outcomes of single dose covid 19 vaccines eight month follow up of a large cohort CORD-Papers-2022-06-02 (Version 1)

Title: Outcomes of Single Dose COVID-19 Vaccines: Eight Month Follow-up of a Large Cohort in Saudi Arabia
Abstract: BACKGROUND: Two vaccines for COVID-19 have been approved and administered in the Kingdom of Saudi Arabia (KSA); Pfizer-BioNtech BNT162b2 and AstraZeneca-Oxford AZD1222 vaccines. The purpose of this study was to describe the real-world data on the outcome of single dose of these COVID-19 vaccines in a large cohort in KSA and to analyse demographics and co-morbidities as risk factors for infection post one-dose vaccination. METHODS: In this prospective cohort study a total of 18543 subjects received one dose of either of the vaccines at a vaccination centre in KSA and were followed up for three to eight months. Data were collected from three sources; clinical data from medical records adverse events (AEs) from a self-reporting system and COVID-19 infection data from the national databases. The study was conducted during the pandemic restrictions on travel mobility and social interactions. RESULTS: The median age of participants was 33 years with an average body mass index of 27.3. The majority were males (60.1%). Results showed that 92.17% of the subjects had no COVID-19 infection post-vaccination as infection post-vaccination was documented for 1452 (7.83%). Diabetes mellitus (p=0.03) organ transplantation (p=0.02) and obesity (p<0.01) were associated with infection post-vaccination. Unlike vaccine type being Saudi male or obese was associated with the occurrence breakthrough infections more than other parameters. AEs included injection site pain fatigue fever myalgia headache and was reported by 5.8% of the subjects. CONCLUSION: Single dose COVID-19 vaccines showed a protection rate of 92.17% up to eight months follow-up in this cohort. This rate in AZD1222 was higher than what have been previously reported in effectiveness studies and clinical trials. Obese male and Saudi were at higher risk of contracting the infection post-vaccination Saudi and male might have more social interaction with the public when mobility and social interactions were limited during the pandemic. Side effects and AEs were within what has been reported in clinical trials.
Published: 2022-04-06
Journal: J Infect Public Health
DOI: 10.1016/j.jiph.2022.04.001
DOI_URL: http://doi.org/10.1016/j.jiph.2022.04.001
Author Name: Alharbi Naif Khalaf
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alharbi_naif_khalaf
Author Name: Al Tawfiq Jaffar A
Author link: https://covid19-data.nist.gov/pid/rest/local/author/al_tawfiq_jaffar_a
Author Name: Alghnam Suliman
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alghnam_suliman
Author Name: Alwehaibe Amal
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alwehaibe_amal
Author Name: Alasmari Abrar
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alasmari_abrar
Author Name: Alsagaby Suliman A
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alsagaby_suliman_a
Author Name: Alsubaie Faisal
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alsubaie_faisal
Author Name: Alshomrani Majid
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alshomrani_majid
Author Name: Farahat Fayssal M
Author link: https://covid19-data.nist.gov/pid/rest/local/author/farahat_fayssal_m
Author Name: Bosaeed Mohammad
Author link: https://covid19-data.nist.gov/pid/rest/local/author/bosaeed_mohammad
Author Name: Alharbi Ahmad
Author link: https://covid19-data.nist.gov/pid/rest/local/author/alharbi_ahmad
Author Name: Aldibasi Omar
Author link: https://covid19-data.nist.gov/pid/rest/local/author/aldibasi_omar
Author Name: Assiri Abdullah M
Author link: https://covid19-data.nist.gov/pid/rest/local/author/assiri_abdullah_m
sha: a51cb0643893743dbe90123bd8494c57b65ba315
license: no-cc
license_url: [no creative commons license associated]
source_x: Elsevier; Medline; PMC; WHO
source_x_url: https://www.elsevier.com/https://www.medline.com/https://www.ncbi.nlm.nih.gov/pubmed/https://www.who.int/
pubmed_id: 35472755
pubmed_id_url: https://www.ncbi.nlm.nih.gov/pubmed/35472755
pmcid: PMC8986276
pmcid_url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8986276
url: https://doi.org/10.1016/j.jiph.2022.04.001 https://www.ncbi.nlm.nih.gov/pubmed/35472755/ https://api.elsevier.com/content/article/pii/S1876034122000843 https://www.sciencedirect.com/science/article/pii/S1876034122000843?v=s5
has_full_text: TRUE
Keywords Extracted from Text Content: J o u r n a l P r e -p r o o f COVID-19 COVID-19 vaccines Pfizer-BioNtech BNT162b2 centre 18,543 subjects AstraZeneca-Oxford AZD1222 vaccines body AstraZeneca-Oxford AZD1222 lymphadenopathy human papillomavirus vaccines vaccinees patients Saudis intramuscular vaccines centre BNT162b2 COVID-19 vaccine kidney joint 2-3 post-COVID-19 participants KSA organ COVID-19 vaccines AEs COVID-19 AZD1222 p<0.01 skin p=0.0014 portal cancer Pfizer-BioNtech BNT162b2 vaccine renal J o u r n a l P r e -p r o o f SARS-CoV-2 J o u r n a l P r e -p r o o f 3 AE non-Saudi Gamaleya SputnikV vaccine abdominal lung
Extracted Text Content in Record: First 5000 Characters:Two vaccines for COVID-19 have been approved and administered in the Kingdom of Saudi Arabia (KSA); Pfizer-BioNtech BNT162b2 and AstraZeneca-Oxford AZD1222 vaccines. The purpose of this study was to describe the real-world data on the outcome of single dose of these COVID-19 vaccines in a large cohort in KSA and to analyse demographics and co-morbidities as risk factors for infection post one-dose vaccination. In this prospective cohort study, a total of 18,543 subjects received one dose of either of the vaccines at a vaccination centre in KSA, and were followed up for three to eight months. Data J o u r n a l P r e -p r o o f 2 were collected from three sources; clinical data from medical records, adverse events (AEs) from a self-reporting system, and COVID-19 infection data from the national databases. The study was conducted during the pandemic restrictions on travel, mobility, and social interactions. The median age of participants was 33 years with an average body mass index of 27.3. The majority were males (60.1%). Results showed that 92.17% of the subjects had no COVID-19 infection post-vaccination as infection post-vaccination was documented for 1452 (7.83%). Diabetes mellitus (p=0.03), organ transplantation (p=0.02), and obesity (p<0.01) were associated with infection post-vaccination. Unlike vaccine type, being Saudi, male, or obese was associated with the occurrence breakthrough infections more than other parameters. AEs included injection site pain, fatigue, fever, myalgia, headache and was reported by 5.8% of the subjects. , which was declared as a global pandemic (1-3). SARS-CoV-2 is highly contagious and transmitted through human-to-human contact (4) . Most COVID-19 cases (81%) are asymptomatic or present with mild to moderate symptoms (5) . However, J o u r n a l P r e -p r o o f 3 other cases are severe (14%) to critical (5%); with a case fatality rate of 2-3% (6) . As of September 2021, more than 222 million confirmed cases of COVID-19 and 4.5 million deaths were reported globally (7) . To reduce the risk of SARS-CoV-2 transmission, preventive strategies have been implemented, including the use of face masks, hand washing/hygiene, contact tracing, travel bans, and government-led cancellation of unnecessary activities (8) . Importantly, prophylactic vaccines are sought as the ultimate intervention to bring the pandemic under control. Over 200 vaccine candidates for COVID-19 were at various stages of clinical development (9) . Of these, at least 50 candidate vaccines have been evaluated in clinical trials and several vaccines have been approved by regulatory authorities, based on demonstrated safety profile and acceptable efficacy rates (10) . COVID-19 vaccine efficacy, in phase III clinical trials, were 95% for the Pfizer-BioNtech BNT162b2 vaccine, 92% for the Gamaleya SputnikV vaccine, 94.5% for Moderna mRNA-1273 vaccine, 70% for the AstraZeneca-Oxford AZD1222 vaccine, and 97% for Sinopharm BIBP COVID-19 vaccine (10) (11) (12) . Three of these vaccines were approved for emergency use by a number of international regulators, including the Saudi FDA, at the end of 2020. Accordingly, Kingdom of Saudi Arabia (KSA) was among the first countries to launch an accelerated program for COVID-19 vaccination (13, 14) . For each vaccine, there were a number of vaccine controlled randomised clinical trials focusing on evaluating safety, immunogenicity, and efficacy (10, 15) , which were the basis for regulatory approvals. However, to gain a better understanding of how COVID-19 vaccines would perform in various populations, it is essential to gather real-world data and analysis post-vaccination, particularly in different ethnic populations and other sub-populations. These sub-populations can be defined based on differences in gender, age, nationality, occupation, and comorbidities. In this prospective cohort study, data for 20,555 vaccinated subjects were collected from a were excluded from the analysis. Therefore, 18543 out of 20555 subjects were included in the study analysis. Subjects were followed up for at least three months (last vaccination was on the 14 th April 2021 and last follow up was on the 10 th August, 2021). Descriptive statistics were applied to summarise the data of subjects' demographical and clinical characteristics and the number of AEs. Comparisons between the two study groups ( Out of 18543, 17091 (92.17%) remained uninfected post-vaccination while SARS-CoV-2 infection was documented for 1452 (7.83%) vaccinated individuals (Table 1) . Forty-six (11.2% of those who received BNT162b2) and 1406 (7.75% from those who received AZD1222) had the infection post two weeks of the single dose vaccination, indicating the protection rate of these vaccines, Table S1 . Age was similar in the two groups of vaccinated subjects (uninfected and To identify risk factors associated with infection post-vaccination, we analysed comorbidity data of subjects in the two groups (Table 1) . Male gender and
Keywords Extracted from PMC Text: coronavirus [2], [3] lung AEs NKA, AA AMA post-COVID-19 COVID-19 Coronavirus-2 KSA Amal patients NKA p=0.0014 body Pfizer-BioNtech BNT162b2 vaccine NRC21R-120-03 AstraZeneca-Oxford AZD1222 COVID-19 vaccines BNT162b2 MNG-HA abdominal individuals Abrar kidney BNT162b2 [11 participants skin JAA IRBC/0862/21 Riyadh alpha 18133 AE FF, MB Pfizer-BioNtech BNT162b2 Gamaleya SputnikV vaccine intramuscular vaccines SAA vaccinees FA AstraZeneca-Oxford AZD1222 COVID-19 Saudis centre MA renal COVID-19 vaccine SARS-CoV-2 IRBC/0714/20 organ 2-3% [6] p<0.01 joint AZD1222 lymphadenopathy human papillomavirus vaccines portal cancer
Extracted PMC Text Content in Record: First 5000 Characters:Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) causes coronavirus infectious disease 2019 (COVID-19), which was declared as a global pandemic [1], [2], [3]. SARS-CoV-2 is highly contagious and transmitted through human-to-human contact [4]. Most COVID-19 cases (81%) are asymptomatic or present with mild to moderate symptoms[5]. However, other cases are severe (14%) to critical (5%); with a case fatality rate of 2-3% [6]. As of September 2021, more than 222 million confirmed cases of COVID-19 and 4.5 million deaths were reported globally [7]. To reduce the risk of SARS-CoV-2 transmission, preventive strategies have been implemented, including the use of face masks, hand washing/hygiene, contact tracing, travel bans, and government-led cancellation of unnecessary activities [8]. Importantly, prophylactic vaccines are sought as the ultimate intervention to bring the pandemic under control. Over 200 vaccine candidates for COVID-19 were at various stages of clinical development [9]. Of these, at least 50 candidate vaccines have been evaluated in clinical trials and several vaccines have been approved by regulatory authorities, based on demonstrated safety profile and acceptable efficacy rates [10]. COVID-19 vaccine efficacy, in phase III clinical trials, were 95% for the Pfizer-BioNtech BNT162b2 vaccine, 92% for the Gamaleya SputnikV vaccine, 94.5% for Moderna mRNA-1273 vaccine, 70% for the AstraZeneca-Oxford AZD1222 vaccine, and 97% for Sinopharm BIBP COVID-19 vaccine [10], [11], [12]. Three of these vaccines were approved for emergency use by a number of international regulators, including the Saudi FDA, at the end of 2020. Accordingly, Kingdom of Saudi Arabia (KSA) was among the first countries to launch an accelerated program for COVID-19 vaccination [13], [14]. For each vaccine, there were a number of vaccine controlled randomised clinical trials focusing on evaluating safety, immunogenicity, and efficacy [10], [15], which were the basis for regulatory approvals. However, to gain a better understanding of how COVID-19 vaccines would perform in various populations, it is essential to gather real-world data and analysis post-vaccination, particularly in different ethnic populations and other sub-populations. These sub-populations can be defined based on differences in gender, age, nationality, occupation, and comorbidities. Therefore, this study was conducted to evaluate the outcome of Pfizer-BioNtech BNT162b2 and AstraZeneca-Oxford AZD1222 COVID-19 vaccines in protecting from COVID-19 in KSA, including national and expatriate subjects from different countries. It also analyses demographics and clinical characteristics of subjects as well as adverse events (AE) post-vaccination. Unlike the recommended regimen of two doses, all subjects in the study received only a single dose of either BNT162b2 or AZD1222 vaccines between 19th December 2020 and 14th April 2021. This was because at the early phase of the vaccination program, KSA has decided to postpone the second dose of COVID-19 vaccines due to vaccine supply issues as well as to achieve a quick rollout of COVID-19 vaccines. In this prospective cohort study, data for 20,555 vaccinated subjects were collected from a single vaccination centre at Ministry of National Guard Health Affairs (MNG-HA) hospitals in Riyadh city, Saudi Arabia, during the first days of vaccination campian. The subjects received either BNT162b2 or AZD1222 vaccines. Clinical data for all subjects were retrieved from the MNG-HA electronic medical records. Co-morbidities were extracted based on the ICD codes. The BMI was extracted as continuous numbers and categorized into obesity based on the CDC cut-off of BMI>30. Confirmation of COVID-19 infections were obtained from the national databases at the Ministry of Health which covers any COVID-19 PCR testing performed in the entire country. Subjects were given access to an online portal for reporting symptoms and adverse events; in addition, vaccine safety records at the Infection Prevention and Control Department at the King Abdulaziz Medical City (KAMC), MNG-HA, were reviewed. Those who were infected prior to vaccination, had two doses of Pfizer vaccine (<100 subjects), had COVID-19 infection within two weeks of vaccination (only 73 cases), or lack data on COVID-19 testing were excluded from the analysis. Therefore, 18543 out of 20555 subjects were included in the study analysis. Subjects were followed up for at least three months (last vaccination was on the 14th April 2021 and last follow up was on the 10th August, 2021). Descriptive statistics were applied to summarise the data of subjects' demographical and clinical characteristics and the number of AEs. Comparisons between the two study groups (No infection post-vaccination versus infection post-vaccination) in terms of demographical and clinical variables, including gender, nationality, and comorbidities were evaluated using chi-2 tests. Multivariate analysis was applied t
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