en Vaccine development, efficacy and safety evaluation Vaccine development, efficacy and safety evaluation پژوهشي Research <strong>Introduction:</strong> Hepatitis B Vaccine (HBV) is a safe and effective vaccine that is nowadays recommended for all infants at birth as well as adults who could be exposed to hepatitis B virus. HBV can provide lifetime protection against hepatitis B virus infection. Despite its highly effective disease prevention, HBV can also cause adverse effects for the vaccinated population. A vast majority of Iran&#39;s population are vaccinated with recombinant hepatitis B vaccine (rHBV) which is manufactured by the Production and Research Complex of Pasteur Institute of Iran. <strong>Methods:&nbsp; </strong>The reported adverse events of rHBV, obtained from Diseases Management Center of Iran&rsquo;s Ministry of Health were compared with those in The Vaccine Adverse Event Reporting System (VAERS, a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention) during 2015 to 2017. <strong>Results:</strong> The most common adverse events after administration of rHBV, manufactured by Pasteur Institute of Iran was injection site reactions and no life threatening adverse event was observed. <strong>Conclusion:</strong> Despite reports by VAERS indicating that HBV can cause adverse events and even death in the United States, no such adverse effects were observed in rHBV manufactured in Iran. AEFI, rHBV, VAERS, CDC, Pasteur Institute of Iran 52 59 http://vacres.pasteur.ac.ir/browse.php?a_code=A-10-1-67&slc_lang=en&sid=1 Hamidreza Hozouri 0000-0002-1912-9395 No Department of Quality Management, Pasteur Institute of Iran, Tehran, Iran. Viral Vaccine Research Center, Pasteur Institute of Iran, Tehran, Iran. Alireza Shamsian Alireza Shamsian No Faculty of Pharmacy, Azad University, Tehran, Iran Mohammadreza Aghasadeghi 0000-0003-2186-0774 No 3Viral Vaccine Research Center, Pasteur Institute of Iran, Tehran, Iran. Delaram Doroud d_doroud@pasteur.ac.ir 0000-0003-4167-9921 Yes Viral Vaccine Research Center, Pasteur Institute of Iran, Tehran, Iran. Production and Research Complex, Pasteur Institute of Iran, Tehran, Iran.