Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the United States

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/105522
• EU PAS number:
  EUPAS105521
• Study ID:
  105522
• Official title and acronym:
  Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the United States
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  Observational retrospective comparative effectiveness database study to evaluate the effectiveness of the Novavax COVID-19 vaccine using the HealthVerity database. This Post-Authorization Effectiveness Study (PAES) will assess the effectiveness of a two-dose primary series Novavax COVID-19 vaccine in preventing clinically defined severe SARS-CoV-2 infection (i.e. COVID-19-associated hospitalization) compared to a matched contemporaneous cohort of unvaccinated individuals. Further, the effectiveness of the Novavax COVID-19 vaccine as a booster dose in preventing COVID-19 associated hospitalization compared to a matched contemporaneous cohort of eligible, but non-boosted individuals will be examined.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Aetion

Spain

Study timelines

Date when funding contract was signed

Actual: 14/12/2021

Study start date

Actual: 13/12/2018

Date of final study report

Planned: 24/09/2024

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Novavax

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)

Other study registration identification numbers and links

2019nCoV-403