Will Fall Bring Another Tripledemic? RSV, Covid-19, Flu Immunization and Pharmacy

While most of us are still enjoying the summer, health officials and pharmacy organizations are already gearing up for the fall immunization season at a quick pace. Training has been assigned, and pharmacies are actively setting up flu clinics in anticipation of a high-demand vaccination season after last year’s “tripledemic” of influenza, COVID-19, and respiratory syncytial virus (RSV).

Many people heard of RSV for the first time last year, given its widespread impact last fall and winter. Others are learning about it for the first time since the Centers for Disease Control and Prevention (CDC) recommended RSV vaccines from Pfizer and GSK in June for people 60 and older. With the U.S. Food and Drug Administration (FDA) approval of the RSV vaccines, health officials are encouraging people to get three vaccines this fall: influenza, COVID, and RSV for older adults

RSV ON THE RISE

First, a bit about RSV. RSV is a viral illness that impacts the respiratory tract, causing mild, cold-like symptoms. While the majority of those infected feel better in week or two, RSV can be very serious for infants and older adults. The CDC notes that almost all children will have had RSV by their second birthday. Older adults who have chronic conditions affecting the heart and lungs, who are immunocompromised, or live in long-term care facilities are at higher risks for serious problems from RSV. Consider the facts about the annual burden of RSV:

• 58,000–80,000 hospitalizations among children younger than 5 years.
• 2.1 million outpatient visits among children younger than 5 years.
• 100–300 deaths among children younger than 5 years.
• 60,000–160,000 hospitalizations for adults 65 years and older.
• 6,000–10,000 deaths for adults 65 years and older.

This compares to last year’s flu season data of 12–26 million medical visits, 300,000–650,000 hospitalizations, and 19,000– 58,000 deaths.

While RSV’s burden is less than influenza, it is still high. And now there is a vaccine to afford protection. The vaccine has not yet been approved for pregnant women, but that is expected later this summer because research is finding vaccination later in pregnancy confers antibodies to the infant.

On the COVID front, the FDA’s Vaccines and Related Biological Products Advisory Committee has asked vaccine makers to reformulate their products to include protection from a new variant, XBB.1.5, for this fall, and that it be updated as a monovalent vaccine. Currently, older adults can decide whether to get a second booster of the bivalent vaccines that were introduced last year.

Only 43% of adults 65 years or older decided to get the bivalent vaccine last year, compared to 71% who received the flu vaccine. There is definitely a group of proactive older adults who call the pharmacies I staff wondering if there is a “new” COVID vaccine or whether they need another of the bivalent. Many of my fellow quilt group members asked me about this topic at our summer picnic. I am certain these individuals will also be asking about the RSV vaccine.

Ofer Levy, who heads Boston Children’s Hospital’s precision vaccines program and is an FDA advisor, said in a recent New York Times article that the new RSV vaccine is a “godsend” and is an important tool that can be deployed to keep people from losing loved ones

POTENTIAL BURDENS OF ADDITIONAL VACCINE PROGRAMS

While I am happy to see the news about the RSV vaccine, I am extremely concerned about the burden an additional vaccine will place on the pharmacy staff this fall, for a number of reasons:

1. Is there sufficient time to educate both patients and providers about the benefits of the new RSV vaccine? Do we know how the vaccine should be administered and stored? Will there be an adequate supply, given this is the first time a vaccine for RSV is available? Are there special considerations or potential side effects? As with other vaccines, can it be given at the same time as those for COVID and influenza? How will payers reimburse for this vaccine? Will they cover pharmacy administration?
2. When is the new monovalent COVID vaccine formulation expected? Weeks from now? Months from now? Before the flu vaccine season really gets underway in mid-tolate September? How quickly will we be able to adapt to the new vaccine and remove supplies of the current bivalent from the pipeline if necessary? Will there continue to be indications for the current bivalent vaccine? What will the new recommendations be for each age group? What educational efforts will be undertaken with the public?
3. Will pharmacy organizations have scheduling systems in place that work and ease the burden at the pharmacy counter? For example, systems that allow/require a patient to complete consent forms and provide insurance information when making an appointment, reducing the time spent when they arrive for their appointment? Will the system allow patients to choose multiple vaccines at one time rather than having to make multiple appointments? Can the system process billing for the vaccine prior to the patient’s arrival? This can be a time saver, but can also create issues when the prebill must be reversed at the originating pharmacy when a patient decides to go elsewhere.
4. Will pharmacy organizations support staffing levels by requiring appointments and/or limiting times when walk-in vaccinations will be given? Will pharmacy staff have the authority to make that decision based on their location’s workload and staffing?
5. What resources can help us educate patients that they can safely receive all three vaccines in one arm? By doing so, the vaccines can be given more quickly and the patient has a more localized area of pain from injections.
6. What messaging will health officials at federal, state, and local levels be sending to the public, and how far in advance will pharmacy organizations be made aware of these communications?

These questions are just those in the front of my mind after reading the Times story about the plans for a “three-pronged” defense against another tripledemic. While the new RSV vaccines and forthcoming reformulated COVID vaccines represent important steps in keeping people healthy, I am concerned this “three-pronged” approach will create a triple workload for an already strained pharmacy community. Pharmacy system vendors should be proactive in working with customers to be sure systems can more than adequately handle the possibilities this “new” flu season may bring. CT

Marsha K. Millonig, B.Pharm., M.B.A., is president and CEO of Catalyst Enterprises, LLC, and an associate fellow at the University of Minnesota College of Pharmacy Center for Leading Healthcare Change. The author can be reached at mmillonig@catalystenterprises.net.