ISSUE1648
- 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
- Describe the recommendations on the second booster vaccine dose for older and immunocompromised persons and the FDA restriction on the use of sotrovimab.
Second Booster Vaccine Dose for Older and Immunocompromised Persons
The FDA has expanded the Emergency Use Authorizations (EUAs) for the mRNA COVID-19 vaccines manufactured by Pfizer-BioNTech (Comirnaty) and Moderna (Spikevax) to allow for their use as a second booster dose ≥4 months after a first booster dose in adults ≥50 years old and in persons aged ≥12 years (Pfizer) or ≥18 years (Moderna) who have undergone solid organ transplantation or have a condition that compromises the immune system to a similar extent.1,2
EFFICACY — Expansion of the EUAs was based on the results of a cohort study in healthcare workers in Israel who had received two primary doses and one booster dose of the Pfizer COVID-19 vaccine ≥4 months previously. A total of 274 persons were boosted again with either the Pfizer vaccine (n=154) or the Moderna vaccine (n=120) and then compared with age-matched controls over ~34 days (Pfizer) or ~25 days (Moderna). Geometric mean titers of neutralizing anti-SARS-CoV-2 antibodies 2 weeks after a second booster dose were significantly higher than those in the control group (by 10.4-fold with Pfizer and by 14.3-fold with Moderna) and slightly higher than those observed 2 weeks after the first booster dose (by 1.4-fold with Pfizer and by 2.0-fold with Moderna). The rate of symptomatic COVID-19 from day 8 was lower in persons who received a second booster dose than in those who did not (by 43% [95% CI 7% to 65%] with Pfizer and by 31% [95% CI -18% to 60%] with Moderna).3
In a 40-day retrospective cohort study in 563,735 persons 60-100 years old in Israel, the rate of death due to COVID-19 was significantly lower in persons who received a second COVID-19 vaccine booster dose during the study period than in eligible persons who did not (28 vs 99 deaths per 100,000 persons; adjusted HR 0.22 [95% CI 0.17-0.28]).4
SAFETY — In the cohort study in healthcare workers, adverse effects with a second booster dose were similar to those with previous vaccine doses.2 According to the FDA, a surveillance study (not published) of ~700,000 persons in Israel who received a fourth dose of the Pfizer vaccine did not generate new safety concerns.1
DOSAGE — The recommended second booster doses of the mRNA vaccines are the same as the initial booster doses (30 mcg for Pfizer; 50 mcg for Moderna). A second booster dose can be given ≥4 months after an initial booster dose of any FDA-authorized or approved COVID-19 vaccine (Pfizer, Moderna, or Johnson & Johnson/Janssen).5,6
- FDA News Release. Coronavirus (COVID-19) update: FDA authorizes second booster dose of two COVID-19 Vaccines for older and immunocompromised individuals. March 29, 2022. Available at: https://bit.ly/38bToLQ. Accessed March 31, 2022.
- CDC. COVID-19 vaccines for moderately or severely immunocompromised people. March 24, 2022. Available at: https://bit.ly/3iREJYo. Accessed March 31, 2022.
- G Regev-Yochay et al. Efficacy of a fourth dose of Covid-19 mRNA vaccine against Omicron. N Engl J Med 2022 March 16 (epub).
- R Arbel et al. Second booster vaccine and Covid-19 mortality in adults 60 to 100 years old. Research Square 2022 March 24 (preprint). Available at: https://bit.ly/3uKhzbY. Accessed March 31, 2022.
- FDA. Fact sheet for healthcare 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. March 29, 2022. Available at: https://bit.ly/3bBH5GV. Accessed March 31, 2022.
- FDA. Fact sheet for healthcare providers administering vaccine (vaccination providers). Emergency Use Authorization (EUA) of the Moderna COVID-19 vaccine to prevent coronavirus disease 2019 (COVID-19). Booster dose only presentation. March 29, 2022. Available at: https://bit.ly/3wQC8WO. Accessed March 31, 2022.
FDA Restricts Use of Sotrovimab
The FDA has begun to restrict use of the anti-SARS-CoV-2 monoclonal antibody sotrovimab in US regions with a high relative prevalence of the BA.2 (Omicron) variant of the virus.1 Sotrovimab, which is available under an Emergency Use Authorization (EUA) for treatment of mild to moderate COVID-19 in high-risk patients ≥12 years old who weigh ≥40 kg,2 is unlikely to be effective for treatment of COVID-19 caused by BA.2; it has significantly less neutralizing activity in vitro against BA.2 than against other variants.3
Sotrovimab is no longer authorized for use in regions where the BA.2 variant of SARS-CoV-2 causes >50% of COVID-19 cases. At the time of publication (March 31, 2022), this was the case in HHS Regions 1 (New England), 2 (NJ, NY, Puerto Rico, Virgin Islands), 5 (Upper Midwest), 9 (AZ, CA, HI, NV, Pacific islands), and 10 (AK, ID, OR, WA).1 BA.2 is likely to become the predominant strain of SARS-CoV-2 in all regions of the US in the coming weeks4; announcements of further restrictions on use of sotrovimab will be published at: https://bit.ly/3wGZNc9.1 Alternative treatments for mild to moderate COVID-19 that retain efficacy against the BA.2 variant include nirmatrelvir/ritonavir (Paxlovid), remdesivir (Veklury), bebtelovimab, and molnupiravir (Lagevrio).5
- FDA Drug Safety and Availability. FDA updates sotrovimab emergency use authorization. March 25, 2022. Available at: https://bit.ly/3wGZNc9. March 31, 2022.
- An EUA for sotrovimab for treatment of COVID-19. Med Lett Drugs Ther 2021; 63:97.
- FDA. Fact sheet for health care providers. Emergency Use Authorization (EUA) of sotrovimab. March 2022. Available at: https://bit.ly/2TfoomJ. Accessed March 31, 2022.
- CDC. COVID data tracker. Variant proportions. Available at: https://bit.ly/3Ka3HhH. Accessed March 31, 2022.
- Treatment of COVID-19 in high-risk outpatients. Med Lett Drugs Ther 2022 March 3 (epub). Available at: https://secure.medicalletter.org/downloads/1643f_table.pdf.
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