From the Guidelines
Spikevax, the COVID-19 vaccine developed by Moderna, is recommended for primary immunization in individuals 12 years and older, with a two-dose regimen given 28 days apart, and booster doses are recommended for eligible individuals, usually at least 2 months after completing the primary series, as per the latest guidelines from the Advisory Committee on Immunization Practices 1.
Key Points
- Spikevax is an mRNA vaccine that works by delivering messenger RNA that instructs cells to produce a harmless piece of the SARS-CoV-2 spike protein, triggering an immune response that helps protect against future COVID-19 infection.
- The vaccine has shown approximately 94% efficacy in preventing symptomatic COVID-19 in clinical trials, as reported in a study published in the Journal of the American Academy of Dermatology 1.
- Common side effects include injection site pain, fatigue, headache, muscle pain, and fever, which typically resolve within a few days.
- Booster doses are recommended for eligible individuals, usually at least 2 months after completing the primary series, with bivalent mRNA vaccines authorized for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series 1.
Recommendations
- Individuals 12 years and older should receive the Spikevax vaccine as part of their primary immunization series, with a two-dose regimen given 28 days apart.
- Eligible individuals should receive a booster dose of the bivalent mRNA vaccine at least 2 months after completing the primary series.
- The vaccine is recommended for use in adults 18 and older, with full FDA approval, while remaining under emergency use authorization for adolescents 12-17.
From the FDA Drug Label
For individuals with certain kinds of immunocompromise turning from 11 years to 12 years of age during the vaccination series, complete the 3-dose series with 1 or 2 doses, as applicable, of SPIKEVAX (COVID-19 Vaccine, mRNA) (2024-2025 Formula) on or after the date the individual turns 12 years of age
- Spikevax is authorized under EUA for certain uses in individuals turning 12 years of age during the vaccination series 2.
- The FDA-licensed vaccine SPIKEVAX (COVID-19 Vaccine, mRNA) (2024-2025 Formula) is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older 2.
From the Research
Spikevax Overview
- Spikevax, also known as mRNA-1273, is a COVID-19 vaccine that has been studied in various clinical trials and research papers 3, 4, 5, 6, 7
- The vaccine has been shown to be safe and effective in preventing severe COVID-19 disease and reducing the risk of complications and death 3, 4, 5, 6, 7
Efficacy of Spikevax
- Studies have demonstrated that Spikevax is effective against various SARS-CoV-2 variants, including the Omicron variant 5, 7
- The vaccine has been shown to induce both mucosal and systemic antibody responses, which is critical in preventing SARS-CoV-2 infection and replication 7
- Booster doses of Spikevax have been found to increase protection against COVID-19, particularly in older adults and those with compromised immune systems 4, 6
Booster Dose Strategies
- Research suggests that booster doses of Spikevax should be administered annually, 3-4 months ahead of peak winter, to reduce COVID-19-related hospitalizations 4
- The use of bivalent mRNA vaccines, such as mRNA-1273.222, has been shown to induce robust immune responses against multiple SARS-CoV-2 variants 7
- Strategic efforts are needed to encourage eligible individuals to receive booster doses, particularly those aged 65 years and older, and those who are immunocompromised 6