COVID-19 Updates and Resources
FDA Authorizes Updated Novavax COVID-19 Vaccine Formulated to Better Protect Against Currently Circulating Variants
On October 2, 2023, the U.S. Food and Drug Administration amended the emergency use authorization (EUA) of the Novavax COVID-19 Vaccine, Adjuvanted for use in individuals 12 years of age and older to include the 2023-2024 formula.
Individuals 12 years of age and older previously vaccinated with a COVID-19 vaccine (and who have not already been vaccinated with a recently updated mRNA COVID-19 vaccine) are eligible to receive one dose and unvaccinated individuals receive two doses.
As part of this action, the Novavax COVID-19 Vaccine, Adjuvanted (Original monovalent) is no longer authorized for use in the United States.
CDC Recommends 2023–2024 COVID-19 Vaccine Schedule
On September 12, 2023, the Centers for Disease Control and Prevention (CDC) recommended that everyone aged 6 months or older receive an updated 2023–2024 COVID-19 vaccine. These monovalent vaccines target the Omicron XBB.1.5 variant and are expected to provide protection against other Omicron variants. Coadministration of other age-appropriate vaccines (e.g., influenza, RSV) is recommended for people without contraindication(s). Updated COVID-19 guidance can be found in CDC’s Interim Clinical Considerations.
COVID-19 Vaccine Commercialization
COVID-19 vaccines are now available directly from manufacturers, rather than from the U.S. government. However, there will be little impact for most people receiving the vaccine as private or employer-based health insurance, Medicare Part B, and Medicaid will cover COVID-19 vaccines at no cost.
Uninsured children and uninsured and underinsured adults will have access to free COVID-19 vaccines through the Vaccines for Children program and CDC’s Bridge Access Program, respectively. Healthcare providers who want to provide COVID-19 vaccines to these individuals should visit the Virginia Vaccines for Adults Bridge and Virginia Vaccines for Children programs to enroll.
For more information on commercialization, please review the VDH COVID-19 Vaccine Commercialization FAQ or submit your inquiry at the VDH Immunization webpage.
Paxlovid and Lagevrio Effective Against Newer SARS-CoV-2 Variants
A study in JAMA Network Open reported on the effectiveness of Paxlovid (nirmatrelvir with ritonavir) and Lagevrio (molnupiravir) for the treatment of acute COVID-19.
This observational cohort study was done at the Cleveland Clinic among patients with a lab-confirmed diagnosis of COVID-19 from April 1, 2022, to February 20, 2023. During this time, the SARS-CoV-2 Omicron variant evolved from BA.2 to BA.4/BA.5, to BQ.1/BQ.1.1, and then to XBB/XBB.1.5.
The primary outcome measure was time to death after a diagnosis of COVID-19 was made in patients who were treated with Paxlovid or Lagevrio vs. patients who received no treatment. The secondary outcome measure was the time to hospitalization or death, whichever came first, in treated vs. untreated patients.
The association between each drug (Paxlovid and Lagevrio) and the outcome measures was adjusted for demographic factors, socioeconomic status, date of COVID-19 diagnosis, coexisting medical conditions, COVID-19 vaccination status, and previous SARS-CoV-2 infection.
For the primary outcome measure, the study showed that taking Paxlovid and Lagevrio reduced the rates of death due to COVID-19 by 84% and 77%, respectively. For the secondary outcome measure, taking Paxlovid or Lagevrio reduced the rates of hospitalization or death—Paxlovid by 37% and Lagevrio by 41%.
Lagevrio to Transition to the Commercial Marketplace in November 2023
The U.S. Department of Health and Human Services (HHS) and the Administration for Strategic Preparedness and Response (ASPR) have informed VDH that the COVID-19 antiviral drug Lagevrio (molnupiravir) will transition to the commercial market in early to mid-November 2023. Lagevrio is currently under FDA Emergency Use Authorization for the treatment of adults with acute COVID-19. Presently, Lagevrio is supplied only by the federal government to states and partners.
During the month of October 2023, HHS will move away from replenishing state and partner supplies of Lagevrio. Instead, during this time, states and partners will be able to order Lagevrio through out-of-cycle requests using the computer program Tiberius. The goal is to use all current existing supplies of Lagevrio (supplied by the federal government) that states and partners have on hand.
Please note that any patient who is dispensed Lagevrio that was provided by the federal government cannot be charged for the product. Please see ASPR’s webpage for additional information. At this time, VDH has not been informed when Paxlovid (nirmatrelvir with ritonavir) will transition from being government-supplied to the traditional commercial marketplace.
COVID-19 Vaccine Resources
COVID-19 Therapeutic Resources
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