ECRI provides lessons learned on COVID-19 vaccine rollout
by A.J. Plunkett (aplunkett@decisionhealth.com)
As you launch COVID-19 vaccine operations, experts caution: Freeze or chill, but do not shake.
Be extra careful with the vaccine and with the dry ice that will keep it cold – mishandling the dry ice can cause injury and possibly even death, warned Ramya Krishnan, Senior Project Engineer, Device Evaluations, for ECRI, during the patient safety organization’s online Q&A session on Wednesday, December 16.
Also, think through how you will schedule and move patients through your facility, advised David Watson, vice president of ECRI’s European Operations. Watson is based in the United Kingdom where the first Pfizer-BioNTech vaccines were administered on December 8.
You will need space to take a patient history (including any previous allergic or anaphylactic reactions to food, drugs or insects) to administer the vaccine, to provide at least 15 minutes of observation for adverse reaction afterward, and an area to care for anyone who does have a reaction — all while maintaining the same social-distancing and infectious-disease precautions you’ve had since the pandemic began, he noted.
Patients with a past history of allergies should be observed for 30 minutes. Be aware that a nurse in Alaska, with no prior history of allergic reaction did have a serious anaphylactic response to the vaccine on December 15.
The U.S. government is shipping the Pfizer-BioNTech vaccine to various states, which will then be in charge of distributing the thermal containers to predesignated locations according to each state’s vaccine rollout plan. Moderna’s vaccine is expected to follow soon.
The CDC has published playbooks and other information to help organizations with the rollout.
Accurate and frequent logging of your refrigerator or freezer temperatures will be among the most important tasks as hospitals and other healthcare providers begin administering the first of two doses of the vaccine.
The vaccines are extremely sensitive to temperature. In addition, they will come in multi-dose vials that must be diluted and then slowly mixed by inverting the bottle back and forth, according to manufacturer’s instructions.
The Pfizer-BioNTech COVID-19 vaccine is being shipped frozen, in thermal containers to keep the first serum approved in the U.S. at ultra-cold temperatures, and then must be kept in those containers or moved to ultra-cold freezers until they are ready for use.
The Moderna vaccine does not need to be kept frozen but is still temperature sensitive.
Both companies are shipping initial storage and administration supplies with each container, as well as detailed instructions on storage and handling, defrosting and ultimately providing the inoculations to patients, said the ECRI experts.
Follow these manufacturer instructions closely, they advised. You do not want to waste any of the vaccine doses.
That includes following the strict, time-honored guidelines for using multi-dose vials with multiple patients, warned Stephanie Uses, PharmD, JD, a patient safety analyst with ECRI. Use one needle on one patient, discard the needle in the appropriate sharps container, use a new needle on the next patient, she said.
Also, be careful to precisely measure the preservative-free sodium chloride the manufacturer provides to dilute the vaccine vials, before slowly inverting the vial back and for the required number of turns, she said.
If you reconstitute the vaccine with too much or too little of the preservative-free mixture you risk giving to little or too much of the vaccine. Too little may render it ineffective and too much may invoke a stronger side effect in the patient. Uses repeated that point several times, noting it was emphasized by the manufacturers.
Both Uses and others noted that while the vaccine is approved by the FDA and has shown to be both effective and safe, there is still not a lot of information about the serum.
While many facilities are rushing to buy ultra-cold freezers, that is not necessary and not even recommended by the CDC, noted Jonathan Gaev, MSE, business line manager-biomed, device evaluations for ECRI.
The shipping containers provided by Pfizer will be sufficient to keep the vaccines frozen as long as the 50-pound supply of dry ice is replaced every five days. Pfizer says it will allow facilities to keep the containers for 30 days.
In addition, each container is equipped with a digital thermometer that will alert Pfizer if temperatures are outside the optimal range, which must stay under at least minus 20 degrees Celsius (or minus 4 degrees Fahrenheit.) Pfizer will then alert the facility to deal with the problem.
If you transfer the vaccine to your own freezer, you must keep track of the temperature. In addition, make sure you plan for emergency power outages, warned Gaev.
Moderna vaccines are not shipped frozen, however they must be kept cold, according to manufacturer instructions, said Krishnan.
If you choose to use the shipping containers and replacing the dry ice — frozen carbon dioxide — as required, you will need cryogenic gloves to handle the frozen C02. The dry ice cannot be handled with regular gloves. You will also need to train staff how to handle the ice as well as the vaccine.
Since the gloves are expensive, if you decided to have multiple people using the gloves, they should also each wear a clean pair of exam gloves to maintain infection control within the gloves, she said.
Also remember that as dry ice degrades and warms, it becomes its gaseous version of carbon dioxide, which can cause respiratory problems or even death if the area is not vented adequately, she warned. So, when replacing the dry ice, ensure that the area is either well ventilated or that you open the container and allow it to dissipate before reentering the area.
Even more importantly, when CO2 is trapped in a tightly contained area such as a freezer, when the gas builds it can pressurize and blow, she warned, damaging the freezer and anyone near it.
Also, do not throw it away in your normal waste containers. It must be handled and disposed of with special care, she said.
(Several safety data sheets are available about dry ice online. Here is one from the University of Washington.)
However, you choose to store your vaccines, do not store the Moderna and Pfizer products together. If you have one freezer or refrigerator, at least put them on separate shelves, says the ECRI team.
Also ensure the patient gets a follow up shot from the same manufacturer. The two vaccines are different and not designed to be used together.
And when you educate the patient on side effects, be sure to also give them an appointment for the follow-up. Be prepared to not only send a text or phone call reminder, said Watson. The U.K. medical offices are prepared to go physically find patients for their follow-up shot.
Here is a checklist provided by ECRI to review your vaccine implementation program. Does your program include:
- Safe and security handling of vaccines
- Cryogenic safety equipment and training
- Scheduling and handling, to include, screening and consent documents, verification of recipients ID, post injection observation period, and scheduling of follow-up shot
- Nurses and pharmacists, trained on procedures and answering questions
- FAQs for recipients.