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Saturday, September 5, 2020

A timeline of emerging infectious diseases in history

The world has entered “a pandemic era” in which humans’ impact on the environment may cause new infectious diseases to emerge more frequently, Anthony Fauci, MD, and his colleague David Morens, MD, wrote in an article for Cell.

Dr. Fauci, director of the National Institutes of Allergy and Infectious Disease, and Dr. Morens, a senior advisor at the NIAID, said activities like deforestation, overfishing and urban crowding can disrupt the natural ecosystem, which may be a contributing factor to the emergence of diseases.

“The COVID-19 pandemic is yet another reminder, added to the rapidly growing archive of historical reminders, that in a human-dominated world, in which our human activities represent aggressive, damaging and unbalanced interactions with nature, we will increasingly provoke new disease emergences,” they wrote. 

Drs. Fauci and Morens shared the following timeline of key emerging and reemerging infectious diseases that have spread across the globe:

Note: Most mortality figures represent estimates. 

430 BCE — The Plague of Athens killed about 100,000 people and is the first transregional pandemic in recorded history. The exact disease that caused this plague is unknown.

541 — The Plague of Justinian killed 30 million to 50 million people and was caused by the bacteria Yersinia pestis.

1340s — “Black Death,” a bubonic plague caused by Yersinia pestis, killed about 50 million people.

1494 — Syphilis, a pandemic brought to Europe from the Americas, has killed more than 50,000 people and is caused by the bacteria Treponema pallidum.

c. 1500 — Tuberculosis is an ancient disease that became a pandemic in the Middle Ages and has killed millions.

1520 — Smallpox, caused by the bacteria Variola major, has killed about 3.5 million people.

1793-1798 — Yellow fever killed about 25,000 people in colonial America in what is referred to as “The American Plague.”

1832 — The 1832 cholera pandemic killed about 18,402 people, spreading across Asia, Europe and the Americas.

1918 — Spanish flu killed about 50 million people and caused additional pandemics in 1957, 1968 and 2009.

1976 – 2020 — Ebola has killed 15,258 people and caused 29 epidemics since it was first detected in 1976.

1981 — Acute hemorrhagic conjunctivitis is a derivative of pink eye that was first recognized in 1969 and caused a pandemic in 1981.

1981 — HIV/AIDS have killed about 37 million people since it was first identified in 1981. It is considered an ongoing pandemic.

2002 — SARS killed 813 people in what health experts call a “near-pandemic” in 2002.

2009 — H1N1 “swine flu” killed 284,000 people in what was the century’s fifth flu pandemic.

2014 — Chikungunya is a mosquito-borne virus that was first identified in 1952 and became pandemic in 2014. Deaths from this virus are uncommon.

2015 — Zika is a type of flavivirus that has existed for decades. It wasn’t until 2015 that the mosquito-borne virus spread pandemically, likely due to a virus mutation.

https://www.beckershospitalreview.com/public-health/a-timeline-of-emerging-infectious-diseases-in-history.html

Sanofi Plans Ingredients Unit IPO Within Months

Sanofi, the French pharmaceutical giant, plans to sell shares in its drug-ingredients division in the next few months, a senior executive said.

The company announced the potential initial public offering in February as Chief Executive Officer Paul Hudson sought to revamp the drugmaker’s strategy, focusing on fields such as cancer.

“We’ll try to launch it on the market,” Sanofi France Chairman Olivier Bogillot said on France Inter radio on Saturday. “We’ll do an IPO in the coming months.”

Sanofi has said the move will help ensure supplies of essential components used to make medicines and reduce the industry’s heavy reliance on Asia, which was exposed at the beginning of the coronavirus outbreak.

“The idea is to create a champion of active ingredients at the European level,” Bogillot said.

The unit is combining Sanofi’s commercial and development activities with six of its European production sites, including facilities in Frankfurt and Brindisi, Italy.

https://www.msn.com/en-us/money/companies/sanofi-plans-ingredients-unit-ipo-within-months-bogillot-says/ar-BB18Jzdj

Friday, September 4, 2020

Moderna Tumbles Amid Insider Sales and Covid Vaccine Jitters

Moderna Inc. shares slid 3.5% on Friday as unease mounted about the biotech’s Covid-19 vaccine trial fueled by ongoing insider shares sales and an enrollment slowdown.

With late-stage trial results weeks away, the stock has shed more than a third of its value from record highs in mid-July. Still, shares have more than tripled since the beginning of the year, prompting several insiders to cash out.

Chief Executive Officer Stephane Bancel, who found himself a newly minted billionaire as a result of the pandemic, disposed of an additional 18,000 shares this week, including some tied to entities controlled by him.

The sales are just the latest in a string of transactions that started in February as insiders have taken advantage 10b5-1 trading plans that allow sales at predetermined times or prices. While the trading plans are legal, they have faced criticism over letting executives skirt insider trading laws. New criticism of the sales cropped up in an NPR report Friday, which said key players at the Cambridge, Massachusetts-based company have sold about $90 million in stock since June and drew attention to changes to Chief Medical Officer Tal Zaks’s trading plan in January. 

The continuous sales aren’t a good look ahead of the company’s upcoming Covid-19 results when investors would want to see confidence from the company’s management.

A CNBC report also likely hit the stock Friday, pointing to a slowdown in enrollment to be sure enough of those hardest hit by the pandemic, namely Black Americans, were taking part in the study. Moderna is racing alongside more experienced drugmakers like AstraZeneca Plc in partnership the University of Oxford as well as Pfizer Inc. and its German partner BioNTech SE to get out late-stage data in thousands of patients showing vaccines will work against the virus.

Other vaccine testers — which have seen three and four digit percentage gains this year — also tumbled with the broader market on Friday. Novavax Inc. plunged 9.8%, Inovio Pharmaceuticals Inc. fell 2.8% and Vaxart Inc. dropped 5.2%.

https://www.msn.com/en-us/money/other/moderna-tumbles-amid-insider-sales-and-covid-vaccine-jitters/ar-BB18IHd7

Ex-FDA Chief On How Coronavirus Vaccine OK Could Come In Stages

The Trump administration is urging individual states to start working on a strategy to distribute a coronavirus vaccine by Nov. 1, but some experts are skeptical of the quick timeline, as it comes just weeks after interim study results.

Early Vaccine Data Within Weeks: U.K.-based AstraZeneca plc AZN 1.03% is expected to release data in mid-September that could confirm that its vaccine can prevent people from contracting the disease.

Prior to a scheduled U.S. Food and Drug Administration meeting Oct. 22, similar readouts are expected from Moderna Inc MRNA 3.45% and BioNTech’s collaboration with Pfizer Inc. PFE 0.05%.

These readouts will merely be interim results, and a final readout will likely be released sometime from the middle of November through the end of the year, Rasmus Bech Hansen, CEO of the drug trial analytics company Airfinity, told Bloomberg TV in an interview. It remains unclear if regulatory authorities in the U.S. and elsewhere will approve a vaccine based merely on interim results, he said. 

The FDA will likely make a decision in late October based solely on the interim results that have been released, he said, adding that doing so is “not unusual,” especially if the interim results are “super successful.”

“It’s one of the reasons why you do the interim read-outs,” he said.

Gottlieb On A Staged Approval Timeline: The FDA will likely follow a “staged approval” strategy, with the vaccine first being made available under an emergency use authorization, former FDA Commissioner Dr. Scott Gottlieb said on CNBC’s “Squawk Box.”

An EUA isn’t a “low standard,” Gottlieb said, adding that it allows the FDA to start distributing a vaccine to high-risk groups while simultaneously collecting post-market safety and efficacy data.

High-risk individuals will likely be defined as front-line health care workers or older people with comorbidities, he said.

Additional groups will be brought on as time passes, but expectations are that mass availability is “clearly” a 2021 event, Gottlieb said.

The Abbott Test: Some confusion exists around the recent announcements of at-home COVID-19 detection kits, Dr. Michael Mina, an epidemiologist at Harvard T.H. Chan School of Public Health, told Fox News. The tests are accurate in detecting whether a person is infected and contagious, he said. 

The kit developed by Abbott Laboratories ABT 1.3%, for example, is 97% accurate in detecting the presence of the disease within the first week of the development of symptoms, the doctor said.

Even if 50% of people chose not to use a kit and another 10% of samples are improperly administered, the prevalence of the virus will still diminish, he said.

https://www.benzinga.com/news/20/09/17388763/ex-fda-commissioner-on-how-coronavirus-vaccine-approval-could-come-in-stages

COVID-19 vaccine developers prepare joint pledge on safety

Several drug makers developing coronavirus vaccines plan to issue an unusual public pledge not to seek government approval until the shots have proven to be safe and effective, WSJ reports.

The companies reportedly involved in the discussions include Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), Moderna (NASDAQ:MRNA) and others.

A joint statement, which could be issued as soon as next week, will commit to making the safety and well-being of vaccinated people the companies’ priority, as industry executives seek to assure the public that they are not cutting corners in their rapid testing and manufacturing of the vaccines, according to the report.

Many Americans are skeptical or hesitant about taking a COVID-19 vaccine, in large part due to concerns that vaccine development or potential authorization are being rushed.

The Centers for Disease Control, which is expected to be involved in distributing vaccines, recently notified U.S. states that they should be ready to launch COVID vaccination campaigns as soon as late October or early November.

https://seekingalpha.com/news/3611895-covidminus-19-vaccine-developers-prepare-joint-pledge-on-safety-wsj

Common cold combats influenza

As the flu season approaches, a strained public health system may have a surprising ally—the common cold virus.

Rhinovirus, the most frequent cause of common colds, can prevent the flu virus from infecting airways by jumpstarting the body’s antiviral defenses, Yale researchers report Sept. 4 in the journal The Lancet Microbe.

The findings help answer a mystery surrounding the 2009 H1N1 swine flu pandemic: An expected surge in swine flu cases never materialized in Europe during the fall, a period when the common cold becomes widespread.

A Yale team led by Dr. Ellen Foxman studied three years of clinical data from more than 13,000 patients seen at Yale New Haven Hospital with symptoms of respiratory infection. The researchers found that even during months when both viruses were active, if the common cold virus was present, the flu virus was not.

“When we looked at the data, it became clear that very few people had both viruses at the same time,” said Foxman, assistant professor of laboratory medicine and immunobiology and senior author of the study.

Foxman stressed that scientists do not know whether the annual seasonal spread of the common cold virus will have a similar impact on infection rates of those exposed to the coronavirus that causes COVID-19.

“It is impossible to predict how two viruses will interact without doing the research,” she said.

To test how the rhinovirus and the influenza virus interact, Foxman’s lab created human airway tissue from stem cells that give rise to epithelial cells, which line the airways of the lung and are a chief target of respiratory viruses. They found that after the tissue had been exposed to rhinovirus, the influenza virus was unable to infect the tissue.

“The antiviral defenses were already turned on before the flu virus arrived,” she said.

The presence of rhinovirus triggered production of the antiviral agent interferon, which is part of the early immune system response to invasion of pathogens, Foxman said.

“The effect lasted for at least five days,” she said.

Foxman said her lab has begun to study whether introduction of the cold virus before infection by the COVID-19 virus offers a similar type of protection.

https://medicalxpress.com/news/2020-09-common-cold-combats-influenza.html

Life sciences SPAC HighCape Capital Acquisition prices $100 million IPO at $10

HighCape Capital Acquisition, a blank check company formed by HighCape Capital targeting the life sciences industry, raised $100 million by offering 10 million units at $10. Each unit consists of one share of common stock and one-third of a warrant, exercisable at $11.50. The company originally planned to offer half-warrants.

The company is led by HighCape Capital co-founders. CEO and Chairman Kevin Rakin and CFO, COO, and Director Matt Zuga both serve as Partners at the HighCape. The company plans to target the life sciences industry, including therapeutics, devices, diagnostics, medical information technology, agrisciences, and animal health.
 
The New York, NY-based company plans to list on the Nasdaq under the symbol CAPAU. Cantor Fitzgerald acted as lead manager on the deal. Relevant Profile: CAPAU

https://www.renaissancecapital.com/IPO-Center/News/70812/Life-sciences-SPAC-HighCape-Capital-Acquisition-prices-$100-million-IPO-at-