ISSUE1642
- Mark Abramowicz, M.D., President: no disclosure or potential conflict of interest to report
- Jean-Marie Pflomm, Pharm.D., Editor in Chief: no disclosure or potential conflict of interest to report
- Brinda M. Shah, Pharm.D., Consulting Editor: no disclosure or potential conflict of interest to report
- Michael Viscusi, Pharm.D., Associate Editor: no disclosure or potential conflict of interest to report
- Discuss the efficacy of monoclonal antibodies against the Omicron variant of SARS-CoV-2.
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:
- 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
- Booster doses of the vaccine are now authorized for use in children 12-15 years old.1,3
- 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
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.
- FDA News Release. Coronavirus (COVID-19) update: FDA takes multiple actions to expand use of Pfizer-BioNTech COVID-19 vaccine. January 3, 2022. Available at: https://bit.ly/3qVaN18. Accessed January 6, 2022.
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). For 5-11 years of age. January 3, 2022. Available at: https://bit.ly/3jX9xri. Accessed January 6, 2022.
- FDA. Fact sheet for health care providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). For 12 years of age and older. January 3, 2022. Available at: https://bit.ly/3bBH5GV. Accessed January 6, 2022.
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disaese 2019 (COVID-19). January 7, 2022. Available at: https://bit.ly/3nosylA. Accessed January 7, 2022.
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
- HHS Public Health Emergency. Updated guidelines regarding allocation of bamlanivimab/etesevimab and REGEN-COV therapeutics: states and territories can continue to order both products. December 31, 2021. Available at: https://bit.ly/3sZHD3o. Accessed January 6, 2022.
- NIH. The COVID-19 Treatment Guidelines Panel's statement on therapies for high-risk, nonhospitalized patients with mild to moderate COVID-19. December 30, 2021. Available at: https://bit.ly/3EUXjHz. Accessed January 6, 2022.
- An EUA for sotrovimab for treatment of COVID-19. Med Lett Drugs Ther 2021; 63:97.
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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