Public Unfortunately there is a difference between approval from the agency, and actual marketing plans. As noted below, I do not believe we are currently marketing or selling the refrigerated versions in the US market at this time. I can’t speak to marketing plans and why that is the case, just to what the current status is as far as I know. Additionally I would note that there could always be additional frozen vaccines in the future (I’m not aware of any currently but that doesn’t rule it out), so I think there is value to having a final comprehensive cold storage guidance in place for bother refrigerators and freezers. Best Regards, Rebecca Rebecca E. Gentile Associate Director, Quality Vaccine & Biological Stability West Point (WP70A-210) 215-652-0120 (work) 215-530-0165 (cell) From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Dr. Graham Barden Sent: Tuesday, September 04, 2018 7:54 AM To: 'Brooker, Rachel' Cc: 'vs@xxxxxxxxxxxxxxxxx' Subject: [vs] Need for vaccine freezers fading EXTERNAL EMAIL – Use caution with any links or file attachments. Rachel, Do you have any contacts at Merck or people on the committee who work at Merck? I just realized Varivax and ProQuad have finally been approved in the US (last year!) to be stored at refrigerator temps, 2-8C, and not frozen:
https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm094073.htm https://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm188806.htm I have never had a rep mention we should purchase the 4C version, so even if approved I do not know availability. In the pediatric world, these are the only vaccines we routinely keep frozen (MMR can be either). I know the refrigerated versions of the vaccines have been available everywhere but the US for a number of years. Just about the time we get the Freezer Specs ironed out, the vaccine most needing those specs can be stored in the refrigerator! Graham Barden Graham Barden MD FAAP DrBarden@xxxxxxxxxxxxxxxxxxxx Coastal Children's Clinic New Bern, NC 28562
www.coastalchildrens.com 252-633-2900 From: vs@xxxxxxxxxxxxxxxxx [mailto:vs@xxxxxxxxxxxxxxxxx] On Behalf Of Brooker, Rachel Sent: Monday, July 16, 2018 4:06 PM To: 'vs@xxxxxxxxxxxxxxxxx' Subject: [vs] Vaccine Storage 7/16 Comment file Hello Everyone, Attached is the comment file from today’s meeting. Since some of you did not receive my email last Thursday the August meeting will be open for discussion of TG suggested resolutions from June and July. We were not able to go through all the comments collected by email so I added the emailed comments to the file. They will be discussed at the next meeting but this will give you all a chance to prepare for those discussions. Also, because we were not able to get through them all we have decided to extend all future JC meetings to an hour and a half. I have already sent out the amended August invitation and will send the others in the next day or two. Lastly, it was also brought up that many members would not be able to attend the August meeting which was to have the CDC presentation but with so many gone Ralph and I will be discussing possibly changing the date or adding a new meeting. Best, Rachel Rachel M. Brooker Standards Development Liaison, Health Sciences NSF International ISO/TC249 US TAG Administrator Email: rbrooker@xxxxxxx Phone: 734.827.6866 Notice: This e-mail message, together with any attachments, contains information of Merck & Co., Inc. (2000 Galloping Hill Road, Kenilworth, New Jersey, USA 07033), and/or its affiliates Direct contact information for affiliates is available at
http://www.merck.com/contact/contacts.html) that may be confidential, proprietary copyrighted and/or legally privileged. It is intended solely for the use of the individual or entity named on this message. If you are not the intended recipient, and have received this message in error, please notify us immediately by reply e-mail and then delete it from your system.