Now Comes The Hardest Part: Getting A Coronavirus Vaccine From Loading Dock To Upper Arm

Pfizer coronavirus vaccine 95% effective, company says - The Washington Post

Source: The Washington Post, by Lena H. Sun and Frances Stead Sellers

Riverside Health System in Virginia has ordered a specialized freezer for each of its five hospitals to keep precious vials of coronavirus vaccine as cold as a deep Antarctic freeze.

Public health officials in Nashville and Baltimore are revamping routine flu clinics to test delivery methods for coronavirus vaccinations.

And in Maine, top health official Nirav Shah spends sleepless nights devising drive-through immunization facilities where vaccinators won’t have to wear winter parkas in addition to their personal protective gear.

Shah’s solution? Fire stations and carwashes.

Those venues are heated “so you have shelter from the snow and cold,” he said. “We haven’t inked any of those agreements yet, but that’s where our head is at.”

Buoyed by promising results from major clinical trials of three coronavirus vaccines, public health officials are preparing for the daunting task ahead of delivering those shots to tens of millions of Americans. On Monday, a third pharmaceutical company announced positive results from late-stage trials of a coronavirus vaccine, saying that its candidate is up to 90 percent effective.

The vaccines need to be distributed across 50 states, plus U.S. territories, that have different demographics and shifting needs. The leading products must be stored at different temperatures and have different minimum orders, with each requiring two shots though the three vaccines don’t all share the same schedule.

Complicating matters: A final decision on who is eligible to get the early doses must wait for a federal advisory group’s recommendations. That can’t happen until regulators authorize the new vaccines. And once set in motion, the distribution — from loading dock to upper arm — has to be accomplished equitably and with as few handoffs as possible because it’s all being done amid a pandemic.

The stakes are enormous. The massive undertaking to immunize most of the population requires extraordinary communication, planning and coordination. Federal, state and local officials are working with hospitals and pharmacies, suppliers of dry ice, gloves and vials, and carriers such as UPS and FedEx. A successful operation could transform the health and economic well-being of society, in the United States and overseas.

“There are a million moving parts,” said Bruce Gellin, president of global immunization at the Sabin Vaccine Institute. “The system is complex to start with, [and] it is being modified to mount an immunization campaign of historic proportions,” he said, warning that while “expectations are sky high,” there are pitfalls at every step.

Officials are wrestling with how to ensure vulnerable populations receive the vaccine. Almost certainly at the front of the line: about 21 million front-line health-care workers. Next up are likely to be other essential workers, many of whom come from Black, Latino and Asian communities hard hit because of socioeconomic factors. Many can’t work from home, don’t have transportation and live in crowded housing.

“It’s like treating an individual patient while rebuilding the entire health-care system,” said Alfred Sommer, former dean of the Johns Hopkins Bloomberg School of Public Health, who was part of the team that vanquished smallpox four decades ago. Challenges will crop up, he said, such as immunizing disadvantaged communities. “Even with special outreach programs, it will not be easy with the vaccines ready for approval.”

Further complicating the logistics: the continued intrusion of politics. The Trump administration has not given information about vaccine distribution to the Biden transition team, President-elect Joe Biden’s chief of staff, Ron Klain, said in an interview Sunday on ABC’s “This Week,” adding to the potential for disruption.

“I have faith that the incoming administration will not completely upend the thousands of man and woman hours of work we’ve put in,” said Cindy Williams, vice president of the Riverside Health System and a member of Virginia’s coronavirus advisory committee. “Creating additional chaos as we’re managing this is really a bad idea.”

Once the vaccines are authorized by the Food and Drug Administration, doses will be allocated to each state according to population, with some held in reserve in case of loss or theft. Within 24 hours of FDA action, doses will be “prepositioned” at key sites designated by each state where vaccines will be administered to the first priority groups.

U.S. government officials anticipate having 40 million doses of vaccines from pharmaceutical giant Pfizer and biotech firm Moderna by the end of the year, enough to vaccinate 20 million people, a small fraction of the U.S. population of 330 million. (The United States will receive about half of Pfizer’s 50 million doses globally.) Government officials say it will be April before most people could get vaccinated.

The good news from AstraZeneca, manufacturer of the third vaccine, which is easier to store and transport, means the company will also apply for regulatory approval in the United States.

Americans will receive coronavirus vaccines free. The federal government is paying for much of the delivery and vaccine administration costs. But state officials are asking Congress for at least $8 billion for vaccination efforts; to date, $200 million in federal funds has been sent to state, territorial and local jurisdictions.

The vials will be sent first to large hospitals and other sites where mass immunization clinics can take place. But even that first step presents daunting travel, storage and handling requirements.

The Pfizer vaccine will be shipped to sites selected by states in GPS-tracked, suitcase-sized “shippers” with 50 pounds of dry ice pellets, and must be kept at minus-70 Celsius. Upon arrival, the dry ice must be refreshed, or the vials of vaccine must be transferred to ultralow-temperature freezers. The specifications are exacting if the vials stay in the shippers: The container cannot be opened more than twice a day, the dry ice must be replenished every five days, and the contents must be used within 15 days. The vials can stay at refrigerator temperature for five days before their contents degrade.

The Moderna vaccine is less demanding, with a storage temperature of minus-20 Celsius, which is the same for many medications.

The shipments need to be coordinated with kits of syringes, needles, face masks and other ancillary supplies.

From there, every state, territory and each of six major metropolitan areas is responsible for its own deployments. States are in varying stages of preparation. Many have designated large hospital systems to be the first places to receive vaccine. Maine, for example, has chosen five hospitals with ultracold freezers to receive its first doses, and each has a plan to reach into the community. But just in case, the state bought an ultracold freezer for its public health emergency warehouse that can store more than 200,000 doses.

Maine has held meetings with transportation officials and the National Guard to work through worst-case scenarios, Shah said. If there’s a flood or loss of power, a backup generator for the freezer would kick in. If shots are transported during a blizzard, the vaccine convoy could follow 30 minutes behind a salt truck.

The Centers for Disease Control and Prevention has told states they don’t need to buy specialized freezers because immunizations in the earliest phases will focus on sites that can vaccinate as many people as possible and will be able to handle the cold chain requirements, even without freezers.

But at the Henry Ford Health System in Detroit, Northwell Health in New York and Riverside in Virginia, officials bought them anyway, executives said on a conference call Thursday about vaccine distribution organized by Premier, the group purchasing organization and supply consultancy for 4,100 hospitals. The executives’ assumption was that early public vaccination clinics will be most efficiently done on the campuses of hospitals with ultracold freezers.

Among them is Riverside Shore Memorial Hospital on Virginia’s Eastern Shore, a medically underserved and rural community that includes poultry and agricultural workers who did not have health insurance until the state recently expanded Medicaid, said Williams, of Riverside Health. It is one of three major health-care providers for the community, and the only one with an ultracold freezer.

Clinicians will need to be trained to administer the vaccines, which have different protocols. The Pfizer version must be diluted before the shot is given — inverting the vial 10 times “gently,” according to the Pfizer instructions. In contrast, the Moderna vaccine does not require on-site mixing and should not be shaken.

To start with, vaccination efforts may favor urban areas. That’s because the vaccines will arrive in big batches: For Pfizer, the minimum order is 975 doses. Moderna’s smallest batch is 100 doses.

In Alaska, “you’re not going to have 900 people within 1,000 square miles,” said Danny Staley, a senior vice president at the Association of State and Territorial Health Officials. “You’re wanting to do that at a mass vaccination clinic, where we know people can use it so we don’t waste it,” he said.

“The most disadvantaging issue is the minimum order,” said Ann Lewandowski, program manager for the Southern Wisconsin Immunization Consortium, a group of 42 rural hospitals in Wisconsin. None has the resources to purchase a special freezer, which can cost $12,000 to $15,000 and might be needed for only a year until vaccines are developed that don’t require such frigid temperatures.

Identifying enough health-care workers to be immunized is also challenging for rural hospitals that may have only 20 nurses and 20 doctors. “You would need to reach out to pharmacists, reach out to dentists and all these other professionals, but 975 is really an impossible goal,” Lewandowski said.

On a recent call, a Pfizer representative told Lewandowski the company hopes to send out smaller batches of 125 doses by April. But even that creates logistical challenges because the vials need to be coordinated with the ancillary kits, which are equipped for 100 doses.

Health-care personnel from rural hospitals may have to drive to get their shots at larger hubs in Madison, Milwaukee or Eau Claire, Lewandowski said. That could pose a barrier for staffers already stretched thin caring for patients with covid-19, the illness caused by the coronavirus.

“These are health-care workers who are taking risks to serve the state in our time of need, and it’s not fair to discriminate against them simply because they live in a geographically challenged place,” Lewandowski said.

A Pfizer spokeswoman said the company is working on a smaller pack size that will be ready the first three months of 2021.

Final recommendations on who gets the first shots will come from an independent committee on immunizations that advises the CDC. There is broad agreement that health-care workers will be first, and will include clinicians, custodial staff, home health aides, pharmacists, paramedics and staff in long-term care facilities, according to discussions Monday during a meeting of the Advisory Committee on Immunization Practices. That first group may also include about three million long-term care residents.

Jose Romero, a pediatric infectious-diseases specialist who chairs the immunization panel, said “essential workers” are likely to be high on the list. That might include people who stock supermarket shelves or pick vegetables, many of whom belong to communities of color devastated by covid-19.

“That is part of the equity question we are trying to solve,” Romero said in an interview.

That assumes priority groups are willing to take the first shots. Health officials say they are increasingly worried about staffers who say they won’t take the vaccine, according to internal surveys and conversations with clinicians.

“When it comes to this vaccine, what I’m hearing from colleagues … is that their confidence is lacking,” Pamela G. Rockwell, a physician representing the American Academy of Family Physicians, said during last month’s meeting of the federal immunization advisory committee.

“I’m already won over,” she said. “We need to win over a lot of primary care physicians … We need to do this right and get our patients convinced that this is safe so we can save our country.”

Federal health officials are also concerned.

“I am worried that people are going to equate the complicated storage and handling as somehow more reason to be hesitant about the vaccine, when in fact, it has nothing to do with how well the vaccines work,” said a senior federal health official involved in distribution with the Defense Department and private industry. The official spoke on the condition of anonymity because they were not authorized to speak publicly on the record.

At Riverside, a survey last month of about 1,000 employees, most in nursing and administrative positions, found about a third said they would take the vaccine, another third said they would not, and the remainder wanted more data on safety and efficacy. A separate poll of physicians found nearly half would not take the vaccine. The surveys were conducted before reports about the vaccines’ effectiveness, and acceptance is likely to increase, said Riverside’s Williams.

Patients will be more likely to be vaccinated if they ask their doctors if they’re willing to be vaccinated and the physician says yes, she said.

Saad B. Omer, an epidemiologist and infectious-diseases expert who directs the Yale Institute for Global Health, has done extensive studies about the political and social factors influencing trust in vaccines. What he sees now is not “your run-of-the-mill vaccine hesitancy.” President Trump’s actions fueled mistrust in science, he said.

But health-care personnel can be persuaded. Strong endorsements from a trusted person, such as Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases, can make a huge difference, according to a study Omer conducted recently.

Experts who study vaccine hesitancy say promotional campaigns that use social media and increase community engagement with trusted leaders will be key to encouraging use of a new vaccine.

Adam Abadir, director of communications at the Baltimore City Health Department, said the city’s health officials had been using routine flu clinics to hone strategies such as tailored social media campaigns and outreach through pastors and other trusted community members.

“We now have partners in place who can deliver the messages,” Abadir said, even though he doesn’t yet know what those messages will say.

In Nashville, the annual “Flulapalooza” mass vaccination event at Vanderbilt University Medical Center — last year, they managed 15,000 shots on site in one day — was modified as Flula-2-uza to test strategies for the coronavirus, which may involve reversing their strategy and venturing out to remote workers.

The new vaccines are likely to produce more unpleasant side-effects than a flu shot, potentially leading recipients to need a day or two off work.

“Any group of individuals that work together, we can’t vaccinate them all at the same time,” said Thomas Talbot, chief hospital epidemiologist at Vanderbilt, which will likely be among the first sites to receive the Pfizer vaccine and is looking at how to stagger immunizations to minimize the impact on departments.

In Baltimore, a mobile flu clinic in a predominantly Latino community drew more than 150 people on a recent stormy morning to a school parking lot, where a team of Spanish-speaking officials were working with next year in mind.

Drive-through vaccination isn’t viable for people in the city who lack transportation, said Rebecca Dineen, assistant commissioner for the city’s Bureau of Maternal and Child Health. So the health department is pushing hard to foster links in public housing and with neighborhood leaders who will be key to coronavirus distribution.

“You don’t need a fancy innovative approach,” Dineen said. “A lot of it is really knowing your people.”

Shah, in Maine, is hoping that beyond cultivating relationships with pharmacies and physicians offices, fire stations and carwashes will be all the innovation he needs.

“We think the fire departments are a pretty good source for sites because there are so many, many small towns in Maine,” he said.

EMS clinicians can be vaccinators there or at carwashes.

“People trust them,” he said. “And trust matters a lot.”

Newsom: Up To 2.4 Million California Health Care Workers Could Get Coronavirus Vaccines As Soon As December

Newsom: Up to 2.4 million California health care workers could get  coronavirus vaccines as soon as December - SFChronicle.comSource: San Francisco Chronicle, by Catherine Ho

California could start administering coronavirus vaccines to as many as 2.4 million of the state’s highest-priority health care workers in early December, Gov. Gavin Newsom said Monday.

The state is making vaccine distribution plans around the estimated assumption that the first vaccines will be authorized by the FDA in early December. That first approval will likely be for the vaccine made by Pfizer and German firm BioNTech, followed by the vaccine made by Moderna. Federal health officials have said states will begin receiving doses within 24 hours after the first vaccine receives FDA authorization.

“We’re waiting for FDA approval of at least one or more vaccines to occur in a number of weeks,” Newsom said. “We’re currently calendaring early December. … For planning purposes, we’re anticipating that FDA approval in early December. That hopefully will be Pfizer and Moderna.”

Pfizer said it submitted its application for FDA authorization Friday. Both Pfizer and Moderna recently shared Phase 3 clinical trial data indicating their vaccines are about 95% effective. AstraZeneca on Monday also shared early data showing its vaccine is 70% effective on average — 62% effective under one dosing scheme, and 90% effective under another dosing scheme.

However, depending on how many doses of the first vaccines are made available, there may not be enough doses for all 2.4 million California health care workers at first, Newsom said. Members of the state’s vaccination committees are working on a plan to divide those health care workers into subsets based on priority. That plan may be shared publicly as soon as the end of November.

“We begin with a framework of scarcity,” he said.

Newsom cautioned that mass vaccination will not likely occur until spring or summer 2021, reiterating previous estimated timelines made by state and federal officials regarding when most Americans will be able to get vaccinated.

Newsom said California has identified the need to buy 16 ultra-cold freezers and 61 smaller freezers to help transport and store the Pfizer vaccine, which must be kept at minus 70 degrees Celsius, or minus 94 degrees Fahrenheit. Some California hospitals have gone ahead and bought their own ultra freezers, and Pfizer plans to ship its vaccine in special containers equipped with dry ice. Newsom said the state’s freezers will supplement those efforts, and will likely be placed in regions that may struggle on their own to obtain such specialized freezers.

Moderna’s vaccine does not need freezers quite that cold. Its vaccine is kept at minus 20 degrees Celsius, and more hospitals and clinics have access to freezers that can accommodate that temperature. Moderna will work with McKesson, the Texas-based pharmaceutical distributor that until recently was headquartered in San Francisco, to distribute its vaccine.

In terms of cost, Newsom said the U.S. Centers for Disease Control and Prevention has committed $28 million to California for the first phase of vaccine distribution. The state has distributed $16 million so far — $10 million for planning and $6 million for staffing, Newsom said. He called the federal funding “inadequate,” and said the second round of funding “needs to be substantially greater.”

It’s unclear how much it would cost to distribute coronavirus vaccines in California. Newsom said he is working with House Speaker Nancy Pelosi, Minority Leader Kevin McCarthy and Vice President-elect Kamala Harris to seek more federal funding for vaccine distribution.

Trump’s New Drug-Pricing Plan Overhauls Outpatient Drug Pay Starting Jan. 1

White House expands international reference pricing to pharmacy drugs

Source: Modern Healthcare, by Rachel Cohrs

The Trump administration is trying to overhaul some providers’ payments for outpatient drugs in six weeks as it makes a last-ditch attempt to finalize drug-pricing policies that have languished in regulatory limbo.

A model through the Center for Medicare and Medicare Innovation announced Friday would require mandatory participation from healthcare providers starting Jan. 1, 2021, though there are several categories of exceptions. The model would change providers’ payment for administering drugs from a percentage of a drug’s average sales price to a flat fee and tie reimbursement to prices charged in foreign countries.

Providers have already sounded the alarm about reimbursement cuts.

“Hospitals will have to absorb losses while drug companies are free to continue their trend of charging exorbitant prices. This will put hospitals in the terrible position of having to divert resources from other patient care simply to buy the drug therapies they need for their patients,” said American Hospital Association Executive Vice President Tom Nickels.

Most-favored nation model

The Trump administration’s international reference pricing plan is limited to setting reimbursement for outpatient drugs. The model is supposed to begin on Jan. 1, 2021, which gives providers only six weeks to prepare.

Instead of paying drugs’ average sales price, Medicare will now also factor in a “most-favored nation” price determined by finding the lowest price a drugmaker offers in certain OECD member countries. The international price would carry heavier weight in the formula over a four-year phase-in period.

Hospitals questioned the rule’s legality and warned it could harm healthcare providers.

“We urge the Administration to withdraw this rule immediately and replace it with a serious effort at drug pricing reform,” Nickels said.

Providers are now paid a percentage of a drug’s average sales price to administer Part B drugs, which some have criticized as incentivizing high drug prices. The model would replace this method with a flat add-on fee.

The administration estimated the rule could save the federal government and beneficiaries more than $80 billion over seven years, but some of the savings will come from reduced beneficiary access. If drugmakers don’t lower their prices, then some providers may choose to not administer certain drugs at a loss, thus reducing access.

“Eligible providers and suppliers will need to decide if the difference between the amount that Medicare will pay and the price that they must pay to purchase the drugs would allow them to continue offering the drugs,” the final rule states.

Community oncologists were displeased with the changes, and called the model “brazen and unhinged.”

“Rather than give community oncology providers the support they need during this third wave of the pandemic, as they struggle to keep their facilities and staff COVID-19 free while treating cancer patients, the Trump Administration is essentially throwing these providers under the bus,” Community Oncology Alliance Executive Director Ted Okon said.

Participation would be mandatory for healthcare providers with some exceptions, including cancer hospitals, children’s hospitals, ambulatory surgical centers, critical-access hospitals, rural health clinics, federally qualified health centers, and Indian Health Service facilities.

Some providers may also be able to apply for exceptions from the model due to financial hardship, said Manatt, Phelps & Phillips Senior Advisor Ian Spatz.

Capitol Street Managing Director Ipsita Smolinski said the rule is likely to be challenged by drugmakers and providers because it is nationwide and mandatory.

“The MFN rule does not fit with the parameters of the CMS innovation center: to be a limited pilot that will be tested and expanded if it works, and restricted or discontinued if it doesn’t work,” Smolinski said.

The model says that it will eventually include the top 50 drugs that make up the most Medicare Part B spending.

Drugmakers are likely to sue to stop the actions, and Trump admitted as much during a speech on Friday.

“I presume they’ll sue, and it is a suit that they should never be able to win,” Trump said.

The most-favored nation policy could also be vulnerable on regulatory grounds because the administration skipped straight from a regulatory draft to an interim final rule, even though an intermediate proposal was under White House review for more than a year. Legally, an agency has to find that it has “good cause” to issue a final rule without first publishing a proposed rule.

“PhRMA is considering all options to stop this unlawful onslaught on medical progress and maintain our ability to win the fight against COVID-19,” said Pharmaceutical Research and Manufacturers of America President and CEO Stephen Ubl.

President-Elect Joe Biden has not expressly endorsed international reference pricing plan like Trump is proposing, but Biden has advocated for an independent board to assess fair prices for drugs without competition. Those assessments would include pricing data from other countries.

“I hope they have the courage to keep it, because the powerful drug lobby, Big Pharma, is putting pressure on people like you wouldn’t believe,” Trump said Friday, though he has not conceded that he lost the election.

Friday was the last business day the Trump administration had to ensure the regulations it is issuing take effect before Inauguration Day.

Drug rebate reform

The Trump administration also moved forward with a policy prohibiting pharmacy benefit managers frfom retaining rebates paid by drugmakers. This rule applies to the Medicare Part D program.

Insurers and pharmacy benefit managers have balked at the policy, as it would expose the amounts of rebates they receive from drugmakers and redistribute money they use to keep premiums steady.

The final rule would go into effect in 2022.

Drugmakers support and have actively lobbied for rebate reform, but pharmacy benefit managers said they would sue to stop the rule from taking effect.

“PCMA will explore all possible litigation options to stop the rule from taking effect and destabilizing the Medicare Part D program that millions of beneficiaries rely on,” said Pharmaceutical Care Management Association President and CEO JC Scott.

America’s Health Insurance Plans also criticized the proposed rebate reform and said it would take action to try to reverse the policy.

Congress could also gain scored savings from trying to stop the policy, Spatz said.

What Amazon’s Big Pharmacy News Means For US Health Care

A printed insert from PillPack announcing that “Amazon Pharmacy” will now be listed on medications.

Source: Vox, by Dylan Scott

Amazon and American health care look, at first glance, like a mismatch. Yet the 21st century’s most ruthlessly efficient retailer has been trying for several years now to gain a bigger foothold in the bloated, borderline nonsensical health system of the world’s richest nation.

Which is why whenever Amazon makes a new health care maneuver, like the company’s recent announcement that prescription drugs would be sold through its flagship website at a discount for Prime members, the same question inevitably gets asked: Is Amazon coming to disrupt health care?

The short answer is no. At least, not yet.

Amazon bought PillPack, an online pharmacy, two years ago with an eye toward making a move like this: integrating the pharmacy business into its monolithic online store. PillPack gave Amazon the licenses to operate a pharmacy in almost every state, and the vision was always that you would eventually be able to fill a prescription for your blood pressure drug at the same time you were shopping for … everything else you buy on Amazon.

On its face, the recent news is an incremental step. Amazon Pharmacy is now just one more pharmacy to choose from, alongside Walgreens, CVS, and the like. Some people might get drugs more cheaply thanks to discounts being offered through Prime, but most will still use their health insurance plan and pay the same amount they would anywhere else. This is bad news for some specialty businesses, namely GoodRx, but the major pharmacy chains aren’t going anywhere anytime soon.

But Amazon surely isn’t finished expanding its health care portfolio. The latest pharmacy play is a chance for the company to get a better idea of what it takes to run a pharmacy business — to handle the logistical and administrative challenges — before it takes another step. The rest of the sector has been put on notice.

“They’re buying information. They’re making an investment to gain some information to figure out whether it’s worth it to make a much bigger investment,” Craig Garthwaite, who studies health care economics at the Kellogg School of Management at Northwestern University, told me. “This might not work, but they would never figure out if they can be a major player without being a minor player first.”

What Amazon Pharmacy can offer patients

Amazon Prime members, of which there are nearly 120 million in the United States, will enjoy two major benefits through Amazon Pharmacy. They can get medications delivered for free within two days and they qualify for discounts, up to 80 percent off generics and up to 40 percent off brand-name drugs, that might allow them to buy drugs on their own for a cheaper price than they could get using their insurance benefits.

(As for people who don’t have Prime or can’t afford it, it would seem they are cut out of these deals, another example of the fundamental inequities in America’s health care system that Amazon is not going to fix.)

The company has already built a slick interface that allows people to enter the last four digits of their Social Security number and pull up their insurance benefits. When people go to check out with their prescription, the website will show insured customers two prices: one with their insurance benefits, one with the Prime discount. For certain generic drugs especially, the Amazon price is going to be cheaper even for people with insurance. For the uninsured, they will now get easy access to discounts on their prescriptions.

“Amazon is offering simplicity, which is something they’re really good at,” Garthwaite said.

From a business strategy standpoint, this is a pincer movement that allows Amazon to gobble up more of the retail pharmacy business, where patients typically use their insurance, and more of the discount drug cottage industry that has grown to offer uninsured patients with rebates similar to, if usually smaller than, what insured patients enjoy. PillPack also catered primarily to patients with chronic conditions, who need the same medications every month. Amazon Pharmacy could expand the company’s reach to capture the one-off prescriptions people receive when they get the flu or have an injury.

The company already has a storage-and-shipping infrastructure on which to build this new venture. There are some obvious pitfalls that Amazon will want to prepare for. For example, some insured patients who opt not to use their benefits and instead take the company’s discount might be annoyed to find out that their purchase didn’t count toward their health insurance plan’s deductible. Who gets the blame in that scenario, the insurer or Amazon? They’ll also want to expand their counseling services so people can get questions about their prescriptions answered, though that is the kind of service that PillPack is already experienced at providing.

So at bottom, the current version of Amazon Pharmacy looks like a natural extension of the 2018 PillPack purchase. The bigger question then is what comes next.

“For now, I think they are just going to be replacing existing market share,” says Stacie Dusetzina, a health policy professor at the Vanderbilt University School of Medicine. “But they may decide at some point to be more disruptive once they have gotten settled into this new space.”

What the future for Amazon’s health care business might look like

The Amazon news is most immediately a threat to GoodRx, which offers discounts on prescription drugs for uninsured and underinsured patients. Amazon is now proposing the same service, with all the brand loyalty and retail convenience that comes with its name. In a note to investors, UBS Research analysts called Amazon “a significant competitive threat” to GoodRx. The company’s stock price plummeted 20 percent after Amazon announced its news.

The major pharmacies, like CVS and Walgreens, have been anticipating a move like this for some time. Both already offer discount cards and free delivery, essentially the same service that Amazon is now offering. But they do face a risk if Amazon becomes particularly adept at the online pharmacy business.

Garthwaite identified two ways in which the company could build on the current service and potentially absorb an even bigger share of prescription drug sales. First, it would need to figure out cold storage. Biologics that treat rheumatoid arthritis or cancer and need to be handled sensitively require special storage and transportation.

The other, related question is whether they could reduce delivery times from two days to same-day or even two hours. Imagine going to a doctor, who writes a prescription for you and sends it to Amazon, and the medication is delivered to your door on the same day, all without your having to step inside a brick-and-mortar pharmacy.

“That actually sounds like a compelling product at that point,” Garthwaite said.

And Amazon could use that superlative convenience paired with its newly established relationships with health insurance plans to start competing more directly with the major pharmacy chains. It might vie to be labeled a “preferred” pharmacy by health plans, which reduces the out-of-pocket obligation for patients.

Over the long haul, Amazon might even become experienced enough with pharmacy benefits to start administering them itself, creating a new competitor for pharmacy benefits managers (PBMs). The recent mergers of health plans and PBMs may limit the company’s ability to make those inroads. Health insurers won’t be eager to cooperate with a new competitor for one of their other lines of business. But that doesn’t mean Amazon won’t give it a try.

Can Amazon unlock lower drug prices? That looks less likely. Existing companies like GoodRx already offer the same kind of discounts on drugs Amazon is now proposing. The major PBMs already command huge market shares — Caremark, Express Scripts, and Optum alone make up 75 percent of the entire market — that give them significant leverage in their negotiations with drug manufacturers. Amazon can take some of their business, but they’re already operating at such a scale that the online retailer won’t have much of an advantage if it tries to bargain for lower prices.

At least not yet. This should be treated as a trial period for Amazon. Company CEO Jeff Bezos is known to be unafraid of failure. A different venture into employee medical clinics struggled to gain traction, but that didn’t stop Bezos from making the investment to test out the concept.

It may be that Amazon will have the same problems scaling up its pharmacy business. But the company also clearly sees an opportunity for growth. The potential for future disruption is baked into this business proposition.

“While this move may not really be the disruption to drug prices that people were hoping for, Dusetzina told me, “it may give Amazon the experience they need in this space to make a bigger move in the future.”

After Two COVID-19 Exposures, Newsom And His Family Will Quarantine Until Dec. 5

Gavin Newsom takes the oath of office

Source: Los Angeles Times, by Taryn Luna

Gov. Gavin Newsom and his family will spend Thanksgiving in quarantine after his children were exposed in two separate incidents to someone who tested positive for COVID-19, cases that the governor said Monday prompted an informal lockdown of his Fair Oaks estate over the weekend.

During a midday news conference from his home office, Newsom said everyone in his family, including the children’s au pair, has tested negative for the virus.

“When we discovered, rather we were told, of the positive case and the fact that the CHP officer was in close contact with those three kids, we immediately went through the process and protocols and reviews that are well established by the state, and also went to greater lengths to get more specificity about local guidelines as well,” Newsom said.

The governor has worked from home since learning late Friday that three of his children were exposed to an infected member of the California Highway Patrol, which provides a security detail for Newsom, his wife Jennifer Siebel Newsom and four children ages 4 to 11. One of his children had already been placed in quarantine at home after coming into contact with a private-school classmate with the virus, his office said.

The Newsom family quarantine comes amid a surge in COVID-19 cases across California, with officials reporting record-breaking numbers. The news of the exposure continued to raise questions about the governor’s personal life during the COVID-19 pandemic following recent criticism over his decision to attend a Napa Valley birthday dinner at an upscale restaurant earlier this month with several high-profile Capitol lobbyists.

The governor’s office said Friday night that one of Newsom’s children was exposed to a classmate with the virus at the children’s Sacramento private school, which resumed in-person instruction this month. Newsom’s team did not immediately disclose the exposure from the CHP officer and instead waited to announce the family-wide quarantine until after test results came back negative Sunday evening.

The California Highway Patrol declined to provide the number of officers in the first family’s detail who have tested positive for the virus since the pandemic began, citing “privacy concerns and legal requirements.” The agency also declined to say how many officers assigned to the Capitol have become infected.

Newsom didn’t directly answer a question Monday about whether he had any second thoughts about his children attending school in-person. He said the school decided that his child who was exposed to the other student with the virus would need to quarantine.

The governor also said that “no one else is in the household,” other than his family and an au pair who has been working and “living with us for many many months” and is “part of the pod.”

Jesse Melgar, a spokesman for Newsom, said the first family’s two-week quarantine period will end on Dec. 5.

Astra-Oxford Vaccine Found Effective in Preventing Covid

Staff at CSL are working in the lab on November 08, 2020 in Melbourne, Australia. where they will begin manufacturing AstraZeneca-Oxford University COVID-19 vaccine.

Source: Bloomberg, by Suzi Ring and Naomi Kresge

A Covid-19 vaccine developed by the University of Oxford and AstraZeneca Plc prevented a majority of people from getting the disease in a large trial, another promising development in the quest to end the pandemic, and the rollout could begin next month.

The vaccine stopped an average of 70% of participants from falling ill, an early analysis of the data show. The effectiveness rose to 90% for one of two regimens, using half a dose followed by a full one later, close to the high bar set by Pfizer Inc. and Moderna Inc.

Astra and Oxford officials said they’re preparing to submit the findings to regulators and don’t expect the different outcomes in the study to affect the process. The U.S. could potentially take longer to sign off because a clinical trial in that country will need more time before it delivers results.

“Our goal was to make sure we can have a vaccine that is accessible everywhere,” Andrew Pollard, who is leading the Astra-Oxford trials, said Monday at a press briefing. “I think we have actually managed to do that.”

The results, based on trials in the U.K. and Brazil, were reviewed after 131 participants contracted Covid-19. The full two doses showed an efficacy of 62%. Among those who received the vaccine, there were no severe cases and no participants were hospitalized. The group is planning to submit the data for peer review in the next 24 hours.

Astra shares dropped as much as 4.2% in London, losing ground after some analysts questioned the data, including the fact that the subset of the trial showing 90% efficacy included fewer patients. The stock is still up about 30% since mid-March, but Moderna and Pfizer shares surged when they reported their results.

Ruud Dobber, head of Astra’s biopharmaceuticals business, said in an interview with Bloomberg Television that it’s too early to speculate about how regulators will react.

Moderna shares rose 1.7% and Pfizer was down 1.1% at 11 a.m. in New York.

The larger U.S. Astra trial, which could be key for approval there, has injected about 10,500 people with both doses. Mene Pangalos, Astra’s head of biopharma research, told reporters the team is planning to talk to the U.S. Food and Drug Administration immediately and hopes to have another arm administering the half dose-full dose regimen starting within weeks.

“That scenario is possible,” that other regulators could move before the U.S., he said. “We need to share the data with the FDA, which we will do very quickly, and then we will work out what the most appropriate steps are.”

Despite the apparently lower efficacy than shots from Pfizer and Moderna, which each prevented about 95% of cases, the British vaccine has some advantages. Their shot can be kept at refrigerator temperatures, while those from Pfizer and Moderna, based on novel messenger RNA technology, require freezing for longer-term storage and transport. That would make Astra’s easier to deploy globally, particularly in lower- and middle-income countries. It also comes at a lower cost.

The Astra-Oxford team cautioned against comparing the efficacy levels of the vaccines too closely at this stage. Pam Cheng, who runs Astra’s global operations and is overseeing the manufacturing of the vaccine, said the half dose-full dose regimen shouldn’t affect global production or supplies of the shot, other than to potentially increase the number of doses available.

AstraZeneca expects to have more than 300 million doses ready to ship globally by the end of the first quarter of next year, with about 100 to 200 million doses being produced monthly. For the U.K., the company expects to have up to 4 million doses ready by year-end, and 40 million by the end of the first quarter.

The differing results of the two regimens may leave questions about the best way to give the AstraZeneca shot. Analysts at Barclays Plc had put consensus expectations for what would be deemed a success from AstraZeneca at 70% to 90%, following conversations with investors in Europe and the U.S.

AstraZeneca said it will immediately prepare to submit data to authorities around the world that have a framework in place for early approval. The company said it will seek an emergency use listing from the World Health Organization for an accelerated pathway to vaccine availability in low-income countries.

Vaccine developers will not know how long any protection lasts for a number of months as they monitor antibody levels to see how quickly they fade. U.K. and European Union regulators are conducting accelerated reviews of the results from both Astra and Pfizer, which has applied for an emergency use authorization in the U.S.

Astra and Oxford have been among the fastest-moving vaccine developers. After years spent working on a vaccine against Covid’s relation Middle East Respiratory Syndrome, Oxford’s scientists had an advantage that allowed them to move quickly to create a shot.

“I have little doubt that this vaccine is going to have a big impact globally,” Astra’s Pangalos said.

FDA Allows Emergency Use Of Antibody Drug Trump Received

Source: Associated Press, by Marilynn Marchione

U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month.

The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms.

The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions.

Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said.

Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV.

Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to uncontrolled spread of the virus.

Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory help the body start to fight the virus right away.

The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied.

There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own.

FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises.

In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks.

The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients.

The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars.

Amazon Expands Push Into Health Care With Online Pharmacy

Amazon Expands Push Into Health Care With Online Pharmacy - BloombergSource: Bloomberg, by Angelica LaVito and Matt Day

Amazon.com Inc. unveiled its biggest push into selling prescription drugs with the launch of a digital pharmacy and discounts for paying U.S. Prime members that sent shock waves through shares of drugstore chains and distributors.

The e-commerce giant on Tuesday unveiled Amazon Pharmacy, a section of its retail website and mobile application that lets people order medication. Shoppers can pay using their health insurance. Prime members who don’t use their insurance are eligible for discounts on generic and brand-name drugs on Amazon’s site or at about 50,000 participating pharmacies.

Amazon’s new offering comes more than two years after its $753 million acquisition of PillPack, an online pharmacy known for organizing prescriptions into packets. This expansion puts the Seattle-based e-commerce company into more direct competition with pharmacy giants CVS Health Corp. and Walgreens Boots Alliance Inc., the two largest chains in the U.S.

CVS shares fell as much as 8.5% in early trading in New York, while Walgreens Boots dropped as much as 10.3%. GoodRx Holdings, a digital prescription-drug platform, fell 15% at 9:55 a.m. Drug distributor Cardinal Health Inc. lost as much as 9%, and rival McKesson Corp. slid as much as 6.8%.

The move also helps Amazon compete with Walmart Inc. and other big-box stores that already sell prescription drugs.

Analysts have long expected Amazon to dive deeper into health care in a bet the company can bring its digital real estate and logistical prowess to bear on a roughly $4 trillion industry in the U.S. with a reputation for inefficiency. The company rattled drug retailers with its PillPack acquisition, but Amazon has been slow to integrate the online pharmacy startup into its offerings.

The announcement Tuesday marks the first time that shoppers can order prescription drugs directly on Amazon. Previously, they were redirected to PillPack’s website. An integrated pharmacy removes one of the few gaps in Amazon’s offerings compared with major big box and grocery rivals, some of whom have long filled shoppers’ prescriptions in the same stores where they sold flat-screen televisions or cans of soup.

The discounts are a clear play for people who pay for their medications with cash, whether they are uninsured or are looking to save money. Strong demand for transparency and better deals have helped fuel the rise of discount card programs like GoodRx Holdings Inc. Amazon will display both the price when using insurance and the price without. Infusing transparency into a system that has been frustratingly opaque for consumers could alter the supply chain.

“We designed Amazon Pharmacy to put customers first – bringing Amazon’s customer obsession to an industry that can be inconvenient and confusing,” said TJ Parker, vice president of Amazon Pharmacy and co-founder of PillPack.

Amazon’s push comes as consumers are shunning stores and ordering more items online, a trend the coronavirus pandemic has accelerated. With consumer behavior shifting, chain drugstores have already started rethinking their strategies. CVS acquired health insurer Aetna for $68 billion in 2018 and is adding more health services to its stores. Walgreens is dabbling with numerous partnerships to add items like groceries and mobile phones to its stores.

Amazon could find it difficult to quickly pry away customers from pharmacy chains. For many consumers, asking doctors to steer recurring prescriptions elsewhere is cumbersome, especially for those who rely on insurance to pay for their medication.

In some cases, such a switch might also require an office visit — at a time when Americans have been steering clear of the doctor’s office out of concerns about the pandemic. And the ubiquity of the biggest pharmacy chains means most consumers have one nearby, and shopping at them is an ingrained habit.

Amazon’s entry into a market doesn’t guarantee its dominance. Drugstores have long insisted that patients prefer to talk to their pharmacist at the counter, an experience Amazon will try to recreate digitally.

Amazon Chief Executive Officer Jeff Bezos has positioned Prime, Amazon’s paid membership program, at the center of the company’s efforts to create loyal customers. What was originally an unlimited shipping program has grown in recent years to include video streaming, games and digital storage, and discounts at Amazon-owned Whole Foods Market.

Who Will Be The First To Get COVID-19 Vaccines?

Source: Associated Press

Who will be the first to get COVID-19 vaccines?

No decision has been made, but the consensus among many experts in the U.S. and globally is that health care workers should be first, said Sema Sgaier of the Surgo Foundation, a nonprofit group working on vaccine allocation issues.

An expert panel advising the U.S. Centers for Disease Control and Prevention is also considering giving high priority to workers in essential industries, people with certain medical conditions and people age 65 and older.

Once a vaccine gets a green light from the Food and Drug Administration, the panel will look at clinical trial data on side effects and how people of various ages, ethnicities and health statuses responded. That will determine the panel’s recommendations to the CDC on how to prioritize shots.

State officials are expected to follow the CDC’s guidance as they distribute the first vaccines.

Vaccine supplies will be limited at first. There won’t be enough to protect everyone, yet getting the shots to the right people could change the course of the pandemic.

Many other questions about distribution remain unanswered, Sgaier noted, such as whether to distribute shots equally across the country, or to focus on areas that are hot spots.

Pfizer To Start Pilot Delivery Program For Its COVID-19 Vaccine In Four U.S. States

Reuters

Source: Reuters, by Staff

Pfizer Inc PFE.N has launched a pilot delivery program for its experimental COVID-19 vaccine in four U.S. states, as the U.S. drugmaker seeks to address distribution challenges facing its ultra-cold storage requirements.

Pfizer’s vaccine, which was shown to be more than 90% effective in preventing COVID-19 based on initial data, must be shipped and stored at -70 degrees Celsius (minus 94°F), significantly below the standard for vaccines of 2-8 degrees Celsius (36-46°F).

“We are hopeful that results from this vaccine delivery pilot will serve as the model for other U.S. states and international governments, as they prepare to implement effective COVID-19 vaccine programs,” Pfizer said in a statement on Monday.

It picked Rhode Island, Texas, New Mexico, and Tennessee for the program after taking into account their differences in overall size, diversity of populations, immunization infrastructure, and need to reach individuals in varied urban and rural settings.

The four states will not receive vaccine doses earlier than other states by virtue of the pilot, nor will they receive any differential consideration, Pfizer said.

The company expects to have enough safety data on the vaccine from the ongoing large scale late-stage trials by the third week of November before proceeding to apply for emergency use authorization (EUA).

Pfizer and its partner BioNTech SE 22UAy.F have a $1.95 billion deal to supply 100 million doses of the vaccine to the U.S. government, which has an option to acquire up to an additional 500 million doses.

Earlier on Monday, rival Moderna Inc MRNA.O said its experimental vaccine was 94.5% effective in preventing COVID-19 based on interim data from a late-stage trial, boosting hopes that vaccines against the disease may be ready for use soon.

Both the Pfizer and Moderna vaccines use a new technology called synthetic messenger RNA to activate the immune system against the virus.

Last Updated 11/25/2020

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