Inactivated Iav Vaccine Thermostabilized In Pt Film Retain Immmunogenicity At 40c For 12 Weeks
Figure 4
In vivo results of mice immunized with: PBS inactivated IAV stored at 80°C inactivated IAV stored at 40°C for 12 weeks inactivated IAV in PT film stored at 40°C for 12 weeks. Survival curve. Five mice were used for each group. Log rank test was performed to compare the survival of different groups. Weight loss curve post infection. Area under curve of ELISA assay for flu-specific IgG for serum samples. Dashed line indicates the limit of detection. Error bars represent the standard error . Data were analyzed using one-way repeated-measures ANOVA. Tukeys multiple comparison test was used to evaluate the statistical differences between means. Statistical significance is indicated as *** or n.s. indicates not significant. HAI titer from HAI assay for serum samples. The assay was performed in duplicate and error bars represent the variation between the duplicate.
Routine Equipment Maintenance Logbooks
An equipment logbook should contain the following records of each piece of equipment:
- Date of installation, serial number, and model number.
- Equipment instructions and list of routine maintenance tasks.
- Dates of any routine tasks performed .
- Dates of repairs or servicing, including invoices.
- The name of the person, company, and contact information of the company providing the service.
Mishaps In Vaccine Storage Or Handling
- Do not assume the vaccine cannot be salvaged.
- Record the temperature inside the refrigerator at the time the problem is discovered. Mark the affected vaccine vials or packages
- Transfer the vaccine to a working refrigerator as quickly as possible.
- Record the length of time the vaccine may have been exposed to non-optimal temperatures.
- Contact the vaccine manufacturer listed on the vaccine vial for further instructions and to determine if the vaccine can still be used.
South Dakota Department of Health 605-773-3737 or 1-800-738-2301
Also Check: Umcka Cold And Flu Cvs
Handling And Administering Vaccines
All immunisation providers should be familiar with the handling and disposal of sharps. The Australian guidelines for the prevention and control of infection in healthcare sets out how to do this.
Only suitably trained and qualified people can administer vaccines. See your state or territory website for accredited vaccination training courses for nurses.
The Australian Immunisation Handbook has comprehensive information about vaccine procedures, including pre-vaccination, administration and post-vaccination care. It includes details on:
- route of administration
If We Remove The Vegetable Bins Can We Use This Area For Flu Vaccine Refrigeration
No. This part of a household refrigerator is designed to keep a different temperature to the rest of the unit. Since this part of the refrigerator is usually closest to the motor, it provides an ideal environment for vegetables but certainly not for flu vaccines.
If you wish to put this part of the refrigerator to better use, swap out the vegetable bins for bottles of water. This can help maintain the temperatures within the unit. Be sure to label these bottles so they are not inadvertently consumed.
Read Also: Sambucol Cold And Flu Relief Directions
If An Inactivated Influenza Vaccine Approved For Adult Use Is Inadvertently Administered To A Child Is This Considered A Valid Dose
If an inactivated influenza formulation approved for adults is inadvertently administered to a child, this should be counted as a single valid dose for the child. However, this is considered a vaccine administration error. Healthcare personnel should take steps to determine how the error occurred and put strategies in place to prevent it from happening in the future. In addition, we encourage providers to report all vaccine administration errorseven those not associated with an adverse eventto the Vaccine Adverse Event Reporting System external icon. A discussion of strategies to prevent errors can be found in the Vaccine Administration chapter of Epidemiology and Prevention of Vaccine-Preventable Diseases . Additional resources can be found on CDCs vaccine administration web page.
Essential Steps In Proper Cold Chain Management
To be confident that you are maintaining vaccines’ potency, practices must:
- have a reliable refrigerator capable of maintaining a stable temperature. Ensure the fridge is big enough for the practices storage needs and how frequently you order vaccines
- develop clearly documented processes to maintain the cold chain. This may include identifying potential situations that risk vaccine potency and implementing appropriate management strategies
- ensure that all practice staff handling vaccines receive ongoing training that is appropriate for the responsibilities of their role
- monitor and record the maximum and minimum temperature of refrigerators used to store vaccines at least once a day and before using any vaccines
- know what to do if the refrigerator temperature varied outside the recommended range of 28ºC
Recommended Reading: How Often Can You Get A Flu Vaccine
How Long Do Flu Viruses Remain Infectious
A 2011 study showed that influenza A viruses are likely to survive and remain infectious on most surfaces for at least 4 hours, though rarely more than 9 hours. Metallic and non-metallic hard surfaces pose the greatest risk and surfaces that allowed influenza A viruses to survive for between four and nine hours included light switches made of polyvinyl chloride and a computer keyboard. These should be regularly cleaned if they are in an area where people frequently touch them.
Surfaces that viruses were unlikely to remain viable after four hours on included wood, particularly varnished wood or pine , silver or antimicrobial agent impregnated cloths, and porous items, like soft toys and clothes.
An earlier study, conducted in 1982 looked at how long laboratory-grown viruses survived on various surfaces. Both influenza A and B viruses survived for 2448 hr on hard, nonporous surfaces such as stainless steel and plastic but survived for < 812 hr on cloth, paper, and tissues. The study concluded that the transmission of the virus from donors who are shedding large amounts could occur for 28 hr via stainless steel surfaces and for up to 15 minutes via paper tissues. Viruses survived on hands for up to 5 min after transfer from the environmental surfaces.
Immunogenicity Of Stored Influenza Vaccine Patches
To determine if the in vitro vaccine stability of microneedle patches correlated with in vivo immunogenicity, mice were immunized using microneedle patches containing trivalent influenza vaccine that had been stored for 13 months at 25°C and compared to ID injection of fresh vaccine. There was no significant difference in immune response to the H1N1 influenza strain between the mice immunized with a stored microneedle patch and by an ID injection . Immune response to the H3N2 strain was higher for stored microneedle patches than ID injection . For both strains, all mice were seropositive after vaccination with stored microneedle patches, but only 50% â 70% were seropositive after ID vaccination . However, immune responses to the B strain of influenza could not be measured due to lack of access to the virus needed for the assay.
Also Check: Do I Need High Dose Flu Shot
Polymer Microneedle Patches Containing Influenza Vaccine
Polymer microneedle patches were prepared by a two-step micro-molding process. The vaccine formulation consisting of concentrated monovalent vaccine, sucrose, fish gelatin and sulforhodamine B dye in 100 mM dibasic potassium phosphate buffer pH 7.4 was cast onto a PDMS mold (100 microneedles per array each microneedle measuring 700 μm in length and 200 μm in width at the base. Vacuum was applied to ensure that the formulation filled the entire microneedle cavity and the formulation was allowed to air dry at room temperature overnight.
In the second step, the backing formulation consisting of fish gelatin and sucrose in 100 mM dibasic potassium phosphate buffer pH 7.4 was cast onto the mold under vacuum and subsequently dried at room temperature overnight before demolding the microneedle patch. This drying protocol for fish gelatin microneedles has consistently given sharp and robust structures. The patches had a moisture content less than 2% as tested with the Karl Fischer titration method and were stored with a dessicant in individuals pouches. The strength of needles was checked before and after short-term insertion in pig skin explant for bending and brittleness under the microscope. The patches were adjusted to obtain a final dose of 3 μg per patch and further mounted onto a 1 cm2 paper backing for insertion.
What Happens When Patients Receive Ineffective Doses
Mishaps can affect vaccine potency. In busy clinics, healthcare staff members juggle many tasks. A distracted doctor or nurse can accidentally leave a vaccine vial on a countertop, instead of placing it back into a medical refrigerator. These small accidents can impact the potency of a vaccine.
These are known as temperature excursion events. They occur when vaccines are stored in ranges outside of the manufacturer’s recommended ranges. Unfortunately, ambient temperatures can damage the vaccine’s potency. Medical staff can’t tell whether these doses are still good by looking at them.
If a healthcare provider doesn’t follow CDC guidelines, they can administer these doses to unwitting patients. The vaccines may cause an inadequate immune response in their bodies and poorly protect patients against diseases.
These mishaps negatively impact both patients and their primary healthcare providers. Patients may need to return for revaccination. These mistakes can lower their opinion of the vaccine provider. The medical clinic can also lose thousands of dollars due to wasted doses.
Healthcare settings should have procedures in place to protect patients from ineffective doses. They should use a medical refrigerator to ensure that the cold chain remains intact. American Biotech Supply has several dedicated models that can safely store vaccines.
You May Like: Pfizer Cold And Flu Medicine
Naming Who Is Responsible
Nominate a member of the practice team to:
- manage the cold chain
- comply with cold chain management guidelines
The practice must clearly state the role and responsibilities within a position description and give appropriate training. Another staff member should be trained as back-up when the responsible person is not at work.
Best Practices For Refrigerated Vaccine Storage And Handling
With flu season rapidly approaching, pharmacies will once again be filling their refrigerators full of lifesaving influenza vaccines to add to their already extensive vaccine inventory.
With flu season rapidly approaching, pharmacies will once again be filling their refrigerators full of lifesaving influenza vaccines to add to their already extensive vaccine inventory.
Its crucial that the cold chain isnt broken, so the efficacy of those vaccines isnt put at risk. Unfortunately, a paper published in 2007 in Vaccine estimated that a shocking 14% to 35% of refrigerated vaccines are exposed to freezing at some point,1 and that doesnt even encompass all excursions.
In light of this, here are some of the most commonly missed best practices for refrigerated vaccine storage and handling:
1. Selecting a Thermometer
Make sure youre using a thermometer that will accurately measure the temperature of the vaccine, not the ambient air. For this reason, food thermometers arent recommended plus, they fluctuate rapidly when the door is opened. The probe of the thermometer should be suspended in glycol.
The thermometer should have a Certificate of Traceability, and you should have documentation that it has been calibrated. Also, remember that calibration doesnt last forever, so be sure to send your thermometer off to be recalibrated before the due date, which is often put on a tag attached to it.2-3
2. Selecting a Refrigerator
3. Stabilizing the Temperature
4. Appropriate Labeling
Recommended Reading: How Old Is The Flu Shot
Thermostabilization Of Laiv Using Pbv
Liquid LAIV was stabilized by PBV, a foam-drying process that simultaneously sublimes, boils, and evaporates liquid samples at 10°C and 3Torr28,53, to efficiently remove liquid and create a thermostable biologic. Liquid LAIV was combined 1:1 with a protective carbohydrate solution and underwent primary drying by boiling under vacuum at near-subzero temperatures, prior to secondary stability drying at elevated temperatures. The secondary stability drying phase of LAIV included 24h at 45°C to achieve glass transition phase the glass state was achieved by rapidly cooling the dried LAIV formulation below 37°C. In the glass state, molecular mobility is essentially arrested29, preventing degradation of immobilized LAIV during storage and conferring long-term stability. The dry-powder T-LAIV was micronized, then sieved to 2060µM mesh size, and portions were aliquoted for stability testing. Finally, dry-powder T-LAIV was mixed with sieved Lactohale lactose carrier at a dose of 1×107EID50 and aliquoted into blister packs with or without dried Advax adjuvant73.
Importance Of Maintaining The Cold Chain
Vaccines are sensitive biological products that may become less effective, or even destroyed, when exposed to temperatures outside the recommended range and/or to direct sunlight or fluorescent light . Temperatures falling outside the recommended range require immediate action to avoid loss of product. An immediate loss of potency of cold-sensitive vaccines may occur following freezing. For vaccines exposed to temperatures above the recommended temperature range, there is some loss of potency with each episode of exposure. Repetitive exposure to heat episodes could result in a cumulative loss of potency that is not reversible .
The proper storage and handling of vaccines is important for several reasons:
When a cold chain break is identified after a vaccine has been administered, consult your jurisdictional/local public health office or immunization program for advice. The type and cost of the vaccine and the duration and temperature of the exposure will be taken into account when the situation is assessed. Serological testing or revaccination may be recommended .
1.2.1 A Note on Light Exposure
Exposure to light can reduce the potency of some vaccines . Studies have shown that both UV light and fluorescent light cause damage to certain vaccines . As with exposure to adverse temperatures, the deleterious effects of light exposure on light-sensitive vaccines are cumulative . Refer to the product monograph of each vaccine to determine light exposure restrictions.
Also Check: How Long Have Flu Shots Been Around
Cold Chain Break Management
If vaccines are exposed to temperatures outside the recommended range or other inappropriate storage conditions, immediate action should be taken in order to avoid product loss. It should not be assumed that vaccine inappropriately exposed to light or to temperatures outside the recommended range cannot be salvaged.
Pt Films Thermally Stabilize Live Iav In Vitro And Retains Infectivity In Vivo
The results from the HSV-2 experiments demonstrated that PT films are highly capable of thermally stabilizing vaccines for DNA viruses. However, further investigation was needed to determine how suitable PT films are for stabilizing vaccines for RNA viruses. Therefore, we dried an IAV in 10wt% pullulan and 0.5M trehalose and stored the samples for 12 weeks at 40°C. The titers of the samples were determined at different storage times and compared to those of IAV samples that were stored at 40°C. As Fig. shows, the IAV samples stored at 40°C became inactive within 14 days, while the IAV samples stored in PT only had a titer loss of 2.0log PFU/film after the same time period. Much like what was observed in the tests with HSV-2, the IAV samples that had been dried in PT films showed a gradual loss of titer following an initial period of rapid loss. After 4 weeks of storage at 40°C, these samples showed a titer loss of 2.9log PFU/film however, this loss decreased to 0.3log PFU/film from Week 4 to Week 12. Thus, the total titer loss for the IAV samples preserved in PT film was 3.2log PFU/film after 12 weeks of storage at 40°C. Although the in vitro results showed that PT films were able to offer some thermal protection for IAV, it also proved to be less thermally stable than HSV-2, as significant titer loss was observed within the first 4 weeks.
Figure 3
Read Also: Are There 2 Types Of Flu Shots
How Often Should We Log Refrigerator Temperatures When Storing The Flu Vaccine
When storing any vaccine, you should log the minimum and maximum refrigerator temperatures at the beginning and end of each day. If the unit does not display the minimum and maximum temperatures, log the current temperature at the beginning and end of each day.
You can also measure the temperature of the room where the refrigerator is kept. In the event of a temperature excursion or refrigerator failure, you will have a better idea of the temperature your vaccines have been exposed to, which can help with the troubleshooting process. Do not use the calibrated temperature monitor from the refrigerator to measure the room temperature, but rather a standard household thermometer.
Protective Immunity Against H1n1 Infection
Despite the differences in kinetics of immune responses observed in the vaccinated cohorts, all groups survived lethal challenge with homologous virus almost 3 months after vaccination . The body weight losses did not exceed 17% and no significant differences were observed among groups . Thus, skin immunization with pMN encapsulating subunit influenza vaccine was as protective as vaccine-coated mMN or IM vaccination.
Don’t Miss: How To Stop Flu Virus From Spreading
Refrigerator And Freezer Maintenance
3.5.1 General Principles
Regular maintenance is required to achieve proper operation, to maintain required temperatures, and to extend the useful life of the appliance.
The most important action to take if the vaccine storage unit is not working properly is to protect the vaccine supply. Move the vaccine to a properly functioning storage unit with appropriate temperatures. After this has been accomplished, attempt to find the cause of the problem and correct it. See Section 6: Storage Troubleshooting for more details.
3.5.2 Daily Maintenance Tasks
Check the Internal Temperature
The minimum and maximum temperature inside each compartment of the vaccine storage unit must be checked with a calibrated thermometer and recorded numerically on a temperature log at least twice each day: in the morning before the fridge door is first opened and once at the end of the day when the door is closed for the last time. More frequent temperature monitoring is required following thermostat adjustments. The temperatures should be recorded on a temperature log and/or charted on a graph for visual focus when it is outside the optimal temperature range. If the temperature is outside the recommended range, the designated vaccine coordinator or delegate should be notified without delay.
Note: There is a potential for equipment failure of automated temperature recorders, therefore it is recommended that staff check and record temperatures twice daily as a quality assurance measure.