Covid-19 Vaccine, mRNA comment watch save

  • TRADE NAMES: Elasomeran; Moderna Covid-19 Vaccine, mRNA; mRNA-1273; Spikevax (Moderna Biotech)
  • INDICATIONS: Prevention of coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
  • SYNONYM: Moderna Covid-19 Vaccine, mRNA
  • CLASS: Covid-19 vaccine, Vaccine
  • FDA APPROVAL DATE: 01/31/2022
  • CLINICALLY IMPORTANT, POTENTIALLY HAZARDOUS INTERACTIONS WITH:
    None known
  • PREGNANCY: Available data on pregnant women are insufficient to inform vaccine-associated risks of Moderna Covid-19 Vaccine, mRNA in pregnancy.

Do not administer Moderna Covid-19 Vaccine, mRNA to individuals with a known history of severe allergic reaction (e.g., anaphylaxis) to any component of this vaccine.

Postmarketing data demonstrate increased risks of myocarditis and pericarditis, particularly within 7 days following the second dose of Moderna Covid-19 Vaccine, mRNA. The observed risk is higher among males under 40 years of age than among females and older males. The observed risk is highest in males 18 through 24 years of age. Although some cases required intensive care support, available data from short-term follow-up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae. The CDC has published considerations related to myocarditis and pericarditis after vaccination, including for vaccination of individuals with a history of myocarditis or pericarditis (https://www.cdc.gov/vaccines/covid-19/clinical-considerations/myocarditis.html).

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Page last updated 08/03/2024

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Incidence

<1% 1‑5% 5‑10% 10‑15% 15‑20% 20‑30% >30%

Seriousness

Hospitalization possible
Life threatening
Fatal

Warnings in other populations

BreastfeedingBreast feeding

GeriatricGeriatric

PediatricPediatric