2021 Biopharma Update on the Novel Coronavirus: January 19

CV Update_Jan 19_2021

News information is not all-inclusive and updates are published once a week on Tuesdays. 



Swedish medtech start-up Capitainer secured SEK31 million to roll out its new qDBS dried blood spot testing system to confirm COVID-19. Capitainer’s qDBS system uses a smart chip to help patients to collect their own volume defined dried blood spot at home.


Testing Therapies, Antivirals and Vaccines

Mesenchymal stem cells derived from umbilical cord tissue could help treat ARDS in COVID-19 patients, according to results of a Phase I/IIa clinical trial published by University of Miami researchers. The findings, published January 5 in Stem Cell Translational Medicine, showed no evidence of adverse events, increased survival and decreased levels of inflammatory cytokines in 12 patients receiving the cell therapy, compared with 12 patients in a control group.

Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing its single-dose COVID-19 vaccine candidate created an immune response that lasted at least 71 days. The length of time was associated with the interim data point in the participants aged 18 to 55 years.

Gritstone Oncology, based in Emeryville, California, announced that it is advancing the development of its own second-generation vaccine against COVID-19. It inked a deal with the National Institute of Allergy and Infectious Diseases (NIAID) to launch a Phase I trial. It will be run through the NIAID-supported Infectious Diseases Clinical Research Consortium (IDCRC), with support from the Bill & Melinda Gates Foundation.

The vaccine utilizes epitopes—specific parts of known antigens—from the La Jolla Institute for Immunology. It will then deploy its own Gritstone EDGE and vaccine platform technologies to develop a vaccine that contains the spike protein, but other additional viral epitopes that are predicted to be good targets for T-cell immunity. The technology leverages self-amplifying mRNA and adenoviral vectors to deliver the antigens. They hope it will be able to protect against a range of SARS and coronaviruses in case of future coronavirus pandemics.

Vaccine trials for juvenile patients are underway. Pfizer and Moderna have begun recruiting juvenile patients for vaccine trials and results could be seen by summer, Bloomberg reports. AstraZeneca is also initiating trials in patients ages 12-18.

India’s Bharat Biotech published a fact sheet that contained warnings about who should avoid taking its Covaxin vaccine. In its announcement, the company warned people who are either immuno-compromised or on a medication that impacts the immune system should not receive the vaccine. Read more about Bharat’s vaccine and India’s vaccination efforts here.

A batch of Moderna’s mRNA vaccine may have been associated with a higher number of allergic reactions in Los Angeles, the L.A. Times reported. As a result, the state’s highest epidemiologist has urged healthcare providers to halt using that particular batch.


Organizational Actions/Announcements 

Publicly-traded companies that have been heavily involved in developing therapies and vaccines for COVID-19 have seen significant spikes in their stock prices over the past 10 months, including Germany’s BioNTech, which has surged 187% in one year.


Other Industry News

Will there be enough doses of the two authorized mRNA COVID-19 vaccines to meet the lofty goal of 100 million inoculations within 100 days of the start of Joe Biden's presidential administration? Pfizer’s chief executive officer believes that goal is something that can be achieved.

Although there are now two authorized vaccines against COVID-19 available in the United States and a third likely on the way with Johnson & Johnson’s candidate, the nation and world are nowhere near being done with the novel coronavirus, especially with new, more contagious variants now circulating. That is the thought of Scott Gottlieb, the former commissioner of the U.S. Food and Drug Administration and a board member of Pfizer, one of the companies that developed an authorized vaccine. 

Researcher Liam Townsend and colleagues at the Department of Infectious Diseases, St. James’s Hospital and Department of Clinical Medicine, Trinity Translational Medicine Institute, Trinity College, Dublin, Ireland, studied the lung function recovery and overall health of people who had varying degrees of COVID-19 severity. The results were published in the Annals of the American Thoracic Society. “We found that fatigue, ill-health and breathlessness were all common following COVID-19,” said Townsend. “However, these symptoms appeared to be unrelated to the severity of initial infection or any single measurement at the time of an outpatient appointment.”

A drop-off in virulence is possible for the SARS-CoV-2 virus -- once enough of the global population has been vaccinated or exposed to it, according to a new study from scientists at Emory University and The Pennsylvania State University. The findings, published last Tuesday in Science, use immunological and epidemiological data on endemic, cold-causing human coronaviruses to model transmission in a world where most adults have had an initial immune exposure to the virus, via infection or vaccine.

Updated - comparing COVID-19 vaccines looking at timelines, types, efficacy and prices. For more information, please read here. 

COVID-19 has led to a reduction in life expectancy in the United States, particularly among African American and Latino communities across the United States, a University of Southern California study has found. Because of the death toll from the virus, the researchers said life expectancy for Americans will shorten by 1.13 years to 77.48 years. Read more here.

With the changing of presidential administrations, Operation Warp Speed will morph into something different under the Joe Biden White House. Warp Speed was successful in funneling billions of dollars in research funding, but has fallen under a cloud due to multiple setbacks with vaccine delivery. Read more about the end of Warp Speed and the Biden platform at Politico.

Alex Azar, Secretary of Health and Human Services (HHS), submitted his letter of resignation last week, which was a bit pro forma, wince he was out of a job on January 20 anyway. In it, he warned against President Trump inciting more violence because it would “threaten to tarnish these and other historic legacies of this administration.” In addition, he wrote a list of accomplishments during his tenure in the position, which critics are noting are rather rosy, given the Trump administration’s bungling of the COVID-19 pandemic response, with Vox calling it “flailing and incompetent” with “even the U.S. vaccine rollout (devolving) into something of a disaster.”

Earlier this week, HHS Secretary Alex Azar indicated the federal government was “releasing the entire supply” of the COVID-19 vaccines to states instead of “holding second doses” in reserve. But on January 15, he told NBC News’ Lester Holt that there was no reserve of the vaccine. It’s unclear exactly what is actually happening, but Pfizer stated that “Operation Warp Speed has asked us to start shipping second doses only recently,” and the company was working “to ensure Americans receive their first and second doses of the vaccine on time.” Colorado Gov. Jared Polis shot back, stating, “I’m shocked we were lied to and there is no national reserve. Federal announcements that 2nd dose being held in reserve was going to be released led us to expect 210,000 doses next week, other Govs made similar plans. Now we find out we’ll only get 79,000 next week.”

Azar also took the opportunity in his final days to attack the incoming Biden administration’s plan to get 100 million shots in arms in the first 100 days. Azar claimed that would be “squandering of the opportunity” the Trump White House had laid out for them.

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