Trials Begin For Covid Vaccination During Pregnancy
Pregnant women were excluded from the initial Pfizer-BioNTech clinical trials. The trial participants are 18 and older and anywhere from 24 to 34 weeks into their pregnancy.
The Hill:
Pfizer Begins Coronavirus Vaccine Trial In Pregnant Women
Pfizer and BioNTech on Thursday announced a new trial aiming to test the safety and efficacy of its coronavirus vaccine among pregnant women. The companies, which together produced one of the two COVID-19 vaccines the Food and Drug Administration approved for emergency use in the U.S., said in a press release that it had given doses to its first group of participants in the new study, which aims to provide clear data on any impacts the inoculation may have for expectant mothers and their newborn children. (Castronuovo, 2/18)
Bloomberg:
Covid Vaccine For Pregnancy Trials To Begin As Pfizer-BioNTech Start Tests
Covid vaccine developers are beginning trials in pregnant women, looking to provide reassurance that the shots are safe for expectant mothers. Pfizer Inc. and German partner BioNTech SE dosed the first patients in a trial of their messenger RNA vaccine in 4,000 women in the latter stages of pregnancy, the companies said on Thursday. The partners will run a mid-stage study for 350 volunteers between 27 and 34 weeks gestation to confirm safety, before moving into advanced trials for women between 24 and 34 weeks pregnant. (Ring and Kresge, 2/18)
In other vaccine development news —
The Hill:
Fauci: Vaccine For COVID-19 Variant 'Likely Will Take Several Months'
Anthony Fauci, the nation’s top infectious diseases expert, on Thursday said that a vaccine for a variant strain of the coronavirus believed to have originated in South Africa will likely take “several months.” (Budryk, 2/18)
The Washington Post:
Pfizer And Moderna Vaccine Manufacturing Is Stressing A Supply System That Previously Served A Scientific Niche
Acuitas Therapeutics, a tiny biotechnology firm in Vancouver, B.C., has just 30 employees and leases its labs from the University of British Columbia. The company doesn’t even have a sign on its building. Until last year, it outsourced production of only small volumes of lipid nanoparticles, fat droplets used to deliver RNA into cells, for research and a single approved treatment for a rare disease. But now, one of Acuitas’s discoveries has become a precious commodity. A proprietary molecule called an ionizable cationic lipid is a crucial piece of the mRNA vaccine made by Pfizer and its German partner BioNTech, and it is in urgent demand for production of billions of vaccine doses worldwide. (Rowland, 2/18)
Stat:
To Get Ahead Of Variants, Covid Drug Makers Use Evolution As Guide
Before becoming a Covid-19 drug, each candidate was just a tiny fragment of someone’s immune system, part of a swarm of Y-shaped proteins unleashed to try to keep the coronavirus from invading more cells. If the person recovered, these antibodies might end up in a blood sample in a lab. Some proved more effective than others. Yet even as researchers pinpointed the best of the bunch as possible medications, they knew their power could wane: What worked against the coronavirus as it was last year could falter as the pathogen evolved. (Boodman, 2/19)
