mRNA Technology Gave Us the First COVID-19 Vaccines. It Could Also Upend the Drug Industry

https://time.com/5927342/mrna-covid-vaccine/?fbclid=IwAR1wC2ZhNbrGepu9WiPIsYMFWwA_VNgwppCQQCwzb_wQYt4EXBNF3wd2s40

How mRNA Technology Gave Us the First COVID-19 Vaccines | Time

“No!” The doctor snapped. “Look at me!”

I had been staring her in the eyes, as she had ordered, but when a doctor on my other side began jabbing me with a needle, I started to turn my head. “Don’t look at it,” the first doctor said. I obeyed.

This was in early August in New Orleans, where I had signed up to be a participant in the clinical trial for the Pfizer-BioNTech COVID-19 vaccine. It was a blind study, which meant I was not supposed to know whether I had gotten the placebo or the real vaccine. I asked the doctor if I would really been able to tell by looking at the syringe. “Probably not,” she answered, “but we want to be careful. This is very important to get right.”

I became a vaccine guinea pig because, in addition to wanting to be useful, I had a deep interest in the wondrous new roles now being played by RNA, the genetic material that is at the heart of new types of vaccines, cancer treatments and gene-editing tools. I was writing a book on the Berkeley biochemist Jennifer Doudna. She was a pioneer in determining the structure of RNA, which helped her and her doctoral adviser figure out how it could be the origin of all life on this planet. Then she and a colleague invented an RNA-guided gene-editing tool, which won them the 2020 Nobel Prize in Chemistry.

The tool is based on a system that bacteria use to fight viruses. Bacteria develop clustered repeated sequences in their DNA, known as CRISPRs, that can remember dangerous viruses and then deploy RNA-guided scissors to destroy them. In other words, it’s an immune system that can adapt itself to fight each new wave of viruses—just what we humans need. Now, with the recently approved Pfizer-BioNTech vaccine and a similar one from Moderna being slowly rolled out across the U.S. and Europe, RNA has been deployed to make a whole new type of vaccine that will, when it reaches enough people, change the course of the pandemic.

Drs. Ugur Sahin and Ozlem Tureci, Co-founders, BioNTech. In January 2020, before many in the Western world were paying attention to a new virus spreading in China, Dr. Ugur Sahin was convinced it would spur a pandemic. Sahin, who in 2008 co-founded the German biotech company BioNTech with his wife Dr. Ozlem Tureci, went to work on a vaccine and by March called his contact at Pfizer, a much larger pharmaceutical company with which BioNTech had previously worked on an influenza vaccine using mRNA. Less than a year later, the Pfizer-BioNTech COVID-19 vaccine became the first ever mRNA vaccine available for widespread use. Even so, Sahin, BioNTech’s CEO, and Tureci, its chief medical officer, maintain that BioNTech is not an mRNA company but rather an immunotherapy company. Much of the couple’s work—both at BioNTech and at their previous venture, Ganymed—has focused on treating cancer. But it is mRNA, and the COVID-19 vaccine made possible by the technology, that has pushed the famously hardworking couple into the ­limelight—and helped them become one of the richest pairs in Germany, though they reportedly still bicycle to work and live in a modest apartment near their office.

Up until last year, vaccines had not changed very much, at least in concept, for more than two centuries. Most have been modeled on the discovery made in 1796 by the English doctor Edward Jenner, who noticed that many milkmaids were immune to smallpox. They had all been infected by a form of pox that afflicts cows but is relatively harmless to humans, and Jenner surmised that the cowpox had given them immunity to smallpox. So he took some pus from a cowpox blister, rubbed it into scratches he made in the arm of his gardener’s 8-year-old son and then (this was in the days before bioethics panels) exposed the kid to smallpox. He didn’t become ill.

Before then, inoculations were done by giving patients a small dose of the actual smallpox virus, hoping that they would get a mild case and then be immune. Jenner’s great advance was to use a related but relatively harmless virus. Ever since, vaccinations have been based on the idea of exposing a patient to a safe facsimile of a dangerous virus or other germ. This is intended to kick the person’s adaptive immune system into gear. When it works, the body produces antibodies that will, sometimes for many years, fend off any infection if the real germ attacks.

One approach is to inject a safely weakened version of the virus. These can be good teachers, because they look very much like the real thing. The body responds by making antibodies for fighting them, and the immunity can last a lifetime. Albert Sabin used this approach for the oral polio vaccine in the 1950s, and that’s the way we now fend off measles, mumps, rubella and chicken pox.

At the same time Sabin was trying to develop a vaccine based on a weakened polio virus, Jonas Salk succeeded with a safer approach: using a killed or inactivated virus. This type of vaccine can still teach a person’s immune system how to fight off the live virus but is less likely to cause serious side effects. Two Chinese companies, Sinopharm and Sinovac, have used this approach to develop vaccines for COVID-19 that are now in limited use in China, the UAE and Indonesia.

Another traditional approach is to inject a subunit of the virus, such as one of the proteins that are on the virus’s coat. The immune system will then remember these, allowing the body to mount a quick and robust response when it encounters the actual virus. The vaccine against the hepatitis B virus, for example, works this way. Using only a fragment of the virus means that they are safer to inject into a patient and easier to produce, but they are often not as good at producing long-term immunity. The Maryland-based biotech Novavax is in late-stage clinical trials for a COVID-19 vaccine using this approach, and it is the basis for one of the two vaccines already being rolled out in Russia.

The plague year of 2020 will be remembered as the time when these traditional vaccines were supplanted by something fundamentally new: genetic vaccines, which deliver a gene or piece of genetic code into human cells. The genetic instructions then cause the cells to produce, on their own, safe components of the target virus in order to stimulate the patient’s immune system.

For SARS-CoV-2—the virus that causes COVID-19—the target component is its spike protein, which studs the outer envelope of the virus and enables it to infiltrate human cells. One method for doing this is by inserting the desired gene, using a technique known as recombinant DNA, into a harmless virus that can deliver the gene into human cells. To make a COVID vaccine, a gene that contains instructions for building part of a coronavirus spike protein is edited into the DNA of a weakened virus like an adenovirus, which can cause the common cold. The idea is that the re-engineered adenovirus will worm its way into human cells, where the new gene will cause the cells to make lots of these spike proteins. As a result, the person’s immune system will be primed to respond rapidly if the real coronavirus strikes.

This approach led to one of the earliest COVID vaccine candidates, developed at the aptly named Jenner Institute of the University of Oxford. Scientists there engineered the spike-protein gene into an adenovirus that causes the common cold in chimpanzees, but is relatively harmless in humans.

The lead researcher at Oxford is Sarah Gilbert. She worked on developing a vaccine for Middle East respiratory syndrome (MERS) using the same chimp adenovirus. That epidemic waned before her vaccine could be deployed, but it gave her a head start when COVID-19 struck. She already knew that the chimp adenovirus had successfully delivered into humans the gene for the spike protein of MERS. As soon as the Chinese published the genetic sequence of the new coronavirus in January 2020, she began engineering its spike-protein gene into the chimp virus, waking each day at 4 a.m.

Her 21-year-old triplets, all of whom were studying biochemistry, volunteered to be early testers, getting the vaccine and seeing if they developed the desired antibodies. (They did.) Trials in monkeys conducted at a Montana primate center in March also produced promising results.

Bill Gates, whose foundation provided much of the funding, pushed Oxford to team up with a major company that could test, manufacture and distribute the vaccine. So Oxford forged a partnership with AstraZeneca, the British-Swedish pharmaceutical company. Unfortunately, the clinical trials turned out to be sloppy, with the wrong doses given to some participants, which led to delays. Britain authorized it for emergency use at the end of December, and the U.S. is likely to do so in the next two months.

Johnson & Johnson is testing a similar vaccine that uses a human adenovirus, rather than a chimpanzee one, as the delivery mechanism to carry a gene that codes for making part of the spike protein. It’s a method that has shown promise in the past, but it could have the disadvantage that humans who have already been exposed to that adenovirus may have some immunity to it. Results from its clinical trial are expected later this month.

In addition, two other vaccines based on genetically engineered adenoviruses are now in limited distribution: one made by CanSino Biologics and being used on the military in China and another named Sputnik V from the Russian ministry of health.

There is another way to get genetic material into a human cell and cause it to produce the components of a dangerous virus, such as the spike proteins, that can stimulate the immune system. Instead of engineering the gene for the component into an adenovirus, you can simply inject the genetic code for the component into humans as DNA or RNA.

Let’s start with DNA vaccines. Researchers at Inovio Pharmaceuticals and a handful of other companies in 2020 created a little circle of DNA that coded for parts of the coronavirus spike protein. The idea was that if it could get inside the nucleus of a cell, the DNA could very efficiently churn out instructions for the production of the spike-protein parts, which serve to train the immune system to react to the real thing.

The big challenge facing a DNA vaccine is delivery. How can you get the little ring of DNA not only into a human cell but into the nucleus of the cell? Injecting a lot of the DNA vaccine into a patient’s arm will cause some of the DNA to get into cells, but it’s not very efficient.

Some of the developers of DNA vaccines, including Inovio, tried to facilitate the delivery into human cells through a method called electroporation, which delivers electrical shock pulses to the patient at the site of the injection. That opens pores in the cell membranes and allows the DNA to get in. The electric pulse guns have lots of tiny needles and are unnerving to behold. It’s not hard to see why this technique is unpopular, especially with those on the receiving end. So far, no easy and reliable delivery mechanism has been developed for getting DNA vaccines into the nucleus of human cells.

That leads us to the molecule that has proven victorious in the COVID vaccine race and deserves the title of TIME magazine’s Molecule of the Year: RNA. Its sibling DNA is more famous. But like many famous siblings, DNA doesn’t do much work. It mainly stays bunkered down in the nucleus of our cells, protecting the information it encodes. RNA, on the other hand, actually goes out and gets things done. The genes encoded by our DNA are transcribed into snippets of RNA that venture out from the nucleus of our cells into the protein-manufacturing region. There, this messenger RNA (mRNA) oversees the assembly of the specified protein. In other words, instead of just sitting at home curating information, it makes real products.

Scientists including Sydney Brenner at Cambridge and James Watson at Harvard first identified and isolated mRNA molecules in 1961. But it was hard to harness them to do our bidding, because the body’s immune system often destroyed the mRNA that researchers engineered and attempted to introduce into the body. Then in 2005, a pair of researchers at the University of Pennsylvania, Katalin Kariko and Drew Weissman, showed how to tweak a synthetic mRNA molecule so it could get into human cells without being attacked by the body’s immune system.

Stéphane Bancel, CEO, Moderna. Moderna’s COVID-19 vaccine was first tested in humans less than three months after news of the novel virus broke. But that lightning-fast development process belies the years of work that got Moderna to where it is today. The startup was founded in 2010 with the belief that mRNA technology, then still fairly new, could help treat any number of ailments. CEO Stéphane Bancel, pictured above, joined a year later. Moderna wasn’t originally focused on vaccines, but over time, its scientists began working toward vaccines against several infectious diseases as well as some forms of cancer. That experience came in handy when the COVID-19 pandemic arrived, leaving the world clamoring for a vaccine that could fight the deadly virus—and fast. Bancel’s company took the challenge in stride, using its mRNA platform to develop a vaccine around 95% effective at protecting against COVID-19 disease in less than a year.

When the COVID-19 pandemic hit a year ago, two innovative young pharmaceutical companies decided to try to harness this role played by messenger RNA: the German company BioNTech, which formed a partnership with the U.S. company Pfizer; and Moderna, based in Cambridge, Mass. Their mission was to engineer messenger RNA carrying the code letters to make part of the coronavirus spike protein—a string that begins CCUCGGCGGGCA … —and to deploy it in human cells.

BioNTech was founded in 2008 by the husband-and-wife team of Ugur Sahin and Ozlem Tureci, who met when they were training to be doctors in Germany in the early 1990s. Both were from Turkish immigrant families, and they shared a passion for medical research, so much so that they spent part of their wedding day working in the lab. They founded BioNTech with the goal of creating therapies that stimulate the immune system to fight cancerous cells. It also soon became a leader in devising medicines that use mRNA in vaccines against viruses.

In January 2020, Sahin read an article in the medical journal Lancet about a new coronavirus in China. After discussing it with his wife over breakfast, he sent an email to the other members of the BioNTech board saying that it was wrong to believe that this virus would come and go as easily as MERS and SARS. “This time it is different,” he told them.

BioNTech launched a crash project to devise a vaccine based on RNA sequences, which Sahin was able to write within days, that would cause human cells to make versions of the coronavirus’s spike protein. Once it looked promising, Sahin called Kathrin Jansen, the head of vaccine research and development at Pfizer. The two companies had been working together since 2018 to develop flu vaccines using mRNA technology, and he asked her whether Pfizer would want to enter a similar partnership for a COVID vaccine. “I was just about to call you and propose the same thing,” Jansen replied. The deal was signed in March.

By then, a similar mRNA vaccine was being developed by Moderna, a much smaller company with only 800 employees. Its chair and co-founder, Noubar Afeyan, a Beirut-born Armenian who immigrated to the U.S., had become fascinated by mRNA in 2010, when he heard a pitch from a group of Harvard and MIT researchers. Together they formed Moderna, which initially focused on using mRNA to try to develop personalized cancer treatments, but soon began experimenting with using the technique to make vaccines against viruses.

In January 2020, Afeyan took one of his daughters to a restaurant near his office in Cambridge to celebrate her birthday. In the middle of the meal, he got an urgent text message from the CEO of his company, Stéphane Bancel, in Switzerland. So he rushed outside in the freezing temperature, forgetting to grab his coat, to call him back.

Bancel said that he wanted to launch a project to use mRNA to attempt a vaccine against the new coronavirus. At that point, Moderna had more than 20 drugs in development but none had even reached the final stage of clinical trials. Nevertheless, Afeyan instantly authorized him to start work. “Don’t worry about the board,” he said. “Just get moving.” Lacking Pfizer’s resources, Moderna had to depend on funding from the U.S. government. Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, was supportive. “Go for it,” he declared. “Whatever it costs, don’t worry about it.”

It took Bancel and his Moderna team only two days to create the RNA sequences that would produce the spike protein, and 41 days later, it shipped the first box of vials to the National Institutes of Health to begin early trials. Afeyan keeps a picture of that box on his cell phone.

An mRNA vaccine has certain advantages over a DNA vaccine, which has to use a re-engineered virus or other delivery mechanism to make it through the membrane that protects the nucleus of a cell. The RNA does not need to get into the nucleus. It simply needs to be delivered into the more-accessible outer region of cells, the cytoplasm, which is where proteins are constructed.

The Pfizer-BioNTech and Moderna vaccines do so by encapsulating the mRNA in tiny oily capsules, known as lipid nanoparticles. Moderna had been working for 10 years to improve its nanoparticles. This gave it one advantage over Pfizer-BioNTech: its particles were more stable and did not have to be stored at extremely low temperatures.

Katalin Kariko, Senior vice president, BioNTech. In 1995, after years of struggle, Hungarian-born Katalin Kariko was pushed off the path to full professorship at the University of Pennsylvania. Her work on mRNA, molecules she believed could fundamentally change the way humans treat disease, had stalled. Then, in 1997, she met and began working with immunologist Drew Weissman. In 2005, they published a study describing a modified form of artificial ­mRNA—a discovery, they argued, that opened the door to mRNA’s use in vaccines and other therapies. Eventually, Kariko and Weissman licensed their technology to the German company BioNTech, where Kariko, shown here in a portrait shot by a photographer working remotely, is now a senior vice president. Her patience paid off this year. The mRNA-based Pfizer-­BioNTech corona­virus vaccine, which Kariko helped develop, has been shown to be 95% effective at preventing COVID-19.
Katalin Kariko, Senior vice president, BioNTech. In 1995, after years of struggle, Hungarian-born Katalin Kariko was pushed off the path to full professorship at the University of Pennsylvania. Her work on mRNA, molecules she believed could fundamentally change the way humans treat disease, had stalled. Then, in 1997, she met and began working with immunologist Drew Weissman. In 2005, they published a study describing a modified form of artificial ­mRNA—a discovery, they argued, that opened the door to mRNA’s use in vaccines and other therapies. Eventually, Kariko and Weissman licensed their technology to the German company BioNTech, where Kariko, shown here in a portrait shot by a photographer working remotely, is now a senior vice president. Her patience paid off this year. The mRNA-based Pfizer-­BioNTech corona­virus vaccine, which Kariko helped develop, has been shown to be 95% effective at preventing COVID-19.

By November, the results of the Pfizer-BioNTech and Moderna late-stage trials came back with resounding findings: both vaccines were more than 90% effective. A few weeks later, with COVID-19 once again surging throughout much of the world, they received emergency authorization from the U.S. Food and Drug Administration and became the vanguard of the biotech effort to beat back the pandemic.

The ability to code messenger RNA to do our bidding will transform medicine. As with the COVID vaccines, we can instruct mRNA to cause our cells to make antigens—molecules that stimulate our immune system—that could protect us against many viruses, bacteria, or other pathogens that cause infectious disease. In addition, mRNA could in the future be used, as BioNTech and Moderna are pioneering, to fight cancer. Harnessing a process called immunotherapy, the mRNA can be coded to produce molecules that will cause the body’s immune system to identify and kill cancer cells.

RNA can also be engineered, as Jennifer Doudna and others discovered, to target genes for editing. Using the CRISPR system adapted from bacteria, RNA can guide scissors-like enzymes to specific sequences of DNA in order to eliminate or edit a gene. This technique has already been used in trials to cure sickle cell anemia. Now it is also being used in the war against COVID. Doudna and others have created RNA-guided enzymes that can directly detect SARS-CoV-2 and eventually could be used to destroy it.

More controversially, CRISPR could be used to create “designer babies” with inheritable genetic changes. In 2018, a young Chinese doctor used CRISPR to engineer twin girls so they did not have the receptor for the virus that causes AIDS. There was an immediate outburst of awe and then shock. The doctor was denounced, and there were calls for an international moratorium on inheritable gene edits. But in the wake of the pandemic, RNA-guided genetic editing to make our species less receptive to viruses may someday begin to seem more acceptable.

Throughout human history, we have been subjected to wave after wave of viral and bacterial plagues. One of the earliest known was the Babylon flu epidemic around 1200 B.C. The plague of Athens in 429 B.C. killed close to 100,000 people, the Antonine plague in the 2nd century killed 5 million, the plague of Justinian in the 6th century killed 50 million, and the Black Death of the 14th century took almost 200 million lives, close to half of Europe’s population.

The COVID-19 pandemic that killed more than 1.8 million people in 2020 will not be the final plague. However, thanks to the new RNA technology, our defenses against most future plagues are likely to be immensely faster and more effective. As new viruses come along, or as the current coronavirus mutates, researchers can quickly recode a vaccine’s mRNA to target the new threats. “It was a bad day for viruses,” Moderna’s chair Afeyan says about the Sunday when he got the first word of his company’s clinical trial results. “There was a sudden shift in the evolutionary balance between what human technology can do and what viruses can do. We may never have a pandemic again.”

The invention of easily reprogrammable RNA vaccines was a lightning-fast triumph of human ingenuity, but it was based on decades of curiosity-driven research into one of the most fundamental aspects of life on planet earth: how genes are transcribed into RNA that tell cells what proteins to assemble. Likewise, CRISPR gene-editing technology came from understanding the way that bacteria use snippets of RNA to guide enzymes to destroy viruses. Great inventions come from understanding basic science. Nature is beautiful that way.

Past Covid-19 Infection Gives Vaccine-Like Immunity For Months, Study Finds

Coronavirus immunity: What do we know? | COVID-19 Special - YouTube

TOPLINE

Most people who have recovered from Covid-19 have similar levels of immunity against future infection to those who received a coronavirus vaccine, a study by Public Health England found, offering early hope against fears of a short-lived immunity spurred on by reports of people catching the virus twice, though the researchers warn that those with immunity may still be able to carry and transmit the virus to others. 

KEY FACTS

Naturally acquired immunity from a previous Covid-19 infection provides 83% protection against reinfection when compared with people who have not had the disease before, government researchers found in a study of more than 20,000 healthcare workers.

The study, which has not yet been peer reviewed for rigor by other scientists, shows that this protection lasts for at least five months and is at a level just below that offered by vaccines from Pfizer-BioNTech (95%) and Moderna (94%) and significantly above that of the vaccine developed by the University of Oxford and AstraZeneca (62%), though manufacturers don’t know for how long this immunity lasts.

The figures suggest reinfection is relatively rare — occurring in fewer than 1% of the the 6,614 people who had already tested positive for the disease — though the scientists warned that while “those with antibodies have some protection from becoming ill with Covid-19 themselves,” early evidence suggests that they can carry and transmit the virus to others.

“It is therefore crucial that everyone continues to follow the rules and stays at home, even if they have previously had Covid-19, to prevent spreading the virus to others,” Public Health England wrote.

The study will continue to follow participants for another 12 months to determine “how long any immunity may last, the effectiveness of vaccines and to what extent people with immunity are able to carry and transmit the virus,” as well as investigate the highly-contagious new variant of coronavirus spreading across the U.K.. 

CRUCIAL QUOTE

Professor Lawrence Young, a virologist and Professor of Molecular Oncology at Warwick Medical School in England, said an important takeaway from the study is that we don’t yet know how long antibody protection will last outside of the five month window. He said it is “possible that many people who were infected during the first wave of the pandemic may now be susceptible to re-infection.” Young said it will be interesting to see whether people previously infected with Covid-19 and are subsequently vaccinated have “an even longer-lived protective immune response” and whether or not these findings hold true for the new virus variant currently spreading in the U.K..

WHAT TO WATCH FOR

The information gathered from reinfection cases could prove important as the pandemic progresses, especially when it comes to designing and implementing an effective vaccination program and deciding whether to ease lockdown measures. Whether or not those who are immune to serious illness are capable of transmitting the infection to others will be a crucial deciding factor.

WHAT WE DON’T KNOW

It’s not yet clear for how long the protection provided by vaccines last. This will have to be studied over time, as with this case of natural immunity, and is something manufacturers are already doing. Moderna believes their vaccine offers at least a year’s protection against disease. Whether or not this protection prevents individuals from infecting others will also need to be figured out. 

BIG NUMBER

384,784. That’s how many people have died from Covid-19 in the U.S. since the pandemic began, according to Johns Hopkins university. According to CDC projections, this figure is set to grow 25% in the next three weeks. At the moment, more than 23 million people have contracted the disease in the U.S..

Notes for the 39th Annual J.P Morgan Healthcare Conference, 2021

https://www.sheppardhealthlaw.com/articles/healthcare-industry-news/

2021 JP Morgan Healthcare Conference | Zoetis

Sitting in the dark before 6 am in my Los Angeles house with my face lit up by yet another Zoom screen, wearing a stylish combination of sweatpants, dress shirt and last year’s JPM conference badge dangling around my neck for old times’ sake, I wonder at the fact that it’s J.P. Morgan Annual Healthcare Conference week again and we are where we are. Quite a year for all of us – the pandemic, the healthcare system’s response to the public health emergency, the ongoing fight for racial justice, the elections, the storming of the Capital – and the subject of healthcare winds its way through all of it – public health, our healthcare system’s stability, strengths and weaknesses, the highly noticeable healthcare inequities, the Affordable Care Act, Medicaid and vaccines, healthcare politics and what the new administration will bring as healthcare initiatives.

I will miss seeing you all in person this year at the J.P. Morgan Annual Healthcare Conference and our annual Sheppard Mullin reception – previously referred to as “standing room only” events and now as “possible superspreader events.” What a difference a year makes. I admit that I will miss the feeling of excitement in the rooms and hallways of the Westin St. Francis and all of the many hotel lobbies and meeting rooms surrounding it. Somehow the virtual conference this year lacks that je ne sais quoi of being stampeded by rushing New York-style street traffic while in an antiquated San Francisco hotel hallway and watching the words spoken on stage transform immediately into sharp stock price increases and drops. There also is the excitement of sitting in the room listening to paradigm shifting ideas (teaser – read the last paragraph of this post for something truly fascinating). Perhaps next year, depending on the vaccine…

So, let’s start there. Today was vaccine day at the JPM Conference, with BioNTech, Moderna, Novovax and Johnson & Johnson all presenting. Lots of progress reported by all of the companies working on vaccines, but the best news of the day was the comment from BioNTech that the UK and South Africa coronavirus variants likely are still covered by the BioNTech/Pfizer vaccine. BioNTech’s CEO, Prof. Uğur Şahin, M.D., promised more data and analysis to be published shortly on that.

We also saw continued excitement for mRNA vaccines, not only for COVID-19 but also for other diseases. There is a growing focus (following COVID-19 of course) on vaccines for cancer through use of neoantigen targets, and for a long list of infectious disease targets.  For cancer, though, there continues to be a growing debate over whether the best focus is on “personalized” vaccines or “off the shelf” vaccines – personalized vaccines can take longer to make and have much, much higher costs and infrastructure requirements. We expect, however, to see very exciting news on the use of mRNA and other novel technologies in the next year or two that, when approved and put into commercialization, could radically change the game, not only as to mortality, but also by eliminating or significantly reducing the cost of care with chronic conditions (which some cancers have become, thanks to technological advancement). We are fortunate to be in that gap now between “care” and “cure,” where we have been able with modern medical advances to convert many more disease states into manageable chronic care conditions. Together with today’s longer lifespans, that, however, carries a much higher price tag for our healthcare system. Now, with some of these recent announcements, we look forward to moving from “care” to “cure” and substantially dropping the cost of care to our healthcare system.

Continuing consolidation also was a steady drumbeat underlying the multiple presentations today on the healthcare services side of the conference – health plans, health systems, physician organizations, home health. The drive to scale continues, as we have seen from the accelerated pace of mergers and acquisitions in the second half of 2020, which continues unabated in January 2021. There was today’s announcement of the acquisition by Amerisource Bergen of Walgreens Boots Alliance’s Alliance Healthcare wholesale business (making Walgreens Boots Alliance the largest single shareholder of Amerisource Bergen at nearly 30% ownership), following the announcement last week of Centene’s acquisition of Magellan Health (coming fast on the heels of Molina Healthcare’s purchase of Magellan’s Complete Care line of business).

On the mental health side – a core focus area for Magellan Health – Centene’s Chief Executive Officer, Michael Neidorff, expressed the common theme that we have been seeing in the past year that mental health care should be integrated and coordinated with primary and specialty care. He also saw value in Magellan’s strong provider network, as access to mental health providers can be a challenge in some markets and populations. The behavioral/mental health sector likely will see increased attention and consolidation in the coming year, especially given its critical role during the COVID-19 crisis and also with the growing Medicaid and Medicare populations. There are not a lot of large assets left independent in the mental health sector (aside from inpatient providers, autism/developmental disorder treatment programs, and substance abuse residential and outpatient centers), so we may see more roll-up focus (such as we have seen recently with the autism/ABA therapy sector) and technology-focused solutions (text-based or virtual therapy).

There was strong agreement among the presenting health plans and capitated providers (Humana, Centene, Oak Street and multiple health systems) today that we will continue to see movement toward value-based care (VBC) and risk-based reimbursement systems, such as Medicare Advantage, Medicare direct contracting and other CMS Innovation Center (CMMI) programs and managed Medicaid. Humana’s Chief Executive Officer, Bruce Broussard, said that the size of the MA program has grown so much since 2010 that it now represents an important voting bloc and one of the few ways in which the federal government currently is addressing healthcare inequities – e.g., through Over-the-Counter (OTC) pharmacy benefits, benefits focused on social determinants of health (SDOH), and healthcare quality improvements driven by the STARS rating program. Broussard also didn’t think Medicare Advantage would be a negative target for the Biden administration and expected more foreseeable and ordinary-course regulatory adjustments, rather than wholesale legislative change for Medicare Advantage.

There also was agreement on the exciting possibility of direct contracting for Medicare lives at risk under the CMMI direct contracting initiative. Humana expressed possible interest in both this year’s DCE program models and in the GEO regional risk-based Medicare program model that will be rolling out in the next year. Humana sees this as both a learning experience and as a way to apply their chronic care management skills and proprietary groups and systems to a broader range of applicable populations and markets. There is, however, a need for greater clarity and transparency from CMMI on program details which can substantially affect success and profitability of these initiatives.

Humana, Centene and Oak Street all sang the praises of capitated medical groups for Medicare Advantage and, per Michael Neidorff, the possibility of utilizing traditional capitated provider models for Medicaid membership as well. The problem, as noted by the speakers, is that there is a scarcity of independent capitated medical groups and a lack of physician familiarity and training. We may see a more committed effort by health plans to move their network provider groups more effectively into VBC and risk, much like we have seen Optum do with their acquired fee for service groups. Privia Health also presented today and noted that, while the market focus and high valuations today are accorded to Medicare lives, attention needs to be paid to the “age in” pipeline, as commercial patients who enroll in original Medicare and Medicare Advantage still would like to keep their doctors who saw them under commercial insurance. Privia’s thesis in part is to align with patients early on and retain them and their physicians, so as to create a “farm system” for accelerated Medicare population growth. Privia’s Chief Executive Officer, Shawn Morris, also touted Privia’s rapid growth, in part attributable to partnering with health systems.

As written in our notes from prior JPM healthcare conferences, health systems are continuing to look outside to third parties to gain knowledge base, infrastructure and management skills for physician VBC and risk arrangements. Privia cited their recent opening of their Central Florida market in partnership with Health First and rapid growth in providers by more than 25% in their first year of operations.

That being said, the real market sizzle remains with Medicare Advantage and capitation, percent of premium arrangements and global risk. The problem for many buyers, though, is that there are very few assets of size in this line of business. The HealthCare Partners/DaVita Medical Group acquisition by Optum removed that from the market, creating a high level of strategic and private equity demand and a low level of supply for physician organizations with that expertise. That created a focus on groups growing rapidly in this risk paradigm and afforded them strong valuation, like with Oak Street Health this past year as it completed its August 2020 initial public offering. Oak Street takes on both professional and institutional (hospital) risk and receives a percent of premium from its contracting health plans. As Oak Street’s CEO Mike Pykosz noted, only about 3% of Medicare dollars are spent on primary care, while approximately two-thirds are spent on hospital services. If more intensive management occurs at the primary care level and, as a result, hospitalizations can be prevented or reduced, that’s an easy win that’s good for the patient and the entire healthcare system (other than a fee for service based hospital). Pykosz touted his model of building out new centers from scratch as allowing greater conformity, control and efficacy than buying existing groups and trying to conform them both physically and through practice approaches to the Oak Street model. He doesn’t rule out some acquisitions, but he noted as an example that Oak Street was able to swiftly role out COVID-19 protocols rapidly and effectively throughout his centers because they all have the same physical configuration, the same staffing ratio and the same staffing profiles. Think of it as a “franchise” model where each Subway store, for example, will have generally the same look, feel, size and staffing. He also noted that while telehealth was very helpful during the COVID-19 crisis in 2020 and will continue as long as the doctors and patients wish, Oak Street believes that an in-person care management model is much more effective and telehealth is better for quick follow-ups or when in-person visits can’t occur.

Oak Street also spoke to the topic of Medicare Advantage member acquisition, which has been one of the more difficult areas to master for many health plans and groups, resulting in many cases with mergers and acquisitions becoming a favored growth vehicle due to the difficulties of organic membership growth. Interestingly, both Oak Street and Humana reported improvements in membership acquisition during the COVID-19 crisis. Oak Street credited digital marketing and direct response television, among other factors. Humana found that online direct-to-consumer brokers became an effective pathway during the COVID-19 crisis and focused its energy on enhancing those relationships and improving hand-offs during the membership enrollment process. Humana also noted the importance of brand in Medicare Advantage membership marketing.

Staying with Medicare Advantage, there is an expectation of a decrease in Medicare risk adjustment revenue in 2021, in large part due to the lower healthcare utilization during the COVID crisis and the lesser number of in-person visits during which HCC-RAF Medicare risk adjustment coding typically occurs. That revenue drop however likely will not significantly decrease Medicare Advantage profitability though, given the concomitant drop in healthcare expenses due to lower utilization, and per conference reports, is supposed to return to normal trend in 2022 (unless we see utilization numbers fall back below 90% again). Other interesting economic notes from several presentations, when taken together, suggest that while many health systems have lost out on elective surgery revenue in 2020, their case mix index (CMI) in many cases has been much higher due to the COVID patient cases. We also saw a number of health systems with much lower cash days on hand numbers than other larger health systems (both in gross and after adjusting for federal one-time stimulus cash payments), as a direct result of COVID. This supports the thesis we are hearing that, with the second wave of COVID being higher than expected, in the absence of further federal government financial support to hospitals, we likely will see an acceleration of partnering and acquisition transactions in the hospital sector.

Zoetis, one of the largest animal health companies, gave an interesting presentation today on its products and service lines. In addition to some exciting developments re: monoclonal antibody treatments coming on line for dogs with pain from arthritis, Zoetis also discussed its growing laboratory and diagnostics line of business. The animal health market, sometime overshadowed by the human healthcare market, is seeing some interesting developments as new revenue opportunities and chronic care management paradigms (such as for renal care) are shifting in the animal health sector. This is definitely a sector worth watching.

We also saw continuing interest, even in the face of Congressional focus this past year, on growing pharmacy benefit management (PBM) companies, which are designed to help manage the pharmacy spend. Humana listed growth of its PBM and specialty pharmacy lines of business as a focus for 2021, along with at-home care. In its presentation today,  SSM Health, a health system in Wisconsin, Oklahoma, Illinois, and Missouri, spotlighted Navitus, its PBM, which services 7 million covered lives in 50 states.

One of the most different, interesting and unexpected presentations of the day came from Paul Markovich, Chief Executive Officer of Blue Shield of California. He put forth the thesis that we need to address the flat or negative productivity in healthcare today in order to both reduce total cost of care, improve outcomes and to help physicians, as well as to rescue the United States from the overbearing economic burden of the current healthcare spending. Likening the transformation in healthcare to that which occurred in the last two decades with financial services (remember before ATMs and banking apps, there were banker’s hours and travelers cheques – remember those?), he described exciting pilot projects that reimagine healthcare today. One project is a real-time claims adjudication and payment program that uses smart watches to record physician/patient interactions, natural language processing (NLP) to populate the electronic medical record, transform the information concurrently into a claim, adjudicate it and authorize payment. That would massively speed up cash flow to physician practices, reduce paperwork and many hours of physician EMR and billing time and reduce the billing and collection overhead and burden. It also could substantially reduce healthcare fraud.

Paul Markovich also spoke to the need for real-time quality information that can result in real-time feedback and incentivization to physicians and other providers, rather than the costly and slow HEDIS pursuits we see today. One health plan noted that it spends about $500 million a year going into physician offices looking at medical records for HEDIS pursuits, but the information is totally “in the rearview mirror” as it is too old when finally received and digested to allow for real-time treatment changes, improvement or planning. Markovich suggested four initiatives (including the above, pay for value and shared decision making through better, more open data access) that he thought could save $100 billion per year for the country. Markovich stressed that all of these four initiatives required a digital ecosystem and asked for help and partnership in creating one. He also noted that the State of California is close to creating a digital mandate and statewide health information exchange that could be the launching point for this exciting vision of data sharing and a digital ecosystem where the electronic health record is the beginning, but not the end of the healthcare data journey.

Can you spread Covid-19 if you get the vaccine?

https://qz.com/1954762/can-you-spread-covid-19-if-you-get-the-vaccine/?utm_source=YPL

Can you spread Covid-19 if you get the vaccine? — Quartz

We know that the vaccines now available across the world will protect their recipients from getting sick with Covid-19. But while each vaccine authorized for public use can prevent well over 50% of cases (in Pfizer-BioNTech and Moderna‘s case, more than 90%), what we don’t know is whether they’ll also curb transmission of the SARS-CoV-2 virus.

That question is answerable, though—and understanding vaccines’ effect on transmission will help determine when things can go back to whatever our new normal looks like.

The reason we don’t know if the vaccine can prevent transmission is twofold. One reason is practical. The first order of business for vaccines is preventing exposed individuals from getting sick, so that’s what the clinical trials for Covid-19 shots were designed to determine. We simply don’t have public health data to answer the question of transmission yet.

The second reason is immunological. From a scientific perspective, there are a lot of complex questions about how the vaccine generates antibodies in the body that haven’t yet been studied. Scientists are still eager to explore these immunological rabbit holes, but it could take years to reach the bottom of them.

Acting the part

Vaccines work by tricking the immune system into making antibodies before an infection comes along. Antibodies can then attack the actual virus when it enters our systems before they have a chance to replicate enough to launch a full-blown infection. But while vaccines could win an Oscar for their infectious acting job, they can’t get the body to produce antibodies exactly the same way as the real deal.

From what we know so far, Covid-19 vaccines cause the body to produce a class of antibodies called immunoglobulin G, or IgG antibodies, explains Matthew Woodruff, an immunologist at Emory University. IgG antibodies are thugs: They react swiftly to all kinds of foreign entities. They make up the majority of our antibodies, and are confined to the parts of our body that don’t have contact with the outside world, like our muscles and blood.

But to prevent Covid-19 transmission, another type of antibodies could be the more important player. The immune system that patrols your outward-facing mucosal surfaces—spaces like the nose, the throat, the lungs, and digestive tract—relies on immunoglobulin A, or IgA antibodies. And we don’t yet know how well existing vaccines incite IgA antibodies.

“Mucosal immunology is ridiculously complicated,” says Woodruff. “Rather than thinking of immune system as a way to fight off bad actors, it’s really a way for your internal environment to maintain some sort of homeostatic existence with a really dynamic outside world,” as you breathe, eat, drink, and touch your face.

People who get sick and recover from Covid-19 produce a ton of these more-specialized IgA antibodies. Because IgA antibodies occupy the same respiratory tract surfaces involved in transmitting SARS-CoV-2, we could reasonably expect that people who recover from Covid-19 aren’t spreading the virus any more. (Granted, this may also depend on how much of the virus that person was exposed to.)

But we don’t know if people who have IgG antibodies from the vaccine are stopping the virus in our respiratory tracts in the same way. And even if we did, scientists still don’t know how much of the SARS-CoV-2 virus it takes to cause a new infection. So even if we understood how well a vaccine worked to prevent a virus from replicating along the upper respiratory tract, it’d be extremely difficult to tell if that would mean a person couldn’t transmit the disease.

Making it real

Because of all that complication, it’s unlikely that immunological research alone will reveal how well vaccines can prevent Covid-19 transmission—at least, not for years. But there’s another way to tell if a vaccine can stop a person from transmitting a virus to others: community spread.

As more and more people get both doses of a Covid-19 vaccine (and wait a full two weeks after their second dose for maximum immunity to kick in), public health officials can see how fast case counts fall. It may not be a perfect indicator of whether we’re stopping the virus in its tracks—there are many other variables that can slow transmission, including lockdown measures—but for practical purposes, it’ll be good enough to help make public health decisions.

Plus, even though the data we have from clinical trials isn’t perfect, it’s a pretty good indicator that the vaccine at least stops some viral replication. “I can’t imagine how the vaccine would prevent symptomatic infection at the efficacies that [companies] reported and have no impact on transmission,” Woodruff says.

Each of the vaccines granted emergency use in western countries—Moderna, Pfizer-BioNTech, and AstraZeneca—have all shown high efficacy in phase 3 clinical trials. (The Sinopharm and Sinovac vaccines from China and the Bharat Biotech vaccine in India have also been shown to be effective at preventing Covid-19, but aren’t widely approved for use yet.)

Frustratingly, it’s just going to take more time to see if people who got the vaccine are involved in future transmission events. That’s why it’s vital that even after receiving both doses of the Covid-19 vaccine, all individuals wear masks, practice physical distancing, and wash their hands when around those who haven’t been vaccinated—just in case.

How Does the AstraZeneca COVID-19 Vaccine Compare to Pfizer’s and Moderna’s?

covid 19 vaccine

It’s cheaper, easier to distribute, and relies on very different tech than its competitors.

  • AstraZeneca’s COVID-19 vaccine has been approved for emergency use in the United Kingdom, India, and Mexico.
  • Unlike its competitors, AstraZeneca’s vaccine is a modified version of a common cold virus that spreads among chimpanzees.
  • This is the first vaccine of its kind to be approved for human use, but other companies are developing similar tech to fight COVID-19.

The United Kingdom became the first country to approve AstraZeneca’s COVID-19 vaccine for emergency use on Dec. 30, just weeks after Pfizer’s and Moderna’s vaccine candidates received a green light from the Food and Drug Administration in the United States. The approval is another promising sign in the global immunization rollout—especially because this option, developed by Oxford University and biopharmaceutical company AstraZeneca, could be key to reaching people in rural and underfunded areas.

Unlike its competitors, the AstraZeneca COVID-19 vaccine can be stored at higher temperatures, costs less per dose, and uses different technology to immunize people. Although the vaccine hasn’t been approved for use in the U.S. yet, it could reach arms stateside in February at the earliest, The New York Times reports. Here’s what we know about the vaccine so far, and how it stacks up against Pfizer’s and Moderna’s.

How does the AstraZeneca COVID-19 vaccine work?

AstraZeneca’s vaccine uses adenovirus-vectored technology. Translation: It’s a harmless, modified version of a common cold virus that usually only spreads among chimpanzees. This altered virus can’t make you sick, but it carries a gene from the novel coronavirus’ spike protein, the portion of the virus that triggers an immune response. This allows the immune system to manufacture antibodies that work against COVID-19, teaching your body how to respond should you become infected.

In other words, AstraZeneca’s vaccine mimics a COVID-19 infection without its life-threatening side effects, per a release from the company. The reason researchers chose a chimpanzee adenovirus is simple: The modified virus needs to be new to the people being vaccinated—otherwise, the body won’t create those all-important antibodies. Anyone could already have antibodies for a cold spread among humans, but far fewer people have been exposed to a cold spread among chimps.

The Pfizer-BioNTech and Moderna vaccines, meanwhile, rely on mRNA technology, which essentially introduces a piece of genetic code that tricks the body into producing COVID-19 antibodies, no virus required. All three vaccines require two shots spaced about a month apart. Although no adenovirus-vectored vaccine has been approved for human use before, companies like Johnson & Johnson, CanSino, and NantKwest are all working on their own versions.

How does the AstraZeneca vaccine compare to the Moderna and Pfizer vaccines?

Storage and distribution

AstraZeneca’s vaccine is the easiest to transport so far—it can be stored for up to six months between 36 and 46°F, normal refrigerator temperatures. The Moderna and Pfizer options, meanwhile, must be stored at subzero temperatures until they’re ready to be used, at -4°F and -94°F, respectively. (mRNA technology is relatively fragile compared to adenovirus-vectored tech, meaning it must be kept at much lower temperatures to remain effective and stable.)

AstraZeneca’s higher storage temperature could make distribution much easier. “A clinic, a nursing home, or even [regional] health departments may not have freezers that can hold things at -94°F,” says Kawsar Talaat, M.D., an infectious disease doctor, vaccine researcher, and assistant professor in the department of International Health at Johns Hopkins University. Being able to use a typical fridge “allows time for distribution, allows the vaccine time to get to more rural areas, [and allows vaccines] to be kept at a clinic for a longer period of time.”

Cost

The new vaccine also beats its competitors on price: AstraZeneca’s vaccine costs providers about $4 per dose, while Pfizer’s costs $20 and Moderna’s costs $33, Al Jazeera reports. These prices will most likely fluctuate as time goes on and the vaccines evolve.

Efficacy

The two mRNA vaccines have a slight edge in efficacy; both Pfizer and Moderna report being about 95% effective against COVID-19 after the second shot in clinical trials, while AstraZeneca has reported an average efficacy of 70%, and up to 90% if the dosing is adjusted. (For comparison, the annual flu shot is usually between 40 and 60% effective, per the CDC.)

Side effects

All three vaccines’ side effects are similar, including potential injection site pain and flu-like symptoms, including fever, fatigue, headaches, and muscle pain, which are to be expected as your immune system is primed.

Which COVID-19 vaccine is the best?

There’s no “best” vaccine option, as there’s not enough research to confirm that yet. Vaccines aren’t a silver bullet, especially as the pandemic rages on: They must be combined with masks, hand-washing, and social distancing to work as effectively as possible, per the CDC. No matter which COVID-19 vaccine becomes available to you first, you can feel confident in its ability to protect you, as long as you continue being cautious until positive cases, hospitalizations, and deaths are significantly reduced nationwide.

In the meantime, it’s likely “that all the manufacturers are working on making their vaccines more stable at easier-to-manage temperatures,” Dr. Talaat explains. As their formulations change, their pros and cons will, too.

For now, we can be thankful that AstraZeneca’s vaccine is nearing worldwide clearance. “The next generation of vaccines, like AstraZeneca’s, which is kept at refrigerator temperatures, is a major advancement,” Dr. Talaat says. “When you’re talking about distribution to the entire world, it’s much easier to do because we already keep vaccines cold. It’s a lot harder to keep things frozen.”

Nearly 60% of COVID-19 spread may come from asymptomatic spread, model finds

How asymptomatic cases fuelled spread of coronavirus - Times of India

People with COVID-19 who don’t exhibit symptoms may transmit 59 percent of all virus cases, according to a model developed by CDC researchers and published Jan. 7 in JAMA Network Open. 

Since many factors influence COVID-19 spread, researchers developed a mathematical approach to assess several scenarios, varying the infectious period and proportion of transmission for those who never display symptoms according to published best estimates.  

In the baseline model, 59 percent of all transmission came from asymptomatic transmission. That includes 35 percent of new cases from people who infect others before they show symptoms and 24 percent from people who never develop symptoms at all. Under a broad range of values for each of these assumptions, at least 50 percent of new COVID-19 infections were estimated to have originated from exposure to asymptomatic individuals. 

The more contagious variant first identified in the U.K. and since found in six states underscores the importance of the model findings, said Jay Butler, MD, CDC deputy director for infectious diseases and a co-author of the study.

“Controlling the COVID-19 pandemic really is going to require controlling the silent pandemic of transmission from persons without symptoms,” Dr. Butler told The Washington Post. “The community mitigation tools that we have need to be utilized broadly to be able to slow the spread of SARS-CoV-2 from all infected persons, at least until we have those vaccines widely available.”

Whether vaccines stop transmission is still uncertain and was not a scenario addressed in the model. 

‘Shkreli Awards’ Shame Healthcare Profiteers

Lown Institute berates greedy pricing, ethical lapses, wallet biopsies, and avoidable shortages.

Greedy corporations, uncaring hospitals, individual miscreants, and a task force led by Jared Kushner were dinged Tuesday in the Lown Institute‘s annual Shkreli awards, a list of the top 10 worst offenders for 2020.

Named after Martin Shkreli, the entrepreneur who unapologetically raised the price of an anti-parasitic drug by a factor of 56 in 2015 (now serving a federal prison term for unrelated crimes), the list of shame calls out what Vikas Saini, the institute’s CEO, called “pandemic profiteers.” (Lown bills itself as “a nonpartisan think tank advocating bold ideas for a just and caring system for health.”)

Topping the list was the federal government itself and Jared Kushner, President’s Trump’s son-in-law, who led a personal protective equipment (PPE) procurement task force. The effort, called Project Airbridge, was to “airlift PPE from overseas and bring it to the U.S. quickly,” which it did.

“But rather than distribute the PPE to the states, FEMA gave these supplies to six private medical supply companies to sell to the highest bidder, creating a bidding war among the states,” Saini said. Though these supplies were supposed to go to designated pandemic hotspots, “no officials from the 10 hardest hit counties” said they received PPE from Project Airbridge. In fact, federal agencies outbid states or seized supplies that states had purchased, “making it much harder and more expensive” for states to get supplies, he said.

Number two on the institute’s list: vaccine maker Moderna, which received nearly $1 billion in federal funds to develop its mRNA COVID-19 preventive. It set a price of between $32 and $37 per dose, more than the U.S. agreed to pay for other COVID vaccines. “Although the U.S. has placed an order for $1.5 billion worth of doses at a discount, a price of $15 per dose, given the upfront investment by the U.S. government, we are essentially paying for the vaccine twice,” said Lown Institute Senior Vice President Shannon Brownlee.

Webcast panelist Don Berwick, MD, former acting administrator for the Centers for Medicare & Medicaid Services, noted that a lot of work went into producing the vaccine at an impressive pace, “and if there’s not an immune breakout, we’re going to be very grateful that this happened.” But, he added, “I mean, how much money is enough? Maybe there needs to be some real sense of discipline and public spirit here that goes way beyond what any of these companies are doing.”

In third place: four California hospital systems that refused to take COVID-19 patients or delayed transfers from hospitals that were out of beds. Wall Street Journal investigation found that these refusals or delays were based on the patients’ ability to pay; many were on Medicaid or were uninsured.

“In the midst of such a pandemic, to continue that sort of behavior is mind boggling,” said Saini. “This is more than the proverbial wallet biopsy.”

The remaining seven offenders:

4. Poor nursing homes decisions, especially one by Soldiers’ Home for Veterans in western Massachusetts, that worsened an already terrible situation. At Soldiers’ Home, management decided to combine the COVID-19 unit with a dementia unit because they were low on staff, said Brownlee. That allowed the virus to spread rapidly, killing 76 residents and staff as of November. Roughly one-third of all COVID-19 deaths in the U.S. have been in long-term care facilities.

5. Pharmaceutical giants AstraZeneca, GlaxoSmithKline, Pfizer, and Johnson & Johnson, which refused to share intellectual property on COVID-19, instead deciding to “compete for their profits instead,” Saini said. The envisioned technology access pool would have made participants’ discoveries openly available “to more easily develop and distribute coronavirus treatments, vaccines, and diagnostics.”

Saini added that he was was most struck by such an attitude of “historical blindness or tone deafness” at a time when the pandemic is roiling every single country.

Berwick asked rhetorically, “What would it be like if we were a world in which a company like Pfizer or Moderna, or the next company that develops a really great breakthrough, says on behalf of the well-being of the human race, we will make this intellectual property available to anyone who wants it?”

6. Elizabeth Nabel, MD, CEO of Brigham and Women’s Hospital in Boston, because she defended high drug prices as a necessity for innovation in an op-ed, without disclosing that she sat on Moderna’s board. In that capacity, she received $487,500 in stock options and other payments in 2019. The value of those options quadrupled on the news of Moderna’s successful vaccine. She sold $8.5 million worth of stock last year, after its value nearly quadrupled. She resigned from Moderna’s board in July and, it was announced Tuesday, is leaving her CEO position to join a biotech company founded by her husband.

7. Hospitals that punished clinicians for “scaring the public,” suspending or firing them, because they “insisted on wearing N95 masks and other protective equipment in the hospital,” said Saini. Hospitals also fired or threatened to fire clinicians for speaking out on COVID-19 safety issues, such as the lack of PPE and long test turnaround times.

Webcast panelist Mona Hanna-Attisha, MD, the Flint, Michigan, pediatrician who exposed the city’s water contamination, said that healthcare workers “have really been abandoned in this administration” and that the federal Occupational Safety and Health Administration “has pretty much fallen asleep at the wheel.” She added that workers in many industries such as meatpacking and poultry processing “have suffered tremendously from not having the protections or regulations in place to protect [them].”

8. Connecticut internist Steven Murphy, MD, who ran COVID-19 testing sites for several towns, but conducted allegedly unnecessary add-ons such as screening for 20 other respiratory pathogens. He also charged insurers $480 to provide results over the phone, leading to total bills of up to $2,000 per person.

“As far as I know, having an MD is not a license to steal, and this guy seemed to think that it was,” said Brownlee.

9. Those “pandemic profiteers” who hawked fake and potentially harmful COVID-19 cures. Among them: televangelist Jim Bakker sold “Silver Solution,” containing colloidal silver, and the “MyPillow Guy,” Mike Lindell, for his boostering for oleandrin.

Colloidal silver has no known health benefits and can cause seizures and organ damage. Oleandrin is a biological extract from the oleander plant and known for its toxicity and ingesting it can be deadly,” said Saini.

Others named by the Lown Institute include Jennings Ryan Staley, MD — now under indictment — who ran the “Skinny Beach Med Spa” in San Diego which sold so-called COVID treatment packs containing hydroxychloroquine, antibiotics, Xanax, and Viagra, all for $4,000.

Berwick commented that such schemes indicate a crisis of confidence in science, adding that without facts and science to guide care, “patients get hurt, costs rise without any benefit, and confusion reigns, and COVID has made that worse right now.”

Brownlee mentioned the “huge play” that hydroxychloroquine received and the FDA’s recent record as examples of why confidence in science has eroded.

10. Two private equity-owned companies that provide physician staffing for hospitalsTeam Health and Envision, that cut doctors’ pay during the first COVID-19 wave while simultaneously spending millions on political ads to protect surprise billing practices. And the same companies also received millions in COVID relief funds under the CARES Act.

Berwick said surprise billing by itself should receive a deputy Shkreli award, “as out-of-pocket costs to patients have risen dramatically and even worse during the COVID pandemic… and Congress has failed to act. It’s time to fix this one.”

More Evidence Points to Role of Blood Type in COVID-19

Additional evidence continued to suggest blood type may not only play a role in COVID-19 susceptibility, but also severity of infection, according to two retrospective studies.

In Denmark, blood type O was associated with reduced risk of developing COVID-19 (RR 0.87, 95% CI 0.83-0.91), based on the proportion of those with type O blood who tested positive for SARS-CoV-2 compared with a reference population, reported Torben Barington, MD, of Odense University Hospital, and colleagues.

However, there was no increased risk for COVID-19 hospitalization or death associated with blood type, the authors wrote in Blood Advances.

Limitations to the data include that ABO blood group information was only available for 62% of individuals, and that the sex of the testing population was skewed, with women accounting for 71% who tested negative and 67% who tested positive.

They pointed to the recent research that blood type plays a role in infection, noting the lower than expected prevalence of blood group O individuals among COVID-19 patients. Researchers also observed how blood groups are “increasingly recognized to influence susceptibility to certain viruses,” among them SARS-CoV-1 and norovirus, adding that individuals with A, B, and AB blood types may be at “increased risk for thrombosis and cardiovascular diseases,” which are important comorbidities among patients hospitalized with COVID-19.

ABO and RhD blood group information was available for 473,654 individuals who were tested for SARS-CoV-2 from February 27 to July 30, as well as for 2,204,742 individuals not tested for SARS-CoV-2 as a reference.

Of the individuals tested, 7,422 tested positive for SARS-CoV-2. About a third of both those who tested positive and negative were men, and those with positive tests were slightly older (52 vs 50, respectively).

Among individuals testing positive for SARS-CoV-2, about 38% (95% CI 37.5-39.5%) belonged to blood group O versus about 42% of those in the reference population. There were significantly more group A and AB individuals in the positive testing group versus the reference population, though the difference was non-significant for group B. When group O individuals were removed, there was no difference between the remaining groups.

Blood Type Linked to COVID-19 Severity?

Meanwhile, a second, smaller study in Blood Advances did report a connection between blood type and COVID-19 severity.

Blood types A or AB in COVID-19 patients were associated with increased risk for mechanical ventilation, continuous renal replacement therapy, and prolonged ICU admission versus patients with blood type O or B, according to Mypinder Sekhon, MD, of the University of British Columbia in Vancouver, and colleagues. Inflammatory cytokines did not differ between groups, however.

These authors also cited research that found that blood groups were linked to virus susceptibility, but that the relationship between SARS-CoV-2 infection severity and blood groups remains “unresolved.” However, COVID-19 appears to be a multisystem disease with renal and hepatic manifestations.

“If ABO blood groups play a role in determining disease severity, these differences would be expected to manifest within multiple organ systems and hold relevance for multiple resource-intensive treatments, such as mechanical ventilation and continuous renal replacement therapy,” Sekhon and colleagues wrote.

They collected data from six metropolitan Vancouver hospitals from Feb. 21 to April 28, identifying 95 COVID-19 patients admitted to an ICU with known ABO blood type.

Among these patients, 57 were group O or B, while 38 were group A or AB. A significantly higher proportion of A/AB patients required mechanical ventilation versus O/B patients (84% vs 61%, respectively, P=0.02). Similar figures were seen for patients requiring continuous renal replacement therapy (32% vs 9%, P=0.04). Median ICU stay length was also longer for A or AB patients compared with O or B patients (13.5 days vs 9 days, P=0.03).

There was no difference in probability of ICU discharge, and eight patients died in the O/B group versus nine patients in the A/AB group. Not surprisingly, biomarkers of renal and hepatic dysfunction were higher in the A/AB group, as well.

“The unique part of our study is our focus on the severity effect of blood type on COVID-19. We observed this lung and kidney damage, and in future studies, we will want to tease out the effect of blood group and COVID-19 on other vital organs,” Sekhon said in a statement.

About 25% of patients were missing data on blood group, and the nature of the study makes it impossible to infer causality, the authors acknowledged. Ethnic ancestry and outcomes in patients with COVID-19 could be an unaddressed confounder. Additionally, anti-A antibody titers may affect COVID-19 severity, and these were not measured.

This terrible year taught me something about hope

The first month of the pandemic was also supposed to be the month I got pregnant, but my clinic closed and plans changed. Doctors and nurses needed personal protective equipment to tend to patients with covid-19, not women with recurrent miscarriages.

When the clinic reopened several months later, it turned out my husband and I had only been delaying yet another loss: In late August, he obeyed the medical center’s strict coronavirus protocols by waiting anxiously in the car while I trudged inside, masked and hand-sanitized, to receive a miscarriage diagnosis alone. I searched the ultrasound screen for the rhythmic beat of a heart, and then accepted that whatever had once been there was now gone.

But that was 2020 for you, consistent only in its utter crappiness. For every inspiring video of neighbors applauding a shift change at the hospital, another video of a bone-tired nurse begging viewers to believe covid was real, it wasn’t a hoax, wear a mask.

For every protest organized by activists who understood racism is also a long-term crisis, an appearance by the Proud Boys; for every GoFundMe successfully raising money for a beloved teacher’s hospital bills, a bitter acknowledgment that online panhandling is our country’s version of a safety net.

Millions of citizens stood in line for hours to vote for the next president and then endured weeks of legal petitions arguing that their votes should be negated. The basis for these legal actions were conspiracy theories too wild to be believed, except that millions of other citizens believed them.

And that was 2020 for you, too: accepting the increasingly obvious reality that the country was in peril, built on iffy foundations that now buckled under pressure. My loved ones who worked as waiters or bartenders or physical therapists were choosing between health and paychecks, and even from the lucky safety of my work-from-home job, each day began to feel like watching America itself arrive at a hospital in bad shape, praying that doctors or clergy could find something they were able to save.

Is there a heartbeat?

You want the answer to be yes, but even so, it was hard to imagine how we would come back from this.

What kind of delusional person would even try to get pregnant in this world? In my case it would never be a happy accident; it would always be a herculean effort. And so it seemed I should have some answers.

How do you explain to a future child: Sorry, we can’t fix climate change; we can’t even get people to agree that we should wear masks in grocery stores? How do you explain the frustration of seeing brokenness, and then the wearying choice of trying to fix it instead of abandoning it? How do you say, Love it anyway. You’re inheriting an absolute mess, but love it anyway?

I found myself asking a lot of things like this in 2020, but really they were all variations of the same question: What does it mean to have hope?

But in the middle of this, scientists worked quietly in labs all over the world. They applied the scientific method with extraordinary discipline and speed. A vaccine was developed. Tens of thousands of volunteers rolled up their sleeves and said, Try it out on me.

It was approved, and a nurse from Long Island was the first American televised receiving it. Her name was Sandra Lindsay, an immigrant from Jamaica who had come to the United States 30 years ago and who had spent the last year overseeing critical care teams in back-to-back shifts. She said she had agreed to go first to show communities of color, long abused, brushed-off or condescended to by the medical system, that the vaccine was safe.

Here was hope. And more than that, here was hope from a woman who had more reason than most to be embittered: an exhausted health-care worker who knew too well America’s hideous racial past and present, who nonetheless also knew there was only one way out of the tunnel. Here she was, rolling up her own sleeve, and there were the lines of hospital employees ready to go after her, and there were the truck drivers ferrying shipments of syringes.

I can’t have been the only person to watch the video of those early inoculations, feeling elated and tired, and to then burst into tears. I can’t have been the only person to realize that even as 2020 revealed brokenness, it also contained such astounding undercurrents of good.

The scientific method works whether you accept it or not. Doctors try to save you whether you respected public-health guidelines or not. Voter turnout was astronomical because individual citizens realized they were all, every one of them, necessary pieces in a puzzle, even if they couldn’t see what the final picture was supposed to look like.

The way to believe in America is to believe those things are passed down, too.

Sometime in October, a couple of months after my last miscarriage — when the country was riding up on eight months of lonely and stoic birthdays, graduations, deaths and weddings — I went into the bathroom and saw a faint second line on a First Response pregnancy test. It was far from my first rodeo, so I knew better than to get excited. I mentioned it to my husband with studied nonchalance, I told him that I’d test again in a few days but that we should assume the worst would happen.

Two weeks after that, I had a doctor’s appointment, and then another a week later, each time assuming the worst, but each time scheduling another appointment anyway, until eventually I was further along than I’d ever gotten before — by one day, then three days, then thirty.

I am not a superstitious person. I don’t believe that good things always come to those who deserve them. I believe that stories regularly have sad endings and that it’s often nobody’s fault when they do, and that we should tell more stories with sad endings so that people who experience them know that they’re not alone.

But 2020 has taught me that I am, for better or worse, someone who wants to hope for things. To believe in the people who developed vaccines. In the people who administered them. In Sandra Lindsay. In the people who delivered groceries, who sewed masks, who have long cursed America’s imperfect systems and long fought to change them, who still donate $10 to a sick teacher’s GoFundMe.

At my most recent appointment, the doctor’s office was backed up in a holiday logjam. I sat in the exam room for nearly three hours while my husband again waited anxiously in the car. I texted him sporadic updates and tried to put hope in a process that so far had not seemed to warrant my hope.

It all felt precarious. The current reality always feels precarious.

And yet there we all are together, searching for signs of life, hoping that whatever we emerge to can be better than what we had before, and that whatever we build will become our new legacy. The sonographer finally arrived and turned on the machine.

There was a heartbeat. There was a heartbeat.

Lie of the Year: Coronavirus Downplay and Denial

https://www.politifact.com/article/2020/dec/16/lie-year-coronavirus-downplay-and-denial/?fbclid=IwAR3qlz1c1UvQt2s1z6uIbjw4bYHRWIVuasQ0CHeg4H4lFS0AtUjFJnJtQGw

2020 Lie of the Year: Coronavirus Disinformation - YouTube

A Florida taxi driver and his wife had seen enough conspiracy theories online to believe the virus was overblown, maybe even a hoax. So no masks for them. Then they got sick. She died. A college lecturer had trouble refilling her lupus drug after the president promoted it as a treatment for the new disease. A hospital nurse broke down when an ICU patient insisted his illness was nothing worse than the flu, oblivious to the silence in beds next door.   

Lies infected America in 2020. The very worst were not just damaging, but deadly. 

President Donald J. Trump fueled confusion and conspiracies from the earliest days of the coronavirus pandemic. He embraced theories that COVID-19 accounted for only a small fraction of the thousands upon thousands of deaths. He undermined public health guidance for wearing masks and cast Dr. Anthony Fauci as an unreliable flip-flopper

But the infodemic was not the work of a single person. 

Anonymous bad actors offered up junk science. Online skeptics made bogus accusations that hospitals padded their coronavirus case numbers to generate bonus payments. Influential TV and radio opinion hosts told millions of viewers that social distancing was a joke and that states had all of the personal protective equipment they needed (when they didn’t).

It was a symphony of counter narrative, and Trump was the conductor, if not the composer. The message: The threat to your health was overhyped to hurt the political fortunes of the president. 

Every year, PolitiFact editors review the year’s most inaccurate statements to elevate one as the Lie of the Year. The “award” goes to a statement, or a collection of claims, that prove to be of substantive consequence in undermining reality. 

It has become harder and harder to choose when cynical pundits and politicians don’t pay much of a price for saying things that aren’t true. For the past month, unproven claims of massive election fraud have tested democratic institutions and certainly qualify as historic and dangerously bald-faced. Fortunately, the constitutional foundations that undergird American democracy are holding. 

Meanwhile, the coronavirus has killed more than 300,000 in the United States, a crisis exacerbated by the reckless spread of falsehoods.

PolitiFact’s 2020 Lie of the Year: claims that deny, downplay or disinform about COVID-19. 

‘I always wanted to play it down’

On Feb. 7, Trump leveled with book author Bob Woodward about the dangers of the new virus that was spreading across the world, originating in central China. He told the legendary reporter that the virus was airborne, tricky and “more deadly than even your strenuous flus.”

Trump told the public something else. On Feb. 26, the president appeared with his coronavirus task force in the crowded White House briefing room. A reporter asked if he was telling healthy Americans not to change their behavior.

“Wash your hands, stay clean. You don’t have to necessarily grab every handrail unless you have to,” he said, the room chuckling. “I mean, view this the same as the flu.”

Three weeks later, March 19, he acknowledged to Woodward: “To be honest with you, I wanted to always play it down. I still like playing it down. Because I don’t want to create a panic.”

His acolytes in politics and the media were on the same page. Rush Limbaugh told his audience of about 15 million on Feb. 24 that coronavirus was being weaponized against Trump when it was just “the common cold, folks.” That’s wrong — even in the early weeks, it was clear the virus had a higher fatality rate than the common cold, with worse potential side effects, too.

As the virus was spreading, so was the message to downplay it. 

“There are lots of sources of misinformation, and there are lots of elected officials besides Trump that have not taken the virus seriously or promoted misinformation,” said Brendan Nyhan, a government professor at Dartmouth College. “It’s not solely a Trump story — and it’s important to not take everyone else’s role out of the narrative.” 

Hijacking the numbers 

In August, there was a growing movement on Twitter to question the disproportionately high U.S. COVID-19 death toll.  

The skeptics cited Centers for Disease Control and Prevention data to claim that only 6% of COVID-19 deaths could actually be attributed to the virus. On Aug. 24, BlazeTV host Steve Deace amplified it on Facebook.

“Here’s the percentage of people who died OF or FROM Covid with no underlying comorbidity,” he said to his 120,000 followers. “According to CDC, that is just 6% of the deaths WITH Covid so far.”

That misrepresented the reality of coronavirus deaths. The CDC had always said people with underlying health problems — comorbidities — were most vulnerable if they caught COVID-19. The report was noting that 6% died even without being at obvious risk. 

But for those skeptical of COVID-19, the narrative confirmed their beliefs. Facebook users copied and pasted language from influencers like Amiri King, who had 2.2 million Facebook followers before he was banned. The Gateway Pundit called it a “SHOCK REPORT.”

“I saw a statistic come out the other day, talking about only 6% of the people actually died from COVID, which is very interesting — that they died from other reasons,” Trump told Fox News host Laura Ingraham on Sept. 1.

Fauci, director of the National Institute of Allergy and Infectious Diseases, addressed the claim on “Good Morning America” the same day. 

“The point that the CDC was trying to make was that a certain percentage of them had nothing else but just COVID,” he said. “That does not mean that someone who has hypertension or diabetes who dies of COVID didn’t die of COVID-19 — they did.”

Trump retweeted the message from an account that sported the slogans and symbols of QAnon, a conspiracy movement that claims Democrats and Hollywood elites are members of an underground pedophilia ring. 

False information moved between social media, Trump and TV, creating its own feedback loop.

“It’s an echo effect of sorts, where Donald Trump is certainly looking for information that resonates with his audiences and that supports his political objectives. And his audiences are looking to be amplified, so they’re incentivized to get him their information,” said Kate Starbird, an associate professor and misinformation expert at the University of Washington.Weakening the armor: misleading on masks

At the start of the pandemic, the CDC told healthy people not to wear masks, saying they were needed for health care providers on the frontlines. But on April 3 the agency changed its guidelines, saying every American should wear non-medical cloth masks in public.

Trump announced the CDC’s guidance, then gutted it.

“So it’s voluntary. You don’t have to do it. They suggested for a period of time, but this is voluntary,” Trump said at a press briefing. “I don’t think I’m going to be doing it.”

Rather than an advance in best practices on coronavirus prevention, face masks turned into a dividing line between Trump’s political calculations and his decision-making as president. Americans didn’t see Trump wearing a mask until a July visit to Walter Reed National Military Medical Center.

Meanwhile, disinformers flooded the internet with wild claims: Masks reduced oxygen. Masks trapped fungus. Masks trapped coronavirus. Masks just didn’t work.

Covid-19 news from Dec. 10

In September, the CDC reported a correlation between people who went to bars and restaurants, where masks can’t consistently be worn, and positive COVID-19 test results. Bloggers and skeptical news outlets countered with a misleading report about masks.

On Oct. 13, the story landed on Fox News’ flagship show, “Tucker Carlson Tonight.” During the show, Carlson claimed “almost everyone — 85% — who got the coronavirus in July was wearing a mask.”

“So clearly (wearing a mask) doesn’t work the way they tell us it works,” Carlson said.

That’s wrong, and it misrepresented a small sample of people who tested positive. Public health officials and infectious disease experts have been consistent since April in saying that face masks are among the best ways to prevent the spread of COVID-19.

But two days later, Trump repeated the 85% stat during a rally and at a town hall with NBC’s Savannah Guthrie. 

“I tell people, wear masks,” he said at the town hall. “But just the other day, they came out with a statement that 85% of the people that wear masks catch it.”

The assault on hospitals 

On March 24, registered nurse Melissa Steiner worked her first shift in the new COVID-19 ICU of her southeast Michigan hospital. After her 13-hour day caring for two critically ill patients on ventilators, she posted a tearful video.

“Honestly, guys, it felt like I was working in a war zone,” Steiner said. “(I was) completely isolated from my team members, limited resources, limited supplies, limited responses from physicians because they’re just as overwhelmed.” 

“I’m already breaking, so for f—’s sake, people, please take this seriously. This is so bad.”

Steiner’s post was one of many emotional pleas offered by overwhelmed hospital workers last spring urging people to take the threat seriously. The denialists mounted a counter offensive.

On March 28, Todd Starnes, a conservative radio host and commentator, tweeted a video from outside Brooklyn Hospital Center. There were few people or cars in sight.

“This is the ‘war zone’ outside the hospital in my Brooklyn neighborhood,” Starnes said sarcastically. The video racked up more than 1.5 million views.

Starnes’ video was one of the first examples of #FilmYourHospital, a conspiratorial social media trend that pushed back on the idea that hospitals had been strained by a rapid influx of coronavirus patients. 

Several internet personalities asked people to go out and shoot their own videos. The result: a series of user-generated clips taken outside hospitals, where the response to the pandemic was not easily seen. Over the course of a week, #FilmYourHospital videos were uploaded to YouTube and posted tens of thousands of times on Twitter and Facebook.

Nearly two weeks and more than 10,000 deaths later, Fox News featured a guest who opened a new misinformation assault on hospitals.

Dr. Scott Jensen, a Minnesota physician and Republican state senator, told Ingraham that, because hospitals were receiving more money for COVID-19 patients on Medicare — a result of a coronavirus stimulus bill — they were overcounting COVID-19 cases. He had no proof of fraud, but the cynical story took off

Trump used the false report on the campaign trail to continue to minimize the death toll. 

“Our doctors get more money if somebody dies from COVID,” Trump told supporters at a rally in Waterford, Mich., Oct. 30. “You know that, right? I mean, our doctors are very smart people. So what they do is they say, ‘I’m sorry, but, you know, everybody dies of COVID.’”  

The real fake news: The Plandemic

The most viral disinformation of the pandemic was styled to look like it had the blessing of people Americans trust: scientists and doctors.

In a 26-minute video called “Plandemic: The Hidden Agenda Behind COVID-19,” a former scientist at the National Cancer Institute claimed that the virus was manipulated in a lab, hydroxychloroquine is effective against coronaviruses, and face masks make people sick. 

Judy Mikovits’ conspiracies received more than 8 million views in May thanks in part to the online outrage machine — anti-vaccine activists, anti-lockdown groups and QAnon supporters — that push disinformation into the mainstream. The video was circulated in a coordinated effort to promote Mikovits’ book release.

A couple of months later, a similar effort propelled another video of fact-averse doctors to millions of people in only a few hours. 

On July 27, Breitbart published a clip of a press conference hosted by a group called America’s Frontline Doctors in front of the U.S. Supreme Court. Looking authoritative in white lab coats, these doctors discouraged mask wearing and falsely said there was already a cure in hydroxychloroquine, a drug used to treat rheumatoid arthritis and lupus.

Trump, who had been talking up the drug since March and claimed to be taking it himself as a preventive measure in Mayretweeted clips of the event before Twitter removed them as misinformation about COVID-19. He defended the “very respected doctors” in a July 28 press conference

When Olga Lucia Torres, a lecturer at Columbia University, heard Trump touting the drug in March, she knew it didn’t bode well for her own prescription. Sure enough, the misinformation led to a run on hydroxychloroquine, creating a shortage for Americans like her who needed the drug for chronic conditions. 

A lupus patient, she went to her local pharmacy to request a 90-day supply of the medication. But she was told they were only granting partial refills. It took her three weeks to get her medication through the mail. 

“What about all the people who were silenced and just lost access to their staple medication because people ran to their doctors and begged to take it?” Torres said.No sickbed conversion

On Sept. 26, Trump hosted a Rose Garden ceremony to announce his nominee to replace the late Ruth Bader Ginsburg on the U.S. Supreme Court. More than 150 people attended the event introducing Amy Coney Barrett. Few wore masks, and the chairs weren’t spaced out.

In the weeks after, more than two dozen people close to Trump and the White House became infected with COVID-19. Early Oct. 2, Trump announced his positive test.

Those hoping the experience and Trump’s successful treatment at Walter Reed might inform his view of the coronavirus were disappointed. 

Trump snapped back into minimizing the threat during his first moments back at the White House. He yanked off his mask and recorded a video.

“Don’t let it dominate you. Don’t be afraid of it,” he said, describing experimental and out-of-reach therapies he received. “You’re going to beat it.” 

In Trump’s telling, his hospitalization was not the product of poor judgment about large gatherings like the Rose Garden event, but the consequence of leading with bravery. Plus, now, he claimed, he was immune from the virus.

On the morning after he returned from Walter Reed, Trump tweeted a seasonal flu death count of 100,000 lives and added that COVID-19 was “far less lethal” for most populations. More false claims at odds with data — the U.S. average for flu deaths over the past decade is 36,000, and experts said COVID-19 is more deadly for each age group over 30.

When Trump left the hospital, the U.S. death toll from COVID-19 was more than 200,000. Today it is more than 300,000. Meanwhile, this month the president has gone ahead with a series of indoor holiday parties. 

The vaccine war 

The vaccine disinformation campaign started in the spring but is still underway.

In April, blogs and social media users falsely claimed Democrats and powerful figures like Bill Gates wanted to use microchips to track which Americans had been vaccinated for the coronavirus. Now, false claims are taking aim at vaccines developed by Pfizer and BioNTech and other companies.

  • A blogger claimed Pfizer’s head of research said the coronavirus vaccine could cause female infertility. That’s false.
  • An alternative health website wrote that the vaccine could cause an array of life-threatening side effects, and that the FDA knew about it. The list included all possible — not confirmed— side effects.
  • Social media users speculated that the federal government would force Americans to receive the vaccine. Neither Trump nor President-elect Joe Biden has advocated for that, and the federal government doesn’t have the power to mandate vaccines, anyway.

As is often the case with disinformation, the strategy is to deliver it with a charade of certainty. 

“People are anxious and scared right now,” said Dr. Seema Yasmin, director of research and education programs at the Stanford Health Communication Initiative. “They’re looking for a whole picture.” 

Most polls have shown far from universal acceptance of vaccines, with only 50% to 70% of respondents willing to take the vaccine. Black and Hispanic Americans are even less likely to take it so far.

Meanwhile, the future course of the coronavirus in the U.S. depends on whether Americans take public health guidance to heart. The Institute for Health Metrics and Evaluation projected that, without mask mandates or a rapid vaccine rollout, the death toll could rise to more than 500,000 by April 2021.

“How can we come to terms with all that when people are living in separate informational realities?” Starbird said.