Overview of the
Vaccines for Children (VFC)
Recommendations & Requirements
For Vaccine Storage & Handling
Steve VanTine
Sr. Field Services Representative (Bay Area Region)
California Dept. of Public Health
Communicable and Infectious Disease Division
Immunization Branch
Same price as the 2012 Lexus CT 200h
803 vaccine doses
15cu ft. refrigerator
$32,000. worth of vaccine
Required Vaccine Storage
Temperatures
Refrigerator
35°- 46° F
(2°-8° C)
Freezer
Varicella, MMR, MMRV,
Zostavax
+ 5° F (-15° C) or colder
32°F. is freezing
Effect of temperature on vaccines
Inactivated vaccines and toxoids
Too cold
(freezing 32°F. or below)
 Adjuvanted – Adjuvants enhance immune response to an
antigen. Antigen and adjuvant bond is immediately and
irreversibly broken; adjuvant effect is lost.
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Hep A
Hep B
diphtheria-tetanus-pertussis (DTaP, Tdap)
Haemophilus influenzae type b (Hib)
human papillomavirus (HPV)
Pneumococcal
 Non-adjuvanted- denaturing protein, structural damage
Effect of temperature on vaccines
Inactivated vaccines and toxoids
Too warm (above 35°- 46ºF.)
Damage is gradual
Very stable compounds.
 All inactivated vaccines can tolerate room
temperature (~77ºF.) for ~ 72 hours
Effect of temperature on vaccines
Live vaccines
Freezing 5°F. or below
 Lyophilized is freeze dried - undiluted, any
lyophilized vaccines cannot be damaged by
freezing (including inactivated
 Caution: DO NOT FREEZE DILUENT
Effect of temperature on vaccines
Live vaccines
Too warm ( above 5ºF.)
Damage is rapid or “quick”
 Varicella – does not tolerate any heat
 MMR also heat sensitive (store between - 58F to
46F). Although stable in either the refrigerator or
freezer, we recommended to store in freezer.
Best practices for vaccine storage
 Store only vaccine in vaccine storage units.
 Separate the VFC vaccine supply from privately purchased vaccine.
 Keep vaccines in their original boxes until you are ready to use them. Some
vaccines are sensitive to UV light (i.e. HPV, MMR, MMRV, rotavirus, varicella,
and zoster vaccines)
 Group vaccines by pediatric, adolescent, and adult types.
 Place vaccine in breathable plastic mesh baskets and clearly label baskets by
type of vaccine.
 Keep baskets 2-3 inches from walls and other baskets.
 Keep vaccines with shorter expiration dates to front of shelf.
 Transfer short-dated vaccine
 If you have vaccine that will expire in 4 months or less, contact other VFC
Providers to see if they can use the vaccine prior to the expiration date.
 Keep refrigerator temperatures between 35ºF to 46ºF. Aim for 40º F
 Keep freezer temperatures at 5ºF or below.
What NOT to do…
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No vaccine in doors, along walls
No vaccine in solid plastic trays or containers.
No food or lab specimens in refrigerator.
No vaccine in drawers or on floor of refrigerator.
 Never plug into outlet controlled by wall
switch.
 Do not ignore out of range temperatures
What’s wrong with this picture?
What’s wrong with this picture?
 Dormitory-style unit
 Ice in freezer unit
 Too much vaccine for size
 Soda in the door
 Lab specimen in the fridge
 Vaccine on top shelf probably frozen
Clinic refrigerator repeatedly dropped below freezing
over a 17-month period in 2005 and 2006
Both of these providers documented similar out of
range temperatures for at least 6 months
Use Separate Temp Logs
Thermometer Recommendations
 CDC – Certified/Calibrated by NIST, ASTM, or other
appropriate agency.
 “Certified in accordance with NIST or ASTM standards”: A certificate of
calibration shows that your thermometer has undergone additional
testing to ensure accuracy.
 Personal preference: Measure temperature of liquid/
or measure ambient air temperature.
Types of Thermometers
Thermometers that measure air.
1.
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Probe hanging in air.
Thermometers that measure liquid
2.
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Probe is immersed in a glycol solution.
3.
Infrared thermometers and computerized thermometers.
4.
Continuous recording:
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Gives the ability to review and store all past temperatures (on a
paper wheel or electronically) for future reference.
Graphs temperature over time. Do not confuse a high/low
recording thermometer with a continuous-tracking thermometer.
High/low units only offer basic information about the warmest
and coldest temperature a thermometer has reached.
DO NOT RELY ON PAPER WHEEL OR ELECTRONIC RECORDS
TO DOCUMENT VACCINE TEMPERATURES. It is a VFC
Requirement to use the VFC Approved Temperature Logs to
physically monitor and record temperatures twice a day.
Thermometer – Digital
Certified/Calibrated
Thermometer (Only C˚)
Certified/Calibrated
Continuous Recording
NOT CERTIFIED/CALIBRATED
NOT CERTIFIED/CALIBRATED
NOT CERTIFIED/CALIBRATED
Temperatures can vary within the same unit.
-1.6O
37.4°F.
42.3°F.
46.7°F.
33.4°F.
31.8°F
Place thermometer or thermometer probe
towards center of the unit.
Storage and Handling Problem Protocol
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Notify your facility manger
Contact your Field or VFC Rep and discuss the
problem.
Do NOT contact the manufacturer.
Your Field Rep will complete a “Vaccine
Storage and Handling Problem Report”.
Do NOT use the vaccine until its efficacy has
been determined.
Temperature is “Out of Range”
Freezer is too Warm
1. The freezer Temp is above +5
˚F
Call your Field Rep or VFC Rep. They may refer this
problem to Merck, (1-800-827-4829) for resolution.
Have specific information available, i.e.. lot number,
date received, temperatures, how long temperature
“out of range”, etc .
Temperature is “Out of Range”
Refrigerator Too Cold Too Warm
Temperature is 32 – 35 ˚ F:
 Adjust the refrigerator temperature control to
recommended range (recommended
temperature: 40 ˚ F)
Temperature is 32 ˚F or colder, or 47 ˚ F and warmer:
 Contact your Field Services Rep or VFC Rep
IMMEDIATELY (the Immunization Branch has
established protocols for these situations)!
Questionable Vaccine Viability
 Do NOT allow clinic staff to use vaccine until efficacy
is determined.
 Label vaccine as “Do Not Use”
 Wait for resolution before taking any action.
 Do not discard vaccines – leave in refrigerator or
freezer.
 Any spoiled or expired vaccine needs to be returned to
the VFC Program
 Contact your VFC Field Rep for further instructions.
Recent Changes
 Use of a biosafe glycol-encased probe or a similar temperature buffered probe
rather than measurement of ambient air temperatures, and;
 Use of digital data loggers with detachable probes that record and store
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temperature information at frequent programmable intervals for 24 hour
temperature monitoring rather than non-continuous temperature monitoring,
and;
Use of stand-alone refrigerator and stand-alone freezer units suitable for
vaccine storage rather than combination (refrigerator+freezer) or other units
not designed for storing fragile biologics, such as vaccines, and;
Discontinuing use of dorm-style or bar-style refrigerator/freezers for ANY
vaccine storage, even temporary storage, and;
Weekly review of vaccine expiration dates and rotation of vaccine stock.
http://www.cdc.gov/vaccines/recs/storage/interim.htm
Steven VanTine
Sr. Field Services Representative
(510) 412-1601
steven.vantine@cdph.ca.gov
Christina Sadorra Sapad, MPA
Jr. Field Services Representative
(510) 412-1609
christina.sadorra@cdph.ca.gov
Augustine Yoo
VFC Representative
(510) 412-1608
Augustine.Yoo@cdph.ca.gov
Brenton Louie
VFC Representative
(510) 412-1607
Brenton.Louie@cdph.ca.gov
Veronica Plaza
CAIR Implementation Specialist
(510) 412-1602
Veronica.Plaza@cdph.ca.gov
Karina Alvarez
CAIR Implementation Specialist
Karina.Alvarez@cdph.ca.gov