LAC DPH COVID-19 Updates: New Booster Recommendations, Observation Period, Co-Administration September 8, 2022 ACIP, Advisory Committee on Immunization Practices, BA.4/BA.5, bivalent, Booster, CDC, COVID-19, FDA, influenza, JYNNEOS, Moderna, mRNA, orthopoxvirus, Pfizer, Providers, SARS-CoV-2 1455 The CDC recommends that people ages 12 years and older receive a booster dose of bivalent mRNA COVID-19 vaccine at least 2 months after their last COVID-19 vaccine dose (either the final primary series dose or the last booster). This is regardless of how many boosters or which type(s) of vaccine they received in the past. The recommendations for people under 12 years of age have not changed. The CDC guidance on observation after vaccination has been updated. COVID-19 vaccines can be co-administered with influenza and/or other vaccines. However, there are additional considerations for orthopoxvirus vaccine. Providers are asked to schedule or refer their patients, especially those at high risk for serious COVID-19, for both yearly influenza and bivalent COVID-19 booster vaccines. Background Monovalent COVID-19 vaccines (i.e., vaccines based on the original, ancestral, strain of SARS-CoV-2) have dramatically reduced COVID-19 hospitalizations and deaths. As the SARS-CoV-2 virus evolves, declines in neutralizing antibodies from previous infection and from vaccination have been noted. Moderna and Pfizer Omicron-specific bivalent COVID-19 vaccines result in higher antibody response for Omicron variants as well as other SARS-CoV-2 variants. The current FDA-authorized bivalent vaccines, referred to as “updated boosters,” contain two mRNA components of SARS-CoV-2 spike protein, one based on the original (ancestral) strain of SARS-CoV-2 and the other based on the Omicron BA.4 and BA.5 variants. The bivalent COVID-19 boosters are expected to provide increased protection against BA.4/BA.5, the currently circulating variants, as well as broadening the antibody response toward other variants. On 8/31/22, the FDA authorized the use of bivalent formulations of the Pfizer and Moderna COVID-19 vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent Moderna vaccine is authorized for individuals ages 18 years and older, and the bivalent Pfizer vaccine is authorized for individuals ages 12 years and older. The FDA also deauthorized the use of monovalent mRNA COVID-19 vaccines as booster doses for individuals ages 12 years and older. On 9/1/22, the CDC endorsed the recommendations of its Advisory Committee on Immunization Practices (ACIP) for the use of bivalent COVID-19 boosters from Pfizer for people ages 12 years and older and from Moderna for people ages 18 years and older. The Western States Scientific Safety Review Workgroup concurred with the ACIP recommendation the same day. At the ACIP meeting, the CDC presented modeling data that suggests that initiating a robust bivalent booster vaccine campaign in September could prevent more than 135,000 COVID-19 related hospitalizations and nearly 10,000 COVID-19 deaths. New COVID-19 Vaccine Booster Recommendations Summary of Booster Recommendations Adults ages ≥18 years: One Pfizer or Moderna updated (bivalent) booster at least 2 months after the last dose* Adolescents ages 12-17 years: One Pfizer updated booster at least 2 months after the last dose* Children ages 5-11 years who received a Pfizer primary series: One Pfizer monovalent booster at least 5 months after completing the primary series (or 3 months for those who are moderately or severely immunocompromised). * This recommendation is regardless of how many boosters the person received previously. The last vaccine dose can be the final COVID-19 primary series dose or the last booster dose. The bivalent booster may be from a different manufacturer than the primary series or previous booster(s). Children ages 6 months-4 years and children 5-11 years who received a Moderna primary series: Booster doses not currently recommended The monovalent mRNA COVID-19 vaccines should continue to be used to complete a primary series, including third doses for persons with moderate to severe immune compromise. A person is now considered “up to date” with COVID-19 vaccination if they have completed a COVID-19 vaccine primary series and received the most recent booster dose recommended for them by the CDC. Refer to the CDC Clinical Considerations and CDC At-A-Glance COVID-19 Vaccine Schedules for more details. Note: Bivalent booster vaccines are already available from some pharmacies and providers and supply will increase in the coming weeks. Observation After Vaccination Observation after COVID-19 vaccination is now optional. The following is a summary of the updated CDC guidance for observation periods after COVID-19 vaccination: Consider observing people for syncope, especially adolescents, for 15 minutes after vaccination. Consider observing people with the following medical histories for 30 minutes after vaccination to monitor for allergic reactions: Allergy-related contraindication to a different type of COVID-19 vaccine Non-severe, immediate (onset within 4 hours) allergic reaction after a previous dose of COVID-19 vaccine. Anaphylaxis after non-COVID-19 vaccines or injectable therapies For details, see Post-vaccination observation period. Coadministration of COVID-19 Vaccines with Other Vaccines COVID-19 vaccines may be administered without regard to timing of other recommended vaccines, including the seasonal influenza vaccine. This includes simultaneous administration of COVID-19 vaccine and other vaccines. However, there are additional considerations if administering an orthopoxvirus vaccine (including JYNNEOS vaccine) as described below. If JYNNEOS vaccination is recommended for prophylaxis in the setting of a monkeypox outbreak, vaccine doses should not be delayed because of recent receipt of a Moderna, Novavax, or Pfizer COVID-19 vaccine; no minimum interval between COVID-19 vaccination and JYNNEOS vaccination is necessary. People, particularly adolescent or young adult males, might consider waiting 4 weeks after JYNNEOS vaccination before receiving a Moderna, Novavax, or Pfizer COVID-19 vaccine. This is because of the observed risk for myocarditis and pericarditis after receipt of ACAM2000 orthopoxvirus vaccine and these COVID-19 vaccines and the unknown risk for myocarditis and pericarditis after JYNNEOS vaccination. For more information on co-administration of other vaccines, including best practices, see CDC Clinical Considerations. Vaccination After COVID-19 Infection Growing epidemiologic evidence indicates that vaccination following COVID-19 infection further increases protection from subsequent infection and hospitalization. People with COVID-19 infection should defer any COVID-19 vaccination at least until they have recovered from the acute illness and have finished isolation. In addition, people who recently had COVID-19 infection may consider delaying a primary series dose or booster dose by 3 months from symptom onset or positive test (if infection was asymptomatic). There is a low risk of reinfection in the weeks to months following infection and studies have shown that increased time between infection and vaccination may result in an improved immune response to vaccination. However, a decision on the timing of the booster dose should also consider the patient’s risk for having severe COVID-19 outcomes. For details, see COVID-19 vaccination and SARS-CoV-2 infection. Actions Requested of Providers Contact your patients, especially those at high risk for severe COVID-19, and schedule or refer them for both yearly influenza and bivalent COVID-19 booster vaccines. Individuals at high risk for severe COVID-19 infection include those greater than age 50 and those with underlying medical conditions including diabetes, immunosuppression, chronic kidney disease, chronic lung disease, chronic cardiovascular disease, and chronic neurological disease. If you are a vaccine provider, order the new bivalent boosters for your patients. If you are not a vaccine provider, consider enrolling. While onboarding, you can refer your patients to other sites offering bivalent boosters by visiting ph.lacounty.gov/VaccineAppointment (English) or ph.lacounty.gov/comovacunarse(Spanish). Familiarize yourself with updated COVID-19 vaccine resources (see below). Resources CDC Clinical Considerations CDC At-A-Glance COVID-19 Vaccine Schedules FDA Pfizer vaccine fact sheet for Healthcare Providers | Recipients/Caregivers FDA Moderna vaccine fact sheet for Healthcare Providers | Recipients/Caregivers COVID-19 Variant data: Sign up to COVID Watch to receive a weekly surveillance email newsletter that includes data on circulating variants. For past versions, visit http://publichealth.lacounty.gov/acd/ncorona2019/covidwatch/ LAC DPH Provider COVID-19 Vaccination Hub (refresh browser to view the latest version) LAC DPH vaccine schedules for the public: Webpage ph.lacounty.gov/covidvaccineschedules (English) ph.lacounty.gov/calendariosdevacunasdeCOVID (Spanish) PDF English Spanish (other translations pending). This communication was sent by Nava Yeganeh, MD, Medical Director, Vaccine Preventable Disease Control Program, Los Angeles County Department of Public Health To view this and other communications or to sign-up to receive LAHANs, please visit publichealth.lacounty.gov/lahan.