of ADRs of COVID-19 vaccines in real-life context is essential for a more robust establishment of its safety profile.

Evaluation of retinal and optic disc vascular structures in individuals before and after Pfizer-BioNTech vaccination.

We conducted this study to detect possible changes in posterior segment structures using the optical coherence tomography angiography (OCTA) in individuals vaccinated with the Pfizer-BioNTech vaccine. The study included healthcare professionals who presented to the Ophthalmology Clinic of Health Sciences University Antalya Training and Research Hospital, who were scheduled to receive the first dose of the Pfizer-BioNTech vaccine. The exclusion criteria were any eye pathology (e.g., glaucoma, uveitis, diabetic retinopathy, amblyopia), myopia with the absolute value of refractive error >6, axial length >26mm, history of eye surgery, and presence of systemic disease.OCTA was performed to 40 healthcare professionals before vaccination and on the third day after vaccination. After Pfizer-BioNTech vaccination, there was a statistically significant decrease in the total vascular, foveal vascular, parafoveal vascular and perifoveal vascular density of the superficial capillary plexus and the perifoveal vascular density of the deep capillary plexus and a statistically significant increase in the retinal foveal thickness and total retinal parafoveal thickness compared to the pre-vaccination values (p<0.0001, p=0.009, p<0.0001, p=0.001, p=0.04, p=0.03, and p=0.05, respectively). We consider that the decrease in the retinal vascular density may be due to vascular endothelial damage and inflammation in vaccinated people. It can be suggested that increased inflammation plays a role in the retinal thickness in vaccinated people similar to patients with a history of COVID-19. We also consider that spike protein may be effective in these processes.

An Immediate Allergic Reaction Following the Anti-COVID-19 Vaccine Pfizer-BioNTech: A Case Report

Objective: To date, the vaccine is the only weapon to stop the global pandemic caused by the SARS-CoV-2. But, several clinical cases of complications have been reported in the literature especially allergic reactions. Case Report: We report a case of 35-year-old woman, known asthmatic with history of chronic urticaria, allergic rhinoconjunctivitis and angioedema after taking NSAIDs. The patient was presented 10 minutes after administrating Pfizer-BioNTech vaccine, an immediate allergic reaction complicated 12 hours followed by angioedema Discussion: During the first wave of COVID-19, and after the initiation of the vaccination program in Morocco, vaccinating people with severe allergies was not recommended. This reality was changed after the second wave of SARS-CoV-2 Delta, on condition of doing it under medical monitoring. We should propose to all risky persons to take premedication if needed to avoid such reactions considering the benefits incurred. The use of anti-histamines seems to be necessary. But as in our patient’s case, anti-histamines alone were not sufficient to avoid this local reaction. They probably reduced the intensity of the reaction but did not avoid it. Therefore, we proposed a combination of drugs made by corticosteroids and anti-histamines as a premedication may be a safe alternative for the patients with risks and last but not least a, close monitoring was proposed. Conclusion: The main purpose of this case is to raise awareness of this side effect among practitioners and make them capable to manage it correctly.

Outcome of COVID-19 mRNA Vaccination in Patients Treated With Clozapine WHO Previously Went Through SARS-COV-2 Infection.

The outbreak of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic had multiple consequences for the health care system, especially for patients with mental illnesses. Schizophrenia patients particularly appear to have a higher risk of complications due to coronavirus-19 (COVID-19). Clozapine remains the gold standard for treatment-resistant schizophrenia (TRS). However, the COVID-19 pandemic had an important negative impact on clozapine treatment, mainly because of its administration protocol, which was very difficult to follow during the restrictions imposed in the pandemic, and its side effects in patients with COVID-19 infection. Vaccination is an effective method of avoiding SARS-CoV-2 infection or its severe complications, especially in susceptible populations. Data on adverse events after vaccination against COVID-19 are limited, both in the general population and in schizophrenia patients. The study aimed to investigate the safety of COVID-19 vaccination in patients treated with clozapine for hematological parameters. We conducted an analytical cross-sectional study between July 1, 2021, and June 30, 2022. We compared 2 groups of COVID-19 vaccinated patients who had previously experienced SARS-CoV-2 infection: The first group was treated with clozapine, whereas the second group was treated with other antipsychotics. The primary objective was to identify granulocytopenia, leukocytopenia, and lymphocytopenia. The results were measured after the second dose of the Pfizer-BioNTech vaccine. This study included 100 patients. White blood cell count changes were limited to a few cases of mild granulocytopenia (8.16% in the clozapine group and 3.92% in the nonclozapine group, P = 0.37) with no cases of severe granulocytopenia or agranulocytosis. As far as leukocyte counts are concerned, mRNA COVID-19 vaccination seems to be safe in patients treated with clozapine who previously had SARS-CoV-2 infection. Leukocyte changes had no clinical implications.

Abstract #1395500: Silent Thyroiditis as a Complication of Severe Acute Respiratory Syndrome Coronavirus 2 Vaccine

Silent autoimmune thyroiditis, a type of chronic autoimmune thyroiditis, as an adverse effect of Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination is infrequently reported in the literature. We hereby describe a case of silent thyroiditis followed by Grave’s orbitopathy after vaccination against SARS-CoV2. An 84-year-old male presented to clinic with a 10-pound weight loss with no other symptoms of hyperthyroidism, no personal history of thyroid illnesses, or recent viral infections. He had normal thyroid function 3 months prior to presentation. He had received 3 doses of SARS-CoV2 Pfizer-BioNTech vaccine with the last dose 5 months prior to presentation. Thyroid exam was normal. Laboratory testing revealed thyroid stimulating hormone (TSH) level of 0.005 IU/ml (0.45-4.5 IU/ml), total T4 14.4 g/dl (4.5-12.1 g/dl), and total T3 1.22 nmol/l (0.6-1.81 nmol/l). Thyroid Ultrasound revealed a heterogeneous atrophic thyroid gland with no nodules or hypervascularity. He was started on Methimazole by primary care provider. Four months later, he was seen in the Endocrinology clinic and reported no hyperthyroidism symptoms. His TSH level at that time was 65.9 IU/ml, free T4 0.47 ng/dl (normal: 0.82-1.77 ng/dl), total T3 level 75 ng/dl (normal: 71-180 ng/dl), thyroid stimulating immunoglobulin 2.05 IU/l (0-0.55 IU/L), thyrotropin receptor antibody level 2.8 (0-1.75). Methimazole was discontinued. At 6 months after initial presentation laboratory testing showed TSH 5.010 IU/ml, free T4 1.2 ng/dl, thyroid peroxidase antibody of 148 IU/ml (normal 0-34 IU/ml), thyroglobulin antibody 131.6 IU/ml (normal 0.0-0.9 IU/ml). He was diagnosed with silent autoimmune thyroiditis. A few weeks later, the patient presented to an ophthalmologist with bilateral eye bulging and impaired vision. He was diagnosed with acute Graves’ orbitopathy and started on pulse-dose of intravenous Methylprednisolone 250 mg twice daily and urgently referred to a tertiary ophthalmology center for teprotumumab infusion. His thyroid function tests were normal at that time on no thyroid medications. The underlying mechanisms of thyroid impairment following SARS-CoV2 vaccination are not completely understood. There is a role of molecular mimicry between SARS-CoV2 antigens and thyroid antigens that may help to hasten the emergence of autoimmunity in vulnerable individuals. Our patient developed multiple thyroid-related antibodies following vaccination. Silent painless thyroiditis is a self-limiting condition, characterized by temporary thyrotoxicosis, followed by a brief period of hypothyroidism and then a complete return to normal thyroid function. A radioactive iodine uptake scan can help differentiate between the different causes of thyrotoxicosis in the acute thyrotoxic phase. Development of severe Graves orbitopathy following silent autoimmune thyroiditis after SARS COV2 vaccination has not been previously reported.

Effect of different COVID-19 vaccines on some biomarkers in diabetics

After the emergency approval of different COVID-19 vaccines the administration of millions of doses, many concerns arise for adverse effects, especially in vulnerable groups such as diabetics. In this study, we investigate what effects different COVID vaccines could have on several biomarkers in diabetic patients and whether that raises a concern for this group or not. Materials and methods: this study includes two groups of diabetics each group consists of 20 participants ; One of the groups under study, where they received the COVID-19 vaccine either AstraZeneca or Pifizr-BioNTech vaccine and the other groups were controlled or the Pfizer-BioNTech vaccine, the other group-the control group- did not take any vaccine. Blood samples were taken from both groups about a week after the first dose and statistical studies were conducted on the results. Results: Noticed an increase in all biomarkers. Increase in RBS could simply be due to immune response, same thing could be said for the CRP increase. Ferritin increase was not important; it was only apparent in three patients and that could be due to active infection. The increase in D-dimer levels was apparent in all patients and that raises the biggest concern. Conclusion: the biggest issue was seen in the rising of D-dimer levels because it raises concern about clotting disorders and heart disease which is already a concern for diabetic patients. Further investigation should be done and careful monitoring for clotting risks is necessary after the vaccine.

E057 A systematic review of new rheumatic immune-mediated inflammatory diseases (R-IMID) following SARS-CoV-2 vaccinations

Abstract Background/Aims There are sporadic reports about the development of new rheumatic immune-mediated inflammatory diseases (R-IMIDs) in adults after receiving SARS-CoV-2 vaccines. This systematic review (SR) aimed to critically review and summarize the clinical profile, patient demographics, treatment, and prognosis of new-onset R-IMIDs following SARS-CoV-2 vaccination. Methods We retrieved English-language articles (Case reports and series and observational studies) on new-onset R-IMIDs following SARS-CoV-2 vaccination, published until June 2022, from standard databases (MEDLINE, Embase, Cochrane). The search strings used during the literature search incorporated ‘SARS-CoV-2 vaccination’ (along with related MeSH terms) and various key terms for R-IMIDs [which included (but was not limited to) inflammatory arthritis, connective tissue disease (CTD), vasculitis, systemic lupus erythematosus, Sjogren’s syndrome, sarcoidosis, systemic sclerosis, idiopathic inflammatory myositis, anti-synthetase syndrome, Adult-onset Stills disease (AOSD), giant cell arteritis (GCA), and polymyalgia rheumatica (PMR)]. The protocol was registered in PROSPERO (CRD42022318561). Results Of the total 2179 articles retrieved, 1986 articles were excluded following the title-abstract screening, and 107 articles that did not meet inclusion criteria. We included the remaining 86 articles (130 cases) upon full-text screening. Furthermore, we added four articles (six cases) based on a manual search, comprising 90 articles (136 cases) for final analysis. These 136 new R-IMID cases were reported from 27 different countries. Of these, more than one-third of the cases were reported from three countries (viz., Italy, Japan, and the USA). The patients had a mean age of 57 (range:17-90) years, and the majority were females (63.0%). Most patients developed R-IMIDs after receiving Pfizer-BioNTech vaccine (76; 55%), followed by Oxford AstraZeneca vaccine (35; 25%). The mean duration between SARS-CoV-2 vaccination and R-IMIDs development was 9.2 (range:1-90) days. The second dose of the vaccine resulted in more R-IMIDs (74;54%) than the first (53;39%). CTDs (34; 25%) and small vessel vasculitis (33; 24%) were the commonest R-IMID manifestations, followed by inflammatory arthritis and AOSD, each in 13 (9.5%) cases. Nearly half of the patients with CTDs had Idiopathic Inflammatory Myositis. PMR and GCA accounted for 16 (11.7%) and 5 (3.6%) cases, respectively. However, no cases of axial spondylarthritis were reported. Most (118; 86%) R-IMID patients were treated with corticosteroids, with a small number receiving steroid-sparing drugs, such as methotrexate, rituximab and cyclophosphamide. Most (125; 91%) went into either disease remission or improvement following the treatment. Only three patients were admitted to the intensive care unit (ICU) to manage their disease; One of them died due to fatal myositis and rhabdomyolysis; two surviving ICU patients had ANCA-associated vasculitis with lung involvement. Conclusion Although rare, this SR highlights the emergence of de novo R-IMIDs following SARS-CoV-2 vaccination. We cannot confirm the causality between the vaccination and the onset of R-IMID. However, further research is warranted in this area. Disclosure A. Nune: None. K. Bora: None. K.P. Iyengar: None. B. Barman: None. V. Durkowski: None. S. Venkatachalam: None. S. Bilgrami: None. L. Ottewell: None. C. Manzo: None.