Abstract
Background:
Many coronavirus disease 2019 (COVID-19) vaccines were approved worldwide. Their safety was the primary concern. In Egypt, Oxford–AstraZeneca (AZ) vaccine was the first approved vaccine initially for healthcare workers (HCWs).
Objective:
We aim to determine adverse events and hematological abnormalities following the COVID-19 AZ vaccine and estimate the infection rate of the candidates by COVID-19 between the first and second doses of vaccination.
Methods:
Within 8–10 days of receiving their initial dose of the AZ vaccine, 909 HCWs were assessed for adverse events as part of a prospective longitudinal study. Complete blood counts (CBCs) were evaluated before and one month after vaccination.
Results:
37.2% of the candidates experienced side effects following vaccination. Pain at the injection site was the most common (25.4%) and more frequent in participants between 20 and 40 years (27.9%). The mean total leukocyte count (TLC), absolute leukocyte count (ALC), absolute neutrophil count (ANC), and absolute monocyte count (AMC) increased one month following vaccination (P < 0. 001). Sixty-six vaccinated HCWs were infected with COVID-19 between the two vaccine doses. 82% were infected after 14 days of the first dose, while 18% were infected before 14 days (P < 0.0001).
Conclusions:
Most of the vaccinated personnel did not experience any side effects after the first dose of the vaccine. Furthermore, the most common complaints were pain at the injection site, fatigue, fever, headache, arthralgia, myalgia, and chills. Infected people with COVID-19 after the first dose had significantly more severe disease if they were infected before 14 days than those who got infected later on.
Keywords: AstraZeneca, COVID-19, Egypt, healthcare workers, vaccine
INTRODUCTION
Coronavirus disease 2019 (COVID-19) is a widely spreading infectious disease that killed over 6 million people by May 2022 as listed by the Johns Hopkins University data tracker. More than 160 COVID-19 vaccine candidates are developing worldwide, with 25 in various clinical trial stages.[1]
Oxford–AstraZeneca (AZ) vaccines (ChAdOx1 nCoV-19) were the first approved vaccines in Egypt. It was first approved for high-risk groups, such as healthcare workers (HCWs), before becoming available to the general public.[2] Clinical studies have linked it to various mild-to-moderate side effects, including discomfort or swelling at the injection site.[2] The development of undesired side effects arouses a question: Is a single dose effective? So that the second dose can be skipped? We assessed the short-term side effects of the AZ vaccination in HCWs.
The AZ vaccine's side effects were previously investigated in the Egyptian population, but only a small group (63 people) participated,[3] so larger studies were needed like ours, which investigated 909 candidates.
Many studies have shown hematological alterations following vaccination; leukocytosis was seen following the pneumococcal vaccine.[4] However, neutropenia was discovered following a novel Shigella sonnei vaccination.[5] Platelet (PLT) abnormalities have also been identified after measles-containing vaccines, such as idiopathic thrombocytopenic purpura.[6]
This study aimed to identify adverse events following vaccination with the COVID-19 AZ vaccine on Egyptian HCWs. It also extends to assess abnormalities regarding hematological values,[7] especially with the needs to know more detailed adverse event findings, including patient features and comorbidities, that help to have more knowledge on the precise determination of causality.[8] To the limit of our knowledge, our study is the first study to assess these side effects in Upper Egypt. Moreover, we screened for the candidates who get infected by COVID-19 between the first and second doses of the AZ vaccine, with most of the studies investigating the efficacy after two doses[9]
METHODS
Study design
A prospective longitudinal study was conducted in the first call on the COVID-19 vaccine on all eligible HCWs (909), recruited from the infection control unit of our hospital. The study was carried out from February 2021 to May 2021. HCWs aged 18–80 years who accepted the initial call of the AZ vaccination and were negative for serum-specific immunoglobulin M/immunoglobulin G (IgM/IgG) antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) at the time of screening, as evaluated by a commercial test (Innovita, China). Candidates were excluded if they had a fever, cough, runny nose, sore throat, diarrhea, dyspnea, or tachypnea in the 14 days before vaccination. In addition, pregnant women, those with a history of seizures, mental illness, on immunosuppressive drugs, and unable to stick to the study schedule were also excluded.
A local ethical committee approved the study in compliance with the Helsinki Declaration (RBI: 17300574). Written consent regarding participation in the study was obtained from the participants before receiving the vaccine dose, in the infection control unit.
Before being enrolled, participants were serologically tested for SARS-CoV-2 infection irrespective of symptoms. The AZ vaccination schedule was in the form of two doses three months apart. Participants were interviewed daily (over the phone) to describe any adverse reactions they had within 8–10 days of getting their first dose of vaccinations even if the candidate was free from an adverse reaction. A participant who developed any side effects was asked to attend our hospital's COVID-19 vaccine clinic. The participants were free to leave the study at any time.
Assessment protocol
A. Interviewed questionnaire, including personal history such as name, age, pregnancy, or lactation, history of smoking, comorbid conditions such as diabetes mellitus (DM), hypertension (HTN), cardiovascular diseases (CVDs), chronic obstructive pulmonary disease (COPD), or asthma, renal disease, previous history of infection with COVID-19 within three months before the time of the vaccine, and drug history of immunosuppressive therapy.
B. Clinical assessment of possible complications (daily evaluation of the participants by telephone contact with the evaluators: Local symptoms include irritation, erythema, swelling, and itching; systemic symptoms include headaches, dizziness, difficulty sleeping, flushing, muscle aches, body aches, tiredness, pyrexia, chills, sore throat, nasal congestion, nasal bleeds, sneezing, rhinorrhea, cough, dyspnea, palpitation, nausea, vomiting, diarrhea, constipation, stomach cramps, lack of appetite, acute allergic reaction, acne, abnormal taste, or loss of taste.
In addition, individuals were asked whether they had taken any medications after vaccination to rule out this potential confounding factor.
C. Laboratory assessment: Serological testing to detect antibodies against SARS-CoV-2 and estimation of IgG titer were performed before vaccination. A complete blood count (CBC) was done to evaluate total leukocyte count (TLC), absolute neutrophil count (ANC), absolute lymphocyte count (ALC), absolute monocyte count (AMC), PLTs, and hemoglobin level. Blood samples were withdrawn just before vaccination and one month after the first dose.
Assessment of the candidates who got infected by COVID-19 between the first and second doses of AZ vaccine
After the first dose, candidates were followed weekly for suspected COVID-19 infection. Confirmation of COVID‐19 infection with positive SARS‐CoV‐2 ribonucleic acid (RNA) was identification by real‐time polymerase chain reaction (PCR) methods in throat swab specimens,[10] and severity was subdivided into mild, moderate, severe, and critical cases.[11] They were further classified into two groups, the first group was infected with COVID-19 within the first 14 days and the second got infected after 14 days; we compared both groups regarding the severity of the infection and associated comorbidities.
Statistical tests
Data were analyzed using Statistical Package for the Social Sciences (SPSS) software package version 21 (IBM SPSS Inc., Chicago, Illinois, USA). Descriptive statistics were performed as frequency and cross-tabulations for categorical variables. The Chi-square test and Fisher's exact test were used to compare independent categorical variables, while the Mann–Whitney U-test was used for blood parameters as quantitative data as it was not normally distributed. A significant P-value was set at < 0.05.
RESULTS
Among one thousand HCWs invited to the research, 909 accepted participation [Figure 1]. The demographic features of the studied groups are shown in Table 1.
Figure 1:
Study participants’ demographics and general characteristics. CBC, complete blood count, HWCs, healthcare workers
Table 1:
Study participants' demographics and general characteristics of respondent HCWs to COVID-19 vaccination
| Characteristics | Frequency n=909 | Percentage (%) |
|---|---|---|
| Gender | ||
| Male/female | 571/338 | 62.8%/37.2% |
| Age group | ||
| 20-/40-/60- | 556/279/70 | 61.4%/30.8%/7.7% |
| Smoking history | ||
| Nonsmokers/smokers | 867/42 | 95.4%/4.6% |
| History of chronic disease | ||
| Yes/no | 171/738 | 18.8%/81.2% |
| Occupation | ||
| Doctor | 651 | 71.6% |
| Nurse | 97 | 10.7% |
| Pharmacist | 46 | 5.1% |
| Chemist | 49 | 5.4% |
| Worker | 29 | 3.2% |
| Admin | 37 | 4.1% |
| PPE used | ||
| Strict | 449 | 49.4% |
| Moderate | 286 | 31.5% |
| Never | 174 | 19.1% |
| Influenza vaccinated history | ||
| Yes/no | 400/509 | 44%/56% |
| History of previous confirmed COVID-19 infections before the vaccine | ||
| Yes/no | 95/814 | 10.5%/85.5% |
PPE: Personal protection equipment
Comparison between symptomatic and asymptomatic participants following the AZ vaccine: Most of the vaccinated people (62.8%) did not experience side effects. Postvaccination symptoms are shown in Table 2.
Table 2:
Features of the participants concerning the presence or absence of postvaccination symptoms
| Characteristics | n (%) | Symptomatic | Non-symptomatic | P |
|---|---|---|---|---|
| Gender | ||||
| Male | 571 (62.8%) | 216 (37.8%) | 355 (62.2%) | 0.32 |
| Female | 338 (37.2%) | 139 (41.1%) | 199 (58.9%) | |
| Age group | ||||
| 20- | 556 (61.4%) | 213 (38.3%) | 343 (61.7%) | 0.03* |
| 40- | 279 (30.8%) | 122 (43.7%) | 157 (56.3%) | |
| 60- | 70 (7.7%) | 19 (27.1%) | 51 (72.9%) | |
| Smoking history | ||||
| Nonsmokers | 867 (95.4%) | 334 (38.5%) | 533 (61.5%) | 0.13 |
| Smokers | 42 (4.6%) | 21 (50%) | 21 (50%) | |
| History of chronic disease | ||||
| No | 738 (81.2%) | 289 (39.2%) | 449 (60.8%) | 0.89 |
| Yes | 171 (18.8%) | 66 (38.6%) | 105 (61.4%) | |
| DM | 63 (6.9%) | 21 (33.3%) | 42 (66.7%) | 0.28 |
| CVD | 40 (4.4%) | 15 (37.5%) | 25 (62.5%) | 0.87 |
| COPD/asthma | 21 (2.3%) | 10 (47.6%) | 11 (52.4%) | 0.36 |
| Autoimmune disease | 14 (1.5%) | 5 (55.6%) | 4 (44.4%) | 0.28 |
| HTN | 101 (11.1%) | 38 (38.4%) | 61 (61.6%) | 0.94 |
| Renal disease | 2 (0.2%) | 1 (50.0%) | 1 (50.0%) | 0.73 |
| Complaining from symptoms from influenza vaccine (n=397)* | ||||
| Yes | 59 (14.9%) | 24 (40.7%) | 35 (59.3%) | 0.41 |
| No | 338 (84.1%) | 119 (35.2%) | 219 (64.8%) | |
| Previous confirmed COVID-19 infections | ||||
| Yes | 95 (10.5%) | 37 (38.9%) | 58 (71.1%) | 0.98 |
| No | 814 (85.5%) | 318 (39.1%) | 496 (60.9%) | |
| History of food allergy | ||||
| Yes | 47 (5.2%) | 19 (40.4%) | 28 (59.6%) | 0.84 |
| No | 862 (94.8%) | 336 (39.0%) | 526 (61.0%) | |
*Three were missing. CVD: Cardiovascular disease, COPD: Chronic obstructive pulmonary disease, DM: Diabetes mellitus, HTN: Hypertension. A P-value is significant if <0.05
The frequency of the reported postvaccination reactions concerning the gender of the participants: Within 8–10 days after receiving the first dose of the AZ vaccine [Table 3].
Table 3:
Reported postvaccination symptoms concerning the gender of the participants
| Sex Characteristics | Frequency | (%) | Male n (%) | Female n (%) | P | |
|---|---|---|---|---|---|---|
|
Detailed symptoms raised due to the COVID-19 vaccine
| ||||||
| Very common (>10%)** | Injection site pain | 231 | 25.4% | 123 (21.5%) | 108 (32.0%) | 0.0001* |
| Fatigue | 215 | 23.7% | 124 (21.7%) | 91 (26.9%) | 0.04* | |
| Fever | 180 | 19.8% | 107 (18.7%) | 73 (21.6%) | 0.169 | |
| Headache | 165 | 18.2% | 90 (15.8%) | 75 (22.2%) | 0.01* | |
| Muscle pain | 164 | 18% | 82 (14.4%) | 82 (24.3%) | 0.0001* | |
| Joint pain | 133 | 14.6% | 76 (13.3%) | 57 (16.9%) | 0.08 | |
| Chills | 119 | 13.1% | 67 (11.7%) | 52 (15.4%) | 0.07 | |
| Common (<10%-≥1%) | Dizziness | 57 | 6.3% | 27 (4.7%) | 30 (8.9%) | 0.01* |
| Sore throat | 48 | 5.3% | 25 (4.4%) | 23 (6.8%) | 0.07 | |
| Nasal symptoms | 38 | 4.2% | 26 (4.6%) | 12 (3.6%) | 0.292 | |
| Nasal congestion | 31 | 3.4% | 22 (3.9%) | 9 (2.7%) | 0.339 | |
| Runny nose | 19 | 2.1% | 12 (2.1%) | 7 (2.1%) | 0.975 | |
| Difficult sleep | 26 | 2.9% | 11 (1.9%) | 15 (4.4%) | 0.02* | |
| Flush | 14 | 1.5% | 7 (1.2%) | 7 (2.1%) | 0.232 | |
| Cough | 13 | 1.4% | 10 (1.8%) | 3 (0.9%%) | 0.224 | |
| Taste change | 11 | 1.2% | 5 (0.9%) | 6 (1.8%) | 0.187 | |
| Dyspnea | 10 | 1.1% | 7 (1.2%) | 3 (0.9%) | 0.455 | |
| Uncommon (<1%-≥0.1) | GIT symptoms | 7 | 0.8% | 5 (0.9%) | 2 (0.6%) | 0.482 |
| Nausea | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Constipation | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Abdominal pain | 3 | 0.3% | 2 (0.4%) | 1 (0.35) | 0.890 | |
| Vomiting | 1 | 0.1% | 0 (0.0%) | 1 (0.2%) | 0.193 | |
| Diarrhea | 3 | 0.3% | 3 (0.5%) | 0 (0.0%) | 0.182 | |
| Sneezing | 3 | 0.3% | 3 (0.5%) | 0 (0%) | 0.182 | |
| Nasal bleeds | 3 | 0.3% | 3 (0.5%) | 0 (0%) | 0.247 | |
| Chest pain | 3 | 0.3% | 2 (0.4%) | 1 (0.3%) | 0.688 | |
| Allergic reaction | 2 | 0.2% | 0 (0%) | 1 (0.3%) | 0.372 | |
| Ear pain | 2 | 0.2% | 1 (0.2%) | 1 (0.3%) | 0.606 | |
| Lymphadenopathy | 1 | 0.1% | 1 (0.2%) | 0 (0%) | 0.628 | |
| Skin symptoms: | 9 | 1% | 3 (0.5%) | 6 (1.8%) | 0.07 | |
| Rash | 1 | 0.1% | 1 (0.2%) | 0 (0.0%) | 0.441 | |
| Itching | 1 | 0.1% | 1 (0.2%) | 0 (0.0%) | 0.441 | |
| Erythema | 3 | 0.3% | 1 (0.2%) | 2 (0.6%) | 0.290 | |
| Swelling | 7 | 0.8% | 3 (0.5%) | 4 (1.2%) | 0.273 | |
| Skin signs due to extravasation of blood (ecchymosis, petechiae) | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Urticarial lesions | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Eczematous | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Angioedema | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
| Acne | 0 | 0% | 0 (0.0%) | 0 (0.0%) | ||
GIT, gastrointestinal tract, *A P-value is significant if <0.05; Chi-square test was used, **:The recorded unpleasant side effects were gathered into three groups (the recorded side effects after vaccination were classified into very common (≥ 1/10), common/frequent (≥ 1/100 and <1/10), uncommon/infrequent (≥ 1/1000 and <1/100), rare (≥ 1/10000 and <1/1000), and very rare (< 1/10000) according to the Council for International Organizations of Medical Sciences (CIOMS),[20] a) Very common side effects such as pain at the injection site (25.4%) followed by fatigue (23.7%), fever (19.8%), headache (18.2%), muscle pain (18%), joint pain (14.6%), and chills (13.1%); interestingly, females experienced more injection site-related pain, fatigue, headache, and muscle ache in comparison with males with a statistical significance (P=0.0001, 0.04, 0.01, and 0.0001, respectively), b) Common or frequent side effects were dizziness (6.3%), sore throat (5.3%), nasal symptoms (4.2%; n=31, 3.4% nasal congestion, and n=19, 2.1% runny nose), difficult sleep (2.9%), flush (1.5%), cough (1.4%), taste change (1.2%), dyspnea (1%), and with dizziness and difficult sleep more in females than males with a statistically significant difference (P=0.01 and 0.02, respectively), c) Uncommon or infrequent side effects include GIT-related side effects, which were three reported cases of diarrhea (0.3%), as well as three cases of abdominal pain (0.3%) and one (0.1%) case had vomiting. Cutaneous adverse reactions (CARs); seven cases of swelling (0.8%), three cases of erythema (0.3%), three issues of nasal bleeds (0.3%), and only one case each of itching and rash, three cases suffered from chest pain, two cases had an allergic reaction and ear pain, and one had lymphadenopathy without significant gender difference
The reported postvaccination symptoms concerning the participants’ age [Table 4].
Table 4:
Reported postvaccination symptoms concerning the age of the participants
| Age categories Characteristics | Frequency | (%) | 20-<40 n=534 | 40-60 n=305 | >60 n=70 | P |
|---|---|---|---|---|---|---|
|
Detailed symptoms raised due to the COVID-19 vaccine
| ||||||
| Pain at the injection site | 231 | 25.4% | 149 (27.9%) | 74 (24.3%) | 8 (11.4%) | 0.01* |
| Fatigue | 215 | 23.7% | 135 (25.3%) | 75 (24.6%) | 5 (7.1%) | 0.003* |
| Fever | 180 | 19.8% | 109 (20.4%) | 64 (21.0%) | 7 (10%) | 0.09 |
| Headache | 165 | 18.2% | 103 (19.3%) | 56 (18.4%) | 6 (8.6%) | 0.09 |
| Muscle pain | 164 | 18% | 106 (19.9%) | 53 (17.4%) | 5 (7.1%) | 0.03* |
| Joint pain | 133 | 14.6% | 83 (15.5%) | 47 (15.4%) | 3 (4.3%) | 0.03* |
| Chills | 119 | 13.1% | 79 (14.8%) | 36 (11.8%) | 4 (5.7%) | 0.07 |
| Dizziness | 57 | 6.3% | 39 (7.3%) | 18 (5.9%) | 0 (0%) | 0.05* |
| Sore throat | 48 | 5.3% | 32 (6.0%) | 15 (4.9%) | 1 (1.4%) | 0.260 |
| Nasal symptoms | 38 | 4.2% | 28 (5.2%) | 10 (3.3%) | 0 (0%) | 0.07 |
| Difficult sleep | 26 | 2.9% | 15 (2.8%) | 10 (3.3%) | 1 (1.4%) | 0.7 |
| Flush | 14 | 1.5% | 7 (1.3%) | 6 (2.0%) | 1 (1.4%) | 0.757 |
| Cough | 13 | 1.4% | 11 (2.1%) | 2 (0.7%) | 0 (0%) | 0.148 |
| Taste change | 11 | 1.2% | 6 (1.1%) | 5 (1.6%) | 0 (0%) | 0.506 |
| Dyspnea | 10 | 1.1 | 8 (1.5%) | 2 (0.7%) | 0 (0%) | 0.348 |
| Skin symptoms | 9 | 1% | 8 (1.5%) | 1 (0.3%) | 0 (0%) | 0.176 |
| GIT | 7 | 0.8% | 3 (0.6%) | 4 (1.3%) | 0 (0%) | 0.365 |
| Nasal bleeds | 3 | 0.3% | 3 (0.6%) | 0 (0%) | 0 (0%) | 0.348 |
| Chest pain | 3 | 0.3% | 0 (0%) | 3 (1.0%) | 0 (0%) | 0.05* |
| Allergic reaction | 2 | 0.2% | 0 (0%) | 1 (0.3%) | 0 (0%) | 0.371 |
| Ear pain | 2 | 0.2% | 2 (0.4%) | 0 (0%) | 0 (0%) | 0.495 |
| Lymphadenopathy | 1 | 0.1% | 1 (0.2%) | 0 (0%) | 0 (0%) | 0.704 |
GIT: Gastrointestinal tract, Analysis of variance (ANOVA) test was used to compare groups.; a P-value is significant if <0.05. *significant as it is <0.05
Hematological derangement after one month following vaccination [Table 5].
Table 5:
CBC changes before and after the first dose of AstraZeneca to healthcare workers
| Characteristics | Before 1st dose | After 1 month | P |
|---|---|---|---|
| TLC | |||
| Median (IGQ) | 6.20 (2.62) | 6.81 (3.20) | <0.001 |
| Mean±SD | 6.42±1.82 | 7±2.12 | |
| ALC | |||
| Median (IGQ) | 2.00 (0.80) | 2.2 (0.81) | <0.001 |
| Mean±SD | 2.12±0.65 | 2.34±0.68 | |
| ANC | |||
| Median (IGQ) | 3.30 (2.20) | 3.60 (2.50) | <0.001 |
| Mean±SD | 3.52±1.44 | 3.74±1.57 | |
| AMC | |||
| Median (IGQ) | 0.40 (0.20) | 0.50 (0.20) | <0.001 |
| Mean±SD | 0.42±0.14 | 0.50±0.19 | |
| PLT | |||
| Median (IGQ) | 249.50 (81.25) | 247.50 (74.50) | 0.323 |
| Mean±SD | 251.66±70.26 | 250.84±68.53 | |
| HB | |||
| Median (IGQ) | 14.65 (2.40) | 14.50 (2.40) | 0.021 |
| Mean±SD | 14.25±1.72 | 14.17±1.75 | |
AMN: Absolute monocyte count, ANC: Absolute neutrophil count, HB: Hemoglobin, SD: Standard deviation, PLT: Platelet, TLC: Total leukocyte count. A P-value is significant if >0.05
Characteristics of candidates who get infected by COVID-19 virus between the first and second doses of AZ vaccine: Sixty-six vaccine recipients got COVID-19 infection; the details are shown in Figure 2 [Table 6].
Figure 2:
The severity of COVID-19 infection after the first dose of the AstraZeneca vaccine
Table 6:
Socio-demographic criteria, chronic disease history, and COVID-19 infection status of vaccination-infected COVID-19 HCWs
| More than 14 days | Less than 14 days | P | |
|---|---|---|---|
| Number (%) | 54 (82) | 12 (18) | <0.0001 |
| Gender (male) (n (%)) | 32 (59) | 9 (75) | 0.02 |
| Age group (n (%)) | |||
| 20- | 34 (63) | 7 (58) | 0.3 |
| 40- | 11 (20) | 2 (17) | |
| 60- | 9 (17) | 3 (25) | |
| Occupation (n (%)) | |||
| Chemist | 2 (4) | 0 | 0.0003 |
| Doctor | 44 (81) | 12 (100) | |
| Nurse | 4 (7) | 0 | |
| Pharmacist | 3 (6) | 0 | |
| Secretary | 1 (2) | 0 | |
| History of chronic disease (n (%)) | |||
| DM | 1 (2) | 1 (8) | 0.07 |
| CVD | 7 (13) | 2 (17) | |
| COPD/asthma | 5 (9) | 1 (8) | |
| HTN | 2 (4) | 2 (17) | |
| Autoimmune disease | 0 | ||
| Renal disease | 0 | ||
| COVID-19 infection status (n (%)) | |||
| Critical | 1 (2) | 1 (8) | <0.0001 |
| Moderate | 9 (17) | 4 (33) | |
| Mild | 44 (81) | 6 (50) | |
| Severe | 0 | 1 (8) | |
| Outcome (n (%)) | |||
| Died | 1 (2) | 1 | 0.1 |
| Survival | 53 (98) | 11 | |
COPD: Chronic obstructive pulmonary disease, CVD: Cardiovascular disease, DM: Diabetes mellitus, HTN: Hypertension. Fisher's exact test, significant P- value >0.05
DISCUSSION
Vaccine development has generally been a lengthy process that averages 10–15 years. The mumps vaccine had the quickest period from antigen discovery to licensure, taking only four years. Vaccines for COVID-19 are being produced at a rate never seen before due to recent technological advancements and teamwork.[12] Nevertheless, vaccination safety communication difficulties exist.[13]
In Egypt, many rumors regarding vaccine safety have been spread among the general population, which made a barrier against vaccination and pushed us to investigate possible side effects after the AZ vaccine, especially its impact on blood elements.
More than half of the participants (62.2%) did not experience side effects, in line with a previous study.[14] In another large study (2026 candidates), the incidence of adverse events was similar among vaccine and placebo recipients.[15] However, another smaller study (400 candidates) found that most were symptomatic (93.5%) after the same type of COVID-19 vaccine.[16]
To investigate possible factors implicating the development of symptoms, gender, chronic illness, previous history of food, or drug allergy, previous COVID-19 infection did not ameliorate or exaggerate postvaccination adverse reactions previously found in another study.[14] Interestingly, participants aged 40–60 years suffered from a higher incidence of adverse reactions, unlike the results of previous research, which did not detect age deference.[14] However, younger people experienced more adverse effects than older people, as proven by another study.[17]
The most common postvaccination side effect was injection site pain. Generally, the National Centre for Immunization Research and Surveillance (NCIRS) agrees that vaccination site-related pain is the most experienced side effect regardless of the type of vaccine.[18] In agreement with our results, in a previous Saudi study, pain at the injection site after the AZ vaccine was presented in 85% of participants.[14] Fatigue and headache are also common complaints after Oxford–AZ vaccines in our study (23.7% and 18.2%, respectively). Still, it is much less than what has been reported by another study in which it was found that 90% and 62% of vaccinated people suffered from fatigue and headache, respectively,[14] and young age in that study may explain the higher incidence of these side effects.
Cutaneous adverse reactions (CARs) were very rare in our studied cohort; CARs from mRNA-based COVID-19 vaccines have been reported in the literature.[19] On the contrary, the adenoviral vector AZ vaccines remain scarce. In a large study (5322 participants), cases with CARs were 36, with a female preponderance, mainly in the form of urticaria, followed by eczematous reactions and angioedema.[21] However, we found that most CARs from AZ were nonserious and uncommon (≤ 1%), mainly in the form of local swellings, erythema, and rash.
GIT-related side effects were an uncommon side effect in our study. In a previous study, vomiting was very common (28% of cases),[14] while only 0.1% of our studied personnel complained of it.
It is important to include hematological tests in early vaccine trials to identify potential safety signals. Regarding the AZ vaccine, it was found to be associated with an accumulation of thrombotic events in association with thrombocytopenia, which resulted in a temporary suspension of inoculation in several countries,[22] unlike our results, which did not detect a significant difference in PLT count before and one month after vaccination. Interestingly, two cases of transient thrombocytopenia were detected and recovered after one week of follow-up. The concern of abnormal coagulopathy attracted the researchers with much less attention regarding the impact on white blood cells and their deferential count or hemoglobin levels. It is crucial to investigate ANC postvaccination as neutropenia is not uncommon, but many vaccine trials do not have a sampling schedule that allows its detection. Additionally, there is an ethnic variability in the level of circulating neutrophils, which thus necessitates ANC evaluation in different ethnicities.[5] Neutropenia was detected following the viral vector vaccine in previous studies[23]; on the contrary, in our research significant increase in TLC with raised ANC was detected.
Another important issue in our research was to study the people who get infected after the first dose. We detect more severe disease in those who got infected before 14 days. This phenomenon can be explained by the better immunological response observed after 14 days and proved by a previous large study, which found that postvaccine antibody responses showed positive anti-spike IgG results that increased over the 2–4 weeks after the first vaccination and varied significantly by age.[24] Another study investigated the efficacy after 28–34 days.[25]
Study limitations include the necessity to determine possible adverse reactions after the second dose and compare them to the first dose. It is noteworthy that our study was conducted when the thromboembolic complications of the AZ vaccine were announced, and some countries decided to postpone the second dose, so we included only side effects after the first dose. Moreover, the study was one of the earliest studies performed in our country when vaccination was selected for HCWs, so most of the participants were young, which may create a selection bias. It would be insightful if the study assessed the long-term side effects of the AZ vaccine, which was difficult due to the inaccessibility of candidates. Finally, follow-up of blood pictures to evaluate blood elements is a must to detect whether the link between the COVID-19 vaccines and possible hematological side effects relies heavily on temporal association or permanent effect.
CONCLUSIONS
This study assessed the short-term side effects associated with the COVID-19 AZ vaccine. We found that most of the vaccinated personnel did not experience any side effects after vaccination, with middle age groups (40–60) suffering from more unpleasant reactions, and most of the symptomatic participants reported pain at the injection site, fatigue, and fever. The finding of our study is reassuring for the concerned public about the safety of the available vaccines.
Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
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