First Patient Gets BioNTech MRNA Herpes Vaccine Candidate
Reuters reports on the first-in-human phase of a clinical trial of a vaccine designed to prevent HSV-2, the virus behind genital herpes. Separately, the World Health Organization has updated its human papillomavirus vaccine recommendations to include a 1-dose strategy.
Reuters:
BioNTech Doses First Patient In Herpes Vaccine Candidate Clinical Trial
BioNtech has dosed the first patient with its BNT163 herpes vaccine candidate designed to prevent genital lesions as part of a first-in-human Phase 1 clinical research study, the German vaccine maker said on Wednesday. The vaccine candidate is meant to prevent HSV-2, the herpes simplex virus that causes genital herpes, and potentially HSV-1, which causes oral herpes and can lead to genital herpes. (12/21)
In updates on the HPV vaccine —
CIDRAP:
WHO Supports 1-Dose HPV Vaccine Strategy
The World Health Organization (WHO), in a revised position paper, has updated its human papillomavirus (HPV) vaccine recommendations to include a single-dose schedule, an effort to expand vaccination amid a worrying global decline in coverage. Earlier this year, WHO vaccine advisers endorsed the one-dose strategy as an alternative to the standard three-dose regimen. (Schnirring, 12/21)
In other pharmaceutical news —
Bloomberg:
A Tiktok Trend Sold Out Ozempic Leaving Diabetics Dizzy, Scared
For more than a month, Shane Anthony, a 57-year-old auto mechanic, hasn’t been able to get his diabetes medication. Ozempic, an injection that keeps blood sugar levels in check for patients with type 2 diabetes, has been in shortage for about four months, according to the database maintained by the US Food and Drug Administration, and is backordered at Anthony’s Seattle pharmacy. (Court, 12/21)
Stat:
California Wants To Revoke A CVS Mail-Order License For Illegally Filling Opioid And ADHD Prescriptions
California authorities are seeking to revoke a license held by a CVS Health mail-order pharmacy unit for violating several state laws that govern shipments of various controlled substances — including prescription painkillers and ADHD medicines — directly to patients. (Silverman, 12/21)
Stat:
Gene Therapy Promising For Children With "Bubble Boy" Syndrome
H.T. Begay is a happy kid. He’s smiley, silly, and definitely trying to make you laugh. The four-year-old’s two neat braids of dark hair wave behind him as he runs among the dust, dogs, and sheep near his family’s ranch on their Navajo reservation in Arizona. On a table inside the family’s sweat lodge is a little altar. Next to a pair of tiny baby booties is a certificate that reads, “The first patient in the world to receive Autologous Gene Therapy for Artemis-deficient SCID 06/23/2018.” (Trang, 12/21)
Stat:
Kids With Rare Diseases Get Mitochondria From Their Mothers
At a far distant point in Earth’s ancient past, two separate, single-celled life forms — an archaeon and a bacteria — became one in an act either of symbiosis or enslavement, depending on which microbiologist you ask. And over the next 2 billion or so years, that bacteria evolved to be the mitochondria that power nearly every cell in the human body. These capsule-shaped organelles don’t just turn oxygen and nutrients into chemical energy. They also metabolize cholesterol and synthesize hormones and neurotransmitters. (Molteni, 12/21)