FDA Reviews Update To Pfizer Vaccine For Kids
WASHINGTON (AP) ¿ Federal health officials on Monday questioned whether to approve an updated version of Pfizer's best-selling anti-infection vaccine for children, despite company studies that failed to meet certain goals.
The Prevnar 13 vaccine reduces risk of infection by 13 varieties of pneumococcal disease, which causes ear infections, meningitis and pneumonia. The new version of the vaccine protects against six more varieties of the disease.
But Food and Drug Administration reviewers said that company studies failed to meet the preselected goals for three types of the disease, according to documents posted online.The missed goals were statistical measures for vaccine response selected by the FDA. However, since no other vaccine fights the same strains of the disease as Prevnar, the FDA said the significance of the missed goals "may not be clear." Dr. Emilio Emini, Pfizer's chief of vaccine research, said the missed goals were due to statistical groupings of patients in the study, not a flaw with the vaccine itself. Pfizer's briefing documents note that the World Health Organization's vaccine guidelines say meeting the study goals in question is "desirable, but not an absolute requirement."
Select the service that is right for you!COMPARE ALL SERVICES
Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.
- $2.5+ million portfolio
- Large-cap and dividend focus
- Intraday trade alerts from Cramer
- Weekly roundups
Access the tool that DOMINATES the Russell 2000 and the S&P 500.
- Buy, hold, or sell recommendations for over 4,300 stocks
- Unlimited research reports on your favorite stocks
- A custom stock screener
- Upgrade/downgrade alerts
Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.
- Diversified model portfolio of dividend stocks
- Alerts when market news affect the portfolio
- Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
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.
- Real Money + Doug Kass Plus 15 more Wall Street Pros
- Intraday commentary & news
- Ultra-actionable trading ideas
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.
- 100+ monthly options trading ideas
- Actionable options commentary & news
- Real-time trading community
- Options TV