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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. 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.

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 Wednesday, a World Health Organization (WHO) panel recommended the use of AstraZeneca and the University of Oxford’s COVID-19 vaccine for all adults over 18. The recommendation is not an official emergency use listing but could pave the way to broader use of the vaccine—including by the COVAX Facility and African Vaccine Acquisition Task Team, both of which have secured hundreds of millions of doses with plans to distribute to participating countries in the coming months. On Thursday, Africa Centers for Disease Control and Prevention (CDC) Director John Nkengasong said his organization was also recommending use of the AstraZeneca/Oxford vaccine, except for in countries where the B1351 COVID-19 variant, first identified in South Africa, has become dominant. Africa CDC made its decision after data from a study in South Africa indicated poor efficacy of the vaccine in preventing mild to moderate illness caused by the variant, while WHO did not make the same specification, noting that the vaccine was still likely to be effective in preventing more severe COVID-19 cases.The US Food and Drug Administration (FDA) on Tuesday granted emergency use authorization (EUA) to Eli Lilly’s combination monoclonal antibody therapy to treat mild to moderate cases of COVID-19 in patients ages 12 and up who are at high risk for progressing to severe disease. The therapeutic, a combination of bamlanivimab and etesevimab, cut the risk of hospitalization and death among COVID-19 patients by 70 percent in a late-stage clinical trial. The FDA had previously issued an EUA for bamlanivimab in November. New protocols have also enabled a shorter infusion time for bamlanivimab alone and with etesevimab, reducing it from an hour to as few as 16 and 21 minutes, respectively. Eli Lilly has so far made 100,000 doses of the combination therapy available and plans to manufacture an additional 150,000 throughout the first quarter of 2021.The anti-inflammatory drug tocilizumab, most often used to treat rheumatoid arthritis, helped reduce the COVID-19 death rate in a major clinical trial based in the United Kingdom. The RECOVERY Trial tested a group of 2,022 patients receiving tocilizumab, 82 percent of whom also received dexamethasone or a similar steroid, against a control arm of 2,094 patients receiving standard care alone. Results from the study, released last week and not yet peer-reviewed, showed that tocilizumab reduced the rate of death by 14 percent, with a larger reduction among patients on ventilators. Tocilizumab also increased the probability of discharge within 28 days from 47 percent to 54 percent.

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. Two new COVID-19 vaccine candidates, from Novavax and Johnson & Johnson (J&J), will undergo regulatory review for emergency authorization in the coming weeks. On Thursday, Novavax announced rolling reviews of its two-dose vaccine had begun by several regulatory agencies, including the European Medicines Agency, US Food and Drug Administration (FDA), UK Medicines and Healthcare products Regulatory Agency, and Health Canada. Phase 3 trials of the vaccine—preliminary data from which showed 90 percent efficacy in the United Kingdom and 49 percent efficacy in South Africa—will continue while the reviews occur. The same day, J&J announced it had submitted an application for emergency use authorization from the FDA for its single-dose vaccine, after phase 3 trial data indicated the shot was 72 percent effective in the US trial and completely protective against hospitalization and death. An independent advisory committee will meet in late February to review the J&J vaccine data, after which the FDA will make a decision on authorization.Leaders of the COVAX Facility, a global initiative aimed at providing equitable access to COVID-19 vaccines, released plans on Wednesday outlining a country-by-country forecast for vaccine distribution in the coming months. The immediate doses COVAX has secured—336 million from AstraZeneca/Oxford and 1.2 million from Pfizer/BioNTech—are expected to cover about 3.3 percent of the total population of the 145 participating countries within the first half of 2021. Doses will be distributed in proportion to each country’s population size and are anticipated to reach the most vulnerable populations, including health care workers. The details of the plan reflect an estimate of availability and are subject to change based on several factors, including the timeline of regulatory authorization for the AstraZeneca/Oxford vaccine.IAVI and Scripps Research have announced results from a phase 1 clinical trial evaluating a novel vaccine approach to prevent HIV, which showed success in stimulating production of rare immune cells needed to start the process of generating antibodies against the virus. The targeted response was detected in 97 percent of participants who received the vaccine. The study, results of which were presented at the virtual International AIDS Society HIV Research for Prevention conference on Wednesday, demonstrated proof of concept for the vaccine approach and will set the stage for continued clinical trials refining and extending the method. IAVI and Scripps intend to move forward by partnering with Moderna to develop and test an mRNA-based vaccine that harnesses the approach to produce the same beneficial immune cells.