Category: Covid-19 Vaccine

If you have anyone in your life whos old enough to remember, there was a time, in the first half of the 20th century, that might draw comparisons to life today. There was fear, uncertainty and lots of concern for public health.

It wasnt the novel coronavirus, of course, the current pandemic sweeping the globe. It was an epidemic called paralytic poliomyelitis, or infantile paralysis -- perhaps best known as polio.

In fact, polio was once one of the most feared diseases in the U.S., according to the Centers for Disease Control and Prevention, which goes on to say online that in the early 1950s, before polio vaccines were available, polio outbreaks caused more than 15,000 cases of paralysis each year.

Parents were scared to let their children go outside; travel and commerce between cities were sometimes restricted, and quarantines were imposed.

Polio wreaked havoc on communities.

I might not remember what I went to the kitchen for today, but I can remember everything about the day I went with my family to get the (polio) vaccine, said Gary Tietze, who lives in the San Antonio area and is the father to one of the co-authors of this story.

Once vaccines were introduced specifically, trivalent inactivated poliovirus vaccine (IPV) in 1955 and trivalent oral poliovirus vaccine (OPV) in 1963 the number of polio cases fell rapidly to less than 100 in the 1960s and fewer than 10 in the 1970s, according to the CDC. Thanks to a successful vaccination program, the United States has now been polio-free since 1979.

But back to those old enough to remember, like Tietze: Have you ever heard the stories of people rushing out for their sugar cubes? (That was the way some of the oral vaccines were given).

Jan Smolinski, of Michigan, recalls that time in her life vividly.

She was 20 years old, and preparing for her wedding.

The day of my wedding shower, which must have been on a Sunday in April -- my whole wedding party, we went, and it must have been to a community center (or) a church or a school, Smolinski said. And wed wait and there were doctors, nurses and volunteers. And youd receive your sugar cube. And then you got the second dose a couple months later, because that was the day after (our) wedding. My husband and I went to St. Regis Church in Detroit and got a second dose. That was 1964. The next day, we reminded everyone, Go get your sugar cubes tomorrow! And that was before we left on our honeymoon.

It was Jonas Salk who became a national hero, the Science History Institute said, when he quelled the fear of the dreaded disease with his polio vaccine, approved in 1955. His came first, and then Albert Bruce Sabin introduced an oral vaccine in the United States in the 1960s that replaced Salks. [Read more about Salk and Sabin.]

Smolinski took the oral version, hence, the sugar cube.

It must have come as a relief to have a vaccine after all those years.

People with more serious polio symptoms could experience the sensation of pins and needles in the legs; develop meningitis, an infection of the covering of the spinal cord; and paralysis. Of the 57,628 reported cases, there were 3,145 deaths, according to the website Healthline. Franklin D. Roosevelt, the 32nd President of the United States, was diagnosed with polio, in 1921, at the age of 39.

No one is certain of the circumstances leading to FDRs contraction of polio, but many believe he was exposed to the virus at a Boy Scout camp in New York. It was uncommon for a middle aged person to contract polio, according to the FDR Library. Most cases of the disease were acquired by children. [Read more about Roosevelts circumstances.]

Tietze, who was a young boy at the time, said there were people he knew who ended up paralyzed or dead from the virus. A cousin who lived across the road from his familys dairy farm was hospitalized with polio.

We didnt see him for a long time, Tietze said of his cousin. When they finally got out of the hospital, they were quarantined. They lived close to us, and we didnt see them for maybe a couple years. He was (paralyzed). He was young when he got it -- 8 or 9.

Tietze admitted that whats happening right now is different in many aspects, but, he said, in the same regard, living through the time of polio was scary -- even traumatic.

He spoke of the iron lung, used on some polio patients, and remarked on how frightening they looked.

In the image below, two young children are in an iron lung, a type of pressure ventilator that began use in the 1920s. It was intended for polio patients whose chest muscles had been effected by the virus, which led to problems breathing. The iron lung would create different pressures, stimulating breathing in the patient.

Smolinski spoke of the iron lung, as well. Her husband had a friend in one.

You were totally encapsulated, Smolinski said. It was quite noisy.

The now-76-year-old said what sticks with her especially is the fear that surrounded the disease. In a lot of ways, her experience sounds a bit like Tietzes.

When Smolinski was little, in the late 40s or early 50s, she had two cousins who got polio. They were both hospitalized -- and they recovered, but it was a stressful time for the family.

I remember my mom and dad being nervous, Smolinski said. It didnt affect my daily life, but I remember being very scared for my cousins.

There was one summer she remembers specifically as being very bad. Many grew concerned about children playing outside, and people even referred to it as polio season. Smolinski said she was probably 9 or 10 years old when polio concerns were incredibly high.

She wonders about how a vaccine would be distributed today. Its a similar situation in some ways to whats going on with the novel coronavirus, but also so different. Its a new era.

But as a little girl, Smolinski thinks back mostly on the situation with her cousins. Its always a little more real when something touches your own family, isnt it?

My parents were very upset, Smolinski said. It was their nieces. It was (also) like, it could happen in our own family. Thats where the fear came in.

Related/read next: How does an iron lung work? Polio survivor, 82, among last to use breathing equipment (2018 report) | Discover Magazine: The deadly polio epidemic and why it matters for coronavirus

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Now and then: As world waits for COVID-19 vaccine, a look back on the age of polio - KSAT San Antonio

Microsoft co-founder Bill Gates' increased media presence lately has made him the target of conspiracy theories.

Fighting misinformation and conspiracy theories about the novel coronavirus has almost been as hard as battling the pandemic itself. And a new survey has found that one conspiracy theory aboutMicrosoftco-founderBill Gatesis taking hold.

A conspiracy theory that Gates is planning to use a future COVID-19 vaccine to implant microchips in billions of people in order to monitor their movements has gained supporters particularly among Fox News viewers and Republicans, the survey found.

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The representative survey of 1,640 US adults by YouGov for Yahoo News found that half of respondent Americans who say Fox News is their primary television news source believe the conspiracy theory. It's the largest group responding this way, followed by self-described Republicans and "Voted for Donald Trump in 2016" -- 44% of both those groups said they believed the conspiracy theory was true. Twenty-six percent of respondent Republicans said it was false, and 31% said they weren't sure.

Representatives for Fox News, the Republican Party, the White House and the Trump 2020 campaign didn't immediately respond to requests for comment. The Bill and Melinda Gates Foundation, which the namesake founders use to fund medical research and vaccine programs around the world, also didn't immediately respond to a request for comment.

Yahoo and YouGov's survey didn't find that everyone believed these conspiracy theories though. Just 24 percent of independents, 19% of Democrats and 12% of people who "Voted for Hillary Clinton in 2016" believed the conspiracy theory about Gates. Instead, forty-five percent of independents, 52% of Democrats and 63% of Clinton voters said they don't believe it. The rest said they were not sure.

Keep track of the coronavirus pandemic.

The survey findings underscore the level at which conspiracy theories have overtaken public perception of the coronavirus. The virus, which has infected more than 1.6 million people in the US and killed nearly 100,000 Americans, has upended daily life since it was first detected in December of last year. Governments around the world have ordered citizens to isolate themselves and shelter in place in an effort to slow the virus' spread and reduce strain on hospitals and morgues.

As people adjust to these efforts, they've also begun reading and spreading conspiracy theories about the coronavirus. Such theories address everything from the political ambitions of people involved in the response to whether the coronavirus is as deadly as governments and health agencies are reportingto how and where the virus originated (expertssay it came from wild animals). So many people wrongly believed5G wireless played a rolein spreading coronavirus that theyvandalized nearly 80 cell towers in the UKover it.

Facebook, Twitter and YouTube have all said they're responding to conspiracy posts, adding links to more information and in some cases pulling down content that the companies believe could lead to people unknowingly harming themselves.

Gates has become a center for attention among conspiracy theorists in part because of his high profile efforts to vaccinate people around the world, as well as his recent media appearances over the past couple months. He's also criticized government responses to the crisis, such as in a March editorial published in The Washington Post.

"There's no question the United States missed the opportunity to get ahead of the novel coronavirus," he wrote in a column published March 31. "The choices we and our leaders make now will have an enormous impact on how soon case numbers start to go down, how long the economy remains shut down and how many Americans will have to bury a loved one because of COVID-19."

One analysis done by The New York Times and media watcher Zignal Labs in April found misinformation about Gates was the most widespread of all coronavirus falsehoods.

Aside from conspiracy theories about Bill Gates, Yahoo and YouGov's May survey also found that only half of Americans now say they intend to get vaccinated "if and when a coronavirus vaccine becomes available." Twenty-three percent of people say they won't, and 27% say they're not sure.

See more here:

Over 40% of Republicans wrongly believe Bill Gates will use COVID-19 vaccines to implant microchips in them - CNET

Patients in clinical trials are usually faceless. But as the experimental Covid-19 vaccine being developed by Moderna Therapeutics has begun advancing through studies, it has found a much more visible advocate: trial volunteer Ian Haydon, a 29-year-old in Seattle.

Haydon has spoken about the vaccine on CNN and CNBC. He even said hed volunteer to be exposed to the novel coronavirus, SARS-CoV-2, if researchers want to test to see if the vaccine was actually effective. But up until now he has left out a key detail: He is, apparently, one of three people in the trial who had a systemic adverse reaction to the vaccine.

Twelve hours after receiving his second dose, he developed a fever of more than 103 degrees, sought medical attention, and, after being released from an urgent care facility, fainted in his home. He recovered within a day.

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He has not brought up the side effects previously, he said, out of an abundance of caution.

I understand that sharing the story, its going to be frightening to some people, he said. I hope that it doesnt fuel any sort of general antagonism towards vaccines in general or towards even this vaccine.

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But he decided to speak now because he hopes his story counterbalances the desperation that some people feel to push a vaccine to market regardless of the consequences. Haydon points out that the whole purpose of the study he was in, known as a Phase 1 clinical trial, is to find the right dose of the vaccine going forward. That means to find a dose that causes the body to produce antibodies, but does not result in too many side effects.

As we rush to get a vaccine developed as quickly as possible, the reality of vaccine development is that it can only be rushed so much and the trial still needs to take place, Haydon said. They have to move at the speed they move at. And stories like what happened to me, they matter because they shape the approval process.

In the 45-person Moderna study, four participants experienced what are known as Grade 3 adverse events side effects that are severe or medically significant but not immediately life-threatening. Neither the company nor the National Institute of Allergy and Infectious Diseases, which is running the trial, have previously detailed the nature of those incidents, but Moderna did disclose that three, likely including Haydon, received the highest dose of the vaccine that was tested, and had reactions that involved their whole bodies. A fourth received a lower dose and had a rash at the injection site.

Such side effects are noteworthy, but it doesnt stop the train, said William Schaffner, a professor of preventive medicine and infectious diseases at Vanderbilt University Medical Center. The goal of studies is to establish a threshold at which something might go wrong.

With drugs, Schaffner said, patients tolerate the risk of side effects because they want to get better. In contrast, Schaffner said, we give vaccines to healthy people in anticipation that they might contact the germ, the virus, down the road. But because we give them to healthy people, actually our standards for safety are higher than they are for drugs.

In Haydons words: The point of the Phase 1 trial is to look out for health problems. He said he received great medical care, and though he felt more sick than he ever has before, he was never afraid for his long-term health. I dont regret the decision I made to enroll in this study.

Haydon, a communications manager at a university, initially found out about the study, which was being run in Seattle, from a colleague who sent him a link. He, along with thousands of other people, applied. They called him 11 days after he applied.

He went to the trial site for a physical, and signed a 20-page consent form. The vaccine, it told him, could conceivably cause severe anaphylactic shock, and there was no way to predict exactly how his immune system would respond to the new vaccine. Hed looked at research on other Moderna experimental vaccines, which work via an entirely new technology that uses messenger RNA, the bodys key envoy of genetic information inside cells, and thought they seemed relatively safe. During the physical, researchers took blood; the lab work came back a week later, and he received his first dose of the vaccine on April 8.

Haydon doesnt like needles, and was as worried about the blood draw which uses a bigger needle than the actual shot. He remembers waiting, and being told that the reason he was waiting was because researchers were giving doses in ascending order, and he was to receive the high dose of the vaccine. But the injection was uneventful. If his eyes were closed, he said, he would not have felt it. He was given a paper log on which to write down any symptoms, a digital thermometer, and a small ruler to measure any reactions at the injection site.

He had arm pain the next day, like being punched in the arm, he said, and for a day he had trouble lifting his arm at the shoulder. But within days he was back to normal.

Haydon said he was slightly nervous before the second dose. He knew that second doses were given to increase the immune systems response, and wondered if he might have more side effects. His arm became sore much more quickly this time. He got home from the clinic at about noon. At around 10 p.m., he started to get chills. Hes normally too hot at night, but he bundled up in sweats. His fingertips felt cold. He fell asleep, but woke up a few hours later with a raging fever.

At 1:30 a.m., his temperature was 103.2 degrees. At 3:45, it was 103 degrees. He was nauseous, and his muscles hurt.

The clinic where he was vaccinated had given him a 24-hour phone number to call, but hed been reticent. His girlfriend, with whom he lives, called. They said to go to urgent care. It was a 10-minute drive. They arrived at 5 a.m.

The doctors met him in what looked like space suits. Even though hed had a vaccine, he was also a potential Covid patient. They took him into an exam room, took a lot of blood, and gave him a nasal swab. He asked them to avoid his left arm, where hed gotten the vaccine, but they ended up taking blood from both of his arms. His fever had already fallen to 99.8 degrees. They gave him Tylenol. The physician taking care of him offered to try to get him admitted to a neighboring hospital, but he decided to head home.

He and his girlfriend arrived home at 7 a.m., and he slept until noon. His temperature was 101.5. He got up to go to the bathroom, and became so nauseous he threw up. On his way back from the bathroom, he fainted. His girlfriend caught him and kept his head from hitting the floor.

She then called one of the doctors working in the study, and asked what they should do. The doctor told them he could go back to urgent care, or call 911, and reminded them that all his medical costs would be covered by the study.

But he got to a couch and was given sports drinks. He spent the afternoon there, with a wet towel on his head, fighting the fever. By 9:45 p.m., it was back down to 99.1. It tapered off. He says he felt better within a few days, and has had no side effects since.

Haydon said the experience left him as sick as hed ever felt. But standard flu-like symptoms that resolve within a day are not necessarily considered a reason not to use a vaccine that prevents a more serious illness.

Given the stakes of a Covid-19 vaccine, the side effects described in the Moderna release would likely be seen as acceptable even if they turned out to be seen in future studies. The severe effects were only seen at high doses that are not being taken forward. The other vaccine for which early data are available caused fever in almost half of recipients.

But its also not clear what will happen as the vaccine moves into larger studies. Humans have a very diverse immune system, said Larry Schlesinger, the president and CEO of the Texas Biomedical Research Institute, a nonprofit. And then you add on top of that diabetes or, you know, age 70 and you can imagine that the immune response will be very, very different.

The difficulty, Schlesinger said, is that right now we are only getting tidbits of information about the new vaccine.

Tidbits of science are always dangerous for the public to read because they give a false understanding, or a false sense of security, that were making progress or not, Schlesinger said. And then tomorrow we hear something completely opposite. And before you know it, the credibility of the scientific process is undermined and people stop listening.What does he think now? Its just not enough information at the current time. Thats why we need clinical trials and volunteers like Ian Haydon.

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He had a severe reaction to Moderna Covid-19 vaccine. He's still a believer - STAT

Acclaimed American public health expert Ashish Jha has told former Congress president Rahul Gandhi that three vaccine candidates are showing promising results in the fight against the raging coronavirus disease (Covid-19) and expressed confidence that there could be a new vaccine by next year.

Three vaccine candidates are showing promising results. These are from America, China, and Oxford University. For now, they all seem promising and maybe one or all of them may turn out to be effective. Im confident that the vaccine will be available by next year. India has to prepare a plan on how to avail the vaccines for its population, he added.

Jha is a professor of Global Health at TH Chan School of Public Health and director, Harvard Global Health Institute. He made the remarks during his interaction with Gandhi, who has been holding a series of dialogues with global experts on various aspects of Covid-19 via video-conference since the viral outbreak.

Coronavirus outbreak: Full coverage

Asked by Gandhi, if the Bacillus CalmetteGurin (BCG) vaccine, which is used against meningitis and tuberculosis in children, is helpful and the virus doesnt operate in hot weather, Jha said: BCG vaccine can be helpful. There is some circumstantial evidence that these vaccines can be helpful, but its not very good evidence. New testing is underway and well know in the next few months if these vaccines play a major role. There is some evidence that the weather makes a difference. There is less transmission of the disease in being outdoors than indoors.

He added: Its a new virus. There is new testing. New studies are going on and in the next couple of months, well know much more. Some nice randomised trials are being carried out. I suspect that in the next three months, well know much more if these vaccines will play a major role. Im personally sceptical that the BCG vaccine will be an important mediator. I dont know, but well know soon. But theres certainly not enough evidence to make policy as of now.

Jha said there is some evidence, which shows that the weather makes a difference. Theres going to be easy transmission if 15 people are staying in one small room. But once these people are outdoors, and theres the air that would make the situation a bit better.

Jha claimed that the world is entering an age of pandemics.

Im confident that this is not the last large global pandemic you and I are going to see in the next 20 years. We got lucky that in the 2009 H1N1 swine flu didnt cause that much harm, even though it was declared a pandemic. A virus that gets started somewhere spreads very quickly globally, he added.

There are also big environmental changes. All of this economic growth that you see in China and India and many other places have lifted people out of poverty. But the growth also led to deforestation and rampant encroachment on animal habitats. Most pandemics that come to humans jump from animals. This virus has existed in bats but there was a small change probably in the genome and all of a sudden it became suitable for human hosts. I think climate change is going to make many of these things worse, he said.

The other thing that has happened with economic growth is that people are eating a lot more meat, which means more interactions between humans and animals. Put all of it together. If you look at the last 100 years, youll see the increasing frequency of these kind of outbreaks and Covid-19, of course, is the worst in a hundred years. But, Im confident that were going to have more global pandemics in the coming years and decades. We have to ask ourselves: how we are going to better prepare for the next one? Jha asked.

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There will be a Covid-19 vaccine by next year: Global health expert to Rahul Gandhi - Hindustan Times

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How long until theres a Covid-19 vaccine? Its the question of the year, and one that Barrons tackled in this weeks cover story. Now, Bernstein Research is out with its own take on the question. Its answer? Late this year or early next year at best, though the vaccine wouldnt be widely available until later next year.

We are cautiously optimistic vaccines will work (to some extent), wrote Vincent Chen, the lead author on the note and one of the experts quoted in our cover story. We would not expect the first generation of vaccines to be perfect game-changing vaccines. If COVID-19 continues to be a problem, we would expect future generations may improve upon the current crop.

Chens note comes after a week in which shares of Moderna (ticker: MRNA) rose 19% on Monday on news that the company was seeing promising early data in the Phase 1 trial of its Covid-19 vaccine, and then fell 10% on Tuesday as experts noted that the press release contained little data.

Also in the news was AstraZeneca (AZN), which announced a commitment of up to $1.2 billion from the U.S. government to manufacture the Covid-19 vaccine developed by an Oxford University lab.

In his note, Chen wrote that it was hard to pick winners among the many Covid-19 vaccine programs. He flagged the coming manufacturing challenge, but said there could be enough of the messenger RNA-based vaccines available in 2021 to treat up to 1.5 billion people, and enough of the adenovirus vector vaccines in 2021 to treat up to 2.5 billion people. He said that there could be around one billion doses of the protein subunit vaccine being developed by Sanofi (SNY) and GlaxoSmithKline (GSK) in 2021.

But thats if all of the leading programs work. Keep in mind mRNA and adenovirus vaccines have never been marketed, let alone manufactured or commercialized at global scale, Chen wrote.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

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A Covid-19 Vaccine Could Be Ready Late This Year, Bernstein Analyst Says - Barron's

A new survey by Yahoo News and YouGov has found that 44% of Republicans believe that Bill Gates will use the COVID-19 vaccination to implant a location-tracking microchip into the vaccine recipient, a conspiracy theory that has gained traction among fringe groups and conservative pundits.

The survey also found that 26% of Republicans do not believe the false microchip vaccine narrative, while 31% remained undecided on the topic. Half of the people surveyed who use Fox News as their main source of TV news also believe the debunked theory.

However, the poll also noted that 19% of Democrats, 24% of Independents, and 15% of people who use MSNBC as their source of TV news also believe the microchipping myth.

For the survey, YouGov conducted an online interview of a "nationally representative" group of 1,640 US adults who were a part of YouGov's opt-in panel between May 20 and 21. There is about a 3% margin of error.

An earlier Yahoo News and YouGov poll also found that only 55% of Americans surveyed would want the coronavirus vaccine when it becomes available. The rest were either unsure (26%) or did not plan on receiving the vaccine (19%).

President Donald Trump has said that he is "very confident" that a coronavirus vaccine will be ready by the end of the year, while experts have predicted that the vaccine development could take up to 12 to 18 months to prepare.

Mike Cohen/Getty Images for The New York Times

According to data by media analysis group Zignal Labs, over 16,000 posts on Facebook related to Bill Gates and coronavirus vaccine misinformation have been liked and commented almost 900,000 times, the New York Times reported in April.

However, Facebook isn't the only platform used to spread these conspiracies. On YouTube, the 10 most popular videos about Gate's purported microchipping vaccine have received over 5 million views, according to the same New York Times and Zignal Labs report.

On Twitter, images and tweets describing Bill Gates as a "deep state puppet" who wants a vaccine in order to control the population are also being posted and circulated.

These social media platforms have tried to take steps to curtail the anti-vaccination or coronavirus misinformation movement on its website. On May 11, Twitter announced that it would start labeling "misleading" coronavirus information. Last year, YouTube announced that it would demonetize videos on its platform that are pushing the anti-vaccine agenda.

YouTube and Facebook also recently took down the 26-minute "Plandemic" movie from its platforms. The debunked film featured discredited scientist Judy Mikotivs' claims that the US and vaccine companies created the coronavirus pandemic for profit.

However, the Bill Gates conspiracy theorists don't just live online in the form of bots and fringe theorists on social media. Public figures like Roger Stone and Laura Ingraham have also been pushing this same message.

Bill Gates has been a longtime supporter of vaccinations, and so far, Gates has donated $300 million to coronavirus vaccine efforts, according to Vox.

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Study finds over 40% of Republicans think Bill Gates will use a COVID-19 vaccine to impl... - Business Insider - Business Insider

Scientists have warned there could be major delays in producing a Covid-19 vaccine if current UK infection rates remain low and lengthy waiting times are needed to show if candidate products are working. As a result, some researchers insist that ministers must now consider implementing radical alternative measures to speed up vaccine development.

In particular, they argue that Britain should consider deliberately infecting volunteers involved in vaccine-testing projects in line with World Health Organization proposals to set up such human challenge trials. Earlier this month, the WHO issued a 19-page set of guidelines on how these trials might operate.

However, other UK scientists have reacted with horror at the proposal to implement human challenge trials for a Covid-19 vaccine on the grounds that these could cause serious illness and possibly deaths of volunteers who had been deliberately infected with the virus.

The dilemma was summed up by Jonathan Ives of the Centre for Ethics in Medicine at Bristol University. If we were to do this, we would be asking healthy people to put their wellbeing and their lives at risk for the good of society at large. On the other hand, taking that risk could speed up vaccine development and save many, many lives. So I think there could be grounds for going ahead with challenge trials, though it would be based on a very finely balanced argument.

Figures released last week suggest about 7% of the UK population may have already been infected with Covid-19 virus, a relatively low level of infection that poses problems for testing vaccines. A sufficient number of volunteers has to be exposed to the virus to see if a vaccine protects them or not. But if their chances of being in contact with an infected person are low, it will take a long time to demonstrate the efficacy of a vaccine candidate.

As a result, scientists have proposed that human challenge trials could be introduced to test a vaccine quickly and so save thousands of lives by preventing future infections. Levels of infection in the community are already low, and if this virus behaves like other respiratory diseases and coronaviruses, there may be even lower levels over the summer, said Professor Lawrence Young of Warwick University Medical School. There will not be enough people secreting the virus to be in contact with volunteers in vaccine projects. It is just not going to work.

Young argues that human challenge trials should be considered very seriously for the UK. These would involve giving volunteers either a placebo or a vaccine, as is normally done in trials. But instead of waiting to find out how the two groups fare without interference, scientists would deliberately infect them with the Covid-19 virus. This would very quickly show if a vaccine works or not.

Only very healthy young people around the age of 25 who have given informed consent would be used, added Young, who points out that such trials have already been used to test the efficacy of vaccines for flu and the common cold.

Only very healthy young people around the age of 25 who have given informed consent would be used

However, these ailments pose relatively low risks to volunteers. Covid-19 can have serious side-effects, mainly for the elderly but also in a few rare cases of young, apparently healthy people. This point is acknowledged by Young. Before we went ahead with challenge trials, we would need to have developed some very effective therapy an anti-viral drug perhaps that could be used in the few cases where something went seriously wrong.

This latter point has been stressed by WHO in its guidelines for human challenge trials. It suggests the least risky group to infect would be those aged 1830 years. Only 1% of this group end up hospitalised with Covid-19, while fatality rates are around 0.03%. Challenge studies should then be conducted in specialised facilities, with especially close monitoring and ready access to early supportive treatment for participants, add the guidelines.

The idea of carrying out human challenge trials for a Covid-19 vaccine was also backed by Professor Arpana Verma, of Manchester University. Vaccines give us the ability to protect the most vulnerable people in society. That is one of their key strengths. So I think it would be entirely justifiable to go ahead with such trials.

But the proposal was firmly opposed by immunologist Professor Eleanor Riley of Edinburgh University. Challenge studies are done for many diseases but only when strict criteria are followed. Firstly, the virus should be really well studied and its clinical behaviour understood in detail. It should also be incapable of causing severe illness in healthy individuals, or there should be a highly effective drug to clear the infection. None of these criteria are met for Covid-19, and I would be very concerned to hear challenge studies were being planned.

The crucial point is that we should be thinking now whether we want to go ahead with human challenge trials, said Young. We shouldnt wait until we have a vaccine candidate on our hands and not know what to do with it.

Read the rest here:

UK scientists want to infect volunteers with Covid-19 in race to find vaccine - The Guardian

Novel coronavirus disease 2019-nCoV

Moderna is front and center in the race to develop a vaccine for Covid-19. In a press release on Monday it stated, With todays positive interim Phase 1 data and the positive data in the mouse challenge model, theModernateam continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA (Biologics License Application).

The company has also been cited by Dr. Anthony Fauci who expressed "cautious optimism" Friday about the initial results from a coronavirus vaccine trial which were widely celebrated this week and said it remains "conceivable" that a vaccine for the deadly pathogen could be available by the end of the year per an NPR report.

[I am not in a position to offer judgment on the medical aspects of Modernas trial results and outlook. What I am providing are the historical financial results of the company, how the stock is valued and what it could mean for the shares.]

Historical financial results

Moderna has not sold any products to generate revenue. It has relied upon collaboration revenue from other companies and grants to fund its research. These are perfectly fine ways to generate revenue, but at some point in time the company needs to successfully develop products that can be sold. The company has 23 mRNA development candidates in its portfolio with 13 in clinical studies.

Moderna development pipeline

Below are 2016 to 2019 revenue, net losses and operating cash flow results.

Its revenue stream is erratic

2016: $108 million

2017: $206 million

2018: $135 million

2019: $60 million

Average the past four years: $127 million

Bottom line losses are growing

2016: $(230) million

2017: $(270) million

2018: $(402) million

2019: $(514) million

Negative operating cash flows means capital must be consistently raised

Deferred revenue between 2016 and 2017 essentially offset each other.

2016: Positive $164 million

2017: Negative $(162) million

Without the deferred revenue imbalance cash flows were

2016: Negative $(97) million

2017: Negative $(169) million

2018: Negative $(331) million

2019: Negative $(459) million

At least it doesnt have any debt

As of December 2019 Moderna had just over $1.1 billion in cash and short-term investments and an additional $160 million in long-term investments. Its total assets were $1.6 billion versus only $415 million in total liabilities, with no debt. Its balance sheet is strong but given its large negative cash flows it needs to be.

Shares are valued at 25.6x its market cap to revenue

Since the company is losing money using a PE ratio doesnt work, so the fallback is to use a market cap to revenue ratio.

Moderna had 353.1 million shares outstanding as of its March quarter results and 371.2 million as of April 30, per its 10-Q filing. With the stock closing at $69 on Friday its market cap is $25.6 billion.

Determining what revenue to use for the analysis is a bit challenging. In the March quarter the company only generated $8.4 million in revenue vs. $16 million a year ago. It did receive $483 million from the U.S. governments BARDA (Biomedical Advanced Research and Development) group in April for its Covid-19 work, but expects its coronavirus expenses to essentially match the amount of this grant.

There are multiple vaccines that generate over $1 billion in sales per year and Mercks total vaccine business generated $8.4 billion in revenue last year, according to Bernstein.

Assuming that Moderna can successfully develop and manufacture a vaccine for Covid-19 this analysis uses $1 billion in revenue per year for the company. It could be higher than this, but there could also be multiple vaccines available and Moderna may not be successful.

Using $1 billion the companys market cap to ratio would be 25.6x.

Concept of SARS-CoV-2 or 2019-ncov coronavirus

How does this compare to other pharmaceutical companies

This is a bit of an apples to oranges comparison since Moderna is and will be much smaller but will have a higher growth rate than these large companies. However, it does provide some reference on how highly valued Moderna is. These figures are based on 2019 revenue and Fridays market caps.

ABBV

AstraZeneca

Genetech/Roche

Merck

Pfizer

These 5 companies market cap to revenue average is 4.8x.

Modernas share price could be 60% too high or just about right

Giving Moderna a 10x market cap to revenue ratio would be just over twice the 4.8x valuation of the five large pharmaceutical companies. At a 10x ratio and using $1 billion in revenue per year gives a $10 billion market cap. Unfortunately, at Modernas current share price of $69 it has a market cap of $25.6 billion or 156% higher than the calculated value.

If it was valued at 10x revenue the share price would be $27, or lower by 61%, or where it was in March. To support the current share price with a 10 times market cap to revenue ratio the company will need to consistently generate $2.6 billion in revenue per year or at least be on a path to this level.

Getting there may be doable. It could come from a higher revenue stream from a very successful Covid-19 vaccine or a combination of the other 22 mRNA development candidates in the companys pipeline.

It does appear that the share price increase above $25 in the March timeframe is largely or entirely due to its work on its coronavirus vaccine. If that is the case the increase from $25 to $69 has added $16 billion in market cap. Working back using a 10x market cap to revenue ratio would mean that Modernas Covid-19 revenue will need to reach $1.6 billion in revenue per year. Of course a higher valuation multiple will lower the revenue bar, but a lower valuation multiple would raise it.

Moderna stock price

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Buyer Beware: Covid-19 Vaccine Maker Moderna Is Valued In The Stratosphere - Forbes

The ethical challenges that have arisen so far in the coronavirus pandemic largely boil down to the age-old struggle between individual freedoms and the public good. Issues like restricting movement and commerce to protect community health or requiring health care workers to treat infected patients, even at the risk of getting infected themselves, are specific examples of this larger dilemma. These debates, even in the United States where rugged individualism is celebrated, have been settled for the most part in favor of the common good.

Ethical questions in the next phase of the pandemic are bound to be more fractious. They will turn from our common goal of maximizing the greater good to brokering disagreements between individual groups that may not be so easy to resolve.

The development of a vaccine is bound to raise ethical questions like these: Who should get it first? How will we judge claims to it? How will we give priority to different groups or communities?

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These issues may come up sooner than expected. The biotechnology company Moderna has tested a new vaccine on eight patients that appeared to be safe and stimulated an immune response against SARS-CoV-2, the virus that causes Covid-19. Other vaccine candidates are in the pipeline. Oxford University scientists, for example, have announced they will begin testing of a new coronavirus vaccine in 6,000 volunteers. If the vaccine is effective, it could be available by early fall (though most experts say an effective vaccine wont be available till next year).

But as weve seen with viral testing kits, manufacturing and distribution problems will almost immediately create shortages, at least in the short term. To quickly manufacture the nearly 8 billion doses required to protect everyone on the planet will be impossible.

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When a vaccine comes on the market, the U.S. Centers for Disease Control and Prevention and other advisory groups will issue guidelines on who should get first dibs. The top tier will include health care and other workers whose jobs are considered essential in the pandemic. People most likely to die if stricken may also get priority.

But these are just guidelines. The ultimate decisions on who gets vaccinated will be made by state and local health departments and community hospitals interpreting the federal guidelines.

The decisions will be fraught, as different groups jockey for their place in line. There will be disagreements.

In Texas during the 2009 H1N1 influenza pandemic, for example, some health care providers werent sure if they should interpret vaccination guidelines from the CDC as giving priority to police officers and firefighters. Others in the state argued that school nurses and teachers should be in the top tier. Some senior citizens were perplexed that they werent considered a priority.

When we eventually reach the point of having a vaccine in hand but in short supply, I worry that disadvantaged communities, which have been among the hardest hit by Covid-19, will be left out. In state after state, black and brown communities are disproportionately infected and dying.

In New York City, for example, blacks and Latinos are dying at twice the rate of the general population. In Chicago, African-Americans account for nearly 70% of coronavirus deaths but make up 30% of the citys population. In Los Angeles, people in low-income neighborhoods are three times as likely to die as those in wealthier neighborhoods.

The reasons behind these differences arent fully known, but almost certainly include poor community infrastructure like lack of stable housing, lack of health insurance, and social segregation. Minorities tend to experience worse outcomes in a plethora of diseases; there was no reason to think that their outcomes in this pandemic would be any different.

Residents in these communities will need the vaccine as much as if not more than wealthy and connected citizens. To ensure they get their fair share, they will need representation to advocate for their interests when allocation decisions are made. They have the right to know how authorities will distribute the vaccine to their neighborhoods, as transportation problems may hinder their ability to go to hospitals or other vaccination sites.

If doctors are prioritized for getting the vaccine, will the delivery persons, grocery store clerks, and home health aides who often live in underserved communities also be given preference? Not giving due priority to these communities will only deepen their mistrust in the health care system that is already present and was worsened by debacles like the bungled rescue efforts after Hurricane Katrina.

Covid-19 does not respect borders. Rates of infection and deaths in countries in Africa have been lower than in Europe, Asia, and the United States, but there is every reason to believe they will eventually bear a disproportionate share, as they have from other infectious diseases over the past century. Poor countries have less money to buy vaccines and drugs even though they might eventually have more need for them. We must plan now to ensure they get their share of Covid-19 therapies.

Rationing antiviral drugs and other therapies has largely been absent in the U.S. during the Covid-19 pandemic, largely because no treatment has been shown to be of clear-cut benefit. That will change if and when a vaccine becomes available, and difficult choices will need to be made about allocation.

To meet that challenge head on, the CDC must develop a plan with input from the states to ensure that the vaccine is available wherever it is most needed and that disadvantaged communities in this country get their fair share. The plan must communicate clearly why certain groups will receive priority for early vaccination. It should also include a means to evaluate and rapidly redress grievances in the allocation process.

If we are to avoid worsening mistrust in health care and in government and possibly even social strife, we need transparent and ethical federal guidelines for distributing a Covid-19 vaccine now, before we must begin making the difficult decisions about allocating it.

Sandeep Jauhar is a cardiologist at Northwell Health in New York. His most recent book is Heart: A History (Farrar, Straus and Giroux, 2018).

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With a Covid-19 vaccine in hand, who should get it first? - STAT

We need vaccines, immunologist Jacob Glanville says. He knows about combating infections; the fast-talking, curly-haired former Pfizer staff scientist has spent years searching for a universal flu vaccine, and his San Francisco-based startup Distributed Bio spearheads a variety of vaccination projects. As one might expect, his team is working diligently to find biopharmaceutical tools to fight Covid-19, but heres the twist: Its opting out of the scientific communitys sprint to find a vaccine. Instead, Distributed Bio is part of a parallel coronavirus research scramble: the hunt for antibody treatments.

Along with a wide mix of research teams in laboratories across the world, Glanville is pursuing antibody treatments as a complementary tool to fight Covid-19. Unlike vaccines, antibody treatments dont produce lasting protection against a disease. Instead, these treatments are meant to equip bodies with tools to immediately (albeit temporarily) fight off an infection, or prevent an imminent contagion.

This is partly a matter of timing. Vaccines take forever, Glanville says. Traditional trials require administering the vaccine to healthy people, then observing whether they develop immunity. Proving efficacy necessitates waiting. And waiting. Even though buzzy biotech companies like Moderna have managed to leap into human trials in a matter of months, many researchers still doubt the optimistic immunization timelines put forth by politicians and pundits. I think antibodies have a faster pathway to deployment, says Robert Carnahan, the associate director of the Vanderbilt Vaccine Center, which is also working on its own antibody treatment research. We either let everybody get the disease or we get a vaccine, and antibodies can bridge us to that moment where we have it.

When exposed to viruses, immune systems create antibodies, proteins that protect the body from foreign substances. This is happening to people who are fighting SARS-CoV-2 around the world. The antibodies linger in their blood after symptoms subside, protecting them from further infection. Right now, the blood plasma from recovered coronavirus patients can be transfused into people who are currently fighting the disease, as a way to introduce effective antibodies into their systems. Using blood from recovered patients to fend off disease is an old treatment, and convalescent serum has been used to treat MERS, SARS, and Ebola patients. So far, it appears convalescent serum can help people who are infected with Covid-19 recover. However, it has several major drawbacks. The most obvious is a matter of scale. Theres a finite supply of convalescent blood in the world, so it simply isnt possible to harvest enough of it, even if every single previously infected person happily gave blood every week. Collecting and distributing the blood is also a complicated, labor-intensive process.

And there's another problem, which is that the process just isn't that efficient. Each donor's blood would contain antibodies to a wide swath of previous infections, not just Covid-19. So the number of antibodies in their serum that can actually fight this particular virus might be very low. Antibody treatments apply the logic of convalescent serum and refine its concept by creating more targeted, potent, and scalable versions of the kinds of antibodies we produce that can banish Covid-19, produced en masse in labs rather than drained from human arms. Ideally, the treatment process itself would also be much less cumbersome than the serum infusion. You might be able to do a subcutaneous injection, like an outpatient procedure, Glanville says.

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Of course, the therapeutic dose is currently only a hypothetical. Scientists are still in the arms race portion of their research, and its not clear which type of antibody treatment will pull ahead. Many already believe they have pinpointed effective antibodies and have evidence that they can neutralize Covid-19. But they still need to make sure the antibodies that look promising in a laboratory setting will work when introduced into infected animals, and then that they will work when introduced into infected humansand then that they can be mass-produced in a safe, cost-effective, and timely manner. There are a lot of different approaches that people are trying, all of which hold promise, says Yale University chemistry professor David Spiegel, who also cofounded a New Haven-based pharmaceutical company called Kleo Pharmaceuticals. It's experimental science.

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The Promise of Antibody Treatments for Covid-19 - WIRED