The 2019 novel coronavirus disease [COVID-19] is an exceedingly transmissible disease of the respiratory tract, first isolated in December 2019 in Wuhan, Hubei Province, China, and then expanding globally. It triggers a severe acute respiratory syndrome named coronavirus disease 2019 (COVID-19) . In March 2020, the World Health Organization (WHO) announced COVID-19 to be a global pandemic. Over the following two years, COVID-19 affected millions of people across the world, with a high mortality rate and a lack of a defined treatment protocol [1,2,3]. The disease affected various aspects of life, including but not limited to social, economic and health aspects . Clinically, COVID-19 symptoms ranged from asymptomatic or mild upper respiratory tract symptoms to severe and fatal respiratory distress syndrome. It has also been reported to affect other organ systems, mainly the gastrointestinal tract .
The possible effect of COVID-19 on reproductive health and especially male fertility has been a point of discussion by the scientific community and the public since the start of the pandemic. It was suggested that SARS-CoV-2 affects male fertility relies on its ability to cross the blood-testis barrier and its binding to the angiotensin-converting enzyme 2 (ACE2) in Leydig cells [6,7,8]. Others have suggested that SARS-CoV-2 affects spermatogenesis via an immune-mediated type of orchitis or the disease-associated inflammatory response .
As in many other viral diseases, in response to the COVID-19 pandemic, different types of vaccines were made, aiming at minimising disease severity, and in turn its adverse social and economic effects. Pfizer-BioNTech mRNA COVID-19 vaccine received the U.S. Food and Drug Administration (FDA) approval on August 23, 2021, for individuals ages 16 years and older . Pfizer-BioNTech mRNA COVID-19 vaccine is mainly composed of messenger ribonucleic acid (mRNA), lipids, salts, and sugars .
The list of approved vaccines has been extended to include many other internationally and locally accepted vaccines such as Moderna, Janssen and AstraZeneca. In Iraq, the first vaccine that gained local authorities’ approval and was licensed for use was the Sinopharm vaccine, followed by Pfizer-BioNTech and then AstraZeneca. However, most of the vaccinated Iraqis have received the Pfizer-BioNTech mRNA COVID-19 vaccine, mainly related to the availability of this vaccine possible by the US government donations and Iraqi Ministry of Health Contracts.
Since the start of the COVID-19 pandemic, there was a great deal of debate and discussion on the possible effects of COVID-19 on male fertility. This discussion has been extrapolated to the use of different COVID-19 vaccines. The fear of adverse effects of the COVID-19 vaccine on male fertility has always been a reason for vaccination hesitancy among the public . Recent reports have explored the effects of mRNA COVID-19 vaccines on male infertility [4, 12, 13]. In two small prospective cohort studies of healthy men, Gonzalez et al.  and Lifshitz et al.  did not observe a reduction in semen parameters up to 90 days after COVID-10 mRNA vaccination. However, these studies enrolled only a small number of young and healthy men from the United States and Israel. In order to provide more data on the matter of COVID-19 vaccines and male infertility, we designed this study to evaluate and estimate the safety of the Pfizer-BioNTech mRNA COVID-19 vaccine on male fertility as represented by the semen parameters in a sample of Iraqi men. We believe more data is needed regarding the topic from different countries and patient cohorts.