Research Roundup: J&J vaccine authorized by FDA, COVAX starts African rollout, vaccine makers evaluate boosters

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 Tuesday, leaders of the global vaccine platform COVAX announced the initiative’s plans to distribute 237 million doses of the AstraZeneca/University of Oxford COVID-19 vaccine to 142 countries by the end of May 2021. COVAX’s rollout began with deliveries to India, Ghana, and Cote D’Ivoire two weeks ago, followed by 11 million doses distributed between Angola, Cambodia, the Democratic Republic of the Congo (DRC), and Nigeria last week. Around 1.2 million doses of the Pfizer/BioNTech vaccine will also be delivered in the first quarter of 2021, in supplement to the new allocation plan. COVAX, led by the World Health Organization; Gavi, the Vaccine Alliance; and the Coalition for Epidemic Preparedness Innovations, with UNICEF as the implementing partner, intends to deliver 2 billion doses to 190 countries by the end of the year.Pharmaceutical company Merck will partner with Johnson & Johnson (J&J) to help produce J&J’s single-dose COVID-19 vaccine, which was authorized for emergency use in the United States on February 27. The United States has purchased 100 million doses of the vaccine, with 94 million anticipated by the end of May and the full amount by the end of June. The Merck collaboration, announced by President Joe Biden last week, is intended to boost manufacturing capacity of the vaccine but is not expected to significantly impact supply within the next three months. The deal is geared toward the second half of the year, according to an administration official, when the threat of variants could require manufacturing of booster shots and when the United States may turn attention to sending vaccine doses abroad.Up to 4.3 percent of people with HIV in the DRC were able to naturally suppress the virus without medication, according to a study published last Tuesday in EBioMedicine, a journal published by The Lancet. Typically, so-called “elite controllers” make up less than 1 percent of people with HIV. The new study, among HIV-positive individuals in the DRC tested from 2017 and 2019, found the prevalence of elite controllers to be between 2.7 and 4.3 percent, the largest group detected in a single country. While it remains unknown how elite controllers are able to suppress infection, scientists hope further research could serve as a basis for the development of a vaccine or new treatments to combat the virus. The research team included scientists from Abbott Diagnostics, Université Protestante au Congo, Johns Hopkins School of Medicine, the US National Institute of Allergy and Infectious Diseases, and University of Missouri—Kansas City

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.