Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

Miranda Hester

The US Food and Drug Administration (FDA) has given an 

 for Eli Lilly’s monoclonal antibodies bamlanivimab and etesevimab administered together to treat mild to moderate coronavirus disease 2019 (COVID-19) in both adults and pediatric patients who are aged 12 years and older, weigh at least 88 pounds, and are at high risk of developing severe COVID-19.

The authorization was based on a clinical trial of patients with COVID-19 at risk of disease progression. Participants were given an intravenous infusion of bamlanivimab (2800mg) and etesevimab (2800mg) that was administered together. The dose significantly reduced hospitalization and death related to COVID-19 over the course of 29 days of follow-up when compared to a placebo. The efficacy and safety is under continual evaluation.

Possible side effects include pruritus, rash, dizziness, and nausea. Serious and unexpected adverse effects were observed with bamlanivimab, both with and without coadministration of etesevimab, and included infusion-related reactions, anaphylaxis, and hypersensitivity. Clinical worsening after receiving bamlanivimab has been noted, but it’s unknown whether this was because of progression of COVID-19 or because of bamlanivimab use. Additionally, bamlanivimab and etesevimab are not authorized for use in patients who are hospitalized because of COVID-19 or require oxygen therapy because of the disease.

In the press release from the FDA for the authorization, Patrizia Cavazzoni, MD, acting director of the FDA’s Center for Drug Evaluation and Research said, “Today’s action, which provides another treatment for COVID-19, reflects the FDA’s strong commitment to working with sponsors to expand potential treatment options health care providers can use to fight this pandemic. As part of our Coronavirus Treatment Acceleration Program, the FDA uses every resource at our disposal to make treatments such as these monoclonal antibodies available while continuing to study their safety and effectiveness.”

US Food and Drug Administration. Coronavirus (COVID-19) update: FDA authorizes monoclonal antibodies for treatment of COVID-19. US Food and Drug Administration. Published February 9, 2021. Accessed February 11, 2021. 

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-monoclonal-antibodies-treatment-covid-19-0

Articles

The US Food and Drug Administration (FDA) issued an emergency use authorization (EUA) of monoclonal antibodies bamlanivimab and etesevimab to treat mild coronavirus disease 2019 (COVID-19) in both pediatric and adult patients.

FDA issues EUA for bamlanivimab and etesevimab to treat COVID-19

 more members to be appointed to the White House COVID-19 Response team, who will work to implement the Biden administration’s COVID-19 plan, which includes rapidly vaccinating as many Americans as possible, increasing testing rates, and restoring the public’s trust in the scientific information disseminated by the federal government.

David A. Kessler, MD, has been selected to be the Chief Science Officer of the COVID Response team. Kessler is currently a professor of pediatrics and epidemiology and biostatistics at the University of California, San Francisco and has served as the dean of medical schools at both Yale and University of California, San Francisco. He has previously served as the commissioner of the US Food and Drug Administration from 1990 to 1997 and was chair of the boards for both the Center for Science in the Public Interest and the Elizabeth Glaser Pediatric AIDS Foundation. He’s also an author of several books on public health.

In the press release for the announcement, President-elect Biden stated, “The individuals announced today will bolster the White House’s COVID-19 Response team and play important roles in carrying out our rescue plan and vaccination program. At a time when American families are facing numerous challenges I know these public servants will do all that is needed to build our nation back better.”

1. President-elect Joe Biden and Vice President-elect Kamala Harris announce additional members of the White House COVID-19 response team. President-Elect Joe Biden. Published January 15, 2021. Accessed January 15, 2021. 

https://buildbackbetter.gov/press-releases/president-elect-joe-biden-and-vice-president-elect-kamala-harris-announce-additional-members-of-the-white-house-covid-19-response-team/

The Biden transition team has named more members of the COVID-19 response team, including pediatrician and lawyer Dr. Kessler.

David A. Kessler, MD, named Chief Science Officer of the COVID Response team   

The opioid crisis has raised many questions about what leads to the misuse of opioids. Little research has been done into how parental and adolescent prescription use and misuse could be associated. An 

Investigators did a cross-sectional, nationally representative study that included parent-adult pairs from the annual 2015-2016 National Survey on Drug Use and Health. The data were collected from January 2015 to December 2017. The exposure was parental past 12-month exclusive medical prescription opioid use as well as any misuse and the primary outcome was adolescent past 12-month medical prescription opioid use or any misuse.

The cohort included 15,200 total parent-adolescent pairs made up of 9400 mother-child and 5800 father-child pairs. The children were aged 12 to 17 years and a slight majority were male. When controlled for other factors, parental prescription opioid use was linked with adolescent prescription opioid medical use adjusted odds ratio [aOR], 1.28; 95% CI, 1.06-1.53) as well as opioid misuse (aOR, 1.53; 95% CI, 1.07-2.25), but parental misuse was not associated. Additionally, parental use of prescription stimulant was linked with adolescent medical prescription opioid use (aOR, 1.40; 95% CI, 1.02-1.91). Adolescent prescription opioid misuse linked with parent-adolescent conflict (aOR, 1.26; 95% CI, 1.05-1.52), adolescent depression (aOR, 1.75; 95% CI, 1.26-2.44), and parental marijuana use (aOR, 1.84; 95% CI, 1.13-2.99). Delinquency (aOR, 1.55; 95% CI, 1.38-1.74) and perceived schoolmates’ drug use (aOR, 2.87; 95% CI, 1.95-4.23) were linked with misuse, but weakly linked to medical use.

The researchers concluded that parental use of prescription opioids was linked to their teenager’s prescription opioid use, but parental misuse was not linked. This means that restricting opioid prescribing for parents is an important public health goal. When parents are given a prescription for opioids, they should be told about the risk of use of the prescription drug on their child. Furthermore, they should be told to mitigate risks. Asking parents about such use should become a part of pediatric practice.

1. Griesler P, Hu M, Wall M, Kandel D. Assessment of prescription opioid medical use and misuse among parents and their adolescent offspring in the US. 

. 2021;4(1):e2031073. doi:10.1001/jamanetworkopen.2020.31073

An investigation examines whether parental prescription opioid use impacts a child’s opioid use and misuse.

 Does parental opioid use and misuse influence teen opioid use?

2020 will go down as the year when life screeched to a halt for many and health care workers and scientists became the heroes. How will it change medicine and what will 2021 hold?



sat down with Andrew J. Schuman, MD, FAAP, to discuss his reflections on 2020 and what he thinks may happen in 2021.

Podcasts

Contemporary Pediatrics sat down with Andrew J. Schuman, MD, FAAP, to discuss his reflections on 2020 and what he thinks may happen in 2021.

Miranda Hester

Articles

FDA issues EUA for bamlanivimab and etesevimab to treat COVID-19

David A. Kessler, MD, named Chief Science Officer of the COVID Response team

Does parental opioid use and misuse influence teen opioid use?

Reflecting on 2020, looking toward 2021