FDA Revises an Emergency Use Authorization, Pregnant Women Recommended to Receive COVID-19 Vaccine, and the NIH Update Treatment Guidelines
FDA Removes Emergency Authorization for Tixagevimab/Cilgavimab1
The FDA announced that the use of tixagevimab co-packaged with cilgavimab (Evusheld) is no longer authorized for emergency use in the United States. The statement is a revision to the FDA’s previous authorization of the medication to protect individuals against certain COVID-19 variants.
The FDA’s action “prevents exposing patients to possible side effects of Evusheld such as allergic reactions, which can be potentially serious, at a time when fewer than 10% of circulating variants in the U.S. causing infection are susceptible to the product,” the FDA stated in a press release.
The revision comes after researchers found that the treatment is unlikely to protect against developing COVID-19 if exposed to variants, which are responsible for more than 90% of infections in the United States, according to the press release.
There are several other treatments for patients who become infected with COVID-19 including remdesivir and molnupiravir that are expected to protect individuals from current variants of the disease.
Vaccination Against COVID-19 Reduces Severe Symptoms, Complications in Pregnant Women2
Women who are pregnant and are vaccinated for COVID-19 reduce the risk of severe maternal morbidity and mortality, according to a recent study that examined the effectiveness of vaccines to protect against the omicron variant.
In a large, prospective, observational study (INTERCOVID-2022), a total of 41 hospitals across 18 different countries compared women who are pregnant and have COVID-19 (n = 1545) with women without the disease (n = 3073). Overall, the researchers found that, when compared with women without COVID-19, women with the disease had an increased risk for maternal morbidity and mortality index, severe perinatal morbidity and mortality index, and severe neonatal morbidity index.
Further, the researchers found that vaccine effectiveness for severe complications of COVID-19 was 48% after a complete regimen. The effectiveness increased to 76% after a booster dose.
“Women with complete or boosted vaccine doses had reduced risk for severe symptoms, complications, and death” the researchers concluded. “Vaccination coverage among pregnant women remains a priority.”
The NIH Provides Updates on the Use of Interleukin-1 Inhibitors for Treatment3
The NIH has updated its COVID-19 Treatment Guidelines, adding two new treatment recommendations for health care providers. Both treatments are interleukin-1 (IL-1) inhibitors and are used in the treatment and management of other diseases.
Anakinra is an FDA-approved recombinant human IL-1 receptor antagonist and is used to treat rheumatoid arthritis and cryopyrin-associated periodic syndromes. It was approved for emergency use to treat COVID-19 in certain hospitalized adults with pneumonia. Canakinumab is an FDA-approved monoclonal antibody typically used for the treatment of systematic juvenile idiopathic arthritis that targets IL-1 beta.
The NIH has added the following recommendations regarding the two treatments based on new data:
- There is insufficient evidence to recommend either for or against the use of anakinra.
- Canakinumab is not recommend for the treatment of COVID-19.
- FDA announces Evusheld is not currently authorized for emergency use in the US. News release. US Food and Drug Administration; January 26, 2023. Accessed February 7, 2023. https://www.fda.gov/drugs/drug-safety-and-availability/fda-announces-evusheld-not-currently-authorized-emergency-use-us
- Villar J, Soto CP, Gunier RB, et al. Pregnancy outcomes and vaccine effectiveness during the period of omicron as the variant of concern, INTERCOVID-2022: a multinational, observational study. LANCET. Published online January 17, 2023. doi:10.1016/S0140-6736(22)02467-9
- National Institutes of Health. Interleukin-1 inhibitors. National Institutes of Health: COVID-19 treatment guidelines. January 26, 2023. Accessed February 7, 2023. https://www.covid19treatmentguidelines.nih.gov/therapies/immunomodulators/interleukin-1-inhibitors/