ACIP releases interim recommendation for use of Moderna COVID-19 vaccine
On Dec. 19, 2020, after a transparent, evidence-based review of available data, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for use of the Moderna COVID-19 vaccine in persons aged ≥18 years for the prevention of COVID-19, reported the U.S. Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the Moderna COVID-19 vaccine on Dec. 18, 2020. Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP’s interim recommendations for allocating initial supplies of COVID-19 vaccines.
The Moderna COVID-19 (mRNA-1273) vaccine is a lipid nanoparticle-encapsulated, nucleoside-modified mRNA vaccine encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. This vaccine is the second COVID-19 vaccine authorized under an EUA for the prevention of COVID-19 in the United States. Vaccination with the Moderna COVID-19 vaccine consists of two doses (100 μg, 0.5 mL each) administered intramuscularly, one month (four weeks) apart.
To guide its deliberations regarding the vaccine, ACIP employed the Evidence to Recommendation (EtR) Framework, using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. Use of all COVID-19 vaccines authorized under an EUA, including the Moderna COVID-19 vaccine, should be implemented in conjunction with ACIP’s interim recommendations for allocating initial supplies of COVID-19 vaccines. The ACIP recommendation for the use of the Moderna COVID-19 vaccine under EUA is interim and will be updated as additional information becomes available.
After a systematic review of available data, the Work Group used the GRADE approach to assess the certainty of evidence for outcomes related to the vaccine, rated on a scale of one (high certainty) to four (very low certainty). Work Group conclusions regarding certainty of evidence for the Moderna COVID-19 vaccine were presented to ACIP at public meetings.
Among Moderna vaccine recipients, reactogenicity symptoms, defined as solicited local injection site or systemic adverse reactions during the seven days after vaccination, were frequent but mostly mild to moderate. Systemic adverse reactions were more commonly reported after the second dose than after the first dose and were more frequent and severe in persons aged 18–64 years than in those aged ≥65 years. Most local and systemic adverse reactions occurred within the first one to two days after vaccine receipt and resolved in a median of two to three days.
Severe local or systemic adverse reactions (grade ≥3 reactions) occurred more commonly in vaccine recipients than in placebo recipients (21.6 percent versus 4.4 percent). Among vaccine recipients, 9.1 percent reported a grade ≥3 local injection site reaction, and 16.5 percent reported a grade ≥3 systemic adverse reaction. The frequency of serious adverse events observed was low in both the vaccine (1.0 percent) and placebo (1.0 percent) recipients and without meaningful imbalances for specific serious adverse events between the two groups. No specific safety concerns were identified in subgroup analyses by age, race, ethnicity, underlying medical conditions, or previous SARS-CoV-2 infection. A detailed summary of safety data, including information on reactogenicity, is available at https://www.cdc.gov/vaccines/covid-19/info-by-product/moderna/reactogenicity.html.
Before vaccination, the EUA Fact Sheet should be provided to recipients and caregivers. Providers should counsel Moderna COVID-19 vaccine recipients about expected local and systemic reactogenicity. The Moderna COVID-19 vaccine is not interchangeable with other COVID-19 vaccine products; the safety and efficacy of a mixed-product series have not been evaluated. ACIP does not state a product preference; a person may receive any recommended COVID-19 vaccine series. However, persons should complete the series with the same COVID-19 product they received for the first dose. Additional clinical considerations, including details of administration and use in special populations (e.g., persons who are pregnant, immunocompromised or who have a history of severe allergic reactions) are available at https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.
The interim recommendation and clinical considerations are based on use of the Moderna COVID-19 vaccine under an EUA and might change as more evidence becomes available. ACIP will continue to review additional data as they become available; updates to recommendations or clinical considerations will be posted on the ACIP website.
Adverse events that occur in a recipient after receipt of COVID-19 vaccine should be reported to the Vaccine Adverse Events Reporting System (VAERS). FDA requires that vaccination providers report vaccination administration errors, serious adverse events, cases of multisystem inflammatory syndrome, and cases of COVID-19 that result in hospitalization or death after administration of COVID-19 vaccine under EUA. Reporting by anyone who gives or receives a COVID-19 vaccine is encouraged for any clinically significant adverse event, whether or not it is clear that a vaccine caused the adverse event. Information on how to submit a report to VAERS is available at https://vaers.hhs.gov/index.html.
