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Urged to Release Criteria

The Biotechnology Innovation Organization (BIO) has urged the US Department of Health and Human Services to publish the new criteria it developed for the emergency authorization of a coronavirus vaccine, the New York Times reports.

Last month, the Food and Drug Administration appeared poised to announce stricter standards for the emergency authorization of a SARS-CoV-2 vaccine, such as requiring vaccine makers to follow trial volunteers for a median two months after their last dose before seeking authorization. This, CNN noted at the time, would make it unlikely that any candidate vaccine would be able to receive authorization by the US election in early November. However, Politico then reported that President Donald Trump cast doubt on whether he would allow the new criteria to be adopted. 

According to the Times, this state of affairs "is causing growing angst within the biotech industry." It reports that Michelle McMurry-Heath, the president and CEO of BIO, has sent a letter to Alex Azar, the health secretary, asking him to publicly release the guidelines. "The release of FDA guidance would provide scientists and researchers greater regulatory clarity and strengthen public confidence in any future vaccine that may be authorized or approved," she writes in the letter.

The Scan

Sick Newborns Selected for WGS With Automated Pipeline

Researchers successfully prioritized infants with potential Mendelian conditions for whole-genome sequencing or rapid whole-genome sequencing, as they report in Genome Medicine.

Acne-Linked Loci Found Through GWAS Meta-Analysis

Researchers in the European Journal of Human Genetics find new and known acne vulgaris risk loci with a genome-wide association study and meta-analysis, highlighting hair follicle- and metabolic disease-related genes.

Retina Cell Loss Reversed by Prime Editing in Mouse Model of Retinitis Pigmentosa

A team from China turns to prime editing to correct a retinitis pigmentosa-causing mutation in the PDE6b gene in a mouse model of the progressive photoreceptor loss condition in the Journal of Experimental Medicine.

CRISPR Screens Reveal Heart Attack-Linked Gene

Researchers in PLOS Genetics have used CRISPR screens to home in on variants associated with coronary artery disease that affect vascular endothelial function.