Category Archives: Vaccination

A few superspreaders transmit the majority of coronavirus cases

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Corona A few superspreaders transmit the majority of coronavirus ...

The coronavirus has traveled the globe, infecting one person at a time. Some sick people might not spread the virus much further, but some people infected with the SARS-CoV-2 are what epidemiologists call “superspreaders.”

Elizabeth McGraw, the director of the Center for Infectious Disease Dynamics at Pennsylvania State University, explains the evidence and why superspreaders can be crucial to a disease’s transmission.

What is a superspreader?

Early in the outbreak, researchers estimated that a person carrying SARS-CoV-2 would, on average, infect another two to three people. More recent studies have argued, however, that this number may actually be higher.

As early as January, though, there were reports out of Wuhan, China, of a single patient who infected 14 health care workers. That qualifies him as a super spreader: someone who is responsible for infecting an especially large number of other people.

Since then, epidemiologists have tracked a number of other instances of SARS-CoV-2 superspreading. In South Korea, around 40 people who attended a single church service were infected at the same time. At a choir practice of 61 people in Washington state, 32 attendees contracted confirmed COVID-19 and 20 more came down with probable cases. In Chicago, before social distancing was in place, one person that attended a dinner, a funeral and then a birthday party was responsible for 15 new infections.

During any disease outbreak, epidemiologists want to quickly figure out whether superspreaders are part of the picture. Their existence can accelerate the rate of new infections or substantially expand the geographic distribution of the disease.

 

What are the characteristics of a superspreader?

Whether someone is a superspreader or not will depend on some combination of the pathogen, the patient’s biology and their environment or behavior.

Some infected individuals might shed more virus into the environment than others if their immune system has trouble subduing the invader. Additionally, asymptomatic individuals – up to 50% of all those who get COVID-19 – will continue their normal activities, inadvertently infecting more people. Even people who ultimately do show symptoms are capable of transmitting the virus during a pre-symptomatic phase.

A person’s behaviors, travel patterns and degree of contact with others can also contribute to superspreading. An infected shopkeeper might come in contact with a large number of people and goods each day. An international business traveler may crisscross the globe in a short period of time. A sick health care worker might come in contact with large numbers of people who are especially susceptible, given the presence of other underlying illnesses.

Public protests – where it’s challenging to keep social distance and people might be raising their voices or coughing from tear gas – are conducive to superspreading.

 

How big a part of COVID-19 are superspreaders?

Several recent preprint studies, which haven’t yet been peer-reviewed, have shed light on the role of superspreading in COVID-19’s dispersion around the globe.

Researchers in Hong Kong examined a number of disease clusters by using contact tracing to track down everyone with whom individual COVID-19 patients had interacted. In the process, they identified multiple situations where a single person was responsible for as many as six or eight new infections.

The researchers estimated that only 20% of all those infected with SARS-CoV-2 were responsible for 80% of all local transmission. Importantly, they also showed that these transmission events were associated with people who had more social contacts – beyond just family members – highlighting the need to rapidly isolate people as soon as they test positive or show symptoms.

Another study by researchers in Israel took a different approach. They compared the genetic sequences of coronavirus samples from patients inside the country to those from other places. Based on how different the genomes were, they could identify each time SARS-CoV-2 entered Israel and then follow how it spread domestically.

These scientists estimated that 80% of community transmission events – one person spreading the coronavirus to another – could be tracked back to just 1-10% of sick individuals.

And when another research group modeled the variation in how many other SARS-CoV-2 infections a single infected person tends to cause, they also found there were occasionally individuals who were very infectious. These people accounted for over 80% of transmissions in a population.

 

When have superspreaders played a key role in an outbreak?

There are a number of historical examples of superspreaders. The most famous is Typhoid Mary, who in the early 20th century purportedly infected 51 people with typhoid through the food she prepared as a cook.

During the last two decades, superspreaders have started a number of measles outbreaks in the United States. Sick, unvaccinated individuals visited densely crowded places like schools, hospitals, airplanes and theme parks where they infected many others.

Superspreaders have also played a key role in the outbreaks of other coronaviruses, including SARS in 2003 and MERS in 2015. For both SARS and MERS, superspreading mainly occurred in hospitals, with scores of people being infected at a time.

 

Can superspreading occur in all infectious diseases?

Yes. Researchers have identified superspreaders in outbreaks of diseases caused by bacteria, such as tuberculosis, as well as those caused by viruses, including measles and Ebola. Just as appears to be the case with the coronavirus, some scientists estimate that in an outbreak of any given pathogen, 20% of the population is usually responsible for causing over 80% of all cases of the disease.

The good news is that the right control practices specific to how pathogens are transmitted – hand-washing, masks, quarantine, vaccination, reducing social contacts and so on – can slow the transmission rate and halt a pandemic.

 

 

 

U.S. Passes 2 Million Coronavirus Cases as States Lift Restrictions, Raising Fears of a Second Wave

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Communication, Contact Tracing, Coronavirus, Crisis, Crisis Management, Economic Crisis, Economy Reopening, Health Policy, Infection Control, Infection Control Plan, Infectious Virus, Messaging, Mortality, Pandemic, Protest, Public Debate, Public Discourse, Public Health, Public Safety, Quarantine, Social Distancing, Vaccination, Vaccine, Vulnerable Populations, World Health Organization (WHO) • Leave a comment

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U.S. Reaches More Than 2 Million Coronavirus Cases - YouTube

The number of confirmed U.S. coronavirus cases has officially topped 2 million as states continue to ease stay-at-home orders and reopen their economies and more than a dozen see a surge in new infections. “I worry that what we’ve seen so far is an undercount and what we’re seeing now is really just the beginning of another wave of infections spreading across the country,” says Dr. Craig Spencer, director of global health in emergency medicine at Columbia University Medical Center.

AMY GOODMAN: I certainly look forward to the day you’re sitting here in the studio right next to me, but right now the numbers are grim. The number of confirmed U.S. coronavirus cases has officially topped 2 million in the United States, the highest number in the world by far, but public health officials say the true number of infections is certain to be many times greater. Officially, the U.S. death toll is nearing 113,000, but that number is expected to be way higher, as well.

This comes as President Trump has announced plans to hold campaign rallies in several states that are battling new surges of infections, including Florida, Texas, North Carolina and Arizona — which saw cases rise from nearly 200 a day last month to more than 1,400 a day this week.

On Tuesday, the country’s top infectious disease expert, Dr. Anthony Fauci, called the coronavirus his worst nightmare.

DR. ANTHONY FAUCI: Now we have something that indeed turned out to be my worst nightmare: something that’s highly transmissible, and in a period — if you just think about it — in a period of four months, it has devastated the world. … And it isn’t over yet.

AMY GOODMAN: This comes as Vice President Mike Pence tweeted — then deleted — a photo of himself on Wednesday greeting scores of Trump 2020 campaign staffers, all of whom were packed tightly together, indoors, wearing no masks, in contravention of CDC guidelines to stop the spread of the coronavirus.

Well, for more, we’re going directly to Dr. Craig Spencer, director of global health in emergency medicine at Columbia University Medical Center. His recent piece in The Washington Post is headlined “The strange new quiet in New York emergency rooms.”

Dr. Spencer, welcome back to Democracy Now! It’s great to have you with this, though this day is a very painful one. Cases in the United States have just topped 2 million, though that number is expected to be far higher, with the number of deaths at well over 113,000, we believe, Harvard University predicting that that number could almost double by the end of September. Dr. Craig Spencer, your thoughts on the reopening of this country and what these numbers mean?

DR. CRAIG SPENCER: That’s a really good question. So, when you think about those numbers, remember that very early on, in March, in April, when I was seeing this huge surge in New York City emergency departments, we weren’t testing. We were testing people that were only being admitted to the hospital, so we were knowingly sending home, all across the epicenter, people that were undoubtedly infected with coronavirus, that are not included in that case total. So you’re right: The likely number is much, much higher, maybe 5, 10 times higher than that.

In addition, we know that that’s true for the death count, as well. This has become this political flashpoint, talking about how many people have died. We know that it’s an incredible and incalculable toll, over 100,000. Within the next few days, we’ll have more people that have died from COVID than died during World War I here in the United States. So that’s absolutely incredible.

We know that, also, just because New York City was bad, other places across the country might not get as bad, but that doesn’t mean that they’re not bad. So, we had this huge surge, of a bunch of deaths in New York City, you know, over 200,000 cases, tens of thousands of deaths. What we’re seeing now is we’re seeing this virus continue to roll across this country, causing these localized outbreaks.

And this is, I think, going to be our reality, until we take this serious, until we actually take the actions necessary to stop this virus from spreading. Opening up, like we’ve seen in Arizona and many other places, is exactly counter to what we need to be doing to keep this virus under control. So, yeah, I worry that what we’ve seen so far is an undercount and what we’re seeing now is really just the beginning of another wave of infections spreading across the country.

NERMEEN SHAIKH: Well, Dr. Spencer, I want to ask — it’s not just in the U.S. that cases have hit this dreadful milestone. Worldwide, cases have now topped 7 million, although, like the U.S., the number is likely to be much higher because of inadequate testing all over the world. But I’d like to focus on the racial dimension of the impact of coronavirus, not just in the U.S., but also worldwide. Just as one example, in Brazil — and this is a really stunning statistic — that in Rio’s favelas, more people have died than in 15 states in Brazil combined. So, could you talk about this, both in the context of the U.S., and explain whether that is still the case, and what you expect in terms of this racial differential, how it will play out as this virus spreads?

DR. CRAIG SPENCER: Absolutely. What we’re seeing, not just in the United States, but all over the world, is coronavirus is amplifying these racial and ethnic inequities. It is impacting disproportionately vulnerable and already marginalized populations.

Starting here in the U.S., if you think about the fact, in New York City, the likelihood of dying from coronavirus was double if you’re Black or African American or Latino or Hispanic, double than what it was for white or Asian New Yorkers, so we already know that this disproportionate impact on already marginalized and vulnerable communities exists here in the United States, in the financial capital of the world. It’s the same throughout the U.S. A lot of the data that we’re seeing over the past few days, as we’re getting this disaggregated data by race and ethnic background, is that it is hitting these communities much harder than it is hitting white and other communities in the United States.

The statistics that you give for Brazil are being played out all over the world. We know that communities that already lack access to good healthcare or don’t have the same economic ability to stay home and participate in social distancing are being disproportionately impacted.

That is why we need to focus on and think about, in our public health messaging and in our public health efforts, to think about those communities that are already on the margins, that are already vulnerable, that are already suffering from chronic health conditions that may make them more likely to get infected with and die from this disease. We need to think about that as part of our response, not just in New York, not just in the U.S., but in Brazil, in Peru, in Ecuador, in South Africa, in many other countries, where we’re seeing the disproportionate number of cases coming from now.

We’re seeing — you know, I think it was just pointed out that three-quarters of all the new cases, the record-high cases, over 136,000 this past weekend on one day, three-quarters of those are coming from just 10 countries. And we know that that will continue, and it will burn through those countries and will continue through many more.

As of right now, we haven’t seen huge numbers in places like West Africa and East Africa, sub-Saharan Africa, where many people were concerned about initially. Part of that is because they have in place a lot of the tools from previous outbreaks, especially in West Africa around Ebola. But it may be that we need more testing. It may be that we’re still waiting to see the big increase in cases that may eventually hit there, as well.

NERMEEN SHAIKH: Dr. Spencer, you mentioned that on Sunday — it was Sunday where there were 136,000 new infections, which was a first. It was the highest number since the virus began. But even as the virus is spreading, much like states opening in the U.S., countries are also starting to reopen around the world, including countries that have now among the highest outbreaks. Brazil is now second only to the U.S. in the number of infections, and Russia is third, and these countries are opening, along with India and so on. So, could you — I mean, there are various reasons that countries are opening. A lot of them are not able — large numbers of people are not able to survive as long as the country is closed, like, in fact, Brazil and India. So what are the steps that countries can take to reopen safely? What is necessary to arrest the spread of the virus and allow people at the same time to be out?

DR. CRAIG SPENCER: It’s tough, because we know that this virus cannot infect you if this virus does not find you. If there’s going to be people in close proximity, whether it’s in India or Illinois, this virus will pass and will infect you. I have a lot of concern, much as you pointed out, places like India, 1.3 billion people, where they’re starting to open up after a longer period of being locked down, and case numbers are steadily increasing.

You’re right that a lot of people around the world don’t have access to multitrillion-dollar stimulus plans like we do in the United States, the ability to provide at least some sustenance during this time that people are being forced at home. Many people, if they don’t go outside, don’t eat. If they don’t work, you know, their families can’t pay rent or really just can’t live.

What do we do? We rely on the exact same tools that we should be relying on here, which is good public health principles. You need to be able to locate those people who are sick, isolate them, remove them from the community, and try to do contact tracing to see who they potentially have exposed. Otherwise, we’re going to continue to have people circulating with this virus that can continue to infect other people.

It’s much harder in places where people may not have access to a phone or may not have an address or may not have the same infrastructure that we have here in the United States. But it’s absolutely possible. We’ve done this with smallpox eradication decades ago. We need to be doing this good, simple, bread-and-butter, basic public health work all around the world. But that takes a lot of commitment, it takes a lot of money, and it takes a lot of time.

AMY GOODMAN: It looks like President Trump is reading the rules and just doing the opposite — I mean, everything from pulling out of the World Health Organization, which — and if you could talk about the significance of this? You’re a world health expert. You yourself survived Ebola after working in Africa around that disease. And also here at home, I mean, pulling out of Charlotte, the Republican convention, because the governor wouldn’t agree to no social distancing, and he didn’t want those that came to the convention to wear masks. If you can talk about the significance, what might seem trite to some people, but what exactly masks do? And also, in this country, the states we see that have relaxed so much — he might move, announce tomorrow, the convention to Florida. There’s surges there. There’s surges in Arizona, extremely desperate question of whether a lockdown will be reimposed there. What has to happen? What exactly, when we say testing, should be available? And do you have enough masks even where you work?

DR. CRAIG SPENCER: Great. Yes. So, let me answer each of those. I think, first, on the World Health Organization, and really the rhetoric that is coming from the White House, it needs to be one of global solidarity right now. We are not going to beat this alone. I think that that’s been proven. This idea of American exceptionalism now is only true in that we have the most cases of anywhere in the world. We are not going to beat this alone. No country is going to beat this alone. As Dr. Fauci said, this is his worst nightmare. It’s my worst nightmare, as well. This is a virus that was first discovered just months ago, and has now really taken over the world. We need organizations like the World Health Organization, even if it isn’t perfect. And I’ve had qualms with it in the past. I’ve written about it, I’ve spoken about it, about the response as part of the West Africa Ebola outbreak that I witnessed firsthand. But at the end of the day, they do really, really good work, and they do the work that other organizations, including the United States, are not doing around the world, and that protects us. So, we absolutely, despite their imperfections, need to further invest and support them.

In terms of masks, masks may be, in addition to social distancing, one of the few things that really, really helps us and has proven to decrease transmission. We know that if a significant proportion of society — you know, 60, 70, 80% of people — are wearing masks, that will significantly decrease the amount of transmission and can prevent this virus from spreading very rapidly. Everyone should be wearing masks. I think, in the United States right now, we should consider the whole country as a hot zone. And the risk of transmission being very high, regardless of whether you’re in New York or North Dakota, people should be wearing a mask when they’re going outside and when they’re interacting with others that they generally don’t interact with.

We know the science is good. I will say that from a public health perspective, there was some initial reluctance and, really, I guess, some confusion early on about whether people should be using masks. We didn’t have a lot of the science to know whether it would help. We do now. And thankfully, we’re changing our recommendations.

We also were concerned about the availability of masks early on. As you mentioned, there was questions around availability of personal protective equipment, whether we had enough in hospitals to provide care while keeping providers safe. It’s better now, but there are still a lot of people who are saying that they’re reusing masks, that we still need more personal protective equipment. So, for the moment, everyone should be wearing a mask.

AMY GOODMAN: And for the protests outside?

DR. CRAIG SPENCER: Absolutely. Yeah, of course. Just because I think we have personal passions around public health crises, that doesn’t prevent us from being infected. From a public health perspective, of course I have concerns that people who are close and are yelling and are being tear-gassed and are not wearing masks, if that’s all the case, it’s certainly an environment where the coronavirus could spread.

So, what I’ve been telling everyone that’s protesting is exercise your right to protest — I think that’s great — but be safe. We are in a pandemic. We’re in a public health emergency. Wear a mask. Socially distance as much as you possibly can. Wash your hands.

AMY GOODMAN: And are you telling the authorities to stop tear-gassing and pepper-spraying the protesters?

DR. CRAIG SPENCER: I mean, well, one, it’s illegal. You should definitely stop tear-gassing. We know that what happens when people get tear-gassed is they cough, and it increases the secretions, which increases the risk. It increases the transmissibility of this virus.

In addition to that, you know, holding people and arresting them and putting them into small cells with others without masks is also, as we’ve seen from this huge number of cases in places like meatpacking plants or in jails, in prisons, the number of cases have been extremely high in those places. Putting people into holding cells for a prolonged period of time is not going to help; it’s definitely going to increase the transmissibility of this virus.

So, yes, everyone should be wearing a mask. I think everyone should have a mask on when you’re anywhere that your interacting with others can potentially spread this.

I think your other question was around testing. We know that right now testing has significantly increased in the U.S. Is it adequate? No, I don’t think so. I know I hear from a lot of people who say they still have to drive two to three hours to get a test. We still have questions around the reliability of some of serology tests, or the antibody tests. Those are the tests that will tell you whether or not you’ve been previously exposed and now have antibodies to the disease. Some of the more readily available tests just aren’t that great. And so, we can’t use them yet to make really widespread decisions on who might have antibodies, who might have protection and who can maybe more safely go back into society without the fear of being infected.

NERMEEN SHAIKH: Dr. Spencer, we just have 30 seconds. Very quickly, there are 135 vaccines in development. What’s your prognosis? When will there be a vaccine or a drug treatment?

DR. CRAIG SPENCER: We have one drug that shortens the time that people are sick. We don’t know about the impact on mortality. There are other treatments that are in process now. Hopefully some of them work.

In terms of vaccines, we will have a vaccine, very likely, that we know is effective, probably at some time later this year. The bigger process is going to be how do we scale it up to make hundreds of millions of doses; how do we do it in a way that we can get it to all of the people that deserve it, not just the people that can pay for it. I think these are going to be some of the bigger questions and bigger problems that we’re going to face, going forward. But I’m optimistic that we’ll have a vaccine or many vaccines, hopefully, in the next year.

AMY GOODMAN: Dr. Craig Spencer, we want to thank you so much for being with us, director of global health in emergency medicine at Columbia University Medical Center. And thank you so much for your work as an essential worker. Dr. Spencer’s recent piece, we’ll link to at democracynow.org. It’s in The Washington Post, headlined “The strange new quiet in New York emergency rooms.”

When we come back, George Floyd’s brother testifies before Congress, a day after he laid his brother to rest. Stay with us.

 

 

 

 

The Essence of Big Pharma

Posted on by • Posted in 2020 Election Issues, Access, Access & Quality of Healthcare, Big Pharma, Coronavirus, Corporate Greed, Employer-Based Health Insurance, Health Insurance Coverage Adequacy, High Deductible Health Plans, High Drug Prices, High Premiums, High Prices, Out of Pocket Expenses, Pandemic, Pharmaceutical Industry, Public Debate, Public Funding, Public Good, Public Health, Scientists, Underinsured, Uninsured, Vaccination, Vaccine, World Health Organization (WHO) • Leave a comment

 

Why We Should Be Reading Albert Camus During the Pandemic

Posted on by • Posted in 2020 Election Issues, Blame, Clinical Testing, Conspiracy Theories, Contact Tracing, Coronavirus, Crisis, Crisis Management, Denial, Economic Crisis, Infection Control, Infection Control Plan, Infectious Virus, Leadership, Mortality, Pandemic, Public Health, Public Safety, Social Distancing, Vaccination, Vaccine • Leave a comment

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Looking at Albert Camus's “The Plague” - The New York Times

The author’s masterpiece, The Plague, will make you think, ask all sorts of Socratic questions of yourself and form resolutions about how you intend to measure your life after getting through this global catastrophe.

It’s amazing how many pandemic books there are, and how thoroughly the idea of a global pandemic had crept into our popular culture well before the current situation. My daughter and I watched the Tom Hanks movie Inferno over the weekend, mostly because we wanted to gaze at the city of Florence. It’s not a great movie, but it is visually stunning in several ways. The plot is not something I gave much attention to when I first saw the film a couple of years ago: a rich Ted-talking eccentric decides to kill off most of the people of the world to save the Earth from over-population and the ravages 16 billion people would mean for other species and the health of the biosphere.

When I first saw the film in 2016, I regarded the plotline (will the vial of lethal germs be released or not?) as nothing but the usual “James Bond” setup for whatever else happened in the film. This time I watched it with greater alertness.

The fact is, of course, that COVID-19 is a serious global nuisance that has disrupted the lives of all Americans in a way that almost nobody could have predicted (well, there is Bill Gates, of course), but it is not the Black Plague, which swept away somewhere between one-fourth and one-half of all Europeans between 1348-1352, or the Yellow Fever epidemic in Philadelphia, which killed one in 10 inhabitants of America’s largest city in 1793, or the Spanish Flu, which killed somewhere between 57 and 100 million people worldwide in 1918.

If the coronavirus eventually kills 5 million people worldwide, and a couple of hundred thousand Americans before the vaccines gallop in to save the day a year or 18 months hence, it will have been a comparatively minor event in the history of global pandemics. The moment when it appeared that the hospital and medical infrastructure of New York might collapse has now passed. And though the death toll continues to climb towards perhaps 150,000 American dead by Aug. 1, 2020, the national dread that created a sustained will-we-survive and how-will-we-cope conversation in virtually every household in the United States is mostly over. The question now is when and how (and if) the country can return to what the late John McCain called regular order.

In the past two months I have read more than a dozen pandemic books, from Daniel Defoe’s A Journal of the Plague Year (1721), to Stephen King’s endless The Stand (1978). They are all interesting. If you outline the takeaway insights from these books, written over the span of many hundreds of years, they all make essentially the same points:

  1. Every government starts in denial, moves through some form of coverup, and eventually has to come to terms with the facts on the ground. 
  2. The rich flee to their country estates (or the Hamptons) and whine about all the inconvenience.
  3. The poor (as always) do most of the suffering, not merely because they are poor and have less access to the Maslovian necessities of life, but because they wind up putting themselves into harm’s way to help other people and even help the undeserving rich.
  4. The only sure methods of dealing with the epidemic (before the coming of vaccines) are social distancing, masks and the avoidance of direct body contact, and quarantining — and these do work.
  5. Economic activity grinds to a halt, but new forms of employment emerge, such as enforcing quarantines or monitoring the spread of the disease through contact tracing.
  6. People who have contracted the disease but who do not yet exhibit symptoms are the principal transmitters of the disease to others.
  7. Government has no choice but to subsidize the lives of people who have no savings and cannot work, because the alternative is food riots, looting, and perhaps revolution.
  8. Quacks, charlatans, and mountebanks abound, as always, to exploit exploitable people.
  9. Bad leaders and some portions of the population spend their time embracing and spreading conspiracy theories and searching for some group, some nation, some tribe to blame for the catastrophe.
  10. Social mores, including sexual codes, begin to break down as people slowly adopt an “eat, drink, and be merry, for tomorrow you shall certainly die” attitude.
  11. The natural sociability of humanity is such that we invariably rush back into the public square too soon, before the disease has been mastered, thus causing a second or a third wave of infection and death.

 

 

 

 

How Jefferson and Franklin Helped End Smallpox in America

Posted on by • Posted in 2020 Election Issues, Clinical Research, Clinical Trials, Leadership, Physician, Smallpox, Vaccination, Vaccine • Leave a comment

https://www.governing.com/context/How-Jefferson-and-Franklin-Helped-End-Smallpox-in-America.html

Drawing Lessons from a Government Protest in North Dakota

As the world eagerly awaits a vaccine for the coronavirus, 200 years ago a smallpox cure struggled to gain acceptance. This is how our founding fathers helped promote the medical breakthrough that saved countless lives.

The great scourge of Thomas Jefferson’s era (1743-1826) was smallpox. Historians have estimated that perhaps as many as 2 billion people have died of smallpox in recorded history. That’s a pretty arbitrary figure, but it certainly indicates how serious the problem was. Modern epidemiology has not only eliminated smallpox as a threat to civilization but has been engaged in a protracted debate about whether to snuff it out altogether once and for all, or to keep a tiny bit of it alive in a handful of tightly secured vials in case we need to study it in the face of other disease epidemics. It was officially declared eradicated in 1980.

For most of human history, you either got it or you didn’t and then you either survived it or you didn’t. George Washington was infected by smallpox in Barbados in 1751. He survived, and though he was slightly disfigured, he was thereafter immune to the disease. It is possible that this early brush with smallpox saved the American Revolution 20 years later. In 18th-century Europe, 400,000 people died annually of smallpox.

By the time Jefferson was born in 1743, there was an experimental inoculation procedure, but it was quite dangerous and therefore highly controversial. The idea was to give healthy individuals a very tiny amount of actual smallpox under quarantine and very carefully controlled conditions and simply hope that the person’s immune system would be able to fight it off. Survival would immunize that individual for life. The procedure required many weeks of quarantine, fasting, puking, and rest, followed by a very light diet through convalescence. John Adams wrote a fascinating account of his own inoculation in 1764. He was 28 years old.

Young Thomas Jefferson’s first journey out of his native Virginia was to Philadelphia in 1766 to be inoculated. He would have undertaken the procedure in Williamsburg or Norfolk had it been available. He made the long journey (eight to 10 days in either direction) because he wanted to protect himself from the disease and study the procedure at the same time for possible incorporation into his own community at Monticello. With his characteristic taciturnity about personal things, Jefferson did not leave us a detailed account of the medical procedure, which required prolonged isolation, personal discipline and a great deal of patience.

Inoculation was first introduced in Europe 40 years earlier. Lady Mary Wortley Montague (1689-1762) had spent time in Turkey as the wife of the British ambassador to the Ottoman Empire. There she had witnessed inoculation in the zenanas (segregated women’s quarters) she visited. She called the procedure “engrafting,” which she described in an important “Letter to a Friend” on April 1, 1717. Mrs. Montagu’s brother had died of smallpox four years earlier and she herself had survived a bout of smallpox in 1715, but with her famous beauty disfigured. She had her five-year-old son Edward inoculated in the British Embassy in Turkey.

Lady Mary Wortley Montagu in Ottoman Travel Dress. She was the first to introduce smallpox inoculation in Europe.

When she returned with her family to Britain, she became an outspoken advocate for the procedure. The English medical establishment decried inoculation and denounced Mary Montagu. Still, in 1721 when a smallpox epidemic broke out in England, she had her daughter inoculated in London. This was the first recorded use of the procedure in England. The medical establishment was slow to accept the efficacy of inoculation, which it regarded as an “oriental folk remedy.” It seemed counter-intuitive and just wrong-headed to give a healthy person a dose of smallpox to try to prevent her or him from getting it by accident. 

Franklin Learns About Inoculation the Hard Way

New England Puritan minister Cotton Mather (1663-1728) first promoted inoculation in America. In 1706, Reverend Mather purchased a black slave he named Onesimus (from the Epistle to Philemon). Ten years later, Onesimus told Mather he had been made immune to smallpox in Africa by having the pus of an infected person rubbed on an open wound on his arm. This is known as the variolation method. Mather interrogated other slaves to learn more, confirmed the story, and became an advocate for inoculation. He was subjected to the usual criticism and pushback. An explosive device was thrown through the window of his home. In this instance, racism joined fear as a means of discrediting the medical procedure. What possible wisdom could come from a slave?

The smallpox plague that disturbed Britain in 1721 found its way that same year to Boston. Now Mather and Dr. Zabdiel Boylston, the only physician in Boston who supported the technique, offered their inoculation services to anyone who would trust them. Of the 242 people Boylston inoculated, only six died, or one in 40. Of those who did not undergo the procedure, one in seven died.

America’s greatest exemplar of the Enlightenment, Benjamin Franklin, became a passionate advocate of the procedure after his first son Franky died of smallpox on Nov. 21, 1736, at the age of four. Because Franklin was known to be a friend to inoculation, rumors spread in Philadelphia that Franky had died from the procedure. To set the record straight, the grieving father wrote an article in the Pennsylvania Gazette on Dec. 30, 1736: He had “intended to get [Francis] inoculated as soon as he should have recovered sufficient strength from a flux with which he had been long afflicted.” Franklin assured the public that his son “received the distemper in the common way of infection.”

In 1774, Franklin, who was an indefatigable creator of associations, societies, clubs and public institutions, including volunteer fire departments and lending libraries, established the Society for Inoculating the Poor Gratis to help the poor people of Philadelphia have access to inoculation. In his famous autobiography, Franklin wrote: “In 1736 I lost one of my sons, a fine boy of four years old, by the smallpox taken in the common way. I long regretted bitterly and still regret that I had not given it to him by inoculation. This I mention for the sake of the parents who omit that operation, on the supposition that they should never forgive themselves if a child died under it.”

Edward Jenner and the Fight to Vaccinate

As a young man, the future English physician Edward Jenner (1749-1823) overheard an English milkmaid say, “I shall never have smallpox for I have had cowpox. I shall never have an ugly pockmarked face.” Many years later, remembering the incident, Jenner, now a doctor, interrogated other milkmaids and then experienced one of the most important “eureka” moments in history. Without understanding how germs work, with no knowledge of anything called a virus, Dr. Jenner realized that cowpox (also known as kinepox) must be closely related to smallpox, and that surviving it seemed to make individuals immune to the more deadly disease. He reckoned that cowpox and smallpox must share some essential epidemiological element and since cowpox was neither lethal nor usually disfiguring, careful use of cowpox material would represent a superior protection against smallpox than variolation, which was a more dangerous procedure.

On May 14, 1796, Jenner inoculated an eight-year-old boy named James Phipps with kinepox pus. Phipps developed mild fever and discomfort. Ten days later he felt fine. Two months after that, Dr. Jenner inoculated the boy again, but this time with serum from a fresh smallpox sore. No disease developed. The smallpox vaccine had been born. Our term “vaccination” dates from this episode. Vaccination comes from the Latin word for cow, “vacca.” Jenner called the cowpox serum “vaccinia.” The terminology reminds us that all western vaccination stems from this moment in 1796.

No good deed goes unpunished, apparently, not even one that changes the history of the planet. In Britain, Edward Jenner was subjected to the usual harassment and ridicule. The paper he submitted to the Royal Society of England was rejected by none other than Sir Joseph Banks, one of Britain’s premier naturalists, botanists, and patrons of science. It took many years and the vaccination experiments of other physicians and scientists before Jenner’s work was vindicated.

Eventually, Jenner received worldwide recognition for his discovery. Devoted like Jefferson to the philanthropic principles of the Enlightenment, Dr. Jenner not only made no effort to enrich himself but devoted so much of his time and energy to promoting vaccination that he endured periods of real poverty. Finally, in 1802, the British Parliament voted him a reward of £10,000. Five years later he received £20,000 more from Parliament.

The true vaccine found its way to America thanks to Dr. John Haygarth of Bath. He sent some of Jenner’s material to Benjamin Waterhouse, a professor of physics at Harvard University. Waterhouse, in turn sent serum and reports of the vaccine’s efficacy to Thomas Jefferson, now the third president of the United States.

Dr. Edward Jenner discovered the true smallpox vaccine in 1796.

Jefferson’s Scientific Approach to Vaccines

In the new world, inoculation had a very rough reception. When John Dalgleish and Archibald Campbell began inoculating individuals in Norfolk, Virginia, an angry mob burned down Campbell’s house. Similar incidents occurred in Salem and Marblehead, Mass. In Charleston, S.C., an inoculation control law of 1738 imposed a fine of £500 on anyone providing or receiving inoculation within two miles of the city. A similar law was passed in New York City in 1747.

The measures in New England were so draconian that Benjamin Waterhouse noted the paradox: “New England, the most democratical region on the face of the earth voluntarily submitted to more restrictions and abridgements of liberty, to secure themselves against that terrific scourge, than any absolute monarch could have enforced.” (This, strangely prescient, anticipates the current debate about liberty versus public health). It was in the middle colonies — Maryland, Pennsylvania, New Jersey — that inoculation was most tolerated in the second half of the 18th century. That’s why Jefferson made the long journey to Philadelphia to be inoculated in 1766.

Jefferson first became aware of the discovery of a true smallpox vaccine from the newspapers he read in Philadelphia and the new capitol in Washington, D.C. Then, on Dec. 1, 1800, just after Jefferson’s election to the presidency, Benjamin Waterhouse sent him his pamphlet on the vaccine with a lovely cover letter saying that he regarded Jefferson as “one of our most distinguished patriots and philosophers.” Jefferson responded immediately, thanking Waterhouse for the publication and declaring, with his usual grace, that “every friend of humanity must look with pleasure on this discovery, by which one evil the [more] is withdrawn from the condition of man: and contemplating the possibility that future improvements & discoveries, may still more & more lessen the catalogue of evils. in this line of proceeding you deserve well of your [country?] and I pray you to accept my portion of the tribute due you.”

The following June, Waterhouse sent Jefferson a long letter explaining how the vaccine must be administered, how the serum could be preserved over time, and how much the controversial procedure needed the public support of a man of Jefferson’s stature in the “republic of letters.” President Jefferson became known as a defender and promoter of vaccination. In fact, he even arranged for his protégé Meriwether Lewis to carry some of the serum with him up the Missouri River in 1804-05, instructing him to “carry with you some matter of the kine pox, inform those of them with whom you may be, of its efficacy as a preservative from the small pox; and instruct & encourage them in the use of it. This may be especially done wherever you may winter.” Unfortunately, by the time the Lewis and Clark Expedition reached their winter encampment in today’s North Dakota, the serum had become inert. Thus Jefferson’s philanthropic initiative to vaccinate the Native Americans of the American West was stillborn.

Then, on May 14, 1806, now in his second term, Jefferson wrote perhaps the greatest presidential fan letter of all time. He took time from his duties as president to write the following letter to Edward Jenner. I quote it in its entirety:

SIR,— I have received a copy of the evidence at large respecting the discovery of the vaccine inoculation which you have been pleased to send me, and for which I return you my thanks. Having been among the early converts, in this part of the globe, to its efficiency, I took an early part in recommending it to my countrymen. I avail myself of this occasion of rendering you a portion of the tribute of gratitude due to you from the whole human family. Medicine has never before produced any single improvement of such utility. Harvey’s discovery of the circulation of the blood was a beautiful addition to our knowledge of the animal economy, but on a review of the practice of medicine before and since that epoch, I do not see any great amelioration which has been derived from that discovery. You have erased from the calendar of human afflictions one of its greatest. Yours is the comfortable reflection that mankind can never forget that you have lived. Future nations will know by history only that the loathsome small-pox has existed and by you has been extirpated. Accept my fervent wishes for your health and happiness and assurances of the greatest respect and consideration.

Who would not have wished to receive this magnificent, selfless, public-spirited, and enlightened letter? Unfortunately, we do not know how or even if Dr. Jenner responded. Except in medical circles, Edward Jenner has been largely forgotten.

 

 

 

 

 

Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine

Posted on by • Posted in Antibodies, Biotech, Clinical Research, Clinical Trials, Coronavirus, Data, Expectations, National Institute for Allergy and Infectious Diseases (NIAID), Vaccination, Vaccine, Vaccine RNA • Leave a comment

Vaccine experts say Moderna didn’t produce data critical to assessing Covid-19 vaccine

Moderna taps $1.34B stock offering to bankroll its promising COVID ...

Heavy hearts soared Monday with news that Moderna’s Covid-19 vaccine candidate — the frontrunner in the American market — seemed to be generating an immune response in Phase 1 trial subjects. The company’s stock valuation also surged, hitting $29 billion, an astonishing feat for a company that currently sells zero products.

But was there good reason for so much enthusiasm? Several vaccine experts asked by STAT concluded that, based on the information made available by the Cambridge, Mass.-based company, there’s really no way to know how impressive — or not — the vaccine may be.

While Moderna blitzed the media, it revealed very little information — and most of what it did disclose were words, not data. That’s important: If you ask scientists to read a journal article, they will scour data tables, not corporate statements. With science, numbers speak much louder than words.

Even the figures the company did release don’t mean much on their own, because critical information — effectively the key to interpreting them — was withheld.

Experts suggest we ought to take the early readout with a big grain of salt. Here are a few reasons why.

The silence of the NIAID

The National Institute for Allergy and Infectious Diseases has partnered with Moderna on this vaccine. Scientists at NIAID made the vaccine’s construct, or prototype, and the agency is running the Phase 1 trial. This week’s Moderna readout came from the earliest of data from the NIAID-led Phase 1.

NIAID doesn’t hide its light under a bushel. The institute generally trumpets its findings, often offering director Anthony Fauci — who, fair enough, is pretty busy these days — or other senior personnel for interviews.

But NIAID did not put out a press release Monday and declined to provide comment on Moderna’s announcement.

The n = 8 thing

The company’s statement led with the fact that all 45 subjects (in this analysis) who received doses of 25 micrograms (two doses each), 100 micrograms (two doses each), or a 250 micrograms (one dose) developed binding antibodies.

Later, the statement indicated that eight volunteers — four each from the 25-microgram and 100-microgram arms — developed neutralizing antibodies. Of the two types, these are the ones you’d really want to see.

We don’t know results from the other 37 trial participants. This doesn’t mean that they didn’t develop neutralizing antibodies. Testing for neutralizing antibodies is more time-consuming than other antibody tests and must be done in a biosecurity level 3 laboratory. Moderna disclosed the findings from eight subjects because that’s all it had at that point. Still, it’s a reason for caution.

Separately, while the Phase 1 trial included healthy volunteers ages 18 to 55 years, the exact ages of these eight people are unknown. If, by chance, they mostly clustered around the younger end of the age spectrum, you might expect a better response to the vaccine than if they were mostly from the senior end of it. And given who is at highest risk from the SARS-CoV-2 coronavirus, protecting older adults is what Covid-19 vaccines need to do.

There’s no way to know how durable the response will be

The report of neutralizing antibodies in subjects who were vaccinated comes from blood drawn two weeks after they received their second dose of vaccine.

Two weeks.

“That’s very early. We don’t know if those antibodies are durable,” said Anna Durbin, a vaccine researcher at Johns Hopkins University.

There’s no real way to contextualize the findings

Moderna stated that the antibody levels seen were on a par with — or greater than, in the case of the 100-microgram dose — those seen in people who have recovered from Covid-19 infection.

But studies have shown antibody levels among people who have recovered from the illness vary enormously; the range that may be influenced by the severity of a person’s disease. John “Jack” Rose, a vaccine researcher from Yale University, pointed STAT to a study from China that showed that, among 175 recovered Covid-19 patients studied, 10 had no detectable neutralizing antibodies. Recovered patients at the other end of the spectrum had really high antibody levels.

So though the company said the antibody levels induced by vaccine were as good as those generated by infection, there’s no real way to know what that comparison means.

STAT asked Moderna for information on the antibody levels it used as a comparator. The response: That will be disclosed in an eventual journal article from NIAID, which is part of the National Institutes of Health.

“The convalescent sera levels are not being detailed in our data readout, but would be expected in a downstream full data exposition with NIH and its academic collaborators,” Colleen Hussey, the company’s senior manager for corporate communications, said in an email.

Durbin was struck by the wording of the company’s statement, pointing to this sentence: “The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.”

“I thought: Generally? What does that mean?” Durbin said. Her question, for the time being, can’t be answered.

Rose said the company should disclose the information. “When a company like Moderna with such incredibly vast resources says they have generated SARS-2 neutralizing antibodies in a human trial, I would really like to see numbers from whatever assay they are using,” he said.

Moderna’s approach to disclosure

The company has not yet brought a vaccine to market, but it has a variety of vaccines for infectious diseases in its pipeline. It doesn’t publish on its work in scientific journals. What is known has been disclosed through press releases. That’s not enough to generate confidence within the scientific community.

“My guess is that their numbers are marginal or they would say more,” Rose said about the company’s SARS-2 vaccine, echoing a suspicion that others have about some of the company’s other work.

“I do think it’s a bit of a concern that they haven’t published the results of any of their ongoing trials that they mention in their press release. They have not published any of that,” Durbin noted.

Still, she characterized herself as “cautiously optimistic” based on what the company has said so far.

“I would like to see the data to make my own interpretation of the data. But I think it is at least encouraging that we’ve seen immune responses with this RNA vaccine that we haven’t seen with previous RNA vaccines for other pathogens. Whether it’s going to be enough, we don’t know,” Durbin said.

Moderna has been more forthcoming with data on at least one of its other vaccine candidates. In a statement issued in January about a Phase 1 trial for its cytomegalovirus (CMV) vaccine, it quantified how far over baseline measures antibody levels rose in vaccines.

 

 

 

New Coronavirus Vaccine Candidate Shows Promise In Early, Limited Trial

Posted on by • Posted in Clinical Research, Clinical Trials, Coronavirus, Food and Drug Administration (FDA), Pandemic, Vaccination, Vaccine, Vaccine RNA • Leave a comment

https://www.npr.org/sections/coronavirus-live-updates/2020/05/18/857997341/new-coronavirus-vaccine-candidate-shows-promise-in-early-limited-trial

Moderna's coronavirus vaccine shows promise in first human trial ...

A vaccine manufacturer is reporting preliminary data suggesting its COVID-19 vaccine is safe, and appears to be eliciting in test subjects the kind of immune response capable of preventing disease.

Moderna, Inc., of Cambridge, Mass., developed the vaccine in collaboration with the National Institute of Allergy and Infectious Diseases. The results reported Monday come from an initial analysis of a Phase I study primarily designed to see if the vaccine is safe.

The company reports no serious side-effects; however, modest side-effects included redness at the injection site, headache, fever and flu-like symptoms, although none of these lasted more than a day.

The first 45 volunteers for the vaccine trial were divided into three groups, with each group getting a different dose of the vaccine. All groups got an initial shot, followed by a booster shot a month later.

In addition to safety, the company also looked at the vaccine’s ability to induce antibodies to the coronavirus — what’s known as its immunogenicity. It did, for all subjects at all dose levels. In addition, eight of the subjects were tested for the presence of neutralizing antibodies that prevent the virus from infecting cells in the laboratory. All eight did.

The Food and Drug Administration has given Moderna the green light to begin a Phase II study expected to enroll an additional 600 volunteers — half older than 55 — to provide additional immunogenicity data. The company hopes by July to begin a Phase III study, aimed at showing that the vaccine can actually prevent disease.

The Moderna vaccine is made using messenger RNA, or mRNA, a molecule containing the genetic instructions to make a protein on the coronavirus surface that is recognized by our immune systems. Although mRNA vaccines have been studied for several years, so far none has been licensed by the FDA.

The advantage of mRNA vaccines over more traditional vaccines is they can be made quickly. The company says it was just 63 days from the time Chinese scientists revealed the genetic sequence to the time a vaccine was injected into the first volunteer.

Moderna’s is one of about a dozen COVID-19 vaccine candidates that have begun studies in humans.

 

 

 

Jay Powell warns US recovery could take until end of 2021

Posted on by • Posted in 2020 Election Issues, Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Economic Crisis, Economic Recovery, Economic Stimulus, Economy Reopening, Employee Benefits, Employee Furlough, Employee Hiring Freeze, Employee Layoffs, Employee Pay Cuts, Employee Protections, Employer-Based Health Insurance, False Hope, Health Insurance Coverage Adequacy, Health Policy, Infection Control, Infection Control Plan, Job, Job Market, Job Search, Job Security, Pandemic, Public Health, Public Safety, Quarantine, Social Distancing, Underinsured, Unemployment, Unemployment Insurance, Uninsured, Vaccination, Vaccine, Wishful Thinking • Leave a comment

https://www.ft.com/content/2ed602f1-ed11-4221-8d0b-ef85018c96ea

Fed Makes Second Emergency Rate Cut to Zero Due To Coronavirus ...

Fed chair says economy may not fully bounce back until virus vaccine is available.

Federal Reserve chair Jay Powell has warned that a full US economic recovery may take until the end of next year and require the development of a Covid-19 vaccine.

“For the economy to fully recover, people will have to be fully confident. And that may have to await the arrival of a vaccine,” Mr Powell told CBS News on Sunday. A full revival would happen, he said, but “it may take a while . . . it could stretch through the end of next year, we really don’t know”.

He added: “Assuming there is not a second wave of the coronavirus, I think you will see the economy recover steadily through the second half of this year.”

Mr Powell told CBS it was likely there would be a “couple more months” of net job losses, with the unemployment rate climbing to as high as 20-25 per cent. But he said it was “good news” that the “overwhelming” majority of those claiming unemployment benefits report themselves as having been laid off temporarily, meaning they are expecting to go back to their old jobs.

Oil prices and stocks in Asia rose on Monday despite the gloomy outlook. West Texas Intermediate, the US crude benchmark, climbed 4.4 per cent to take it above $30 a barrel for the first time in two months. Brent crude, the international benchmark, rose 3.6 per cent to $33.67 a barrel. Japan’s Topix was up 0.4 per cent and China’s CSI 300 index of Shanghai- and Shenzhen-listed stocks added 0.6 per cent.

Donald Trump, US president, said last week that he hoped to have a vaccine ready by the end of 2020. But public health experts, including Anthony Fauci, the head of the US National Institute of Allergy and Infectious Diseases, and Rick Bright, the recently ousted head of the US Biomedical Advanced Research and Development Authority, have warned that the process is likely to take longer.

Dr Fauci, a high-profile member of Mr Trump’s coronavirus task force, has said he expects the search for a vaccine to take at least a year to 18 months. But Dr Bright has said that was too optimistic.

Some world leaders have also raised doubts about the immediate prospects for a vaccine. Giuseppe Conte, prime minister of Italy, said at the weekend that his country could “not afford” to wait for a vaccine, while Boris Johnson, UK prime minister, warned that a vaccine “might not come to fruition” at all.

Mr Powell said that while lawmakers had “done a great deal and done it very quickly”, Congress and the Fed may need to do more “to avoid longer-run damage to the economy”.

The Fed chair said fiscal policies that “help businesses avoid avoidable insolvencies and that do the same for individuals” would position the US economy for a strong recovery post-crisis.

Mr Powell also reiterated his position against using negative interest rates, something Mr Trump has called for. The Fed chair told CBS that the Federal Open Market Committee had eschewed negative interest rates after the last financial crisis in favour of “other tools” such as forward guidance and quantitative easing.

The US Congress has already approved nearly $3tn of economic relief measures intended to support struggling businesses and individuals, but there is growing consensus in Washington that more fiscal stimulus will be needed — even if Democrats and Republicans are divided over how to dole out federal funds.

Late on Friday, the Democrat-controlled House of Representatives passed Nancy Pelosi’s plan for $3tn in new stimulus spending.

Mr Trump has repeatedly called for the next stimulus to include a cut to payroll taxes — deductions for entitlements such as social security and Medicare. Last week, Larry Kudlow, the top White House economic adviser, suggested that lower corporate taxes and looser business regulation should be part of any future relief package.

The Trump administration has taken a more bullish stance on the US economic recovery than Mr Powell, with White House officials repeatedly insisting that the economy will bounce back before the end of the year.

Mr Powell told CBS it was a “reasonable expectation that there will be growth in the second half of the year” but “we won’t get back to where we were by the end of the year”.

 

 

 

 

 

Rick Bright, ousted director of vaccine agency, warns that administration lacks ‘centralized, coordinated plan’

Posted on by • Posted in 2020 Election Issues, Biomedical Advanced Research and Development Authority (BARDA), Chloroquine, Clinical Testing, Contact Tracing, Coronavirus, Credibility, Crisis, Crisis Management, Denial, Dept of Health and Human Services (HHS), Economic Crisis, Economic Recovery, Economic Stimulus, Economy Reopening, Emergency Preparedness, Health Policy, Hydroxychloroquine, Infection Control, Infectious Virus, Leadership Culture, Leadership Intent, Leadership Listens, Leadership Trust, National Strategy, Personal Protective Equipment (PPE), Scientists, Supply Chain, Transparency, Trust, Truth, Vaccination, Vaccine • Leave a comment

https://www.cnn.com/2020/05/14/politics/coronavirus-whistleblower-testimony/index.html?fbclid=IwAR0KfVp-njw8vqKFdaLbBC4r4NAx3KeS4rFg2vmFbSneW7PcqOwVYult9rc

Virus whistleblower tells lawmakers US lacks vaccine plan | Where ...

Rick Bright, the ousted director of a crucial federal office charged with developing countermeasures to infectious diseases, testified before Congress on Thursday that the US will face an even worse crisis without additional preparations to curb the coronavirus pandemic.

“Our window of opportunity is closing,” Bright said. “Without better planning, 2020 could be the darkest winter in modern history.”
Bright criticized the Trump administration for failing to implement a “standard, centralized, coordinated plan” to combat the virus and questioned its timeline for a vaccine. His testimony came a week after filing a whistleblower complaint alleging he was fired from his job leading the Biomedical Advanced Research and Development Authority for opposing the use of a drug frequently touted by President Donald Trump as a potential coronavirus treatment.
About an hour before Bright’s hearing, Trump tweeted that he had “never met” or “even heard of” Bright, but considers the NIH senior adviser a “disgruntled employee, not liked or respected by people I spoke to and who, with his attitude, should no longer be working for our government!”
Before the House Committee on Energy and Commerce’s health subcommittee, Bright urged the Trump administration to consider a number of actions, including increasing production of essential equipment and establishing both a national test strategy and a national standard of procurement of supplies. He calls on top officials to “lead” through example and wear face coverings and social distance.
Bright claimed that the administration missed “early warning signals” to prevent the spread of the virus. He said that he would “never forget” an email from Mike Bowen, the hearing’s other witness and the vice president of the medical supply company Prestige Ameritech, indicating that the US supply of N95, the respirator masks used by health care professionals, was at a perilous level.
“He said, ‘We’re in deep shit,'” testified Bright. “‘The world is.'”
Bright said he “pushed” that warning “to the highest levels” he could at Health and Human Services but received “no response.”
“From that moment, I knew that we were going to have a crisis for health care workers because we were not taking action,” said Bright. “We were already behind the ball.”
In his written statement, Bright blamed the leadership of HHS for being “dismissive” of his “dire predictions.” Bright wrote that he knew the US had a “critical shortage of necessary supplies” and personal protective equipment during the first three months of the year and prodded HHS to boost production of masks, respirators, syringes and swabs to no avail. He alleged that he faced “hostility and marginalization” from HHS officials after he briefed White House trade adviser Peter Navarro and members of Congress “who better understood the urgency to act.”
And he charged that he was removed from his post at BARDA and transferred to “a more limited and less impactful position” at NIH after he “resisted efforts to promote” the “unproven” drug chloroquine.
A Department of Health and Human Services spokesperson responded that it was “a personnel matter that is currently under review” but said it “strongly disagrees with the allegations and characterizations.”
Bright is seeking to be reinstated to his position as the head of BARDA. The Office of Special Counsel, which is reviewing Bright’s complaint, has determined that was a “substantial likelihood of wrongdoing” in removing him from his post, according to Bright’s attorneys.
Rep. Anna Eshoo, a California Democrat and the panel’s chairwoman, said Bright “was the right person, with the right judgment, at the right time.”
“We can’t have a system where the government fires those who get it right and reward those who get it completely wrong,” added Eshoo.
In his testimony, Bright also cast doubt on the Trump administration’s goal of manufacturing a vaccine in 12 to 18 months as overly optimistic, calling it “an aggressive schedule” and noting that it usually takes up to 10 years to make a vaccine.
“My concern is if we rush too quickly, and consider cutting out critical steps, we may not have a full assessment of the safety of that vaccine,” Bright said. “So, it’s still going to take some time.”
Some Republicans on the subcommittee said that the hearing shouldn’t have been held at all.
Rep. Michael Burgess of Texas, the top Republican on the panel, said “every whistleblower needs to be heard,” but added the hearing was “premature” and a “disservice” to the Special Counsel’s investigation since Bright’s complaint was filed only a week ago.
And Republican Rep. Richard Hudson of North Carolina claimed that the hearing was not about the whistleblower complaint but “undermining the Administration during a national and global crisis.”
Thursday’s subcommittee meeting comes two days after a blockbuster hearing in the Senate that featured Dr. Anthony Fauci, who leads the National Institute of Allergy and Infectious Diseases. Fauci said that access to a vaccine in time for the fall school year would be “a bit of a bridge too far” and warning against some schools opening too soon, which Trump later called “not an acceptable answer.”
Fauci testified from his modified quarantine at home since he had made contact with a White House staffer who tested positive. But Bright appeared masked and in-person for his hearing on Capitol Hill, as did the lawmakers who questioned him. Many members of the House have steered clear of Capitol Hill since the onset of the outbreak, although they are expected to return on Friday to vote on a multi-trillion dollar Democratic bill responding to the crisis.

 

 

The coronavirus is a moving target

Posted on by • Posted in 2020 Election Issues, Centers for Disease Control & Prevention (CDC), Clinical Research, Clinical Trials, Coronavirus, Economic Crisis, Economy Reopening, Evidence-Based Plan, Health Policy, Infection Control, Infectious Virus, Mortality, Pandemic, Scientists, Vaccination, Vaccine • Leave a comment

https://www.axios.com/coronavirus-research-treatment-vaccines-aedfbf2c-cf09-4a36-ac99-2afb04298e5d.html

The coronavirus is a moving target for efforts to tackle it - Axios

Solutions for COVID-19 are being developed at the same time as knowledge about the disease evolves, a serious challenge for doctors treating patients and for researchers trying to create vaccines and treatments.

Why it matters: What was first thought of as a respiratory infection now appears much more complex, making efforts to tackle the disease more complicated.

“We’re laying the track as the train is moving and the train is coming very fast,” says Mark Poznansky, director of the Vaccine & Immunotherapy Center at Massachusetts General Hospital. “That is an extraordinary place to be at the global level.”

What’s happening: When the world first encountered COVID-19 four months ago, it was deemed a respiratory infection that hammers the lungs. That’s still the case but in recent weeks, clinicians have been reporting wide-ranging manifestations of the disease in some people.

  • Some of this could be that, with enough cases, there are outliers and anomalies. But that underscores that doctors and researchers are learning as they go.

Details: Renal failure, sepsis, damaged blood vessels, skin lesions, stroke, gastrointestinal problems and blood clots in the lungs and kidneys are being seen in some COVID-19 patients.

  • 20% of hospitalized patients in one study in Wuhan, China had heart damage.
  • 31% of people with the disease studied in a Danish ICU had blood clots.

“It comes across more as a systemic disease exhibited initially as a respiratory disease,” says Poznansky. It’s unclear whether the cause is the virus itself, the immune system’s response to it, or the treatment received.

That has implications for developing vaccines. The goal is to prevent infection but not exacerbate the immune effects in response to the virus.

  • “Is [a vaccine] protective or not in a context where we don’t know what exactly defines a protective immune response to COVID-19?” asks Poznansky.
  • The evolving understanding underscores the need to have multiple vaccines in development. (The current count is 123, per the Milken Institute’s tracker.)

What to watch: The changing percent of the disease will feature in regulatory discussions.

  • “This is the question companies will be discussing with regulators: which surrogate endpoints are acceptable as a proxy for going all the way to the worst possible outcomes in a patient?” says Phyllis Arthur, vice president of infectious diseases and diagnostics policy at biotech trade organization BIO.

The bottom line: Pandemics bring a potent mix of uncertainty and urgency to science that experts say requires both nimbleness and rigor to navigate.

  • “This is what a pandemic is like. It’s uncomfortable,” says Arthur. “You need to move swiftly and do good, solid, evidence-based, risk-benefit ratio assessments and understand what you know and don’t know, and make evidence based policy decisions knowing you don’t have perfect information.”