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.

Recovered coronavirus patients should still get the vaccine, experts say

Research suggests most people who recovered from covid-19 are immune for at least eight months. Yet epidemiologists are largely still urging this population to get the vaccine if it’s their turn in line. 

Official guidance says vaccines should be offered regardless of whether people were previously infected. 

That’s per the Centers for Disease Control and Prevention, which also says the vaccine is safe for people who have had a prior infection. Former CDC director Thomas Frieden said he’d advise most people to get the vaccine, even if they’ve had covid-19.

But Frieden added that he doesn’t think it’s wrong for someone in a low-risk group who’d already had the illness to defer if they thought someone else could use the dose. 

The limits on vaccine supply bolster the argument that recovered people should let others go first. 

As administration of the vaccine bottlenecks across the country, the pressure is on to get the shots in as many arms as quickly as possible. 

Researchers at the University of Colorado Boulder found that prioritizing people who don’t already have natural immunity could allow health officials to get more impact from limited supplies, especially in areas where many people have already been infected, according to a modeling study that has not been peer reviewed

The researchers found that you would need to vaccinate 1 in 5 elderly people in New York to bring death rates down by 73 percent. But you can get the same result vaccinating only 1 in 6 people if you prioritize people who don’t already have antibodies to the virus, according to Kate Bubar, a PhD student in applied mathematics and quantitative biology, who co-authored the study.

And although a previous covid-19 infection isn’t a guarantee of immunity, it’s pretty good protection on its own.Researchers have found that eight months after infection, about 90 percent of patients show lingering, stable immunity. 

Still, risk can vary from person to person.  

“If I were over 70 or otherwise ill, I would certainly take the vaccine even if I’d had [covid-19]. If I were 30 and healthy, I should not be getting it now (unless a health care worker), but if for some reason I did get offered it I would probably decline,” Marc Lipsitch, an infectious-disease specialist at the Harvard T.H. Chan School of Public Health, said in an email.  

Some epidemiologists worry about the logistics of trying to weed out people with natural immunity.

It could complicate the process as health providers are already struggling to get the vaccine distributed quickly. So far around 6.7 million people have been vaccinated, even though 22.1 million doses have been distributed, according to a Washington Post analysis.

Eleanor Murray, an assistant professor of epidemiology at Boston University School of Public Health, worried that trying to verify someone’s past illness would add bureaucratic hurdles. 

“Confirming whether or not someone has had COVID already adds an unnecessary layer of red tape onto vaccine prioritization. Given that the prioritization is designed to get vaccine first to those people who are most likely to get infected and/or get very sick from infection, it makes sense to reduce the barriers to vaccinating this group as much as possible,” Murray said. 

Murray also cautioned that we don’t know how long people’s natural immunity lasts and that it could vary from person to person. This uncertainty may be an added reason to encourage people to get the vaccine.

There’s also a risk that telling people who had covid-19 to hold off on getting the vaccine could end up feeding into anti-vaxxer narratives. Some experts are reluctant to discourage anyone from getting the vaccine if they are eligible, especially given that vaccine hesitancy is widespread. 

There’s already a problem with people being offered the vaccine but not getting it. 

In Santa Rosa County, Fla., only about 40 percent of emergency responders who are eligible to get the vaccine have gotten it or signed up to do so soon. In New York, where around 30 percent of health care workers have declined the vaccine, the state’s Gov. Andrew Cuomo (D) has threatened that anyone who skips a dose now won’t be eligible for a priority vaccine later. 

The low participation rate is concerning, especially at long-term care centers. 

But not everyone who turns down a vaccine is a hardcore anti-vaxxer, Frieden cautions. He says that there is a “movable middle” of people. They aren’t going to be camping out overnight to get an early vaccine, but they may be convincible if costs and other barriers are low. Frieden says it’s crucial to keep a door open for those people, for instance, seeing whether they might be willing to schedule a shot three weeks from now instead of immediately. 

The slow pace of vaccinations has sparked a heated debate over how to stretch supplies.

A vocal group of experts has pushed for officials to consider giving as many people as possible the first dose of the two-shot regimen, even if it means risking a delayed second dose. President-elect Joe Biden has announced his incoming administration will take this approach, sending all doses out the door as quickly as possible instead of holding half back. 

“The plan, announced Friday by the Biden transition team, pivots sharply from the Trump administration’s strategy of holding in reserve roughly half the doses to ensure sufficient supply for people to get a required second shot,” our colleagues reported.

But some epidemiologists, including Frieden, argue that distribution is a bigger problem than supply at this point. Although he said he supports releasing most vaccines, he worries that some of the debates about how to stretch supply are “distractions” from the real obstacles of administration, which he blames in part on a lack of a coordinated federal plan for getting shots into arms. 

“What Operation Warp Speed has generally done is said, ‘We’re responsible for getting the drugs to the states, and after that, it’s their problem,’ ” Frieden said. “That’s a way to facilitate finger pointing; that’s neither a plan nor a solution.” 

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.”

Two Dead Every Minute: U.S. Covid-19 Cases Surge In 2021

COVID-19 on pace to become the third-leading cause of death in Arizona this  year - The Gila Herald

TOPLINE

In the first week of 2021, roughly two people died from Covid-19 in the U.S. every minute, amid a struggling national vaccination effort, soaring coronavirus cases and the deadliest day of the pandemic yet.

KEY FACTS

According to data from the Covid Tracking Project, 19,418 people died from the disease in the first seven days of 2021.

The U.S. is the country hardest hit by the novel coronavirus — more than 4,000 people died on Thursday, the deadliest day yet of the pandemic, and over 355,000 people have died from the disease since the pandemic began. 

Experts warn that things are likely to get worse before they get better as hospitals across the country are stretched to breaking point — hospitals in LA are reportedly rationing oxygen and many are running out of beds. 

More than 132,000 Americans are currently admitted in hospitals for Covid-19-related care. 

Widespread vaccination, which could help turn the tide against the virus, has failed to gain momentum and the U.S. is way behind its inoculation targets.

The Centers for Disease Control and Prevention says that only 28% of the more than 21 million vaccines it has distributed have been used —  many are reportedly languishing in storage. 

WHAT TO WATCH FOR

President-elect Joe Biden has said he will release all available Covid-19 vaccine doses for immediate use upon taking office, ending Trump’s strategy of saving doses to ensure people have access to a recommended second shot. Some countries, such as the U.K., have decided to space out doses beyond what manufacturers recommend in a bid to provide as many people as possible with some degree of immunity. Experts are torn on the strategy. The U.S. Food and Drug Administration recommends the vaccines are distributed as intended, with a second shot after a 21 or 28 day gap. The British medical regulator, and more recently the World Health Organization, say the second shot can be delayed, although they do not agree on how long this should be.

CRUCIAL QUOTE

Biden warned that the U.S. is falling “far behind” what is needed to control the pandemic. Trump’s approach would take “years,” he said. 

WHAT WE DON’T KNOW

A highly infectious variant of coronavirus, first discovered in the U.K., could be circulating in the U.S.. At least 52 cases have been reported so far. Fortunately, scientists do not believe the variant is able to evade the recently-developed vaccines. 

U.S. surpasses 300,000 daily coronavirus cases, the second alarming record this week

CDC advises 'universal' masks indoors as US Covid deaths again break records  | Coronavirus | The Guardian

The United States on Friday surpassed 300,000 daily coronavirus cases, the second alarming record this week. The number, which roughly equates to the population of St. Louis, Pittsburgh or Cincinnati, comes about two months after the country reported 100,000 coronavirus cases a day for the first time, and one day after more than 4,000 people died from the virus, also a record.

The United States has reported 21.8 million infections and 367,458 deaths.

Storming of Capitol was textbook potential coronavirus superspreader, experts say

https://www.washingtonpost.com/health/2021/01/08/capitol-coronavirus/

Wednesday’s storming of the U.S. Capitol did not just overshadow one of the deadliest days of the coronavirus pandemic — it could have contributed to the crisis as a textbook potential superspreader, health experts warn.

Thousands of Trump supporters dismissive of the virus’s threat packed together with few face coverings — shouting, jostling and forcing their way indoors to halt certification of the election results, many converging from out of town at the president’s urging. Police rushed members of Congress to crowded quarters where legislators say some of their colleagues refused to wear masks as well.

“This was in so many ways an extraordinarily dangerous event yesterday, not only from the security aspects but from the public health aspects, and there will be a fair amount of disease that comes from it,” said Eric Toner, senior scholar at the John Hopkins Center for Health Security.

Experts said that resulting infections will be near-impossible to track, with massive crowds fanning out around the country and few rioters detained and identified. They also wondered if even a significant number of cases would register in a nation overwhelmed by the coronavirus. As Americans shared their shock and anger at the Capitol breach Thursday, the United States reported more than 132,000 people hospitalized with the virus, and more than 4,000 deaths from covid-19, the disease caused by the coronavirus — making it the highest single-day tally yet.

“It is a very real possibility that this will lead to a major outbreak but one that we may or may not be able to recognize,” Toner said. “All the cases to likely derive from this event will likely be lost in the huge number of cases we have in the country right now.”

Trump devotees who flocked to the capital this week said they were unconcerned by the virus, belittling common precautions known to slow its spread and echoing the president’s dismissive attitude toward rising case counts. Trump had encouraged them to gather in defiance of his election loss: “Big protest in D.C. on January 6th,” he tweeted last month. “Be there, will be wild!”

Mike Hebert, 73, drove two days from Kansas to participate. Marching toward the Capitol on Wednesday with an American flag, he said he did not feel the need to wear a face covering.

“I am as scared of the virus as I am of a butterfly,” said Hebert, adding that he is a veteran who was shot twice in Vietnam.

Sisters Courtney and Haley Stone left New York at 11 p.m. to make it to the Capitol by morning so they could quietly counterprotest, draped in Biden gear. “Do you want a mask? I have one,” Haley, 22, asked a Trump supporter, only to be rebuffed.

“Oh, you believe in the mask hoax?” the woman replied.

Health experts predicted Wednesday’s events will contribute to an ongoing case surge in the greater Washington region. The average number of daily new infections in Virginia, Maryland and the District of Columbia reached a record high Thursday, and current covid-19 hospitalizations in the District have risen 19 percent in the past week.

They also noted differences with other large gatherings such as Black Lives Matter protests. Fewer people wore masks during the Capitol protests and riot, they said, and crowds were indoors.

“If you wanted to organize an event to maximize the spread of covid it would be difficult to find one better than the one we witnessed yesterday,” said Jonathan Fielding, a professor at the schools of Public Health and Medicine at UCLA.

“You have the drivers of spreading at a time when we are bearing the heaviest burden of this terrible virus and terrible pandemic,” he said.

Calling in to CBS News Wednesday, Rep. Susan Wild (D-Pa.) described her evacuation to a “crowded” undisclosed location with 300 to 400 other people.

“It’s what I would call a covid superspreader event,” she said. “About half the people in the room are not wearing masks, even though they’ve been offered surgical masks. They’ve refused to wear them.”

She did not identify the lawmakers forgoing face coverings beyond saying they were Republicans, including some freshmen. The Committee on House Administration says it is a “critical necessity” to mask up while indoors at the Capitol, and D.C. has a strict mask mandate.

“It’s certainly exactly the kind of situation that we’ve been told by the medical doctors not to be in,” Wild said.

“We weren’t even allowed to get together with our families for Thanksgiving and Christmas,” she said, “and now we’re in a room with people who are flaunting the rules.”

At least one member of Congress has tested positive since the mob spurred an hours-long lockdown. Newly elected Rep. Jacob LaTurner (R-Kan.) tested positive for the coronavirus late Wednesday evening, according to a statement posted on his Twitter account. It said he is not experiencing symptoms.

“LaTurner is following the advice of the House physician and CDC guidelines and, therefore, does not plan to return to the House floor for votes until he is cleared to do so,” the statement said.

Luke Letlow, a 41-year-old congressman-elect from Louisiana, died of covid-19 last month.

Any infections among members of Congress and their staff will be far easier to contact-trace than those among rioters, said Angela Rasmussen, an affiliate at the Center for Global Health Science and Security at Georgetown University.

“It certainly would have been easier if they were detained by Capitol police and identified, but testing suspects may be something to consider as law enforcement begins to identify them,” Rasmussen said in an email.

She noted that some may try to evade identification and criminal charges, and said she is deeply concerned for the households and communities they might expose.

“I think really rigorous contact tracing of people who are not identified as being present on Capitol grounds will not be possible,” she said.

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. 

States ranked by percentage of COVID-19 vaccines administered: Jan. 8

E.U. Starts Effort to Vaccinate 450 Million - The New York Times

North Dakota has administered the highest percentage of COVID-19 vaccines it has received, according to the CDC’s COVID-19 vaccine distribution and administration data tracker.

The CDC’s data tracker compiles data from healthcare facilities and public health authorities. It updates daily to report the total number of COVID-19 vaccines that have been distributed to each state and the total number each state has administered.

As of 9 a.m. ET Jan. 7, a total of 21,419,800 vaccine doses have been distributed in the U.S. and 5,919,418 have been administered, or 27.64 percent. That means about 1.8 percent of the U.S. population has been vaccinated. 

Below are the states ranked by the percentage of COVID-19 vaccines they’ve administered of those that have been distributed to them.

  1. North Dakota
    Doses distributed to state: 43,950
    Doses administered: 27,289
    Percentage of distributed vaccines that have been administered: 62.09
  2. West Virginia
    Doses distributed to state: 126,275
    Doses administered: 74,016
    Percentage of distributed vaccines that have been administered: 58.61
  3. South Dakota
    Doses distributed to state: 59,900
    Doses administered: 33,389
    Percentage of distributed vaccines that have been administered: 55.74
  4. New Hampshire
    Doses distributed to state: 77,075
    Doses administered: 37,369
    Percentage of distributed vaccines that have been administered: 48.48
  5. Connecticut
    Doses distributed to state: 219,125
    Doses administered: 100,889
    Percentage of distributed vaccines that have been administered: 46.04
  6. Nebraska
    Doses distributed to state: 132,800
    Doses administered: 53,548
    Percentage of distributed vaccines that have been administered: 40.32
  7. Montana
    Doses distributed to state: 69,025
    Doses administered: 27,693
    Percentage of distributed vaccines that have been administered: 40.12
  8. Tennessee
    Doses distributed to state: 454,800
    Doses administered: 179,811
    Percentage of distributed vaccines that have been administered: 39.54
  9. Iowa
    Doses distributed to state: 191,675
    Doses administered: 74,224
    Percentage of distributed vaccines that have been administered: 38.72
  10. Kentucky
    Doses distributed to state: 244,350
    Doses administered: 94,443
    Percentage of distributed vaccines that have been administered: 38.65
  11. Vermont
    Doses distributed to state: 48,550
    Doses administered: 18,740
    Percentage of distributed vaccines that have been administered: 38.6
  12. Maine
    Doses distributed to state: 96,475
    Doses administered: 37,128
    Percentage of distributed vaccines that have been administered: 38.48
  13. Rhode Island
    Doses distributed to state: 72,175
    Doses administered: 27,696
    Percentage of distributed vaccines that have been administered: 38.37
  14. New Mexico
    Doses distributed to state: 133,125
    Doses administered: 48,306
    Percentage of distributed vaccines that have been administered: 36.29
  15. Colorado
    Doses distributed to state: 361,375
    Doses administered: 130,445
    Percentage of distributed vaccines that have been administered: 36.1
  16. Utah
    Doses distributed to state: 191,075
    Doses administered: 62,662
    Percentage of distributed vaccines that have been administered: 34.8
  17. Oklahoma
    Doses distributed to state: 264,000
    Doses administered: 85,978
    Percentage of distributed vaccines that have been administered: 32.57
  18. Texas
    Doses distributed to state: 1,676,925
    Doses administered: 545,658
    Percentage of distributed vaccines that have been administered: 32.54
  19. New York
    Doses distributed to state: 1,134,800
    Doses administered: 353,788
    Percentage of distributed vaccines that have been administered: 31.18
  20. Massachusetts
    Doses distributed to state: 449,025
    Doses administered: 137,858
    Percentage of distributed vaccines that have been administered: 30.7
  21. Ohio
    Doses distributed to state: 576,250
    Doses administered: 175,681
    Percentage of distributed vaccines that have been administered: 30.49
  22. Indiana
    Doses distributed to state: 409,625
    Doses administered: 123,835
    Percentage of distributed vaccines that have been administered: 30.23
  23. Florida
    Doses distributed to state: 1,355,775
    Doses administered: 402,802
    Percentage of distributed vaccines that have been administered: 29.71
  24. Illinois
    Doses distributed to state: 737,125
    Doses administered: 213,045
    Percentage of distributed vaccines that have been administered: 28.9
  25. Missouri
    Doses distributed to state: 401,050
    Doses administered: 113,369
    Percentage of distributed vaccines that have been administered: 28.27
  26. New Jersey
    Doses distributed to state: 572,250
    Doses administered: 155,458
    Percentage of distributed vaccines that have been administered: 27.17
  27. Maryland
    Doses distributed to state: 371,425
    Doses administered: 100,049
    Percentage of distributed vaccines that have been administered: 26.94
  28. Delaware
    Doses distributed to state: 64,375
    Doses administered: 16,677
    Percentage of distributed vaccines that have been administered: 25.91
  29. Hawaii
    Doses distributed to state: 95,200
    Doses administered: 24,558
    Percentage of distributed vaccines that have been administered: 25.80
  30. South Carolina
    Doses distributed to state: 225,850
    Doses administered: 58,044
    Percentage of distributed vaccines that have been administered: 25.7
  31. Minnesota
    Doses distributed to state: 378,425
    Doses administered: 97,098
    Percentage of distributed vaccines that have been administered: 25.66
  32. Pennsylvania
    Doses distributed to state: 789,250
    Doses administered: 202,498
    Percentage of distributed vaccines that have been administered: 25.66
  33. Wisconsin
    Doses distributed to state: 322,775
    Doses administered: 82,170
    Percentage of distributed vaccines that have been administered: 25.46
  34. Alaska
    Doses distributed to state: 87,325
    Doses administered: 21,830
    Percentage of distributed vaccines that have been administered: 25
  35. Virginia
    Doses distributed to state: 556,625
    Doses administered: 136,924
    Percentage of distributed vaccines that have been administered: 24.60
  36. Oregon
    Doses distributed to state: 262,100
    Doses administered: 61,672
    Percentage of distributed vaccines that have been administered: 23.53
  37. Washington
    Doses distributed to state: 518,550
    Doses administered: 121,354
    Percentage of distributed vaccines that have been administered: 23.40
  38. Wyoming
    Doses distributed to state: 40,400
    Doses administered: 9,324
    Percentage of distributed vaccines that have been administered: 23.08
  39. California
    Doses distributed to state: 2,314,350
    Doses administered: 528,173
    Percentage of distributed vaccines that have been administered: 22.82
  40. Idaho
    Doses distributed to state: 104,925
    Doses administered: 22,822
    Percentage of distributed vaccines that have been administered: 21.75
  41. Louisiana
    Doses distributed to state: 298,825
    Doses administered: 64,664
    Percentage of distributed vaccines that have been administered: 21.64
  42. North Carolina
    Doses distributed to state: 647,450
    Doses administered: 139,474
    Percentage of distributed vaccines that have been administered: 21.54
  43. Nevada
    Doses distributed to state: 187,375
    Doses administered: 39,761
    Percentage of distributed vaccines that have been administered: 21.22
  44. Michigan
    Doses distributed to state: 662,450
    Doses administered: 137,887
    Percentage of distributed vaccines that have been administered: 20.81
  45. Alabama
    Doses distributed to state: 245,100
    Doses administered: 48,888
    Percentage of distributed vaccines that have been administered: 19.95
  46. Arizona
    Doses distributed to state: 453,275
    Doses administered: 88,266
    Percentage of distributed vaccines that have been administered: 19.47
  47. Arkansas
    Doses distributed to state: 212,700
    Doses administered: 40,899
    Percentage of distributed vaccines that have been administered: 19.23
  48. Kansas
    Doses distributed to state: 191,225
    Doses administered: 36,538
    Percentage of distributed vaccines that have been administered: 19.11
  49. Mississippi
    Doses distributed to state: 159,625
    Doses administered: 28,356
    Percentage of distributed vaccines that have been administered: 17.76
  50. Georgia
    Doses distributed to state: 619,250
    Doses administered: 103,793
    Percentage of distributed vaccines that have been administered: 16.76

Biden plans to release nearly all available vaccine doses in an attempt to speed delivery.

President-elect Joseph R. Biden Jr. plans to release nearly all available coronavirus vaccine doses “to ensure the Americans who need it most get it as soon as possible,” the Biden transition team said Friday, a move that represents a sharp break from the Trump administration’s practice of holding back some of the vaccine.

The announcement coincided with a letter from eight Democratic governors — including Andrew M. Cuomo of New York and Gretchen Whitmer of Michigan, both of whom have clashed with President Trump — imploring the current administration to release all available doses to the states as soon as possible.

“The failure to distribute these doses to states who request them is unconscionable and unacceptable,” the governors wrote in the letter, which was obtained by The New York Times and sent Friday to the secretary of health, Alex M. Azar II, and Gen. Gustave F. Perna, who is in charge of vaccine distribution. “We demand that the federal government begin distributing these reserved doses to states immediately,” the letter said.

Because both of the vaccines with emergency approval require two doses, the Trump administration has been holding back roughly half of its supply to ensure those already vaccinated receive the booster dose. The vaccine rollout has been troubled from the start.

As of Thursday, the Trump administration had shipped more than 21 million vaccine doses, and millions more were already in the federal government’s hands. Yet only 5.9 million people had received a dose. State and local public health officials, already overwhelmed with rising infections, have been struggling to administer the vaccine to hospital workers and at-risk older Americans while most people remain in the dark about when they might be protected. Mr. Biden has promised that 100 million doses of the vaccine would be administered by his first 100th day in office.

Releasing the vast majority of the vaccine doses raises the risk that second doses would not be administered on time. Officials from the Food and Drug Administration — experts whose advice Mr. Biden has pledged to follow — have spoken out strongly against changing the dosing schedule, calling such a move “premature and not rooted solidly in the available evidence.”

A transition official, speaking anonymously to provide insight into the president-elect’s thinking, said would use the Defense Production Act, if needed, to ensure that enough doses are available.

However, the official also noted that the Biden team has “faith in our manufacturers that they can produce enough vaccines to ensure people can get their second dose in a timely manner, while also getting more people their first dose.”

A spokesman for Operation Warp Speed, the Trump administration’s vaccine initiative, released a statement sharply criticizing Mr. Biden’s approach.

“If President-elect Biden is calling for the distribution of vaccines knowing that there would not be a second dose available, that decision is without science or data and is contrary to the FDA’s approved label,” said the spokesman, Michael Pratt. “If President-elect Biden is suggesting that the maximum number of doses should be made available, consistent with ensuring that a second dose of vaccine will be there when the patient shows up, then that is already happening.”

A spokesman for the transition team, T.J. Ducklo, said Mr. Biden “believes we must accelerate distribution of the vaccine while continuing to ensure the Americans who need it most get it as soon as possible.”

“He supports releasing available doses immediately, and believes the government should stop holding back vaccine supply so we can get more shots in Americans’ arms now,” Mr. Ducklo said. “He will share additional details next week on how his Administration will begin releasing available doses when he assumes office on January 20th.”

Dr. Leana Wen, an emergency physician and public health expert at the George Washington University School of Public Health, said she was surprised and concerned about the new strategy, which seemed to offer a solution incongruous with the biggest problems in the vaccine rollout. Distribution has sputtered in large part because of a lack of administering capacity and several logistical hurdles, rather than a severe shortage of doses.

“This is not the problem we’re trying to solve right now,” Dr. Wen said.

For such a plan to work, Dr. Wen added, the Biden administration will need to be confident in both improved distribution tactics and sufficient vaccine production, “so all who receive the first dose of the vaccine will receive the second in a timely manner.”

Should a high number of delayed second doses occur — ostensibly shirking the regimens laid out in clinical trials — “it runs the risk of substantially eroding public trust in vaccines,” Dr. Wen said. The recommended timeframe for administering the second dose for the Pfizer-BioNTech vaccine is 21 days later, and for the Moderna vaccine, 28 days.

Mr. Biden’s announcement came amid growing pressure to step up the slow pace of mass vaccinations.

Speaking at a news briefing on Friday, Dr. Stephen Hahn, the F.D.A. commissioner, urged states that have utilized only a small part of their supply to begin vaccinating lower-priority groups, while still observing government guidelines.

“We think that will go a long way toward using these vaccines appropriately and getting them into the arms of individuals,” he said.

Mr. Biden also formally announced nearly two dozen members of his National Security Council staff on Friday, including a senior official for global health threats whose office was downgraded before the coronavirus pandemic.

Among the 21 appointees is Elizabeth Cameron, who will be the council’s senior director for global health security and biodefense, the job she held until John R. Bolton, Mr. Trump’s then-national security adviser, eliminated the office in May 2018, reassigning its responsibilities elsewhere within the N.S.C. Ms. Cameron has argued publicly that the move “contributed to the federal government’s sluggish domestic response” to the pandemic, and Mr. Biden vowed as a candidate to restore the office.