Insights^

White House to Start Sending Out 400 Million N95 Masks Next Week

The Biden administration will begin distributing 400 million N95 masks from the National Strategic Stockpile to pharmacies and other locations starting next week.  The administration expects the program to be fully operational by early February and has plans for sending out high-quality masks to children in the future.  The announcement follows new guidance from the Centers for Disease Control and Prevention that says N95 masks offer far better protection from COVID-19 than cloth masks, but stopped short of officially recommending that people opt for N95 masks.

Democrats’ Push for Voting Rights Reform Falters in the Senate

Sens. Joe Manchin (D-WV) and Kirsten Sinema (D-AZ) joined all 50 Republican Senators in opposing a rules change to allow for voting rights legislation to pass with a simple majority, putting an end to Democrats’ efforts to bring about comprehensive voting rights reforms.  The late-night vote was unsurprising, as both Sinema and Machin have been forthright in their opposition to changing Senate rules, despite publicly backing some of the voting rights reforms included in the Democrats’ bill.  While President Joe Biden vowed to continue the fight for voting rights just hours before the Senate’s vote, it remains unclear if and how the Democrats will continue to pursue voting rights legislation.

Biden Speaks on BBB’s Uncertain Future

The Build Back Better (BBA) Act, Democrats’ sweeping social and climate spending package, isn’t completely dead, as President Biden conveyed during a two-hour press conference on Wednesday.  To keep Democrats’ policy agenda moving forward, Biden proposed breaking up the bill into smaller measures that could more easily pass.  Unfortunately for Democrats, this would involve sacrificing two of their key priorities – the expanded child tax credit and federally subsidized community college.  However, the path forward for BBB remains uncertain.  The day after Biden’s press conference, House Speaker Nancy Pelosi (D-CA) said she would prefer passing a “skinny” BBB through the budget reconciliation process as opposed to “chunks” as Biden proposed.  Additionally, some worry an attempt to revive BBB in some fashion will jeopardize Democrats’ attempts to pass an omnibus appropriations bill by February 18.

HHS to Provide $103 Million for Health Care Workforce

On January 18, the Department of Health and Human Services (HHS) announced the availability of $103 million in funding to address burnout and provide behavioral health services to the health care workforce.  The funding, which was provided through the American Rescue Plan, will come at a time when the nation’s health care workers face undue burden and stress as the Omicron variant pushes health care providers to the brink.  According to HHS Secretary Xavier Becerra, the funding will be focused on rural and underserved areas, whose health care systems have been hit especially hard by the pandemic.

ICYMI: Get Ready for Donald, Melania Trump Portraits at National Portrait Gallery

A spokesperson for the National Portrait Gallery in Washington, DC confirmed that the museum has commissioned for the  portraits of former President Donald Trump and former First Lady Melania Trump, but declined to offer a timeline or additional details.  Since the 1990s, the museum has worked with the White House to commission a portrait near the end of a president’s term.  Typically, portraits of former presidents appear in the National Portrait Gallery a year or two after leaving office.  A photograph of Trump will remain on display at the museum until the official portrait is finally completed.

CDC Shortens Pfizer Booster Shot Waiting Period to 5 Months

The Centers for Disease Control and Prevention (CDC) announced on Tuesday that people who received the Pfizer COVID-19 vaccine should receive a booster shot after five months, rather than six.  The same day, the CDC authorized the Pfizer COVID-19 vaccine as a booster in children ages 12 to 15 and recommended that moderately or severely immunocompromised 5- to 11-year-olds receive an additional vaccine dose 28 days after their second dose.  The updated recommendations for children come as pediatric COVID-19 cases skyrocketed nationwide.  While the CDC’s booster interval recommendation for Johnson and Johnson recipients remained unchanged at two months, the Food and Drug Administration (FDA) on Friday updated Moderna’s booster authorization to shorten the interval from six to five months similar to Pfizer.

Senate Democrats Renew Push of Voting Rights Legislation

After 2021 ended with a stalemate on the Democrats’ $1.7 trillion Build Back Better Act, Senate Democrats are starting 2022 with a renewed focus on passing voting rights legislation.  Senate Majority Leader Chuck Schumer (D-NY) and other top Democrats have tied the latest push on voting rights with the one-year anniversary of the January 6^th Capitol riot, underscoring a need to defend democracy and protect voting rights.  To pass the legislation and avert a likely filibuster from Republicans, Schumer has been pushing for a specific exemption to allow the voting rights bill to pass with a simple majority and return to the “talking filibuster.”  However, just like with Build Back Better, Democrats are facing opposition from Sen. Joe Manchin (D-VW), who has repeatedly expressed concerns over changes to Senate rules.  Schumer has said he will give Democrats and Republicans in the Senate until January 17^th to drop their opposition and allow Senators to begin debating the voting rights bill before he moves to change Senate filibuster rules.

CDC Stands by Updated COVID Isolation and Quarantine Guidelines

On Tuesday, the CDC recommitted to guidelines issued on December 29 that said individuals who test positive for COVID-19 and whose symptoms have resolved only need to isolate for five days instead of the originally required 10 days.  Shortly after the guidelines were initially updated, some public health officials criticized the agency for not requiring people to test negative for COVID-19 before leaving isolation.  However, the CDC updated its guidelines on January 4 with data to show that people are less likely to spread COVID-19 after five days.  The following day, the American Medical Association (AMA) issued a statement criticizing the CDC’s updated guidelines for not requiring a negative test to leave isolation.  AMA also pointed to CDC data that said 31% of people remain infectious five days after testing positive for COVID-19.

Rush, Lawrence Announce Retirements from Congress

On January 4, Rep. Bobby Rush (D-IL) announced that he will not be seeking reelection for a 16^th term in Congress.  A longtime civil rights activist, Rush first won his election to the House of Representatives in 1992, where his committee assignments have included the Energy and Commerce Committee and the Agriculture Committee.  While Rush cited a desire to spend more time with family as his primary reason for stepping down, he has vowed to continue to fight for racial injustice and equity and make his “voice heard in the public realm.”  The following day, Rep. Brenda Lawrence (D-MI) announced that she will also not be running for reelection this year.  A former US Postal Service employee, Lawrence first became involved in local Detroit-area politics in 1997 before finally being elected to Congress in 2012.  Rush and Lawrence are respectively the 24^th and 25^th House Democrats to announce their retirement at the conclusion of the 117^th Congress.

ICYMI: Snowstorm Leaves US Senator Stranded for 27 Hours

Countless motorists were stuck on I-95 between Washington, DC and Richmond, VA on Monday after a mix of snow and ice caused a roughly 50-mile traffic jam.  Among the motorists stranded was Sen. Tim Kaine (D-VA), who said his trip to Washington took 27 hours.  According to state transportation officials, the logjam began when rapidly accumulating snow caused some vehicles near Fredericksburg, VA to crash, creating a chain reaction that backed up traffic for miles.  Shortly after arriving in Washington, Sen. Kaine went to Red Hen, a popular Italian restaurant in the District, to celebrate his son’s birthday.

“Should we just send one to every American?”  That’s what White House Press Secretary said on December 7 when asked during a press briefing why more Americans don’t have access to rapid antigen tests. Psaki’s response – which many deemed sarcastic – sparked a wave of backlash from members of the medical community who think that’s exactly what the Biden administration should do and make tests available to everyone at no cost.  So why isn’t the administration doing it?

Rapid tests are seen as an important public health tool for reducing the spread of COVID-19 because they can be used at home by an individual and provide results in as little as 15 minutes.  While not as accurate as PCR tests, rapid tests are available over- the-counter, which makes it easier and more convenient for people to get access tests.  And more people taking rapid tests would mean identifying more COVID-19 cases than would otherwise be possible with only PCR testing. Having an increase in access to rapid tests could also make forthcoming COVID-19 antiviral pills more useful, since their effectiveness depends on being taken within the first five days of illness.  Due to the convenience of rapid tests and their potential to stop the spread of COVID-19, some public health experts have pointed to over-the-counter tests as a way to potentially control the pandemic and return to “normal life.”

Currently, the availability of rapid tests in the US pales in comparison to other wealthy nations, where people can readily access tests at little or no cost.  In Germany, rapid tests are available in grocery stores for less than $1, while people in the United Kingdom can request mail-order rapid tests free-of-charge.

Here are some of the reasons why Americans can’t get rapid tests as easily as Germans or the British.

• Regulatory issues.  Some manufacturers say the regulatory framework on rapid tests is too stringent because it requires test performance benchmarks to be at the same level of PCR tests, which test developers say is too high.  Additionally, US standards for approval are higher compared to some other peer nations, including the UK.
• Supply chain problems.  There has been a consistent shortage of raw materials used to manufacture the diagnostic components of at-home tests.  Additionally, low COVID-19 case numbers during the summer caused some manufacturers like Abbott to pull-back on test production, leaving the company unable to keep up with increased demand for tests once case numbers began to jump in July 2021.
• Lack of federal investment.  While the US government has invested billions of dollars into the development of vaccines, much less has been put towards the development and purchase of rapid tests.  In contrast, countries like the UK and Germany invested billions in both vaccines and at-home tests.

Fortunately, rapid tests are a part of the Biden administration’s plans to combat COVID-19.  On December 2, President Joe Biden announced that insurance companies will soon reimburse individuals who buy over-the-counter rapid tests.  Other recent actions the administration has taken include investing $650 million to strengthen manufacturing capacity for rapid tests and a $70 million investment to develop an accelerated pathway within the Food and Drug Administration (FDA) to evaluate rapid tests.

But…rapid tests might not make a huge difference, anyway.  While rapid tests were frequently lauded by public health officials as a way to curb the pandemic, real-world evidence in countries where rapid tests are readily available suggests otherwise. In Germany, infections, hospitalizations, and deaths have increased dramatically since October, while the UK has seen COVID-19 case numbers grow since restrictions were fully lifted in July (although hospitalizations and deaths remain low).

And even though Biden recently committed to new investments in testing, which could result in 300 million new rapid tests per month, it would still amount to less than one test per month per person in the US.

While convenience of rapid tests is undeniable, a boost in the availability of tests might accomplish little in the US, where most of the country is already grappling with a surge of new cases.

Right now, “fully vaccinated” means two shots of an mRNA vaccine or one shot of the Johnson & Johnson vaccine.  But that could change.  In a recent interview, NIAID Director Dr. Anthony Fauci said the definition of fully vaccinated could change from two to three mRNA doses as mounting evidence shows waning efficacy of a two-dose regimen over time.  With the administration now recommending all US adults to get their COVID-19 booster shots, is it just a matter of time until the definition of fully vaccinated changes from two to three doses?

The Evidence for One More Shot

Evidence shows that the immunity against infection from COVD-19 does wane over time, including cases that are asymptomatic or mildly symptomatic.  A study from the Centers for Disease Control and Prevention (CDC) published in September found effectiveness against infection among adults in New York fell from 92% to 75% between May and July 2021.  Additionally, a study based on data from the Veterans Health Administration (VHA) found effectiveness against infection among veterans fell from 88% to 48% between February and October 2021.

However, evidence suggests that vaccine effectiveness against severe disease and hospitalization remains strong, despite declining protection against infection  The New York study found vaccine effectiveness in preventing hospitalization only declined from 95% to 90% over the three-month period, while a study in the Netherlands found vaccine effectiveness against hospitalization remained unchanged at 94% between July and October 2021.

New Variant, New Urgency

Concerns that the new Omicron variant is both more transmissible and may be somewhat resistant to immunity from vaccines or prior infection is underscoring an emphasis from the Biden administration on booster shots.  On November 29, the CDC updated its COVID-19 booster recommendations to say everyone ages 18 and older “should” get a booster shot as added protection against the new variant.  A few days later, President Joe Biden announced a new plan to ensure that the nearly 100 million eligible Americans who have not yet received their booster shots do so as soon as possible.  The plan includes:

• Sending texts, calls, and emails to eligible Americans.
• Launching a new public education campaign.
• Expanding pharmacy availability through December 2021.

While it’s too early to tell how much protection current vaccines will offer against the Omicron variant, experts say the higher antibody response generated by a booster shot could provide broad protection against new variants.  Experts are also keen to stress that Delta remains the dominant variant in the US, and it remains unknown if Omicron will eventually become the new dominant strain.  With the Delta variant already contributing to a rise in cases nationwide, booster shots remain as important as ever.

If booster shots are so important regardless of which variant is circulating, then why doesn’t the administration just change the definition of fully vaccinated from two shots to three?  First of all, some public health experts fear changing the definition suddenly could spark confusion.  The FDA and CDC only authorized booster shots for all American adults just before Thanksgiving, and new changes could be problematic given the current administration’s challenges in communicating public health information and guidelines.

More importantly, changing the definition of fully vaccinated to three shots could undermine efforts to reach Americans who have yet to receive their first two shots.  Only about 60% of American adults have been fully vaccinated, and some public health experts believe efforts to reach the unvaccinated would be more effective in preventing a spike in hospitalizations than convincing young, health Americans to get a third dose.  Still as evidence on waning immunity mounts and concerns over the Omicron variant rise, it remains a possibility that the federal government could revise its definition of fully vaccinated some time next year.

Biden Outlines Plan to Combat COVID-19 through Winter

On December 2, President Joe Biden announced a new strategy aimed at preventing a winter surge of COVID-19 as concerns loom over the newly discovered Omicron variant.  Key components of the plan include requiring travelers entering the US by air to test negative for COVID-19, launching a public education campaign to encourage booster shots, extending the requirement for masks to be worn on public transit and airplanes, and requiring health insurers to completely reimburse the cost of at-home tests for COVID-19.  While Biden stopped short of recommending shutdowns of schools or businesses, he did warn that case numbers are likely to rise in the coming weeks as temperatures drop, and more people gather indoors.

FDA Panel Narrowly Recommends Merck’s COVID-19 Antiviral Pill

On November 30, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) narrowly voted 13-10 to recommend an emergency use authorization (EUA) for Molnupiravir, Merck’s oral antiviral to treat COVID-19.  While initial clinical trial results showed Molnupiravir was 50% effective in reducing the risk of hospitalization or death, a new data set released by Merck last week showed the drug was only 30% effective in preventing hospitalization, sparking discussion among the advisers on Molnupiravir’s efficacy.  VRBPAC members also discussed concerns that the drug could potentially create immune-resistant variants and whether the drug posed any risk to pregnant women.   While most advisers agreed the benefits of oral COVID-19 antiviral treatment outweigh the risk, the FDA could be compelled to write a narrower EUA than initially expected.

Congress Passes Stopgap Funding Bill through February 18, Averts Shutdown

On Thursday, the House approved by a 221-212 vote a continuing resolution to ensure government funding through February 18, 2022.  Notably, the stopgap funding measure does not address looming cuts to Medicare that are scheduled to go into effect next year, although a Democratic aide has reportedly said that lawmakers intend to address the Medicare cuts in a separate bill before the end of the year.  Later that evening, the Senate passed the continuing resolution in a 69-28 vote.   Initially, several Republican Senators threatened to hold up debate on the spending measure in protest of the administration’s vaccination mandate for employers.  However, Senate leaders eventually ended the stalemate by allowing Republicans to take a simple majority vote on an amendment to defund the vaccine mandate that ultimately failed along a party line vote.

Oregon Congressman Peter DeFazio Announces Retirement

On December 1, Rep. Peter DeFazio (D-OR) announced he will not seek reelection in 2022, thus ending his 36-year career in Congress. DeFazio represents a competitive district in eastern Oregon that President Biden won by only four points in 2020, fueling concerns among Democrats that Republicans are poised to retake the majority in the House in 2022. The Oregon Congressman currently chairs the Transportation and Infrastructure Committee, which he has served on since 1987.  Since DeFazio’s retirement announcement, Reps. Eleanor Holmes Norton (D-DC) and Rick Larsen (D-WA) have declared their candidacy for the top Democratic spot on the committee.

ICYMI: White House Hosts 99^th National Christmas Tree Lighting

On Thursday night, the White House hosted its 99^th National Christmas Tree lighting on the Ellipse in President’s Park.  The event was hosted by LL Cool J and featured performances by Billy Porter, H.E.R., Keb’ Mo’, Maren Morris, Patti Labelle, and the Howard Gospel Choir.  The event will be broadcast on TV Sunday December 5, and the tree will be open to the public from Saturday, December 4 until January 1, 2022.  The National Christmas Tree is separate from the official White House Christmas Tree, which is displayed annually in the Blue Room of the Executive Mansion.