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. 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 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.