Interim Study Findings and Timeline for FDA Application
- January 28, 2021: Novavax presented information concerning the status of the Phase 3 study of its vaccine candidate, NVX-CoV2373, being conducted in the United States and Mexico. This study is testing a 2-dose regimen, with the doses administered 3 weeks apart. The Company plans to enroll a total of 30,000 study participants, with two-thirds of the participants receiving the NVX-CoV2373 vaccine.
- As of January 27, 2021, a total of 16,748 people had been enrolled. The Company expects enrollment to be completed during the first half of February 2021 and that preliminary results may be available by April 2021.
- The Company expects the NVX-CoV2373 vaccine to be approved for emergency use first in the United Kingdom (UK) based on findings from the study reported below. However, the Company is also discussing the types of data needed to obtain an emergency use authorization in other countries around the world, including the United States.
- In the United States, the Food and Drug Agency could consider approving the NVX-CoV2373 vaccine for emergency use based on data from the UK study. In this case, emergency use authorization could be granted before the end of March 2021.
- Novavax is part of Operation Warp Speed and obtained $1.6 billion for vaccine research and the manufacture of 100 million vaccine doses.
- January 28, 2021: Novavax announced the results of interim analyses from the Phase 3 study of its vaccine candidate, NVX-CoV2373, being conducted in the United Kingdom (UK). This study is testing a 2-dose regimen, with the doses administered 3 weeks apart. The study enrolled more than 15,000 people between the ages of 18 and 84.
- In the interim analyses, the vaccine was nearly nearly 90% effective in preventing symptomatic COVID-19, beginning 7 days after the second dose. A total of 62 cases of symptomatic COVID-19 were observed (56 in the placebo group and 6 in the NVX-CoV2373 group). Only one participant developed severe COVID-19. This participant was in the placebo group.
- Of the 62 cases observed, 32 were caused by the UK variant of the SARS-CoV-2 virus and 24 were caused by the original virus first identified in Wuhan, China. (In the remaining 6 cases, the virus has not been sequenced.) Vaccine efficacy was estimated at 95.6% against the original virus and 85.6% against the UK variant.
- No safety concerns were identified.
- The final analyses will be conducted when a total of 100 cases have been observed.
- November 9, 2020: Novavax announced that its COVID-19 vaccine candidate, NVXCoV2373, has been granted Fast Track Designation by the US Food and Drug Administration (FDA). The Fast Track process is designed to streamline FDA review of new drugs and vaccines that may help treat or prevent a serious health problem. The goal is to get drugs and vaccines to patients as quickly as possible without compromising safety.
Participant Enrollment
- October 27, 2020: Novavax announced that 5,500 people have been enrolled in the Phase 3 trial being conducted in the United Kingdom to test its COVID-19 vaccine candidate, NVXCoC2373. (For more information about this study, see Table 3 under Phase 3 studies.) The company increased the planned number of study participants from 9,000 to 15,000 and expects to have all participants enrolled by the end of November 2020. This is an event-driven study. The first interim analysis will be performed when at least 66 people in the study have developed laboratory-confirmed symptomatic COVID-19. With the increase in the number of study participants, the company expects to be able to conduct their first interim analysis as soon as the first quarter (January-March) of 2021.
Around the World
- November 4, 2020: Novavax announced that it has signed a non-binding agreement with the Australian Government to supply 40 million doses of the company’s vaccine candidate, NVXCoC2373. The vaccine could be delivered as soon as the first half (January-June) of 2021. The agreement depends on whether the vaccine is shown to be safe and effective in ongoing Phase 3 trials and is approved for use by Australia’s Therepeutic Goods Administration (TGA). The TGA is equivalent to the Food and Drug Administration (FDA) in the United States. Novavax has established similar agreements with the governments in other countries, including: the United States, the United Kingdom, and Canada. They have also established agreements with partners to distribute the vaccine in Japan, South Korea, and India.