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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. The US Food and Drug Administration (FDA) on Saturday authorized Johnson & Johnson’s (J&J) COVID-19 vaccine for emergency use in adults over the age of 18, making it the third vaccine to be approved for use in the United States. The authorization follows a recommendation from an independent advisory panel to the FDA, which convened Friday to review the data and subsequently voted to endorse the vaccine. Phase 3 trial data released in late January showed 66 percent efficacy overall in preventing moderate to severe disease 28 days after vaccination, 72 percent efficacy among participants in the United States, and complete protection against hospitalization and death due to COVID-19, which was reinforced by FDA analysis released in advance of the independent panel meeting last week. The shot—made by J&J’s vaccine division, Janssen—requires only one dose and can be shipped and stored using standard refrigeration. The United States has purchased 100 million doses of the vaccine, and distribution is expected to begin this week.On Wednesday, 600,000 doses of the AstraZeneca/University of Oxford COVID-19 vaccine produced by the Serum Institute of India landed in Accra, Ghana, marking the COVAX Facility’s first delivery to the African continent. Ghana will begin its rollout of the doses early this week, prioritizing frontline health workers and others at high risk. The shipment, a first step toward COVAX’s goal of ensuring equitable access to COVID-19 vaccines around the world, was followed by a delivery to Cote d’Ivoire on Friday, and more shipments are expected in the coming days and months. COVAX intends to deliver nearly 2 billion vaccine doses this year, anticipated to cover up to 20 percent of participating countries’ populations.Last week, Moderna reported it had developed a new version of its COVID-19 vaccine designed to specifically work against the B.1.351 COVID-19 variant, first identified in South Africa. The new vaccine has been sent to the National Institutes of Health, which will test to determine if using it as a booster shot would stimulate a strong immune response. Also last week, Pfizer and BioNTech announced they had initiated a study on the safety and immunogenicity of a third dose of their vaccine to evaluate the effect of a booster on immunity against currently circulating variants, as well as any potential new variants. Both the Moderna and Pfizer/BioNTech vaccines are mRNA based, allowing them to be updated relatively quickly by creating a modified mRNA sequence.

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.