June 24, 2014

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Announcements

ANNOUNCEMENTS


NQF Draft Report Available for Public Comment: “Priority Setting for Health Care Performance Measurement: Getting to Measures that Matter for Adult Immunizations”

The draft report of the National Quality Forum (NQF) and its accompanying environmental scan of measures, titled “Priority Setting for Health Care Performance Measurement: Getting to Measures that Matter” are now available for public comment on the NQF website. The public comment period will close at 6 p.m. (ET) on July 14. The final report will be delivered to HHS and posted on NQF’s website on August 15, 2014.

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GSK Received Warning Letter from the FDA about Inspection at Influenza Vaccine Manufacturing Facility

On June 12, 2014, GSK received a Warning Letter from the U.S. Food and Drug Administration  (FDA) relating to an inspection FDA carried out in early April 2014 at its influenza vaccine manufacturing facility in Ste-Foy, Quebec, Canada. Pending FDA approvals, GSK anticipates providing between 28–33 million doses of flu vaccine to US for 2014–15 season in a timely fashion. The number of doses estimated at the NAIIS face-to-face meeting was 35 million. Access the June 24 press release: “GSK Statement: FDA Warning Letter – Ste-Foy Manufacturing Facility.” The NAIIS is working with GSK to see if a call can be arranged in the next week to update Summit partners on this issue. We will let the Summit know once this can be arranged.


Summit Meetings Cancelled on June 26 and July 3

In the meantime, due to the Advisory Committee on Immunization Practices (ACIP) meeting and the July 4th holiday, the regular Summit calls on June 26 and July 3 are cancelled.


Update on NAIIS Meeting

Presentations and other materials seen at the NAIIS face-to-face meeting are live on the Summit website at: www.izsummitpartners.org. Summit partners can find materials produced and presented by the Summit’s WGs on the WGs’ individual home pages. Thanks to everyone who submitted responses to the survey. We will present the results as soon as the data is analyzed. Additionally, we anticipate that a written summary of the Summit meeting will be available shortly.


FDA Licensed Novartis Manufacturing Facility in Holly Springs, N.C. for the Production of Cell-culture Influenza Vaccine

Novartis announced on June 13, 2014, that the FDA licensed its manufacturing facility in Holly Springs, N.C. for the production of cell-culture influenza vaccines. This is the first US facility of its kind and is now approved for commercial production. The site will produce seasonal and pre-pandemic influenza vaccines, and has the capacity to significantly ramp up production in the event of a pandemic. Access the announcement: “Novartis Holly Springs facility becomes first US pandemic-ready site licensed by the FDA to produce cell-culture influenza vaccines“.


Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine

Pfizer announced on Tuesday, June 17, 2014, the filing to the FDA of bivalent rLP2086, Pfizer’s recombinant vaccine candidate currently under development for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroup B. Access the press release: “Pfizer Announces Submission of Biologics License Application to the FDA for Investigational Meningococcal B Vaccine.”


Reminder: Please email L.J or LaDora if you have any updates on activities to provide to the Summit.

 

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