Vaccines

COVID-19 Roundup: Vaccines Safe for Pediatric Patients With MIS-C, Molnupiravir Does Not Reduce Hospital Admissions, Deaths, COVID-19 Recovery Improved as Standard of Care Evolved, and More

Jessica Ganga
01/20/2023

COVID-19 Vaccine Safe for Pediatric Patients With Multisystem Inflammatory Syndrome1

In a multicenter cross-sectional study, researchers determined that the COVID-19 vaccine is safe for children who are diagnosed with multisystem inflammatory syndrome (MIS-C) and are not at risk for adverse events.

The researchers analyzed data from 385 patients aged 5 years or older with prior MIS-C who were eligible for the COVID-19 vaccine. Of the total, 185 patients received at least one vaccine dose. The median time from the diagnosis of MIS-C to the first vaccine dose was 9 months. Of the total, 31 patients received one dose, 142 received two doses, and 12 received three doses.

Minor adverse events were observed including arm soreness and/or fatigue, and patients were treated with either acetaminophen or ibuprofen. There were no patients who required further testing or hospitalization, and there were no serious adverse events reported.

The study included several limitations including recall bias regarding mild symptoms, and families of non-vaccinated patients may have been less likely to return phone calls regarding the study.

“In this cohort study of patients with a history of MIS-C, 48.1% of those surveyed were vaccinated for COVID-19 and none experienced serious adverse reactions, including a diagnosis of myocarditis or MIS-C recurrence,” the researchers concluded. “These findings support the CDC recommendation for COVID-19 vaccination at least 90 days following MIS-C diagnosis, with ongoing surveillance of adverse events.

Molnupiravir Does Not Reduce Hospitalizations, Death2

The use of molnupiravir in patients being treated for COVID-19 at home recover quickly, but the use of molnupiravir does not reduce hospital admissions or deaths in patients vaccinated for COVID-19, according to a recent study.

Participants who were eligible for the study were aged 50 years or older and had COVID-19 for 5 days or fewer. In total, 12,529 patients received treatment with molnupiravir (800 mg, twice daily) and usual care, and 12,525 patients received usual care. One percent (n = 105) patients in the molnupiravir plus care group were hospitalized or died. Similarly, in the usual care group, 1% of patients (n = 98) were hospitalized or died.

Some serious adverse events were recorded in patients in each group, but none of the events were related to molnupiravir.

“This trial of vaccinated adults at increased risk of an adverse outcome and unwell with confirmed SARS-CoV-2 infection showed that early treatment with molnupiravir did not reduce already low hospital admission or deaths,” the researchers concluded. “Our findings suggest that, in a highly vaccinated population at high risk (but not the highest risk) of complications from COVID-19, the avoidance of hospitalisation and death is primarily achieved via extensive vaccination.”

COVID-19 Recovery and Mortality Improved as Standards of Care Evolved3

A recent study examining COVID-19 standard of care measures throughout the pandemic found improvements in recovery and mortality over time in adults hospitalized with COVID-19.

The standard of care for those hospitalized with COVID-19 changed dramatically throughout the pandemic. Researchers from the NIH and Adaptive COVID-19 Treatment Trial (ACTT) investigators aimed to quantify the impact standard of care changes had on hospitalized patients with COVID-19 as the pandemic progressed.

In an observational study, the authors looked at data from sequential cohorts of hospitalized patients in the first four stages of the ACTT to determine whether recovery and mortality improved as the standard of care for COVID-19 evolved.

The authors compared the three remdesivir-only groups from the first three stages of ACTT. ACTT-1 compared remdesivir plus the standard of care to placebo plus the standard of care, while in ACTT-2 and ACTT-3, the control group was remdesivir plus the standard of care. The authors found that the odds of baseline intubation in ACTT-2 were 25% lower than for comparable ACTT-1 patients. The authors, however, did not find evidence that these changes affected 28-day recovery or mortality.

The authors also found that recovery and mortality improved from ACTT-2 to ACTT-3, the authors note that this improvement could be explained due to an increase in the use of dexamethasone. Antibiotics also declined gradually between these stages as well.

“These results support excluding nonconcurrent controls from analysis of platform trials in rapidly changing therapeutic areas,” the authors concluded.

Bivalent mRNA Booster Provides Additional Protection Against COVID-194

Bivalent mRNA booster provides additional protection against COVID-19 infection compared with two, three, or four previous monovalent vaccinations alone.

Researchers compared the effectiveness of the bivalent vaccine compared with monovalent vaccines. Between September 14 and November 11, 2022, the researchers used data from 360,626 nucleic acid amplification tests performed at 9,995 pharmacies. Adults aged 18 and older were used for the analysis and reported symptoms consistent with COVID-19.

After analyzing the data, the researchers found that the bivalent vaccine provide protection against symptomatic COVID-9 in immunocompetent people who received a monovalent vaccine previously.

“Staying up to date with COVID-19 vaccination, including getting a bivalent booster dose when eligible, is critical to maximizing protection against COVID-19,” the researchers note.

 

References:

  1. Elias MD, Truong DT, Oster ME, et al. Examination of adverse reactions after COVID-19 vaccination among patients with a history of multisystem inflammatory syndrome in children. JAMA Netw Open. Published online January 3, 2023. doi:10.1001/jamanetworkopen.2022.48987
  2. Butler CC, Hobbs FDR, Gbinigie OA, et al. Molnupriravir plus usual care versus usual care alone as early treatment for adults with COVID-19 at increased risk of adverse outcomes (PANORMIC): an open-label, platform-adaptive randomised controlled trial. Lancet. Published online December 22, 2022. 
  3. Potter GE, Bonnett T, Rubenstein K, et al. Temporal improvements in covid-19 outcomes for hospitalized adults: a post hoc observational study of remdesivir group participants in the adaptive COVID-19 treatment trial. Ann Intern Med. 2022;175(12):1716-1727. doi:10.7326/M22-2116.
  4. Link-Gelles R, Ciesla AA, Fleming-Dutra KE, et al. Effectiveness of bivalent mRNA vaccines in preventing symptomatic SARS-CoV-2 infection—increasing community access to testing program, United States, September-November 2022. The Centers for Disease Control and Prevention; November 22, 2022. Accessed January 20, 2023. https://www.cdc.gov/mmwr/volumes/71/wr/mm7148e1.htm?s_cid=mm7148e1_w