What’s Going on with Booster Shots?

There’s been a lot of discussion about COVID-19 booster shots lately – so much so, that it’s hard to keep track of who can get booster shots and what kind of booster shots are available.  Here, we provide a lay of the land on booster shots.

Why are booster shots necessary?  Booster shots provide an extra “boost” to immunity through an additional dose that cues the immune system to produce a stronger antibody response.  While all three currently approved vaccines from Pfizer, Moderna, and Johnson & Johnson are highly effective in protecting against hospitalization and death, a growing number of studies show that vaccine efficacy gradually wanes over time. 

Who can get booster shots now?  Pfizer’s COVID-19 vaccine is the only vaccine that is currently authorized by the Food and Drug Administration (FDA) to be used as a booster dose.  The FDA formally amended the emergency authorization use (EUA) for the Pfizer vaccine on September 22.  According to the amended EUA, the following people are eligible for booster shots at least six months after their initial series of shots:

  • People over age 65.
  • People ages 18 to 64 at high risk of severe COVID-19 due to chronic medical conditions or compromised immune systems.
  • People with greater risk of workplace exposure, such as frontline medical workers, teachers, and emergency responders.

More booster shots are on the way.  The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted during an October 14-15 public meeting to recommend booster doses from Moderna and Johnson & Johnson. The panel recommended the Moderna booster be administered under the same criteria as Pfizer’s – six months after the second dose for people over 65, individuals at risk for serious complication from COVID-19, and essential workers.  However, the panel recommended broader criteria for the Johnson & Johnson booster – it said anyone who received the single dose Johnson & Johnson vaccine should be eligible to receive a second booster dose at least two months later

  • Why? Several studies have shown the Johnson & Johnson vaccine is less effective that other currently approved shots, particularly against new variants like Delta.

What happens next: The CDC Advisory Committee on Immunization Practices (ACIP) will meet on October 20-21 to offer its recommendations on who should get the Moderna and Johnson & Johnson booster shots.  Its recommendations are subject to a final decision from the CDC director.  Afterwards, the FDA could officially authorize booster shots from both companies in the following days. 

The conversation on booster shots hasn’t been without controversy.  Over the past few months, scientists, researchers, and public health officials within the federal government haven’t seen eye-to-eye on when booster shots should become available, and who should get them. 

  • For example, CDC Director Rochelle Walensky partially overruled ACIP last month when the panel initially declined to offer booster shots for essential workers under 65 who do not have chronic medical conditions.  Some ACIP members said that without additional data, they weren’t comfortable automatically allowing younger people to get boosters just because of their jobs.  While Walensky acknowledged the panel’s uncertainty, she said in a statement that CDC must use “imperfect data” to “take actions that we anticipate will do the greatest good.”
  • There are also ethical considerations as billions worldwide remain unvaccinated.  While many public health experts believe people with chronic health conditions should get additional shots, they feel extra doses should be allocated to countries with low vaccination rates first in order to prevent more dangerous variants from developing. 

The administration’s internal disputes have been quite apparent to the public.  Back in August, President Biden announced a plan to start distributing booster shots to all eligible Americans as soon as September 20.  However, the health care agencies tasked with rolling out boosters have taken a more conservative approach, and one month later after Biden’s original deadline, only certain segments of the population have access to one vaccine booster.   

With limited information and uncertainty about the future of the virus, administration officials are between a rock and a hard place.  On one hand, federal officials don’t have enough data to make definitive decisions on who needs a booster and how much a booster would improve efficacyOn the other hand, the administration knows it can’t wait for definitive findings to become available, especially if case number surge once again in the next few months as colder temperatures drive more Americans indoors.

At the end of the day, COVID-19 is still a novel virus, and there are many unanswered questions on how long protection from vaccines last and how much that protection varies between different groups of people.  While new data on vaccines will continue to gradually become available, federal health officials will have to continue discussing and weighing the risks and benefits of authorizing vaccines in the US.   

Collins Leaves Big Shoes to Fill at NIH

Francis Collins announced plans to retire from his role as Director of the National Institutes of Health (NIH) on October 5.  This is a big deal for the Biden administration, as this leaves another crucial leadership position vacant, as the administration still has not nominated a Commissioner for the Food and Drug Administration (FDA).

Brief background: The Staunton, Virginia native first came to NIH in 1993 to serve as Director of the National Human Genome Research Institute, a role he held for 15 years.  Under his leadership, the institute made landmark discoveries of disease genes and contributed to the international Human Genome Project, which for the first time fully mapped all genes of the human genome.  Collins was later nominated to lead NIH under then-President Barack Obama and was confirmed by the Senate in 2009.

Why is he retiring?  Even though a public health emergency is still ongoing, Collins told reporters that his “hour-to-hour oversight” is no longer as necessary now that three vaccines are out and case numbers are declining nationwide.  According to reports from Politico, Collins initially wanted to quit last winter, but National Institute of Allergy and Infectious Diseases (NIAID) Director Anthony Fauci convinced him to stay on a little while longer.

It wasn’t a spur of the moment decision.  Collins said he had been thinking about retirement for the past 3-4 months.  By making the decision now, Collins hopes to facilitate a smooth transition for the next NIH director.

Who’s taking over?  Principal Deputy Director Lawrence Tabak, number two at NIH, is most likely to serve as acting director in the interim.  But it’s unclear if he’s in the running for the top job – Collins said in an October 5 interview that he wants a woman to succeed him.  The only certainty is that Fauci won’t be the next NIH director – he’s already said no to the role.

Whoever takes over will have big shoes to fill.  During his decade-plus at the helm of NIH, Collins:

And whoever becomes the next NIH director has plenty of challenges to look forward to, including:

  • Leading the agency though the next (and hopefully final) phase of the pandemic.
  • Shaping the development of the Advanced Research Projects Agency, or ARPA-H.
  • Overseeing clinical trials for COVID-19 treatments.
  • Defending the administration’s public health policies and handling of the  pandemic on Capitol Hill. 

It’s also worth noting that Francis Collins is a bit of a Renaissance man.  Here are some of his other accomplishments outside of leading the world’s largest medical agency.

Collins won’t be the NIH director anymore, but he isn’t leaving NIH.  In fact, he’s planning to return to his laboratory at the National Human Genome Research Institute. 

What Employers Need to Know About the New Vaccine Mandate

The White House says it’s time for the unvaccinated to roll up their sleeves.  To help boost vaccination rates as the Delta variant continues to take its destructive toll across the nation, President Biden laid out a new COVID-19 action plan with some new requirements for private businesses.

How it works: The Biden administration is directing the Occupational Safety and Health Administration (OSHA) to develop a rule that will require all private sector employers with 100 or more employees to ensure their workforce is fully vaccinated and require any unvaccinated workers who remain unvaccinated to show a negative test result at least once a week.  Furthermore, the administration says it will require private employers to provide paid time off for employees to go get vaccinated.  OSHA will issue the rule through an emergency temporary standard (ETS) that will take effect immediately upon publication in the Federal Register.

This requirement is expected to impact 80 million workers in the private sector.  

Can OSHA do this?  OSHA has the authority to issue an ETS if it’s been determined that:

  1.  “Employees are exposed to grave danger from exposure to substances or agents determined to be toxic or physically harmful or from new hazards,” and
  2. The ETS is “necessary to protect employees from such danger.” 

Remember: OSHA mandated that certain health care workers be vaccinated via an ETS issued in June 2021.

And yes, the mandate is constitutional.  In 1905, the Supreme Court ruled 7-2 to uphold a $5 fine for failing to be vaccinated against smallpox in Jacobson v. Massachusetts.  According to the high court, an individual cannot deprive his or her neighbors of their own liberty by allowing the spread of disease.

What happens next? White House Coronavirus Response Coordinator Jeffrey Zients said on September 10 that the ETS will be drafted “over the coming weeks.”  This means OSHA will release the rule much sooner than the ETS for health care workers, which was in development for six months before being published in June of this year. 

What employers should do.  While OSHA spends the next few weeks developing an ETS, private businesses can do several things to be prepared.

  • Plan for potential costs, including the cost of testing and time off to be tested.
  • Prepare processes to collect vaccination information.  Put in place a system to request, collect, and maintain vaccination information, and designate a group of employees to verify evidence of vaccination status.
  • Create a testing policy.  Figure out whether your organization will offer on-site testing to workers, allow workers to self-administer tests at home, or get tested by a third party.
  • Consider a mandatory vaccine policy that goes further than the ETS and allows your business to forgo the weekly testing option. 
  • Prepare for accommodation requests for employees who do not want to be vaccinated for health or religious reasons.

Prepare for enforcement.  OSHA inspections can be conducted without notice, and the agency has a robust system in place to handle whistleblower-style complaints from employees.

Get ready for lawsuits. The debate over vaccine mandates won’t end after the ETS is issued.  Arizona became the first state to file a lawsuit against the administration on September 16, and 24 Republican state attorneys general threatened to take legal action in a September 16 letter.  Still, employers should continue preparing for the new ETS as OSHA continues to move forward full steam ahead.

What Happened, What You Missed: September 20-24

Walensky Overrides CDC Advisory Panel, Approves Booster Doses for At-Risk Workers

Late Thursday, Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky  took the unusual step of overriding a recommendation from the Advisory Committee on Immunization Practices (ACIP) on whether adults aged 18-64 with frequent exposure to the virus should receive a COVID-19 booster shot.  While ACIP members felt there is not enough data to show that boosters are necessary for at-risk workers like nurses and teachers, Walensky said providing boosters for these individuals would help the US prepare for the “next stage in the pandemic.”  She also pointed out that the decision would align the CDC with an FDA decision made earlier this week on boosters for high-risk workers.  Walensky did however approve other recommendations made by ACIP to allow individuals over age 65 and people with chronic health conditions to receive a third booster dose.

Pfizer Releases Vaccine Data for Kids, J&J Posts Booster Shot Data

Pfizer announced on September 20 that a two-dose regiment of its COVID-19 vaccine administered three weeks apartment generated a strong immune response in children aged 5-11, according to topline results from a phase 2/3 clinical trial.  The trial used a third of the vaccine dose that is currently approved for people 12 and older.  Pfizer plans to file the full results to the FDA soon, teeing up an emergency use authorization for children within the next several weeks.  The following day, Johnson & Johnson announced that a second “booster” dose of its single-dose COVID-19 vaccine generated a strong immune response.   

House Advances Doomed Appropriations, Debt Ceiling Bill

On September 21, the House approved legislation to fund the federal government through December 3, 2021 and suspend the debt ceiling through December 22, 2022.  The combined appropriations-debt ceiling bill, which passed on a 220-211 party line vote, could be considered in the Senate as soon as Monday, September 27.  However, the measure is certain to fail in the upper chamber due to a lack of support from Republican Senators.  Instead, Republicans are urging Democrats to pass a debt ceiling suspension by attaching it to the human infrastructure package , which Democrats say is not possible due to “parliamentary obstacles.”  Government funding expires on October 1, while Treasury Secretary Janet Yellen says the government could begin to default on its debt sometime next month.

CMS Final Rule Extends Open Enrollment, Boosts User Fees

In its third part of its 2022 Notice of Benefit and Payment Parameters rule, the Center for Medicare and Medicaid Services (CMS) finalized proposals to extend the open enrollment deadline for Affordable Care Act (ACA) plans through January 15, 2022 and create a new monthly special enrollment period geared toward low-income individuals.  The final rule also increases the user fee for 2022 to 2.75% for insurers in the federally run exchange and 2.25% for state-based exchanges..  According to CMS, the user fees are intended to support consumer outreach activities, including the Navigator program.

ICYMI: Capitol Fence Goes Up, Capitol Fence Goes Down

Metal fencing that was erected in advance of a rally last Saturday went down almost as quickly as it came up.  The rally, which was organized to support the hundreds of people arrested for the January 6 riot, ultimately attracted more law enforcement and news media than actual protestors.  Work crew began to disassemble the fencing on Sunday afternoon, and by Monday afternoon, the fencing was completely gone.

How a New HHS Office Wants to Tackle Climate Change…and Public Health

The Biden administration means business on climate change.  As its latest climate-friendly move, the administration formed the Office of Climate Change and Health Equity (OCCHE) on August 30.  What does this new office mean in the fight against rising global temperatures?

About OCCHE

The mission of OCCHE is to advocate for environmental justice and equitable health outcomes and use the regulatory and statutory powers of HHS to fight climate change.  OCCHE will:

  • Address health disparities made worse by climate change.
  • Identify communities vulnerable to climate change.
  • Promote training opportunities to build the climate and health workforce.
  • Advance research on the public health benefits of addressing climate change.

Go deeper:  Biden laid out his vision in a January 27 Executive Order on Tackling the Climate Crisis at Home and Abroad.

Why it matters:  The health care industry accounts for 8.5% of the country’s carbon emissions. Climate change disproportionately impacts on vulnerable populations, making sick patients ever sicker.  Thus, health care stakeholders should take seriously OCCHE’s intention to collaborate with business and industry groups for environmental justice and health equity outcomes.  HHS Secretary Xavier Becerra predicted OCCHE “will become a permanent fixture within HHS.”

The Most Important Public Health Issue of Our Time

OCCHE’s Interim Director Dr. John Balbus, formerly of the National Institute for Environmental Health Science referred to climate change as the “most important public health [issue] of our time.”  Yet, the administration’s Fiscal Year 2022 budget request for HHS only allocates $6 million for OCCHE.  Additionally, Mataka said the office could issue new regulations or guidance, although OCCHE is unlikely to engage in regulatory action until it develops more knowledge about the relationship between climate change and wellness.

The Climate Change/Public Health Connection

The underlying causes of climate change – transportation, food, socioeconomic systems – are virtually the same as the underlying causes of health disparities.  Climate change has also shown to be more impactful on disadvantaged communities, including low-income individuals, the elderly, and people with chronic illnesses.  While the Biden administration is trying to address climate change on a large scale, they are sending a clear message by establishing OCHHE that the federal government has a specific role in protecting the health of vulnerable populations due to climate change.  In turn, the administration is expecting health care providers to step up and examine their own role in contributing to climate change.  Further actions that OCCHE and other public health organizations may take on include gathering data on climate-related health behaviors, analyzing the health impact of climate-related policies, and studying the health benefits of reduced carbon emissions.

What Happened, What You Missed: September 6-10

Biden Announces Sweeping Vaccination Mandate for Health Care Workers

On September 9, President Joe Biden announced plans to mandate vaccinations for all health care workers at facilities that receive federal funding.  The announcement was a major component of a six-part planned aimed at addressing a nationwide surge in COVID-19 cases.   The vaccination mandate for health care workers is an extension of last month’s announcement on vaccination requirements for nursing home employees.  Biden also announced plans to require all federal employees to get vaccinated and require employers with 100 or more employees to mandate COVID-19 vaccines.  He further urged schools to use previously allocated funding to expand COVID-19 testing and called for an international summit on the global response to the COVID-19 pandemic.

HHS Releases Report on Proposals to Address High Drug Prices

On September 9, the Department of Health and Human Services (HHS) released a comprehensive plan to reduce drug prices in response to a July 9  Executive Order on Promoting Competition in the American Economy.  The report was initially released to members of Congress on August 23 but not made public until yesterday.  Among the report’s chief proposals is allowing the HHS secretary to negotiate Medicare Part B and Part D drug prices directly with pharmaceutical manufacturers and make those prices available to other purchasers.  The report also calls for promoting biosimilars and generics to foster competition and a cap on catastrophic spending under Part D.  Many of the report’s recommendations have already been included in Democrats’ $3.5 trillion Build Back Better Act.

Speaker Pelosi Rebuffs Calls to “Pause” $3.5T Infrastructure Bill

Despite calls from Sen. Joe Machin (D-WV) to take a “strategic pause” to rework the $3.5 trillion “human” infrastructure bill, House Speaker Nancy Pelosi (D-CA) supported House members to continue holding hearings to mark up the legislative text this week. Both Manchin and his moderate Democratic colleague Sen. Kyrsten Sinema (D-AZ) have stated that they will not support a $3.5 trillion bill, with Manchin specifying he won’t back more than $1.5 trillion in spending.  During the week, the Education and Labor; Science, Space, and Technology; Small Business; Veterans Affairs; and Ways and Means committees have already marked up portions of the reconciliation bill relevant to their jurisdiction.

SCOTUS to Return to In-Person Arguments in October

On September 9, the Supreme Court announced it will return to hearing oral arguments in the court building starting next month.  Since May 2020, the Supreme Court has been holding oral arguments exclusively by telephone. The court building will remain closed to the public and access to the courtroom will be limited to the Justices, certain Supreme Court personnel, and journalists with press credentials.  However, live audio feeds for those unable to sit in the courtroom will continue

ICYMI: Fencing Returns to US Capitol

Metal fencing will be reinstalled around the US Capitol as a security precaution ahead of a planned rally on September 18.  The rally is expected to feature far-right activists protesting the treatment of those arrested in connection with the January riot at the US Capitol.  Fencing was initially erected around the US Capitol immediately following the January 6 riot before finally being removed in July.  To prepare for the rally, Speaker Nancy Pelosi (D-CA) has been holding briefings with congressional leadership on security preparations. However, the US Capitol Police has so far decline to comment on or confirm the fencing and other security measures.

What Does Health Care Rulemaking Look Like This Year?

Even Congress tries to complete $4.5T in domestic policy changes plus appropriations in the next 3 months, the Biden Administration is cranking away on health care rulemaking.  Here’s a quick overview of some key rules on the horizon from the Department of Health and Human Services (HHS).

Go deeper:  Refresh your memory on OMB and rulemaking here.

Below are the health care rules currently under review at www.reginfo.gov.  At the moment, the public is unable to comment on the any of the rules listed until their publication in the Federal Register.

TitleCategoryTypeStatus
Streamlining HHS
Guidance Practices
Internal HHS PolicyProposed RuleReceived at OMB on
6/28/21
Reporting Requirements Related to Air
Ambulance and Agent
and Broker Services and HHS Enforcement
Provisions
InsuranceProposed RuleReceived at OMB on
7/7/21
Establishing
Over-the-Counter
Hearing Aids and
Aligning Other
Regulations
Medical DevicesProposed RuleReceived at OMB on
8/18/21
Medicare Coverage of
Innovative Technology (MCIT) and Definition of “Reasonable and
Necessary”
MedicareProposed RuleReceived at OMB on
8/27/21
Securing Updated and Necessary Statutory
Evaluations Timely
Internal HHS PolicyProposed RuleReceived at OMB on
8/31/21
Premarket Tobacco
Product Applications
and Recordkeeping
Requirements
Tobacco ProductsFinal RuleReceived at OMB on
4/5/21
Format and Content of Reports Intended to
Demonstrate
Substantial Equivalence
Tobacco ProductsFinal RuleReceived at OMB on
4/5/21
Medical Device De
Novo Classification Process
Medical DevicesFinal RuleReceived at OMB on
6/28/21
Updating Payment
Parameters and
Improving Health
Insurance Markets for
2022 and Beyond
InsuranceFinal RuleReceived at OMB on
8/19/21

Don’t Be Caught “Surprised”

HHS has more rules coming out on the No Surprises Act

  • By October 1, the Biden administration is required to publish a rule on an audit process to ensure that plans and insurers are complying with the QPA calculation and requirement. 
  • By December 27, the administration must outline the details of an independent dispute resolution (IDR) process if providers and health plans fail to agree on an out-of-network rate.

Annual Payment Rules

Expected around late October/early November, CMS will post the final Medicare payment policies and reimbursement rates for FY 2022, including the Home Health Prospective Payment System, the Hospital Outpatient Prospective Payment System (HOPPS), and the Physician Fee Schedule. 

  • Stakeholders can still comment on the proposed HOPPS and Physician Fee Schedule at regulations.gov through September 13 and September 17, 2021, respectively. 

All eyes may be on Congress this fall as lawmakers work to finish FY 2022 appropriations, a $1.2T bipartisan infrastructure bill, and a $3.5T “human” infrastructure package.  However, keen observers would be remiss to ignore the Executive Branch, where forthcoming rulemaking will surely impact health care providers of all stripes.

What Happened, What You Missed: August 30-September 3

CDC Advisory Committee Takes More Cautious Approach on Boosters

Members of the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) agreed in an August 30 meeting that booster shots of COVID-19 vaccines should be prioritized for residents of long-term care facilities, followed by front-line health care workers.  While the advisory committee did acknowledge that booster shots could eventually be needed for the rest of the US population, the panel declined to endorse the White House’s strategy to make booster shots available to all adults who were eight months past the date of their final vaccine shot as soon as September 20.  While ACIP members did say they would meet at a later date to discuss whether boosters are necessary for the rest of the population, they did not say when.  Two days later, the Food and Drug Administration (FDA) announced that its vaccine advisory committee will meet on September 17 to discuss the necessity of booster shots.

New Report Pegs Date of Medicare Insolvency in 2026

According to the Medicare Trustees 2021 report, the Medicare hospital insurance trust fund is projected to become insolvent in 2026, which is unchanged from the previous year’s report.  While some experts had feared that the COVID-19 pandemic would exacerbate the program’s financial woes, the report found that spending for non-COVID care in late 2020 and early 2021 more than offset the cost of pandemic-related care throughout 2020.  However, the trustees noted in their report that there is still “an unusually large degree of uncertainty” regarding the impact of the pandemic.  On a related note, the report found the projected insolvency of the Social Security trust fund to be 2034 instead of last year’s estimated date of 2035.

HHS Establishes a New Climate, Health Equity Office

On August 30, the Department of Health and Human Services (HHS) established the Office of Climate Change and Health Equity in response to President Joe Biden’s Executive Order on Tackling the Climate Crisis at Home and Abroad.  The new office is tasked with addressing health disparities driven by climate change, developing requirements for providers to reduce carbon emissions, and offering training for the health care and climate workforce.  In a statement, HHS Assistant Secretary for Health Rachel Levine pointed out that many of the same communities disproportionately affected by the COVID-19 pandemic are likely to struggle the most with the effects of climate change.  Therefore, to find solutions and form initiatives, the office will partner with the health care sector, which accounts for 8.5% of the nation’s carbon emissions.

Census to Deliver User-Friendly Redistricting Data Two Weeks Early

The US Census Bureau announced on September 1 that it will release easier-to-use formats of the 2020 Census Redistricting Data on September 16, two weeks before an initially planned release on September 30.  While the bureau already released 2020 redistricting data on August 25, it was presented in a “legacy” format that requires additional steps before it can be processed, whereas, the data to be released on September 16 can be more quickly utilized by states to redraw their congressional maps ahead of 2022 midterm elections.  Also on September 1, the Department of Justice issued guidance for states on redistricting that promises enforcement of the Voting Rights Act, which prohibits congressional districts from being formed around membership in a racial or language minority group. 

ICYMI: Is the US Capitol Fence Coming Back?

According to reports, the US Capitol Police is considering if a perimeter fence needs to be restored around the US Capitol ahead of a planned September 18 demonstration, where members of far-right extremist groups are expected to rally in support of the people charged in connection with the January 6 riot.  A perimeter fence was installed immediately after the January 6 riot before being fully removed in July.   The Capitol Police Board are currently weighing several security plans for September 18 with some involving restoring the fencing and others taking different approaches. 

What Happened to the Cancer Moonshot?

In his final State of the Union address in January 2016, then-President Barack Obama asked then-Vice President Joe Biden to lead the Cancer Moonshot initiative, a new national effort to accelerate research in cancer treatment.  Over the past five years, however, attention on the Cancer Moonshot has seemingly waned to the point that it barely pops up in the national discourse on health policy.  Is the Cancer Moonshot still around, and if so, what has it even accomplished?

Background

The Cancer Moonshot is far from being the federal government’s first push to deliver new cancer treatments.  The National Cancer Institute (NCI) was first established in 1937 to support cancer research.  Incorporated within the National Institutes of Health (NIH) in 1944, NCI remains the oldest center and has the largest budget among the other 27 centers and institutes of NIH. Decades later, President Richard Nixon signed the National Cancer Act of 1971 into law, which provided NCI with more autonomy within NIH and authorized $1.6 billion in funding for NCI over three years.  Additionally, the Orphan Drug Act of 1983 spurred many pharmaceutical companies to invest in drugs to treat rare diseases like cancer. 

Beyond NCI,  the federal government has done little to invest large sums of money focusing on research into the prevention and treatment of cancer, which  has limited the progress in the war against cancer.  The overall death rate from cancer has only declined 5% since 1950, and new cancer drugs produced between 2003 and 2013 has only boosted overall survival by 3.4 months.  Given the technical and scientific difficultly of developing cancer treatments, a more concerted effort rather than a piecemeal approach may be necessary to deliver progress. 

How the Moonshot Got Started

Shaped by his oldest son’s death from brain cancer in 2015, Biden declared after the 2016 State of the Union that the goal of the Cancer Moonshot was to double the rate of progress towards a cure for cancer. Shortly thereafter, Biden convened a Cancer Moonshot Task Force that established a BlueRibbon Panel charged with outlining research priorities to help the new initiative meet its goals.  Comprised of clinicians, scientists, cancer patients, and advocates, the panel issued a report in October 2016 that established seven working groups to identify research opportunities and offer recommendations on how the Cancer Moonshot can support those opportunities.  Since then, Congress authorized the Cancer Moonshot through enactment of the 21st Century Cures Act in December 2016, which set up the initiative within NCI and provided $1.8 billion funding over seven years.  For FY 2021, the Cancer Moonshot was appropriated $195 million.

Progress So Far

The Cancer Moonshot initiative uses its funding to invest in research that aligns with the initiative’s key priorities, such as generation of human tumor atlases, expanded use of early detection strategies, and establishing a network for direct patient engagement.  According to a midpoint progress update issued in January 2021, the initiative has so far funded over 240 research projects and more than 70 cancer science programs.  The Cancer Moonshot cites over a dozen projects on its website that have yielded progress, including:

  • The Immuno-Oncology Translational Network, whose research has led to insights into ovarian cancers responses to immunotherapy and the use of immunotherapy in certain types of head and neck cancers.
  • The My Pediatric and Adult Rare Tumor Network, which has developed a pipeline for biospecimen collection/analysis rare cancers and established several new specialized rare tumor clinics around the country.
  • The Fusion Oncoproteins in Childhood Cancers Consortium, whose researchers have developed several novel cancer models to study rare cancers and have made significant advances in understanding how each fusion affects the protein’s function and localization in the cell.

Room for Improvement

However, some scientists say Cancer Moonshot has the potential to deliver on greater progress.  To achieve this, a group of scientists proposed early this year in Lancent Oncology, a “Cancer Moonshot 2.0” that can meaningfully improve outcomes for cancer patients with a “scaled up, redoubled, and accelerated” approach.  Among the research areas suggested by the group include:

  • New database formats to capture biological data.
  • Non-invasive liquid biopsy approaches that can be used to screen high-risk individuals to identify precancers and early cancers.
  • Machine learning innovations that link the molecular structure of cancer pathways to more specific and effective drugs.
  • New drug delivery systems that target specific cancer vulnerabilities, such as bispecific antibodies and nanotechnologies.

While the Cancer Moonshot is still alive and kicking, the initiative may not be subject to as much attention when it was first conceived in 2016, likely due to less-than-stellar advancements and the domination of other issues in the public health discourse.  As difficult as cancer research may be, a redoubling of efforts and additional funding could pave the way for new treatments that exemplify the term “moonshot.”

What Happened, What You Missed: August 16-20

Biden Administration Preparing to Make Booster Shots Available in September

On August 18, President Joe Biden announced his administration is preparing to offer a third dose of the Pfizer and Moderna mRNA vaccines by the week of September 20.  The administration wants the additional doses to function as a “booster shot” after new data has indicated that the efficacy of the Pfizer and Moderna vaccines decreases over time.  The administration also anticipates offering booster shots to individuals who received the single-dose Johnson & Johnson vaccine but is awaiting further information before making a final decision.  Before the administration can officially begin distribution of additional doses, the Food and Drug Administration and the CDC’s vaccine advisory committee must review and authorize booster shots.  The Biden administration’s decision has drawn criticism from health experts who say there isn’t sufficient data to justify booster shots, especially as most of the world’s population remains unvaccinated.

HHS to Mandate Vaccinations for Certain Long-Term Care Workers

President Biden also announced on August 18 that he is directing the Department of Health and Human Services (HHS) to require long-term care facilities to have their employees vaccinated in order to continue to receive funding from Medicare and Medicaid.  The announcement comes as vaccination rates for long-term care workers has lagged nationally, leaving elderly residents vulnerable to the virus.  According to data from the Centers for Medicare and Medicaid Services, just over 60% of nursing home staff is vaccinated, compared to nearly 83% of nursing home residents.  There have been mixed reactions from the nursing home industry regarding Biden’s announcement.  Both LeadingAge and the America Health Care Association (AHCA) have said the administration should require all health care workers to be vaccinated instead of singling out nursing homes, although LeadingAge does support requiring vaccination as a condition of employment for nursing home workers.  Additionally, AHCA has warned vaccination requirements could prompt some long-term care workers to flee to other industries.

KFF: Spending per Person for MA Enrollees Grew Higher, Faster Than Traditional Medicare

A report issued August 17 by the Kaiser Family Foundation (KFF) found the federal government spent $321 more per person for Medicare Advantage (MA) beneficiaries compared to those enrolled in traditional Medicare in 2019, resulting in an additional $7 billion in annual spending.  The report also found that spending per MA enrollee is growing faster compared to traditional Medicare, which could cause overall MA spending to double by 2029.  According to the report, several features of the MA payment system are contributing to rising costs, including how benchmarks for plan payments are set and the risk adjustment process.  The report’s release comes as the Biden administration looks to increase the solvency of the Medicare trust fund by reforming payments to privately managed plans like MA.

Pelosi Urges Moderate Democrats to Back $3.5 Trillion Budget Resolution

Speaker Nancy Pelosi (D-CA) sent a Dear Colleague letter to all House Democrats on August 17 urging the caucus to support passage of the $3.5 trillion Fiscal Year (FY) 2022 budget resolution when the House returns from recess on August 23.  Pelosi’s letter was a direct response to nine moderate House Democrats who in an August 13 letter threatened to block the FY 2022 budget resolution unless the $1 trillion bipartisan infrastructure bill is passed first.  In her Dear Colleague letter, the Speaker expressed that any delay in passing either measure could threaten a “once-in-a-generation opportunity” to enact policies that will help working families.

ICYMI: Washington Monument Closed after Lightning Strike

The Washington Monument remains closed after it was struck by lightning at 12:30 a.m. on August 15.  According to the National Park Service, the lightning strike damaged the monument’s electronic access system that operates the door and the elevators.  Work crews are waiting on parts before repairs can resume, and it remains unclear when the parts will arrive.  According to The Washington Post, lightning hits the Washington Monument several times a year, and last Sunday’s strike marks the second lightning hit in 2021. 

ARPA-H, the Proposed Agency to Transform Biomedical Research

The internet.  GPS.  The computer mouse.  These are some of the technological innovations made possible by the Defense Advanced Research Projects Agency (DARPA), a Defense Department agency tasked with advancing research and development of science and technology programs.  Now, the Biden administration wants to replicate DARPA’s success in biomedical research with a newly proposed entity called Advanced Research Projects Agency for Health (ARPA-H). 

What Is ARPA-H?

The Biden administration’s Fiscal Year (FY) 2022 budget request provided a $6.5 billion investment for APRA-H, which would be directed to drive “transformational innovation” in health research and speed application and implementation of health breakthroughs.  The initial focus of ARPA-H would be cancer, disabilities, and Alzheimer’s disease.  According to a concept paper provided by the White House, examples of projects that could be pursued by ARPA-H include:

  • mRNA vaccines to prevent most cancers.
  • Molecular “zip codes” that target drugs only to specific tissues and cell types, to eliminate serious side effects.
  • Highly accurate, inexpensive, wearable monitors for blood pressure and blood sugar that provide real-time data to patients and providers.
  • Holistic systems that eliminate racial disparities in maternal morbidity and mortality rates and premature births.
  • A process to design, test, and approve a vaccine against any newly emerging human virus in 100 days.

The National Institute of Health (NIH) further explains that ARPA-H will predominantly focus on “time-limited” projects with goals, metrics, and accountability.  It also states that the director of ARPA-H will be selected based on having a “proven innovation and partnership-building track-record,” and ARPA-H program managers will be recruited from industry, academia, or other sectors based on “scientific vision, judgement, and management skills.”

ARPA-H is also included in the Cures 2.0 discussion draft that was released by Reps. Diana DeGette (D-CO) and Fred Upton (R-CO).  However, the discussion draft is still a work in progress, and it contains far fewer details on the proposed agency than those provided by the Biden administration. 

How Would ARPA-H Advance Biomedical Research?

Ideally, ARPA-H would need many of the same authorities used by DARPA to accomplish its mission to delivery breakthroughs in biomedical research.  Key authorities would include:

  • The ability to hire individuals rapidly based on “a unique skill set” outside the typical civil services hiring system and pay those individuals a competitive wage, as well as the ability to recruit experienced program managers from the private sector. 
  • Broad, flexible funding authority that make it possible to mix and match the best ideas with minimal bureaucracy that allow for projects that can be funded for multiple years or don’t necessarily fit into one-year intervals.
  • Exemptions from the traditional review process for biomedical research, which can take up to 18 months or longer, to get from an idea to a scientific review before the actual work begins.

According to a July 26 Federal News Network interview with NIH Director Francis Collins, an ARPA-H with “some new authorities” could make a difference for experimental drugs that show a lot promise during clinical trials but fail to attract investment from pharmaceutical companies due to an experimental products being perceived as too risky or having a limited market share.  In these cases, Collins explained ARPA-H could chose to invest in certain experimental drugs and hand them over to the private sector when necessary.

The Structure of APRA-H

The Biden administration has stipulated that ARPA-H would be a “distinct division” within NIH, with a “unique culture and organization.”  However, some medical experts have argued ARPA-H should be a stand-alone entity within the Department of Health and Human Services (HHS), including a former chair from DARPA’s advisory committee, who suggested NIH’s approach to research and innovation is too time-consuming and bureaucratic.  In response, Collins told The Washington Post in mid-June that putting ARPA-H outside of NIH would be a big mistake because it would lead to “administrative duplications” and preclude the chance for ARPA-H program managers to develop synergy with their colleagues at NIH.  While the Cures 2.0 discussion draft has yet to define ARPA-H’s structure and home, Collins has said that DeGette and Upton are leaning towards having the new agency withing NIH.

Collins also threw cold water on the notion that ARPA-H could create internal jealously within NIH in his Federal News Network interview by countering that many NIH employees are excited about the prospect of a new research agency and that “unfriendly competitiveness” exists in other parts of the government.  It’s worth noting that the administration’s FY 2022 budget request includes a major increase in NIH funding rather than diverting away funds to create a new agency. 

Next Steps

APRA-H only becomes a reality when FY 2022 appropriations bills are signed into law, and the FY 2022 appropriations process has gotten off to a slow start.  The House passed an appropriations minibus for FY 2022 on July 31 that includes $3 billion for ARPA-H, while the Senate only began reviewing its FY 2022 spending proposals on August 2. , Notably, the proposals to create a new biomedical research agency been favorably viewed by members of both parties, meaning ARPA-H is unlikely to be cut from the legislation. However, given lawmakers’ slow progress on appropriations and long list of other items that require their attention in the next 60 days, all FY 2022 spending measures are unlikely to be finalized by the end of the FY 2021 on September 31.  This means NIH may not be able to take the first steps in building up ARPA-H until Congress finalizes the FY 2022 appropriations bills later in the fall or winter.

Once FY 2022 funding is squared away, Collins hopes to hit the ground running.  In his Federal News Network interview, the NIH director said he hopes to recruit 50-100 program managers for the agency’s first year, with results on research projects expected in the following one to two years as ARPA-H continues to “staff up and ramp up.”  Collins also projected to have 50-60 projects going at ARPA-H by the end of FY 2022, assuming all FY 2022 spending bills are enacted by December 2021.

What Happened, What You Missed: July 26-30

New CDC Guidance Say Vaccinated People Should Wear Masks Indoors

On July 27, the Centers for Disease Control and Prevention (CDC) issued updated guidance that advises fully vaccinated people to wear masks in “pubic, indoor settings” in counties with “substantial” or “high” levels of COVID-19 transmission.  The guidance also calls for all students, teachers, and staff at K-12 schools to wear masks, regardless of vaccination status.  CDC says it updated the guidance on masking in response to the high transmissibility of the Delta variant as well as new data that shows vaccinated people who catch COVID-19, but are asymptomatic, can spread the Delta variant just as easily as those who are unvaccinated.  Since the new guidance was released, several jurisdictions including Washington, DC and Chicago have issued new requirements for vaccinated individuals to wear masks when indoors. 

Biden Announces New Vaccinations and Testing Requirements for Federal Workforce

On July 29, President Joe Biden announced new requirements for all civilian federal employees, onsite contractors, and military servicemembers to be vaccinated or otherwise face regular testing, masking, and social distancing requirements.  Biden first hinted at a vaccine mandate for federal workers on Tuesday following the CDC’s announcement on its new masking guidelines for vaccinated people. However before his announcement, on Monday the Department of Veterans Affairs announced it will require its frontline health care workers to be vaccinated within eight weeks. 

Pfizer Says Vaccine Efficacy Wanes after 6 Months, Makes Case for Third Dose

On July 28, Pfizer released a new study that showed the overall effectiveness of its two-dose COVID-19 vaccine declined from 96% to 84% after six months.  Pfizer separately released data on Wednesday that found a third dose of its vaccine increases antibody levels against the Delta variant by nearly five times for people ages 18 to 55 and more than 11 times among people 65 to 85.  However, it remains unclear if higher antibody levels actually lead to better protection, and the CDC has stated that currently approved vaccines provide adequate protection against the Delta variant.  Pfizer also announced that it plans to seek emergency authorization use under the Food and Drug Administration for a third dose sometime in August.

Senators Reach Agreement on $550 Billion Infrastructure Package

On July 27, a bipartisan group of Senators reached agreement on a $550 billion infrastructure bill that would provide $550 billion in new spending for roads, bridges, rail transit, clean water, broadband internet, airports, and environmental clean-up.  The bill would be partially paid for by repurposing COVID-19 relief funds and delaying implementation of the Medicare Part D drug rebate rule.  Next, the Senate is expected to hold a vote on Friday and work through the weekend.  Progress on the bipartisan infrastructure bill means Democrats can now  move on and focus solely on their $3.5 trillion human infrastructure bill that they intend to pass through budget reconciliation. 

Former WY Sen. Mike Enzi Dies after Bicycle Accident

Former Wyoming Republican Senator Mike Enzi died on July 26 at age 77 due to injuries sustained from a bicycle accident just days before.  Enzi served as the Mayor of Gillette, WY and as a State Lawmaker before being elected to the Senate in 1996, where he would go on to serve four terms before retiring in 2020.  Known as one of the more conservative members of his party, Enzi served as Chairman of the Senate Budget Committee and Senate Health, Education, Labor and Pensions Committee.

ICYMI: Athletes from the Nation’s Capital Shine in 2020 Olympics

Aside from being home to our nation’s capital, the Washington, DC area is home to nearly a dozen members of the US Olympic Team who are currently competing in the 2020 Summer Olympics in Tokyo, Japan.  Probably the most well-known is 24-year-old swimmer Katie Ledecky, a Bethesda, MD native who won a gold medal in the 1500-meter freestyle  plus two silver medals in different swimming events.  Ledecky is joined on the 2020 US Olympic Swim Team by two other area natives – Torrie Huske of Arlington, VA and Phoebe Bacon of Chevy Chase, MD.  Other Team USA athletes include several basketball players from the Washington Wizards and Washington Mystics, as well as two members of the women’s soccer team, Washington Spirit.