Introduction:

COVID-19 vaccines are the foremost asset to overcome the ongoing pandemic; therefore,
mass vaccination has become a high priority for the world's governments. While
vaccination strategies need to be accelerated to minimise daily fatalities and relieve
the pandemic's economic burdens, vaccine hesitancy (VH) remains a serious challenge for
these efforts. VH refers to "delay in acceptance or refusal of vaccines despite
availability of vaccine services",; and it is an emerging public health challenge
nourished by misinformation related to vaccines effectiveness and safety. Aversion to
vaccines' potential side effects is the most frequent cause of VH among population
groups. Therefore, a recent systematic review revealed that raising public awareness of
vaccines' effectiveness and side effects is vital for improving vaccine uptake.

Public health systems globally experience a novel and unique challenge due to the variety
of vaccines manufacturers and the high levels of public awareness about those
manufacturers and their marketing strategies. This unprecedented situation is predicted
to create what we can refer to as "vaccine selectivity, " increasing the pressure on our
weakened health systems and economies and increasing vaccine hesitancy levels.
Independent (non-sponsored) studies with rigorous methods can perfectly lead the
pharmacovigilance efforts of COVID-19 vaccines globally. Given their independent nature
and transparent design, these studies can play a key role in suppressing vaccine
hesitancy levels by enhancing public confidence in vaccines.

Design

This project comprises two phases; a) a cross-sectional survey for the short-term side
effects of COVID-19 vaccines; b) a prospective cohort study for the long-term safety of
COVID-19 vaccines.

Phase A:

A validated self-administered questionnaire will be developed and delivered online to the
target population groups (HCW, OA & ST). The questionnaire will be inquiring about the
short-term side effects that emerged within 30 days following the vaccine shot (either
the first or the second dose). The side effects will be classified as local or systemic,
and their onset, duration, and intensity will be self-assessed and self-reported by the
respondents. This phase is proposed to take place until December 31st, 2021.

Phase B:

A validated self-administered questionnaire will be developed and delivered online to the
volunteers who participated in Phase A and expressed their interest to report their
long-term side effects. In this phase, the vaccine effectiveness and side effects will be
evaluated after booster doses. Phase B will take place for five consecutive years
starting from 2022.