This Day On The Street
Continue to site right-arrow
ADVERTISEMENT
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Novavax Reports Positive Top-Line Results From Two Phase 1 Trials Of Pandemic Influenza Vaccine

Stocks in this article: NVAX

The adjuvanted vaccines induced strong immunogenicity at all antigen doses tested, including the lowest (3.75 µg) dose, based on hemagglutination inhibition assay (HAI) responses against the vaccine virus at day 42.

  • 88 to 100% of subjects receiving adjuvanted vaccine at all dose levels demonstrated serum HAI titers ≥40, a seroprotection level believed to be associated with reduced risk of disease.
  • 86 to 100% of subjects receiving adjuvanted vaccine at all dose levels demonstrated seroconversion rates with either a four-fold rise in HAI titer or a titer of ≥1:40 from a negative baseline.
  • Immune responses would fulfill U.S. Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) seroprotection and seroconversion criteria for accelerated approval at the lower bound of the 95% confidence level.
  • When tested against another avian A/H5N1 virus different from that in the vaccine, up to 80% of subjects receiving adjuvanted vaccine developed HAI titers ≥40 against the drifted virus.

Notably, in both trials the unadjuvanted vaccine elicited HAI titers ≥ 40 in >82% of subjects at a dose of 45 µg, which would fulfill CBER criteria for accelerated approval. The unadjuvanted vaccine also elicited HAI titers ≥40 in more than 52% of subjects against the drifted virus.

Gregory Glenn, M.D., Novavax' Senior Vice President and Chief Medical Officer, stated, "We have reviewed the preliminary top-line results of these trials and believe that achieving similar immune responses to our vaccine in future clinical trials, regardless of which of the two adjuvants is used, if any, would meet the immunogenicity criteria for accelerated approval of a pandemic influenza vaccine set by CBER. These data would also fulfill immunogenicity criteria set forth by the European Medicines Agency." Dr. Glenn added, "The response measured to the drift variant antigen is especially encouraging as the data suggest that our vaccine can be protective when the vaccine strain did not perfectly match a pandemic virus strain, which is an important consideration in the emergent response to a pandemic. We believe that with the results from these trials we have sufficient data to advance our avian influenza vaccine program into later-stage clinical testing."

2 of 3

Select the service that is right for you!

COMPARE ALL SERVICES
Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!

Markets

DOW 17,778.15 +421.28 2.43%
S&P 500 2,061.23 +48.34 2.40%
NASDAQ 4,748.3960 +104.0840 2.24%

Brokerage Partners

Rates from Bankrate.com

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs