Tag: biontech

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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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

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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.

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Omicron Is Less Likely To Cause Hospitalization And Develop Into Severe Disease, South African Study Suggests

People who contract the omicron variant are 80% less likely to be hospitalized compared to previous variants and those hospitalized with omicron are at a 70% lower risk of severe disease than delta, according to a new study by South Africa’s National Institute for Communicable Diseases released Wednesday.

Key Facts

The study was conducted in South Africa between October 1 and November 30 and has not been peer-reviewed.

The study’s authors said high levels of population immunity due to vaccination or “natural infection” are likely to have been a cause behind the lower risk of disease severity compared to people who had been diagnosed with delta between April and November.

They added it is “difficult to disentangle” the effect of high levels of population immunity with “intrinsic lower virulence” when narrowing down the reason for reduced disease severity.

Crucial Quote

Professor Cheryl Cohen of the National Institute for Communicable Diseases, one of the study’s authors, said the data “really suggest a positive story of a reduced severity of Omicron compared to other variants,” Reuters reported.

Key Background

Omicron is driving a surge in new cases of Covid-19 in the U.S. The spike has prompted Chicago and Boston to join several cities that require proof of vaccination to enter indoor venues this week, while the National Hockey League will reportedly announce Wednesday its decision to pull out of the 2022 Beijing Olympics after it and the league’s players association agreed to halt the season until December 26 due to soaring Covid cases.

To combat the surge, the Biden Administration said Tuesday it will provide 500 million rapid at-home tests to Americans for free and deploy federal military medical personnel to help hospitals. Public health experts are bracing for a winter surge of cases driven by the omicron variant, which can evade some protection conferred by vaccinations and prior infections, as well as cases linked to the delta variant. Officials caution that they are still relying on preliminary data about the omicron variant’s severity compared with earlier forms of the virus.

Tangent

Some U.S. health experts and the Biden Administration have recommended a booster shot as the best way to increase protection against omicron. In Israel, officials are pursuing a fourth dose. Seniors and healthcare workers there will soon be able to receive a fourth Covid vaccine shot, the country’s Pandemic Expert Committee said Tuesday.

Fauci and Collins painted a stark but realistic picture of the winter ahead, on the heels of a week of coronavirus-related setbacks. Coronavirus cases, hospitalizations and deaths rose across much of the country last week, with officials warning of a surge just as millions of Americans — already weary after nearly two years of the pandemic — are expected to travel for Christmas and New Year’s.

On Friday, Pfizer and BioNTech announced that coronavirus vaccines for children younger than 5 would be pushed back further into 2022, as the companies modified their trials to include a third dose. On Sunday, New York, one of the country’s early epicenters in the pandemic, reported 22,478 cases.

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Lisa Kim

Lisa Kim

I am a Greece-born reporter covering breaking news. Email me at lkim@forbes.com

Source: Omicron Is Less Likely To Cause Hospitalization And Develop Into Severe Disease, South African Study Suggests

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Moderna Data Shows mRNA Isn’t a Quick Fix For The Flu Vaccine

The first data from clinical trials of Moderna’s mRNA-based seasonal flu vaccine, released by the company Friday morning, were underwhelming — a finding that shows gene-based vaccines might not be a fix for all the problems with vaccine development.

The overwhelming success of the mRNA COVID-19 vaccines, made by Moderna and Pfizer / BioNTech, supercharged interest in that strategy for developing shots. The shots inject people with tiny snippets of the gene for a virus, which the body builds and then uses to learn how to fight the virus.

Current flu shots contain inactivated copies of the influenza virus. mRNA vaccines are faster to design and produce because manufacturers don’t have to grow copies of the virus, which is why experts have for years seen them as the future of vaccines.

Moderna launched a clinical trial of an mRNA seasonal flu vaccine this summer, hoping to capture the same success as it did with its COVID-19 vaccine. Typically, seasonal flu shots are around 40 to 60 percent effective, and pharmaceutical companies want to make that better. Three other companies are also working on mRNA flu shots.

Moderna released its first results during an investor phone call and presented slides showing that the mRNA flu shots did generate antibodies — but the levels of those antibodies weren’t higher than those for other flu shots already on the market. They also had more side effects than existing shots.

The findings don’t necessarily mean that mRNA flu shots aren’t any better than what we have now. Because mRNA vaccines are faster to design and make, the shots don’t have to be developed as far in advance. Companies may not have to do as much guesswork around what strain of the flu to target them against each year because they can wait to make the shots until they see what strains are circulating.

And as far as efficacy goes, there’s still a lot more data to collect: Moderna is preparing to conduct larger trials that would test how well the shots actually keep people from getting sick in the real world (not just testing antibody levels)..

Still, this early data shows that the immune system is tricky and that mRNA vaccines probably aren’t an easy shortcut for stopping a virus as persistent as the flu. More studies will be needed to figure out if there is a specific benefit to using mRNA vaccines to fight the flu, wrote chemist and writer Derek Lowe in Science. But it’s not a sure thing.

Nicole Wetsman

By Nicole Wetsman

Source: Moderna data shows mRNA isn’t a quick fix for the flu vaccine – The Verge

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More contents:

Reopening Stocks Lead The Market Higher After Strong Jobs Report, Pfizer Announcement

The stock market rallied to record levels yet again on Friday after a better than expected October jobs report, a big announcement from Pfizer and a slew of strong corporate earnings results all helped boost investor optimism about America’s economic recovery.

Key Facts

All three major averages touched new highs: The Dow Jones Industrial Average rose 0.6%, over 200 points, while the S&P 500 gained 0.4% and the tech heavy Nasdaq Composite increased 0.2%.

The United States added back 531,000 jobs in October—better than the 450,000 expected by economists, according to data released by the Labor Department on Friday.

The long-struggling labor market is showing signs of improvement, notching its best monthly showing since July, while the unemployment rate ticked down to 4.6%—its lowest level in more than a year.

A major announcement on Friday from vaccine maker Pfizer also helped boost stocks tied to the reopening of the economy: The company said it will seek FDA approval for its antiviral pill, which reduces the risk of hospitalization and death from Covid-19 by 89%.

Although the Pfizer announcement caused shares of other vaccine makers such as Moderna, BioNTech and Merck to plunge, travel and leisure stocks widely rallied on the news and led the market’s gains on Friday.

Solid earnings also helped drive optimism, including from the likes of Uber, which reported its first-ever adjusted quarterly profit as demand for ride-sharing recovered, and Airbnb, which had its “strongest quarter ever” as travel continued to rebound.

What To Watch For:

While reopening stocks have performed well recently, several pandemic favorites have struggled. Shares of at-home fitness equipment maker Peloton plunged over 30% on Friday after reporting dismal quarterly earnings—making CEO John Foley no longer a billionaire. Other companies have also seen their businesses take a hit from the reopening of the economy: Smart TV company Roku and online education company Chegg both reported lackluster earnings this week.

Tangent:

The Federal Reserve said on Wednesday that despite labor shortages, supply chain constraints and inflation fears, the U.S. economy was recovering well. The central bank announced that it would begin reducing the historic level of stimulus it has been providing markets since the Covid-19 pandemic began. Fed chairman Jerome Powell also clarified his stance on high inflation, saying it was “expected to be transitory.” Markets have since rallied on the news.

Key Background:

The stock market has continued to hit fresh highs in recent weeks: The S&P 500 rose over 5% in October for its best month so far in 2021 and is up nearly 2% so far in November. Optimism around the reopening of the U.S. economy has grown, in large part thanks to third-quarter corporate earnings that have proved resilient despite higher costs and inflation fears. Of the 445 companies in the S&P 500 that have reported results so far, nearly 81% have beaten expectations, according to Refinitiv.

Further Reading:

Peloton Shares Plunge Over 30%—And CEO John Foley Is No Longer A Billionaire (Forbes)

Stocks Hit Fresh Records After Fed Says It Will Taper Pandemic Stimulus (Forbes)

U.S. Economy Added 531,000 Jobs Last Month—But 7.4 Million Americans Are Still Unemployed (Forbes)

Billions Wiped From Covid Pharma Heavyweights—Including Moderna, Regeneron, Merck—As Pfizer’s Antiviral Pill Triggers Selloff (Forbes)

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Sergei Klebnikov

Sergei Klebnikov

I am a New York-based reporter covering billionaires and their wealth for Forbes. Previously, I worked on the breaking news team at Forbes covering money and markets.

Source: Reopening Stocks Lead The Market Higher After Strong Jobs Report, Pfizer Announcement

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Related Contents:
Murphy, Richard McGill (1 July 2014). “Is Asia the next financial center of the world?B
EATTIE, ANDREW (13 December 2017). “What Was the First Company to Issue Stock?”. Investopedia.

“History of the NY Stock Exchange”. Library of Congress. May 2004.

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