The Advisory Committee on Immunization Practices (ACIP) of the CDC met virtually on February 23 and 24 for its regular triennial vaccine meeting. For archives of minutes and slides, go to the ACIP meeting website and click on Meeting Materials.
The CDC conducted a virtual Clinician Outreach and Communications Activity (COCA) call on February 24 outlining changes in recommendations regarding COVID-19 vaccines. The COVID Vaccine Recommendations are available on their Clinical Considerations website. Below are the key highlights:
ACIP
- Recommendations were approved for travel vaccines including cholera vaccine in children and tick-borne encephalitis (TBE) vaccine
- Evidence to recommend PCV15 (VAXNEUVANCE TM) in children was presented pending FDA approval. The work group recommends that PCV15 be approved as an option for children, but not preferred over PCV13 (Prevnar)
- (PreHevbrio TM:VBI Vaccines) a 3-dose, 3-antigen Hepatitis B vaccine for adults age 18 and older has been added to Hepatitis B vaccine recommendations as a safe and noninferior product
- Data on (PRIORIX:GSK) MMR vaccine was reviewed pending FDA approval
- Evidence for a preferential recommendation of Enhanced influenza vaccines (High-Dose IIV, adjuvanted IIV, Recombinant IV) for seniors was reviewed. While there is some evidence of superiority over standard dose for these vaccines, there is not sufficient evidence to prefer one enhanced product over the others
COCA – COVID Vaccines
- The CDC allows for an extended dosing interval between the first two doses of the primary mRNA COVID vaccine series of 8 weeks for some individuals to reduce myocarditis risk and increase effectiveness
- Summarized vaccine schedules are now available by product at the top of the “Primary Series” section and the top of the “Guidance for Immunocompromised” section of the CDC’s COVID vaccine Clinical Considerations website.
Travel Vaccines
The ACIP voted to recommend lyophilized CVD 103-HgR for children and adolescents age 2-17 years traveling to an area with active cholera transmission.
The ACIP voted to recommend Tick-borne encephalitis vaccine (TICOVAC:Pfizer) for laboratory workers with a potential for exposure to TBE virus and for persons who are moving or traveling to a TBE-endemic area and will have extensive exposure to ticks based on their planned outdoor activities and itinerary. They also recommend that TBE vaccine may be considered in shared clinical decision making for persons traveling to or moving to a TBE-endemic area who might engage in outdoor activities in areas ticks are likely to be found. The decision to vaccinate should be based on an assessment of their planned activities and itinerary, risk factors for a poorer medical outcome, and personal perception and tolerance of risk. It is estimated that one million persons need to be vaccinated to prevent once case of TBE.
Pneumococcal Vaccine
Pneumococcal conjugate vaccine 15 valent (PCV15: VAXNEUVANCE TM) by Merck is anticipated to be granted FDA approval for use in children. The pneumococcal workgroup is not considering any changes to the pneumococcal vaccine schedule, but is evaluating whether PCV15 should be considered as an option to for pneumococcal conjugate vaccination as a standard recommendation for all children age <2 years and whether it should be used in children age 2 through 18 years with underlying medical conditions according to current dosing and schedules. It is not being considered as preferred over PCV13:PREVNAR, but as an option to it.
The PCV15 non-PCV13 serotypes include 22F and 33F. Acute otitis media and invasive pneumococcal data show that the two additional serotypes included in PCV15 cause 8-17% of remaining pneumococcal disease in children age less than 5 years.
PCV15 has a safety profile consistent with licensed PCVs. Immunogenicity studies show PCV15 is non-inferior to PCV13 in twelve of the shared serotypes, and is superior in serotypes 22F, 33F, and 3. Non-inferiority was met with concomitant use of other pediatric vaccines. No clinical outcomes are available.
PCV15 is anticipated to be licensed before the end of Q2 2022 and PCV20 is anticipated to be licenses before the end of Q2 2023. ACIP vote to recommend PCV15 is anticipated in June 2022 if it is FDA licensed by that time.
Hepatitis B Vaccine
(PreHevbrio TM:VBI Vaccines) a 3-dose, 3-antigen Hepatitis B vaccine for adults age 18 and older is to be included as an option for adult Hepatitis B vaccination within the existing ACIP Hep B vaccine recommendations as a safe and non-inferior product. The three vaccine antigens are small, medium and large Hep B surface antigens combined with an Alum-adjuvant grown in Chinese hamsters. It is comparable with Engerix-B for immunogenicity and reactogenicity.
It has not been evaluated for use in patients who are breastfeeding or pregnant patients, or in patients on dialysis.
Measles, Mumps, Rubella (MMR) Vaccine
(PRIORIX:GSK) is a MMR vaccine pending FDA approval. It has been used in 100 countries outside the U.S> with over 400 million doses distributed. It is a lyophilized vaccine needing reconstitution and is stored refrigerated. It is given as a 0.5 mL dose subcutaneously with the first dose at 12 months, the second dose at age 4-6 years. The second dose can be given at age <4 years with a minimum interval between doses of at least 28 days and can be given at age 7 years and older. Safety and immunologic response were similar when given concomitant with Varicella, Kinrix, Havrix, and PCV13. Studies suggest it can be interchangeable with M-M-R-II.
If approved, PRIORX will not need to receive an ACIP vote for recommendation, it will just be added as an option for MMR vaccination with a policy note.
Enhanced Influenza Vaccines (HD-IIV, aIIV, RIV)
Enhanced influenza vaccines (EIV) include High-dose Fluzone:Sanofi (HD-IIV), adjuvanted Fluad:Seqirus (aIIV), and recombinant Flublok:Sanofi (RIV). They are all indicated for persons age 65 and older. These individuals have the potential to have a decreased immune response to influenza vaccines. Eighty percent of persons age 65 and older are already receiving an enhanced influenza vaccine. The influenza work group has been evaluating whether a preferential recommendation over standard influenza vaccines in persons age 65 and older might impact influenza burden over the course of a season.
The risk of a preferential recommendation is if it were to cause some delay or reduced coverage in seniors receiving the vaccine due to delay in delivery, restricted supply, or patient waiting to be vaccinated due to trying to get access to the perceived right type of vaccine. This impact was modeled and was especially significant in a high severity season.
Overall, there is evidence of benefit favoring each EIV over standard dose IIVs in older adults. There is not sufficient evidence favoring one EIV over other EIVs. More information will be presented at future meetings.
The 2021-2022 influenza season has been predominated by Influenza A:H3N2. There have been a higher number of cases this season than last season, but still a low incidence season compared to other recent seasons, with lower cases of hospitalizations and death from influenza. Protective behaviors such as masking and limiting contacts continue to decrease the impact of influenza this season.
COCA – COVID-19 Vaccines
Changes to the CDC’s Interim Clinical Considerations for Use of COVID-19 Vaccines Currently Approved or Authorized in the United States were reviewed during the Clinician Outreach and Communications Activity (COCA) call on February 24, 2022. Many of these clinical considerations were previously included in the January Immunization Update.
The additional recommendations published on the clinical considerations website on 2/22/2022 include an extended dosing interval between the first two doses of the primary mRNA COVID vaccine series of 8 weeks for some individuals to reduce myocarditis risk and increase effectiveness.
Persons who should continue to receive their primary series doses at a 3-week interval (Pfizer) or 4-week interval (Moderna) include persons age 65 and older, persons who are moderately or severely immunocompromised, and those needing rapid protection such as during high levels of community transmission.
Those who can receive their mRNA vaccine primary series with a dosing interval of 8 weeks between the first and second doses include all others age 12-64 (Pfizer) or 18-64 (Moderna), with special emphasis on recommending this longer interval to those at higher risk for myocarditis such as young men age 12 through 39 years.
Summarized vaccine schedules are now available by product at the top of the “Primary Series” section and the top of the “Guidance for Immunocompromised” section of the CDC’s COVID vaccine Clinical Considerations website.
If you have any questions regarding immunization, feel free to contact Tamara Sheffield, MD, MPA, MPH, Medical Director, Community Health and Prevention, Intermountain Healthcare, at (801) 442-3946.