Medical Health Cluster

16 marzo, 2022

COVID-19 vaccine, mRNA-Pfizer (Rx)

Dosing & Uses

Dosage Forms & Strengths

injection, frozen suspension concentrate

  • Requires dilution before administration
  • Purple cap and label border multiple-dose vial (after dilution yields six [30-mcg] doses/vial)

COVID-19 Disease Prevention

August 23, 2021 (full FDA approval): Indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) for individuals aged ≥16 years

2-dose primary series: 0.3 mL (30 mcg) IM x2 doses administered 3 weeks apart

3-8 week interval between doses

  • 8-week interval may be optimal for some people aged ≥12 years, especially for males aged 12-39 years owing to the small risk of myocarditis associated with mRNA COVID-19 vaccines
  • Shorter interval (3 weeks) between dose 1 and 2 remains the recommended interval for people who are moderately or severely immunocompromised, adults aged ≥65 years, and others who need rapid protection owing increased concern about community transmission or risk of severe disease
  • CDC COVID-19 vaccine interim immunization schedule February 25, 2022

Third primary dose for severely immunocompromised individuals (EUA)

  • August 12, 2021: Emergency Use Authorization (EUA) allows a third primary dose (0.3 mL) administered at least 28 days following the 2-dose regimen of an mRNA vaccine in individuals who have undergone solid organ transplantation or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise
  • CDC recommends booster dose (4th dose) given 5 months after the third primary dose

Homologous booster dose (EUA)

  • A single booster dose (0.3 mL) recommended at least 5 months after completing primary series with the Pfizer-BioNTech COVID-19 Vaccine to individuals aged ≥12 years

Heterologous boosters (EUA)

  • The EUA allows use of each of the available COVID-19 vaccines as a heterologous (or “mix and match”) booster dose to individuals aged ≥18 years following completion of primary vaccination with a different available COVID-19 vaccine
  • 0.3 mL IM may be administered as a heterologous booster dose following completion of primary vaccination with another authorized or approved COVID-19 vaccine
  • Eligible population(s) and dosing interval are the same as those authorized for a booster dose of the vaccine used for primary vaccination (ie, at least 5 months after mRNA-Moderna vaccine or 2 months after single-dose Janssen [Johnson & Johnson] vaccine)

Créditos: Comité científico Covid

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