CDC Updates Operational Guidance for Schools, Early Childcare1
The Centers for Disease Control and Prevention (CDC) recently issued updated guidance to assist K-12 schools and early care and education (ECE) programs to foster safe in-person learning environments.
The new guidance no longer recommends routine testing to screen for COVID-19 in K-12 schools. However, K-12 schools and ECE programs should consider implementing screening testing for those students and staff in high-risk activities during high COVID-19 community levels or in response to an outbreak.
Additionally, the changes no longer recommend Test to Stay requirements. Quarantine for individuals exposed to COVID-19 should be limited to those in high-risk congregate settings.
Finally, the update guidance recommends the use of masks for individuals living in areas with high COVID-19 community levels and those who have been exposed to the virus. Individuals who test positive for COVID-19 should isolate and wear a mask around others after isolation through Day 10 of infection. Prevention strategies should be implemented for all K-12 and ECE programs undergoing an outbreak.
 
Health Impairments After Acute COVID-19 or MIS-C2
Researchers indicated that evaluating post-discharge outcomes of children and adolescents hospitalized for acute COVID-19 or multisystem inflammatory syndrome in children (MIS-C) are limited, particularly for children who became critically ill.
To learn more about this issue, researchers conducted a multicenter prospective cohort study in 25 pediatric hospitals in the United States to assess risk factors for post-discharge sequelae in this patient population.
Their study results revealed that more than 1 in 4 children and adolescents hospitalized with acute COVID-19 or MIS-C experienced persistent symptoms or activity impairment for at least 2 months after admission. Patients with MIS-C and respiratory conditions or obesity are at greater risk of prolonged recovery.
The authors concluded that their findings emphasize the significance of post-discharge follow-up of these severely ill patients and additional interventions (eg, occupational or physical therapy) and clinical follow-up of these high-risk cohorts may decrease long-term sequelae.
              
NIH Updates Guidelines for Anti-SARS-CoV-2 Monoclonal Antibodies3
On August 18, 2022, the National Institute of Health (NIH) updated their COVID-19 Treatment Guidelines regarding the in vitro susceptibility of the circulating SARS-CoV-2 variants of concern to the available anti-SARS-CoV-2 monoclonal antibodies (mAbs). The updates also reviewed the projected clinical activity of the different anti-SARS-CoV-2 mAbs against the Omicron BA.4 and BA.5, which are now the dominant subvariants in the U.S.
The NIH panel found that the Omicron variant and its subvariants have noticeably diminished in vitro susceptibility to several anti-SARS-CoV-2 mAbs, especially bamlanivimab plus etesevimab and casirivimab plus imdevimab. Sotrovimab is active against the Omicron BA.1 and BA.1.1 subvariants, but it has substantially decreased in vitro neutralization activity against the Omicron BA.2, BA.4, and BA.5 subvariants. However, bebtelovimab retains in vitro neutralization activity against circulating Omicron subvariant.
Therefore, the panel recommended the use of bebtelovimab 175 mg intravenous injection as an alternative therapy only when both ritonavir-boosted nirmatrelvir and remdesivir are not available, reasonable to use, or clinically suitable.
The panel noted that since the Omicron variant is currently the dominant variant in the United States, they recommend against using bamlanivimab plus etesevimab, casirivimab plus imdevimab, or sotrovimab for treating COVID-19.
 
Novavax Vaccine Available for Those Aged 12 Years and Older4         
The US Food and Drug Administration (FDA) announced on August 19, 2022 that the Novavax COVID-19 Vaccine, Adjuvanted is available under an emergency use authorization (EUA) to prevent COVID-19 in individuals aged 12 and older.
The vaccine is given as a two-dose primary series in a ready-to-use liquid formulation administered intramuscularly 3 weeks apart. The vaccine contains the SARS-CoV-2 spike protein and Matrix-M adjuvant.
The most common adverse effects reported include pain/tenderness, redness and swelling at the injection site, fatigue, muscle pain, headache, joint pain, nausea/vomiting, and fever.
 
FDA Approved Moderna, Pfizer Bivalent Booster Vaccines5
On August 31,2022, the FDA amended the EUAs of the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize bivalent formulations of the vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines will also be referred to as “updated boosters,” and contain two messenger RNA components of SARS-CoV-2 virus; one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2.
The Moderna COVID-19 vaccine, Bivalent, is authorized for use as a single booster dose in individuals 18 years of age and older. Among study participants, the most commonly reported adverse effects include pain, redness and swelling at the injection site, fatigue, headache, muscle pain, joint pain, chills, swelling of the lymph nodes in the same arm of the injection, nausea/vomiting, and fever.
The Pfizer-BioNTech COVID-19 vaccine, Bivalent, is authorized for use as a single booster dose in individuals 12 years of age and older. Among the study participants who received the Pfizer bivalent vaccine, the most commonly reported adverse effects included pain, redness and swelling at the injection site, fatigue, headache, muscle pain, chills, joint pain, and fever. 
 
—Yvette C. Terrie, BSPharm, RPh
 
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