Novavax Statement on Proof of Vaccination for Phase 3 Clinical Trial Participants in the United Kingdom
In the U.K., the National Health Service (NHS), Vaccines Task Force (VTF) and National Institute for Health Research (NIHR), are working to ensure that all who received NVX-CoV2373 will have their vaccination dates entered into the NHS App. For the most current information and status, please visit Important information for participants in light of COVID-19 vaccine deployment on the NIHR website.
We are grateful to the many thousands of participants who have volunteered in our clinical trials to help create a safer future for all.
Novavax recognizes the desire for participants in our U.K. Phase 3 clinical trial to have proof of vaccination as life begins to normalize. We firmly believe that clinical trial participants should not be disadvantaged in pursuing post-restriction activities and are actively supporting authorities on solutions for trial participants.
All participants who have remained blinded in our Phase 3 studies have had the opportunity to receive a full course of our investigational Novavax vaccine, which earlier this year demonstrated strong efficacy in clinical trials. A vaccination letter from Novavax is currently being made available from all trial sites.
Novavax remains focused on advancing development of NVX-CoV2373, including completion of our filing for regulatory authorization. The manufacture of a protein-based vaccine is complex, and we believe that we have overcome the primary challenges associated with the analytical work needed to complete our submission with the Medicines and Healthcare products Regulatory Agency (MHRA), which we expect during the third quarter of this year.
For more information, please see the Questions & Answers portion recently posted on the NIHR’s Be Part of the Research website available under Vaccine Passports/Certification and Travel – Study Vaccines.