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Vaccines for the novel coronavirus: How they are approved, who would get one first and other key things to know

A vaccine could mean a turning point in the fight against a novel coronavirus that has infected at least 7.8 million people in the United States, killed more than 214,000 nationwide and unraveled aspects of most everyone’s lives.

But approving a vaccine quickly is complex. And distributing it to some 330 million Americans, and to other countries, will require a feat of logistics.

Here’s what you need to know about the COVID-19 vaccine effort.

What’s the timeline?

It depends on two main factors: how long the vaccines take to develop and get approved, and how quickly they can be manufactured and distributed.

Experts say multiple vaccines are needed to immunize the U.S. population. Clinical trials on several vaccine candidates could soon have produced enough data to assess whether they’re effective.

Moderna and Pfizer are farthest along, with vaccines deep into phase 3 clinical trials involving tens of thousands of people, according to Moncef Slaoui, the scientific head of Operation Warp Speed, a federal program working toward immunizing Americans as quickly as possible.

Both are mRNA vaccines, which introduce genetic code for viral antigens that could teach the body’s immune system to respond to the virus. This new platform has yet to produce an approved vaccine of any kind. 

Slaoui, who spoke Oct. 6 at a virtual event co-hosted by the University of Washington and Johns Hopkins University, said he expected “efficacy outcomes” — data on whether the vaccines work — within the next seven weeks.

The federal government also is investing in three other platforms besides mRNA, including adenovirus-based vaccines and adjuvanted protein vaccines, which could reach efficacy sometime next year.

Scaling up the manufacture of vaccines is “equally important and, frankly, even more complicated” than clinical development of them, Slaoui said. He discouraged vaccine makers from filing for emergency approval until their vaccines are available to distribute.

The mRNA vaccines already are being stockpiled, pending trial results and regulators’ approval.

Slaoui said he felt comfortable that within two months, one or both mRNA vaccines would reach efficacy and would have enough already stored to vaccinate 30 million Americans by year’s end and 50 million more in January. 

That’s an optimistic timeline.

Dr. Robert Kadlec, Health and Human Services (HHS) Assistant Secretary for Preparedness and Response, said the U.S. can expect vaccine delivery starting in January.

And Dr. Anna Wald, a UW professor of medicine, epidemiology and laboratory medicine, said that even if limited quantities are shipped later this year, she didn’t expect vaccines to impact the pandemic’s course until spring 2021.

“Why don’t we wait and do it right?”
— Dr. Larry Corey

Because the trials are so large, data accumulates quickly, and scientists stand to learn more about how effective the vaccines are the longer they wait to review results, said Dr. Larry Corey, former director of the Fred Hutchinson Cancer Research Center and co-leader of a national network coordinating clinical trials on vaccines.

“We will learn a hell of a lot more” by waiting until December, Corey

‘Love Hormone’ Could Hold Key to Treating COVID | Health News

By Robert Preidt, HealthDay Reporter

(HealthDay)

FRIDAY, Oct. 9, 2020 (HealthDay News) — The so-called love hormone, oxytocin, may be worth investigating as a treatment for COVID-19, a new study suggests.

One of the most serious complications of infection with the new coronavirus is a “cytokine storm,” in which the body attacks its own tissues.

There are currently no U.S. Food and Drug Administration-approved treatments for COVID-19, which means that “repurposing existing drugs that can act on the adaptive immune response and prevent the cytokine storm in early phases of the disease is a priority,” according to the researchers.

Previous research suggests that oxytocin — a hormone that’s produced in the brain and is involved in reproduction and childbirth — reduces inflammation.

In this new study, researcher Ali Imami, a graduate research assistant at the University of Toledo in Ohio, and colleagues used a U.S. National Institutes of Health database to analyze characteristics of genes treated with drugs closely related to oxytocin.

The investigators found that one drug in particular, carbetocin, has similar characteristics (called a signature) to genes with reduced expression of the inflammatory markers that trigger cytokine storm in COVID-19 patients.

Carbetocin’s signature suggests that the drug may trigger activation of immune cells called T-cells that play an important role in immune response. In addition, carbetocin’s signature is also similar to that of lopinavir, an antiretroviral medication under study as a treatment for COVID-19.

All of these factors indicate that oxytocin may have potential as a targeted treatment for cytokine storms in COVID-19 patients, the researchers said in a news release from the American Physiological Society.

“Understanding the mechanisms by which oxytocin or the oxytocin system can be a new immune target is crucial,” the authors concluded in their report, which was published online recently in the journal Physiological Genomics.

However, they added that “safety and efficacy of intravenous oxytocin in hospitalized patients with COVID-19 remains to be assessed.”

The U.S. Centers for Disease Control and Prevention has more on COVID-19.

Copyright © 2020 HealthDay. All rights reserved.

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Antimatter Particles Hold Key In Timely Attack Against Growing Tumors

KEY POINTS

  • A timer invented by experts permits PET scanners to attack  cancer cells in their weakest
  • The invention may pave the way to less invasive radiation treatment for cancer patients
  • Inventors hoped the technology can be made more affordable in a decade

Doctors may soon kill cancer tumors with less invasive side effects of radiation treatment. This is after a team of experts designed a scanner that can time the antimatter particles that are significant in detecting the levels of the oxygen concentration in cancer tissues. For years, medical experts have witnessed how low levels of oxygen prevented the timely killing of rapidly growing cancer cells. 

A team of Japanese atomic physicists and nuclear medicine experts designed a timer that can detect the oxygen concentration of tissues growing throughout ta cancer patient’s body. Specifically, the timer permits the positron emission tomography (PET) scanners to know when to attack the cancer cells in their weakest before they can grow to be more aggressive. 

In a study published in Communications Physics, the team of experts from the University of Tokyo and the National Institute of Radiological Sciences (NIRS) in Japan explained that positrons are the positively charged antimatter particles that are extremely low in mass. With how tiny their sizes are, these antimatter particles pose no risk in medical applications. They produce gamma rays that have shorter wavelengths than the electromagnetic waves from X-rays. 

Treatment tool for colon cancer A cinnamon-derived compound may help treat colorectal cancer, researchers said. Photo: Reuters

“We imagine targeting more intense radiation treatment to the aggressive, low-oxygen concentration areas of a tumor and targeting lower-intensity treatment to other areas of the same tumor to give patients better outcomes and fewer side effects,” Dr. Miwako Takahashi, a nuclear medicine physician from NIRS and co-author of the research, said in a press release.

Detecting the amount of oxygen flow in body tissues could tell doctors when to attack the cancer cells. At present conditions, experts are only able to detect tumors when they already have low levels of oxygen which means they have already developed into a hardened lump of tissues or mass.  

Hence, low oxygen levels in tumors indicate that the cells are already aggressive and have become harder to kill. At this stage as well, cancer cells grow to be more resilient against radiation treatment. 

The experts hoped that in less than a decade, their findings could lead to better and less invasive cancer treatments that could also be available economically.

Dr. Christian Hinrichs (R), an investigator at the National Cancer Institute in immunotherapy for HPV+ cancers, shows a survivor of metastatic cancer the difference between his CT scan showing cancerous tumors and a clean scan after treatment Dr. Christian Hinrichs (R), an investigator at the National Cancer Institute in immunotherapy for HPV+ cancers, shows a survivor of metastatic cancer the difference between his CT scan showing cancerous tumors and a clean scan after treatment Photo: AFP / SAUL LOEB

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Contract Tracing, Key to Reining in the Virus, Falls Flat in the West

LONDON — As the coronavirus stampeded across Europe and the United States this spring, governments made their depleted citizens a tantalizing promise: Soon, legions of disease detectives would hunt down anyone exposed to the virus, confining them to their homes and letting everyone else get on with their lives.

Nearly eight months on, as a web of new infections spreads across Europe and the United States, that promise has nearly evaporated.

Despite repeated vows by Western nations to develop “world-beating” testing and tracing operations, those systems have been undone by a failure of governments to support citizens through onerous quarantines or to draw out intimate details of their whereabouts. That has shattered the hope of pinpoint measures replacing lockdowns and undermined flagging confidence in governments.

Beholden to privacy rules, Western officials largely trusted people to hand over names to contact tracers. But that trust was not repaid, in large part because governments neglected services that were crucial to winning people’s cooperation: a fast and accurate testing system, and guarantees that people would be housed, fed and paid while they isolated.

“Public health leaders fell in love with the idea of contact tracing as an important tactic — and it is — but that’d be like if you’re going into war and were just talking about the tanks,” said Brian Castrucci, president of the de Beaumont Foundation, a public health charity in Maryland.

Just as important, officials overlooked the impact of raging mistrust in government and a thicket of conspiracy theories about the virus’s spread. Fearful of plunging themselves or their friends into a painful period off work, infected patients have handed over a paltry number of contacts and often flouted self-isolation rules. Contact tracers are struggling to reach people who test positive, and being rebuffed once they do.

In theory, countries were to build mass testing programs that would provide quick diagnoses. Then a group of tracers would find others who had crossed paths with the infected person and tell them to stay home.

Elected officials presented the system as a critical bridge between lockdown and a vaccine, allowing them to contain small outbreaks without shutting down large parts of society. But construction of that bridge has been rocky, at best.

The West’s public health systems have not matched the success in parts of East Asia where the fear of epidemics became more ingrained after SARS and MERS.

Following those outbreaks, places like Taiwan and South Korea built robust tracing systems and legal frameworks for limiting civil liberties during an epidemic. Some contact tracers have used cellphone and credit card data to identify people who were potentially exposed.

But in Europe and the United States, which have largely relied on the public to provide information and follow quarantine rules voluntarily. The response has been spotty

The West also ran up against the blunt fact that contact tracing, while useful in containing limited cases, has become overwhelmed by a new explosion of infections. In the past week, Europe has averaged about

Diversity emerges as key challenge for coronavirus drug trials

The coronavirus pandemic has hit disproportionately hard in Black and Hispanic communities, where infection rates and death rates have reached staggering levels. 

But as scientists race to develop vaccines against the SARS-CoV-2 virus and treatments for the COVID-19 disease it causes, many trials are struggling to enroll people from those very communities.

Government and private sector scientists trying to enroll tens of thousands of Americans in a handful of studies of potential coronavirus vaccines are working overtime to reach out to underrepresented communities. But they have reported running up against rumors and misinformation in minority communities in places like Seattle and New York City, where mistrust remains deeply rooted. 

That mistrust comes from America’s long history of discrimination against minority groups, some of whom have been used as human guinea pigs for sadistic experiments.  

The U.S. Public Health Service denied treatment to 600 Black men who had syphilis, even after penicillin became a widely available treatment, in the gruesome Tuskegee experiments. Native Americans were forced to undergo sterilization procedures, and some were used to test dangerous new pharmaceuticals. 

To many, that history is all too recent. Surveys conducted by the Pew Research Center and the Robert Wood Johnson Foundation in recent years have found both Black Americans and Native Americans are less trusting of medical doctors than are whites. 

“There are countless examples that all get pushed into a general well-founded feeling that when people are coming to do experiments or trials in Black communities, maybe there’s an ulterior motive,” said Prabhjot Singh, a health systems expert at the Arnold Institute of Global Health.

Enrolling a diverse set of patients and volunteers in trials is both a scientific and cultural imperative, said some of those involved in designing trials today.  

On the scientific side, so little is known about the way the coronavirus attacks the body and the way COVID-19 manifests that diversity — in age groups, ethnic groups and even socioeconomic status — is necessary to learn who is at risk of serious or severe symptoms. 

Some diseases strike certain ethnic groups more than others. People of African descent, Hispanic descent and Middle Eastern descent are more likely to be impacted by sickle cell disease. Some cardiovascular drugs are less effective in people of Asian descent than in those of European origin. 

Studies that include a diverse range of people can identify whether a vaccine would have different safety and efficacy profiles among different racial or ethnic groups. The goal, scientists said, is to develop treatments that work for everyone, even if that means different groups respond better to one treatment over another. 

“Having a clear representation of different minorities in these trials, you can ensure a vaccine is working across populations,” said Alejandro Cané, head of Vaccines Medical and Scientific Affairs at Pfizer. 

On the cultural side, enrolling a diverse range of people during the trial phase can lead to a broader acceptance once a vaccine or treatment is approved and becomes widely used.

“There is an element

Global Precision Medicine Market 2020 with (COVID-19) Impact Analysis, Product Type, Application, Key Manufacturers, Regions and Forecast to 2025

The MarketWatch News Department was not involved in the creation of this content.

Sep 29, 2020 (CDN Newswire via Comtex) —
A wide-ranging analysis report titled Global Precision Medicine Market 2020 by Company, Regions, Type and Application, Forecast to 2025 provides a brief overview of the market covering the scope, size, disposition, and growth of the industry. The report presents an estimate of the current market scenario and data related to the competitive landscape of the industry. It delivers five-year industry forecasts, growth rates, and an analysis of the industry key players and their market shares. The report shows information regards to several regions that have successfully established its position in the global Precision Medicine market. The geographical and competitive dynamics of this global market will help you get a comprehensive picture of the market.

An industrial chain, market measurements regarding revenue, sales, value, capacity, regional market examination, section insightful information, and the market forecast is provided. The report gives global Precision Medicine market share analysis, as well as analyzes market position, market share, and segmented revenue. Further company and financial overview, product portfolio, new project launched, recent development analysis are the parameters added with this report.

NOTE: Our analysts monitoring the situation across the globe explains that the market will generate remunerative prospects for producers post COVID-19 crisis. The report aims to provide an additional illustration of the latest scenario, economic slowdown, and COVID-19 impact on the overall industry.

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The report investigates the development, trends, and new entrants in the sector, with elaborate profiles of the leading companies operating in the market, including: Johnson & Johnson, Novartis, Illumina, IBM, Thermo Fisher Scientific, GE Healthcare, Almac Group, Laboratory Corporation of America Holdings, Roche, Abbott Laboratories, Randox Laboratories, Intel Corporation, Healthcore, Qiagen, Biomrieux Sa, Cepheid

In market segmentation by types, the report covers: Diagnostics, Therapies

In market segmentation by applications, the report covers the following uses: Oncology, Neurosciences, Immunology, Respiratory, Others

The report provides a 5-year forecast (2020-2025) assessed based on how the global Precision Medicine market is predicted to grow in major regions like: North America (United States, Canada and Mexico), Europe (Germany, France, UK, Russia and Italy), Asia-Pacific (China, Japan, Korea, India, Southeast Asia and Australia), South America (Brazil, Argentina), MENA (Saudi Arabia, UAE, Turkey and South Africa)

Industry Size & Forecast: The report offers estimations on the global Precision Medicine market industry size on the basis of value and volume are provided in this part of the report. This report offers deep insights into the prevailing and upcoming market trends. Then it has examined the high-growth segments including product type, application, and end-users, taking into account their CAGR, share, and size. Market developments and future opportunities estimated to emerge in the market industry are looked into in this study. The forecasts are provided taking into consideration product, application, and regional segments of the market.

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A Peek At Over the Highlights of the Report:

  • The study provides a synopsis