Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye.

BACKGROUND/OBJECTIVE(S)/INTRODUCTION: TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine, which was developed and recently granted emergency use authorization (conditional marketing authorization) in Türkiye. The objective of this study is to assess the spectrum and the distribution of adverse events reported following the administration of the first 150,000 doses as primary and booster vaccine doses in 22 state hospitals of 17 provinces in Türkiye. PATIENTS/MATERIALS AND METHODS: In this cohort study, a verbal survey was conducted via telephone calls between 10 January and 17 January 2022, utilizing a structured questionnaire algorithm on a sample group of 20,000 persons on the third- and seventh-days following vaccination. The algorithm consisted of two parts focusing on both systemic and local adverse effects. Other adverse events reported by the participants were also recorded. 6023 people and 5345 people agreed to participate in the telephone survey on the 3rd- and 7th- days of having received the first dose of the vaccine, respectively. RESULTS: Thirty-six-point-six percent of the participants on the 3rd day and 22.5% of the participants on the 7th day reported any adverse event following the first dose of the vaccine. On both follow-up days, the most commonly reported (29.7% for Day 3 and 13.1% for Day 7) adverse events were on the injection site. Among the local adverse events, the most frequently reported one was the pain on the injection site (27.9% for Day 3 and 12.4% for Day 7), induration (4.8% for Day 3 and 2.7% for Day 7) and swelling (3.5% for Day 3 and 2.0% for Day 7). Fatigue/weakness (9.6% for Day 3 and 8.3% for Day 7) and headache (7.9% for Day 3 and 8.0% for Day 7) were the most frequent systemic adverse events. Younger age, vaccine dose, and female sex were associated with having any adverse event and pain (on the injection site). Female sex was associated with more swelling (on the injection site), induration (on the injection site), fever, and a higher impact on daily living. CONCLUSION(S): In this study, we conducted a rapid assessment of adverse events following the first dose of the TURKOVAC vaccine. The vaccine appears to have a good safety profile in the first 7 days following vaccination. Younger age, vaccine dose, and female sex are associated with any adverse event and pain (on the injection site). These results present valuable information for the community and may contribute to increasing vaccine confidence.KEY MESSAGESAs a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, which has a favorable safety profile, can be an alternative to other COVID-19 vaccines including mRNA and viral vector vaccines.

Self-Reported Allergic Adverse Events Following Inactivated SARS-CoV-2 Vaccine (TURKOVAC™) among General and High-Risk Population.

TURKOVAC™ is a whole-virion inactivated COVID-19 vaccine which was developed and granted emergency use and conditional marketing authorization in December 2021 in Türkiye. The objective of this study is to assess the distribution and the severity of allergic adverse events following the administration of the vaccine as the primary or the booster dose in 15 provinces in Türkiye. In this cohort study, between February and May 2022, in the selected 15 provinces having an adequate number of health care personnel in the community health centers to conduct the study, 32,300 people having the first, the second, or the booster dose of the vaccine were invited to the survey. A total of 29,584 people voluntarily agreed to participate to the survey and were given a structured questionnaire after a minimum of 10 days following the vaccination. In our study, only 0.5% of the participants (142 persons) reported to experience any allergic reaction, and 12 of them (8.5%) reported to be given medical treatment in a health center. Male predominance (55.6%) was observed among participants reported to experience any allergic reaction. No hospitalization was recorded. Of the participants, 4.4% (1315 people) reported to have a history of allergy. The most reported allergens were drugs. Among the participants without a known history of allergy (n = 28,269), 0.4% of them (110 people) reported to experience an allergic reaction following the vaccination, and 5.4% of the allergic reactions (six people) were reported to be treated in a health center. The percentage of the participants given any medical treatment among the participants without a known history of allergy is 0.02%. No immediate or anaphylactic reaction was reported. Among the participants with a known history of allergy (n = 1315), 32 people (2.4% of them) reported to experience an allergic reaction following the vaccination, and 18.7% of the allergic reactions (six people) were reported to be prescribed a medical treatment. The percentage of the participants given any medical treatment among the participants with a known history of allergy is 0.4%. A known history of allergy increased the risk of having an allergic experience by approximately six times following vaccination. As a whole-virion inactivated SARS-CoV-2 vaccine, the TURKOVAC™ vaccine, with a low allergic reaction-related adverse event profile, can be an alternative to other COVID-19 vaccines.

Seasonal Influenza Vaccine Effectiveness in Preventing Laboratory Confirmed Influenza in 2014-2015 Season in Turkey: A Test-Negative Case Control Study.

BACKGROUND: Influenza has an important public health impact worldwide with its considerable annual morbidity among persons with or without risk factors and its serious complications among persons in high-risk groups. The seasonal influenza vaccine is essential for preventing the burden of influenza in a population. Since the vaccine is reformulated each season according to the virus serotypes in circulation, its effectiveness can vary from season to season. Vaccine effectiveness is defined as the relative risk reduction in vaccinated individuals in observational studies. AIMS: To calculate influenza vaccine effectiveness in preventing laboratory-confirmed influenza in the Turkish population for the first time using the national sentinel surveillance data in the 2014-2015 influenza season. STUDY DESIGN: Test-negative case-control study. METHODS: We compared vaccination odds of influenza positive cases to influenza negative controls in the national influenza surveillance in Turkey to estimate influenza vaccine effectiveness. RESULTS: The influenza vaccine effectiveness against influenza A (H1N1) (68.4%, 95% CI: -2.9 to 90.3) and B (44.6%, 95% CI: -27.9 to 66.6) were moderate, and the influenza vaccine effectiveness against influenza A (H3N2) (75.0%, 95% CI: -86.1 to 96.7) was relatively high; all had low precision given the low vaccination coverage. Overall, the influenza vaccination coverage rate was 4.2% (95% CI: 3.5 to 5.0), which is not sufficient to control the burden of influenza. CONCLUSION: In Turkey, national surveillance for influenza should be strengthened and utilised annually for the assessment of influenza vaccine effectiveness with more precision. Annual influenza vaccine effectiveness in Turkey should continue to be monitored as part of the national sentinel influenza surveillance.

[Molecular diagnosis and phylogenetic analysis of the first MERS case in Turkey]. / Türkiye'de tespit edilen ilk MERS olgusunun moleküler tanisi ve fi logenetik analizi.

Coronaviruses (CoV) are enveloped, spherical, single-stranded positive-sense RNA viruses causing mainly respiratory and intestinal infections in animals and humans. Until recently five types of human coronaviruses (HCoV-OC43, HCoV-HKU1, HCoV-NL63, HCoV-229E, SARS-CoV) have been known, however a novel CoV has been identified in 2012 in Saudi Arabia. This virus, namely MERS-CoV (Middle East Respiratory Syndrome Coronavirus), was classified within Coronaviridae family, Coronavirinae sub-family, Betacoronavirus genus, clade C. It causes acute respiratory infections in humans and transmits via respiratory route and close contact between humans. The aim of this study was to present the first MERS case from Turkey identified by molecular methods and the results of viral sequence analysis. A 42-year-old male Turkish citizen who worked as an employee in Jeddah, Kingdom of Saudi Arabia, admitted to hospital with the complaints of fever and malaise on 25-26 September 2014. Since his symptoms went on and got worse, he returned to Turkey, and hospitalized in a hospital's intensive care unit in Hatay on 6th of October with the symptoms of fever, malaise, sweating, cough and respiratory distress. He transferred to a university hospital on 8th of October and died on 11th October. The tracheal aspirate sample obtained before he died was sent to Virology Unit of Reference Laboratories of the Turkish Public Health Institution. Detection of viral RNA was performed by using a commercial real-time PCR kit (hCoV-EMC Real-Time RT-PCR, Fast Track Diagnostics, Luxembourg) targeting the MERS-CoV E protein (upE), ORF1a and ORF1b gene regions. The reference method Superscript III One Step RT-PCR (Invitrogen, USA) recommended by World Health Organization (WHO) was also applied for confirmation. Both of the methods yielded positive results for MERS-CoV RNA. For the amplification of nucleocapsid (N) and RNA-dependent RNA polymerase (RdRp) genes, hemi-nested PCR (Invitrogen, ABD) was conducted, followed by sequence analysis of 204 nucleotide part of N gene. Phylogenetic tree of N gene was obtained with the use of MEGA6 software. N gene was chosen as it comprised a two aminoacid deletion in the corresponding published sequence from the patient treated in London, United Kingdom. There was no nucleotide or aminoacid change in our isolate, namely ANK/1079/2014 when compared with human Betacoronavirus 2c EMC/2012 reference strain found in Genbank database. The target gene regions selected in our study (UpE, ORF1a, ORF1b, N and RdRp) which were also recommended by WHO, shown to have high specificity and sensitivity for the diagnosis and confirmation of MERS-CoV, and also recommended by WHO. The previous studies indicated that, the viral genomes detected in the earliest cases of humans (clade A) are genetically distinct from the others (clade B) which were isolated from dromedary camels and humans. In our study, according to phylogenetic analysis of partial N gene segment, isolate ANK/1079/2014 has taken place within clade A. In conclusion, MERS-CoV appears to have limited circulation in Arabian Peninsula and Middle-Eastern countries, it should be considered in mind that travel-related cases may export the virus outside these regions leading autochtonous infections in the other parts of the world.