Covid-19 vaccine producer Moderna faces a patent infringement lawsuit in the US, relating to the lipid nanoparticles (LNPs) that protect the mRNA in its vaccine. The suit claims Moderna is infringing technology from six US patents, developed by Arbutus Biopharma and licensed to Genevant a joint venture between Arbutus and Roivant Sciences.
The case will not impede the sale or manufacture of Modernas Covid-19 vaccine, but Genevant is seeking royalties for use of its patented technology.
The dispute precedes the Covid-19 pandemic. Since 2018, Moderna had sought to invalidate several of Arbutus key LNP patents. While one patent was invalidated in full, a second was partially upheld, and a third was upheld in full. In December 2021, a federal court rejected Modernas appeals against the latter two decisions, opening the door to an infringement case.
Vaccines and medicines based on nucleic acids are viewed as holding enormous potential as a disruptive therapeutic technology. Historically though, these medicines have been challenging to develop, said Peter Lutwyche, Genevant chief executive, during a conference call with industry analysts on February 28.
Nucleic acids are hydrophilic molecules, and do not readily cross cells lipid membranes. They are also easily degraded in the body, so require protection. The need for a delivery technology capable of delivering RNA cargo intact to its intended target has been one of the most significant challenges in the development of these medicines, said Lutwyche. The answer was precise formulations of lipid nanoparticles.
Genevant says that Moderna infringed its patented recipe of four lipid types, which included cationic lipids, phospholipids, cholesterol and polyethylene glycol (PEG)-conjugated lipids. Genevant claims that, in Modernas phase I trial of its Covid-19 vaccine, it used a lipid combination overlapping those covered by Genevants patents.
Arbutus, headquartered in Vancouver, Canada, is developing LNP technology to deliver RNA interference therapies for hepatitis B. It set up Genevant as a joint venture with Roivant Sciences to develop and license the technology more widely. Alnylam Pharmaceuticals uses it in Onpattro (patisiran). This was the first approved therapy to rely on small interfering RNA, and treats patients with hereditary transthyretin amyloidosis a rare, progressive, often fatal disease.
Genevant notes that it has partnership agreements in place for its LNP technologies with, amongst others, Takeda, to develop medicines for liver disease; BioNTech, for cancer targets and some rare diseases; and Gritstone, for a self-amplifying RNA Covid-19 vaccine programme.
The penalty for patent infringement is a reasonable royalty, according to US patent law. A royalty, outside litigation, in the biotech space for a typical license looks something like a single digit percent on net sales, says Jacob Sherkow, a biotech intellectual property expert at the University of Illinois at Urbana-Champaign, US.
When you have a big biotech product like this, theres almost always going to be some patent disputes surrounding it
Even a small percentage of the $18 billion (14 billion) projected 2021 sales of the Moderna vaccine will be significant, notes Sherkow. I imagine the two sides are pretty far apart as to what they think an appropriate license fee is, he says. If I was Arbutus, I would be asking for the moon. And if youre Moderna, you dont want to give that up. Were going to need a bunch of interim decisions from the court before the parties can get closer.
In a statement, Moderna said it was aware of the alleged patent infringements. Moderna denies these allegations, and will vigorously defend itself against Genevants claims in Court. Our Covid-19 vaccine is a product of Modernas many years of pioneering mRNA platform research and development, including creation of our own proprietary lipid nanoparticle delivery technology.
In 2013, Arbutus had licensed some of its LNP technology to Canadian company Acuitas Therapeutics. Acuitas later sublicensed those rights to Moderna. This sublicensing was contested in a Canadian court and settled in February 2018, ending Acuitas rights to use or license the technology. According to Arbutus, Acuitas licenses only covered four specific viral targets, not including coronaviruses.
Sherkow says the large amounts of money Moderna has made from its vaccine make patent litigation more attractive. When you have a big biotech product like this, theres almost always going to be some patent disputes surrounding it, he says. He suspects the litigation will take at least three years: It cant get much faster, but boy can it get slower.
Despite the prospect of tens of millions of dollars in legal fees, Sherkow sees both sides pursuing the case through court rather than settling. To be honest, for both sides itll be worth it, he says. Thats just the economics of patent litigation. For Genevant, there is also the scientific kudos in claiming a contribution to Modernas highly successful Covid-19 vaccine.
Moderna is no stranger to patent disputes. The company tangled with the US National Institutes of Health, disputing claims that three government scientists had contributed to the development of its Covid-19 vaccine. In December, the company dropped its fight over the modified genetic sequence for the Sars-CoV-2 spike protein, noting in a statement that the company would like to avoid any distraction to the important public private efforts ongoing to address emerging Sars-CoV-2 variants, including Omicron.
Europe (Precision Vaccinations)
The European Centre for Disease Prevention and Control (ECDC) agency recently issued a public health notice regarding the prevention and control of infectious diseases related to visitors from Ukraine.
On March 8, 2022, the ECDC reported a large number of people from Ukraine are entering the European Union (EU) countries Hungary, Poland, Romania, Slovakia. Unfortunately, many of those people, mainly women and children, are under-vaccinated against infectious diseases.
The ECDC stated, Ensuring continuity of routine vaccinations and addressing gaps in prior vaccination histories is an essential element of the public health support for displaced people.
In this context, ensuring vaccination coverage against poliomyelitis, measles, tuberculosis, and COVID-19 should be a priority.
According to ECDC data, the current under-vaccinations status is as follows:
Furthermore, Table #1 shows the number of cases of relevant vaccine-preventable diseases in the last four years and the corresponding vaccination coverage in Ukraine.
And Table #2 provides an overview of the vaccinations to be offered in the absence of documented evidence of prior immunization. Where possible, combination vaccines should be used to facilitate vaccination.
The ECDC stated a Priority should be given to protection against easily transmitted infectious diseases possibly associated with serious outcomes, such as COVID-19, measles, and poliomyelitis.
This ECDC report presents the 5Cs model as a framework for designing appropriate strategies to facilitate vaccination acceptance and uptake. The 5Cs are Confidence, Constraints, Complacency, Calculation, and Collective responsibility.
These under-vaccination concerns could also apply to the U.S.
The U.S. CDC confirmed on March 1, 2022, that, based on a request from the U.S. Department of State and consistent with the determination made by the Secretary of Homeland Security, it would extend the exercise of its enforcement discretion regarding certain aspects of its Global Travel During the COVID-19 Pandemic.
According to this exercise of enforcement discretion, covered persons will not be required to provide proof of a negative COVID-19 test result before boarding a flight to the United States or complete the attestation at Section 1 of the Combined Passenger Disclosure and Attestation to the United States of America form.
This exercise of enforcement discretion is limited to specific groups of individuals, to the extent, they were physically present in Ukraine as of February 10, 2022, and will expire on April 1, 2022, subject to any further extensions, consistent with the action of the Secretary of Homeland Security.
The CDC added Travelers may further be subject to additional public health measures as may be required by state and local health authorities at their arrival location in the U.S.
Additional travel vaccination news is posted at Vax-Before-Travel.
PrecisionVaccinations publishes fact-checked, research-based antibody, antiviral, and vaccine news.
Note: This news article is an aggregation for various reports and has been edited to present for mobile readers.
Johnny T. Stine, who was sentenced on Monday to five years probation for selling unapproved covid-19 vaccines.Screenshot: YouTube
A Redmond, Washington man was sentenced to just five years of probation and a $246,000 fine on Monday for selling his own homemade covid-19 vaccine, which he offered to inject during the earliest days of the pandemic. The judge admitted he couldve sentenced the man to jail time, but opted for a longer probation period instead.
Johnny T. Stine, who founded a shoestring-budget biotech company called North Coast Biologics, offered to inject people with his unapproved covid-19 vaccine for between $400 and $1,000, starting as early as March 2, 2020--when there were just 102 identified cases of covid-19 in the U.S. and six confirmed deaths.
Legitimate covid-19 vaccines produced by companies like Pfizer, Moderna, and Johnson & Johnson, took almost a year to fully develop and test to ensure they were safe and effective. The vaccines have been an amazing tool for preventing serious illness and death during the pandemic.
The 57-year-old Stine advertised his vaccine on social media platforms like Facebook and LinkedIn, drawing the attention of the FDA, which issued a notice against his company in May of 2020. But Stines unregulated covid-19 vaccine wasnt the only thing that the federal authorities objected to. Stine was also selling cancer vaccines that he said would cure people.
From 2018-2020, Mr. Stine made more than $200,000 selling cancer patients his vaccines that he said would cure their disease, U.S. Attorney Nick Brown said in a statement about Stines sentencing on Monday.
He truly preyed on those who were desperate for any glimmer of hope, injecting people with unapproved substances developed in his rented garage, with no assurance of safety or purity, Brown continued.
The Homeland Security Investigation team set up a sting operation, posing as a vaccine buyer, and Stine admitted to agents that hed traveled around the country selling his covid-19 vaccine, in places like California and Oregon.
As Seattles King 5 TV news outlet notes, Stine first entered a consent decree with the state of Washington in mid-2020 and agreed to stop selling the vaccines, which seemed to please the government. The only problem? Stine kept selling his vaccines, and was busted trying to give his covid-19 vaccine to an undercover agent in Idaho. They even captured text messages sent by Stine as he unknowingly peddled his vaccines to undercover police.
A text message exchange between an undercover agent and Stine as they set up a vaccination.Screenshot: King 5
The prosecutors were obviously not happy that Stine went back on his word and tried to sell his vaccines again after getting caught the first time.
Mr. Stine is dangerously arrogant or overwhelmingly greedy, or both, the prosecutors in the case wrote, according to a press release.
Time and again, he placed his misguided confidence and personal interest ahead of the wellbeing of the people whose health he endangered by providing them unapproved, and most likely ineffective, medical treatment; medical treatment that dissuaded them from pursuing actual effective treatment and/or from acting in ways that would protect them from infection.
Why didnt Stine get jail time? The judge decided a longer probation period would be better.
This is a difficult and troubling case. It would be completely reasonable to send you to jail, but Im going to give you a longer probation sentence so we can keep an eye on you, Magistrate Judge Brian A. Tsuchida said at Stines sentencing hearing.
The North Coast Biologics website is still available and includes a video of Stine explaining how he sourced lab supplies on eBay. Another video from 2012 shows how Stine converted a garage space in Seattle into his own lab.
The website even includes a YouTube embed of Steve Jobs reading heres to the crazy ones.... Whatever Stine was trying to accomplish, hes not going to be the next Steve Jobs.
Its important for consumers to know when someone is trying to take advantage of them, and the old adage that if its it too good to be true then it isnt true certainly applies here, Special Agent in Charge (SAC) Robert Hammer, who oversees HSI operations in the Pacific Northwest, said in a statement.
Legitimate businesses do not evade law enforcement agencies and they do not evade consumer safety rules. HSI Seattle appreciates the work done by the U.S. Food and Drug Administration and Seattle Police Department, and we will continue utilizing all of our partnerships to ensure the health and safety of our communities.
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NEW BERN, N.C. (WNCT) Its been over two years since the COVID-19 pandemic began. Since then, the medical community has produced three versions of vaccines and a booster shot to combat the virus.
Now, medical professionals are trying to figure out if the future of COVID-19 vaccines is continuous, and if they will look similar to the yearly Flu shot injection.
The flu virus is a different family of virus, Pitt County Health Director Dr. John Silvernail said. And from season to season of influenza, we see what we call antigenic drift, which means that it changes its surface it changes its coat from season to season. So every year its got a new coat.
And we need a new vaccine theoretically to be able to attack that coat and take the coat off the virus and, and attack it. And thats the thats where the new flu vaccine comes from a new flu shot comes from every year.
Right now, experts say they just dont know if the COVID vaccine will become an ongoing yearly shot.
There is so much up in the air because this is such a new thing that were dealing with, from the scientific and epidemiology community. So were very much still figuring out what thats going to look like, says Lead Clinical Pharmacists at CarolinaEast Medical Center, Amy Copely.
We first saw the original wave in early 2020. Then the Delta wave came in late June of 2021. And finally, we saw the Omicron variant arrive in December of last year.
The question is, will we have another wave? What will it be? Copley said.
So far, experts havent caught wind of another variant out there. There are currently sub-variants of Omicron called VA2, but experts say its similar enough to the original Omicron variant that individuals who already contracted Omicron should be immune. Plus, some manufacturers are working on an Omicron-specific booster to combat this.
According to Silvernail, COVID and its vaccines havent been around nearly long enough to tell with certainty what the next step will be.
As to ongoing shots, I dont right now that we know for sure. You know, were about a year and three months into the vaccine era of COVID. Flu vaccines have been around for, you know, 50 years or more.
Copely says SARS COV2, or the virus that causes COVID-19, mutates every two or so weeks, much slower than that of HIV or Influenza. Because of that, the virus has an editor in its mutation that essentially catches mistakes that could ultimately kill the virus.
We may be able to come up with technology in the shot, that would basically knock out that editor. That would be the ultimate goal. So theres some work being done on stuff like that, including Walter Reed has done a lot of research on a pan COVID shot or vaccine. And I think the big questions that still remain would be the dose. What is the ideal dose? The frequency?
If they do produce another version of the COVID-19 vaccine, the questions will be: How often do we need to take it? And, will doses be different for adults and children?
We need a way to contain it and live with it in an endemic state as opposed to pandemic, which means figuring out how do we make it more stable and not have these waves or pulses like weve seen with Delta and with Omicron. And basically have a baseline more controllable state. It doesnt mean it will go away. It doesnt mean people wont get it or wont die from it, but vastly reducing that risk. And one of those paths is vaccination or continued shots.
Silvernail says guidance over the vaccines has been an influx and can be confusing to the general public on what they should and should not get regarding the COVID-19 vaccine. He says if youve completed the series, getting your first two doses, then talk to your doctor, health department, local pharmacists or someone else who can answer the question as to when you as an individual should get a booster or third dose for that vaccine.
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G. Douaud, in collaboration with Anderson Winkler and Saad Jbabdi, University of Oxford and NIH.
CNN
People who have even a mild case of Covid-19 may have accelerated aging of the brain and other changes to it, according to a new study.
The study, published Monday in the journal Nature, is believed to be the largest of its kind. It found that the brains of those who had Covid-19 had a greater loss of gray matter and abnormalities in the brain tissue compared with those who didnt have Covid-19. Many of those changes were in the area of the brain related to the sense of smell.
We were quite surprised to see clear differences in the brain even with mild infection, lead author Gwenalle Douaud, an associate professor of neurosciences at the University of Oxford, told CNN in an email.
Douaud and her colleagues evaluated brain imaging from 401 people who had Covid-19 between March 2020 and April 2021, both before infection and an average of 4 months after infection. They compared the results with brain imaging of 384 uninfected people similar in age, socioeconomics and risk factors such as blood pressure and obesity. Of the 401 infected people, 15 had been hospitalized.
The 785 participants were between the ages of 51 and 81 and were all part of the UK Biobank, an ongoing government health database of 500,000 people begun in 2012.
Douaud explained that it is normal for people to lose 0.2% to 0.3% of gray matter every year in the memory-related areas of the brain as they age, but in the study evaluation, people who had been infected with the coronavirus lost an additional 0.2% to 2% of tissue compared with those who hadnt been infected.
In addition to imaging, the participants were tested for their executive and cognitive function using the Trail Making Test, a tool used to help detect cognitive impairments associated with dementia and test a persons brain processing speed and function. The researchers found that those who had the greatest brain tissue loss also performed the worst on this exam.
Although the areas of the brain most affected appear to be related to the olfactory system, Douaud said it wasnt clear why that was the case.
Since the abnormal changes we see in the infected participants brains might be partly related to their loss of smell, it is possible that recovering it might lead to these brain abnormalities becoming less marked over time. Similarly, it is likely that the harmful effects of the virus (whether direct, or indirect via inflammatory or immune reactions) decrease over time after infection. The best way to find out would be to scan these participants again in one or two years time, she said.
Douaud added that the researchers anticipate reimaging and testing the participants in one or two years.
And while the study finds some association between infection and brain function, its still not clear why. Previous studies have shown people with significant and repeated loss of smell also have an associated loss of gray matter. However, this study did not evaluate whether people actually had a loss of smell.
The authors cautioned that the findings were only of a moment in time but noted that they raise the possibility that longer-term consequences of SARS-CoV-2 infection might in time contribute to Alzheimers disease or other forms of dementia.
The findings were noticeable, but they werent enough to cause alarm, said Dr. Richard Isaacson, a neurologist and director of the Florida Atlantic University Center for Brain Health. Isaacson was not involved in the study.
Isaacson said the findings were noticeable for clinicians, but he added that the overall impact on individuals was difficult to determine and could be small. Its really hard to know the long-term clinical impact and quality of life impact in a situation like this, he said.
The brain may be affected by other mechanisms such as immune, inflammatory, vascular or psychological/behavioral change but not direct infection, said Dr. Alan Carson, a professor of neuropsychiatry at the Center for Clinical Brain Sciences at the University of Edinburgh, who was not involved in the study.
What this study almost certainly shows is the impact, in terms of neural changes, he said. But I dont think it helps us understand the mechanisms underpinning cognitive change after Covid infection.
All Missourians ages 5 and older (Pfizer vaccine) or 18 and older (Moderna or Johnson & Johnson vaccines) are eligible to receive COVID vaccines without charge. If you are seeking a third dose of Pfizer or Moderna, you should first talk with your health-care provider.
Vaccinations are being offered as follows:
University Health: 7900 Lees Summit Road, Kansas City, and 2211 Charlotte St., Kansas City. Vaccinations are being given at both locations, Mondays through Fridays of from 7 a.m. to 3:20 p.m. You must make an appointment in order to receive the vaccination by calling 816-404-2273 or by visiting https://www.universityhealthkc.org/contact/#
Jackson County Health Department:
If you have any question about Jackson County Health Department vaccine clinics or are having difficulty registering for an appointment, call 816-404-6415. Bring your insurance card if you are insured. Bring shot records for all people under the age of 18. Bring your COVID vaccine cards for a booster or additional dose of the Pfizer, Moderna, or Johnson/Johnson vaccine.
If you are confused about additional and booster doses, speak with your healthcare provider. You can also find additional information at https://jacohd.org/booster-doses Upcoming vaccination clinics include:
March 8, 9, 10 and 11, from 9 a.m. to 4 p.m., at the Jackson County Health Department, 313 S. Liberty, Independence. These clinics offer COVID vaccinations for people ages 5 and up. All children, ages 5 to 18, will need a parent or guardian present to sign a consent form for vaccination. Persons seeking a second or third shot will need to bring their vaccine card. Appointments are strongly recommended, as it is possible that the clinics may run out of vaccine for walk-in clients. To make an appointment for a child, ages 5 to 11, please visit https://jacohd. jotform.com/213336744063150.
To make an appointment for anyone over the age of 11, please visit https://jacohd.jotform. com/220034582875154.
Crosetti Health & Wellness: 510 S. Main St., Grain Valley, 816-847-6930. Hours are Monday through Friday, from 9 a.m. to 7 p.m. and Saturday, from 9 a.m. to 1 p.m. No appointments required for vaccinations or testing. Also offering vaccinations are local Hy-Vee stores and private pharmacies.
The state of Missouri has an online vaccine locator allowing you to register for vaccination and make your appointment at https:// covidvaccine.mo.gov/navigator/
The CDC provides a vaccine locator which lists many local pharmacies and stores providing the vaccine. Visit that locator at https://www.vaccines.gov/search/
GENEVA (AP) An expert group convened by the World Health Organization said Tuesday it strongly supports urgent and broad access to booster doses, in a reversal of the U.N. agencys previous insistence that boosters werent necessary and contributed to vaccine inequity.
In a statement, WHO said its expert group concluded that immunization with authorized COVID-19 vaccines provide high levels of protection against severe disease and death amid the global circulation of the hugely contagious omicron variant.
It said vaccination, including the use of boosters, was especially important for people at risk of severe disease.
Last year, WHOs director-general Tedros Adhanom Ghebreyesus called for a moratorium on booster doses while dozens of countries embarked on administering the doses, saying rich countries should immediately donate those vaccines to poor countries instead. WHO scientists said at the time they would continue to evaluate incoming data.
Numerous scientific studies have since proven that booster doses of authorized vaccines help restore waning immunity and protect against serious COVID-19. Booster programs in rich countries including Britain, Canada and the U.S. have been credited with preventing the surge in omicron infections from spilling over into hospitals and cemeteries.
WHO said it is continuing to monitor the global spread of omicron, including a stealth version known as BA.2, which has been documented to have re-infected some people after an initial case of omicron. Theres mixed research on whether it causes more severe disease, but vaccines appear just as effective against it.
WHO noted that the current authorized COVID-19 vaccines are all based on the strain that was first detected in Wuhan, China, more than three years ago.
Since then, there has been continuous and substantial virus evolution and it is likely that this evolution will continue, resulting in the emergence of new variants, the agency said. It added that coronavirus vaccines would likely need to be updated.
At the New York labs of pharmaceutical giant Pfizer, chairman and CEO Dr. Albert Bourla showed correspondent Alina Cho where scientists are working on the next generation of COVID vaccines, testing vaccinated and unvaccinated cell samples against new variants. These are the same labs where they helped pioneer the original vaccine.
Think back to two years ago, as COVID-19 spread across the world, when the normal timeline for the development of a vaccine was eight to ten years. "You went to your team and you said, 'Get one in eight months,'" said Cho. "Did you honestly believe you could get it done?"
"I felt that we don't have option to fail," Bourla replied.
And it was just eight months later when Pfizer executives, partnering with BioNTech, were celebrating promising vaccine results, with an efficacy at more than 90 percent.
Just a month later: the first shots were given. At the same time, Moderna, Johnson & Johnson, and other companies were making their own vaccines.
Bourla helped steer vaccine shipments around the globe from his desk at home. "I spent most of the time here, actually, during the pandemic," he laughed.
"This is where you took a lot of your calls, right? From a lot of world leaders?"
"That's true."
"Like, who called you?"
"Everybody."
There was one world leader who thought the vaccine didn't come soon enough. Pfizer's vaccine results were made public on November 9, 2020 six days after Election Day and President Donald Trump's re-election loss. "He made very clear to the world that he wanted the vaccine to come before the election," Bourla said. "Eventually, the vaccine came after the election. I think that is what frustrated him. He didn't call to thank me or congratulate me, but also he didn't call to complain. He just didn't call."
That, of course, was only one chapter in the politicization of the pandemic. Vaccine hesitancy remains high. Fewer than one-third of all Americans are fully-vaccinated and boosted, well behind many other wealthy countries.
Bourla has a new book discussing the challenges: "Moonshot: Inside Pfizer's Nine-Month Race to Make the Impossible Possible" (Harper Business). In it he writes: "What if we had accomplished these breakthroughs only to discover that the public would refuse the shot for lack of trust in the industry, the company, or the science itself?"
Cho asked, "So, in some ways, do you think that's what happened?"
"I think that, to a very high degree, it happened," he said.
"Doesn't that upset you personally? You've worked so hard on getting this vaccine to market safely. It doesn't upset you?"
"It doesn't upset me. What it makes me feel is very sad. Beyond sad. Because I know the consequences of the way that these people are thinking. And a lot of them are suffering these consequences and they are dying."
Politics have become personal for Bourla. He's been a target of death threats. At one point a fake report surfaced online that he had forced his wife to get the vaccine and it had actually killed her.
He said, "The first thing that I thought, 'I need to call my kids, and I need to call her parents, to make sure that they don't read it before I tell them that your daughter or your mom is still alive.' I was very, very upset."
Bourla has said he considers "vaccine equity" a high priority: making sure everyone globally has equal access to shots. Pfizer charged full-price to wealthy nations, but sold at-cost to poorer countries. Yet, vaccine equity seems far off.
A recent report by Amnesty International states that only four percent of those living in low-income countries are fully vaccinated.
"That's terrible," said Bourla. "And I think that we could have done better by having vaccination centers there, and particularly by convincing people of these countries that they should get the vaccine."
Bourla believes yearly COVID vaccine shots are in our future, just like flu shots, and a vaccine for the 6-month-to-5-year-old set could be approved in the next few months.
After two years of pandemic, Bourla is optimistic that a brighter future might finally be right around the corner.
Cho asked, "Do you envision a world in which we'll be able to take our masks off for good?"
"Oh, yes. I think so. And I think that will be this year," he replied. "Take the vaccines, and we should be able to live our lives."
For more info:
Story produced by Alan Golds. Editor: Karen Brenner.
