OT Coronavirus: America in chaos, News and Updates. One million Americans dead and counting

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Moderna’s mRNA Vaccine for HIV Is Starting Human Trials

Before 2020, many of us had never heard of mRNA. With the development of Covid-19 vaccines dependent on this molecule, though, mention of it was all over the news. In early August, the US reached the milestone of 70 percent of adults having received at least one dose of the vaccine. Covid was the first disease mRNA therapeutics tackled, and given the success of the Pfizer and Moderna vaccines at preventing severe cases of the virus, it won’t be the last.

New candidates are lining up, with scientists saying mRNA could make it possible to develop vaccines against all kinds of diseases that, until now, haven’t had a solution in sight. One of these is HIV; Moderna (whose name, by the way, comes from “modified RNA”) started trials of its experimental mRNA-based HIV vaccine, called mRNA-1644, this week.

The Phase 1 trial will consist of giving the vaccine to 56 adults who don’t have HIV, with the primary goals being to evaluate its safety and monitor the development of an immune response in participants. In addition to the initial version of the vaccine, Moderna developed a variant called mRNA-1644-v2-Core.

As detailed in Moderna’s August 11 submission to the to the National Institutes of Health’s Clinical Trials registry, participants in the trial will be split into four different groups, with one group getting mRNA-1644, a second group getting mRNA-1644-v2, and the remaining two groups getting a mix of both versions. Rather than a blind trial, where people don’t know which injection they’re receiving, participants will be aware of what they’re getting.

This first phase of the clinical trial is scheduled to take around 10 months, and will be followed by Phase 2 and 3 trials. The later-stage trials will likely take much longer than the trials for Covid-19 did; as Covid spread like wildfire in 2019 and 2020 and hundreds of thousands of people got sick, it was much easier to give people a vaccine and quickly see who became infected and who didn’t. HIV is, thankfully, far less prevalent, and you can go a lifetime without ever coming into contact with the virus.

As you’ve probably heard by now through reading up on the Covid vaccines, mRNA-based versions work a little differently than traditional vaccines, which used a weakened bit of a virus to expose our bodies to it.

As detailed in an excellent, very-worth-listening-to ‘Gamechangers’ podcast from The Economist, mRNA vaccines are intended to train our cells to create proteins to fight a given virus. mRNA is the intermediary between DNA and proteins, and proteins control pretty much everything that happens in our cells. DNA makes mRNA, which in turn acts as a “messenger” and instructs our cells to make proteins.

The “workshop” where the proteins get made is the cell’s ribosome. “This is fundamentally the idea behind RNA therapeutics,” said Natasha Loder, health policy editor at The Economist. “It’s about taking control of that workshop…by essentially manipulating these messengers.” In this case, the mRNA carries instructions to synthesize the spike protein on the Covid-19 virus.

For 24 to 48 hours after the mRNA vaccine is injected, the recipient’s cells start to manufacture the spike protein. The body tags it as an invader and launches an immune response. Then, when the person comes in contact with the real virus, their cells are already prepared to fight the infection before it takes over.

Much of the vaccine hesitancy we’re seeing is due to worries that the vaccines were developed too quickly, and are too new to be proven safe. However, as the podcast explains in excellent detail, mRNA therapeutics aren’t a brand-new technology at all—research in the area began as early as the 1970s.

Whether the HIV vaccine will work as well as the Covid vaccine remains to be seen—and it will take far longer—but initial indications are promising. Earlier this year, the International AIDS Vaccine Initiative and Scripps Research tested a piece of the vaccine, and saw 97 percent of study participants developing the intended immune response.

mRNA has been touted as a potential tool for vaccines against everything from malaria to cancer. In the wake of so much catastrophe, we can see this technology as one good thing the Covid-19 pandemic left in its destructive wake; it truly seems we’ve approached a new frontier in medicine.

https://singularityhub.com/2021/08/...e-for-hiv-is-starting-human-trials-this-week/

 

Mississippi Poison Control Calls Rise As Anti-Vaxxers Take Livestock Dewormers to Treat, Prevent COVID-19

• The Food and Drug Administration has not approved ivermectin as a COVID-19 treatment.
• Livestock or animal formulations of ivermectin are highly toxic in humans.
• Ivermectin may cause symptoms such as rashes, vomiting, and abdominal pain.

On Friday, an alert issued to healthcare providers in Mississippi said that the state's Poison Control Center received an influx of calls from individuals with potential exposure to ivermectin – a product used to treat roundworms and other parasites – which they had taken to treat or prevent COVID-19 infection.

While ivermectin can be used by both people and animals, at least 70% of recent calls were related to ingestion of animal formulations of the anti-parasitic agent from livestock supply centers, the alert said.

Symptoms associated with ivermectin toxicity include rash, nausea, vomiting, abdominal pain, neurological disorders, and hepatitis.

The Food and Drug Administration (FDA) has provided a list of approved drugs and treatments, including vaccines, to prevent COVID-19 infection; ivermectin has not been approved.

"For one thing, animal drugs are often highly concentrated because they are used for large animals like horses and cows, which can weigh a lot more than we do — a ton or more. Such high doses can be highly toxic in humans," the FDA said in a consumer update: "Many inactive ingredients found in animal products aren't evaluated for use in people. Or they are included in much greater quantity than those used in people. In some cases, we don't know how those inactive ingredients will affect how ivermectin is absorbed in the human body."

In March, Missouri's Poison Center also experienced an uptick in calls related to ivermectin toxicity. Centers for Disease Control and Prevention (CDC) data shows that Missouri and Mississippi have relatively low vaccination rates— 44% and 37%, respectively — compared to the rest of the country.

No hospitalizations due to ivermectin toxicity have been directly reported to the Mississippi Poison Control Center or the Mississippi State Department of Health, according to the alert.

https://www.insider.com/mississippi-anti-vaxxers-take-livestock-dewormers-to-prevent-covid-2021-8