Evaluation of Self-Reported Allergic Adverse Events Following the Administration of TURKOVAC Vaccine Among the General Group and Individuals with a History of Allergy

TURKOVAC vaccine is a COVID-19 vaccine developed, produced, and licensed in Türkiye, which is inactive, meaning it contains an inactivated virus that does not cause disease but generates an immune response.

The aim of this study is to evaluate the distribution and severity of allergic adverse events reported to have occurred following the administration of the TURKOVAC vaccine as the first, second, or booster dose in 15 provinces in Türkiye.

For this purpose, between February and May 2022, 32,300 people, who had been administered the first, second, or booster dose of the vaccine, were invited to the study in 15 selected provinces that had a sufficient number of personnel to conduct the study in community health centres.

Following the invitation, a survey was administered to 29,584 people who voluntarily agreed to participate in the study, at least 10 days after the administration of the vaccine, to obtain information regarding allergic adverse events.

In the study, only 142 of the 29,584 participants (5 per thousand) reported experiencing any allergic condition after the vaccine. Among these 142 individuals, 12 people (8.5 percent) stated that they were given treatment in a health centre for this reason. A male dominance (approximately one in every 2 people) was observed among the participants who reported experiencing any allergic reaction. No hospitalizations were reported among the participants who reported experiencing any allergic reaction. Among the participants, 1,315 people (4.4 percent) declared that they had a history of allergy prior to the vaccine administration. In this group with a history of allergy in their past, various medications were reported as the most frequently declared cause of allergy.

Among the remaining 28,269 people who reported having no previously known history of allergy, 110 people (4 per thousand) reported having experienced an allergic reaction following the administration of the vaccine, and 6 of these 110 people (5.4 percent) declared that they received treatment in a health centre. The percentage of having received any medical treatment among participants without a previously known history of allergy was determined to be 2 per thousand.

Among the 1,315 participants with a previously known history of allergy, 32 people (2.4 percent) reported having experienced an allergic reaction following the administration of the vaccine, and 6 of these individuals (18.7 percent) declared that they received treatment in a health centre. The frequency of having received any medical treatment among participants with a previously known history of allergy was determined to be 4 per thousand.

No life-threatening conditions that develop suddenly or are defined as "anaphylaxis," requiring hospitalization and the administration of medication, were reported by the participants following the administration of the vaccine.

In the study, it was observed that a known history of allergy can increase the risk of developing an allergic reaction based on self-declaration following the administration of the vaccine by approximately 6 times, but this situation does not create a serious hospitalization condition.

Therefore, TURKOVAC™, which is a COVID-19 vaccine with a history of low allergy-related adverse effects, can be an alternative to other COVID-19 vaccines.

To obtain more detailed information about this study, see:

Kara, A.; Coskun, A.; Temel, F.; Özelci, P.; Topal, S.; Ates, ˙I. Self-Reported Allergic Adverse Events Following Inactivated SARS-CoV-2 Vaccine (TURKOVAC™) among General and High-Risk Population. 
Vaccines 2023, 11, 437. https:// doi.org/10.3390/vaccines11020437