Atea: Favorable Phase 1 Results for Covid med

High Lung Levels of Active Triphosphate Predicted with Oral AT-527 for COVID-19 Patients

Data Supportive of AT-527 550 mg BID Dosing Regimen

Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (“Atea”), a clinical-stage biopharmaceutical company, today presented results from the Phase 1 study of AT-527 in healthy volunteers at the 28th Annual Conference on Retroviruses and Opportunistic Infections (CROI) in a Science Spotlight presentation. AT-527 is an orally administered, direct-acting antiviral developmental agent derived from Atea’s purine nucleotide prodrug platform and is in Phase 2 clinical development for the treatment of COVID-19. AT-527 targets SARS-CoV-2 ribonucleic acid (RNA) polymerase (nsp12), a highly conserved gene which is responsible for both viral RNA replication and transcription. Given this preferential conserved target site, it is anticipated that the antiviral activity of AT-527 will continue even in the presence of naturally-evolving variants which are now emerging.

https://finance.yahoo.com/news/atea-pharmaceuticals-presents-favorable-phase-120000023.html 

How some Philly apartment buildings got their residents COVID vax

 Management at Philadelphia’s luxury Parc Rittenhouse sent residents of the complex the link to register for vaccine appointments at the massive new site operated by FEMA at the Pennsylvania Convention Center. Appointment invitations were intended to go only to certain essential workers, and the link was not meant to be shared by those who received it.

In the email sent to residents Monday in which he shared the link, Parc Rittenhouse building manager Jeffrey Webb also wrote that the building will be “arranging for a local pharmacy to schedule a vaccination clinic on site shortly.”

When contacted by WHYY News, Webb declined to comment. It’s not clear how many residents in the 266-unit building were able to schedule appointments through the link for the FEMA clinic.

The city has said it purged hundreds of unauthorized sign-ups coming from people who were not eligible. Nowhere on the sign-up sheet were eligibility requirements outlined, and the Department of Public Health has said it is working on a technical fix to prevent future links from being shared with unintended recipients.

Parc Rittenhouse was developed by City Councilmember Allan Domb, who owns a dozen units in the building and sits on the condo board. Domb said that he wasn’t aware of the email, but that anything going around should have included the city’s prioritization scheme, which the Parc Rittenhouse message did not.

Domb has been a staunch proponent of mass vaccination sites in Philadelphia, pushing the Kenney administration to open one at Lincoln Financial Field. He criticized the administration for placing too much emphasis on partnerships in the vaccine rollout and not operating out of a centralized city system, which Domb said would give the Health Department a better handle on equity and volume of distribution.

“We went into this process providing to third-party providers the vaccines,” Domb said. “We hoped and prayed they would do the right thing. Many did, a few did not. You can’t give up control — you need to control it.”

The Parc Rittenhouse communication is part of the latest trend in the mad scramble for COVID-19 vaccines: Apartment buildings and condo associations across Philadelphia are arranging vaccinations for their residents. In many instances, health officials and experts view this as a good thing: It increases access for seniors and other high-risk groups that may have trouble seeking out the vaccine on their own. But trusting vaccine providers to determine eligibility outside of city control also leaves the door open for the most vulnerable people to get skipped over.

The city Health Department is encouraging pharmacies and other vaccine providers to partner with community groups, including apartment and condo buildings, to distribute the vaccine where it’s convenient for people to get them, especially if many residents are seniors and may have mobility issues. Department spokesman James Garrow said it’s incumbent on the vaccine providers to make sure the doses are going only to those who are eligible.

“Our agreement with them is they can vaccinate whomever they want, wherever they want, as long as they’re following the current prioritization scheme,” said Garrow.

Right now, that means people in Phases 1A and 1B: health care and other essential workers, those with chronic conditions, and those living in congregate care settings.

The trouble is some apartment complexes are interpreting all of their residents to be eligible, regardless of age or health status, by virtue of living in “congregate care” settings. That designation is not intended for private residences such as apartments, Garrow confirmed. Instead, it’s meant to refer to prisons, homeless shelters, drug and alcohol treatment centers, psychiatric facilities, rehabilitation centers, and specialized services housing.

https://www.american-apartment-owners-association.org/covid-19/latest-news/how-some-philadelphia-apartment-buildings-are-getting-their-residents-covid-19-vaccines

More Money Without Reform for Obamacare

 On February 27^th, the House of Representatives voted 219 to 212 to pass the American Rescue Plan Act.  As part of $1.9 trillion in omnibus spending, the bill represents congressional Democrats’ first serious attempt to amend the Affordable Care Act since that reform went into effect.  The legislation would provide additional funds to entice holdout states to expand Medicaid to able-bodied adults and would expand subsidies for individuals to purchase plans from the ACA’s exchanges.  Yet, recent research suggests that the proposed increase in subsidies might do more to inflate health insurance premiums than to reduce costs for enrollees.

The enthusiasm for Medicare for All in the Democratic presidential primary owed much to popular disappointment with the Affordable Care Act.  In his 2008 campaign for the presidency, Barack Obama had promised “affordable, universal health care for every single American” and to “lower premiums by up to $2,500 for a typical family per year.”

Yet, while the ACA extended Medicaid coverage to 12 million additional Americans, its reforms to insurance markets rules have proven to be counterproductive.  By requiring insurers to price plans without regard to pre-existing medical conditions, the legislation encouraged many Americans to wait until they developed major medical risks before signing up.  This caused the average medical needs of those enrolled to soar, and forced plans to raise premiums, hike deductibles, and tighten networks, in order to stay in business.

As a result, average premiums on the individual market more than doubled from 2013 to 2017.  For 2020, a family of four must pay premiums averaging $17,244 and an additional deductible of $7,767 before the plan covers major medical expenses.  Households headed by older adults, or those in relatively expensive states, may pay even more. 

The individual market has been anchored by the presence of subsidies which expand as necessary to guarantee a defined benefit at a limited share of income to low-to-middle-income Americans.  While the number of subsidized enrollees in ACA plans has held steady since 2014 at just over 8 million, unsubsidized enrollment has plummeted from 9.4 million to 5.2 million.

In the spirit of the proposal made by Joe Biden during his presidential campaign, House Democrats have sought to patch the ACA by expanding subsidies for the purchase of plans.  They propose to do so firstly by expanding eligibility for subsidies to households with incomes more than four times greater than the federal poverty level and secondarily by expanding the generosity of subsidies to which enrollees would be entitled.

The proposed bump in subsidies would remain in effect for only two years; but congressional Democrats will likely seek to make it permanent in a future round of legislation.  According to the Congressional Budget Office, the proposal would cost $22 billion in 2022 – an increase of roughly a third on the amount currently spent on subsidies for the exchange.  CBO estimates that this would reduce the number of Americans uninsured by 1.3 million (out of 30 million).

With health insurance premiums at their current levels, enrollees are exposed to much greater costs than the ACA’s authors initially anticipated.  The House proposal attempts to remedy this with a simple infusion of federal funds.  Yet, it might do less to reduce individuals’ premiums than they might imagine, because even though premiums remain high, they will not exceed the 8.5% of income needed to make many middle-to-upper income individuals eligible for these additional subsidies.  

Nonetheless, the interaction of the subsidies with the ACA’s age band provision (which allow insurers to vary premiums threefold according to policyholders’ age) might still entitle older enrollees to significant subsidies.  A recent study by Brian Blase of the Galen Institute noted that a 60-year old heading a family of four with an income of $159,000 would become eligible for premium subsidies of $15,868 under the proposal.  Instead of simply targeting subsidies at the poor and the uninsurable, the ACA’s “community rating” regulations have artificially inflated the premiums imposed on healthy potential enrollees, which in turn has produced a grievance and demand for subsidies for people who would have no need for them in an actuarially priced market. 

ACA supporters argue that such subsidies may indirectly serve to reduce premiums across the board, by attracting a healthier pool of enrollees into the market.  Yet, the health insurance market they have engineered is not so straightforward.  An increase in the generosity of subsidies also serves to reduce the price sensitivity of plan enrollees.  Maria Polyakova of Stanford University and Stephen Ryan of Washington University in St Louis have estimated that more than half of the value of subsidies is captured by insurers.  The further expansion of subsidies proposed by House Democrats, which would entitle millions to plans costing $0 post-subsidy, would likely generate an additional windfall for insurers.

As the open-ended nature of ACA subsidies already invites cost increases through commitments to increase subsidies proportionately, establishing $0 premium plans and removing the cap on eligibility for subsidies might eliminate much of the incentive for pricing restraint that remains.  With most enrollees shielded from plan cost increases at the margin, insurers and medical providers could conspire with state legislators to increase the cost of insurance at the expense of the federal deficit.  This dynamic is no mere supposition, but already occurs with the practice of silver-loading – by which insurers work hand in hand with state regulators to manipulate benchmark premiums for the sake of claiming greater federal subsidies.

Whatever good the ACA has done to reduce the problem of uninsurable high-risk individuals being unable to afford insurance coverage is the result of the subsidies that the legislation has made available.  Yet, the House proposal moves beyond providing a subsidized safety net for the uninsurable, to provide subsidies for individuals who ought to have no problem purchasing actuarially priced insurance in return for trapping them in an uncompetitive and overpriced exchange.   

It is reasonable for Democrats to want to reduce the cost of ACA plans for enrollees, and increased subsidies in some cases might be appropriate.  But if Congress should not keep throwing more and more money at an inflationary ACA market without limit.  Instead, it need to think more about pairing increases in subsidies with reform, and an expansion in the choice of competitively-priced alternatives.

Chris Pope is a senior fellow at the Manhattan Institute

https://www.realclearhealth.com/articles/2021/03/03/more_money_without_reform_for_obamacare_111175.html

Backlash against J&J COVID-19 vaccine is real and risky

 More than 50 million Americans have received at least one dose of either the Pfizer or Moderna COVID-19 vaccine. So far, Americans have been largely brand-agnostic, but that’s about to change as a new vaccine rolls out.

The Johnson & Johnson vaccine has been hailed as a game changer. It requires only a single dose rather than two doses spaced weeks apart, and it does not need freezer storage, making it a natural fit for hard-to-reach rural areas and underserved communities with limited access to health care and storage facilities.

But while many people are excited about the prospects of only one shot, the new vaccine is also getting backlash. Part of that is coming from lack of clarity about the vaccines’ efficacy numbers, and part of it is more nuanced. On March 2, the U.S. Conference of Catholic Bishops urged Catholics to avoid the Johnson & Johnson vaccine because it uses lab-grown cells that are clones of fetal tissue from abortions in the 1980s.

If states don’t plan carefully for how the vaccines are distributed, the result could be a nightmare of frustrated patients and wasted vaccine.

As experts specializing in health care operations, data analytics, and supply chain management, we have been analyzing COVID-19 vaccine rollout policies. While our research shows there is great promise for the one-dose vaccine, we believe biases against the Johnson & Johnson vaccine cannot be ignored in planning and distribution decisions.

The problem with comparing efficacy numbers

The primary factor complicating acceptance of the Johnson & Johnson vaccine is in the top-line number: It has an efficacy level of 66%, while the other two U.S.-authorized vaccines, made by Pfizer and Moderna, have efficacy levels of at least 90%.

Trying to compare those numbers is tricky, though. Experts are quick to point out that the clinical trials were conducted at different times – Pfizer and Moderna conducted their trials before several other mutated variants had been reported, whereas Johnson & Johnson’s trials were conducted after that. Consequently, Johnson & Johnson has clinical trial data to show its vaccine can work effectively against variants first reported in the U.K., South Africa and Brazil.

In terms of preventing severe disease, hospitalization, and death, the Johnson & Johnson vaccine is comparable to the Pfizer and Moderna vaccines. With continued shortage of vaccine supply, individuals and vaccinators should take any one of the three vaccines whenever they are available so that they can get sufficient protection sooner.

Yet, the sheer difference in the top-line numbers makes it difficult to look away. According to a February 2021 Centers for Disease Control and Prevention survey, when offered the choice between a two-dose COVID-19 vaccine, either Pfizer or Moderna, and a one-dose vaccine, Johnson & Johnson’s, nearly 60% of the respondents preferred the two-dose vaccine and only 7% preferred the one-dose vaccine. Among those who preferred two-dose vaccines, 72% said they were willing to wait a month for it rather than get the one-dose vaccine now.

Such biases can have real consequences. In the European Union, 80% of the COVID-19 vaccine doses made by AstraZeneca – which also has lower reported efficacy and isn’t authorized in the U.S. – were sitting on the shelves. Many people, including some clinicians, reportedly believe it to be inferior to the Pfizer vaccine.

Four strategies for a successful rollout

A one-dose vaccine would be ideal for hard-to-reach rural areas and underserved communities. Meatpacking companies have reached out to officials in North Carolina, for example, and the state plans to target agricultural workers. But distributing only the Johnson & Johnson vaccine now could compound the already deep-seated vaccine hesitancy in some regions.

Policymakers must acknowledge these fears and develop a plan. Here are four strategies for creating as smooth a rollout as possible.

1) Let people know which vaccine they will be getting when they book the appointment. That can avoid people rejecting vaccines at the distribution site, which leads to wasted appointment time slots and potentially wasted vaccine doses. When only the two mRNA vaccines were available, many states did not reveal the vaccine brand when offering appointments, and the public largely perceives the two as interchangable products.

2) Have each vaccination site focus on one type of vaccine, either the Johnson & Johnson vaccine or the Pfizer or Moderna two-dose vaccines to avoid confusion for recipients. Separating vaccine offerings can respect people’s legitimate preferences and avoid last-minute cancellations. Operationally speaking, focusing on a single type of vaccine also simplifies the administration process and prevents handling errors.

3) The Johnson & Johnson vaccine is suitable for small-scale and mobile vaccination sites in rural areas and underserved communities, as well as individuals. However, health officials can help avoid some backlash if they ensure people are offered the option to travel a reasonable distance to larger vaccination sites that offer the Pfizer and Moderna vaccines. Letting people make informed decision can avoid public mistrust.

4) Instead of avoiding comparing the three vaccines, public health experts should be more transparent in educating the public about the effectiveness of the Johnson & Johnson vaccine. For example, the single-dose vaccine is believed to be 100% effective in preventing hospitalizations and deaths from COVID-19.

The Johnson & Johnson vaccine is a strong boost to the COVID-19 vaccination effort in the U.S. However, it may well lead to frustration and waste if vaccine planners don’t prepare for potential biases against this new vaccine. The focus should be to leverage the three vaccines to achieve herd immunity rapidly so that the U.S. can finally leave the prolonged pandemic behind.

Tinglong Dai

Associate Professor of Operations Management & Business Analytics, Johns Hopkins Carey Business School, Johns Hopkins University School of Nursing

Christopher S. Tang

Distinguished Professor and Edward W. Carter Chair in Business Administration, University of California, Los Angeles

Ho-Yin Mak

Associate Professor in Management Science, University of Oxford

https://theconversation.com/backlash-against-johnson-and-johnsons-covid-19-vaccine-is-real-and-risky-heres-how-to-make-its-rollout-a-success-156494

FDA Approves Yescarta® for Relapsed or Refractory Follicular Lymphoma

 -- Yescarta is the First CAR T-Cell Therapy Approved for Indolent Follicular Lymphoma; Approval Marks the Third Indication for a Kite Cell Therapy --

-- 91 Percent of Patients Responded to Yescarta, and Median Duration of Response Was Not Yet Reached in the ZUMA-5 Trial --

Kite, a Gilead Company (Nasdaq: GILD), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to Yescarta® (axicabtagene ciloleucel) for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The approval makes Yescarta the first chimeric antigen receptor (CAR) T-cell therapy approved for patients with indolent follicular lymphoma, follows FDA Breakthrough Therapy Designation and a priority review, and marks the third approved indication for a Kite cell therapy.

The approval is based on results from ZUMA-5, a single-arm, open-label study in which 91 percent of patients with relapsed or refractory FL (n=81) responded to Yescarta, including an estimated 74 percent of patients in a continued remission at 18 months (Kaplan-Meier estimate). Among all FL patients, median duration of response was not reached at a median follow-up of 14.5 months. In the safety analysis set (n=146), Grade 3 or higher cytokine release syndrome (CRS) and neurologic toxicities occurred in 8 percent and 21 percent of patients, respectively.

“Once a follicular lymphoma patient’s disease relapses, the duration of response to care shortens with each round of therapy,” said Caron A. Jacobson, MD, MMSc, Medical Director, Immune Effector Cell Therapy Program, Dana-Farber Cancer Institute and Assistant Professor of Medicine, Harvard Medical School. “Additionally, for follicular patients in the third line of therapy, the five-year survival rate is only 20 percent, highlighting the urgent need for treatments that offer a real chance for durable remission. Impressively, 91 percent of follicular lymphoma patients in the ZUMA-5 study responded to a single infusion of axicabtagene ciloleucel, including an estimated 74 percent of patients in a continued remission at 18 months, giving these patients much-needed hope and oncologists an important addition to the treatment armamentarium.”

http://investors.gilead.com/news-releases/news-release-details/us-fda-approves-yescartar-relapsed-or-refractory-follicular

U.S. scientists doubtful of one-shot regimen for Pfizer, Moderna COVID vaccines

 U.S. scientists are skeptical of a one-shot regimen for Pfizer Inc and Moderna Inc COVID-19 vaccines, saying there isn't enough evidence that a single dose provides long-term protection, the Wall Street Journal reported here.

“It is essential that these vaccines be used as authorized by FDA in order to prevent Covid-19 and related hospitalizations and death,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the Journal.

https://www.reuters.com/article/us-health-coronavirus-vaccine-fda/u-s-scientists-doubtful-of-one-shot-regimen-for-pfizer-moderna-covid-vaccines-wsj-idUSKBN2AY0ON

Adaptive Bio Gets FDA Emergency Use Authorization for T-Detect™ COVID

 First and only clinical T cell-based test for patients to detect the unique T-cell signature specific to SARS-CoV-2, the virus that causes COVID-19

T-Detect COVID correctly confirmed recent or prior COVID-19 infections 97.1% of the time from date of RT-PCR diagnosis with 100% specificity

Adaptive Biotechnologies Corporation (Nasdaq: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, today announced that the U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for T-Detect™ COVID to confirm recent or prior COVID-19 infection. This first-in-class T cell- based test is the first indication resulting from Adaptive’s TCR-Antigen Map collaboration with Microsoft (Nasdaq: MSFT).

“We are proud to receive FDA Emergency Use Authorization for T-Detect COVID, the first indication in an entirely new class of tests that use T cells in the blood to detect disease. People who have been unsure about a prior infection will now have another way to know if they had the virus,” said Chad Robins, chief executive officer of Adaptive Biotechnologies. “The authorization of T-Detect COVID represents a true breakthrough for patients and a pivotal milestone for the diagnostic testing paradigm. We have proven that it is possible to read how T cells detect disease in the blood, and this is just the beginning of a pipeline of tests for many other indications.”

https://finance.yahoo.com/news/adaptive-biotechnologies-announces-fda-emergency-234400010.html