As of May 1, 2023, the Centers for Disease Control and Prevention (CDC) is reporting 104 million COVID cases and over 1.1 million COVID deaths in total for the United States. We are now in a better place since the peak of the Omicron surge in January 2022, with daily reported COVID-19 cases down by 98%, COVID deaths have declined by over 90%, and COVID-19 hospitalization rates have decreased by 93%. As COVID-19 continues its downward trend, the federal Public Health Emergency (PHE) for COVID-19 will expire on May 11, 2023, and will not be renewed. Because of the historic investments and global efforts to mitigate the worst impacts, we are now able to transition out of the emergency phase, but the virus causing COVID-19 appears here to stay. We still have much to learn about the virus and addressing COVID-19 will remain a public health priority.

The XBB.1.5 sub-lineage is the dominant strain in the U.S. and is responsible for 66.9% of sequenced specimens this week vs. 73.2% the previous week. New Omicron variant lineages continue to emerge with the global prevalence of subvariant XBB.1.16 rising weekly and representing the second most prevalent subvariant in the U.S. at 12.5% (~5 fold increase in the last 30 days). The World Health Organization's (WHO) initial Rapid Risk Assessment indicates the overall risk of XBB.1.16 is low. Omicron XBB.1.16 has a similar genetic profile to XBB.1.5. Thus far, no changes in severity have been reported and available data does not suggest XBB.1.16 has additional health risk relative to XBB.1.5. However, it may spread and increase case incidence based on its immune escape characteristics and growth rate estimates. Currently, most of the XBB.1.16 sequences are from India (63.4%) and the United States (10.9%). The WHO Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) continues to assess the variant impact on COVID-19 vaccine performance to inform decisions on vaccine composition updates.

Federal Public Health Emergency (PHE) to End May 11th^* 

During the federal COVID-19 PHE, plans temporarily expanded benefit coverage for COVID-19 related services. The Biden administration announced the PHE expiration will occur on May 11, 2023, and this will affect how COVID-19 vaccines, testing, treatment, and services are provided. The Kaiser Family Foundation (KFF) has published multiple articles on the implications of the PHE expiration and its impact on various health systems. Ventegra has posted a summary of these changes in the News and Insights section of our website.

* Current supplies of federally purchased vaccines and COVID-19 therapies will be used first until these supplies are exhausted – with no change in member and plan cost-sharing when federal supplies are used ($0 member cost and no plan cost for vaccine and medication). At the time of this publication, no manufacturer information on the commercially available formulations has been provided.

The FDA updated the authorization of the Moderna and Pfizer/BioNTech bivalent mRNA COVID-19 vaccines to simplify the vaccination schedules. This follows the FDA’s Vaccines and Related Biological Products Advisory Board (VRBPAC) meeting on January 26 whereby the committee recommended harmonizing the strain composition of U.S. COVID-19 vaccines and supported dosing schedule simplification.

Dr. Peter Marks, director for the FDA Center for Biologics and Evaluation Research (CDER), summarized:

Data supports the simplification, which will help to encourage future vaccination.

The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized in the United States. Current COVID-19 vaccines that remain authorized for emergency use or FDA-approved are Moderna bivalent mRNA, Pfizer-BioNTech bivalent mRNA, and the Janssen (adenovirus) and Novavax (adjuvanted) vaccines for certain circumstances.

ACIP and CDC Recommend Simplification of COVID-19 Vaccine Schedule

COVID-19 vaccination continues to be recommended for everyone ages 6 months and older.

ACIP and CDC recently modified the Interim Clinical Considerations for the Use of COVID-19 Vaccines. The significance of the updated recommendations includes:

Everyone ages 6 years and older should receive 1 dose of Moderna or Pfizer/BioNTech bivalent mRNA vaccine. Those who have received 1 dose are considered up to date and do not need further vaccination.

Those aged 6 years and over who are unvaccinated or previously received only monovalent vaccine doses are recommended to receive 1 bivalent mRNA vaccine dose.

Children aged 6 months to 5 years may require multiple doses of COVID-19 vaccine to be up to date, including at least 1 bivalent mRNA dose of Moderna or Pfizer/BioNTech COVID-19 vaccine. Vaccination is dependent upon previous vaccine received and age – refer to the CDC Vaccine Schedule Table 1 or American Academy of Pediatrics (AAP) Vaccine Dosing Quick Reference Guide for specific details.

People aged 65 years and over have the option to receive 1 additional bivalent mRNA dose at least 4 months after their first bivalent mRNA dose.

The moderately or severely immunocompromised may receive additional bivalent Moderna or Pfizer/BioNTech booster doses. The CDC Vaccine Schedule Table 2 provides detailed recommendations based on age and vaccine product, including for those who previously received only monovalent doses.

According to multiple news sources, the Centers for Disease Control and Prevention plans to end its COVID-19 community levels system. With the end of the PHE, reporting requirements by various entities will change making it more difficult for the CDC to maintain the current metrics. We expect more to come on this from the CDC in the future.

Much has been learned since the onset of the COVID-19 pandemic. Be sure to register for Ventegra University’s upcoming program and join us for a moderated discussion with industry experts on COVID-19: Looking Back and Moving Forward addressing lessons learned and what can be done to prepare for future pandemics.

We will continue to update the Ventegra COVID-19 Resource Center as new information becomes available and encourage you to check back frequently.

Mark Shinmoto, Pharm.D., V.P. Chief Pharmacy Officer