Evaluation of hematological parameters and thrombocytopenia following Pfizer-BioNTech (BNT162b2) SARS-CoV-2 vaccination.

OBJECTIVES: To evaluate hematological parameters and thrombotic profiles of healthy individuals who received Pfizer-BioNTech (BNT162b2) vaccines in Saudi Arabia. METHODS: Hematological parameters and the incidence of anti-platelet factor-4 (anti/PF-4) antibodies were evaluated in 40 participants who were eligible for COVID-19 vaccination in Saudi Arabia (above 18 years old) at Jazan University Hospital. These parameters were assessed at 2 different timepoints; at day 0 (the day of receiving the first dose of Pfizer- BioNTech (BNT162b2) and prior to vaccination) and 14-21 days after receiving the vaccine. RESULTS: Among the participants, 38 (80%) were men, while 12 (20%) were women, with a mean age of 27 years. A total of 15% of the participants reported previous infection with SARS-CoV-2 and 3 patients had a history of diabetes mellitus and hypertension. Hematological parameters results in those vaccines showed no significant changes between the 2 timepoints, such as, day 0 (just before receiving vaccination) and 14 to 21 days post vaccination. Further, anti/PF4 antibodies were negative for all participants following vaccination. CONCLUSION: Our data showed that the incidence of hematological abnormalities or induction of anti/PF4 antibodies following Pfizer-BioNTech (BNT162b2) vaccination is not common, which is consistent with several previous reports. However, larger studies with more participants evaluated at different timepoints following vaccination are warranted to exclude potential transient hematological abnormalities.

Bacterial Coinfections Increase Mortality of Severely Ill COVID-19 Patients in Saudi Arabia.

Coronavirus disease 19 (COVID-19) is an ongoing global pandemic that is caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The severity and mortality rates of COVID-19 are affected by several factors, such as respiratory diseases, diabetes, and hypertension. Bacterial coinfections are another factor that could contribute to the severity of COVID-19. Limited studies have investigated morbidity and mortality due to microbial coinfections in COVID-19 patients. Here, we retrospectively studied the effects of bacterial coinfections on intensive care unit (ICU)-admitted patients with COVID-19 in Asir province, Saudi Arabia. We analyzed electronic medical records of hospitalized patients with COVID-19 at Asir Central Hospital. A total of 34 patients were included, and the clinical data of 16 patients infected with SARS-CoV-2 only and 18 patients coinfected with SARS-CoV-2 and bacterial infections were analyzed in our study. Our data showed that the length of stay at the hospital for patients infected with both SARS-CoV-2 and bacterial infection was 35.2 days, compared to 16.2 days for patients infected with only SARS-CoV-2 (p = 0.0001). In addition, higher mortality rates were associated with patients in the coinfection group compared to the SARS-CoV-2-only infected group (50% vs. 18.7%, respectively). The study also showed that gram-negative bacteria are the most commonly isolated bacteria in COVID-19 patients. To conclude, this study found that individuals with COVID-19 who presented with bacterial infections are at higher risk for a longer stay at the hospital and potentially death. Further studies with a larger population are warranted to better understand the clinical outcomes of COVID-19 with bacterial infections.

Community-Based Seroprevalence of SARS-CoV-2 Antibodies following the First Wave of the COVID-19 Pandemic in Jazan Province, Saudi Arabia.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) continues to spread globally, causing unprecedented effects on global health and economies. Community-based serological data are essential for understanding the true prevalence of infections, specifically the subclinical infections, as COVID-19 asymptomatic infections are common. Such data would also be important for decision making around choosing appropriate epidemiological control measures, as well as for the true estimation of mortality rates in the population. Further, determining the seroprevalence of anti-SARS-CoV-2 antibodies in the population would provide important information on herd immunity. In this study, we conducted a population-based age-stratified serological study to understand the prevalence of SARS-CoV-2 in Jazan Province, Saudi Arabia. Out of 594 participants who were recruited from 29 August to 30 December 2020, just before the vaccination rollout program in Saudi Arabia, about 157 were seropositive for SARS-CoV-2, indicating an estimated seropositivity rate of 26%. Although no significant difference in seropositivity was seen between male and female participants, we found that lower seroprevalence was associated with the younger (below 18 years old) and older populations (older than 56 years) compared with other age groups (19-55 years). These data indicate a high prevalence of SARS-CoV-2 antibodies following the peak of COVID-19 spread in Jazan province; however, most of the population (three-quarters) remains susceptible to SARS-CoV-2 infection.

Low clinical utility of testing for anti-platelet factor 4 in asymptomatic individuals after ChAdOx1 nCoV-19 vaccine.

INTRODUCTION: The development of anti-platelet factor 4 (PF4) antibodies is linked to a rare thrombotic complication described now as vaccine-induced immune thrombotic thrombocytopenia (VITT). This clinical syndrome with thrombosis and thrombocytopenia was reported after exposure to the Oxford-AstraZeneca COVID-19 vaccine, ChAdOx1 nCoV-19 vaccine (AZD1222), and Ad26.COV2.S vaccine (Janssen/Johnson & Johnson). In the absence of the clinical features, the incidence of positive anti-PF4 antibodies in asymptomatic individuals post-vaccination is unclear. METHODS: The aim of this study was to evaluate the development of anti-PF4 antibodies in asymptomatic individuals 14-21 days after receiving the first dose of ChAdOx1 nCoV-19 vaccine (AZD1222) and BNT162b2 vaccine. Prospectively, we collected serum from individuals before and after ChAdOx1 nCoV-19 vaccine and BNT162b2 vaccine and measured anti-PF4 antibodies using the Asserachrom HPIA IgG ELISA (Stago, Asnieres, France). RESULTS: We detected positive anti-PF4 antibodies in 5 of 94 asymptomatic individuals post-vaccine with a rate of 5.3% with low titers (OD 0.3-0.7). Four of 5 individuals who tested positive after the vaccine had also positive anti-PF4 antibodies before the vaccine, which indicates that a majority of the positive results are due to preexisting anti-PF4 antibodies. We did not find a relation between the development of anti-PF4 antibodies and the immune response to the vaccine, status of prior COVID-19 infection, and baseline characteristics of participants. None of the participants developed thrombosis nor thrombocytopenia. CONCLUSION: Our results provide new evidence to guide the diagnostic algorithm of suspected cases of VITT. In the absence of thrombosis and thrombocytopenia, there is a low utility of testing for anti-PF4 antibodies.

Side Effects of COVID-19 Pfizer-BioNTech mRNA Vaccine in Children Aged 12-18 Years in Saudi Arabia.

Background: Massive vaccination campaigns have been undertaken globally to combat the spread of the Coronavirus Disease 2019 (COVID-19). While most COVID-19 vaccines have shown excellent efficacy and safety profiles in clinical studies, real-world monitoring of vaccine safety is still important. In this study, we aimed to investigate the early side effects of Pfizer-BioNTech (BNT162b2) mRNA vaccine in children between 12-18 years old in Saudi Arabia. Method: To investigate the side effects in children in this age range following the administration of either one or two doses of Pfizer-BioNTech (BNT162b2) mRNA vaccine, we conducted a retrospective, cross-sectional study using a self-administered online survey. General and demographic data were collected, and vaccine-associated side effects following vaccination were evaluated. Results: The study recruited a total of 965 eligible participants. Overall, 571 (60%) of the study participants reported at least one side effect following Pfizer-BioNTech (BNT162b2) mRNA vaccination. The most frequently reported side effects were pain or redness at the site of injection (90%), fatigue (67%), fever (59%), headache (55%), nausea or vomiting (21%), and chest pain and shortness of breath (20%). Joint or bone pain were reported less frequently among our participants (2%). Our data showed that more female participants reported side effects compared to male participants, with 52% and 48%, respectively. Side effects were more common after the second dose compared to the first dose in our study cohort. Conclusions: While 60% of the children (12-18 years old) who received Pfizer-BioNTech (BNT162b2) mRNA vaccine reported side effects, our data showed that these side effects were not different from those that were reported in the clinical trials which lasted only for a few days. Side effects were more common after the second dose. Larger epidemiological and molecular studies are needed to evaluate the safety and the effectiveness of COVID-19 vaccine in protection of children against SARS-CoV-2 reinfections.

Knowledge, Attitudes and Perception toward COVID-19 Vaccines among Adults in Jazan Province, Saudi Arabia.

BACKGROUND: Saudi Arabia is one of the countries that initiated early vaccination programs despite the global challenges concerning the availability of COVID-19 vaccines. Massive vaccination campaigns have been undertaken in the country; however, negative perception and hesitancy toward vaccines may exist which could reduce public response to vaccination. Further, studies evaluating the current perception and attitude toward COVID-19 vaccines are scarce. Thus, this study aims to assess the community attitudes and perceptions toward COVID-19 vaccines in Jazan Province, Saudi Arabia. METHODS: A cross-sectional, retrospective study using an online questionnaire was conducted among the public in Jazan, the southern region of Saudi Arabia. General and demographic data were collected, and perception and attitude toward COVID-19 vaccines were evaluated. RESULTS: Most participants in this study were female (67%) with a median age of 23 years. The majority held a bachelor's degree, and they trusted the Saudi healthcare system. Our survey showed that 67% of the study participants had positive perceptions toward COVID-19 vaccines, a finding that is significantly associated with receiving the influenza vaccine in the past, the existence of trust on the current healthcare system and holding positive beliefs toward the effectiveness of the current COVID-19 vaccines in reducing the risk of infection, complication, and mortality. CONCLUSIONS: The proportion of the public in Jazan who believed in the COVID-19 vaccine effectiveness is not inferior from similar international reports. Thus, national awareness programs toward the effectiveness of the vaccine could be enhanced to accelerate vaccination coverage. Further, nationwide surveys are warranted to include larger populations from different communities to assess the overall perception toward COVID-19 vaccines in the whole country.

Evaluation of Side Effects Associated with COVID-19 Vaccines in Saudi Arabia.

BACKGROUND: Pfizer-BioNTech and Oxford-AstraZeneca are recently introduced vaccines to combat COVID-19 pandemic. During clinical trials, mild to moderate side effects have been associated with these vaccines. Thus, we aimed to evaluate short-term post-vaccination side effects. METHODS: Cross-sectional, retrospective study using an online questionnaire was conducted among COVID-19 vaccines recipients in Saudi Arabia. General and demographic data were collected, and vaccine-associated side effects after receiving at least one dose of each vaccine were evaluated. RESULTS: Our final sample consisted of 515 participants with a median age of 26 years. Most of the study participants were female (57%). Nearly 13% of the study subjects have reported previous infections with SARS-CoV-2. Oxford-AstraZeneca and Pfizer-BioNTech vaccines have been received by 75% and 25% of the study participants, respectively. Side effects associated with COVID-19 vaccines have been reported by 60% of the study subjects, and most of them reported fatigue (90%), pain at the site of the injections (85%). CONCLUSION: Side effects that are reported post Oxford-AstraZeneca and Pfizer-BioNTech vaccines among our study participants are not different from those that were reported in the clinical trials, indicating safe profiles for both vaccines. Further studies are needed to evaluate the effectiveness of the current vaccines in protection against SARS-CoV-2 reinfections.