Research Roundup: Pfizer seeks update to vaccine cold storage requirements, first vaccine trial in pregnant women begins, and AstraZeneca vaccine authorized by WHO
Interested in more global health innovation news? Every week GHTC scours media reports worldwide to deliver essential global health R&D news and content to your inbox. Sign-up now to receive our weekly R&D News Roundup email.
On Friday, Pfizer and BioNTech announced they are seeking approval from the US Food and Drug Administration (FDA) to store their COVID-19 vaccine for two weeks at temperatures commonly found in pharmaceutical freezers and refrigerators, a change from its currently required ultra-cold storage. The request comes after new data from stability studies showed the vaccine remains stable between -25°C and -15°C (–13°F to 5°F), which has potential to alleviate some logistical hurdles in the vaccine’s distribution. The existing FDA authorization requires storage between -80°C and -60°C (-112°F to ‑76°F). Moderna’s vaccine, by comparison, is shipped at -25°C to -15°C (-13°F to 5°F), while the Johnson & Johnson vaccine is expected to be shipped at 2°C to 8°C (36°F to 46°F) if authorized.
Pfizer and BioNTech have begun dosing patients in a clinical trial to evaluate their COVID-19 vaccine among pregnant women, according to a statement released Thursday. The phase 2/3 trial will test the two-dose, mRNA-based vaccine in 4,000 women ages 18 and older who are between 24 and 34 weeks pregnant. Pregnant women were not included in initial vaccine studies, leading to a lack of data and mixed messaging on vaccination recommendations for pregnant individuals. The new Pfizer/BioNTech study will focus on the third trimester of pregnancy to minimize risks to the children and will be conducted in the United States, Europe, South America, and Africa.
The World Health Organization (WHO) last week approved AstraZeneca and the University of Oxford’s COVID-19 vaccine as produced by the Serum Institute of India and SKBio for emergency use, making it the second vaccine to receive such a listing after the Pfizer/BioNTech shot was given authorization in late December. The emergency use listing clears the way for the vaccine to be used by the COVAX Facility, a WHO-led global mechanism to procure and equitably distribute COVID-19 vaccines. Pending supply and operational challenges, the goal is for more than 300 million doses of the vaccine to be made available to 145 countries through COVAX in the first half of 2021, according to a statement from AstraZeneca. The authorization follows a recommendation from an independent WHO panel made the week prior.