Novavax

This sponsor has funded 5 studies across 27 countries.

PAS funded by this sponsor.
EU PAS ID Status RMP requirement Title Protocol uploaded Results uploaded
39096 Ongoing EU RMP category 3 COVID-19 Vaccines International Pregnancy Exposure Registry (C-VIPER) No No
42328 Ongoing EU RMP category 3 Brand-specific COVID-19 vaccine effectiveness against severe COVID-19 disease in Europe A contribution of COVIDRIVE, a public-private partnership to... Yes No
103858 Planned EU RMP category 3 Safety of the Novavax COVID-19 vaccine in England using a self-controlled case series design: A post-authorisation safety study using data from the... No No
104622 Ongoing EU RMP category 3 Safety Profile of the NVX-CoV2373 Vaccine in Individuals ≥ 12 Years of Age in the United States No No
105521 Ongoing EU RMP category 3 Effectiveness of the Novavax COVID-19 Vaccine in Reducing Clinically Defined Severe SARS-CoV-2 Infection in Individuals ≥ 12 Years of Age in the... No No

PAS by Risk Management Plan (RMP) requirement

Novavax

The RMP for a medical product outlines strategies to identify, assess, and mitigate risks, including PAS for further evaluation.

Category 1 studies are imposed as condition of marketing authorisation.
Category 2 studies are imposed as specific obligation of marketing authorisation.
Category 3 studies are required under other circumstances.