IAC: Vaccine Supply Updates and June 2020 ACIP Meeting News

Immunization Action Coalition News on Vaccine Supply Updates and June 2020 ACIP Meeting

• Zostavax—Beginning July 1, 2020, Merck will no longer be selling Zostavax, zoster vaccine live. All remaining Zostavax supplies in the U.S. will expire no later than November 2020. 
• Adult Hepatitis B—The adult and dialysis formulations of Merck’s adult hepatitis B vaccine (Recombivax HB) will be returning to the U.S. market the week of July 20.

IAC summarizes the June 2020 ACIP Virtual Meeting

For the first time, the Advisory Committee on Immunization Practices (ACIP) conducted a regular meeting virtually on June 24, 2020.

 
New MenACWY Vaccine Added to VFC Program. ACIP voted unanimously to add MenACWY-TT vaccine (Sanofi Pasteur) as an option within the Vaccines For Children (VFC) program. This vaccine was licensed by the FDA in April 2020 for use in persons 2 years of age and older. No ACIP policy vote was needed, as the addition of MenQuadfi required no changes to the current meningococcal recommendations for dosing and scheduling. Trials are ongoing to seek eventual expansion of the age indication down to 6 weeks of age and to evaluate its use with varying pediatric immunization schedules in use throughout the world. MenQuadfi will become available in the U.S. in 2021.

Recommendations for 2020–21 Influenza Season. ACIP received multiple updates on the 2019–2020 influenza season. Preliminary results indicate an overall vaccine effectiveness (VE) rate of 39% against medically attenuated influenza. Although it would be desirable to see higher VE rates, it is important to remember this means that influenza-related outpatient visits and hospitalizations were reduced by almost 40%, which translates to millions of Americans.  
 
The committee unanimously approved inclusion of several updates to the influenza statement for the 2020–21 season. ACIP recommendations are not official until published in the MMWR.

• Vaccine composition—Three new vaccine strains will be incorporated for H1N1, H3N2, and B Victoria. The B Yamagata strain included in quadrivalent vaccine formulations remains unchanged from the 2019–2020 season.
• New quadrivalent vaccine formulations—Two recently licensed quadrivalent vaccines will be available for persons 65 years and older: Fluzone High-Dose Quadrivalent (Sanofi Pasteur) and Fluad Quadrivalent (Seqirus).  
• Contraindications/precautions table—The title of the table will be simplified to “Contraindications,” with the accompanying text providing more detail concerning which contraindications are printed in package inserts and which derive from ACIP recommendations.
• LAIV recommendations
• Contraindications to the use of LAIV will be added for persons with cochlear implants, active CSF leaks, and anatomical or functional asplenia.
• To prevent possible interference with LAIV replication, intervals between use of antivirals and LAIV will be clarified to address the use of long-acting, single-dose influenza antivirals.
• Egg allergy—Language will be updated to indicate that no special precautions are needed when using egg-free vaccines (RIV and ccIIV) in persons with severe egg allergy.

In anticipation of greatly increased demand for influenza vaccine and possible concurrent spread of SARS-Cov-2 in the upcoming season, CDC has purchased an additional 7.1 million doses of influenza vaccine to be made available for adults through state immunization programs in November or later in the influenza vaccination season.

COVID-19 Update
 
The remainder of the meeting was devoted to updates on COVID-19 disease and clinical epidemiology. The committee also reviewed information on various coronavirus vaccine candidates in development. In addition, ACIP heard from Matthew Hepburn, MD, Joint Product Lead for Operation Warp Speed (OWS), the federal effort to coordinate vaccine development and use in the U.S. Dr. Hepburn noted that OWS was established to take advantage of the best expertise available in the Department of Health and Human Services and Department of Defense. Three complementary teams have been established within OWS to coordinate pre-clinical and clinical research, vaccine manufacturing, and vaccine distribution and administration. The latter group will be headed by CDC’s Dr. Nancy Messonnier.

The ACIP COVID-19 work group presented and solicited feedback on its preliminary work on establishing priority groups to receive vaccine when it becomes available. The guiding principles for the work group’s efforts are: (1) safety is paramount; (2) vaccine clinical trials should be inclusive of populations most affected by the disease, e.g., older adults and selected racial and ethnic groups; (3) vaccine should be distributed in an equitable and efficient manner; and (4) flexibility must be allowed.
 
CDC also provided an overview of the recent precipitous drop in routine vaccination levels in the U.S. due to the pandemic response. The agency stressed that catch-up for childhood vaccination needs to be undertaken now, so that clinical capacity can be directed to back-to-school and influenza vaccination in the summer and fall. CDC has issued multiple resources to assist providers in this effort.

Vaccine Supply Update
 
In the meeting’s final presentation, CDC provided two updates on the nation’s current vaccine supply:

• Adult Hepatitis B—The adult and dialysis formulations of Merck’s adult hepatitis B vaccine (Recombivax HB) will be returning to the U.S. market the week of July 20. 
• Zostavax—Beginning July 1, 2020, Merck will no longer be selling Zostavax, zoster vaccine live. All remaining Zostavax supplies in the U.S. will expire no later than November 2020. 

All recommendations approved by ACIP are provisional until they are approved by the CDC director and published in MMWR. Presentation slides from the June meeting should be posted on the ACIP website in the next 4–6 weeks.