Category: Corona Virus Vaccine

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A coronavirus vaccine is the only thing that can make life ‘perfectly normal’ again, former FDA commissioner says – The Week

March 23, 2020

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Three former Bloomberg campaign organizers on Monday sued him for fraud, saying his campaign rescinded its promise to pay 2,000 employees through November even if he didn't win the Democratic nomination, Politico reports.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

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A coronavirus vaccine is the only thing that can make life 'perfectly normal' again, former FDA commissioner says - The Week

Image of COVID-19 test kit shared as newly developed ‘coronavirus vaccine’ by Roche – Alt News

March 23, 2020

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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Image of COVID-19 test kit shared as newly developed 'coronavirus vaccine' by Roche - Alt News

Vaccine Trials To Fight Coronavirus Offer Hope, Could Be Harbinger Of New Technology – Outlook India

March 23, 2020

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.

Also Read |Goliath The Germ: Where Does India Stand In Humankind's War Against Corona

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

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Vaccine Trials To Fight Coronavirus Offer Hope, Could Be Harbinger Of New Technology - Outlook India

Thousands of scientists are racing to find a vaccine for coronavirus. 41 possibilities are in the works. – The Californian

March 21, 2020

An epidemiologist answers the biggest questions she's getting about coronavirus. Wochit

The first coronavirus vaccine trial began Monday inSeattle when four volunteers got a version of a vaccine against a disease that as of Thursday has killed 150 people in 22 states, with more than 10,000 cases nationwide.

They were the beginning of an all-out effort by thousands of scientists worldwideworking to create vaccines againstthe new coronavirus in what inresearch terms is a blindingly fast response to theglobal threat. As of last week, the World Health Organization had posted a list of 41 possible vaccine candidates on its site.

Still, no one will be lining up this summer for vaccinations. It will be at least a year to 18 months before any vaccine is ready for large-scale use, according to most estimates. Before being deployed, vaccines must go through multiple rounds of testing to make sure they are safe,effective and dont have unintended consequences.

Researchers are not starting from scratch. Work on two previous coronaviruses, Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS)provide a road map for howto create an immune response toSARS-CoV-2,the virus that causes the illness COVID-19.

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The process was immensely sped up by the decision ofprofessor Yong-Zhen Zhang at theShanghai Public Health Clinical Center in China to publish the virus' genome on Jan. 10.

Early financial support from the Oslo-basedCoalition for Epidemic Preparedness Innovations(CEPI), a nonprofit global partnership to develop vaccines, also has been crucial.

(Photo: Getty Images)

While no one knows who will cross the finish line with a vaccine first, several companies and groups are off to strong starts, particularly those alreadyworking on SARS and MERS vaccines. Here are some of the noteworthy efforts underway:

This Boston-based company already was working on RNA therapies and vaccines. It began working with the National Institutes of Allergy and Infectious Disease in February to create an experimental SARS-CoV-2 vaccine. It began testing its first vaccine candidate on humansMonday. Agroup of four people was given the vaccineand researchers will first study its safety. If after several weeks it appears to be safe, another round of testing will begin to see whether it stimulates their immune system to make antibodies against the virus. It was one of three groups that received funding for the effort Jan. 23 from the CEPI.

The Australian research group was working on molecular clamp vaccines against MERS for several years and had a version showingresults in animal studies. It got funding from CEPI and retooled its research for SARS-CoV-2 in February. The clamp method uses a sequence of amino acids to lock down the spikes SARS-CoV-2 uses to infect cells, allowing the immune system to target it before the virus can activate itself. Testing of the trial vaccine in mice is underway and the group is hoping to begin human trials by mid-year.

This Pennsylvania-based biotech company alsoreceived one of the early CEPI grants. Inovio, was working on a DNA-based vaccine against MERS. The company president said it designed a COVID-19 vaccine candidate in three hours after the genetic sequence was published by the Chinese. The company plans to begin human trials in April.

This German-based company was in the news last week after reports surfaced President Donald Trump suggested the U.S. might buy access to its vaccines only for Americans.CureVac, which wasmainly working on anti-cancer vaccines, uses messenger RNA to make vaccines. It signed a development agreement with CEPI on Jan. 31 to work on SARS-CoV-2. The company hopes to have a possible vaccine ready to test within several months.

Maryland-based Novavax was working on vaccines against SARS and MERS.On March 10 it announced a $4 million award from CEPI to work on a SARS-CoV-2 vaccine. It hopes to begin testing in late spring.

A team at Oxford's Jenner Institute in Britain is creating SARS-CoV-2 vaccine seed stock in conjunction with Italian medical product manufacturer Advent. The JennerInstitute wasworking on a vaccine against MERS and currently has a trial underway in Saudi Arabia.

A large consortium of European research universities and biotech companies is working on a vaccine for SARS-CoV-2. The effort received nearly $3 million in European funding on March 9 and includes German, Dutch and Danish universities and biotech companies.

This United Kingdom-based company is one of the worlds largest vaccine producers. It has signed an agreement with CEPI to bring GSKs adjuvant systeminto the SARS-CoV-2 mix. Adjuvants can be added to vaccines to boost the immune response they produce. This could decrease the amount of vaccine (once one becomes available) needed per dose, allowing more doses to be produced more quickly.

Researchers at the Chinese academy are working with scientists atCanSino Biologics, a Hong Kong-based biotech company that licensed a vaccine for the Ebola virus in 2017. According to China's clinical trial registration database, the experimental COVID-19 vaccine is in the early stages of safety testing and tests were approved to begin as soon as March 17.

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Thousands of scientists are racing to find a vaccine for coronavirus. 41 possibilities are in the works. - The Californian

‘I Wanted To Do Something,’ Says Mother Of 2 Who Is First To Test Coronavirus Vaccine – NPR

March 21, 2020

A pharmacist gives Jennifer Haller, left, the first shot in the first-stage study of a potential coronavirus vaccine on March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Ted S. Warren/AP hide caption

A pharmacist gives Jennifer Haller, left, the first shot in the first-stage study of a potential coronavirus vaccine on March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle.

When Jennifer Haller heard that researchers were looking for volunteers to be injected with an experimental coronavirus vaccine, the Seattle mother of two rolled up her sleeve.

Well, not literally. Haller, 43, the first person to receive the vaccine, was wearing a tank top when a pharmacist, sheathed in gloves, a mask and protective eye gear, injected her with an experimental vaccine named mRNA-1273. It made her arm a bit sore, "but besides that, no, no side effects," she says.

With the outbreak rapidly spreading across the nation, Haller says she was excited to enroll in the Phase 1 trial, which started Monday.

"I wanted to do something because there's so many millions of Americans that don't have the same privileges that I've been given," says Haller, who now works from home for a small tech company. "They're losing their jobs. They are concerned about paying bills, feeding their family."

Vaccines typically take years to develop and bring to market. They go through extensive animal trials to ensure they are not only effective, but safe. But as the coronavirus death toll rapidly climbed reaching 11,147 on Friday researchers felt they couldn't wait.

The injection Haller received was developed by the National Institutes of Health and the Massachusetts-based biotechnology firm Moderna Inc. It does not use any form of a live or weakened virus, so Haller can't contract the coronavirus from the vaccine.

That doesn't mean there aren't risks. She had to sign a 45-page waiver just to enroll in the trial.

Despite the uncertainty, Haller says she was moved to volunteer out of a feeling of helplessness. She felt uniquely positioned to contribute, given that her children are older, she has friends and family nearby and a job that allows her maximum flexibility of when and how she works.

"This was just something that I could do and that I wanted to do."

A sprint to Phase 1 trials

The vaccine given to Haller was developed in record time, according to Dr. Tal Zaks, the chief medical officer for Moderna. "We've been able to do that based on the fact that our technology starts with the digital information. So we did not need to have the physical virus, just the information."

Instead of using parts of a killed virus to provoke an immune system, Moderna, working with the NIH, created a synthetic RNA molecule once the virus behind the outbreak in Wuhan, China was identified.

In early January, just days after the virus was identified, researchers had designed synthetic virus particles that they hope will convince the body to produce antibodies against the coronavirus. On March 16, Haller and three other study participants were the first to be vaccinated. Zaks says 45 patients in all will participate in the trial, each at three different dose levels.

Moderna is one of at least 20 drug manufacturers around the world working on potential coronavirus vaccines and treatments. President Trump has reportedly told pharmaceutical executives that he wants to see a vaccine developed in the United States to ensure it controls supplies.

"This should work"

The subjects in the NIH-Moderna trial will receive a two-dose vaccination schedule, 28 days apart. Haller keeps a log of her temperature and any symptoms she might be experiencing. So far, she says, there have been none.

All of the participants will be monitored for a total of 14 months. Regular blood tests will show whether the vaccine is activating their immune systems. Participants in the study will receive $100 for each lab visit for a total of $1100.

Zaks says he is confident in the trial. "This should work," he says, adding, "we've already begun the scale-up activity in our manufacturing site to be able to scale up and produce the vaccine."

Still, even if this first human trial is successful, public health officials don't expect a vaccine to be ready for widespread use for at least 18 months.

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'I Wanted To Do Something,' Says Mother Of 2 Who Is First To Test Coronavirus Vaccine - NPR

Wanted: People Willing to Get Sick to Find Coronavirus Vaccine – The Wall Street Journal

March 21, 2020

Thousands of people have volunteered to be infected in the hope of finding a vaccine for the new coronavirus.

hVIVO, a clinical research group in London, has attracted more than 20,000 volunteers willing to be infected with tamer relatives of the virus that causes Covid-19 in exchange for a fee of 3,500 ($4,480). It says such experiments could play an important role in the development of a vaccine against the new coronavirus, for which there are no proven treatments or vaccines.

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Wanted: People Willing to Get Sick to Find Coronavirus Vaccine - The Wall Street Journal

The coronavirus could kill millions of Americans: ‘Do the math,’ immunization specialist says – CNBC

March 21, 2020

The new coronavirus could kill millions across the United States, said Dr. Kathleen Neuzil, director of the Center for Vaccine Development at the University of Maryland's School of Medicine.

"It would not surprise me," she told CNBC on Thursday when askedwhether the U.S. could see millions of deaths. "We need to prepare for the worst."

Neuzil is the only U.S. member of the World Health Organization's Strategic Advisory Group of Experts on Immunization and previously sat on the Centers for Disease Control's Advisory Committee on Immunization Practices. She's part of the leadership team of infectious disease experts working with NIH to test a coronavirus vaccine and therapies to treat those sick with COVID-19.

"We have 350 million people in the United States, and you do the math," she said on CNBC's "Squawk Box." If 70 million people are eventually infected with this virus and again if there are multiple waves of this virus, then you can do the math and then you can get there."

COVID-19 has now infected more than9,159 across every state in the U.S., according to Johns Hopkins University, and killed at least150 people in the country. On March 1, there were about 100 confirmed cases of the rapidly spreading virus in the U.S.

The number of actual cases in the country is likely significantly higher, state and local officials say. Testing in the U.S. has been hampered by delays and a restrictive diagnostic criteria that limited who could get tested.

Almost half of all confirmed U.S. cases are concentrated in three states: Washington, California and New York, where local and state officials have rolled out aggressive social distancing measures.

Those policies could reduce the number of deaths, said Neuzil, director of the Center for Vaccine Development and Global Health at the University of Maryland's School of Medicine.

"I firmly believe that the very aggressive social distancing and other strategies we're implementing now will reduce the deaths," she said. "What we're worried about is overwhelming that system."

However, there's little uniformity across the country regarding social distancing policies. Without meaningful federal intervention, local leaders have adopted what New York Gov. Andrew Cuomo called Monday a "hodgepodge" of actions across the nation to contain the outbreak.Cuomo and other tri-state area officials on Monday banned all gatherings of 50or more people and placed restrictions on restaurants, bars and other places of recreation.

Governors in Maryland and Washington state, which has the second-highest number of cases behind New York but the nation's most deaths, followed suit with similar actions.

San Francisco Bay area officialsordered some 7 million residents to "shelter in place"on Monday, marking what might be the most aggressive and restrictive measures in the country yet.

"Never since World War II have we faced a situation like this," Washington Gov. Jay Inslee said when announcing new social distancing policies earlier this week. "For the next several weeks, normal is not in our game plan."

Correction: This article was updated to reflect that Neuzil is a past member of the CDC's Advisory Committee on Immunization Practices.

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The coronavirus could kill millions of Americans: 'Do the math,' immunization specialist says - CNBC

We’re still in the early days of coronavirus vaccine research – Axios

March 21, 2020

Moderna has moved incredibly quickly to begin testing a potential vaccine for the new coronavirus in U.S. patients. The biotech company went from taking the genetic sequence of the new coronavirus to manufacturing its first batch of vials in less than a month.

Reality check: Best-case scenario, a vaccine could be ready for production by next year but that's assuming the drug proves to be both safe and effective, which is completely unknown right now.

What they're saying: My colleague Dan Primack and I spoke with Moderna CEO Stphane Bancel to understand the timing of this very fluid situation.

Yes, but: There's no data yet. It's a scientific feat to get to this stage so quickly, but that will matter a lot less if the vaccine doesn't work well or if people suffer serious side effects.

The intrigue: Moderna, which uses a complex gene-based technology that changes how cells function, has a lot of experience researching vaccines it has done some animal testing on a vaccine for a related coronavirus, MERS.

The bottom line: The global desire to find something to prevent another COVID-19 pandemic should not kick aside the need for scientific evidence.

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We're still in the early days of coronavirus vaccine research - Axios

Inoculating the Coronavirus Vaccine Against the Profit Pandemic – The New Republic

March 21, 2020

This week, scientists at the Kaiser Permanente Research Institute in Seattle, Washington, administered the first injection of a trial vaccine for the coronavirus. As The Associated Press reported it, the mood was optimistic. Were on team coronavirus now, said Kaisers Dr. Lisa Jackson. The recipient of this first dose, 43-year-old Jennifer Haller, offered tones of civic pride: This is an amazing opportunity for me to do something. These are just the first steps in what would be, in the best-case scenario, a 12- to 18-month wait for a medical breakthrough. All over the world, similar efforts are ongoing, the hope being that this vital work can be carried out without interruption or interference.

Naturally, we have also recently received a reminder of the extent to which our dreadful politics might provide the impediments necessary to blunt the efforts of vaccine researchers. Word leaked out this week that Donald Trump had apparently tried to lure a team of German researchers to the United States so that they could carry through cutting-edge research on developing a coronavirus vaccine here. (The European Union is now responding to try to keep its researchers there.)

Its not clear exactly what Trump hoped to gain if his efforts succeeded. There was speculation that he had planned to make the vaccine available exclusively for people in the U.S., although as a practical matter, it is difficult to envision how this could have been accomplished. Perhaps Trump was just hoping for bragging rights, that the U.S. had developed the first effective coronavirus vaccine. (In a best-case scenario, it will be at least a year until one is widely available, an inconvenient truth for those who are currently endeavoring to engineer the presidents reelection.)

While it is not worth a lot of effort unraveling Trumps thinking, we should be doing some serious thinking ourselves about the development of a coronavirus vaccine and biomedical research more generally. The situation we see today is that many top-notch researchers, in Germany, China, the U.S., and elsewhere, are racing to develop a vaccine that can enter the testing process. The problem with this picture is that they are working in competition, not collaboration. This means that they are not widely sharing information with each other, since they dont want to give their competitors an edge.

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Inoculating the Coronavirus Vaccine Against the Profit Pandemic - The New Republic

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