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Research Roundup: Upcoming COVID-19 vaccine data, a quantitative antibody diagnostic, and vaccine distribution preparation

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PATH/Rocky Prajapati

In this regular feature on Breakthroughs, we highlight some of the most interesting reads in global health research from the past week.

October 26, 2020 by Anna Kovacevich

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 Thursday, independent advisors to the US Food and Drug Administration (FDA) met in their first full-day meeting to begin laying the groundwork for upcoming COVID-19 vaccine approval guidelines. While there are no guarantees for which, and when, vaccine candidates will be shown to be safe and effective, several vaccine candidates are currently in late-stage trials, and early data on Pfizer’s and Moderna’s candidates may be available this month or next as both companies predict having sufficient safety data by the end of November. Johnson & Johnson’s vaccine trial and the US arm of AstraZeneca’s vaccine trial have been cleared to restart after pauses for safety investigations. Novavax recently began a late-stage trial in Britain and will soon start one in the United States as well, as will Sanofi and GlaxoSmithKline. Once evidence of safety and efficacy is available from vaccine makers, regulatory review will take a few weeks and will require the vaccine be at least 50 percent effective, among other criteria.

LabCorp has launched a COVID-19 antibody test designed to evaluate the strength of a person’s immune response to the virus and assist in determining the effectiveness of vaccine candidates. The Cov2Quant test provides a quantitative measurement of the concentration of IgG antibodies in a person’s blood and is currently available for use in research only, including Centers for Disease Control and Prevention (CDC) epidemiological studies working to better understand how antibodies are produced by the body after exposure and infection. So far, only two quantitative antibody diagnostics have been authorized by the FDA for wider use, both from Siemens Healtineers in early August. It remains unknown exactly how many antibodies a person needs to be considered immune to COVID-19, and quantitative measurement tools will be an essential tool in better understanding COVID-19 immunity.

Pfizer—currently in phase 3 trials for its COVID-19 vaccine candidate and expecting early indications about efficacy this month—is preparing a supply chain and distribution system aimed at delivering hundreds of millions of doses globally. Distribution sites in Kalamazoo, Michigan, and Puurs, Belgium, are at the center of the effort, at which the company will load reusable, temperature-controlled containers on two dozen trucks per day and ship 7.6 million doses daily to nearby airports. Pfizer’s mRNA-based vaccine candidate requires storage at -94 degrees Fahrenheit, which the company is hoping to accomplish with suitcase-sized shipping containers designed to keep doses at ultracold temperatures for up to ten days. Pfizer’s delivery plan utilizes cargo space on 20 planes per day, followed by trucking from airports to vaccination sites, all carried out by FedEx, UPS, and DHL International. Pfizer expects deliveries to take three days and aims to deliver 100 million vaccine doses in 2020 and 1.3 billion in 2021, as part of supply deals with the United States, Europe, Japan, the United Kingdom, and more.

Categories: COVID-19, Diagnostics, FDA, Research Roundup, Vaccines

About the author

Anna KovacevichGHTC

Anna Kovacevich is a senior program assistant at GHTC who supports GHTC's communications and member engagement activities.

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October 19, 2020

Research Roundup: COVID-19 clinical trials paused, Pfizer to expand vaccine trial to adolescents, and first...

Written by Anna Kovacevich / GHTC
Read time:
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.Clinical trials for Johnson & Johnson’s (J&J) COVID-19 vaccine candidate and Eli Lilly’s COVID-19 monoclonal antibody treatment were paused last week, while the US arm of AstraZeneca’s COVID-19 vaccine trial remains on hold since a patient’s potential adverse reaction in September. Vaccine experts say these pauses should be reassuring, not frightening, as they indicate the trial process is functioning as it is designed to; a clinical trial with no reports of adverse events would be unusual. J&J announced its trial pause after an “unexplained illness” in a trial participant, and the company will be reviewing the case along with an independent data monitoring board before making a decision on whether to resume the trial. Eli Lilly’s trial pause came after a potential safety concern flagged by an independent review board, and the board will review the data again at a later date to make a decision on its continuation.Pfizer announced last week it has received approval from the US Food and Drug Administration (FDA) to expand its COVID-19 vaccine trial to include children ages 12 and up. This development will look to understand vaccine safety and efficacy among adolescents and will mark the first inclusion of children under 16 in a COVID-19 vaccine trial in the United States. More than half a million children have been infected with COVID-19 this year, and more than two-thirds of the children who died were Black or Latinx, according to Sara Gozer, president of the American Academy of Pediatricians. While vaccine trials began with a focus on older participants due to their higher risk for more serious illness, pediatricians have emphasized the importance of not leaving children behind as trials progress.FDA has approved Inmazeb, an antibody cocktail made by Regeneron, for use as an Ebola therapeutic. This is the first FDA approval for a treatment specific to Ebola, and means there is now an FDA-approved treatment and vaccine for the virus. The treatment, which has been used during the current Ebola outbreak in the Democratic Republic of the Congo (DRC) under compassionate use protocol, was shown to be effective during a clinical trial conducted during the 2018–2020 outbreak in eastern DRC. The Biomedical Advanced Research and Development Authority has purchased an undisclosed number of Inmazeb doses for the US strategic stockpile, and Regeneron has said it will work to ensure low-income countries will also have access to the treatment.