NEW YORK — Scientists have cleared the first hurdle in developing a COVID-19 vaccine. Now the task at hand is getting the vaccine distributed so health care workers can start sticking it into the arms of Americans and to the virus that has disrupted all walks of life for nearly a year. And while rolling out the vaccine might not be as miraculous as the unprecedented record time in developing one, the logistical effort required for distribution is no less daunting — especially with the emergence of new and more contagious variants of the virus.

Leveraging pharmacy

Critical to this effort are retail pharmacies, many of which are part of Operation Warp Speed, the public-private partnership initiated by the federal government to facilitate and accelerate the development, manufacturing and distribution of COVID vaccines, therapeutics and ­diagnostics.

Utilizing retail pharmacies in getting the vaccine out is logical in that many of these chains have a long history of providing flu shots to customers and already have pharmacists at the ready who are trained to provide ­immunizations.

“Millions of Americans will get vaccinated against COVID-19 at their neighborhood pharmacy or grocery store, and the Department of Health and Human Services (HHS) is working with national and regional retail chains to serve as vaccination centers,” says Cindy Fitton, director of health care marketing at Easton, Pa.-based Follett Healthcare, which is part of Follett Products LLC, a leading manufacturer of innovative equipment for the health care market, including medical-grade refrigerators and freezers; ice and water dispensing equipment; ice machines; and ice storage and transport ­equipment.

The National Association of Chain Drug Stores is also emphasizing the role of the country’s massive retail pharmacy network and advocating that it should be leveraged full throttle in the vaccine rollout. NACDS links the country’s physical health to its economic health, especially in returning Americans to work safely and re-opening schools.

“While the nation should not lose sight of its efforts to expand access to COVID-19 testing and treatment strategies, now is the time to aggressively ramp up the nation’s COVID-19 vaccination initiative adeptly, equitably and safely,” NACDS states. “Leveraging the existing retail pharmacy network — where every American lives within five miles of a store — can swiftly and efficiently accelerate the vaccination of priority populations. This critical action requires the federal government to turn on the existing, yet dormant Federal Pharmacy Partnership Program, a program designed to harness the existing, substantial capabilities and efficient operations of the pharmacy industry to proficiently, safely and equitably vaccinate the American public with COVID-19 vaccines.”

In a recent interview, U.S. Surgeon General Jerome Adams emphasized the importance of retail pharmacies in the process: “The federal government, the Congress approved over a billion dollars to be sent out to states to help with vaccinations,” he said. “So we’re getting that money out as quickly as possible. We’ve increased our locations. That’s in more locations from 1,000 vaccinating sites in the first week to 4,000 in the second and third weeks to 12,000 sites now. And you’re going to be hearing more about us continuing to partner with CVS and Walgreens, to utilize all of their stores as vaccination sites.”

These retail pharmacies have already taken action and are busy getting shots to as many people as possible. CVS Health, for instance, started administering vaccines in skilled nursing facilities in December. Start dates were chosen by individual states, according to CVS, in addition to which types of long-term-care facilities to activate first, with the most at-risk patients prioritized. Of the approximately 15,000 skilled nursing facilities nationwide, nearly 8,000 chose to partner with CVS Health, which says it expects to complete administration of first doses in skilled nursing facilities by January 25, consistent with time lines originally shared with states and provided by the Centers for Disease Control and Prevention (CDC).

“Our work with long-term-care facilities isn’t a mass vaccination effort — quite the opposite,” says Larry Merlo, president and chief executive officer of CVS Health. “We’re dealing with a vulnerable population that requires on-site and, in some cases, in-room visits at facilities with fewer than 100 residents on average. Despite these challenges, we remain on schedule, and the number of vaccines we administer will continue to rise as more facilities are activated by the states.”

CVS Pharmacy teams will make three visits to each long-term-care facility to ensure residents and staff receive their initial shot and critical booster. Most residents and staff will be fully vaccinated three to four weeks after the first visit, depending on which vaccine they receive.

CVS Health has been following COVID-19 vaccination reporting protocols to state immunization registries and the CDC, though what is shared publicly is typically outdated by 48 to 72 hours, which accentuates just how difficult the vaccine distribution process is, as it remains a rapidly moving target.

Per an agreement with HHS, COVID vaccines will eventually be available at all CVS Pharmacy locations throughout the country, subject to product availability and prioritization of populations, which will be determined by states.

When available, vaccines in a retail setting will be offered on an appointment-only basis via CVS.com or through the CVS Pharmacy app, and there will be a dedicated toll-free number for people without online access. CVS Pharmacy says it has the capacity to administer 20 million to 25 million shots per month.

Walgreens is also playing a key role and recently announced it expects to complete the administration of COVID vaccine first doses in skilled nursing facilities by January 25. The company is also rapidly expanding access to vaccinations among assisted living facilities and additional vulnerable populations outlined by states and local jurisdictions as part of expanded distribution plans.

“Since receiving our first allotments of vaccines in late December, Walgreens has remained on track in vaccinating our most vulnerable populations, and we are steadfast in our commitment to accelerating access to COVID-19 vaccines as we receive additional guidance from state governments and jurisdictions,” says John Standley, president of Walgreens. “Walgreens takes immense pride in being a part of protecting our communities from COVID-19 and helping the country take this first step toward emerging from this pandemic.”

Other chains taking part include groceries with pharmacy operations, such as Kroger Health, the health care division of Kroger Co., which announced in December its plan to provide the COVID vaccine nationwide across its 2,200 pharmacies and 220 clinics, partnering with the federal government and state health departments to administer the vaccine in accordance with the rollout plan.

“Kroger Health is a COVID-19 response leader that has provided our patients, associates and other businesses with diagnostic testing tools and supporting resources since the onset of this public health crisis,” says Colleen Lindholz, Kroger Health’s president. “Kroger Health’s experienced health care providers remain committed to helping our patients and associates live healthier lives. The size and scale of our health care operation provides us with the unique ability to efficiently facilitate COVID-19 testing and immunize a large portion of the U.S. population, once the authorized vaccines become more widely available.”

Kroger Health has been working closely with HHS as well as the Department of Defense and various pharmaceutical companies and other businesses to prepare for vaccine ­authorization.

Keeping it cold

One of the trickiest aspects of distributing the vaccine is the temperature it must be stored at during shipment and storage, as even slight departures from recommended storage temperatures will reduce potency and could result in inadequate immune response, according to Fitton.

“Each time the vaccine is exposed to excessive heat or cold, the potency deteriorates; and once potency is lost, it can never be restored,” she says. “The worst case is that patients unknowingly receive a vaccine that provides no protection at all.”

To address this, Follett, as part of Follett Products’ previously announced expansion project, has completed the redesign and expansion of its upright refrigerator and freezer production line.

This new line, Fitton says, is the first step in the overall expansion of the company’s Easton facility that will allow Follett to increase production of the high-performance medical-grade refrigerators and freezers required by Operation Warp Speed.

“The new production line expansion comes at the right time as we ramp up production to support Operation Warp Speed,” says Jeffrey Maybruck, vice president of operations at Follett Products. “We have been working since the summer to expand line capacity and procure components to meet the surge in demand for these high-performance refrigerators and freezers from hospitals and other health care facilities across the country, particularly from VA hospitals that have recently placed some large orders.”

Follett’s wide of range refrigerators and freezers can provide solutions to health care facilities of any size, from large central hospitals to remote clinics and retail pharmacies, while “precise temperature control” can safely store vaccines for maximum efficacy.

Slow start

As of January 2, more than 13 million doses of the Moderna and Pfizer BioNTech vaccines had been distributed in the U.S., with some 4 million doses administered, and it is anticipated that more than 300 million doses of injectable COVID-19 vaccine will be made available in the U.S. in the upcoming months.

Recently some doctors have suggested forgoing the second dose of the vaccines and giving all available doses to more people in one shot, arguing that the immunity from a single dose in more people is better than waiting for more vaccinations to occur, leaving more Americans vulnerable to the virus in the interim. This line of thinking has become more of an option to consider with the variant from overseas starting to pop up in the U.S.

But regardless of how the shots are ultimately given — or at what pace, what remains unchanged is the necessity of safe storage, which, as Fitton emphasizes, is crucial in the fight against the virus.

As she notes, the CDC has issued guidelines and recommendations related to vaccine storage and handling and is encouraging all providers to move toward implementing these guidelines as soon as possible.

This becomes even more important when considering that vaccine appearance, according to Fitton, is not a reliable indicator that the vaccine has been stored under appropriate ­conditions.

The CDC Vaccine Storage and Handling Toolkit outlines best practices from Advisory Committee on Immunization Practices recommendations, product information from vaccine manufacturers and scientific studies.

These best practices including developing and maintaining clearly written, detailed and up-to-date storage and handling standard operating procedures (SOP); training staff on routine and emergency SOP; designating a primary vaccine coordinator; using purpose-built or pharmaceutical-grade units designed to either refrigerate or freeze; using a “digital data logger” or other appropriate temperature monitoring device; storing vaccines in their original packaging with lids closed until ready for administration; and checking and recording storage unit minimum and maximum temperatures at the start of each workday.

Fitton notes that it is essential for those involved in vaccine distribution to ensure they have enough temperature-controlled capacity to meet this exploding need for vaccine storage and that current refrigerators and freezers meet the demanding criteria to maximize the efficacy of vaccines to conquer this ­pandemic.

“Now is the time to invest in the equipment that will help restore a sense of normalcy to the country.”