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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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

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)

Follow me on Twitter or LinkedIn. Send me a secure tip.

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.

COVID-19 Vaccines Not Linked To Pregnancy Loss; Mixing Vaccines May Confer Greater Protection

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 have yet to be certified by peer review.

COVID-19 vaccines not linked with pregnancy loss

Two studies in major medical journals add to evidence that COVID-19 vaccines are safe before and during pregnancy. One study, published in The New England Journal of Medicine on Wednesday, tracked nearly 18,500 pregnant women in Norway, including about 4,500 who had miscarriages.

Researchers found no link between COVID-19 vaccines and risk of first-trimester miscarriage, regardless of whether the vaccines were from Moderna, Pfizer and BioNTech, or AstraZeneca. Overall, the women with miscarriages were 9% less likely to have been vaccinated, according to the researchers’ calculations.

In a separate study published on Thursday in The Lancet, researchers tracked 107 women who became pregnant while participating in trials of AstraZeneca’s vaccine in the UK, Brazil and South Africa. Seventy-two of the women had received the vaccine while the others got a placebo. AstraZeneca’s vaccine had no effect on the odds of safely carrying the pregnancy to term, the researchers reported.

“It is important that pregnant women are vaccinated since they have a higher risk of hospitalizations and COVID-19-complications, and their infants are at higher risk of being born too early,” the authors of the Norwegian study wrote. “Also, vaccination during pregnancy is likely to provide protection to the newborn infant against COVID-19 infection in the first months after birth.”

Vaccine combinations with different technologies may be best

Healthcare workers in France who got a first shot of AstraZeneca’s COVID-19 vaccine and then the Pfizer/BioNTech vaccine for their second shot showed stronger immune responses than those who had received two shots of the Pfizer vaccine, in a recent study. Combining different technologies is known to boost immune responses to other viruses, and the current study suggests it may be true for the coronavirus as well.

Both vaccines in the study deliver instructions that teach cells in the body to make a piece of protein that resembles the spike on the coronavirus and that triggers an immune response. But they do it in very different ways. Both protocols provided “safe and efficient” protection, said Vincent Legros of Universite de Lyon in France, coauthor of a report published on Thursday in Nature.

But combining the AstraZeneca shot with the Pfizer/BioNTech vaccine “conferred even better protection” than two doses of Pfizer’s shot, including against the Delta variant, Legros said. The two technologies combined induced an antibody response of better quality, with more neutralizing antibodies that could block the virus, and more cells that have been “trained” by the vaccine to have increased defense potential, he said.  Combination vaccination “is safe and may provide interesting options… for clinicians to prevent SARS-CoV-2 infection,” Legros concluded.

Cognitive problems seen in middle-aged COVID-19 survivors

A “substantial proportion” of middle-aged COVID-19 survivors with no previous dementia had cognitive problems more than half a year after diagnosis, researchers have found. They looked at 740 people who ranged in age from 38 to 59. About half were white, and 63% were female. On tests of thinking skills, 20% had trouble converting short-term memories to long-term memories, 18% had trouble processing information rapidly, and 16% had trouble with skills needed for planning, focusing attention, remembering instructions, and juggling multiple tasks.

The average time from diagnosis was 7.6 months. About one-in-four patients had been hospitalized, but most of them were not critically ill. “We can’t exactly say that the cognitive issues were lasting because we can’t determine when they began,” said Dr. Jacqueline Becker of the Icahn School of Medicine at Mount Sinai in New York City, who co-led the study published on Friday in JAMA Network Open. “But we can say that our cohort had higher than anticipated frequency of cognitive impairment” given that they were relatively young and healthy, Becker said.

Data support use of Pfizer vaccine in children and teens

The Pfizer/BioNTech COVID-19 vaccine showed 90.7% efficacy against the coronavirus in a trial of children ages 5 to 11, the U.S. drugmaker said on Friday in briefing documents submitted to the U.S. Food and Drug Administration but not formally published. The children were given two shots of a 10-microgram dose of the vaccine – a third of the strength given to people 12 and older.

The study was not primarily designed to measure efficacy against the virus. Instead, it compared the amount of neutralizing antibodies induced by the vaccine in the children to the response of recipients in their adult trial. Pfizer and BioNTech said the vaccine induced a robust immune response in the children. Outside advisers to the FDA are scheduled to meet on Tuesday to vote on whether to recommend authorization of the vaccine for that age group.

A separate study from Israel conducted while the Delta variant was prevalent and published on Wednesday in The New England Journal of Medicine, compared nearly 95,000 12- to -18-year-olds who had received Pfizer’s vaccine with an equal number of adolescents who had not been vaccinated. The results show the vaccine “was highly effective in the first few weeks after vaccination against both documented infection and symptomatic COVID-19 with the Delta variant” in this age group, the research team reported.

By

Source: COVID-19 vaccines not linked to pregnancy loss; mixing vaccines may confer greater protection | Reuters

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“Q&A on COVID-19, pregnancy, childbirth and breastfeeding”. http://www.who.int. Retrieved 6 April 2020. Mimouni F, Lakshminrusimha S, Pearlman SA, Raju T, Gallagher PG, Mendlovic J (May 2020). “Perinatal aspects on the covid-19 pandemic: a practical resource for perinatal-neonatal specialists”. Journal of Perinatology. 40 (5): 820–826. doi:10.1038/s41372-020-0665-6. PMC7147357. PMID32277162. Chen H, Guo J, Wang C, Luo F, Yu X, Zhang W, et al. (March 2020). “Clinical characteristics and intrauterine vertical transmission potential of COVID-19 infection in nine pregnant women: a retrospective review of medical records”. Lancet. 395 (10226): 809–815. doi:10.1016/S0140-6736(20)30360-3. PMC7159281. PMID32151335. “Coronavirus (COVID-19) infection and pregnancy Version 9” (PDF). Royal College of Obstetricians & Gynaecologists. 13 May 2020. Archived from the original (PDF) on 2020-06-05. 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