What’s New With Non–COVID-19 Vaccines

As the COVID-19 pandemic took center stage around the globe, it also shifted much of our focus to the vaccines and efforts to immunize populations against this disease. Although our successes in developing, distributing, and administering the COVID-19 vaccines deserve merit, we must not forget the fight against other vaccine-preventable diseases. Data from the Centers for Disease Control and Prevention (CDC) demonstrate that there was a notable decline in global coverage for most child vaccines from 2019 to 2020, as well as low current adult vaccination coverage in all age groups across most vaccines.^1,2 The CDC reports that a substantial improvement in adult vaccination uptake is needed to reduce the burden of vaccine-preventable diseases. One of the biggest predictors of whether patients get vaccinated is if they receive a strong recommendation from their health care provider.^3,4 Keeping abreast of new vaccine products and recommendations will help in making the best evidence-based practice recommendation for your patients. This article will provide an update on non–COVID-19 adult vaccine recommendations and newly approved non–COVID-19 vaccines.

PNEUMOCOCCAL

Current routine pneumococcal vaccine recommendation is that all adults age 65 years or older receive the pneumococcal polysaccharide vaccine (PPSV23). PPSV23 is also indicated for adults aged 19 to 64 years with certain underlying medical conditions and risk factors. In November 2019, the CDC’s Advisory Committee on Immunization Practice (ACIP) removed the recommendation for routine pneumococcal conjugate vaccination (PCV13) for all adults 65 years or older. PCV13 vaccination is now based on shared clinical decision-making for adults 65 years or older who do not have an immunocompromising condition, cerebrospinal fluid leak, or cochlear implant and have never received a dose of PCV13.⁵ To assist in determining individualized pneumococcal vaccination recommendations for your patients under current guidelines, the CDC has a mobile app called PneumoRecs VaxAdvisor that providers can use. These recommendations will change in 2022 based on the introduction of 2 new pneumococcal vaccines.

Two new pneumococcal vaccines were approved in 2021, leading to upcoming changes in recommendations for pneumococcal vaccination. The first vaccine is Vaxneuvance (PCV15), a conjugate vaccine from Merck that was approved by the United States Food and Drug Administration (FDA) on July 16, 2021. PCV15 protects against 15 different Streptococcus pneumoniae serotypes in adults 18 years and older: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F. Vaxneuvance is a single 0.5-mL intramuscular (IM) injection.⁶ The second vaccine is Prevnar 20 (PCV20), a conjugate vaccine from Pfizer that was approved by the FDA on June 8, 2021. PCV20 protects against the 15 S pneumoniae serotypes covered by Vaxneuvance and 5 additional serotypes: 8, 10A, 11A, 12F, and 15B. PCV20 is a single 0.5-mL IM injection.⁷

Contraindications for both new pneumococcal vaccines include severe allergic reactions to any component of each respective vaccine or diphtheria toxoid. Common adverse effects (AEs) for both vaccines include injection site pain, fatigue, myalgia, headache, and arthralgia.^6,7

To simplify the current pneumococcal vaccine recommendations and account for the 2 new vaccines, the updated pneumococcal vaccination recommendations below were approved by the ACIP in October 2021 and adopted by the CDC director and will become official once published in the CDC’s Morbidity and Mortality Weekly Report (MMWR) in 2022. The updated recommendations for pneumococcal vaccination will be based on age and risk factors. Simplifying the pneumococcal vaccination recommendations could help improve vaccine uptake, equity, and overall health.

• Adults 65 years or older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive either the PCV20 or PCV15 vaccine.⁸
• Adults aged 19 to 64 years with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown should receive either the PCV20 or PCV15 vaccine. Underlying medical conditions and risk factors indicated for pneumococcal vaccination prior to age 65 years include alcoholism, chronic heart/liver/lung disease, cigarette smoking, diabetes, chronic renal failure, nephrotic syndrome, immunodeficiency, iatrogenic immunosuppression, generalized malignancy, HIV, Hodgkin disease, leukemia, lymphoma, multiple myeloma, solid organ transplants, congenital or acquired asplenia, sickle cell disease or other hemoglobinopathies, cerebrospinal fluid leak, or cochlear implant.
• If PCV15 is used for either of the indications above, it should be followed by a dose of PPSV23.⁸

Detailed recommendations on spacing of PCV15 and PPSV23 and possible need for additional pneumococcal vaccinations after the primary dose have not been provided. Be sure to check the final recommendations from the CDC when published in MMWR.

ZOSTER

Shingrix, a recombinant, adjuvanted zoster vaccine indicated for prevention of herpes zoster in adults 50 years and older, received a new FDA indication. In summer 2021, the FDA approved this vaccine for use in patients 18 years or older who are or will be at increased risk for shingles due to immunodeficiency or immunosuppression caused by disease or therapy.⁹ In line with this recommendation, in October 2021 ACIP unanimously approved Shingrix for adults 19 years and older who are immunodeficient or immunocompromised.^8,10 This approval was based on studies of the vaccine in adults with hematologic malignancies or who have received an autologous hematopoietic stem cell transplant.10 Shingrix is administered as a 2-dose series by the IM route with the second dose administered 2 to 6 months after the first.⁹ Individuals who are immunosuppressed or immunocompromised may receive the second dose 1 to 2 months after the first dose.¹⁰ Shingrix was initially approved in 2017 and has replaced the live attenuated virus vaccine Zostavax due to better effectiveness, among other advantages.11 The US Zostavax manufacturer has discontinued its production and there are no remaining doses of this vaccine on the US market.

INFLUENZA

Influenza vaccine is recommended yearly for all individuals 6 months and older. The CDC continues to recommend that nonpregnant adults receive it after the month of August, whereas for pregnant adults in their third trimester the most current recommendation is to receive the influenza vaccine as soon as it is available.¹² Other notable changes for the influenza vaccines are that all are quadrivalent and any influenza vaccine may be administered on the same day as a COVID-19 vaccine.¹² Flucelvax, the cell-based inactivated influenza vaccine (IIV), has also received FDA approval for an expanded age indication for children 6 months and older.¹³ Additionally, use of Flucelvax is a precaution for individuals with a history of severe allergic reaction to any egg-based IIV, live attenuated influenza vaccine (LAIV), or recombinant influenza vaccine of any valency, whereas the use of recombinant influenza vaccine (RIV4) is a precaution for individuals with a history of severe allergic reaction to a previous dose of any egg-based IIV, LAIV, or Flucelvax vaccine of any valency.¹² If Flucelvax or recombinant influenza vaccine are used in these situations, they should be administered under medical supervision and possible consultation with an allergist. For patients with an egg allergy that manifests as more than hives, influenza vaccines other than Flucelvax or Flublok should be administered while under medical supervision.¹² Because severe allergic reactions to vaccines can occur with any dose of the vaccine regardless of history, it is recommended that all vaccination providers understand the office emergency plan and be certified in cardiopulmonary resuscitation.¹⁴ Lastly, consideration should be given to spacing of the LAIV4 administration and certain antiviral medications. LAIV4 should not be given to patients who received oseltamivir or zanamivir 48 hours prior, peramivir 5 days prior, or baloxavir 17 days prior to the vaccine.¹⁴

HEPATITIS B

There are 2 major changes regarding hepatitis B virus (HBV) vaccinations. A new recombinant vaccine called PreHevbrio has been approved, adding to the list of traditional options Engerix-B, Heplisav-B, and Recombivax HB. PreHevbrio is the only 3-antigen HBV vaccine approved in the United States and is indicated for prevention of HBV infections in adults 18 years and older. This vaccine follows a 3-dose schedule consisting of 1-mL IM doses administered at 0, 1, and 6 months. Contraindications include severe allergic reactions to any component of PreHevbrio or after a dose of another HBV vaccination. Common AEs include injection site pain, tenderness, headache, fatigue, and myalgia.^15,16 Although PreHevbrio gained FDA approval on November 30, 2021, it has not been incorporated into CDC’s recommended adult immunization schedule.

In addition to the new vaccine, on November 3, 2021, the ACIP Hepatitis Vaccines Work Group posted an updated recommendation that all adults in the United States aged 19 to 59 years should receive HBV vaccination. Adults 60 years and older are advised to receive vaccination following a risk-based guideline that may include considerations for sexual and occupational exposures, history of injection drug use, chronic liver disease, HIV infections, and international travel.^17,18 Simplifying and consolidating adult HBV vaccination recommendations may help to not only reduce health disparities created by risk-based guidelines that often favor patients with health literacy, awareness of infection risks, and access to preventive health services but also may address the increasing rates of acute HBV infections within this age group.¹⁹

MENINGOCOCCAL

Preexisting meningococcal conjugate (MenACWY) vaccines Menactra and Menveo are indicated for those aged 2 months to 55 years depending on the vaccine. MenQuadfi (MenACWY-TT) is a new conjugate vaccine used for the prevention of invasive meningococcal disease caused by Neisseria meningitidis in individuals beyond the traditional cutoff at age 55 years. This new vaccine was approved by the FDA on April 23, 2020, for use in individuals 2 years and older and is a single 0.5-mL IM injection followed by an optional booster dose 4 years after the primary vaccination for those 15 years and older, depending on the individual’s continued risk. This vaccine is contraindicated in individuals who have had severe allergic reactions to MenQuadfi or another tetanus toxoid– containing vaccine, and AEs include injection site pain, tenderness, headache, fatigue, and myalgia.²⁰

MenQuadfi not only presents a novel design as the first and only quadrivalent meningococcal vaccine to use tetanus toxoid as its protein carrier but also is appealing for its expanded target age group with the addition of adults 55 years and older.²¹ MenACWY vaccines including MenQuadfi are interchangeable, although administration of vaccines made from the same manufacturer is still recommended. In addition, although MenQuadfi uses a tetanus toxoid as its protein carrier, it should not replace or affect other routinely recommended tetanus toxoid–containing vaccines because MenQuadfi is only indicated for prevention of invasive meningococcal disease.²² This new vaccine only protects against N meningitidis serogroups A, C, W, and Y, meaning a separate vaccine will be required for serogroup B meningococcal (MenB) protection. Bexsero and Trumenba are the existing MenB vaccines and recommendations have not changed. MenB vaccination should be considered for those 10 years or older at increased risk of meningococcal disease.²³

CONCLUSION

The pandemic has reshifted our focus to the COVID-19 vaccines. However, other vaccine-preventable diseases remain prevalent. It is important to stay updated about these other non–COVID-19– related vaccine-preventable diseases to provide the best evidence-based practice recommendation for your patients.

References

1. Muhoza P, Danovaro-Holliday MC, Diallo MS, et al. Routine vaccination coverage - worldwide, 2020. MMWR Morb Mortal Wkly Rep. 2021;70(43):1495-1500. doi:10.15585/mmwr.mm7043a1

2. Lu PJ, Hung MC, Srivastav A, et al. Surveillance of vaccination coverage among adult populations -United States, 2018. MMWR Surveill Summ. 2021;70(3):1-26. doi:10.15585/mmwr.ss7003a1

3. National Vaccine Advisory Committee. Recommendations from the National Vaccine Advisory committee: standards for adult immunization practice. Public Health Rep. 2014;129(2):115-123. doi:10.1177/003335491412900203

4. Standards for practice: vaccine recommendation. CDC. Updated May 2, 2016. Accessed December 28, 2021. https://www.cdc.gov/vaccines/hcp/adults/for-practice/standards/recommend.html

5. Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep. 2019;68(46):1069-1075. doi:10.15585/mmwr.mm6846a5

6. Vaxneuvance. Prescribing information. Merck; 2021. Accessed December 11, 2021. https://www.fda.gov/media/150819/download

7. Prevnar 20. Prescription information. Wyeth Pharmaceuticals; 2021. Accessed December 11, 2021. https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert------Prevnar-13.pdf

8. Advisory Committee on Immunization Practices (ACIP). CDC. Updated January 12, 2022. Accessed December 28, 2021. https://www.cdc.gov/vaccines/acip/index.html

9. Shingrix. Prescription information. GlaxoSmithKline; 2021. Accessed December 30, 2021. https://www.fda.gov/media/108597/download

10. US Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices votes unanimously to recommend Shingrix for immunocompromised adults aged 19 and up. News release. GlaxoSmithKline. October 20, 2021. Accessed December 30, 2021. https://www.gsk.com/en-gb/media/press-releases/votes-unanimously-to-recommend-shingrix-for-immunocompromised-adults-aged-19-and-up/

11. Sly JR, Harris AL. Recombinant zoster vaccine (Shingrix) to prevent herpes zoster. Nurs Womens Health. 2018;22(5):417-422. doi:10.1016/j.nwh.2018.07.004

12. Grohskopf LA, Alyanak E, Ferdinands JM, et al. Prevention and control of seasonal influenza with vaccines: recommendations of the Advisory Committee on Immunization Practices, United States, 2021-22 influenza season. MMWR Recomm Rep. 2021;70(5):1-28. doi:10.15585/mmwr.rr7005a1

13. Flucelvax. Prescription information. Seqirus; 2021. Accessed December 30, 2021. https://www.fda.gov/media/115862/download

14. Schedule changes and guidance. CDC. Updated February 11, 2021. Accessed January 2, 2022. https://www.cdc.gov/vaccines/schedules/hcp/schedule-changes.html

15. PreHevbrio. Prescription information. VBI Vaccines; 2021. Accessed December 11, 2021. https://www.fda.gov/media/154561/download

16. VBI Vaccines announces FDA approval of PreHevbrio for the prevention of hepatitis B in adults. News release. VBI Vaccines. December 1, 2021. Accessed December 11, 2021. https://www.vbivaccines.com/press-releases/prehevbrio-approval/

17. Ault K. Universal adult hepatitis B vaccination: introduction. Presented at: Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices meeting; November 3, 2021. Accessed December 11, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/01-HepWG-ault-508.pdf

18. Schillie S, Vellozzi C, Reingold A, et al. Prevention of hepatitis B virus infection in the United States; recommendations of the Advisory Committee on Immunization Practices. MMWR Recomm Rep. 2018;67(1):1-31. doi:10.15585/mmwr.rr6701a1

19. Weng MK. Universal adult hepatitis B vaccination: work group considerations. Presented at: Hepatitis Vaccines Work Group, Advisory Committee on Immunization Practices meeting; November 3, 2021. Accessed January 10, 2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-11-2-3/02-HepWG-weng-508.pdf

20. MenQuadfi. Prescription information. Sanofi Pasteur Inc; 2021. Accessed December 11, 2021. https://www.fda.gov/media/137306/download

21. FDA approves MenQuadfi, the latest innovation in meningococcal (MEnACWY) vaccination. News release. Sanofi. April 24, 2020. Accessed December 11, 2021. https://www.sanofi.com/en/media-room/press-releases/2020/2020-04-24-07-00-00

22. Mbaeyi SA, Bozio CH, Duffy J, et al. Meningococcal vaccination: recommendations of the Advisory Committee on Immunization Practices, United States, 2020. MMWR Recomm Rep. 2020;69(9):1-41. doi:10.15585/mmwr.rr6909a1

23. Patton ME, Stephens D, Moore K, MacNeil JR. Updated recommendations for use of MenB-FHbp serogroup B meningococcal vaccine - Advisory Committee on Immunization Practices, 2016. MMWR Morb Mortal Wkly Rep. 2017;66(19):509-513. doi:10.15585/mmwr.mm6619a6