The vaccines indicated for patients 65+ are: Fluzone High-Dose Quadrivalent and adjuvanted flu vaccines (FLUAD and FLUAD Quadrivalent). The Fluzone High-Dose Quadrivalent (HD) is a four-ingredient, inactivated vaccine that contains four times the antigen to provide extra protection for those 65+. It’s manufactured using an egg-based process and is one of the more expensive options at approximately $64 for each prefilled syringe.

FLUAD and FLUAD Quadrivalent vaccines contain the ingredient squalene that helps increase immune response and allows the manufacturer to use less virus in the vaccine to produce a greater supply. Similarly, these are also made with the egg-based process and cost approximately $60 for both the quadrivalent or standard dose adjuvant vaccine.

In addition to the ones above, there are a number of other less costly options available for standard flu vaccines (SD) priced at around $20. So the question remains: is the high-dose or adjuvanted vaccine better than the standard dose for the senior population?

“Efficacy of High-Dose versus Standard-Dose Influenza Vaccine in Older Adults” was a phase IIIb-IV, multicenter, randomized, double-blind, active-controlled trial that compared the SD vs HD vaccine with an enrollment of 31,989 patients for the trial. The results were statistically significant with the HD trial resulting in 228 influenza cases versus the SD trial’s 301 cases. Similarly, hemagglutination inhibition immunogenicity was measured for the two groups. A month after vaccination, the HD showed significantly higher levels than the SD.

The second trial discussed in this article is by Gravenstein PS, Davidson HE, Taljaard M, et. al. They performed a single-blind, pragmatic, comparative effectiveness, cluster-randomized trial. The study compared HD versus SD in nursing home residents with the primary outcome being hospital admissions. The respiratory-related hospital admissions were significantly lower in the facilities in which the residents received HD than in those that received SD. To expand, there were 185/1000 residents hospitalized in the HD versus 211/1000 in the SD group.

The third study, “Prevention of serious events in adults 65 years of age or older”, was a double-blind, randomized, active-controlled, multicenter trial. Participants were adults ≥65 years, randomized to receive trivalent HD or trivalent SD. The trial length followed participants 6 to 8 months post-vaccination and the primary endpoint was lab-confirmed influenza. The randomization of participants was as follows: 15,991 to IIV-HD and 15,998 to IIV-SD. The rate of all-cause hospitalization was 6.9% (95% CI, 0.5–12.8%) lower in the HD cohort. Likewise, there were 71 pneumonia events in HD vs 118 in SD.

As far as the data for the adjuvant vaccine, a meta-analysis was conducted including all prospective, randomized, and observer-blinded clinical studies. A total of 20 trials were included over the span of 2 years. In each of these studies, a single dose of FLUAD or control vaccine (standard vaccine) was given to each patient. The study population was those aged 65+ and mostly ambulatory patients. The results of the study were statistically significant in that the adjuvant vaccine had a higher immunogenicity than the SD. Another analysis performed showed that patients with cardiovascular diseases, respiratory diseases, or diabetes had a greater benefit from the adjuvant vaccine than SD.

Which leads us to the next question: is the high dose or adjuvant vaccine really better for patients 65 and older? To date, there are no trials comparing the high-dose against the adjuvant vaccine, and the CDC does not recommend one vaccine over another for this age group.

In summary, the trials discussed above have shown that all approved flu vaccines are efficacious at preventing the flu. When comparing the two, however, the HD performed better than the standard dose in patients over 65 years of age. For the prevention of influenza cases, hospitalizations, or pneumonia, the HD was superior.

On the other hand, the adjuvant vaccine also performed better than the standard dose vaccine and resulted in higher rates of immunogenicity in the elderly. However, the CDC does not recommend or prefer one influenza vaccination over another. The most important recommendation one can make as a provider is ensuring that patients over 65 receive one of these vaccinations annually.

In conclusion, both the high dose and adjuvant vaccines are generally well-tolerated and efficacious and are the preferred choice when choosing a vaccine for the elderly population.

References

Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States – 2019–2020 Influenza Season. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/about/burden/2019-2020.html. Published October 6, 2020. Accessed October 17, 2020.

Fluzone High-Dose Seasonal Influenza Vaccine. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/prevent/qa_fluzone.htm. Published September 3, 2020. Accessed October 17, 2020.

Influenza Virus Vaccine (Inactivated). Lexi-Drugs. Lexicomp. Wolters Kluwer Health, Inc. Riverwoods, IL. Available at: https://www.reliasmedia.com/articles/143915-influenza-cases-rising-what-clinicians-need-to-know. Accessed October 20, 2020.

DiazGranados CA, Dunning AJ, Kimmel M, et al. Efficacy of high-dose versus standard-dose influenza vaccine in older adults. N Engl J Med. 2014;371(7):635-645. doi:10.1056/NEJMoa1315727

Gravenstein S, Davidson HE, Taljaard M, et al. Comparative effectiveness of high-dose versus standard-dose influenza vaccination on numbers of US nursing home residents admitted to hospital: a cluster-randomised trial. Lancet Respir Med. 2017;5(9):738-746. doi:10.1016/S2213-2600(17)30235-7

Izurieta HS, Chillarige Y, Kelman J, et al. Relative Effectiveness of Cell-Cultured and Egg-Based Influenza Vaccines Among Elderly Persons in the United States, 2017-2018 [published correction appears in J Infect Dis. 2019 Jun 5;220(1):179]. J Infect Dis. 2019;220(8):1255-1264. doi:10.1093/infdis/jiy716

DiazGranados CA, Robertson CA, Talbot HK, Landolfi V, Dunning AJ, Greenberg DP. Prevention of serious events in adults 65 years of age or older: A comparison between high-dose and standard-dose inactivated influenza vaccines. Vaccine. 2015;33(38):4988-4993. doi:10.1016/j.vaccine.2015.07.006

Adjuvanted Flu Vaccine. Centers for Disease Control and Prevention. https://www.cdc.gov/flu/prevent/adjuvant.htm. Published August 21, 2020. Accessed October 20, 2020.

Podda A. The adjuvanted influenza vaccines with novel adjuvants: experience with the MF59-adjuvanted vaccine. Vaccine. 2001;19(17-19):2673-2680. doi:10.1016/s0264-410x(00)00499-0

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Currently, there are two vaccines approved to prevent shingles: the shingle zoster vaccine live (Zostavax) and shingles recombinant zoster vaccine (Shingrix). Between the two, the Advisory Committee on Immunization Practice prefers Shingrix. The FDA approved Shingrix on October of 2017 as an intramuscular 2-dose vaccine series that is recommended for immunocompetent adults ≥ 50 years³. The effectiveness of Shingrix was evaluated in a two-part, phase III, multicenter trial that evaluated Shingrix efficacy with more than 30,000 participants. The ZOE-50 trial group results concluded that the vaccine efficacy after the 1st year was greater than 97% compared to placebo⁴. The ZOE-70 trial results concluded that vaccine efficacy was about 90% in patients older than 70⁵. In a pooled analysis of both studies in patients over 70, results showed that vaccine efficacy against herpes zoster was 91.3% and 88.8% against postherpetic neuralgia.

Based on findings from the shingles studies, the Centers for Disease Control and Prevention (CDC) published core recommendations for patients ≥ 50 years to receive the Shingrix vaccine⁵, with the second dose of the vaccine being administered 2 to 6 months after the initial dose. While Shingrix is not recommended in patients that have an active acute episode of herpes zoster, it is recommended for patients with a resolved previous infection of herpes zoster. For patients that have had a previous Zostavax vaccine, it is best to wait at least 8 weeks before administering Shingrix. The only known contraindication for the vaccine is for patients that have a severe allergic reaction to the contents of the Shingrix. Finally, it is recommended that any adult with an acute illness wait to receive their vaccine until their illness is resolved.

The two-dose Shingrix vaccine series has an estimated cost of $280, based on most drug store chain pharmacies. While most insurance companies cover the cost of the vaccine for patients, some still require a co-pay. The vaccine must be reconstituted to a 0.5 mL dose prior to injection. Pharmacists play a crucial role in reminding the patient to complete the full series by calling patients to remind them of their second dose within 2-6 months of their initial Shingrix injection.

PharmD Live® telehealth solutions, including Chronic Care Management (CCM) and Medicare Annual Wellness Visits, emphasize the importance of vaccinations, thereby reducing the disease burden on our patient population. We provide patients and their healthcare providers with 24/7 access to a clinical pharmacist, who can assist the patient if he or she experiences a common adverse reaction such as injection site redness, swelling, fever, or upset stomach. The patient’s benefit for receiving the shingles vaccine generally outweighs the risk, and this is assessed during an initial visit with a PharmD Live® clinical pharmacist.

PharmD Live® Blog for Providers offers insight on topics of interest to the healthcare community. Researched by our team of clinical pharmacists, this blog references information that is current as of the date of posting. For further information, please visit the references below, or contact our pharmacy team on the Contact page. Thank you for reading!References1. Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc 2007;82:1341–9. DOI: 10.4065/82.11.13412. Food and Drug Administration. Shingrix [package insert]. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2017.3. Lal H, Cunningham AL, Godeaux O, et al. ; ZOE-50 Study Group. Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults. N Engl J Med 2015;372:2087–96. DOI: 10.1056/NEJMoa15011844. Cunningham AL, Lal H, Kovac M, et al. ; ZOE-70 Study Group. Efficacy of the herpes zoster subunit vaccine in adults 70 years of age or older. N Engl J Med 2016;375:1019–32.DOI: 10.1056/NEJMoa16038005. Centers for Disease Control and Prevention. Shingrix Recommendations. Accessed October 26, 2020.

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Prevnar 13 (PCV13)  is used primarily with children and in some high-risk adults. It helps protect against multiple Streptococcus pneumoniae serotypes.  Specifically it targets Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Studies have shown that the US incidence of invasive pneumococcal disease had declined by 87% since the introduction of Prevnar 13 in 2010. This intramuscular injection is given to children as a four dose series: at 2, 4, 6, and somewhere between 12 to 15 months. Additionally, adults 19 to <65 can be given Prevnar 13 if they are immunocompetent, immunocompromised or if they have functional or anatomic asplenia. Routine vaccination for adults >65 with Prevnar 13 is not recommended. However, ACIP advises the decision to be clinician driven if they feel Prevnar 13  is appropriate for that age group; only patients who are at high risk are often given the vaccine. They include nursing home patients, those residing in low pediatric PCV13 uptake and those traveling to regions where there is no PCV13 immunization program. 

Pneumovax 23 (PPSV23) is used for adults greater than 50 years old and >2 years old who are at an increased risk of pneumococcal disease. This vaccine targets Streptococcus pneumoniae serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F.  A 14-year retrospective study found that PPSV23 resulted in a 57% reduction of disease in adults with certain chronic conditions. This vaccine can be given either intramuscularly or subcutaneously. A single dose of Pneumovax 23 is recommended in adults 19-64 who are at an increased risk for pneumococcal infections like chronic heart disease or alcohol use disorder.  Additionally, Pneumovax 23 vaccine is indicated for all adults >65 years old since incidence increases after this age. 

In conclusion, the need to vaccinate against pneumococcal disease is essential to lessen the likelihood of getting the infection. Streptococcus pneumoniae is the main bacterial cause of pneumonia which causes both morbidity and mortality globally. Both Prevnar 13 and Pneumovax 23 help protect against the disease. However, having a basic understanding of when to give each vaccine and to whom is extremely challenging and at times confusing. 

Below is a concise guide summarizing the main highlights of this article of when to give each vaccine and to whom:

Prevnar 13 (PCV13)

• Types of bacteria it targets: 13 types of pneumococcal bacteria
• Who is it for: Primarily for children. At times for high-risk adults
• Administration: Intramuscularly
• When it should be given:
  • 4 dose series for children: 12-15 months, ages 2, 4 and 6
  • >19YO with the below: cochlear implants, CSF leaks, congenital or acquired asplenia, sickle cell disease, chronic renal failure, congenital or acquired immunodeficiency, generalized malignancy, HIV infection, Hodgkin disease, Iatrogenic immunosuppression, leukemia, lymphoma, multiple myeloma, nephrotic syndrome, solid organ transplant

Pneumovax 23 (PPSV23)

• Types of bacteria it targets: 23 types of pneumococcal bacteria

• Who is it for: only for adults
• Administration: Subcutaneously or intramuscularly
• When it should be given:
  • 19-64 with: Alcoholism, chronic heart disease, chronic liver disease, chronic lung disease, cigarette smoking, diabetes
  • If >19 YO patient received PCV 13, then >/=8weeks PPSV23 is given and revaccination of PPSV23 is done >/= 5 years after initial PPSV23 for patients with asplenia and immunocompromised patients
  • >65 YO: PPSV23 to be given. If the provider has decided to give PCV 13 then wait 1 year to give PPSV23

For more information on how PharmD Live® can help identify patients in need of pneumococcal vaccines, please contact us!

References: 

Merck Vaccines. Indication for Pneumovax 23. 2020 Merck Sharp & Dohme Corp. Accessed October 28, 2020. https://www.merckvaccines.com/pneumovax23/

Musher, M Daniel.  Pneumococcal Vaccination in Adults.  In: File, Thomas and Bond Sheila. UpToDate. UpToDate, Inc.; 2020. Accessed October 28, 2020. https://www.uptodate.com/contents/pneumococcal-vaccination-in-adults?search=pneumovax%2023&source=search_result&selectedTitle=2~84&usage_type=default&display_rank=1#H4126861631

PfizerPro. Prevnar13. 2020. Wyeth Pharmaceuticals. Accessed October 28, 2020. https://www.pfizerpro.com/product/prevnar13pediatric/hcp

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