Archive for the ‘Vaccines’ Category

Vaccinating a Pandemic: The Hurdles Ahead for the Zika Virus

Posted on: March 23rd, 2016 by Jeff Renoe No Comments

This week marks the beginning of spring. And now that it’s here, summer is right on deck. That of course means a few months of sustained sunshine, outdoor festivals, and dining al fresco.

This summer, though, could also mean terror. That’s because this year’s mosquitoes will bring with them more than the usual annoyances and everyday itching. These mosquitoes could mean outbreak, paranoia, and fear. This, inarguably, is the summer of Zika.

Zika-Virus-FINAL1

As we spoke about In February, the World Health Organization has declared the Zika outbreak as a public health emergency. Zika has spread to more than 20 countries, and counting. As of Thursday, there were nearly 450 people infected with Zika in the U.S., 93 of which had been diagnosed as travel-related infections, across 22 states.

While Zika isn’t life-threatening to most adults, the main concern is its link, albeit unproven, to microcephaly, a birth defect in which babies’ brains don’t fully develop. It’s that unknown that has made the production of a Zika vaccine so tricky.

In a best-case scenario, developing a vaccine is difficult. Researchers pore over a multitude of combinations and correlations. Scientists work to strike the perfect balance: stimulate the immune system enough to produce antibodies but avoid actually infecting the disease. From concept to market, the average process takes about 15 years.

That process encompasses three stages: exploratory, preclinical, and Investigational New Drug, or IND. After passing through those stages, testing generally begins, again, in three phases: on 20 to 80 people (Phase I), several hundred people (Phase II), and ultimately several thousand (Phase III).

This process, for any vaccine, can be protracted and byzantine. The vaccine for the dengue virus, a sometimes deadly mosquito-borne germ that’s a close cousin of Zika, took over 20 years to develop. In September 2014, an Ebola vaccine entered Phase I testing, but progress has since halted; there is still no legitimate Ebola vaccine produced in the U.S.

In Zika’s case, the process is even more complicated (paywall) because of the link the virus has had to birth defects. The risks, and regulations, inherent in developing a vaccine for pregnant women are innumerable. Researchers and scientists are split on whether to even offer a Zika vaccine to pregnant women due to fear of harming the unborn.

Other factors contribute to the potential vaccine’s plight. A lack of funding, inadequate distribution, deficient administration, and improper transportation and storage—storing the vaccine outside the proper temperature range can lead to its invalidation by the health department—all serve as sizable roadblocks.

Despite the obstacles, there is hope. According to NBC News, a new dengue vaccine may form the basis for a Zika version. The dengue vaccine is currently being tested in Brazil in a 17,000-person volunteer trial. In theory, researchers would add on a Zika component to help shorten development time.

Until that plays out and a vaccine is available, there are things you can do now, like spray for adult mosquitoes and eliminate standing water to reduce their ability to breed. Whether you’re looking forward to outdoor festivals or alfresco dining as the seasons continue to change, do all you can to protect yourself and don’t forget to stop and enjoy spring.

 

 

Ukrainian Polio and the Hindsight Solution

Posted on: October 15th, 2015 by Jeff Renoe No Comments

Vaccines for Children: Resources for Providers

A recent threat of a Polio outbreak in Ukraine has left parts of Europe scrambling for answers.

As a whole, the nation’s population of children is under vaccinated when compared to the rest of the globe. In a recent interview, Ellyn Ogden of the United States Agency for International Development said, “Ukraine went from 90% coverage a decade ago, to 14% today. This is one of the lowest coverages in the world, including countries at war and those facing security and economic challenges.”

The lack of mass inoculation has led to the first two documented cases of polio in Europe since 2010. Having been caused by a vaccine-derived strain, they both could have been prevented if the population had a higher level of immunization. Once the cases had been diagnosed conversations quickly began to address the potential paroxysm.

In response to the threat, the UN donated 3.7 million vaccines to help fill the gap that’s developed over the last decade to protect the country, and those that surround it, from the disease. What’s followed has been an interesting case of he said, she said that’s played out through the international media.

The local All-Ukrainian Council for Patients’ Rights and Safety lobbyist group claims that the vaccines are unsafe because of mishandlings during transport. The World Health Organization says that the process was carried out in line with internationally defined best practices. One blames the other for recklessness. The other’s made references to a lobby group that’s out to protect the interests of a few of individuals. The back and forth has caused a delay in the immunization efforts, pushing them back, well past the 15 day guideline according to Ogden.

The plan may have been implemented in a much quicker manner had the vaccines been transported with loggers that monitored the ongoing temperature of the vials. The arguments could have been rendered moot had data been available to the public to prove one side over the other. Now, every day that goes by increases the risk of a major outbreak.

  • Click here for more information on how to properly transport, store and handle vaccines according to the Center for Disease Control 
  • To learn more about the global initiative to eradicate polio visit polioeradication.org
  • To learn more about data loggers that can be used to monitor the condition of a package in transit visit dicksondata.com

 

 

 

Vaccine Temperature Buffers: Glycol? Glass Beads? Or What?

Posted on: September 6th, 2015 by Dickson No Comments

 

Glycol or Glass Beads?

The CDC, in its Vaccine Storage and Handling Toolkit for Vaccine and VFC Providers, uses the following language when describing temperature buffers as a necessary edition to a data logger probe: ”Probe in thermal buffer such as glycol . . .”

For Vaccine Providers looking for a data logger, the key part of that sentence is ”such as.” The CDC has yet to fully commit, require, or even recommend a data logger probe be immersed in glycol and glycol only. Here at Dickson, we use glass beads instead of glycol.

Why?

Because they offer the same temperature stability as glycol, without as great of a threat of spillage.
This has been a confusing topic as of late, and the verdict isn’t out yet on whether one type of material to immerse your probe in is better than the other. (When the jury decides, we will be sure to let you know.) But, check out the graph below:

One of our excellent engineers thought he would test each solution, to see if there was any variance in temperature readings. So he did. The probes were placed in the same environment, and thus monitored the same temperature. As you can see, we found very little difference between the two solutions. They each followed the exact same curve at the exact same time as the temperatures they monitored rose and fell.

But why submerse a probe into a bottle filled with glass beads or a glycol solution? Because it takes longer for vaccine temperatures to change than it does the air of your refrigerator or freezer. A sensor (that includes internal device sensors!) without an attached glycol bottle or vial of glass beads records the temperature of the atmosphere. Thus, the sensor will show extraneous temperature readings caused by air fluctuations (for example, the opening and closing of a refrigerator door) which may not be indicative of the temperature of the individual vaccines.

So, get yourself a thermal buffer for your data logger. We recommend glass beads, but we can always do glycol as well.


 

 

An Overview Of The CDC’s OEI-04-10-00430 Vaccines For Children Report

Posted on: July 16th, 2015 by Dickson No Comments

Vaccines for Children: Resources for Providers

In April and May of 2011, a group of analysts from the Office of the Inspector General of the United States of America, conducted an evaluation of 45 Vaccine For Children (VFC) program providers. The team was led by Holly Williams, and was formed to assess the storage conditions of vaccines distributed by the CDC to VFC providers, who were distributing the vaccines to children aged 18 and under, who were eligible under certain program conditions to receive disease fighting vaccines.

The assessment was carried out not like an FBI Mafia or FIFA raid, but more like an academic assessment. The group planned to test the storage conditions of 45 VFC providers, conduct interviews, and collect data. Once the two weeks were over, the team would make their recommendations to the CDC, and provide the results of their study.

What they found, was not good. 76% of the VFC providers surveyed had stored vaccines in unsafe temperature ranges for at least 5 cumulative hours, during a two week study. That 76% number may need a little time to sink in, but nonetheless is alarming to any lay-person. The 5 hours though need a bit of an explanation. Vaccines need to be kept cold to stay effective. Some need to be kept in refrigerators, others in freezers. During the course of this study, for the most part, they were. But for a cumulative 5 hours in over 3/4’s of the Vaccine Providers, they were out of acceptable temperature ranges. What’s the big deal? If a vaccine is stored outside of critical temperature ranges, it loses potency.

Which is a huge, huge problem for the health and well-being of our world.

What else did the report find? Here are a few more alarming statistics:

Each of the 45 providers recorded temperatures that differed from the Inspector General group’s independently measured temperatures.

In other words, the VFC providers were not using accurate (and thus most likely not using calibrated) data loggers or thermometers. Accuracy is if not the most pertinent, then one of the most pertinent issues in thermal measuring.

0 of the 45 VFC providers met all 10 categories of the VFC Operations Guide Requirements.

Those 10 requirements are: Vaccine Storage Equipment, Vaccine Storage Practices, Temperature Monitoring, Vaccine Storage and Handling Plans, Vaccine Personnel, Vaccine Waste, Vaccine Security and Equipment Maintenance, Vaccine Ordering and Inventory Management, Receiving Vaccine Shipments, and Vaccine Preparation.

The most failed category: Vaccine Storage Equipment, where 96% of VFC Providers failed to house their vaccines in proper refrigerators and/or freezers.

The least failed category: Vaccine Preparation, where only 2% of providers failed.

16 of 45 VFC Providers had expired vaccines, 13 of whom were storing them directly next to or within their unexpired vaccine supply.

Maybe the one thing worse than administering vaccines stored outside of proper temperature ranges: administering expired vaccines.

All in all, this report was essential, but alarming. The results were published a little over three years ago. Since then, vaccine providers (both VFC and non-VFC) on the whole have improved their vaccine storage practices immensely.

The CDC responded to the above report with new and more stringent recommendations, and now state and city VFC programs are following suit. Gone are the days of dorm style freezers, and chart recorders.

 


 

*NOTE: All information relayed, discussed, and analyzed above was taken from the Office of Inspector General, Report OEI-04-10-00430, ”Vaccine For Children Program: Vulnerabilities In Vaccine Management.” June, 2012. http://oig.hhs.gov/oei/reports/oei-04-10-00430.pdf.

 

The Do’s and Don’ts of Vaccine Storage

Posted on: June 28th, 2015 by Dickson No Comments

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Vaccine storage and handling can be as confusing as all get-out. There are a lot of resources and materials to consume, and there are different regulations coming at you from different regulating bodies (i.e. the CDC, the VFC Program, County Health Departments, etc.).

Becoming well-versed in the fine details of vaccine storage takes a little time, a little work, and a lot of experience (our Vaccine Storage & Handling White Paper is a good place to start that journey!), but just about any vaccine distributor can pick up the big no-no’s and yes-yes’s of vaccine storage pretty quickly. Here is the Dickson list of “Do’s and Don’ts” for vaccine storage. Know them like the back of your hand.

Do: Monitor with a data logger.

Yes! Data Loggers! The time has come to start monitoring with a data logger (a digital device that takes temperature readings). While the chart on your fridge door may stay intact, that old mercury thermometer has got to go. Digital data loggers allow vaccine providers to set alarms when temperatures go out of range, and provide better accuracy than a mercury thermometer or chart recorder. Speaking of chart recorders . . .

Don’t: Monitor with a chart recorder.

Exchange that old chart recorder for a data logger. Trust us, it’s time. The CDC now recommends data loggers and NOT chart recorders for vaccine storage. While it is nice to have the physical readout of your temperatures on a chart, right in front of your eyes, chart recorders just aren’t accurate or secure enough to guarantee a vaccine’s storage conditions.

Do: Use a temperature probe buffer.

Glass beads or Glycol solution will do the trick. A remote probe and temperature buffer are essential to vaccine monitoring. After the data logger itself, having a remote probe that is encased in a temperature buffer is the next step. Inserting your remote probe into a temperature buffer allows the probe to read temperatures that mimic the temperatures of you vaccine.

Don’t: Use a dorm style fridge.

Dorm style fridges are small, waist high refrigerators common to…college dorms. And they are not effective at keeping temperatures within 35-46F. The CDC ruled these refrigerators out years ago, yet we still come across them from time to time. If you are storing your vaccines in a dorm style fridge, knock it off.

Do: Make sure refrigerators and freezers can’t be unplugged.

How do you do that? With signs, protective plug cases, and letting everyone who might come near the fridge know that it should never, ever be unplugged! Losing power to your cold vaccine storage will be a logistical nightmare, with possibly thousands of dollars of useful vaccines having to be thrown away. So, post signs stating ”Don’t Unplug” at your refrigerator or freezer’s electrical outlet (the CDC provides free printouts for just this purpose), consider buying secure plug cases, and be sure to alert your team (that includes the cleaning crew!) that the refrigerators and freezers should never be unplugged.

Don’t: Use non-calibrated data loggers.

A NIST Traceable Calibration performed by an A2LA or similarly accredited laboratory is the best way to ensure your data logger’s accuracy. Make sure when you buy your data logger, it comes with a Certificate of Calibration.

And those are the things that you should and shouldn’t be doing in vaccine storage. Got other suggestions? Feel free to leave them in the comments below.