ECRI Q&A Provides Lessons Learned on Vaccine Rollout

By A.J. Plunkett

It might take weeks or months before the U.S. gets the COVID-19 vaccine out to all of those who want it. The CDC and most states are first offering the shots to healthcare workers and other essential personnel.

Whether you are a hospital or off-campus location, you must take several key precautions both with administering the vaccine and ensuring the safety of its storage and handling.

Be extra careful with the vaccine and with the dry ice that will keep it cold—mishandling the dry ice can cause injury and even death, warned Ramya Krishnan, senior project engineer of device evaluations for ECRI, during the patient safety organization’s online Q&A session on December 16, 2020.

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 reactions 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 history of allergies should be observed for 30 minutes. In the first days of vaccination in the U.S., a nurse in Alaska, with no prior history of allergic reactions, did have a serious anaphylactic response to the vaccine on December 15 but recovered quickly.

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.

Remember to freeze or chill, but do not shake

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 serum 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, MJ, JD, a patient safety analyst with ECRI. Use one needle on one patient, discard the needle in the appropriate sharps container, then use a new needle on the next patient, she said.

Measure carefully

Also, be careful to precisely measure the preservative-free sodium chloride the manufacturer provides to dilute the vaccine before slowly inverting the vial back and forth the required number of times, Uses said.

If you reconstitute the vaccine with too much or too little of the preservative-free mixture, you risk giving too 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.

The vials are marked as containing five doses. However, after the initial rollout, the FDA and others reported that some sites were getting an additional dose out of the vials than expected.

“It is not uncommon for manufacturers to include overfill when manufacturing injectable medications. The overfill accounts for possible spillage or loss when drawing up the medication,” noted Uses, in response to a query from Inside Accreditation & Quality.

“The dose of the Pfizer COVID-19 vaccine is 0.3 mL per dose, which would add up to a total volume of 1.5 mL needed for five doses. The reconstitution instructions are to add 1.8 mL of preservative-free sodium chloride. You will have an excess of the 1.5 mL needed for the five doses based on adding 1.8 mL of diluent to the medication; if there is minimal loss of medication when drawing up the dose, there can be enough overfill for an extra dose,” said Uses.

“What is important is to ensure that the vaccine is being reconstituted properly with 1.8 mL of diluent,” she said.

Uses and others noted that while the vaccine is approved by the FDA and has been shown to be both effective and safe, there is still not a lot of information about the serum.

Don’t rush to buy ultra-cold freezers

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 of biomed and 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 -20°C (-4°F). 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 its temperature. In addition, make sure you plan for emergency power outages, warned Gaev.

Moderna vaccines are not shipped frozen, but they must be kept cold according to manufacturer instructions, said Krishnan.

Beware handling the dry ice

If you choose to use the shipping containers and replace the dry ice—frozen carbon dioxide—as required, you will need cryogenic gloves, not regular gloves, to handle the dry ice. You will also need to train staff how to handle the ice as well as the vaccine.

Since the gloves are expensive, if you decide to have multiple people use a single pair of cryogenic gloves, they should also each wear a clean pair of exam gloves to maintain infection control, Krishnan said.

Also remember that as dry ice degrades and warms, it becomes carbon dioxide gas, 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 the gas to dissipate before reentering the area.

Even more importantly, when carbon dioxide gas is trapped in a tightly contained area such as a freezer, it can pressurize and explode, she warned, damaging the freezer and anyone near it.

Also, do not throw dry ice 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.)

Manage your medication: Keep vaccines separate

However you choose to store your vaccines, do not store the Moderna and Pfizer vaccines together. If you only have one freezer or refrigerator, at least put them on separate shelves, said 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. Your program should include:

  • Safe and secure handling of vaccines
  • Cryogenic safety equipment and training
  • Scheduling and handling, to include:
  1. Screening and consent documents
  2. Verification of recipients’ ID
  3. Post-injection observation period
  4. Scheduling of follow-up
  • Nurses and pharmacists trained on procedures and answering questions
  • FAQs for recipients

A video recording of the ECRI Q&A is online, but you will be asked to give contact information to access it:

The page also includes links to several key resources, including an ECRI list of manufacturers of dry ice and dry ice coolers, and an ECRI Exclusive Hazard Report on “Dry Ice for Storing Vaccines—How to Handle It Safely.”

A.J. Plunkett is editor of Inside Accreditation & Quality, a Simplify Compliance publication.