Category: Covid-19 Vaccine

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Interested in testing a COVID-19 vaccine? Austin-based research company is seeking participants - KXAN.com

Johnson & Johnson said Thursday it plans to begin the first human studies of its experimental coronavirus vaccine next week, as it races to make the shot available starting early next year.

The New Brunswick, N.J., companys initial study will aim to enroll more than 1,000 healthy adults, starting first in Belgium on July 22 and then the following week in the U.S. Researchers will assess the vaccines safety and ability to induce an immune response, J&J Chief Scientific Officer Paul Stoffels said Thursday on a conference...

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Johnson & Johnson Readies to Start Covid-19 Vaccine Studies - The Wall Street Journal

The first COVID-19 vaccine tested in the U.S. revved up people's immune systems just the way scientists had hoped, researchers reported Tuesday. The shots are poised to begin key final testing.

"No matter how you slice this, this is good news," Dr. Anthony Fauci, the U.S. government's top infectious disease expert, told The Associated Press.

The experimental vaccine, developed by Fauci's colleagues at the National Institutes of Health and Moderna Inc., will start its most important step around July 27: A 30,000-person study to prove if the shots really are strong enough to protect against the coronavirus.

But Tuesday, researchers reported anxiously awaited findings from the first 45 volunteers who rolled up their sleeves back in March. Sure enough, the vaccine provided a hoped-for immune boost.

Those early volunteers developed what are called neutralizing antibodies in their bloodstream molecules key to blocking infection at levels comparable to those found in people who survived COVID-19, the research team reported in the New England Journal of Medicine.

"This is an essential building block that is needed to move forward with the trials that could actually determine whether the vaccine does protect against infection," said Dr. Lisa Jackson of the Kaiser Permanente Washington Research Institute in Seattle, who led the study.

There's no guarantee but the government hopes to have results around the end of the year record-setting speed for developing a vaccine.

"Our goal is to have a vaccine available for broad distribution by year-end or early next year," Moderna president Stephen Hoge told "CBS This Morning" in May, after seeing preliminary data on the Phase 1 trial. "If we and others build data that shows that the vaccine has a potential for benefit, that it's safe and has a potential for efficacy, then, of course, there are circumstances where the vaccine could be deployed to high-risk populations earlier under something called an Emergency Use Authorization. Really though, that's a decision that regulators, in particular the FDA, have to make."

The vaccine requires two doses, a month apart.

There were no serious side effects. But more than half the study participants reported flu-like reactions to the shots that aren't uncommon with other vaccines fatigue, headache, chills, fever and pain at the injection site. For three participants given the highest dose, those reactions were more severe; that dose isn't being pursued.

Some of those reactions are similar to coronavirus symptoms but they're temporary, lasting about a day and occur right after vaccination, researchers noted.

"Small price to pay for protection against COVID," said Dr. William Schaffner of Vanderbilt University Medical Center, a vaccine expert who wasn't involved with the study.

He called the early results "a good first step," and is optimistic that final testing could deliver answers about whether it's really safe and effective by the beginning of next year.

"It would be wonderful. But that assumes everything's working right on schedule," Schaffner cautioned.

And Tuesday's results only included younger adults. The first-step testing later was expanded to include dozens of older adults, the age group most at risk from COVID-19. Those results aren't public yet but regulators are evaluating them, and Fauci said final testing will include older adults, as well as people with chronic health conditions that make them more vulnerable to the virus and Black and Latino populations likewise affected.

Nearly two dozen possible COVID-19 vaccines are in various stages of testing around the world. Candidates from China and Britain's Oxford University also are entering final testing stages.

The 30,000-person study will mark the world's largest study of a potential COVID-19 vaccine so far. And the NIH-developed shot isn't the only one set for such massive U.S. testing, crucial to spot rare side effects. The government plans similar large studies of the Oxford candidate and another by Johnson & Johnson; separately, Pfizer Inc. is planning its own huge study.

Already, people can start signing up tovolunteerfor the different studies.

People think "this is a race for one winner. Me, I'm cheering every one of them on," said Fauci, who directs NIH's National Institute of Allergy and Infectious Diseases.

"We need multiple vaccines. We need vaccines for the world, not only for our own country."

Around the world, governments are investing in stockpiles of hundreds of millions of doses of the different candidates, in hopes of speedily starting inoculations if any are proven to work.

Originally posted here:

Moderna's coronavirus vaccine ready to advance to final phase of testing - CBS News

]]> How to overcome the market failure in developing novel antibiotics? Credit: Shutterstock.

Sign up here for GlobalData's free bi-weekly Covid-19 report on the latest information your industry needs to know.

More than 20 major biopharmaceutical companies, the World Health Organization (WHO), the Wellcome Trust and the European Investment Bank (EIB) have launched the antimicrobial resistance (AMR) Action Fund to help stop the world losing its most powerful tool in healthcare.

This initiative, which is coordinated by trade association the International Federation of Pharmaceutical Manufacturers & Associations(IFPMA), has raised nearly $1bn to respond to the AMR threat. This funding, and technical support from big pharma, will be used to strengthen and accelerate antibiotic development.

The WHO predicts that AMR could claim 10 million lives per year by 2050 and cause a global economic recession as large as the 2008 financial crisis.

AMR is a slow tsunami that threatens to undo a century of medical progress, said WHO director general Dr Tedros Adhanom Ghebreyesus at an IFPMA launch event. Antibiotics are truly game-changing medicines that are used to support cancer treatment and organ transplantation, as well as protect people from deadly infectious diseases, such as human immunodeficiency virus (HIV), malaria and tuberculosis (TB).

This situation has emerged because of the overuse and misuse of antibiotics. This has been exacerbated by the lack of economic incentives for pharma companies to invest in infectious disease research. The aim of developing novel antibiotics is that they will be used as a last resort as bacteria develop resistance, but this means it is incredibly hard for pharma, or investors, to make back their research and development (R&D) costs, let alone make a profit on antibiotics.

As a result, IFPMA director general Thomas Cueni noted there has not been a new class of antibiotics developed since the 1980s.

Although tackling AMR is something that has been high on the agenda of international organisations for almost a decade, since Jim ONeills AMR review was published in 2014, there has been limited progress so far.

However, Covid-19 has put a spotlight on the flaws in the infectious disease treatment landscape. In the last six months, almost 600,000 people have died from Covid-19, while approximately 700,000 die every year as a result of drug-resistant infections.

Covid-19 has posed an unprecedented challenge, but AMR is another challenge we now need to face, explained Bayer president of pharmaceuticals Stefan Oelrich at the IFPMA launch.

Science and industry needs to ensure the world is better prepared for future and emerging health threats, added Merck Group chairman and CEO Stefan Oschmann. GlaxoSmithKline CEO Emma Walmsley agreed, stating: The pandemic is teaching us many things, one is that the world needs to be better prepared for health threats.

Unlike Covid-19, AMR is a predictable and preventable crisis, said Cueni at the launch. We must act together to rebuild the pipeline and ensure that the most promising and innovative antibiotics make it from the lab to patients.

Over the past 12 months, the public and private sectors came together to form a coalition and a fund to overcome this market failure. Cueni declared: The AMR Action Fund is one of the largest and most ambitious collaborative initiatives ever undertaken by the pharmaceutical industry to respond to a global public health threat.

Expected to be operational in the fourth quarter of 2020, the main focus of the AMR Action Fund is to use the $1bn committed to invest in promising small biotechs working on developing innovative antibiotics; the aim is to bring between two and four new antibiotics to the market by 2030.

Companies that receive funding will be determined by an independent scientific advisory board, which will aim to invest in particularly innovative approaches and focus on pathogens on the WHOs 2017 priority list. In addition to TB, which is a serious public health threat, other bacteria on the WHOs critical priority list include those that are a large threat in hospitals: Acinetobacter,Pseudomonasand various Enterobacteriaceae, such as E.coli.

The AMR Action Funds portfolio companies will also benefit from the technical support, expertise and resources from the pharma industry supporters of the fund. This will help to optimise a biotechs chance of success in the antibiotics field.

Although the AMR Action Fund is focusing on improving antibiotics R&D, it will not fully solve the issue of creating a long-term viable economic model for bringing antibiotics to market.

This is may be an important first step in the right direction, as Dame Sally Davies, the UKs Special envoy on AMR, noted at the funds launch. However, Cueni stated that the next debate needs to be about incentives and the longer-term problems. The fund has created push incentives on the R&D side, but then we need pull incentives from the business model, said European Federation of Pharmaceutical Industries and Associations (EFPIA) director general Nathalie Moll at the launch.

Oschmann added that a system that would only pay for consumption would be wrong and that the industry, patients and public health stakeholders need to work together to overcome this next challenge.

The AMR Action Fund will support innovative antibiotic candidates through the most challenging later stages of drug development, ultimately providing governments time to make the necessary policy reforms to enable a sustainable antibiotic pipeline, added IFPMA president and Eli Lilly CEO and chairman David Ricks.

There is already starting to be a shift from policymakers around changing the business model for antibiotics. A noteworthy example is the UK Governments scheme to create a subscription-style payment model for antibiotics. This initiative was announced in 2019 as part of the UKs five-year national action plan on AMR and officially launched in mid-June 2020.

In this model, the National Health Service (NHS) will pay companies upfront for access to their antibiotic product and the price will be based on its value to the NHS, not how much is used. The government hopes the first antibiotics will be available to patients under this model by 2022.

In a statement, Davies noted: Governments and industry must work together to produce new antibiotics and ensure that we can continue to treat common diseases.

The UK is leading the way by encouraging companies to produce new antibiotics to stay one step ahead of life-threatening diseases.

UK Secretary of State for Health and Social Care Matt Hancock added: This new way of buying antibiotics for patients in the NHS breaks down restrictive barriers to offer companies a vital springboard to foster innovation and develop potentially life-saving new products.

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Covid-19 pandemic: the need for second-generation vaccines - Pharmaceutical Technology

To the Editor:

Re A Vaccine Doesnt Work if People Dont Take It (Sunday Review, July 12):

I thank Dr. Phoebe Danziger for her thorough and persuasive argument in favor of a more concerted effort to educate the population about the importance of vaccinations. I wholeheartedly agree that the approach needs to change, engaging social and religious leaders as well as medical professionals.

However, her article identifies but never provides an answer for the primary reason I will wait before vaccinating myself and my family: the deeply corrupt, anti-science government that President Trump has created.

Through intimidation, bullying and threats to fire those who disagree, he has created a Centers for Disease Control and Prevention that is amending its health guidelines within hours of an angry tweet, he has promoted harmful and phony cures, and he has awarded a $1.6 billion vaccine contract to a pharmaceutical company that has never successfully brought a product to market.

Under these conditions, who can possibly trust that the first vaccine to emerge from Operation Warp Speed (a name that also does not imply careful and meticulous work) will have undergone the proper testing and scrutiny that other vaccines have?

I do not doubt the hard work and integrity of the many scientists and doctors who are working on this. But the last few months have given me no reason to trust the government that regulates their work. I have given my young daughter every vaccine recommended by her pediatrician, without a second thought. I will most definitely not be first in line for this one not until Mr. Trump and his crooked team are swept out of office. I believe in science. This administration does not.

Pian RockfeldNew York

To the Editor:

Dr. Phoebe Danziger lays out a number of difficulties in recruiting the large numbers of people needed to accept a Covid-19 vaccine, and thus make it truly effective.

Sorry to add to the problems she outlines, but I would include older Americans among those with concerns. Many drug trials have historically eschewed using older people or those with any pre-existing conditions during drug trials. As a result, we have little way of knowing if a positive effect in children and younger adults will hold true with senior citizens.

I believe in vaccines and I see the complexities. Transparency, clarity about risks and benefits, and a medical-political alliance in communicating are essential. We dont have that now, not even close.

Mary Anne LusheWalled Lake, Mich.

To the Editor:

I agree with Dr. Phoebe Danziger that some strategies, such as green vaccines or coalitions of persuasive leaders, may influence some of those whose distrust of science, government or the world in general would lead them to avoid vaccination. I think what will work to persuade hard core anti-vaxxers is a daily scorecard: Of the people who present with disease, how many of the sick were vaccinated against the disease versus how many were not? If you want to protect yourself and your child, which group do you think you should join?

Joyce AdamsPortland, Ore.

To the Editor:

I know several people who refuse to take vaccines. Sadly, I will miss them!

I. Milton KarabellPhiladelphia

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Waiting for a Covid-19 Vaccine, and Worrying About It - The New York Times

CLEVELAND Cleveland is among dozens of cities where researchers need volunteers to participate in a Phase III clinical trial to evaluate the efficacy, safety, and immunogenicity of mRNA-1273 to prevent COVID-19, according to ClinicalTrials.gov.

The lead sponsor of the study, ModernaTX, Inc. announced it needs 30,000 participants from various cities, including Cleveland and Cincinnati.

A Phase III trial is the final phase in a vaccine's development before it is approved and licensed, during which the vaccine is given to thousands of people and tested for efficacy and safety, according to the CDC.

The study is scheduled to begin on July 27, with an estimated completion date on October 27, 2022.

Anyone 18 and up is eligible to participate in the study. Other criteria includes:

Inclusion Criteria:

Rapid Medical Research is the only local place participating in the Moderna study. It says it will be actively recruiting 300 people from Northeast Ohio.

"You could really be part of a life-saving, world saving vaccination, said Jade Svoboda, the recruitment manager at Rapid Medical Research.

Each participant will meet with a team of doctors seven times over 25 months, according to Svoboda. The Beachwood based company does compensate its clients.

To get in touch with Rapid Medical Research call 216-508-4400 or head to their website.

To find more information about this study, including exclusion criteria, click here.

If you are interested in participating in the study, contact Moderna Clinical Trials at 855-663-6762 or at clinicaltrials@modernatx.com.

RELATED: Study: Could your blood type indicate severity of COVID-19

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Phase III COVID-19 vaccine study seeking volunteers in Cleveland and dozens of other US cities - News 5 Cleveland

As the Centers for Disease Control and Prevention (CDC) is exploring race as a factor for consideration in the prioritization of COVID-19 vaccination receipt, the agency must use lessons from its own past to help guide communication efforts.

In 2001 when letters containing anthrax were mailed to Sens. Tom Daschle (D-S.D.) and Patrick LeahyPatrick Joseph LeahyHouse panel wraps up lightning-fast appropriations for 2021 CDC has to get the messaging right with the COVID-19 vaccine Finger-pointing, gridlock spark frustration in Senate MORE (D-Vt.), two vastly different populations were affected in Washington, DC Brentwood Post office employees, who were predominately Black, and Hart Senate Office staff, who were mostly white.

Focus groups with these two groups revealed stark differences in their perception of the CDCs public health response. Many of the Brentwood postal workers felt significant racial and economic disparities in treatment, often due to simple issues of miscommunication.

When a vaccine for anthrax was offered, it was viewed with significant mistrust often due to inconsistent public health messaging, especially among the postal worker population.

Undoubtedly, anthrax is very different from COVID-19. For anthrax, there was an effective antibiotic treatment with a previously developed vaccine offered only as an alternative after exposure.

The COVID-19 vaccine, if successfully developed, will be a new approach to prevention. However, both diseases involve changing recommendations in the face of uncertainty and hence require nuanced public health responses.

A number of factors affect the decision to receive a vaccine, including risk perception, safety concerns and availability. However, mistrust plays a major role in vaccine uptake, especially when that vaccine is considered novel without a history of prior use.

Much of the mistrust in the medical system existing within communities of color has roots in another CDC led project the Tuskegee Syphilis Study. In Tuskegee, 399 Black men were left untreated with latent syphilis for 40 years, even after the discovery of penicillin, safe and effective treatment of the disease. This study and others have left a long legacy affecting the willingness of people of color to obtain life-saving medical treatment for a wide variety of conditions ranging from cancer to HIV.

Today, 40 percent of Blacks cite that they would not get the COVID-19 vaccine if offered, despite the virus exhibiting a significant toll on this population.

Blacks have been previously shown to be less likely to participate in drug trials.

However, blacks are overrepresented in studies that do not require informed consent, based on a 1996 Food and Drug Administration exception allowing enrollment in cases of incapacitation.

This is not necessarily a bad thing. Such exceptions are needed to make advances for potentially life-saving therapies when a patient is critically ill. However, the discrepancy in these statistics highlights a significant finding. When it comes to communities of color, efforts for recruitment may be blunted unless in the most convenient of cases and the benefits of cutting edge research may be one-sided.

In the case of COVID-19, we must ensure that the knowledge gained from the early use of the vaccine is universal. This includes recruiting diverse participants to clinical trials of the vaccine to understand whether it is equally effective across race, ethnicity, gender, and among groups with various co-morbid medical conditions.

This involves taking the time to have a thoughtful discussion with individuals about the study process, including the use of culturally appropriate approaches to recruitment and the employment of diverse research staff. It is also critical that communities of color be engaged in giving input about such recruitment early in the planning process.

Once the vaccine has been proven to be effective and is available, we must provide equitable access to the vaccine to these same communities. This should not be simply based on who has the strongest lobbying power but instead take into consideration those individuals who may benefit from the vaccine, yet whose voices may not be represented among special interest groups.

I have faith that the CDCs intentions are good, however, more than ever it is important for the agency to invest in a significant public health communication strategy directed at individuals of all racial and ethnic backgrounds. The CDC has an opportunity to make a difference. Lets make sure we get the messaging right this time.

Janice Blanchard, M.D., Ph.D., is a professor of emergency medicine at George Washington University. The opinions expressed are her own.

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CDC has to get the messaging right with the COVID-19 vaccine | TheHill - The Hill

Reuters reports that the leading USexpert on infectious diseases, Dr. Anthony Fauci, predicted on Wednesday the country will meet its goal of a coronavirus vaccine by year's end and was unmoved by the prospect that China would get there first.

While there are no guarantees,

I feel good about the projected timetable,

Fauci told Reuters in an interview.

His comments follow promising early-stage data for the Moderna Inc's coronavirus vaccine, released on Tuesday, that was developed by scientists at the National Institute of Allergy and Infectious Diseases, which Fauci directs.

Fauci also said Moderna's results were especially promising because the vaccine appeared to offer the type of protection seen in a natural infection.

One of the things that you hope for is that your vaccine induces a response that's comparable to a natural infection, because theoretically, the best vaccine you could possibly ever get is a natural infection.

Reuters explained that "Moderna's candidate, which is set to enter the last stage of testing on July 27, is just one of more than a hundred vaccines in development globally, but only one of a few contenders that have earned millions of dollars in backing from Operation Warp Speed, the White House program that aims to deliver more than 300 million doses of a safe and effective COVID-19 vaccine by January."

The market reaction to these comments from Fauci was muted considering the news dropped yesterday that there are promising signs with the vaccine following results of the test on 45 volunteers which revved-up andimproved their immune systems.

Many experts see a safe and effective vaccine as the only way out of the pandemic that has infected millions and killed more than 575,000 people worldwide.

However, the statements made todayshould cement the improved risk-on themes in markets as we run into key economic data released today from China and ahead of US Retail Sales and the European Central Bank, likely playing second fiddle, however, to the EU summit this weekend.

Inflation pressures will be the theme fs the vaccine rubber hits the road, a topic discussed in the following usual suspectsearlier today:

Gold prices march-on above a key support structure as inflation expectations ramp-up

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Breaking: US will have effective Covid-19 vaccine by year-end Fauci - FXStreet

TUCSON (KVOA) - Quality of Life Medical and Research Center in Tucson is one of 87 national clinics to be conducting trials of a COVID-19 vaccine.

As of Tuesday, Arizona has reported 128,097 confirmed cases of COVID-19, and 2,337 known deaths.

Moderna's mRNA-1273 COVID-19 vaccine is set to begin its third phase of trials at 87 clinics throughout the country. The study aims to look at 30,000 people who are at high-risk for contracting the new coronavirus.

The vaccine is being developed to prevent COVID-19 by producing antibodies to the virus.

If you would like to take part in the study, contact your doctor along with Quality of Life Medical Research Center in Tucson at COVID19@QLMC.com or at 520-731-2333.

For more information on COVID-19 studies, visit Clinicaltrials.gov.

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COVID-19 vaccine testing to begin in Tucson - KVOA Tucson News

First COVID-19 vaccine tested in US produced antibodies in all patients during trial  FOX 32 Chicago

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First COVID-19 vaccine tested in US produced antibodies in all patients during trial - FOX 32 Chicago