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THIS REPLACED PCV 7 AND AS A RESULT WE ALSO DEVELOPED ROUTINE RECOMMENDATIONS, AND PERMISSIVE RECOMMENDATIONS FOR 16 YEARS OLD WITH COMPROMISING CONDITIONS. IN DECEMBER 2013 PCV13 WAS LICENSED FOR ADULTS OLDER THAN OR EQUAL TO 50 YEARS OF AGE. AT THE FEBRUARY MEETING THIS YEAR 2012 WE DEFERRED ROUTINE RECOMMENDATIONS FOR ADULTS FOR TWO REASONS, ONE WAS TO WAIT FOR THE RESULTS OF THE CAPET TRIAL, WHICH WE ARE STILL AWAITING AS YOU KNOW AND SECOND WAS Too ABLE TO OBSERVE THE INDIRECT EFFECTS OF IMMUNIZING CHILDREN WITH PCV13. IN JUNE 2012 WE MADE RECOMMENDATIONS FOR THE USE OF PCV13 IN ADULTS WITH IMMUNOCOMPROMISED CONDITIONS, AND THEN IN JANUARY 2013, PCV WAS LICENSED FOR CHILDREN 6 TO 17-YEAR-OLDS, 17 YEARS OLD AND AT THAT POINT WE MADE RECOMMENDATIONS AT THE FEBRUARY MEETING FOR 6 TO 18 YEARS OLD WITH IMMUNOCOMPROMISED CONDITIONS, THUS HARMONIZING THE ADULT AND CHILDHOOD RECOMMENDATIONS. SO FOR TODAY, WE ARE REALLY IN A DIFFERENT ERA. PNEUMOCOCCAL CONJUGATE VACCINES HAVE BEEN USED IN THE U.S. FOR 12 YEARS AND IT'S BEEN ON A FOUR-DOSE SCHEDULE, TWO MONTHS, FOUR MONTHS, SIX MONTHS AND SOMEWHERE BETWEEN 12 AND 15 MONTHS OF AGE. THE USE OF PCV7 HAS LED TO REDUCTIONS IN OT ITIS MEDIA AND LARGE REDUCTIONS IN INVASIVE PNEUMOCOCCAL DISEASE AND PNEUMONIA IN CHILDREN AND ADULTS. WE ARE NOW CONFRONTING INCREASING EVIDENCE THAT IS EMERGING SUPPORTING A THREE-DOSE PCV SCHEDULE. THERE HAVE BEEN SEVERAL RANDOMIZED CONTROL TRIALS EVALUATING THE EFFICACY AND IMMUNOGENICITY OF A THREE-DOSE SCHEDULE AND OBSERVATIONAL STUDIES HAVE LOOKED AT THE IMPACT. THERE ARE AT LEAST 34 HIGH OR UPPER MIDDLE INCOME COUNTRIES THAT HAVE ADOPTED A THREE-DOSE SCHEDULE. EITHER WITH PCV13 OR PCV10. THE OBJECTIVES FOR TODAY'S SESSION IS NOT TO DISCUSS OR POLICY DIRECTIONS SPECIFICALLY, BUT RATHER TO LOOK AT THE INFORMATION THAT'S AVAILABLE FOR THAT PC VK V13 FOR A THREE-DOSE SCHEDULE AND DISCUSS A THREE-DOSE SCHEDULE IN THE ROUTINE CHILDHOOD SCHEDULE FOR PCV13. WE HAVE TWO SPECIFIC QUESTIONS FOR THE COMMITTEE THAT WE ARE POSING TODAY. ONE IS, IS THE EVIDENCE ADEQUATE TO CONSIDER INCLUDING A THREE-DOSE PCV13 SCHEDULE FOR INFANTS, AND SECONDLY, IF NOT, WHAT ADDITIONAL DATA OR INFORMATION WOULD BE REQUIRED FOR THE COMMITTEE? THIS WOULD GIVE DIRECTION TO THE WORK GROUP IN HOW WE SHOULD MOVE FORWARD IN CONSIDERING A THREE-DOSE SCHEDULE IN THE UNITED STATES. SO TODAY WE HAVE THREE PRESENTATIONS, THE FIRST IS AN UPDATE ON THE INDIRECT AND DIRECT EFFECTS AND VACCINE EFFECTIVENESS OF PCV13 AND MATT MOORE WILL GIVE THAT. SECOND LY TAMARA PILISHVILI WILL REPORT AND SHARE WITH YOU All the DATA THAT THE WORK GROUP HAS REVIEWED REGARDING REDUCED DOSE SCHEDULES FOR PCV13 FOR CHILDREN, AND THEN LASTLY, CHARLES STICKER WILL DISCUSS COST EFFECTIVENESS OF PCV13 REDUCED DOSE SCHEDULES. THANK YOU SO MUCH, AND WE HOPE THAT YOU WILL CONTRIBUTE TO THIS DISCUSSION AND GIVE THE WORK GROUP GOOD DIRECTION. SO FIRST WE'RE GOING TO HEAR FROM DR. MOORE. >> THANK YOU VERY MUCH, DR. BENNETT AND THANKS VERY MUCH...
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