Moderna Sues Rival COVID-19 Vaccine Makers Pfizer and BioNTech

Moderna has said it is suing rival vaccine maker Pfizer and its German partner BioNTech, citing infringement on its patents in developing the first COVID-19 vaccine approved in the United States, alleging they copied technology that Moderna developed years before the pandemic.

The lawsuits set up a high-stakes showdown between the leading manufacturers of COVID-19 shots that are a key tool in the fight against the disease. “Moderna believes that Pfizer and BioNTech’s Covid-19 vaccine Comirnaty infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology,” the US-based biotech firm said in a statement on Friday.

“Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty,” Moderna said. Pfizer and BioNTech said they have not fully reviewed the complaint, but expressed surprise over the litigation.

“The Pfizer/BioNTech Covid-19 vaccine was based on BioNTech’s proprietary mRNA technology,” a statement said. “We will vigorously defend against the allegations of the lawsuit.” When the news broke, Pfizer shares fell nearly 1 percent, while BioNTech US-listed shares were down about 1.5 percent and Moderna shares slipped 1.7 percent.

The lawsuit, which seeks undetermined monetary damages, was filed in the US District Court in the state of Massachusetts. Moderna said the lawsuit would also be filed in the Regional Court of Dusseldorf in Germany.

Just a decade old, Moderna, based in Cambridge, Massachusetts, had been an innovator in the messenger RNA (mRNA) vaccine technology that enabled unprecedented speed in developing the COVID-19 vaccine.

The mRNA technology used in the Moderna and Pfizer-BioNTech shots differs from that in traditional vaccines, which rely on injecting weakened or dead forms of a virus to allow the immune system to recognize it and build antibodies.

Instead, mRNA vaccines deliver instructions to cells to build a harmless piece of the spike protein found on the surface of the virus that causes COVID-19. After creating this spike protein, cells can recognize and fight the real virus, hailed as a major advancement in the development of vaccines.

Germany-based BioNTech had also been working in this field when it partnered with the US pharma giant Pfizer.

Lawsuits can take years to resolve

Moderna said it had begun building up the technology in 2010 and patented work on coronaviruses in 2015 and 2016, which allowed for the rollout of its shots in “record time” after the pandemic struck.

The virus has killed at least 6.48 million people worldwide since 2020 and made nearly 600 million ill, according to a Johns Hopkins University tracker. In addition to death and suffering, the disease has led to a reshaping of life ranging from a change in norms on working from home to a scrambling of supply chains and workforces.

Moderna said it pledged in October 2020 not to enforce its COVID-19-related patents while the pandemic continued, but less than two years later changed that stance as the fight shifted gears.“Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable licence should they request one for other markets,” it said.

“Pfizer and BioNTech have failed to do so,” the firm added. Pfizer and BioNTech are already facing multiple lawsuits from other companies which say the partnership’s vaccine infringes on their patents. Germany’s CureVac, for instance, also filed a lawsuit against BioNTech in Germany in July. BioNTech responded in a statement that its work was original.

Moderna has also been sued for patent infringement in the US and has an ongoing dispute with the US National Institutes of Health (NIH) over rights to mRNA technology. These types of lawsuits are not unheard of in the pharmaceutical industry, where patents can be worth billions of dollars, and can take years to resolve.

Source: Moderna sues rival COVID-19 vaccine makers Pfizer and BioNTech | Coronavirus pandemic News | Al Jazeera

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What Is Naloxone? Where To Get Narcan And How To Reverse Overdoses

The overdose crisis continues to worsen in the U.S., and overdose deaths reached an all-time high in 2021. Experts say that a simple drug — naloxone — is a key tool in preventing more deaths. But not enough people know about it, have access to it or actually carry it with them.

“Naloxone is a miracle drug,” Dr. Kimberly Sue, medical director for the National Harm Reduction Coalition and associate professor of medicine at Yale School of Medicine, told TODAY. “It’s literally a Lazarus drug that prevents people from dying of an opioid overdose.”

And in the midst of the overdose crisis, which claimed nearly 108,000 lives just last year, getting naloxone to those who need it is vitally important. Here, experts discuss what naloxone is, how to get it and how it can save lives.

How does naloxone work?

Naloxone, also referred to by the brand name Narcan, is what experts call an opioid antagonist, Dr. Sarah Wakeman, medical director for the Massachusetts General Hospital Substance Use Disorder Initiative, told TODAY. Narcan is not the only branded naloxone product; a high-dose nasal spray called Kloxxado works similarly, according to the FDA.

That means it “binds to the opioid receptors in the brain — the same receptors that opioid drugs or medications like oxycodone or heroin or fentanyl bind to — and then blocks those receptors,” Wakeman explained. In the event of an opioid overdose, naloxone “can actually kick off the opioid from the receptor, reverse the acute effects of an opioid overdose and save someone’s life.”

A standard dose of naloxone is effective against even fentanyl, Wakeman said. If they’ve taken an opioid and something else, or if they took something like cocaine that was tainted with illicit fentanyl, naloxone will still work against the opioid in their system.

“And naloxone won’t be harmful to someone who doesn’t have an opioid in their body,” Wakeman said. “So if there’s a possibility that you think someone is having an overdose … then it is always a good idea to give naloxone.”

When should naloxone be given?

Before using naloxone, check to see if someone has the telltale signs of an overdose, Dr. Ayana Jordan, an addiction expert and associate professor of psychiatry at NYU Grossman School of Medicine, told TODAY. She pointed to the Center for Disease Control and Prevention‘s tips to learn about the signs of an overdose.

According to the CDC, someone having an overdose may have:

  • Loss of consciousness.
  • Weak, slow or no breathing.
  • Small or constricted pupils.
  • Choking or gurgling sounds.
  • Limp body.
  • Clammy or cold skin.
  • Blue or discolored skin, especially around the lips. (However, Jordan notes that this may not apply to people with darker skin.)

In general, someone who is in the midst of an overdose will “have slowed and very shallow breathing to the point that, ultimately, they’ll stop breathing,” Wakeman said. “So they may look blue or cold and not be responsive.”

Giving someone naloxone

Once you’ve identified that someone might be having an overdose, you should call 911, the CDC says. Even if you’re able to reverse the overdose, they will likely still need emergency services. (Some states, but not all, have Good Samaritan laws, which protect people calling for medical help from some drug-related charges, Sue explained.)

From there, the right way to use naloxone depends on the specific formulation you’re using. For most people, that will likely be the nasal spray called Narcan, Wakeman said. In the hospital, naloxone may be given through an IV or as an injection into the muscle, she added.

After administering naloxone, the person should wake up within seconds to minutes, Wakeman said. And you should always start with as low a dose as possible. If someone is a regular opioid user and you give them a massive dose of naloxone all at once, “they’re going to immediately go into withdrawal,” Wakeman explained. While that isn’t necessarily harmful, it is pretty unpleasant and uncomfortable.

After giving someone naloxone, you should stay with them if you can until emergency medical help arrives. “Naloxone works very quickly, but it also wears off very quickly,” Wakeman said. In fact, the effects of naloxone can wear off within 30 minutes. And if someone still has the other opioid in their system, they may fall back into an overdose after the naloxone has worn off.

Where to get naloxone

If you use drugs, your doctor may give you a naloxone prescription as a regular part of their practice. “I make sure that everyone that sees me gets prescribed naloxone and that they understand how to use it,” Jordan said.

Depending on the state, you may be able to get naloxone at a local pharmacy without a prescription through the use of a standing order, Wakeman noted. (Standing orders allow pharmacies to give out prescription medications, like the annual flu vaccine, without requiring each individual person to have their own prescription.)

Another option is to connect with local harm reduction groups in your area, which frequently hand out naloxone kits, Wakeman said. These community-based organizations may also offer in-person or virtual trainings on how to use naloxone. Jordan noted that her research group also does large virtual naloxone training sessions for people who participate in their studies looking at drug use.

If you live in a state without a standing order and want to get naloxone to use on someone else, you can likely get a third-party prescription through a doctor, Sue said. She recommended looking at the local health department’s website for more information about where to get naloxone in your area.

It’s most important for people who use drugs to have access to naloxone. But if you know someone who uses drugs, you should consider carrying naloxone, too, the experts said. “Carrying naloxone is no different than carrying an epi-pen,” Jordan said.

And even though there are several ways to get naloxone now, there are still barriers to actually accessing and using it, Sue explained. She recalled a story of pharmacy staff being simply unaware of the standing order for naloxone, for instance, and noted that harm reduction groups are experiencing an ongoing naloxone shortage.

Additionally, naloxone is something that, by definition, people can’t use on themselves in the event of an overdose, Sue said. (If you are going to use by yourself, Sue recommended calling the Never Use Alone hotline so there is someone who can notify emergency services if you lose consciousness.)

Naloxone is a crucial tool in reducing overdose deaths, experts say

“Really, no one should die from an opioid overdose,” Wakeman said. “Not only do we know how to prevent overdoses and how to treat people who have an opioid use disorder, but we also have this life-saving, immediately-acting medication that will quickly reverse the effects of an opioid overdose.” 

The challenge for experts now is to make naloxone more accessible to those who need it. “There’s no moral or medical reason to keep this life-saving medication behind the counter,” Dr. Bobby Mikkamula, chair of the American Medicine Association’s Substance Use and Pain Care Task Force, told TODAY.

Earlier this year, AMA urged the Biden administration to remove naloxone’s prescription status, which would make it available over-the-counter. “It’s not the kind of thing that needs to be protected or that people need to be protected from,” Mikkamula said. “This saves their lives, and the fewer barriers we have to getting this into their hands and into their medicine cabinets, the better.”

For Jordan, the importance of naloxone comes down to one simple truth: “I can’t help people who are dead,” she said.

By

Source: What Is Naloxone? Where To Get Narcan And How To Reverse Overdoses

Related links:

Overdose Deaths Behind Bars Rise as Drug Crisis Swells The Good Men Project

Report details Alaska demographics hurt most by 2021 spike in drugoverdose deaths Alaska Public Media

11:37 Sun, 31 Jul
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13:02 Fri, 29 JulOpioid Crisis Fentanyl
15:34 Mon, 25 JulNative Americans Pandemic Racism
01:14 Thu, 21 JulNative Americans CDC Alaska
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Moderna COVID Vaccine May Pose Higher Heart Inflammation Risk

Source: Moderna COVID vaccine may pose higher heart inflammation risk – U.S. CDC

More contents:

Fourth Shot Protects Against Severe Omicron Outcomes; COVID May Increase Risk of Rare Eye Blood Clots

The following is a summary of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that has yet to be certified by peer review.

Fourth vaccine dose protects vs Omicron for at least a month

A fourth dose of the COVID-19 vaccine from Pfizer and BioNTech provided significant added protection against severe disease, hospitalization and death for at least a month in older individuals, according to a study conducted when the Omicron variant was dominant.

The estimated effectiveness of the fourth dose during days 7 to 30 after it was administered compared with a third dose given at least fourth months earlier was 45% against infection, 55% for symptomatic disease, 68% for hospitalization, 62% for severe disease and 74% for death, the research team reported on Wednesday in The New England Journal of Medicine.

The study compared 182,122 individuals aged 60 and older who received a fourth dose and 182,122 very similar people who had received a third dose but not a fourth.

“The results of our real-world study suggest that a fourth vaccine dose is, at least initially, effective against the Omicron variant,” the researchers said. “Additional follow-up will allow further assessment of the protection provided by the fourth dose over time.”

A recently published study that looked only at rates of breakthrough infections and serious illness after the fourth dose found that efficacy waned quickly versus infection but held steady versus severe illness.

COVID-19 may increase risk for rare eye clots. Patients with COVID-19 may have an increased risk of rare vision-threatening blood clots in the eye for months afterward, new findings suggest.

Because SARS-CoV-2 infections increase the risk of blood vessel obstructions at other sites in the body, researchers studied nearly half a million COVID-19 patients to see whether they would develop clots in the veins or arteries of the retina, the nerve tissue at the back of the eye that receives images and sends them to the brain.

Over the next six months, 65 patients had a retinal vein occlusion. While that number is low, it reflects a statistically significant 54% increase compared with pre-COVID infection rates, according to a report published on Thursday in JAMA Ophthalmology.

Retinal artery clots were 35% more common after COVID-19 than before, but that difference might have been due to chance. The clots most often occurred in patients with other conditions that increased their risk of blood vessel problems, such as diabetes, high blood pressure, and high cholesterol.

By: Nancy Lapid

Source: Fourth shot protects against severe Omicron outcomes; COVID may increase risk of rare eye blood clots

.

Critics:

By: Mary Van Beusekom

Compared with a third vaccine dose, a fourth dose of the Pfizer/BioNTech COVID-19 vaccine lowered the risk of infection, symptomatic infection, hospitalization, severe illness, and death 52% to 76%—depending on the measure—amid the Omicron surge among older adults.

Protection against infection waned, however, after 5 weeks, but not protection against severe COVID-19. The findings were published yesterday in the New England Journal of Medicine.

Seven to 30 days after the fourth COVID-19 dose, vaccine effectiveness (VE) relative to the third dose was estimated at 45% against infection (95% confidence interval [CI], 44% to 47%), 55% against symptomatic illness (95% CI, 53% to 58%), 68% against COVID-19 hospitalization (95% CI, 59% to 74%), 62% against severe disease (95% CI, 50% to 74%), and 74% against death (95% CI, 50% to 90%).

Fourteen to 30 days after the fourth dose, VE was 52% (95% CI, 49% to 54%) against infection, 61% (95% CI, 58% to 64%) against symptomatic illness, 72% (95% CI, 63% to 79%) against hospitalization, 64% (95% CI, 48% to 77%) against severe disease, and 76% (95% CI, 48% to 91%) against death.

In the fourth week after the fourth dose, the adjusted infection rate was lower by a factor of 2.0 (95% CI, 1.9 to 2.1) than that in the three-dose group and lower by a factor of 1.8 (95% CI, 1.7 to 1.9) than that among controls.

The difference in absolute risk for COVID-19 hospitalization 7 to 30 days after a fourth vaccine dose, relative to a third, was 180.1 per 100,000 people (95% CI, 142.8 to 211.9), while it was 68.8 cases per 100,000 (95% CI, 48.5 to 91.9) for severe disease. A sensitivity analyses of VE against infection had similar results as those in the primary analysis.

Starting in the fifth week after the fourth dose, the rate ratio (RR) for infection began to fall. The adjusted rate of infection in the eighth week after the fourth dose was comparable to that of internal controls. The RR for the three-dose group relative to the four-dose group was 1.1, while the rate ratio for the internal control group, compared with the four-dose groups, was 1.0.

The RRs comparing controls with fourth-dose recipients were larger and lasted longer for severe disease. In the fourth week after the fourth dose, the adjusted rate of severe disease was lower by a factor of 3.5 than in three-dose recipients and a factor of 2.3 than in internal controls.

The adjusted rate of severe illness in the fourth week after the fourth dose was 1.6 cases per 100,000 person-days, compared with 5.5 cases per 100,000 in three-dose recipients and 3.6 cases per 100,000 in internal controls. The adjusted rate differences were 3.9 fewer cases per 100,000 person-days and 2.1 fewer cases per 100,000 than the three-dose group and internal controls, respectively.

.

Covid Year Three Will Be Better, Experts Agree, Unless Rich Countries Ignore The Pandemic Elsewhere

It was March 2020 when the reality of the Covid-19 pandemic hit home in the U.S. When the NBA suspended its season, it seemed to give permission for other closures and stay-at-home orders, and they quickly followed. At that point, there had only been around 3,000 confirmed cases of the disease and about 60 confirmed Covid deaths.

Fast-forward two years, and the numbers are staggering. According to estimates from Johns Hopkins University, as of Wednesday there have been over 79 million confirmed Covid cases and over 960,000 deaths. Several million have been hospitalized and millions more have reported symptoms that linger for weeks or even months, with unknown consequences moving into the future.

“It’s massively higher than I thought,” says Robert Wachter, chair of the Department of Medicine at the University of California, San Francisco. “Particularly when in November 2020 the announcement came out that we had a vaccine that was 95% effective.”

Amanda Castel, a professor of epidemiology at George Washington University’s Milken Institute School of Public Health, said in an email that she’s also surprised that the pandemic is still going, compared to her initial expectation. “In retrospect, I think I was hopeful that it would be more self-limited, like the SARS pandemic.”

The worst of the pandemic is behind us, experts told Forbes, in part because the first two years provided valuable tools for the continued fight against both Covid and future disease epidemics. Ignoring the pandemic in lower-income countries, they say, could mean new variants making their way back to the U.S.

One lesson the experts didn’t expect to learn was how polarizing the response to the pandemic could be, especially as time went on. “I was surprised and alarmed to see how politically polarized Covid-19 responses have become, with some U.S. states (most recently Florida) promoting public health policies that directly oppose the science (and common sense),” Steffanie Strathdee, associate dean of global health sciences at the University of California, San Diego, said in an email.

The depth and intensity of political anger against public health officials was also jarring, says Castel. “To think that many public health leaders at the local, state and national level received death threats and lawsuits because of the evidence-based guidance they issued is appalling.”

“It’s tragic, because the outcomes of that were that hundreds of thousands of people died, who would not have died, if the response had been less political and more governed by the best science,” Wachter adds.

Wachter also says it’s hard to fathom the size of anti-vaccine sentiment based on what things looked like before the pandemic. “The anti-vax movement was previously pretty small and fringe,” he says. “And it was as likely to come from the left as the right—maybe even more likely to come from the left.”

The worst of the pandemic is (probably) behind us

“Years three and four will, hopefully, see a transition of Covid-19 from an emergent condition to an ongoing public health challenge with significantly less morbidity and mortality,” Anand Parekh, chief medical advisor for the Bipartisan Policy Center, says in an email. But not if it’s left to itself, he’s quick to add. “This would require easy access to prevention, testing and treatment.”

“I think the likeliest path will be a version of where we are now,” says Wachter. “With small surges that will not be overwhelming and be regional, partly related to seasonality, maybe partly related to vaccine status in different regions.”

The biggest unknown about this prediction, of course, is whether a new Covid variant emerges, which Strathdee warns is an increased risk if high-income countries choose to ignore the pandemic in the rest of the world. “If we don’t ensure that new medical advances such as vaccines and therapeutics reach the lower- and middle-income countries, new variants will emerge that threaten us all.”

Long Covid will have a potentially long impact

A potentially bigger challenge than surges of new infections in pandemic year three, says Wachter, are the still mostly unknown impacts of long Covid. If it turns out that, as some preliminary estimates suggest, as many as 10% to 20% of people experience lingering symptoms, “that’s tens of millions of people, and that’ll have an impact on the workforce and that’ll have an impact on economic performance.”

Long Covid will take a potential toll on the healthcare system as well, adds Castel. “Until we learn more about how to prevent and treat long Covid, we can anticipate a large burden on the healthcare system for the near future.”

“The high prevalence of long Covid stands to cause significant disability,” Strathdee says. “which affects both mental and physical health, including quality of life. I don’t think we’ve got a good handle yet on how big this problem may be.”

One major concern, says Wachter, is that unlike most respiratory diseases, early studies are warning that Covid may cause long-term health problems. A recent study said that people with even mild Covid showed more incidents of brain damage compared with those uninfected. Another finding: People infected with Covid have higher rates of heart attack and strokes. “If that turns out to be real, you’re talking about a new risk factor in almost 40% of the population,” he says. “A risk factor that may be as potent, as if people have high blood pressure or if they smoke. And that’s a very big deal.”

The tool kit for the next disease surge

Health experts agree that Covid-19 is likely to be around for a long time, and it’s also not going to be the last pandemic. The past two years, they say, have provided a lot of insight into what needs to be done to prepare for the next deadly disease surge.

When it comes to respiratory viruses like Covid, “We need to keep good-fitting N95 face masks, HEPA filters and good old soap and water,” says Strathdee.

“Masks should have been consistently recommended early on in the pandemic, as other countries did,” Parekh agrees. Castel concurs. “Masks are simple to use, relatively easy to obtain, and have proven to be effective in both protecting the wearer and those around them.”

Another key tool for combating future epidemics is testing, Wachter says. “We clearly made a terrible error early on in not working hard to get good tests out there more quickly,” he says. “And particularly, I think we were very late on home testing, both developing them and distributing them.”

One crucial factor that emerged to combat Covid, says Esther Krofah, executive director of FasterCures and the Center for Public Health at the Milken Institute, was research collaboration between scientists, companies and governments to produce vaccines and therapeutics quickly. That’s something she hopes doesn’t go away. “We need to ensure we build sustainable infrastructure to continue such collaboration,” she says, “and move forward efforts to change the culture in medical research to align with the urgent needs of patients.”

Experts do suggest rethinking one of the most contentious aspects of the pandemic response: school closures. “One of the real lessons learned is the negative impact of school closures on kids,” says Wachter. “And I think it will influence our response the next time.”

“Virtual schooling, while necessary intermittently, will need to be more closely considered in the future taking into account the virus’ epidemiology, risk to students and staff, and considerations for childcare/parental workforce,” says Parekh.

Hospitals need to be better prepared for future surges

Covid-19 hit hospitals extremely hard, overworking doctors and nurses to the point of burnout during pandemic surges, as intensive care units and other departments were pushed to capacity and beyond. This means that hospitals will need to work on building their surge capacity, experts say.

“Stockpiling and distributing critical medical material, deploying surge medical staff and ensuring that healthcare systems through federal grants are exercising their response plans are all critical,” Parekh says.

A major challenge for hospitals, says Wachter, will be getting extra capacity in place without breaking the bank. “Nobody’s going to be able to afford to keep a lot of excess bed capacity available, or a lot of excess nursing and doctor capacity,” he says. However, what hospitals can do is better stockpile equipment and protective clothing for healthcare workers. “The things that are not wildly expensive but you do want to have in the basement.”

In addition to better preparing for surges, hospitals also need to be better at identifying threats early so public health measures can be put in place, says Strathdee. “Public health departments and hospitals need to be better equipped to conduct surveillance, which includes systems for timely reporting.”

Castel encourages closer communication between hospitals and public health officials. “Hospitals are often sentinel sites and the first place that persons infected with these illnesses seek care, therefore they must have the capacity to work closely with public health to assist in the timely detection of emerging infectious diseases.”

Rebuilding trust and fighting apathy is critical

“An effective response to a pandemic requires three things: political leadership, national unity and timely resources,” says Parekh. Those first two have been hard to come by since 2020, with one expert confiding to Forbes their concern that political polarization “has significantly impaired the ability of public health authorities to enact countermeasures in the future.”

Another challenge that health experts have seen during the course of the pandemic isn’t just politics but also apathy. “On May 24, 2020, the New York Times covered its whole front page with a story headlined: ‘U.S. Deaths Near 100,000, An Incalculable Loss.’ It listed names of the dead, as the paper did after 9/11. In December 2020, shortly before vaccines became available, we approached 300,000 dead, though the Times did not (and still has not) run a similar story,” Krofah says. “I’m afraid we have become numb to these numbers.”

Wachter notes that if a new surge of Covid comes in the next few months, it may be hard to galvanize a public response. “Everybody is so cognitively over this,” he says. “And the idea that you would have to hunker down again? It’s going to be awfully hard to convince people to do that.”

Other experts agree that separating politics from public health is going to be essential in order to move forward in combating future epidemics. A crucial aspect of that is rebuilding trust in institutions, repaid in kind with clear communication rooted in science. But it’s also, several say, something that has to happen between people’s everyday interactions with each other.

For Castel, what’s needed is that sense of community seen early in the pandemic when “neighbors volunteered to help older, more vulnerable people get groceries, or to make masks, or to donate food to overworked medical personnel,” she says. “Without this sense of community, we would not be where we are today and I can only hope that if faced with another pandemic, that we would all come together again in a united effort to protect and support each other. “

I’m a senior editor at Forbes covering healthcare, science, and cutting edge technology. 

Source: Covid Year Three Will Be Better, Experts Agree, Unless Rich Countries Ignore The Pandemic Elsewhere

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