Age- and Sex-Graded Data Evaluation of Vaccination Reactions after Initial Injection of the BNT162b2 mRNA Vaccine in a Local Vaccination Center in Germany

Abstract

A high vaccination rate of older and particularly chronically ill people against coronavirus disease-2019 (COVID-19) is likely one of the most important factors in containing the pandemic. When Germany’s vaccination campaign started on December 2020, vaccination prioritization was initially carried out starting with older population groups. Side effect rates in 1065 individuals who had received the first dose of the messenger ribonucleic acid (mRNA) vaccine BNT162b2 Tozinameran from BioNTech/Pfizer three weeks earlier were examined retrospectively. An age- and gender-graded data analysis showed clear age and gender differences with regard to vaccine-related adverse effects. In 77% of all individuals over 80 years of age, no local or systemic side effects were reported after the first vaccination, whereas in the age group up to 80 years, only 37% showed no side effects. In the whole study population, 64% of females and 73% of males reported no adverse effects. The initial vaccination with mRNA vaccine BNT162b2 shows an overall low profile of side effects. Particularly in those over 80 years, an extraordinarily good tolerance with equally good effectiveness is evident. The sex comparison showed that women suffer more often from adverse vaccination reactions. In order to achieve sufficient herd immunity, both age- and gender-dependent vaccination reactions and any difference in the maintenance of immunity should be considered in future vaccination strategies.

Impact of age, sex and medical history on adverse reactions to the first and second dose of BNT162b2 mRNA COVID-19 vaccine in Japan: a cross-sectional study

“…As for the severity of adverse reactions: the younger the vaccinated person, the more severe the adverse reaction(s), after both the first and second vaccination. This result seems to support reports of the existence of age and sex differences in response to the vaccine [ 26 ], and previous reports that the COVID-19 vaccine has a stronger immune response in females than in males and in young people than in the elderly [ 22 ]. This is probably due to the fact that antibody response to the vaccine is associated with sex hormone levels in both males and females, with females being more affected, as reported in the influenza H1N1 vaccine [ 27 ].…”

“…Since racial differences in immunity have been reported in the past [ 33 ], and the efficacy of COVID-19 vaccine is also reported to possibly be influenced by race [ 34 ], it cannot be said that the results of this study are necessarily applicable to other races. However, since there are similar reports from other regions with fewer Asians, it is quite possible that the results of this study apply to other races as well [ 22 ]. The second is selection bias.…”

“…However, there is still limited data on which vaccine recipients are most likely to have adverse reactions. Hoffmann et al stated that adverse reactions in vaccinated persons who received the first dose of BNT162b2 in Germany were less common in persons over 80 years of age and in males [ 22 ]. From Korea, Bae et al reported that there was no sex difference in adverse reactions in vaccinated subjects who received the first dose of BNT162b2, but the incidence was higher in younger age groups [ 23 ], and Lee et al reported that the frequency of adverse reactions in vaccinated subjects who received the second dose of BNT162b2 was significantly higher in females and that the incidence was lower in older age groups [ 24 ].…”

Correlation of Immunogenicity and Reactogenicity of BNT162b2 and CoronaVac SARS-CoV-2 Vaccines

“…In the CoronaVac group, headache, tiredness, muscle pain, and injection site pain were more prevalent in females than in males ( Table 3 ). The different levels of vaccine-related AEs between women and men have also been reported by other studies ( 16 , 17 ). A clinical study has pointed out that female participants receiving the BNT162b2 vaccine suffer from more frequent local and systemic vaccination reactions than men ( 16 ).…”

Association between Immunoglobulin G Levels and Adverse Effects Following Vaccination with the BNT162b2 Vaccine among Japanese Healthcare Workers

“…COVID-19 vaccines were developed rapidly for general use, and various side effects have been reported worldwide [ 14 , 15 ]. The rate of adverse effects of COVID-19 vaccines differs between countries because the type of vaccines used also differs by country [ 16 ]. Adverse effects range from mild to severe, including localized reactions, such as swelling and a rash at the injection site, and systemic reactions, including dyspnea and anaphylaxis [ 12 , 17 ].…”