Updated COVID-19 Vaccines Available Soon!

Following yesterday’s green light from the Food and Drug Administration (FDA), today, September 12, 2023, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted 13-1 to recommend the newly reformulated monovalent COVID-19 vaccines for all individuals aged 6 months and older.

HCP attended the ACIP meeting, and provides this summary for home care providers. We encourage you to widely distribute this news to your staff.

The Recommendation

The newly formulated COVID-19 vaccines are recommended for all individuals aged 6 months and older. Strong recommendations were voiced for those at increased risk, such as older adults and immunocompromised individuals.

The Moderna and Pfizer mRNA products are targeted to the XBB.1.5 variant, and will be available immediately. A monovalent XBB.1.5 non-mRNA vaccine mad by Novavax is still under review by the FDA, but will be commercially available immediately upon authorization.

The data presented to the expert panel included human and animal efficacy studies and projections for effectiveness against newly emerging SARSCoV-2 variants. In making its recommendation, ACIP considered the disease burden of COVID-19, including hospitalizations, intensive care usage, and death. Of course, safety data was also presented. It is scientifically sound to predict that no differences in adverse effect severity or prevalence are expected with the new formulation.

Both manufacturers indicated that vaccine supply will not be a concern. The new formulations are available in single dose vials, which will reduce waste. Streamlined dosing will simplify administration and reduce error potential.  For specified periods, the vaccines are stable under regular refrigeration, and minimum orders will be lower than for prior products, resulting in wider access across practice settings.

Note that with these FDA approvals and ACIP recommendation, bivalent vaccines are no longer appropriate for any population group.

As with prior COVID-19 vaccines, co-administration with influenza vaccines is safe and effective. A separate limb is recommended for each vaccine.

The Rationale

The panel determined that the potential benefits outweigh the potential risks in all populations, and in light of ongoing equity concerns, decided that a universal recommendation was appropriate, as opposed to one that is age restricted or based on clinical decision making. The unpredictability of the SARSCoV-2 virus also drove their decision for a universal recommendation.

The only major concern raised was that data for children is very limited at this time. The lack of data was noted as the reason for the one opposing vote. The objection was not against the vaccines; rather it was supportive of shared decision making versus the universal recommendation. It was noted that COVID-19 deaths in children are now similar to those from influenza.

Presenters noted that disease burden has been greatly reduced in the US, but deaths and hospitalizations remain unacceptably high and are climbing. Statistics surrounding these severe outcomes are comparable or higher than for influenza (depending on age group), supporting a COVID-19 vaccination campaign as respiratory illness season begins.

In recent months, over half of the COVID-19 deaths in children occurred in those without underlying conditions, illustrating that everyone can be at risk. It was noted that the oldest and youngest individuals benefit the most from immunization, but the universal recommendation ensures access for all who seek vaccination.

It was reported that while “hybrid immunity” (i.e., vaccination plus infection) does offer slightly better protection than immunization alone, statistics clearly show that immunization reduces severe illness. In one study presented, over 80% of those hospitalized with COVID-19 had not received any booster doses.

Access and Availability

Vaccine product is ready to ship to immunizers from both Pfizer and Moderna. Supply is expected to reach providers within 48 hours. It will be available from all provider types in NYS, including pharmacies. Visit the NYS COVID-19 vaccine website to find a provider.

The vaccines will be covered without cost-sharing for those with Medicaid and Medicare. Note that COVID-19 vaccines are billed via Medicare Part D, not Part B like most vaccines. Commercial insurance carriers are required to cover it, but note that due to system updates following the recommendation, there may a short (several days to 2 weeks) lag time before the immunizations can be successfully billed.

COVID-19 vaccines are included in the Vaccines for Children (VFC) program, which ensures no-cost vaccines to under-and uninsured children. It is estimated that 50% of American children are eligible for VFC. Several ACIP meeting attendees advocated for the Vaccines for Adults program, which is a national proposal to provide this immunization coverage for all ages.

Bridge to Access

The government-sponsored Bridge Access Program will provide COVID-19 vaccine administration free of charge to those who are under- or uninsured. This program will offer immunizations at Federally Qualified Health Centers, through local health departments, and via pharmacy partners.

In this program CVS pharmacies will have on-site immunizations. Walgreens is expected to offer both on-site and off-site COVID-19 vaccines through the Bridge Access Program. Independent pharmacies collaborating with the eTrueNorth network will also offer free vaccines through the Bridge program.