What Happened, What You Missed: November 8-12

Pfizer Asks FDA to Authorize Its COVID-19 Booster Shot for All Adults

On November 9, Pfizer announced it’s asking the Food and Drug Administration (FDA) to amend its emergency use authorization (EUA) to allow all individuals ages 18 and older to get a third “booster” dose of its COVID-19 vaccine.  Currently, only individuals over age 65, people with chronic medical conditions, and at-risk workers are eligible to receive booster doses.  Pfizer also submitted data to the FDA from a Phase 3 clinical trial that found its booster shot is 95% effective against symptomatic COVID-19.  The request comes as more and more data suggests efficacy of currently approved vaccines wanes over time.

Federal Court Blocks Administration’s Vaccination Mandate for Employers

On November 6, a federal court in Louisiana block an emergency temporary standard (ETS) from the Occupational Safety and Health Administration (OSHA) that requires employers with 100 or more employees to develop a mandatory COVID-19 vaccination policy, with an exception for testing.  The 26 states are behind the lawsuit are making the argument that the Department of Labor lacks the authority to issue the rule and did not follow the correct procedure to issue the ETS.  The Department of Justice has vowed to fight the ruling in court.

CBO Says Congress Will Have to Wait for a Full Score on BBB Act

On Tuesday, the Congressional Budget Office (CBO) announced that lawmakers will have to wait some time for a final score on the Build Back Better (BBB) Act, Democrats’ social and climate spending bill.  In a blog post, CBO say it will provide a cost estimate for the full bill “as soon as practicable” and will provide advance notice once a release date can be determined.  CBO has taken a piecemeal approach to issuing cost estimates, and so far, only the titles for Science, Space, and Technology, Homeland Security, Small Business, and Veterans Affairs have been scored.  Several centrist Democrats in both chambers including Sen. Joe Manchin (D-WV) and Rep. Josh Gottheimer (D-NJ) have said they will hold off on supporting the BBB Act until the CBO fully scores the bill.

Former New Hampshire Governor Nixes Senate Run

On November 9, former New Hampshire Governor Chris Sununu, a Republican, declared that he will not be running to represent the Granite State in the US Senate.  Many Republicans considered Sununu to be a top recruit against Sen. Maggie Hassan (D-NH).  Hassan, who won her seat in 2016 by a margin of only 1,017 votes, is considered to be one of the most vulnerable Senators.  Sununu’s decision is a setback for the Republicans’ plans to retake the Senate majority, as the party was already facing a difficult Senate map heading into 2022.

ICYMI: For the First Time, Tomb of the Unknown Soldier Opens to Public

This week, the Tomb of the Unknown Solider in Arlington National Cemetery allowed the public to walk on to the plaza and lay flowers for the first time ever to commemorate 100 years since an unknown soldier, who died in World War I, was interred at the tomb.  Visitors waited in line for hours this week for this opportunity to pay their respects, which has been under the watch of the US Army’s Old Guard for a century. This was a once-in-a-lifetime opportunity as the Arlington National Cemetery does not “anticipate holding another event in our lifetimes in which the public will be able to approach the Tomb in this manner.”

What Happened, What You Missed: September 27-October 1

Pfizer Submits Initial Data on COVID-19 Vaccine in Kids

On September 28, Pfizer submitted initial data to the Food and Drug Administration (FDA) that shows its COVID-19 vaccine generates “robust” protection in children aged 5-11.  The announcement came just a week after Pfizer announced positive topline results in its clinical trials for children.  Pfizer says it will formally apply for Emergency Use Authorization for children in that age range “in the coming weeks,” teeing up FDA authorization potentially by the end of October.  Pfizer also announced that it is expected to have topline results for children under 5 in the fourth quarter of this year. 

CDC: Side Effects from Booster Shots Are Mild

A third “booster” shot from Pfizer’s mRNA COVID-19 vaccine produces side effects consistent with the side effects individuals experienced after their second shot, according to a report posted Tuesday by the Centers for Disease Control and Prevention (CDC).  The report found side effects usually appeared the day after the injection, with the most common side effects being mild-to-moderate arm pain, fatigue, and headache.  According to the White House, over 400,000 Americans have received a third Pfizer shot over the past week, including President Joe Biden, who was administered his booster shot during a live event on Monday.  Both the FDA and the CDC approved booster shots for senior citizens, high-risk workers, and people with chronic medical conditions last week.

Gallup: Delta Variant Likely Prompted More Americans to Get Vaccinated

According to a Gallup poll released on September 29, the percentage of US adults who reported being vaccinated for COVID-19 grew to 75%, largely due to growing concerns of being infected with the virus as the Delta variant continues to take its toll.  The poll also found that a rise in vaccine mandates from employers and the FDA fully approving the Pfizer vaccine may have also contributed to higher vaccination rates.  Additionally, for the first time, Gallup found that a majority of adults who identify as Republican say they have been administered at least one vaccine dose. 

Congress Averts Shutdown, but Leaves Debt Limit Unresolved

President Biden signed a continuing resolution (CR) late Thursday to fund the government through December 3, averting a government shutdown that otherwise would have begun on October 1.  The standalone CR was fast-tracked through Congress after Senate Republicans initially blocked a measure that paired government funding with a debt ceiling increase on Tuesday.  Earlier this week, Treasury Secretary Janet Yellen sent a letter to congressional leadership saying that without any action to raise or suspend the debt ceiling, the government could default on its debt obligations as soon as October 18.  Senate Republicans want Democrats to address the debt ceiling through the budget reconciliation process, but Senate Majority Leader Chuck Schumer (D-NY) has so far refused to do so, setting up a standoff between the two parties for the next few weeks. 

ICYMI: DC’s “Cat Census” Estimates 200,000 Felines in the District

There are about 200,000 cats residing in Washington, DC according to the DC Cat Count, the first-ever project to conduct a census on felines in a major US city.  The project estimates that the overwhelming majority of the District’s cats are owned or cared for while about 3,000 are feral.  Of the cats who receive at least some care from humans, half are indoor-only, while the other half have some access to the outdoors.  To conduct the cat census, the Human Research Alliance collaborated with the Smithsonian to place over 1,500 motion-sensor cameras in locations across the District, resulting in about 1.2 million cat photos.

What’s Going on with the Provider Relief Fund?

The Provider Relief Fund (PRF) was essential for keeping countless health care providers afloat as the health care sector struggled with the COVID-19 pandemic throughout 2020. This is why Congress appropriated $178 billion in the CARES Act for the fund.  Nearly a year and a half after its creation, let’s take a deep dive look at the PRF to see what providers are saying about the program and where the program is today.

The Unsmooth Transition of the PRF

$178 billion in appropriations to the PRF has not equated to $178 billion in relief for hospitals and the distribution process for PRF money has been “uneven” and the plans of distributing the funds have been “opaque.” This unsmooth transition has not only caught the eyes of providers, but also Congress, who has urged HHS to respond to these challenges over the last couple of months.

HHS Responds

Fortunately, recent actions by HHS indicate the department is listening to health care providers.  On September 10, HHS announced it will make available $25.5 billion to affected providers, who can begin applying for the funds in September 29.  Payments will be distributed based on pandemic-related revenue losses between July 1, 2020, and March 31, 2021. 

About $8.5 billion will be set aside for rural Medicare, Medicaid, and Children’s Health Insurance Program (CHIP) providers operating in regions disproportionately affected by the pandemic, with the remaining $17 billion going to smaller providers who can demonstrate lost revenue and increased expenses due to the pandemic.  HHS has also announced it will offer bonus payments to Medicare, Medicaid, and CHIP providers.

To recognize the challenge providers are facing due to the Delta variant and recent natural disasters, HHS also announced it will offer providers a 60-day grace period on reporting requirements for relief fund recipients.  During this 60-day period, HHS will not carry out any enforcement or collection activities.  However, deadlines on PRF grants and the reporting period that HHS extended on June 11, 2021remain unchanged. 

The disbursement of remaining PRF dollars and new flexibility on reporting aren’t the only changes HHS has made recently.  On August 31, HHS announced via the Federal Register the reorganization of the Health Resources and Services Administration Office of Provider Support into the Provider Relief Bureau.  These changes suggest HHS understands the importance of ensuring funds from the PRF are getting to health care providers.

However, even after these recent responses, HHS has yet to lay out a timetable for the disbursement of the remaining PRF dollars, as many hospitals are still grappling with a nationwide surge in COVID-19 cases.  The PRF has been clearly valuable for hospitals by allowing them to survive since the beginning of the pandemic and so, HHS needs to continue to follow through with specific actions that provides meaningful relief.

What Happened, What You Missed: August 23-27

FDA Fully Approves Pfizer/BioNTech COVID-19 Vaccine

On August 23, the Food and Drug Administration (FDA) fully approved the Pfizer/BioNTech COVID-19 vaccine for people age 16 and older, but did not fully approve the vaccine for individuals ages 12 to 15, which is still only authorized for emergency use.  Full approval of the vaccine, which will be marketed as Comirnaty, is likely to spur additional companies and organizations to mandate employees to be vaccinated.  Just a few days later, Pfizer/BioNTech announced that it intends to submit a biologics license application (BLA) for a third dose of its vaccine to act as a booster shot.  Additionally, Moderna submitted a BLA for its COVID-19 vaccine this week, setting the stage for full FDA approval within the next few months.

New Data Shows J&J Booster Shot Increases Immune Response

Johnson & Johnson says data from a phase 2 clinical trial shows a second dose “booster shot” of its single-dose COVID-19 vaccine administered six to eight months after the first dose resulted in a nine-fold increase in antibodies compared to 28 days after the first dose.  The announcement comes amid concerns that the viral vector Johnson & Johnson vaccine may not be as effective as the mRNA vaccines offered by Pfizer/BioNTech and Moderna.  Last week, the Biden administration announced plans to make third-dose booster shots of the Pfizer/BioNTech vaccine to all eligible Americans by late September, but declined to make a final decision on whether recipients of the Johnson & Johnson vaccine should also receive booster shot.  Johnson & Johnson also announced that that it is working with FDA and other regulators regarding the need for booster shots.

Intelligence Report Inconclusive on Origins of COVID-19

According to news reports, an intelligence report delivered to President Joe Biden this week was inconclusive over whether COVID-19 originated naturally via human contact with an infected animal or originated in a laboratory.  In late May, Biden ordered the US intelligence community to produce a report within 90 days on the origins of COVID-19 after a hypothesis that the virus escaped from a laboratory gained traction.  While some scientists have called for all possibilities for COVID-19’s origin to be explored, many believe the most likely scenario is that the virus jumped from animals to humans.  Intelligence officials plan on publicly releasing a summary of the report in the coming days.

House Passes FY22 Budget Resolution after Democrats Reach Agreement

On August 24, the House narrowly approved a $3.5 trillion budget resolution for Fiscal Year (FY) 2022 along a party-line vote, following a period of deadlock between a group of moderate Democrats and party leadership that threatened to derail the budget resolution.  Earlier this month, nearly a dozen centrist-leaning Democrats including Reps. Josh Gottheimer (D-NJ) and Stephanie Murphy (D-FL) communicated that they would not support the budget resolution unless the House first voted on the Senate-passed bipartisan infrastructure bill.  Per their public agreement with the group of centrists, House leadership have committed to consider the bipartisan infrastructure bill by September 27.  House approval of the FY22 budget resolution sets the stage for Congress to advance a social spending bill in both chambers without any Republican support.

ICYMI: Washington Monument Could Reopen Soon

The Washington Monument has been closed since August 15, following a lightning strike that damaged the monument’s electronic access system that operates the door and the elevators.  Since then, the National Park Service has been awaiting replacement parts to get the electronic access system back in working order.  The parts finally arrived on August 25, and the National Park Service says it will begin installing and testing on Thursday in the hopes of reopening “as soon as possible.”