From the Guidelines
Comirnaty is the brand name for the Pfizer-BioNTech COVID-19 vaccine, which is a highly effective mRNA vaccine that has shown high efficacy in preventing severe disease, hospitalization, and death from COVID-19 1.
Key Points
- Comirnaty was the first COVID-19 vaccine to receive full FDA approval in the United States for individuals 16 years and older in August 2021.
- The vaccine requires two initial doses given 21 days apart, followed by booster doses as recommended.
- Comirnaty works by instructing cells to produce a harmless piece of the virus spike protein, which triggers an immune response that helps protect against future COVID-19 infection.
- Common side effects include pain at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever, which typically resolve within a few days.
- Comirnaty is stored at ultra-cold temperatures before use but can be kept at regular refrigerator temperatures for limited periods before administration.
Recent Recommendations
- The Advisory Committee on Immunization Practices (ACIP) has recommended that all persons aged ≥5 years receive 1 bivalent mRNA booster dose ≥2 months after completion of any FDA-approved or FDA-authorized monovalent primary series or monovalent booster doses 1.
- The bivalent Pfizer-BioNTech COVID-19 vaccine has been authorized for use as a booster dose in persons aged ≥5 years who completed any FDA-approved or FDA-authorized primary series 1.
From the FDA Drug Label
COMIRNATY is an FDA-approved vaccine for prevention of COVID-19 in individuals 12 years of age and older COMIRNATY (COVID-19 Vaccine, mRNA) (2024-2025 Formula) Comirnaty is the COVID-19 Vaccine, mRNA.
- It is an FDA-approved vaccine for prevention of COVID-19 in individuals 12 years of age and older.
- It is also authorized under EUA to complete the dosing schedule for immunocompromised individuals who turn from 11 years to 12 years of age during the vaccination series 2.
From the Research
COVID-19 Vaccines
- The available evidence does not specifically mention a "Comenarty" COVID-19 vaccine 3, 4, 5, 6.
- Several COVID-19 vaccines have been developed and approved for use, including Pfizer-BioNTech, Moderna, Janssen (Johnson & Johnson), and others 3, 4, 5, 6.
- These vaccines have been shown to be effective in preventing COVID-19 hospitalization and reducing the risk of severe disease 3, 5, 6.
Vaccine Effectiveness
- The effectiveness of COVID-19 vaccines can vary depending on the specific vaccine and population being studied 3, 5, 6.
- For example, a study found that the Moderna vaccine was 93% effective in preventing COVID-19 hospitalization, while the Pfizer-BioNTech vaccine was 88% effective, and the Janssen vaccine was 71% effective 6.
- Another study found that a third dose of the Pfizer-BioNTech or Moderna vaccine provided improved protection against COVID-19-associated hospitalization among both immunocompetent and immunocompromised adults 5.
Comorbidities and COVID-19
- Patients with underlying health conditions or comorbidities, such as hypertension or diabetes mellitus, are more likely to develop a severe course and progression of COVID-19 7.
- Older patients, especially those 65 years old and above with comorbidities, have an increased admission rate into the intensive care unit (ICU) and mortality from COVID-19 7.