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NVAX > Novavax RSV vaccine given to mothers also protects infants-study

http://finance.yahoo.com/news/novavax-announces-positive-top-line-105000855.html

The purpose of the Phase 2 trial was to evaluate the safety and immunogenicity of the RSV F Vaccine in healthy pregnant women. The trial also assessed the transplacental transfer of maternal antibodies induced by the vaccine, the impact of maternal immunization on infant safety during the first year of life and RSV-specific antibody levels through the infants' first six months of life.

The trial was a randomized, blinded, placebo-controlled Phase 2 trial which enrolled 50 healthy pregnant women in their third trimester. Women were randomized to receive either placebo or 120 micrograms of RSV F Vaccine adjuvanted with 0.4 mg of aluminum phosphate. They were followed through the remainder of their pregnancies, delivery and for an additional 180 days postpartum to assess safety and immunogenicity as measured by serum RSV anti-F IgG, microneutralizing, and palivizumab-competing antibody (PCA) titers. Upon delivery, umbilical cord blood samples were obtained to determine the titers of RSV PCA, anti-F IgG, and microneutralizing titers in their infants. Additional serum samples from the infant participants were obtained over the following six month period to provide a preliminary estimate of the half-life of vaccine-induced maternal antibodies.

Women in the vaccinated group demonstrated a geometric mean 14-fold rise in anti-F IgG, 29-fold rise in PCA, and 2-fold rise in microneutralization titers. In contrast, women who received placebo demonstrated no significant change in their antibody levels. At delivery, the geometric mean anti-F IgG antibody titer in immunized women was 7,244 Elisa Units (EU) and on average, the infants' antibody titer equaled 100% of the mothers' anti-F IgG antibody titer. The geometric mean PCA antibody titer was 212 micrograms/mL in immunized mothers and the average PCA antibody transfer within the mother-infant pairs was 90%. Finally, geometric mean microneutralizing antibody titers in immunized mothers were 759 and 481 micrograms/mL for RSV/A and RSV/B respectively, and the average microneutralizing antibody transfer within the mother-infant pairs was 90% for RSV/A and 100% for RSV/B. The estimated half-lives of infant PCA, anti-F IgG, RSV/A and RSV/B microneutralizing antibodies, based on data through day 60, were 41, 30, 36 and 34 days, respectively.

Gates Foundation Backs New Shot To Prevent Babies From Dying Of Pneumonia

http://www.forbes.com/sites/matthewherper/2015/09/29/gates-foundation-backs-new-shot-to-prevent-babies-from-dying-of-pneumonia/?utm_campaign=yahootix&partner=yahootix

The Bill and Melinda Gates Foundation will spend up to $89 million to fund the development of a vaccine against viral pneumonia. In return, the vaccine’s maker, Novavax, will make the shot available at an undisclosed, but cheap, price in developing countries if it proves effective.

The arrangement is a “big step forward,” says Keith Klugman, the director for pneumonia at the Gates Foundation. “We felt that this was a worthwhile investment to make sure that if the vaccine does work, and if it is licensed, that it will be made available to infants in the developing world virtually simultaneously with the developed world.”

Novavax’s vaccine targets the respiratory syncytial virus (RSV). This is the top cause of pneumonia in children under 1. Each year, RSV kills 160,000 children across the world, and is a leading cause of hospitalization in U.S. hospitals. It also causes respiratory infections in people of all ages, leading to problems in the elderly. But so far, the virus has evaded all attempts to create a vaccine to stop it.

What does exist is a drug called Synagis, sold by AstraZeneca , that is given to premature babies to reduce the severity RSV infection. The drug is rarely used, although because it can cost $6,000 per course, it generates $900 million in annual sales.