Evaluation of Adverse Effects Reported by Participants Following One Dose of TURKOVAC Vaccine via a Telephone Survey Study

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 certain characteristics of adverse effects reported by participants after the first dose following the administration of the TURKOVAC vaccine in a total of 22 hospitals affiliated with the Ministry of Health, located in 17 provinces in Türkiye.

In this study, between January 10 and February 18, 2022, a structured survey algorithm was administered verbally via telephone to a group of 20,000 people who had received the first dose of the TURKOVAC vaccine, on the third (January 10–17) and seventh (February 7–18) days following the first dose. This survey consists of two main sections in which local and systemic adverse effects were queried, respectively. In addition to the survey, other adverse effects specified by the participants were also recorded. Following the first dose, 6,023 people on the third day and 5,345 people on the seventh day agreed to participate in the telephone survey.

Following the first dose of the TURKOVAC vaccine; approximately one-third (36.6 percent) of the participants reported any adverse effects on the third day, and approximately one-fifth (22.5 percent) reported any adverse effects on the seventh day.

The most frequently reported adverse effects were local effects at the site where the vaccine was administered (29.7 percent on the third day, 13.1 percent on the seventh day). Among the local adverse effects, the most frequently reported were pain at the site where the vaccine was administered (27.9 percent on the third day, 12.4 percent on the seventh day), stiffness (4.8 percent on the third day, 2.7 percent on the seventh day), and swelling (3.5 percent on the third day, 2.0 percent on the seventh day).

Weakness/fatigue (9.6 percent on the third day, 8.3 percent on the seventh day) and headache (7.9 percent on the third day, 8.0 percent on the seventh day) were the most frequently reported systemic adverse effects.

It was found that being at the young age group, receiving repeated doses of the vaccine, and being of female gender increased the reporting of any adverse effects and specifically the occurrence of pain at the site where the vaccine was administered. Additionally, being of female gender was found to be associated with increased pain at the site where the vaccine was administered, swelling, fever, and the state of affecting daily life.

In this study, a rapid evaluation of the adverse effects reported after the first dose of the TURKOVAC vaccine was conducted. It was observed that the vaccine has a good safety profile within the first 7 days following the first dose. It is thought that the results of this study will contribute to an increase in confidence toward the vaccine for the public and healthcare workers.

To obtain more detailed information about this study, see:

Ateş Kara, Aslihan Coskun, Fehminaz Temel, Pervin Özelci, Selmur Topal & Ihsan Ateş (2023) Analysis of participant-reported adverse events following the first dose of inactivated SARS-Cov-2 vaccine (TURKOVAC™) through telephone survey in Türkiye, Annals of Medicine, 55:1, 1070-1079, https://doi.org/10.1080/07853890.2023.2183985