Good morning. Today we’re discussing the initiation of large-scale vaccine trials and 3-D printed organs.
Large, late-stage vaccine trials begin
The pulse
On Monday, biopharma companies Moderna and Pfizer kicked off Phase 3 clinical trials off their respective COVID vaccines.
How will the trials work?
Each trial will recruit roughly 30,000 healthy people. Some people will receive COVID vaccine, while others will receive placebo - in the Moderna trial, for example, half will receive two shots of vaccine, 28 days apart, while the other half will receive two shots of saltwater.
The U.S. government is reaching out actively to groups hit hardest by COVID (for example, Blacks, older people, and those with chronic diseases) to encourage them to participate.
How will we know whether the vaccines are effective?
According to Dr. Anthony Fauci, Director of NIAID, the vaccines will be deemed “acceptably effective” if they protect 60% of those who receive it - that is, if there are 60% fewer cases in the treated group than there are in the placebo group.
When will we know how well they work?
Experts expect trial recruitment to finish to be completed within roughly two months, by the end of the summer. After that, it may take two to six months to get data - meaning the earliest we should expect results is sometime in November.
Can I be a part of a trial?
If you’re interested in joining, you can join at coronaviruspreventionnetwork.org.
Bottom line it for me.
The hyped vaccines of the past few months are finally being put to the real test: can they perform safely and effectively in a large group of people?
Source: 3D Natives
Bioprinting in a PanDDDemic
The pulse
3D printing is all the rage these days, and it’s not just Colonel Sanders getting in on the action. Amidst a pandemic, researchers are developing tools to 3D print human organoids in order to test COVID-19 drugs.
Organoids? This is starting to sound very sci-fi.
Organoids are mini replicas of human body parts, like skin and lungs, that are made in a scientific lab. They’re created through the process of bioprinting, an extension of 3D printing that focuses on producing synthetic versions of natural human tissue that are as close to the real thing as possible.
How does that work?
Bioprinting involves carefully layering scaffolds made of biodegradable materials, such as collagen, with real human cells. Blood vessels are even added in to reproduce aspects of the circulatory system. All the components combined form organ-like structures that can imitate real human tissues.
What is bioprinting intended for?
One use currently being studied for bioprinting is the creation of skin grafts for burn victims. Eventually, the idea is to create other fully functional organs such as kidneys and lungs for transplantation. The other hope is that bioprinting can be used to test experimental drugs on various organ systems before turning to animal or human testing.
How does bioprinting fit into COVID-19 efforts?
Theoretically, potential COVID-19 treatments could be tested on organoids
(e.g. lung) to gauge safety and risk profiles. Importantly, such testing would occur in addition to clinical trials, not in place of. Still, it’s another level of testing that could preclude human testing and prevent harm to human subjects.
Bottom line it for me:
Fitting with their futuristic name, organoids created by bioprinting very well could be crucial to future efforts in COVID-19 testing.
Rapidfire
In an effort to appeal to the emerging telehealth market, Tasso has secured $17 million for its home blood testing devices, which could allow for self-administered diagnostic tests.
Two recent studies paint a grim picture of long-term negative effects on the heart after COVID-19 infection. One study looked at a relatively younger population (median age 49) while the other looked at a cohort with an average age of 85. Both found evidence of ongoing cardiac damage months after recovering from their infections.
Congress is likely to pass a bill within the next week that will include a dramatic increase in funding for public health agencies, including $20 B for pandemic-response agency BARDA and $9.4 B for the CDC.
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