OBJECTIVES: As COVID-19 transitions from a global public health emergency to an endemic disease, individuals at increased risk of severe COVID-19 need continued protection due to the constant presence of the SARS-CoV-2 virus. The German Standing Committee on Vaccination (STIKO) recommends all authorized vaccines including NVX-CoV2373, the Novavax COVID-19 vaccine, as a primary series and booster dose. STIKO recommends an annual booster dose for the following high-risk groups: adults > 60 years, adults with chronic medical conditions, persons being cared for in nursing homes, and healthcare workers. To date, there are no real-world data in Germany describing the use of, reactogenicity, and satisfaction with NVX-CoV2373 boosters, particularly as infrequent use of NVX-CoV2373 makes recruitment for real-world studies challenging.
METHODS: To overcome challenges with traditional recruitment, the study will implement a novel direct-to-patient enrollment approach through online technology using study-specific algorithms that evaluate web traffic across more than 1,500 websites, social media platforms, mobile applications, and patient advocacy groups. If an individual’s online activity aligns with the algorithm, a study advertisement will appear, allowing the individual to indicate interest. Interested individuals will receive an email detailing the study design and a link to electronically consent and answer eligibility questions. After consenting, patients will participate in a video conference to provide proof of their NVX-CoV2373 booster and enroll in the study. Participants will then complete a survey to assess their perceptions of motivators of vaccine choice, impact on daily activities, reactogenicity, and overall satisfaction with the vaccine.
RESULTS: Data collection will begin in fall 2023. This cross-sectional study will enroll adults residing in Germany who received an NVX-CoV2373 booster within 30 days of enrollment.
CONCLUSIONS: Study will descriptively characterize users and describe reasons for receiving the NVX-CoV2373 booster and evaluate reactogenicity and any impact on daily activities following the booster dose.
