Novavax Continues Phase 3 Trial of the RSV F Vaccine for Infants via Maternal Immunization and Provides Update on Phase 1/2 Trial of the NanoFlu™ Vaccine
- RSV F Vaccine informational analysis completed in fourth quarter of 2017
- RSV F Vaccine interim analysis expected mid-2018 with approximately 4,600 enrollees
- Filing of RSV F Vaccine BLA anticipated by late 2019
- NanoFlu Vaccine data package to be completed and released in
RSV F Vaccine for Infants via Maternal Immunization
“Novavax has completed an informational analysis of our Phase 3 trial of the RSV F Vaccine for infants via maternal immunization using threshold criteria for a commercial product. As a result, we are accelerating our Phase 3 trial enrollment into 2018. Our maternal immunization program is supported by an
A number of key scientific developments regarding influenza vaccines for the current season have occurred and relate to our NanoFlu program, including:
November 29, 2017, editorial in the New England Journal of Medicine1 detailed public health concerns related to the poor efficacy of existing seasonal influenza vaccines that is due, in part, to genetic changes or drift in the hemagglutinin (HA) protein, leading to low vaccine efficacy
- Based on analyses from the Southern Hemisphere, the effectiveness of the seasonal influenza vaccine was as low as 10% for the A(H3N2) strain2
November 6, 2017, Proceedings of the National Academy of Sciences3 publication identified that the circulating influenza A(H3N2) virus contains an HA structure that has been lost in the corresponding vaccine strain during adaptation to be grown in eggs (“egg-adapted”) as part of the typical seasonal influenza vaccine manufacturing process, which, in turn, affects vaccine efficacy for egg-based vaccines
- Novavax’ NanoFlu vaccine candidate is designed specifically to address these challenges
- The wild-type viruses necessary to assess immunogenicity of the vaccines to circulating strains have been difficult to obtain, grow and maintain genetic stability
- Therefore, a complete Phase 1/2 data package expected in
“Recent information published presents both an opportunity and a challenge for our NanoFlu Vaccine program. First, we have the unique opportunity to determine whether our recombinant, adjuvanted NanoFlu vaccine can address egg-adapted virus mismatch. We can also observe whether our vaccine-induced antibodies can neutralize circulating viruses with antigenic drift in humans, as we demonstrated in our ferret study earlier this year,” said
Respiratory syncytial virus (RSV) is the most common cause of lower respiratory tract infections and the leading viral cause of severe lower respiratory tract disease in infants and young children worldwide, with estimated annual infection and mortality rates of 64 million and 160,000, respectively4. In the US, RSV is the leading cause of hospitalization of infants5. Despite the induction of post-infection immunity, repeat infection and lifelong susceptibility to RSV is common6,7. Currently, there is no approved RSV vaccine available.
Influenza is a world-wide infectious disease that causes illness in humans with symptoms ranging from mild to life-threatening or even death. Serious illness occurs not only in susceptible populations such as pediatrics and older adults, but also in the general population largely because of infection by unique strains of influenza for which most humans have not developed protective antibodies. An estimated one million deaths each year are attributed to influenza8. Current estimates for seasonal influenza vaccine growth in the top seven markets (U.S.,
About Fast Track
The Fast Track Drug Development Program was established under the FDA Modernization Act of 1997. A Fast Track designation is intended for products that treat serious or life-threatening diseases or conditions, and that demonstrate the potential to address unmet medical needs for such diseases or conditions. The program is intended to facilitate development and expedite review of drugs to treat serious and life-threatening conditions so that an approved product can reach the market expeditiously. Specifically, Fast Track designation facilitates meetings to discuss all aspects of development to support licensure and it provides the opportunity to submit sections of a Biologics License Application (BLA) on a rolling basis as data become available, which permits the
1. Paules, C. I. et al. Chasing seasonal influenza – The need for a universal influenza vaccine. NEJM, 2017. DOI: 10.1056/NEJMp1714916.
2. Sullivan, S. G. et al. Low interim influenza vaccines effectiveness,
3. Zost, S.J., et al. Contemporary H3N2 influenza viruses have a glycosylation site that alters binding of antibodies elicited by egg-adapted vaccine strains. PNAS, 2017, 12578-12583, doi: 10.1073/pnas.1712377114.
4. Nair, H. et al. Global burden of acute lower respiratory infections due to respiratory syncytial virus in young children: a systematic review and meta-analysis. Lancet, 2010; 375: 1545-1555.
5. Hall, C.B. et al. Respiratory Syncytial Virus-Associated hospitalizations Among Children Less Than 24 Months of Age. Pediatrics, 2013; 132(2): E341-348.
6. Glezen, W.P. et al. Risk of primary infection and reinfection with respiratory syncytial virus. Am J Dis Child, 1986; 140:543-546.
7. Glenn GM, et al. Modeling maternal fetal RSV F vaccine induced antibody transfer in guinea pigs. Vaccine, 2015, http://dx.doi.org/10.1016/j.vaccine.2015.08.039.
8. Resolution of the
9. Influenza Vaccines Forecasts. Datamonitor (2013)
Statements herein relating to the future of
Source: Novavax, Inc.