New strains set in to Covid-19 plans, lingo — A plea to providers: Stop stockpiling shots — States struggle with vaccine disparities

From: POLITICO's Prescription Pulse - Tuesday Feb 02,2021 05:03 pm
Presented by CVS Health: Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
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By Sarah Owermohle

Presented by CVS Health

With David Lim, Brianna Ehley and Emily Martin

On Tap

— New strains set in to Covid-19 plans, lingo as WHO discusses terminology and the U.S. braces for surges.

— A plea to providers: Stop stockpiling shots. Federal officials urge providers to move second doses.

— States struggle with vaccine disparities in bumpy coronavirus shot rollouts.

It’s Tuesday, welcome back to Prescription Pulse. Important question: How is it already February? Explain the passage of time and send me pharma tips at sowermohle@politico.com or @owermohle. Loop in David Lim (dlim@politico.com or @davidalim) and Brianna Ehley ( behley@politico.com or @briannaehley).

A message from CVS Health:

Our health care system is under unprecedented strain. Through it all, CVS Health has been there. We’re nearly 300,000 employees ensuring millions of Americans can access health care services. We’ve opened thousands of COVID-19 test sites and administered millions of tests. Now, we’re providing the vaccine in long-term care facilities. We’ve been on the frontlines, making health care easier to access and afford.

 
Coronavirus

THE VARIANT FORMERLY KNOWN AS B.1.351? The World Health Organization is drawing up new lingo for Covid-19 variants first found in South Africa, the United Kingdom and Brazil that present new challenges to officials working to curb spread and vaccinate millions, Maria Van Kerkhove, Covid-19 Technical Lead for the World Health Organization, said Monday.

“We're working on the nomenclature. It's too confusing with these variant names. I am on record multiple times to say we need to fix this because it's too hard to communicate all these numbers,” Van Kerkhove said during a CSIS event about the variants.

Those strains could dominate future news. Vaccines appear to be less effective against the one found in South Africa; meanwhile the strain found in Brazil raises the specter of reinfection. And British officials say the strain that surged there — now found across the U.S. — is more transmissible and possibly more deadly.

Health experts have long warned that the virus will adapt and spread, but these variants present big challenges at a crucial juncture in the race to vaccinate hundreds of millions of people across the world.

It leaves federal health officials resorting to basic measures like mask-wearing, reinforcing social distancing rules and urging against travel. You’re forgiven if this talk feels like déjà vu: Health officials know it too.

“People are fatigued. That's the other major global challenge we have right now,” said Van Kerkhove. “People are tired, they want this to be over. I do too...But this virus is not sick of us.”

These measures might be the best we have. Vaccine makers are hard at work to develop booster shots aimed at new variants and possibly multi-valiant vaccines that, much like flu shots, tackle multiple strains.

In the meantime, public health measures are still the best shot according to multiple experts and health officials. But it’s easier said than done.

“We’re really good at pumping the brakes after we’ve wrapped the car around the tree,” Michael Osterholm, a University of Minnesota infectious disease expert who advised Biden on the pandemic during the transition, told POLITICO Friday.

A PLEA TO PROVIDERS: STOP STOCKPILING VACCINE--The Biden administration is advising health care providers across the country against holding back doses of Covid-19 vaccines, amid reports that hospitals are reserving limited supply to ensure that patients receive second doses, Brianna Ehley writes.

Andy Slavitt, a senior adviser to the White House's Covid response team, said during Monday’s White House Covid-19 briefing that providers should be confident that there will be a steady supply of doses and that stockpiling "does not need to happen and should not happen."

Slavitt's remarks come as the Biden team tries to accelerate the pace of vaccinations and get a better hold on the whereabouts of roughly 19 million doses that were shipped but not yet administered.

Roughly 50 million vaccine doses have been delivered but just 31 million have been given out so far. Slavitt said the distribution effort created a backlog of doses that have been sitting in states. He said that issue was also exacerbated by inconsistent information states had previously been receiving from the federal government about how much vaccine they would receive each week.

BIONTECH TARGETS 2 BILLION VACCINE DOSES IN 2021 — Pfizer’s German partner BioNTech said Monday it plans to make 2 billion doses of its coronavirus vaccine in 2021 due to upgrades at a Pfizer production facility in Belgium. That adds to manufacturing at its German plant and a growing number of partners in its European manufacturing network, David Lim writes.

“[W]e will supply the full quantity of vaccine doses in the first quarter we contractually committed to and up to an additional 75 million doses to the European Union in the second quarter,” BioNTech’s SEC filing states.

BIDEN ADMIN SIGNS $232 MILLION DEAL FOR ELLUME TESTS — HHS and the Defense Department announced Monday the federal government will spend $231.8 million to acquire 8.5 million over-the-counter, at-home coronavirus tests from Ellume and establish domestic manufacturing of the rapid tests.

“Making easier to use tests available to every American is a high priority with obvious benefits,” Slavitt said during the White House briefing. “The ability to quickly test, to contact trace and quarantine is a linchpin of our national strategy and will be a vital part of containing the virus and stopping community spread,” he added.

This has been in the making for months. Former HHS testing czar Brett Giroir told POLITICO the government spent months negotiating with Ellume — in part because the department decided it wanted to buy tests, not just invest in domestic manufacturing capacity. The goal of federally procuring Ellume's test, he said, was part of an effort to ensure that not just Americans that could afford the approximately $30 test would have access to it.

It is unclear when exactly the 8.5 million new tests will be delivered, but Ellume said it will be “prioritizing” the partnership with the U.S. government, David writes.

 

Designed specifically for regulatory affairs professionals - AgencyIQ FDA Forecast 2021: In its inaugural year, AgencyIQ's FDA Forecast predicts the FDA regulatory changes that will take place in 2021 and what they will mean for the life sciences industry. Read more about the report and download the summary here.

 
 
Drug Pricing

BIDEN POSTPONES REBATE RULE — The administration this weekend postponed the Donald Trump plan to eliminate rebates that drugmakers pay to pharmacy benefit managers. The rule, originally slated for the beginning of 2022, would go into effect a year later under the agreement.

The decision comes as Biden staff want to review the rule, according to the PBM lobby, the Pharmaceutical Care Management Association. The district judge who announced the order gave PCMA and the health department until this April to submit a joint status report on how the rule might proceed.

One of Trump’s last stands in the fight to slash drug costs, the rebate rule was backed by pharmaceutical companies but disparaged by pharmacy benefit managers and insurers who argued it took away their leverage to negotiate on costs. Drugmakers say that rebates contribute to price increases because they need to continue paying the fees to secure medicines’ places in payer coverage.

 

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Pharma in the States

STATES STRUGGLE TO ADDRESS VAX DISPARITIES — Black and Latino Americans are falling behind in the nationwide race to get vaccinated against Covid-19, even in blue states and localities praised for championing racial equity during earlier phases of the pandemic, POLITICO’s Tucker Doherty and Joanne Kenen write.

The demographic data is limited. The country has that information for just about half of the doses given so far. But among those? Just five percent have gone to Black Americans and only 11 percent were given to Latino recipients, according to the Centers for Disease Control and Prevention.

A POLITICO analysis of the available data suggests the disadvantaged and underserved communities are being bypassed, including in those states that have not yet publicly broken out data by race and ethnicity.

This is a crucial early test for Biden who has promised to tackle racial inequity and even named advisors specifically focused on health disparities. But it takes more than good intentions, write Tucker and Joanne.

“In the absence of a mandate, our natural drift is to inequity,” said Debra Furr-Holden, a public health expert at Michigan State University who serves on the state’s coronavirus racial disparities task force.

 

TRACK FIRST 100 DAYS OF THE BIDEN ADMINISTRATION: The Biden administration hit the ground running with a series of executive orders his first week in office and continues to outline priorities on key issues. What's coming down the pike? Find out in Transition Playbook, our scoop-filled newsletter tracking the policies, people and emerging power centers of the first 100 days of the new administration. Subscribe today.

 
 
Pharma Worldwide

BIONTECH ENLISTS NOVARTIS TO HELP MAKE VACCINE — Novartis said Friday it has signed an initial agreement to provide Covid-19 vaccine manufacturing support to Pfizer and its German partner BioNTech. If a final agreement is reached, Novartis says it will begin manufacturing at its factory in Stein, Switzerland, in the second quarter of 2021. Shipments of finished vaccine would begin in the third quarter.

Novartis says it is in “advanced discussions” with other companies about assisting with aspects of Covid-19 drug and vaccine manufacturing, such as making mRNA, therapeutic proteins and raw materials.

“We expect this to be the first of a number of such agreements,” Novartis head of technical operations Steffen Lang said in a statement.

A message from CVS Health:

Throughout the COVID-19 pandemic, in communities all across the country, CVS Health has been delivering essential care.

Thanks to the efforts of our employees, we’ve opened 4,700 COVID-19 test sites since March and administered over 10 million tests at our stores and through partners in underserved communities.

With millions staying home, we are increasing access to prescription delivery, virtual visits and mental health services.

Now, we’re providing vaccines in long-term care facilities.

Every day, CVS Health works to bring quality, affordable health care into neighborhoods, homes and hands—so it’s never out of reach for anyone.

That’s health care, from the heart.

 
Pharma Moves

Kevin Fu is headed to FDA to serve as the agency’s first acting director of medical device cybersecurity, the University of Michigan announced Monday.

Quick Hits

Roughly 1,500 people in a late-stage trial for the AstraZeneca and Oxford University vaccine were given the wrong dose and not told about the mistake, Reuters exclusively reported.

Andrew Brooks, a research professor at Rutgers University who developed the first saliva test for the coronavirus, died this month, The New York Times reported.

Japan, the world’s third-largest pharmaceutical market, is struggling to start a Covid-19 vaccine program after a 2016 report warned of such a lack of preparedness — forcing the nation to reexamine public health priorities, global cooperation and readiness, The Washington Post reported.

Experts say Joe Biden’s goal of ramping up Pfizer and Moderna’s vaccine production will be difficult because the shots use delicate mRNA and require special expertise and machinery to produce, ABC News reported.

Viagra’s humanized marketing was unique when it was introduced in the 1990s. The approach is becoming more popular for pharmaceutical brands, but humanizing health care in a post-Covid world may be more complicated, MedCity News reported.

Document Drawer

Rep. Katie Porter (D-Calif.) released a report alleging that large pharmaceutical companies buying up small firms, such as Immunex, are stifling innovation and competition, seen through declining R&D and new patents.

Biden signed an executive order that directed CMS to reopen a special enrollment period for healthcare.gov from February 15 until May 15.

 

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Sarah Owermohle @owermohle

 

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