Regeneron Pharmaceuticals shared positive results from the company’s Phase III trial of a candidate drug for children with homozygous familial hypercholesterolemia (HoFH), a rare, life-threatening condition characterized by elevated circulating levels of low-density lipoprotein cholesterol (LDL-C) and accelerated, premature atherosclerotic cardiovascular disease (ACVD.

Moderna, COVID-19 vaccine

White House COVID-19 response coordinator Dr. Ashish Jha said on May 22 he expects a U.S. Food and Drug Administration decision on authorizing Moderna’s vaccine for children under age five within the next few weeks.

Smoking rates declined globally for the first time on record, according to a new report on tobacco use. However, the figures from the Tobacco Atlas report also mask growing numbers of smokers in parts of the world, as well as increased tobacco use among young teenagers in almost half of the countries surveyed.

A chain of events possibly triggered by unrecognized infection with the SARS-CoV-2 coronavirus could be causing the mysterious cases of severe hepatitis reported in hundreds of young children around the world, researchers suggest.

Moderna plans to submit an application to the U.S. health regulator for emergency use authorization (EUA) of the company’s COVID-19 vaccine among kids between the ages of six months to five years by the end of the month, a company spokesperson said.

One in four children with COVID-19 symptoms develop “long COVID,” according to data pooled from 21 earlier studies conducted in Europe, Asia, Australia and South America. Also, according to a study reported on March 14 in JAMA Pediatrics, women who wish to pass protective antibodies induced by COVID-19 vaccines to their babies via breast milk should opt for the mRNA shots from Moderna or Pfizer/BioNTech.

At least 1 in 5 Americans have been infected with COVID-19. In other news, the U.S. Food and Drug Administration approved Gilead Sciences’ supplemental New Drug Application for Veklury (remdesivir) for adults and adolescents with COVID-19 who are not hospitalized but are at high risk of progression to severe COVID-19, hospitalization or death.

Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases and White House chief medical advisor, said they expect the U.S. Food and Drug Administration will authorize the Pfizer-BioNTech vaccine for children under the age of 5 years in the next month.

When used in children, rapid antigen tests for detecting the coronavirus do not meet accuracy criteria set by the World Health Organization and U.S. and UK device regulators, according to researchers who reviewed 17 studies of the tests. Other research appears to confirm smaller, earlier studies that suggested nursing mothers are unlikely to transmit the coronavirus in breastmilk.

The U.S. Centers for Disease Control has not yet seen a signal that the Omicron variant of COVID-19 is more severe in young children despite an increase of the hospitalizations, the agency’s director Dr. Rochelle Walensky said at a press conference on January 7.