treatment

COVID-19 Roundup: Cognitive Impairment, Additional Boosters, Sotrovimab Use

Second Vaccine Booster1

The US Food and Drug Administration (FDA) has authorized a second booster dose of the Pfizer-BioNTech and Moderna COVID-19 vaccines in certain patient populations that are at high risk of severe disease, hospitalization, and death.

Individuals now eligible for a second booster dose include those aged 50 years or older and those aged 12 years or older with certain kinds of immunocompromise. Both patient populations must have received their first booster dose at least 4 months prior. Individuals who have undergone a solid organ transplantation and individuals who are living with a similar level of immunocompromise are among the types of immunocompromised individuals included.

“Current evidence suggests some waning of protection over time against serious outcomes from COVID-19 in older and immunocompromised individuals. Based on an analysis of emerging data, a second booster dose of either the Pfizer-BioNTech or Moderna COVID-19 vaccine could help increase protection levels for these high-risk individuals,” concluded the director of the FDA’s Center for Biologics Evaluation and Research, Peter Marks, MD, PhD.

EUA for Sotrovimab2

The FDA has updated its emergency use authorization to limit the use of sotrovimab for the treatment of mild-to-moderate COVID-19 in certain regions where the BA.2 omicron sub-variant is dominant.

These areas include Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island and Vermont (Health and Human Services [HHS] Region 1), as well as New Jersey, New York, Puerto Rico, and the Virgin Islands (HHS Region 2). The Centers for Disease Control and Prevention (CDC) estimates that the BA.2 subvariant makes up more than 50% of cases in these areas.

This update follows new data that found that sotrovimab is not likely to be effective against this sub-variant.3 Sotrovimab is still authorized for use in all other areas of the United States.

Other available therapies for the treatment of mild-to-moderate COVID-19 in patients at high risk for progression to severe disease that may be effective against the BA.2 sub-variant include paxlovid, remdesivir, bebtelovimab, and molnupiravir.

Cognitive Outcomes After COVID-194

Cognitive status at 6 months after symptom onset was worse in individuals who were hospitalized with COVID-19 when compared with individuals who were hospitalized for non-COVID-19 causes, according to the results of a case-control study. However, the overall burden of neuropsychiatric and neurologic diagnoses and symptoms was similar between the 2 groups.

Researchers examined 85 individuals hospitalized with COVID-19 and 62 matched individuals hospitalized with non-COVID-19 illness at a tertiary referral hospital in Copenhagen, Denmark, from July 2020 to July 2021.

“[L]ong-term mental health complications in patients who had COVID-19 were significant but seemed not to be unique to COVID-19 because similar complications were observed among individuals hospitalized for non-COVID-19 illness of comparable severity; this highlights the importance of including well-matched control groups when investigating post-COVID-19 sequalae,” researchers concluded.

 

—Leigh Precopio

 

References:

  1. Coronavirus (COVID-19) update: FDA authorizes second dose of two COVID-19 vaccines for older and immunocompromised individuals. News release. US Food and Drug Administration; March 29, 2022. Accessed March 30, 2022. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-second-booster-dose-two-covid-19-vaccines-older-and?utm_medium=email&utm_source=govdelivery
  2. FDA updates sotrovimab emergency use authorization. News release. US Food and Drug Administration; March 25, 2022. Accessed March 30, 2022. https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-sotrovimab-emergency-use-authorization
  3. Fact sheet for health care providers; emergency use authorization (EUA) of sotrovimab. News release. US Food and Drug Administration; March 25, 2022. Accessed March 30, 2022. https://www.fda.gov/media/149534/download
  4. Nersesjan V, Fonsmark L, Christensen RHB, et al. Neuropsychiatric and cognitive outcomes in patients 6 months after COVID-19 requiring hospitalization compared with matched control patients hospitalized for non-COVID-19 illness. JAMA Psychiatry. Published online March 23, 2022. doi:10.1001/jamapsychiatry.2022.0284

 

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