Flood Warning...a Flood Warning Continues For Portions Of The Following Waterways In Indiana... East Fork White River...wabash River...white River... .flooding Continues Along The Major Rivers In Central And Southern Indiana As A Result Of Multiple Rounds Of Heavy Rainfall Over The Latter Half Of Last Week. Estimated Rainfall Amounts Totaled Between ...Read More.Effective: March 24, 2020 at 11:26amExpires: March 28, 2020 at 2:00pmTarget Area: Lawrence; Martin
Flood Warning...a Flood Warning Continues For Portions Of The Following Waterways In Indiana... East Fork White River...wabash River...white River... .flooding Continues Along The Major Rivers In Central And Southern Indiana As A Result Of Multiple Rounds Of Heavy Rainfall Over The Latter Half Of Last Week. Estimated Rainfall Amounts Totaled Between ...Read More.Effective: March 24, 2020 at 11:26amExpires: March 28, 2020 at 8:00pmTarget Area: Lawrence; Martin
Flood Warning...a Flood Warning Continues For Portions Of The Following Waterways In Indiana... East Fork White River...wabash River...white River... .flooding Continues Along The Major Rivers In Central And Southern Indiana As A Result Of Multiple Rounds Of Heavy Rainfall Over The Latter Half Of Last Week. Estimated Rainfall Amounts Totaled Between ...Read More.Effective: March 24, 2020 at 11:26amExpires: March 28, 2020 at 11:00pmTarget Area: Lawrence; Martin
Last week, the first volunteers in a study of an experimental COVID-19 vaccine received their first doses, and the vaccines developer, Moderna Therapeutics, is already thinking ahead. Although testing on the vaccine will take at least a year to complete, the work could provide valuable information about how the immune system can fight coronaviruses and could give scientists a head start if any new outbreaks of the virus were to occur.
Non-essential staff at Moderna Therapeutics manufacturing facility, in Norwood, Mass., including president Dr. Stephen Hoge, are working from home as recommended by public health officials, but those involved in manufacturing what may be the first vaccine against the novel coronavirus are ready to scale up production if the first phase of testing on the vaccine shows that its safe.
The vaccine will be studied first in a group of 45 healthy volunteers, who have not been infected with SARS-CoV-2, the virus that causes COVID-19. In this group, scientists are looking to see if the shots are safe, and to test three different dosages to see which seems to activate the strongest immune response. If these initial subjects dont develop any severe side effects or reactions, then researchers will recruit hundreds more healthy volunteers to confirm those results,
For the first phase, Moderna shipped hundreds of vials of the test vaccine to the National Institutes of Health (NIH), which is overseeing the study in multiple centers in the US. For the next, says Hoge, it will be several fold, maybe five-fold larger than the first phase. We are talking thousands of vials.
And if the vaccine proves not just safe, but also successful, the company is preparing for an anticipated incredible demand to scale up the vaccine very, very quickly, Hoge says, we have already started to do work to scale up to producing millions of doses.
Thats made possible, in part, by the non-traditional technology used to make this particular vaccine. Moderna uses mRNA, a genetic form of the virus genome, in its vaccine. When its injected into people, cells then process it so immune cells can recognize it and target it for destruction. Unlike the processes used to make most traditional vaccines, this method does not require growing huge amounts of the virus, which is time-consuming.
Its also why the vaccine was developed in record time. Chinese researchers first posted the genetic sequence of SARS-CoV-2 in mid-January, and by Feb. 7, Moderna had vials of the vaccine ready for the standards-testing needed before the treatment could be cleared for human trials. By the last week of February, that was completed and the company sent vials to NIH for further review by its scientists. Then both Moderna and NIH filed for a request to the Food and Drug Administration, which regulates trials of experimental therapies, to start injecting the vaccine in people for human testing.
Hogue is hopeful that his team can continue to shave valuable time off the process while producing a safe and effective vaccine. The original goal when Dr. Anthony Fauci [director of the NIHs National Institute of Allergy and Infectious Diseases] first announced the vaccine, was to get it into humans in roughly three months. We managed to do that in 63 days, so we already demonstrated the ability to move a little faster than expectations, he says. We have an ethical responsibility to build the data and show the vaccine is safe and effective, and to do that in a sequential way. Still, every chance we have to continue to demonstrate that we can pull the timeline in, we will take.
Testing on patients who have contracted the virus may still be months away, and Fauci predicts that the trials may not conclude for another 12-18 months. But in the meanwhile, every week, day and minute count. From the very beginning, this was a race, a race against the virus, says Hoge. If there is anything we learned in the past month, its that we need to keep pressing every time advantage that we can.
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In an exclusive interview on Sunday Morning Futures, Alex Gorsky, the CEO of Johnson & Johnson,discussed his companys efforts to develop a vaccine for COVID-19, saying, I think well have important data by the end of the year.
Gorsky discussed the goals as many hospitals have beenoverwhelmed amid the coronavirus pandemic, with officials saying they wererunning out of protective gear and ventilators to keep up with the influx of patients infected with the novel coronavirus.
Last month, Johnson & Johnson announced that its Janssen Pharmaceutical Companies would further expedite its investigational coronavirus vaccine program through an expanded collaboration with the Biomedical Advanced Research and Development Authority, part of the Department of Health & Human Services Office of the Assistant Secretary for Preparedness and Response.
Company executives also said last month that in addition to Janssens efforts to develop a vaccine, it was working closely with global partners to screen its library of antiviral molecules to accelerate the discovery of potential COVID-19 treatments in an effort to provide relief for patients around the world.
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Host Maria Bartiromo noted on Sunday that Johnson &Johnson will be conducting human clinical trials for the COVID-19 vaccine thisNovember.
The most important thingthat we can do is stop the virusfrom occurring in the firstplace, Gorsky told Bartiromo. I want to highlight the effortsof our science system around theworld who really, back in lateDecember and early January... quickly ramped up in aprocess that can typically take anywherebetween five to seven years, and theywere able to do it in a matterof weeks and months.
He went on to say that Johnson & Johnson was working hard with partners around the world including the Food and Drug Administration [FDA], academic institutions and theorganizations responsible forvaccines in the United States and in Europe, to do everythingwe can to accelerate thedevelopment.
We continue to runour different clinical trials, he continued. We expect to be starting upvery soon, likely within the nextmonth, and I think well haveimportant data by the end ofthe year.
He added that in addition to finding a working vaccine, the other really important component would be to have an adequate supply.
Right now, we are makingvery significant investment,somewhat at risk, knowing that weneed to have adequate supply inparallel with knowing that thevaccine actually works, he said.
When Bartiromo asked Gorsky if he was willing to takehis supply chain entirely backto America instead of relying on China foractive ingredients inprescription drugs, he responded, I think the facts are that most of the large companies now havelarge global integrative supplychains.
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I think we also recognize thatthis crisis provides us with anopportunity to make sure that wehave always got supplies, notonly on the global basis, but also ona national basis, he continued.I think what we want to bethoughtful of, as we go throughthis in [the] short-term, that weprioritize making sure that were getting the supplies thatwe need, and then, longer-term... the important changes andtransitions that we need to make in ourcurrent system to make sure itis protected.
Fox Business' Maria Bartiromo contributed to this report.
Former New York City Mayor Michael Bloomberg is being sued after backing out of a plan to employ his 2020 staffers through the November election.
Three former Bloomberg campaign organizers on Monday sued him for fraud, saying his campaign rescinded its promise to pay 2,000 employees through November even if he didn't win the Democratic nomination, Politico reports. After laying off staffers last week, Bloomberg said he would be transferring $18 million to the Democratic National Committee rather than form an independent super PAC as planned.
"The Mike Bloomberg 2020 hiring managers expressly promised field staff applicants for Mike Bloomberg 2020 that they would be employed by Mike Bloomberg 2020 to perform work on the primary campaign to elect Michael Bloomberg as the Democratic nominee and on the general election, regardless of whether Bloomberg won the nomination, and stated that the Bloomberg campaign would keep open and financially support its field offices through the general election campaign," the lawsuit says.
Another former Bloomberg worker also filed a proposed class-action lawsuit on Monday for the same reason, The New York Times reports. A lawyer for former Bloomberg field organizer Donna Wood said he deprived these workers "of promised income and health care benefits, leaving them and their families potentially uninsured in the face of a global pandemic."
Hiring materials used by the Bloomberg campaign promised "employment through November 2020 with Team Bloomberg," Politico reports, although according to the Times, signed contracts "stipulated that employment was at-will, allowing for termination at any time." According to Politico, the former staffers "argue in the lawsuit that they can bring these claims based on evidence that they were induced to sign on because of the longevity promises made to them."
Former Bloomberg staffers had blasted the former mayor last week after he announced he was backing out of his super PAC plan, with one telling the Times, "I'm so sorry I worked for this guy." Brendan Morrow
A message circulating on WhatsApp claims that US scientists have developed a vaccine for coronavirus. It claims that President Donald Trump has announced that Roche Medical Company will launch the vaccine this sunday. Great news! Carona virus vaccine ready. Able to cure patient within 3 hours after injection. Hats off to US Scientists. Right now Trump announced that Roche Medical Company will launch the vaccine next Sunday, and millions of doses are ready from it, reads the viral message.
It is also viral on Twitter and Facebook.
Alt News has received several requests on its official Android application to fact-check the claim.
First of all, no vaccine has yet been developed for coronavirus but is still either in the trial stage or research is underway. Alt News had earlier debunked a video which was claimed to be the announcement of the launch of coronavirus vaccine manufactured by drugmaker Roche. A clipped video of the press conference, where CEO of Roche Diagnostics spoke about testing and NOT the vaccine, was shared on social media. You can read our detailed fact-check here.
Does the photo represent coronavirus vaccine?
A Google search revealed that its not a vaccine but a test kit for the novel coronavirus, technically known as SARS-CoV-2. SGTi-flex COVID-19 IgM/IgG is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19s IgM and IgG antibodies in human whole blood (finger prick or venous), serum or plasma., says the website of the test kit manufacturer Sugentech. According to the about-us section, Sugentech, a Republic of Korea-based manufacturer, develops in-vitro diagnostic systems and products based on BT-IT-NT convergence technology.
SD Biosensor is another Republic of Korea-based company which manufactures test kits for qualitative presumptive detection of specific IgM and IgG to 2019 novel coronavirus.
Therefore, an image of a novel coronavirus test kit was shared on social media to claim that US scientists have developed a vaccine for COVID-19 and that Swiss drugmaker Roche Diagnostics will launch the vaccine next Sunday.
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Over last several decades, vaccination has saved millions of lives. Vaccination is one of the most effective ways to prevent diseases and illnesses.
A worldwide vaccination programme helped eradicate smallpox in 1977. In 1796, an English physician, Edward Jenner, observed that milkmaids who had contracted cowpox from cows were not getting infected with smallpox. He inoculated an 8-year old boy with the pus from cowpox blisters and the concept of vaccination was born. Jenner coined the term vaccination aftervacca, the Latin word for cow. Vaccines come in many forms. Jenner used a live virus in his vaccine. Another type of vaccine uses viruses rendered inactive chemically or by heat or by radiation. The most famous example of this is the polio vaccine.
The vaccination is now a beacon of hope against novel coronavirus disease (COVID-19) that is rampaging across the globe spreading fear and death.
How Does Vaccination Help Fight Diseases?
Pathogens, the collective name in medical jargon for viruses, bacteria, microbes and all such nasty organisms responsible for our suffering, have proteins known as antigens on their outer surfaces. When pathogens invade our body, the immune system recognises these antigens and start preparing for a battle to get rid of the invaders. Vaccines are biological preparations of targeted antigens, which when introduced into our body, confer immunity, often lifelong, against a specific disease. Vaccination helps the immune system remember what to do should the real virus appear. A high vaccination rate in a community also confers protection through the phenomenon of Herd Immunity. 25 vaccines are currently available against deadly diseases like chickenpox, rabies, diphtheria, tetanus, measles, rubella, hepatitis.
Vaccines made from the whole pathogens, live or dead, were very effective in provoking the desired immune response in our bodies. But they were not completely safe. A new class of vaccines, called subunit vaccines, solved this problem by using only a part of the pathogen, specifically a protein derived from it. Conjugate vaccines linked this isolated protein chemically with a carrier protein and because of their high safety levels became the mainstay of infant immunisation programmes. The improvement in safety, however, came at a loss of efficacy. To boost the effectiveness, ingredients called adjuvants are added to vaccine formulations. Another important requirement of vaccines is their thermal stability during transportation and storage. This requires a reliable refrigeration system.
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The progression of a vaccine from development to commercial production is arduous and strewn with failures. Vaccines have to go through a daunting process of pre-clinical and clinical trials. Pre-clinical trials are carried out on animals. Clinical trials are in 3 phases. The first phase establishes its safety. During phase 2 trials, scientists determine if the vaccines really protect and if there are any side reactions. And in phase 3, the viability of large scale manufacturing is established. All these trials have to be carried out under the watchful eyes of the regulatory authorities.
Large-scale manufacturing of vaccines is a complex process consisting of many steps. It starts with growing the selected animal or bird cells through a process of fermentation in a series of bioreactors under a precisely controlled environment. When the cells have grown to a desired number, they are infected with the target pathogen. When the pathogens have multiplied adequately, they are harvested from the growth medium. Next comes a series of stringent purification steps. Vaccines are administered to millions of perfectly healthy people and hence the quality requirements are exceedingly stringent. Impurities from the glass of vials in which they are finally filled and their rubber stoppers are also a matter of concern.
First-generation vaccines were very effective, but we did not fully understand their mechanism. With improved knowledge of molecular biology, the science of vaccines has evolved. In 1980s, genetic engineering was used to make a recombinant vaccine. This involved introducing the DNA from the target virus into another virus to produce the active ingredient for the vaccine. This technique was successful for the vaccine against Hepatitis B. The logical advancement of this approach was to consider introducing the DNA or RNA containing the requisite genetic information to build the antigen in our body itself. Our bodies could be converted into in-situ vaccine factories. The advantages of such an approach are enormous. These include improved immunity response, better thermal stability, absence of infectious contaminants and relative ease of large-scale production.
Also Read |From Critical Drugs To Auto Parts, Zips To Solar Panels, How Coronavirus Has Hit Supply Chain
Vaccine Trials for Coronavirus
Trials are underway in more than a dozen laboratories across the world to develop a vaccine for coronavirus.
Though none of the DNA or RNA based vaccines have been granted a commercial license so far, they are our best bet against the ravaging SARS-CoV-2 virus. Many of the current trials underway have adopted this approach. Moderna Therapeutics of USA created an industry record by identifying the vaccine candidate just 42 days after the genomic sequence of the virus was announced. The companys product is a synthetic RNA that will persuade our immune system to create antibodies that will fight SARS-CoV-2. Other biotech companies are trying out techniques that are very similar to that of Moderna. A Japanese company is attempting to make a vaccine out of antibodies harvested from the blood of those who have recovered from COVID-19. These novel approaches to fight the novel coronavirus could be the harbinger of a new vaccine technology that will save the human race from similar scourges in the future.
(The author is a chemical engineer and a science writer.)
FROM THE MAGAZINE | Meet the Corona Warriors
There are some hard limits to the vaccine development process that mean we are not going to see any preventative immune therapies to fight the new coronavirus for at least a year to 18 months. But Moderna, which is behind the first potential vaccine to enter human clinical trials in the U.S., provided new info on Monday that indicates it will seek to provide access to the vaccine to a limited group, likely consisting of healthcare workers, by as early as this fall.
The company will look at possibly doing so under an emergency use authorization from the Food and Drug Administration, which is similar to how certain testing procedures are being granted approval for use now, bypassing the typical process under which such diagnostic tools are given the go-ahead. Modernas solution, which was developed in partnership with the National Institute of Allergy and Infectious Diseases, is already the fastest potential vaccine to enter the human clinical trial phase.
Their proposed vaccine makes use of messenger RNA, rather than relying on either a small or inactive sample of the COVID-19 virus itself the source of most existing effective vaccines. The mRNA method means there is no actual virus introduced to subjects who receive it, which in turn means that they are not at risk of actually contracting the virus from the vaccine itself, which can be an issue in the testing and development phase of any traditional virus-based immune therapy.
Last Monday, Moderna began providing the vaccine to volunteer participants in the first phase of its human clinical trial in Washington state. Despite the speed with which it entered human testing, and the unconventional bypass of the animal testing phase, commercial availability is still at least a year away. But select, limited use for healthcare professionals at an accelerated timetable could help provide additional protection for frontline workers who are risking greater exposure provided Modernas vaccine is effective, and proves safe in its current human testing.
Modernas solution works by convincing the body to generate proteins that resemble the virus but that are harmless, and provoke antibodies that are effective both in fighting off the protein and the actual virus itself. There are other RNA-based vaccines in development, as well as other types of immune treatments, but only Modernas has reached the clinical trial phase thus far. The Boston-based company has been working on mRNA-based treatments for cancer cells, and went public in December 2018.
Pharmaceutical companies are working around the clock to repurpose current medications and develop new therapies and vaccines to treat and prevent COVID-19. During a on-the-record discussion with reporters March 18, the life sciences industry detailed some of their most promising efforts.
During the Council on Foreign Relations sponsored discussion, President and CEO of Pharmaceutical Research and Manufacturers of America (PhRmA) Stephen Ubl said 80 clinical trials are underway and there could be approved treatments in a matter of months.
One of the most promising treatments was not represented at this meeting. Gilead Sciences expects to have data in April from patients it is studying. They are being treated with Remdesivir, an antiviral, intravenous medicine that's been around for years but has not be approved by the FDA. It has reportedly shown to start working in COVID-19 patients within 24 hours.
Sense Of Urgency
"There's a tremendous sense of urgency and the team is working hard to accelerate the program as quickly as possible, working with regulatory agencies and our public health partners to do that," says Associate Vice President R & D Strategy for Vaccines with Sanofi, Clement Lewin.
Sanofi is working on a vaccine based on data it has from SARS. It has also partnered with Regeneron to develop a treatment for COVID-19 pneumonia. Lewin says there is evidence it can help reduce the number of deaths.
Another treatment, this one from Takeda, uses the body's own immune response to create a drug to treat the coronavirus. This hyperimmune globulin (H-IG) is expected to be available in nine to 18 months.
Takeda's Julie Kim says, "When a virus enters your body, your body enters an immune response and produces antibodies to fight and eliminate the virus. When you have recovered, you have a high level of antibodies."
Takeda would take the plasma from fully recovered patients, process it, purify it and turn it into a medicine.
Pharmaceutical Industry Turning On A Dime
"The reason the industry can move so swiftly is because of investments that have been made over the course of decades. We're talking about repurposing treatments already approved by the FDA," says Ubl.
Companies With Vaccines Under Development
With all the attention on new COVID-19 drugs and vaccines, some worry about the supply of medicines to treat other illnesses and conditions. The industry says it is making sure it has adequate raw materials to make them and it hasn't seen any shortages yet.
Also, what about clinical trials for potentially life-saving cancer treatments? Pfizer says there are ways to continue them remotely but no new patients are being admitted.
TWO companies with strong Cork connections are among the pharmaceutical giants racing to find a vaccine for the coronavirus.
Global corporations Novartis and Pfizer, which employ around 4,000 people in Ireland and have Cork bases, have joined the worldwide war on the pandemic.
Novartis has pledged to donate 130 million hydroxychloroquine tablets free to fight Covid-19 - the drug is used to combat malaria and there are hopes it will also hold the key to fighting coronavirus.
Preliminary trials are being held using the drug and the move by Novartis, alongside other pharmaceutical companies, was welcomed by the world of medical science The 130 million tablets will be supplied by the end of May and the company said it will explore "further scaling of capacity to increase supply".
In a statement announcing the move, Novartis Global Head of Strategy, Stephen Moran, said the company is also providing $20million grants to support public health initiatives designed to help communities manage the challenges posed by Covid-19.
There are no vaccines or treatments approved for the disease, but there is currently a 1,500-person trial, led by the University of Minnesota in the U.S, to see whether hydroxychloroquine can prevent or reduce the severity of COVID-19. US President Donald Trump has spoken of his optimism that the drug will be the breakthrough the world is seeking.
Two other trials are studying blood pressure drug losartan as a possible treatment, news agency Reuters reported.
Meanwhile, Pfizer, which last year marked 50 years in Cork and employs 3,700 people in Ireland, has also joined the race to develop a Covid-19 vaccine.
It has reportedly teamed up with BioNTech, a German firm which has announced it will start clinical trials of its experimental vaccine next month.
However, Irishman Dr Mike Ryan, the World Health Organisation's top emergency expert, yesterday warned that a working vaccine was at least a year away.
In an interview on the BBC's Andrew Marr Show, he said: "Once we've suppressed the transmission, we have to go after the virus. We have to take the fight to the virus.
"We have to make sure the vaccine is absolutely safe... we are talking at least a year. The vaccines will come, but we need to get out and do what we need to do now."
News reports emerged over the weekend that the Trump administration attempted to poach scientists working for a German biotech firm in order to obtain exclusive rights to a potential vaccine against the Covid-19 virus. However, the company itself has denied them.
Welt am Sonntag, the Sunday edition of German newspaper Die Welt, reported Sunday that President Donald Trump had offered a large sum of money rumored to amount to $1 billion in an effort to lure scientists working for the Tbingen, Germany-based company CureVac to the U.S. so they could continue their work here. It was reported that would mean the U.S. would have exclusive rights to the vaccine. The company is working with Germanys federally funded Paul Ehrlich Institute on the vaccine against the coronavirus, known as SARS-CoV-2.
The Washington Post reported later Sunday that German officials would discuss the report in crisis meetings Monday, quoting Interior Minister Horst Seehofer as saying that he had heard from several members of the government that the Trump administration had sought to secure rights to the vaccine. Nevertheless, Richard Grenell, the U.S. ambassador to Germany and acting director of national intelligence, tweeted that the Welt am Sonntag story was not true.
Meanwhile, CureVac issued a statement Sunday saying that it rejects current rumors of an acquisition and emphasizing that it focuses on developing an mRNA-based coronavirus vaccine to protect people worldwide. In a tweet Monday, the company implicitly denied the Welt am Sonntag report as well.
To make it clear again on coronavirus: CureVac has not received from the U.S. government or related entities an offer before, during and since the Task Force meeting in the White House on March 2, the tweet read. CureVac rejects all allegations from the press.
The company also said Monday that its CEO, Ingmar Hoerr, would take a temporary medical leave of absence, but that it was not due to coronavirus.
Other companies have also been involved in developing potential vaccines against the novel coronavirus. Moderna, based in Cambridge, Massachusetts, said Monday it had dosed the first participant in the National Institutes of Health-led Phase I clinical trial of mRNA-1273, its investigational vaccine against SARS-CoV-2, which as of Monday afternoon had infected more than 179,000 people worldwide up by nearly 10,000 from the day before.
Photo: Esben_H, Getty Images
