This Day On The Street
Continue to site
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

FDA Reviews Update To Pfizer Vaccine For Kids

MATTHEW PERRONE

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."
1 of 3

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
Dividend Stock Advisor

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
  • Updates with exact steps to take - BUY, HOLD, SELL
Trifecta Stocks

Every recommendation goes through 3 layers of intense scrutiny—quantitative, fundamental and technical analysis—to maximize profit potential and minimize risk.

Product Features:
  • Model Portfolio
  • Intra Day Trade alerts
  • Access to Quant Ratings
Options Profits

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

Product Features:
  • Actionable options commentary and news
  • Real-time trading community
SYM TRADE IT LAST %CHG
PFE $36.15 0.25%
AAPL $118.44 -2.36%
FB $94.14 0.14%
GOOG $631.21 0.90%
TSLA $259.99 -2.31%

Markets

Chart of I:DJI
DOW 17,598.20 -91.66 -0.52%
S&P 500 2,098.04 -5.80 -0.28%
NASDAQ 5,115.3820 -12.8990 -0.25%

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs