Will Animal Safety Testing be Shortcut in the Rush to Develop a Vaccine for the Novel Coronavirus (COVID-19)?

[Wally]

https://www.statnews.com/2020/03/11...s-vaccine-trial-without-usual-animal-testing/

Researchers rush to test coronavirus in humans before they know how well it works in animals

. . . The traditional vaccine timeline is 15 to 20 years. That would not be acceptable here,” said Mark Feinberg, president and CEO of the International AIDS Vaccine Initiative, whose work as chief public health and science officer at Merck Vaccines was instrumental in the development of the immunization against Ebola. “When you hear predictions about it taking at best a year or a year and a half to have a vaccine available … there’s no way to come close to those timelines unless we take new approaches.”

He knows that it’s important to see how well a new vaccine can stop infection in animals, but to him, given the current emergency, it makes sense to start human safety testing before those studies are finished.

“I personally think that’s not only appropriate; I think that’s the only option we have,” Feinberg went on.

Yet ethicists aren’t so sure that the eventual benefits of rushing this unproven vaccine into clinical trials will outweigh the risks. “Outbreaks and national emergencies often create pressure to suspend rights, standards and/or normal rules of ethical conduct. Often our decision to do so seems unwise in retrospect,” wrote Jonathan Kimmelman, director of McGill University’s biomedical ethics unit, in an email to STAT. . . .

This article discusses the fast track development of a coronavirus vaccine by Moderna, a biotech company located in Cambridge, MA. and whether human testing might be allowed to go forward before all the “usual” animal safety testing has been completed.

 

[Wally]

https://www.statnews.com/2020/03/11...s-vaccine-trial-without-usual-animal-testing/

. . . The technology that has allowed Moderna to craft an experimental vaccine so fast has not yielded a single immunization that’s made it to market so far. It’s a trendy idea: Instead of injecting people with a weakened pathogen or proteins from the surface of a pathogen, so that our bodies will learn to fight off such infections in the future, scientists are betting on a kind of genetic hack, a lab-made concoction that gets the body to produce its own virus-like bits which it will then train itself to combat.

At the center of it all is a molecule called messenger RNA, or mRNA. Inside of us, its normal function is to transmit the instructions contained within our DNA to the cellular protein-making factories that carry them out. In Moderna’s recipe, the mRNA is synthetic, programmed with the goal of getting our inner machinery to produce certain coronavirus-like proteins — the very proteins that the pathogen uses to gain entry into our cells. Once those homemade dummy virus particles are there, the thinking goes, our bodies will learn to recognize and clobber the real thing. . . .

 

[Wally]

Here are some additional thoughts on the development of a vaccine for the novel coronavirus (COVID-19). Moderna’s coronavirus vaccine is specifically addressed in this discussion at minute marker 50:30. Note this is a long video and I have not clipped the video, so you will need to fast forward to the minute marker at 41:40 and watch to minute marker 57:00 for discussion re concerns around fast tracking development of a coronavirus vaccine.

Watch video from minute marker 41:40 to 57:00

 

[Wally]

Looks llike the Moderna vaccine safety study in humans will start on Monday. I believe this means that the safety study in humans is leapfrogging over the top of animal safety studies still waiting to be completed. Quite a bold and risky decision by the U.S. public health overseers at the NIH,, especially if the vaccine produces any serious safety issues with those human subjects that would have shown up during animal testing.

If this is your first time looking at this thread, I recommend that you read the full article linked in the first post iand watch the video in post/reply No. 3. The two references in these earlier posts are needed to understand the serious concerns that have been raised, if shortcuts are taken in safety testing protocols, because this is a new type of vaccine and because of the complex nature of a coronavirus.

https://apnews.com/8089a3d0ec8f9fde971bddd7b3aa2ba1

The first participant in a clinical trial for a vaccine to protect against the new coronavirus will receive an experimental dose on Monday, according to a government official.

The National Institutes of Health is funding the trial, which is taking place at the Kaiser Permanente Washington Health Research Institute in Seattle. The official who disclosed plans for the first participant spoke on condition of anonymity because the move has not been publicly announced. . . .

Testing will begin with 45 young, healthy volunteers with different doses of shots co-developed by NIH and Moderna Inc. There’s no chance participants could get infected from the shots, because they don’t contain the virus itself. The goal is purely to check that the vaccines show no worrisome side effects, setting the stage for larger tests.

Dozens of research groups around the world are racing to create a vaccine as COVID-19 cases continue to grow. Importantly, they’re pursuing different types of vaccines — shots developed from new technologies that not only are faster to produce than traditional inoculations but might prove more potent. Some researchers even aim for temporary vaccines, such as shots that might guard people’s health a month or two at a time while longer-lasting protection is developed. . . .

For most people, the new coronavirus causes only mild or moderate symptoms, such as fever and cough. For some, especially older adults and people with existing health problems, it can cause more severe illness, including pneumonia. The worldwide outbreak has sickened more than 156,000 people and left more than 5,800 dead. The death toll in the United States is more than 50, while infections neared 3,000 across 49 states and the District of Columbia.

The vast majority of people recover. According to the World Health Organization, people with mild illness recover in about two weeks, while those with more severe illness may take three weeks to six weeks to recover.

 

[Inara]

I wonder who'd volunteer for that. Members of the army maybe? And then voluntary? Very poor people that get paid a huge amount of money? Voluntary?

 

[Inara]

Here is more information about COVID-19 vaccination:
http://www.virology.ws/2020/03/11/sars-cov-2-the-vaccine-landscape/

Yet, it is still unclear whether Moderna’s vaccine candidate will provoke a sufficient immune response to be effective against SARS-CoV-2. The premise of gene-based platform technologies rests on the ability to target segments of the viral genome that are involved in provoking host immune response. Although we can make well-informed choices on what sequences provoke immunogenicity, we won’t know if the optimal sequence has been selected until human trials are completed (Loftus 2020). So too, there is no precedence for a vaccine of this kind since there are not yet any approved human vaccines that use this gene-based technology (Loftus 2020).

Virologist Dr. Jose Esparza commented the following on Moderna’s vaccine candidate: “The rapid manufacturing of the RNA vaccine is great. But preclinical experiments are important to assess safety before carefully moving ahead with small phase I trials in human volunteers. Special attention should be placed to a potential ‘Antibody Dependent Enhancement of Infectivity’ triggered by the induction of binding but no neutralizing antibodies.”

 

[Wally]

Moderna vaccine trial participant

https://twitter.com/i/web/status/1240468786865528832

 

[Wally]

Here is an interesting article from the Wall Street Journal discussing how a shortage of blood from COVID-19 patients is slowing down the development of treatments. See, https://www.wsj.com/articles/blood-sample-shortages-slow-search-for-coronavirus-drug-11584450000
l

Blood-Sample Shortages Slow Search for Coronavirus Drug

To cure the sick, drug researchers first need the blood of the healthy.

Scientists trying to develop treatments for the new coronavirus have struggled to get a hold of recovered patients’ blood samples, which contain the building blocks needed to create new medicines.

More than 180,000 people globally have been infected by the new coronavirus, but blood samples from recovered patients have been in short supply, say pharmaceutical executives, academic researchers and U.S. public health officials. . . .

Yet several factors have limited quick access to the blood samples, researchers and public health officials say. It is complex to transport the samples across international borders during a pandemic. Health-care systems are overwhelmed by caring for patients and, most of all, arithmetic: It could take four to eight weeks for patients to fully recover to the point where the antibodies can be helpful to drug researchers.

With the virus now spreading in the U.S., supply should increase in the coming few weeks, experts say.

This article also includes a video that gives a good explanation of the technology behind how RNA vaccines (like Moderna’s) and DNA vaccines (like the one being developed by Inovio) are being made and why this new technology could potentially be a game changer in vaccine research and development.
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See also this article - https://www.ft.com/content/40abf052-41e9-11ea-bdb5-169ba7be433d[

 

[Wally]

Dr. Tony Fauci at a recent Coronavirus Task Force Press Briefing talking about the development and safety testing of the Moderna vaccine (and other companies coronavirus vaccines). Watch video of the press briefing from hour/minute marker 56:40 to. 1:01:20.

Watch from minute marker 56:40 to 1:01:20
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Here is a video of NIH Director Dr. Francis Collins discussing the Moderna vaccine. Dr, Collins discusses the vaccine at minute marker 5:32 to 6:58.

Watch from minute marker 5:32 to 6:58
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This article describes an oral vaccine that Israel is developing that they are hoping will also work for the coronavirus. It appears that the animal and human safety studies of this “new type” of vaccine might also be conducted by using fast-track or shortcut safety protocols. See, https://m.jpost.com/health-science/...weeks-we-will-have-coronavirus-vaccine-619101

. . .For the past four years, a team of MIGAL scientists has been developing a vaccine against infectious bronchitis virus (IBV), which causes a bronchial disease affecting poultry. The effectiveness of the vaccine has been proven in preclinical trials carried out at the Veterinary Institute.

“Our basic concept was to develop the technology and not specifically a vaccine for this kind or that kind of virus, . . .The scientific framework for the vaccine is based on a new protein expression vector, which forms and secretes a chimeric soluble protein that delivers the viral antigen into mucosal tissues by self-activated endocytosis, causing the body to form antibodies against the virus.”

Endocytosis is a cellular process in which substances are brought into a cell by surrounding the material with cell membrane, forming a vesicle containing the ingested material.

In preclinical trials, the team demonstrated that the oral vaccination induces high levels of specific anti-IBV antibodies,

“Let’s call it pure luck, . . We decided to choose coronavirus as a model for our system just as a proof of concept for our technology.”

But after scientists sequenced the DNA of the novel coronavirus causing the current worldwide outbreak, the MIGAL researchers examined it and found that the poultry coronavirus has high genetic similarity to the human one, and that it uses the same infection mechanism, which increases the likelihood of achieving an effective human vaccine in a very short period of time .

. . .“All we need to do is adjust the system to the new sequence,” . . .“We are in the middle of this process, and hopefully in a few weeks we will have the vaccine in our hands.” . .

Akunis said he has instructed his ministry’s director-general to fast-track all approval processes with the goal of bringing the human vaccine to market as quickly as possible.

“Given the urgent global need for a human coronavirus vaccine, we are doing everything we can to accelerate development,” MIGAL CEO David Zigdon said. The vaccine could “achieve safety approval in 90 days,”

 

[Sushi]

https://www.uab.edu/news/research/i...19-vaccine-candidate-created-by-altimmune-inc

The University of Alabama at Birmingham is launching a collaboration with the biopharmaceutical company Altimmune, Inc. for preclinical testing of a potential vaccine to prevent COVID-19 disease.

The testing at UAB will investigate immune responses to the vaccine in mice — a key step before the Gaithersburg, Maryland-based Altimmune can launch a Phase 1 human safety and immunogenicity trial in patients in Q3 of this year. The COVID-19 vaccine, called AdCOVID, is a single-dose vaccine candidate that is delivered by an intranasal spray.

 

[Wally]

4/14/2020 - https://www.biospace.com/article/mo...-19-are-in-development-for-covid-19-who-says/

WHO: More than 70 COVID-19 Vaccines are in Development, Three in Clinical Trials