Covid-19: Treatments, Cures, and Vaccines

Novavax reveals early data from it Phase 1 vaccine trial. This vaccine candidate is different from the Moderna and Pfizer candidates. All patients developed anti-bodies and at the 35 day mark the levels remained higher than in patients who have recovered from Covid-19.

About the technology: from Novavax's webpage: NVX‑CoV2373 was created using Novavax’ recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and contains Novavax’ patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

By the way, these folks have never successfully brought a vaccine to market. Though, they are supposedly filing for final FDA approval for a new Flu Vaccine before the end of 2020.

Novavax’s COVID-19 vaccine looks promising in early data

 

Seems like these vaccine developments have highlighted how much progress is on the horizon with respect to medical breakthroughs. Between AI and gene splicing and nanotech the next 10 - 20 years is going to totally revolutionize medicine

 

This is not a shocking move. Gilead has been licensing Remdesivir to manufacturers all over the globe to increase supply. Does make me wonder about every time I turn around another drug manufacturing facility in the US is ramping. What have they been doing all of this time?

Pfizer Announces Agreement with Gilead to Manufacture Remdesivir for Treatment of COVID-19 | Pfizer

 

AI invents new ‘recipes’ for potential COVID-19 drugs | Science | AAAS

As scientists uncover drugs that can treat coronavirus infections, demand will almost certainly outstrip supplies—as is already happening with the antiviral remdesivir. To prevent shortages, researchers have come up with a new way to design synthetic routes to drugs now being tested in some COVID-19 clinical trials, using artificial intelligence (AI) software. The AI-planned new recipes—for 11 medicines so far—could help manufacturers produce medications whose syntheses are tightly held trade secrets. And because the new methods use cheap, readily available starting materials, licensed drug suppliers could quickly ramp up production of any promising therapies.

“If you are going to supply a drug to the world, your starting materials have to be cheap and as available as sugar,” says Danielle Schultz, a chemist at Merck. The new method, posted as a preprint this week, “is really solid,” she says. “I am impressed by the speed at which [the researchers] were able to find new solutions for making existing drugs.”
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o prevent future supply crunches, University of Michigan chemist Timothy Cernak and colleagues turned to a commercial drug synthesis AI program called Synthia. The software can help pharmaceutical manufacturers find the most efficient and cost-effective strategy for synthesizing medicines, most of which are fairly complex molecules that can be built in myriad ways—much as an artist can apply brush strokes in infinite combinations to paint the same landscape. “It’s more options than the human mind can comprehend,” Cernak says.

Cernak and his colleagues scoured the research and patent literature for ways to synthesize 12 medications now being tested as COVID-19 therapies, including remdesivir. They then programmed Synthia to search for new synthetic solutions. They limited their search to options that used cheap, abundant starting materials, didn’t require expensive catalysts or equipment, and could produce kilogram-scale amounts of drug.

In the end, the software found novel solutions for making 11 out of the 12 compounds, including generic antivirals umifenovir and favipiravir, the researchers report this week in a non-peer-reviewed preprint on ChemRxiv. The AI program came up with four different ways to synthesize umifenovir, for example, in one case with cheaper starting materials than those currently in use. “For the same amount of money [or less], we can make these drugs from different starting materials,” Cernak says. The one miss was remdesivir: The software was unable to come up with a solution for making it other than the way than Gilead does, he says.

 

Radical shift in COVID-19 testing needed to reopen schools and businesses, researchers say | Science | AAAS

Even as the United States ramped up coronavirus testing from about 100,000 per week in mid-March to more than 5 million per week in late July, the country fell further behind in stemming the spread of the virus. Now, diagnostics experts, public health officials, and epidemiologists are calling for a radical shift in testing strategy: away from diagnosing people who have symptoms or were exposed and toward screening whole populations using faster, cheaper, sometimes less accurate tests. By making it possible to identify and isolate infected individuals more quickly, proponents say, the shift would slow the virus’ spread, key to safely reopening schools, factories, and offices.

“America faces an impending disaster,” says Rajiv Shah, president of the Rockefeller Foundation. Testing, he says, needs to focus on “massively increasing availability of fast, inexpensive screening tests to identify asymptomatic Americans who carry the virus. Today, we are conducting too few of these types of tests.” Rebecca Smith, an epidemiologist at the University of Illinois, Urbana-Champaign (UIUC), agrees. To stop outbreaks from overwhelming communities, she says, “we need fast, frequent testing,” which could mean faster versions of existing RNA tests or new kinds of tests aimed at detecting viral proteins. But researchers say the federal government will need to provide major financial backing for the push.
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Larremore and his colleagues have modeled the benefits of more frequent tests, even ones that are less accurate than today’s. Fast tests repeated every 3 days, with isolation of people who test positive, prevents 88% of viral transmission compared with no tests; a more sensitive test used every 2 weeks reduced viral transmission by about 40%, they report in a 27 June preprint on medRxiv. Paltiel and his colleagues reached much the same conclusion when they modeled a variety of testing regimes aimed at safely reopening a 5000-student university. In a 31 July paper in JAMA Network Open, they found that, with 10 students infected at the start of the semester, a test that identified only 70% of positive cases, given to every student every 2 days, could limit the number of infections to 28 by the end of the semester. Screening every 7 days allowed greater viral spread, with the model predicting 108 infections. “A higher frequency of testing makes up for poor sensitivity,” Paltiel says.

Smith says these and related studies have prompted UIUC to set up tests for all 60,000 students and faculty multiple times per week when the students return to campus this fall. The approach relies on an experimental fast PCR setup described in an 18 June preprint that bypasses some of the usual slow procedures for isolating viral RNA and tests saliva rather than throat swabs, says Martin Burke, a UIUC chemist who was one of the test’s developers. Smith says her team predicts that if the university tests everyone every 3 to 4 days, on average, it will detect positive cases half a day before those people reach peak infectivity. “Fast and repeated testing is crucial,” Smith says. Antigen tests, which immobilize antibodies on a test strip, promise an even greater speedup. Those antibodies detect viral proteins in saliva or a nasal swab. Such tests cost as little as $1 to $2 each, give a yes/no readout within minutes much like a pregnancy test, and are already used to detect influenza, HIV, and other viruses. Two companies—Quidel Corporation and Becton, Dickinson and Company (BD)—have received emergency use authorization from the U.S. Food and Drug Administration to sell antigen tests for SARS-CoV-2. Other companies have similar tests in the works.

 

Russia becomes first country to approve a COVID-19 vaccine, says Putin

 

Well, Russia doing Russian things. They certainly do not need to worry about anyone suing if it turns out the vaccine is not safe, because Putin will just make those people disappear. So, that probably gives their companies a bit of speed advantage.

 

You really think the pharma companies in the US will be held liable for covid vaccine related deaths and injuries? Never happen.

 

Oh? I do not recall reading about some special immunity being issued as part of Operation Warp Speed. Further, if the product ends up causing major health issues, then both the company providing the candidate and the sponsoring federal agency should be help responsible.

Getting it correct and doing it safely is FAR more important than being fast. Even if it takes years.

Flu Vaccine Side Effects | Guillain-Barré Syndrome Lawsuit Won

 

COVID-19: Tort immunity for vaccines and antivirals – lessons from the swine flu of 1976 | Insights | DLA Piper Global Law Firm

Federal Government Provides Liability Immunity to Manufacturers and Distributors in Fight Against COVID-19: What Companies Need to Know

YOUR LEGAL RIGHTS | Do drug-makers have immunity while creating COVID-19 cures? - MahoningMatters.com

 

Well, then you sir/madam/non-specific are correct. And yet another reason why over 40% of the people in the US will not get the vaccine. Pretty much sounds like experts already fully understand that without years of safety studies, there are going to be major health problems and side effects.

Kind of staggering actually when we are playing with technologies that have never been used in humans before (mRNA) for vaccines.

 

Yeah, I religiously get the flu shot every year but will probably be waiting for a while on this one.

 

Those using older, proven technology should be pretty safe. I'd wait a bit on the newer tech ones.

 

I wonder if people will get to choose if more than one is approved? I would be far more interested in what Johnson & Johnson are working on vs. the mRNA based candidates from Moderna and Pfizer/BioNTech.

 

Silicon Valley company received FDA go ahead to test Niclosamide capsules in Covid-19 patients who are not on ventilators.

Niclosamide has been used for 50 years to safely treat tape worm.

In lab studies it has shown much greater potency than Remdesivir for halting viral spread, and it also has shown to likely lessen the severity of the symptoms.

ANA Therapeutics Announces U.S. FDA Clearance Of IND Application To Initiate Clinical Trial Of Niclosamide In COVID-19 Patients

 

A synthetic antibody delivered via a nasal spray that directly attacks the virus in the airway.

UCSF scientists develop nasal spray to fight COVID-19

 

Cash registers keep ringing for Big Pharma as they move to take advantage of potentially dire medical situation in the US. Astra Zeneca plans to ship millions of doses of FluMist this year vs 750,000 last year as the US tries to keep hospitals from turning into war zones, overrun with sick and dying when flu season starting to crank up and Corona Virus spread still out of control.

AstraZeneca, after prior issues with FluMist, ramps up production in response to pandemic

 

Some possibly good news here if true

Immunity studies offer hope about Covid-19 recovery

A recent batch of studies, many early stage and not yet peer reviewed, show that humans have a "robust" immune response to Covid-19 that may protect them from further infection, even if they had mild symptoms. How long that protection lasts is still unclear, but the studies indicate it could last for months.
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"This is an accumulation of more information that allows people to become more comfortable with the idea that we are going to have immunity that's going to be longer in duration," Lipkin told CNN. "We don't know that for a fact, but there are a few things that are interesting that gave me a basis for optimism."

One of the studies showed that T cells appear to be activated by this novel coronavirus. T cells are important immune cells that stimulate various arms of the immune system and that also attack and kill cells already infected by a virus.

Another study that looked at donor blood samples found that a big part of the population, between 20% to 50% of people in some areas of the US, may have T cells that recognize the novel coronavirus, even if that person has never been infected. It's still unclear why people have them. It may be what's called cross-protection from other coronaviruses that cause the common cold. What scientists still don't know is if this provides protection against Covid-19, but it has potential.