The Medical Letter on Drugs and Therapeutics
COVID-19 Updates
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Pfizer-BioNTech COVID-19 Vaccine

On January 3, the FDA amended its Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (Comirnaty) to incorporate the following changes:

  1. A third primary dose of the vaccine can now be given ≥28 days after the second to children 5-11 years old who have undergone solid organ transplantation or have an equivalent level of immune compromise.1,2
  2. Booster doses of the vaccine are now authorized for use in children 12-15 years old.1,3
  3. The length of time after completion of a primary series with the vaccine at which patients become eligible for booster immunization has been reduced from 6 months to 5 months.1,3
On January 7, the FDA amended the EUA of the Moderna COVID-19 vaccine to shorten the interval between completion of a primary series and receipt of a booster dose from 6 months to 5 months.4

Booster Schedules –
Patients can now receive a booster dose of a COVID-19 vaccine 5 months after completion of a primary series with the Pfizer-BioNTech or Moderna vaccine or 2 months after receiving a primary dose of the Johnson & Johnson/Janssen vaccine.

Monoclonal Antibodies for COVID-19

The anti-SARS-CoV-2 antibody combinations casirivimab plus imdevimab (REGEN-COV) and bamlanivimab plus etesevimab are not active against the Omicron variant of SARS-CoV-2. These antibodies remain available, however, through federal distribution. NIH guidelines state that their use can be considered in regions where the Delta variant still causes a significant proportion of COVID-19 cases if alternative drugs are unavailable or contraindicated.1,2

Sotrovimab, which is authorized by the FDA for treatment of mild to moderate COVID-19 in patients ≥12 years old who weigh ≥40 kg and are at high risk of progressing to severe disease, is the only monoclonal antibody available in the US that has activity against the Omicron variant of SARS-CoV-2.2,3

Additional Content Available: COVID-19 Charts
More information on vaccines and drugs for COVID-19 can be found in the COVID-19 Resources section of our website

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