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Push Toward Approval

The US Food and Drug Administration is under pressure to grant full approval to SARS-CoV-2 vaccines as the Delta variant spreads, the Wall Street Journal reports.

The three SARS-CoV-2 vaccines in use the US are available under Emergency Use Authorizations, though both Pfizer-BioNTech and Moderna have submitted paperwork for full approval. The Journal notes that only Pfizer has completed that process. It adds that a spate of government agencies, schools, and businesses have announced they will be requiring vaccination against COVID-19, though others are holding back to wait for approval.

FDA advisors and former FDA officials tell the Journal that approval of the Pfizer-BioNTech vaccine is expected in September or October.

Peter Marks, director of the FDA's Center for Biologics Evaluation and Research tells the Washington Post that the agency is moving at a "sprint" to accelerate the approval process. "We are going to move with all due diligence to get the review done with our usual high quality, as rapidly as we can," he adds at the Post. "We know how important it is for people to be able to get vaccinated."

The Scan

Positive Framing of Genetic Studies Can Spark Mistrust Among Underrepresented Groups

Researchers in Human Genetics and Genomics Advances report that how researchers describe genomic studies may alienate potential participants.

Small Study of Gene Editing to Treat Sickle Cell Disease

In a Novartis-sponsored study in the New England Journal of Medicine, researchers found that a CRISPR-Cas9-based treatment targeting promoters of genes encoding fetal hemoglobin could reduce disease symptoms.

Gut Microbiome Changes Appear in Infants Before They Develop Eczema, Study Finds

Researchers report in mSystems that infants experienced an enrichment in Clostridium sensu stricto 1 and Finegoldia and a depletion of Bacteroides before developing eczema.

Acute Myeloid Leukemia Treatment Specificity Enhanced With Stem Cell Editing

A study in Nature suggests epitope editing in donor stem cells prior to bone marrow transplants can stave off toxicity when targeting acute myeloid leukemia with immunotherapy.