What Happened, What You Missed: May 2-6

E&C Leaders Release FDA User Fee Package

On Wednesday, bipartisan leaders of the House Energy and Commerce Committee released a legislative proposal to reauthorize the Food and Drug Administration’s (FDA) ability to collect fees from drug, biosimilar, and device manufacturers for five years.  Additionally, the bill contains several policy riders that would give the FDA more control over the accelerated approval program, promote diversity in clinical trials, and reinstate a ban on electric shock devices for aggressive behavior, among other items.  The Health Subcommittee is expected to markup the user fee bill next Wednesday, with the goal passing the legislation in Congress by August.

FDA Approves Marketing of New Alzheimer’s Test

The FDA on Wednesday approved the marketing of an in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.  Produced by Fujirebio Diagnostics, the test works by measuring the ratio of certain proteins in the fluid that surrounds the brain.  In a press release, the FDA said the availability of an in vitro diagnostic test could eliminate the needs for PET scans, which are time-consuming and expensive.  In a clinical study, the test detected Alzheimer’s disease in 97% of people who had amyloid plaques present in a PET scan.  The National Institute of Health (NIH) estimates that over six million Americans may have Alzheimer’s disease. 

Survey: Most Parents Will Wait to Get Young Kids Vaccinated

18% of parents of children under 5 say they’ll get their kids vaccinated for COVID-19 as soon as a shot is authorized, according to a survey from the Kaiser Family Foundation.  Another 38% say they’ll take a “wait and see” approach before getting their kids vaccinated, while 56% want more information about vaccine safety and efficacy before making a decision.  Delays in FDA authorization of vaccines for young kids also left parents with mix feelings, with 22% saying the delays have made them more confident in the vaccine and 13% sayings the delays have made them less confident.  The survey was conducted in mid-April 2022, right before Moderna filed to authorize its vaccine for kids under 5 with the FDA.

Rent-A-Cops Arrive on Capitol Hill to Provide Security

To help address staffing shortages, the US Capitol Police (USCP) recently started deploying private security guards around the US Capitol Complex.  The private officers will wear grey dress pants and a navy-blue blazer rather than the police uniform and will be unarmed.  According to the USCP, the private officers will be stationed inside secure building like the House and Senate office buildings and will help augment existing patrols.

ICYMI: Jazz in the Garden Returns to National Mall on May 20

In two weeks, Jazz in the Garden will return to the National Gallery of Art Sculpture Garden along the National Mall.  The free concert series is a favorite summer tradition in Washington, DC, and this year’s series is set to features several genres including jazz, Afro-Brazilian, and bluegrass.  The series was closed during summer 2020 and was only open on a limited basis for summer 2021.  Guests will be required to register for the concert in advance.

Is Public Pressure Impacting the FDA’s Vaccine Review Strategy?

Parents of young children are frustrated and mad.  While adults have been able to get third and even fourth COVID-19 vaccines doses for some time now, children under six years are still unable to get their shots while the rest of society reverts to a pre-pandemic normal.

Anger among parents hit a boiling point last week when White House Chief Medical Advisor Dr. Anthony Fauci confirmed reports that the Food and Drug Administration (FDA) will not approve vaccines for kids under 6 until it can simultaneously review and approve vaccines from both Pfizer and Moderna.

However, less than a week later, FDA officials seemingly changed course when they announced that they may move forward on reviewing Moderna’s vaccine without waiting for Pfizer’s application – meaning that young children could get vaccinated as soon as June.  What caused the FDA to take an about face on its vaccine review strategy?

At the time of Fauci’s comment on April 21, Moderna was poised to begin applying for an emergency use authorization (EUA) within the next week or two, as initial data showed its vaccine generated strong protection in kids.  News that the FDA could soon begin reviewing Moderna’s EUA application set off a sign of relief among parents, who have had to contend with constant delays in the race to get young kids vaccinated.

However, Pfizer’s vaccine for children under 5 is still undergoing clinical trials for a three-dose regimen after results from a two-dose regimen did not yet provide strong protection against the virus, and it’s not clear when Pfizer will be ready to submit its data.  By waiting to review vaccines from both companies, the timeline for getting shots into kids’ arms faced a decent chance of getting extended once again.

What was the FDA thinking?  According to reports,  FDA officials wanted to review vaccines from Moderna and Pfizer simultaneously because approving both at the same time would be less confusing for parents than approving each at different times.  Additionally, FDA officials were worried about a possible backlash from parents if the agency approved Moderna’s vaccine first and Pfizer’s several week later when Pfizer’s vaccine demonstrated stronger efficacy. 

Despite the FDA’s rationale, reports that federal officials were delaying the review process once again elicited a strong backlash from concerned parents and lawmakers.  In the days following Fauci’s comments, lawmakers wrote to the FDA requesting an explanation as to why vaccines for young children were being delayed again, and parents and pediatricians launched an advocacy campaign to urge the FDA to review each vaccine application “at the earliest opportunity.”

Did Public Pressure Make a Difference?

The FDA finally changed its tune on April 29, when a top official announced the agency will consider vaccine applications as soon as they are ready.  While it is not clear if the FDA shifted its strategy purely in response to political and public pressures, it wouldn’t be first time public pressure might have made a difference. 

In mid-2021, the FDA appeared to be on track to approve the vaccine for children aged 5-11 by early fall, just in time for the start of school.  However, in July, the FDA asked Pfizer and Moderna to expand the size of their clinical trials for children to make sure they could detect potentially rare side effects, namely myocarditis, or heart inflammation – effectively pushing the timeline for vaccine approval out to winter 2021 or early 2022.  This drew sharp criticism from parents and pediatricians, who argued that complications from COVID-19 posed a greater threat to kids than myocarditis.

The strongest sign of pressure on the FDA came in the form of an August 2021 letter from the American Academy of Pediatrics (AAP) that called on agency to stick to its original timeline for collecting data and authorize vaccines for children under 12 as soon as possible.  A month after the pediatricians weighed in, the FDA issued an unprecedented statement saying that it would no longer wait for additional follow-up data from expanded clinical trials to made a decision on an EUA and stick to its original timeline. 

Like many things with the pandemic, nothing is certain as the FDA determines how it will review vaccines for younger children.  Moderna only began to submit data for its EUA on April 28, and the FDA has laid out a tentative schedule that leaves open the possibility that kids under 6 could get their shots sometimes this June.  However, things could still change. An FDA official say the agency could still review EUA applications from Moderna and Pfizer simultaneously if both are filed less than a week apart, and many parents and pediatricians say June is still too long of a wait for young kids to get vaccinated, especially considering that the review process for other age groups took less time. 

However, actions undertaken by the FDA last fall and last week suggest that the agency isn’t immune to public pressure.  This sets up a precedent where advocacy could sway the FDA review process in the future – for better or for worse.

Will We Need More Booster Shots?

People will only need annual COVID-19 booster shots after getting their third vaccine dose, according to a top Food and Drug Administration (FDA) official at the 2022 Innovation in Regulatory Science Summit in January 2022.  Since then, however, mounting evidence over waning immunity plus the potential of a new wave of COVID-19 are feeding calls for people to get their fourth vaccine doses sooner rather than later.  Does that mean Americans can expect to get a second booster shot in the coming months?

First, some Americans are already able to get a second booster shot.  According to guidance from the Centers for Disease Control and Prevention (CDC), people ages 12 years and older who are moderately or severely immunocompromised should receive a total of four mRNA vaccine doses.  This includes transplant patients and those undergoing chemotherapy for cancer.

Drug manufacturers are already asking for approval on second boosters for additional populations.  In mid-March, Pfizer and Moderna submitted applications to the FDA for an emergency use authorization (EUA) for a second booster dose of their respective COVID-19 vaccines.  While Pfizer is specifically seeking an EUA for adults over age 65, Moderna is requesting an EUA for anyone over 18 years of age. 

The submission of both applications came just days after Pfizer CEO Albert Bourla said a fourth vaccine dose will probably be needed for everyone.

  • One reason for this is mounting data that shows protection acquired from a third COVID-19 vaccine dose wanes over time.  According to CDC data, a booster shot’s effectiveness in protecting against hospitalization dropped from 91% to 78% between August 2021 and January 2022 – a timeframe that includes both the Delta and Omicron variants. 
  • Another reason for a fourth shot is a need to protect Americans ahead of a new wave of COVID-19 cases.  In recent weeks, a new Omicron subvariant known as BA.2 has driven an increase in cases across Europe, which many experts say could foreshadow an increase in cases in the US within the coming weeks.  Although BA.2 is roughly 30% more transmissible than the original Omicron strain, it does not appear to be more severe or lead to more hospitalizations.  While overall COVID-19 case numbers are still trending downward in the US, 10 states have reported an increase in case numbers over the last 14 days. 

Due to these concerns over waning immunity and growing case numbers, nearly a dozen countries including Australia, Belgium, Denmark, Israel, Poland, Sweden, and the United Kingdom have already begun offering fourth doses, albeit eligibility is limited to seniors and medically vulnerable people in most cases.  Additionally, reports suggest the FDA could authorize second boosters for all adults over age 50 as soon as March 29.  However, that doesn’t necessarily mean the government will follow suit in recommending a fourth mRNA vaccine dose to every individual age 12 and up who’s already cleared to get a third dose anytime soon, as a couple issues stand in the way.  These include:   

  • Regulatory approval.  The FDA’s vaccine advisory committee will meet on April 6 to discuss the need for additional COVID-19 booster shots.  However, the advisory panel will NOT be reviewing any EUA applications from Pfizer or Moderna or taking a vote on recommendations – instead, the committee will discuss the timing and populations for additional doses in the coming months.  The April 6 agenda is a sign of the federal government’s cautious approach to boosters, which means it might take some time for federal regulators to sign off on additional doses, especially for the broader population.  In September 2021, for instance, a CDC advisory panel declined to recommend third doses for people who work in “high-risk” settings like health care practitioners and teachers – a decision which was ultimately overruled by CDC Director Rochelle Walensky.
  • Data.  Even though a number of countries have already cleared fourth shots for certain populations, the jury’s still out on whether a second booster will make a difference for non-elderly adults who are not considered medically vulnerable.  Preliminary results from a study involving 154 health care workers in Israel found that a fourth mRNA dose is only “partially effective” in protecting against the Omicron variant.  Without any strong evidence of the effectiveness of a fourth shot, US regulators are likely to continue to take a cautious approach on recommending additional boosters for the broader population.
  • Funding.  Lawmakers dropped $15 billion in additional COVID-19 funding from the Fiscal Year (FY) 2022 omnibus appropriations bill, and so far, congressional leaders are locked in a stalemate on passing separate legislation on additional COVID-19 support.  Without additional funding, Biden administration officials have warned that they won’t have enough money to purchase a potential fourth vaccine dose for even 70% of all Americans.  And barring additional funding, the federal government will no longer be able to cover the cost of vaccinations for uninsured people starting on April 5, which means uninsured immunocompromised Americans may not be able to afford a booster if they need one.

Ultimately, the trajectory of the COVID-19 pandemic may ultimately inform whether additional boosters are necessary for Americans, and in turn, whether Congress decides to allocate enough money to pay for additional vaccine doses.  While White House Chief Medical Advisor Anthony Fauci has acknowledged that the BA.2 subvariant is likely to cause cases to rise in the US, he doesn’t anticipate new cases will culminate in a major surge that results in high levels of hospitalizations

Indeed, a good portion of the US population has acquired some degree of immunity through infection, vaccination, or both over the last two years of the pandemic, which could protect Americas from the worst consequences if case numbers continue to rise over the next few weeks.  However, if hospitalizations suddenly spike across multiple populations, it may be too late for the federal government to act swiftly on additional boosters.

What Would the End of the Public Health Emergency Mean for EUAs?

The current public health emergency (PHE) is set to expire on April 16.  While the Biden administration is likely to extend the PHE, administration officials have yet to comment on their specific plans.  Uncertainty over the end of the PHE has fueled conversations over what the implications would look like for temporary health care policies that expire once the PHE officially concludes. 

Blog posts from the last two weeks have looked at how the end of the PHE would affect Medicare’s temporary telehealth waivers and Medicaid coverage.  This week’s blog post focuses on how ending the PHE would impact the Food and Drug Administration’s (FDA) emergency use authorizations (EUAs).

Background:  An EUA allows the FDA to authorize unapproved medical products or unapproved uses of approved medical products – like vaccines and treatments – to be used to diagnose, treat, or prevent serious or life-threatening diseases in cases where there are no adequate, approved, and available alternatives.  Since the start of the COVID-19 PHE on January 31, 2020, the FDA issued hundreds of EUAs for pharmaceutical and medical devices related to COVID-19.

How? Section 564 of the Federal Food, Drug and Cosmetic (FD&C) Act allows the FDA to issue four different types of EUAs during a PHE for diagnostics, respiratory equipment, medical devices, and drugs/biologics.  However, the FDA still has the authority to issue an EUA outside of a PHE thanks to the Pandemic and All-Hazards Preparedness Reauthorization Act (PAHPRA) of 2013, which grants Department of Health and Human Services flexibility to declare that “circumstances exist” outside of a PHE to allow EUAs to be issued.

What does the end of the PHE mean for the EUAs?  Unlike the other temporary authorities related to telehealth and Medicaid, all EUAs that are issued by the FDA remain in effect until the FDA withdraws the EUA declaration.  For instance, the EUA declarations issued for the Zika and Ebola pandemics were never withdrawn and are currently in effect, even though their respective PHEs have long since expired. 

However, one FDA policy, separate from EUAs, will expire at the conclusion of the PHE – enforcement discretion.  This policy allows the FDA to waive enforcement of its usual requirements for pre-market approval to allow drug products to be modified for additional uses without full approval from the agency.  In contrast, drug products approved via an EUA must still meet specific criteria on safety and effectiveness.  Once the PHE ends, the FDA will revert to its regular enforcement policies, and all products where enforcement discretion once applied must then meet all standard FDA legal requirements in order to continue to be sold in the US.  

Planning for a Post-EUA Future

Unlike the EUAs for Zika and Ebola treatments, the FDA has communicated that it doesn’t want the COVID-19 EUAs to stick around forever and manufacturers should expect an “eventual resumption of normal operations.”  To this end, the FDA issued two draft guidance documents in late December to help facilitate a return to normal:

Uncertain Future for Stakeholders

On February 22, the FDA held a webinar for industry stakeholders about its draft guidance documents on its post-pandemic transition plans, and like their counterparts in telehealth and Medicaid, the stakeholders from the pharmaceutical and medical device industries had a lot of questions. 

  • Of the four EUA declarations, three are specific to devices, and it’s not clear if the agency will withdraw those EUAs all at once or at different times.
  • The webinar did not offer stakeholders a clear answer on whether HHS issues the advance notice on withdrawing the EUA declarations first, or FDA will finalize its two guidance documents on its transition plans.   Instead, FDA staff told attendees that whatever happens first depends on the course of the pandemic.  If hospitalizations continue to decline and stay low, HHS may pull the EUA declarations first; otherwise, finalization of the guidance documents could come sooner.
  • The FDA says more guidance is on the way, but it’s unknown when it will be released.  According to FDA staff, this would pertain to the types of data FDA will consider when transitioning a drug product from an EUA to formal market access, such as how real-world evidence will be considered. 

While pharmaceutical industry stakeholders can feel relieved that EUAs won’t expire with the end of the PHE and that the FDA is making plans for a post-pandemic world, question about what that world will look like simply add to the narrative that the federal government’s take on health care policies once the PHE ends need significant refinement.

When Can Kids Under 5 Get Vaccinated?

An average 672 children per day last week were admitted to the hospital with COVID-19 last week, the highest number since the COVID-19 public health emergency began.  Surging case numbers are also causing schools to close and temporarily revert to virtual learning.  While children ages 5-17 can be vaccinated for protection against COVID-19, this currently isn’t an option for children under 5 years of age.  Even though pharmaceutical companies have been working on vaccines for younger children, some bumps in the road means the timeline for getting this cohort vaccinated hasn’t exactly been static.

Pfizer’s Swing and a Miss

Pfizer was the first COVID-19 vaccine developer to begin testing vaccine in children under five.  For its late-stage clinical trial, Pfizer administered two 3-microgram doses three weeks apart, which is less than one-third of the dose given to older children. 

Pfizer initially hoped to submit data on the efficacy of its vaccine in children in the first quarter of 2022, but an announcement from the company on December 17, 2021 signaled a delay in the timeline young children can get vaccinated.  According to Pfizer, its 3-microgram dose yielded high level of protection in children ages 6- to 24-months-old but did not generate a sufficient level of protection in children ages 2 to 5. 

Now, Pfizer is amending its clinical trial to add a third 3-microgram dose for children 6 months to 5 years of age.  If the updated trials are successful, Pfizer says it will submit data to the Food and Drug Administration (FDA) in April, which pushes the timeline for young children to get the company’s vaccine back by a few months. 

What about Moderna?

News that Pfizer is extending its trial left parents of younger kids understandably upset.  Fortunately, Pfizer is not the only company developing vaccines for children.  Moderna is currently conducting trials in children ages 6-months to 5-years-old, and the company expects to have results available by the end of January, which means the FDA could provide emergency approval as soon as late February or early March 2022.  Moderna is also testing younger children with a higher-microgram dosage than Pfizer, which presumably increases the likelihood that Moderna’s vaccine will yield an adequate immune response.

Children’s Risk Still Very Low

Even though it will probably be a few more months until younger children can get their shot, parents should feel some assurance that young children’s risk of complications from COVID-19 is extremely low.  The COVID-19 death rate for children ages 0-17 in the US is 0.1%, by far the lowest for any age group (in comparison, the death rate for US adults ages 50-64 is 1.39%). 

While pediatric hospitalizations related to COVID-19 are at a record-high, many of these hospitalizations are incidental, meaning children are being hospitalized with, but not for COVID.  An example of an incidental pediatric hospitalization could be for a child who falls on the playground, is admitted to the hospital for a broken bone, and only tests positive as a part of routine screening.

Additionally, young children who are infected with COVID-19 overwhelmingly exhibit mild symptoms or are asymptomatic, with hospital stays rare.  And while it is possible that young children can become COVID-19 long-haulers, studies are increasingly showing that long-COVID in kids is also rare

News of Pfizer’s clinical trial results was certainly disappointing for parents.  But with the possibility of better clinical trial results in the future plus strong data on the low level of risk for young children, parents should have a somewhat optimistic outlook heading into the third year of the pandemic.

What Happened, What You Missed: December 13-17

After Senate Hearing, Califf Poised to Lead FDA

Both Republicans and Democrats serving on the Senate Health, Education, and Labor, and Pensions (HELP) Committee signaled support for Robert Califf, MD in a December 14 nomination hearing for Commissioner of the Food and Drug Administration (FDA).  Ahead of the hearing, several Senators in the Democratic caucus including Bernie Sanders (I-VT) and Joe Manchin (D-WV) had expressed their opposition to Califf due to his response to the opioid crisis while serving as FDA commissioner in 2016-2017 and his ties to the pharmaceutical industry.  However, positive comments from the committee’s Republicans such as Ranking Member Richard Burr (R-NC) and Susan Collins (R-ME) indicates that Califf is likely to attract enough votes to secure his confirmation.  The HELP Committee is expected to vote on Califf’s nomination sometime in early 2022.

Standstill on Negotiations, Parliamentarian’s Review Delay Vote on BBB

A stalemate in negotiations between Sen. Joe Manchin (D-WV) and President Joe Biden means a vote on Democrats’ climate and social spending bill, known as Build Back Better (BBB), probably won’t come until sometime next year.  Given the Senate’s 50-50 split, Machin’s support is critical to securing the bill’s passage, and he has expressed concerns over the scope and size of the bill.  Adding to the delay is Senate Parliamentarian Elizabeth MacDonough’s ongoing review of BBB to ensure its provisions comply with the Byrd rule.  The review is likely to continue into next week and could face further delays due to MacDonough’s ongoing cancer treatment. 

CMS: Government Assistance Helped Hospital Spending to Double in 2020

According to a report released by the Centers for Medicare and Medicaid Services (CMS) on Wednesday, health care spending rose 9.7% in 2020, more than double the 4.3% increase in 2019.  In the report, CMS researchers said financial assistance from federal programs like the Provider Relief Fund and Paycheck Protection Program accounted for most of the increase.  Notably, the jump in health care spending came as the economy contracted by 2.2%.  Other key findings from the report include a 3.7% drop in out-of-pocket costs in 2020 due to individuals using fewer health care services and a 3.5% decrease in private insurer spending in 2020 due to a decline in office visits and elective procedures.

Democratic Congressman Cites Potential GOP Takeover in Retirement Decision

On December 16, Rep. Alan Lowenthal (D-CA) announced that he will not seek reelection in 2022, bringing the total number of incumbent Democrat Representatives who are not running for reelection next year to 19.  Originally a psychology professor, Lowenthal began his career in public service with his election to the Long Beach City Council in 1992, followed by a 14-year stint in the California State Legislature and his election to Congress in 2012.  In an interview with the Long Beach Post, Lowenthal said the prospect of Republicans regaining a majority in the House in next year’s midterm election as well as a desire to spend more time with family factored into his decision to retire.  Lowenthal was known for his dedication to protecting the planet while serving on committees focused on transportation, natural resources, and the environment.

ICYMI: DC Faces Champagne Shortage Thanks to Weather, Supply Chain Issues

New Year’s Eve revelers in the nation’s capital might have a tough time finding top-self champagne to ring in 2022 thanks to subpar weather in France’s Champagne region, according to some DC-area liquor suppliers.  And it’s not just champagne – folks in the beverage industry say a shortage of truck drivers and glass have made it difficult to source other liquors like bourbon.  Until things change, DC-area beverage purveyors suggest consumers try different brands of champagne and other alcoholic beverages during the holiday season.

Will COVID-19 Antiviral Pills Make a Difference?

A new era in treating COVID-19 could be upon us. On November 30, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) will discuss Merck’s request for an emergency use authorization (EUA) for Molnupiravir, an  oral antiviral drug to treat COVID-19.  But Molnupiravir isn’t the only oral COVID-19 antiviral in the mix – in October 2021, Pfizer requested an EUA for Paxlovid, its antiviral pill.  If FDA advisors recommend an EUA for Molnupiravir, and eventually Paxlovid, could it change the course of the pandemic as we know it?

The FDA has already authorized a few treatments for COVID-19, but they have serious drawbacks.

  • Remdesivir the only treatment to have received full FDA approval, has limitations.  For example, it has to be administered intravenously (meaning it’s difficult to provide in an outpatient setting), it’s expensive (about $2,600 for a three-day regimen), and recent research says it’s not very effective.
  • Monoclonal antibodies, which have received an EUA from the FDA, offers another treatment option. While studies show monoclonal antibodies are effective at reducing hospitalization and death, they suffer from many of the same drawbacks as remdesivir – they still have to be provided intravenously, and they’re still expensive (about $2,000 per treatment).

Enter Molnupiravir and Paxlovid. Both antiviral drugs stop SARS-CoV-2, the virus that causes COVID-19, from replicating in the body, but do so in different ways.  Molnupiravir, which was first developed as a flu treatment, works by fooling the virus’s RNA into creating mutations that render the virus unable to survive.  Paxlovid takes a different approach by disrupting the virus’s replication by destroying enzymes vital to its reproduction.

Both treatments offer clear advantages compared to their predecessors. A prominent advantage is early intervention, which is key to administering antiviral treatments.

  • Severe COVID-19 has two stages – one where the virus initially infects a person, and another when the immune system overreacts and spirals out of control. Remdesivir is typically administered in the second phase, when a patient is already hospitalized – and the damage may already be done.
  • Molnupiravir and Paxlovid, on the other hand, attack the virus before it can wreak havoc and put people in the hospital, avoiding further stress on the health care system.  

Additionally, both antiviral pills can be administered orally, meaning patients can take them in any setting. And unlike intravenous treatments, Merck and Pfizer’s antiviral drugs are much easier to ship and store.

  • Oh, and about that name. Molnupiravir comes from Mjölnir, the mythical hammer of the Norse god Thor.

Plans for distribution of the antiviral pills are shaping up.  The Biden administration purchased 1.7 million courses of Molnupiravir for $1.2 billion back in June and is now considering options to buy 1.4 million more.  Based on this agreement, Molnupiravir will cost roughly  $700 per patient, a more than 50% reduction from currently approved treatments.

Additionally, the administration is planning to buy enough courses of Paxlovid for 10 million people.  To allow their drugs to be manufactured around the globe and sold at lower prices in poorer countries, both Merck and Pfizer have entered into license-sharing agreements.

However, Molnupirabir and Paxlovid aren’t magic bullets, and while they are far better than currently approved treatment options, they still have limitations of their own.

  • First, both have a strict dosing regimen.  Each must be taken over a five-day period, with Molnupiravir taken four times a day and Paxlovid taken three times a day. 
  • Second, both antivirals must be taken within the first five days of illness.  Unfortunately, a lack of access to both rapid at-home antigen tests and testing labs that can quickly process PCR results means the onset of symptoms, a positive test result, and a prescription for an oral antiviral may exceed the five-day window.
  • Third, there are questions about the efficacy of the oral antivirals.  Merck originally reported in October 2020 that Molnupiravir reduces risk of hospitalization or death by 50%.  However, in November, updated data from Merck revealed that its antiviral only cut the risk of hospitalization and death by 30%.  Pfizer says that Paxlovid reduces the risk of hospitalization and death by 89%, but these results have yet to be peer-reviewed.

Despite these limitations, both Molnupiravir and Paxlovid could be the most important pharmaceutical development since the introduction of vaccines. However, just like vaccines won’t make a difference until people get their shots, new antiviral pills won’t help unless people take them. If the administration wants to ensure oral antivirals are utilized effectively , it needs to drastically improve the testing infrastructure and ensure adequate distribution to suppliers. Doing so will ensure as many people as necessary have access to antivirals and allow the new drugs to be an effective additional tool to fight the pandemic.  

What Happened, What You Missed: November 15-19

FDA Clears Moderna, Pfizer COVID-19 Booster Shots for All Adults

On Friday, the Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for both the Moderna and Pfizer COVID-19 vaccines to authorize booster shots for individuals ages 18 and older at least six months after their second dose.  Previously, boosters had been limited to people ages 65 and older, individuals with underlying medical conditions, and people deemed at-risk due to occupational and institutional exposure.  Later today, the Centers for Disease Control (CDC) Advisory Committee on Immunization Practices (ACIP) will meet to discuss whether to recommend boosters for all adults.  Due to rising case numbers, several states including California, Colorado, and Rhode Island preempted the FDA and CDC, and went ahead to recommend that all adults get booster shots. 

Administration Finalizes Rule to Require Insurers to Share Data on Drug Costs

On November 17, the Biden administration issued an interim final rule outlining requirements for group and individual health insurance market plans to submit data on prescription drug costs to the federal government.  The data will then be used by the Department of Health and Human Services (HHS) to publish a report on drug pricing trends and their impact on insurance premiums and out-of-pocket costs.  However, the requirements won’t go into effect for some time – insurers will have until December 2022 to comply, and HHS won’t issue its first report until June 2023.  The rule implements provisions of the No Surprises Act and the Consolidated Appropriations Act of 2021.

Build Back Better Act Passes House, Faces Changes in Senate

On Friday, the House approved the Build Back Better Act by a 220-213 vote.  Rep. Jared Golden (D-ME) was the sole Democrat to vote against the $1.75 trillion measure, although he indicated he could support a final bill that includes changes to state and local tax (SALT) deductions.  Today’s vote followed a long Thursday that saw the release of the final score of the bill and ended with a record-breaking eight-and-a-half-hour speech by House Republican Leader Kevin McCarthy (R-CA).  The social and climate spending bill will now proceed to the Senate for consideration, where it could undergo further changes if the parliamentarian strikes provisions that are deemed unrelated to the federal budget.   

Leahy, the Most-Senior Sitting Senator, to Retire

On November 15, Sen. Patrick Leahy (D-VT), the president pro tempore of the Senate and the chamber’s current longest-serving member, announced that he will not seek an additional term in 2022.  First elected to the Senate in 1974, Leahy has chaired the Agriculture, Judiciary, and Appropriations committees, and is currently the Chair of the Appropriations Committee after Democrats regained control of the Senate in the 2020 general election.  While Leahy has indicated as recently as May that he would seek a ninth term, he ultimately made the decision to retire and exclaimed that “it’s time to pass the torch.”  Of note, Leahy’s retirement announcement was followed by Rep. Jackie Speier (D-CA), who announced on November 16 that she will not seek an additional term.  Both Leahy and Speier occupy deep-blue seats representing Vermont and the San Francisco Bay Area respectively, that Republican are unlikely to flip.

ICYMI: DC’s Indoor Mask Mandate Ends on Monday

On November 16, Washington, DC Mayor Muriel Bowser announced that the city will drop its mask mandate for public indoor spaces beginning Monday, November 22.  In its place, Bowser said the city will adopt a new set of guidelines on indoor masking based on an individual’s level of risk and vaccination status.  Masks will still be required in certain settings regardless of vaccination status, including schools and childcare facilities, libraries, public transportation, and congregate facilities.  Additionally, private businesses will also maintain the option to impose their own mask requirements. 

What Happened, What You Missed: October 25-29

FDA Panel Recommends Pfizer Vaccine for Children Ages 5-11

On October 26, the Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted to recommend amending Pfizer’s Emergency Use Authorization (EUA) to allow its COVID-19 vaccine to be administered in children ages 5-11.  Pfizer has reduced its vaccine dose for children under 12 to one-third of the adult dose and said clinical trials show the lower dose is over 90% effective in preventing symptomatic COVID-19 in children.  Although the vote was unanimous (with one abstention), there was some discussion on weighing the benefits of vaccination against potential risks, namely rare instances of heart inflammation.  Before the vaccine actually becomes available to kids under 12, it will be reviewed by the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) on November 2-3, and the CDC director will need to sign-off on the ACIP’s decision.

Dems Release New $1.75T Reconciliation Proposal

On October 28, the House Rules Committee released the text of a new $1.75 trillion social spending and climate bill, a far cry from the $3.5 trillion budget resolution approved by Congress earlier this year.  Notable provisions of the bill include investments in affordable housing, an extension of the child tax credit, and an extension of Affordable Care Act (ACA) premium tax credits through 2025.  Notable provisions that were left out of the legislation, include paid family leave, prescription drug reform, and SALT. Since the proposal’s announcement, Sinema has issued a supportive yet noncommittal statement on the text, while Machin has declined to indicate his position. Based on the noncommittal responses from the Senators and wanting more time to read through the newly released text, the Congressional Progressive Caucus did not quite sign off on the reconciliation bill, which now has led to the delay in passing the bipartisan infrastructure bill.   

Biden, Obama Get Involved with Consequential Virginia Gubernatorial Race

Over the past week, both President Joe Biden and former President Barack Obama have separately campaigned alongside Virginia Democratic gubernatorial candidate and former Governor Terry McAuliffe as polls show that McAuliffe is neck-and-next with his Republican opponent Glenn Youngkin.  While Virginia has voted for the Democratic presidential candidate in every general election since 2004, Virginia’s off-year gubernatorial rate is widely seen as a bellwether for the midterm elections. Democrats are worried about an upset similar to Republican candidate Bob McDonnell’s victory in 2009 for the governorship of Virginia, which preceded historic midterm election losses for the party in the House of Representatives the following year.  While former President Donald Trump has endorsed Youngkin, the two have not made any joint campaign appearances.   

CDC Okays Fourth Booster Shot for Immunocompromised

On October 25, the CDC quietly updated its COVID-19 vaccine guidelines to allow “moderately or severely immunocompromised” people to receive a fourth “booster” dose six months after their third booster dose.  Back in August, the FDA and CDC recommended third booster shots for immunocompromised who had been initially vaccinated with the two-dose Pfizer and Moderna vaccines.  The CDC’s rationale for the new guidelines is to combat waning immunity and to account for the fact that immunocompromised people do not generate the same immune response to mRNA COVID-19 vaccines as people with healthy immune systems. The guidelines will impact an estimated 2.7 million immunocompromised Americans, according to the CDC.

Lawmakers Celebrate Third-Annual “Bipawtisan” Halloween Parade

On Wednesday, members of Congress gathered in the Hart Senate Office Building for the third-annual “bipawtisan” Halloween parade, which featured lawmakers’ dogs in costumes.   Sen. Thom Tillis (R-NC), who started the parade back in 2018, brought along his two pups who were respectively dressed as Senate Majority Leader Mitch McConnell (R-KY) and Sen. Kyrsten Sinema (D-AZ).  Other notable costumed canine include the dog of Sen. Mitt Romney (R-UT), who appeared as “Pierre Doglecto,” which is a play on his owner’s anonymous Twitter account.   Additionally, Rep. Sara Jacobs (D-CA) brought her pup Nan, who was dressed as Speaker Nancy Pelosi (D-CA).

ICYMI: Sinema’s Denim Vest Draws Reactions

On Tuesday, Sen. Kyrsten Sinema (D-AZ) sparked controversy when she wore a denim vest while presiding over the US Senate.  The attention over Sinema’s sartorial choices comes as the Senator is under increased scrutiny for her role in negotiations over the Democrats’ social and climate spending bill.  While the denim vest might be different from the attire usually spotted on the Senate floor, it’s not out of character for Sinema.  The senior Arizona Senator is known for her eccentric fashion choices, which have ranged from colorful wigs to backpacks.  Notably, journalists in the Senate press gallery are prohibited from wearing denim

What Happened, What You Missed: October 18-22

FDA Authorizes Moderna, J&J Boosters, Approves Mixed Booster Regimens

On October 20, the Food and Drug Administration (FDA) authorized “booster” shots for people who initially received vaccines from Moderna and Johnson & Johnson (J&J).  Moderna recipients will be eligible for a third dose six months after their second shot if they’re age 65 or older, between ages 18-64 and are at risk of severe complications from COVID-19, or have frequent “occupational exposure” to the virus.  However, all J&J vaccine recipients will be eligible for a booster at least two months after their initial shot, likely due to the J&J vaccine’s lower efficacy.  Of note, the FDA also authorized a “mix-and-match” approach that allows people to receive a vaccine as a booster dose that’s different from the vaccine used in their initial vaccination regimen.  On October 21, a Centers for Disease Control and Prevention (CDC) advisory panel issued booster shot recommendations that were aligned with the FDA’s authorization.  

Two Longtime House Dems Announce Retirement

Earlier this week, Reps. David Price (D-NC) and Mike Doyle (D-PA), both of whom have served in Congress for over 20 years, announced they will not seek an additional term in the 118th Congress.  Their announcements came just a week after House Budget Committee Chairman John Yarmuth (D-KY) announced that he will not be running for reelection.  While all three Democrats represent safe Democratic districts, their retirements are stoking fears that the party is facing an increasingly uphill battle to maintain its majority in the House in the next Congress.  Already, five Democrats who represent competitive districts have announced their retirement plans.

House Dems Inch Toward $2T Reconciliation Framework, but Questions Remain

Leading House Democrats left a closed-door meeting on Wednesday saying they’re optimistic that they could reach an agreement on a $2 trillion reconciliation package as soon as the end of the week.  Scaling down the package from its originally proposed $3.5 trillion level would require significant changes, and President Biden, suggested on Tuesday in meetings with House Democrats, that two years of free community college and lifting the cap on the state and local tax (SALT) deduction could be dropped from the final measure.  However, Democrats representing high cost-of-living districts in the Northeast have said they won’t support a broader reconciliation package without restoration of the SALT deduction. Also, centrist Sen. Joe Manchin (D-WV), whose vote is essential for ensure passage in the Senate, is staying firm on his demand for no more than $1.5 trillion in new spending.

Senate, House Dems Differ on ARPA-H Funding Levels, Placement

The Biden administration’s proposal to create an Advanced Research Projects Agency for Health (ARPA-H) to drive innovation in biomedical research is advancing in Congress, albeit under two different approaches.  On October 18, the Senate Appropriations Committee released a bill that would provide $2.4 billion to the new agency for Fiscal Year (FY) 2022.  However, there are two bills in the House that offer a different FY 2022 funding level for ARPA-H.  House Energy and Commerce Health Subcommittee Chairwoman Anna Eshoo (D-CA) just recently introduced a bill that would provide the new agency $3 billion for FY 2022, the same amount that the House included in its FY 2022 appropriations minibus it passed in July.  Additionally, both chambers differ on the placement of ARPA-H.  The Senate appropriations bill would house the new agency under the National Institutes of Health (NIH), while Eshoo’s bill would make ARPA-H an independent agency within the Department of Health and Human Services (HHS).

ICYMI: Paris Hilton Meets with Lawmakers on Capitol Hill

On Wednesday, actress and socialite Paris Hilton hosted a press conference on Capitol Hill, where she called on President Biden and Congress to take action against congregate care facilities that abuse children.  Hilton, who endured abuse as a teen in a psychiatric youth treatment center in Utah, appeared with other survivors in Washington to advocate for the Accountability for Congregate Care Act.  During her visit, Hilton met with Sen. Mitt Romney (R-UT), Sen. Jeff Merkley (D-OR), and Rep. Ro Khanna (D-CA).

What Happened, What You Missed: October 11-15

Biden Likely to Nominate Califf to Lead FDA

On October 14, The Washington Post first reported that former Food and Drug Administration (FDA) Commissioner Robert Califf is the Biden administration’s top pick to lead the FDA.  Califf previously served as FDA Commissioner for nearly a year during the second term of the Obama administration.   Despite the agency’s important role in addressing the COVID-19 pandemic, the FDA has been without a permanent leader since the current administration took office in January.  If confirmed, Califf will play a pivotal role in leading the FDA through what is hopefully the final stage of the pandemic and overseeing the review of vaccines and treatments.  However, the White House has said a final decision has yet to be made, and sources close to the vetting process have acknowledged that the situation could still change.

FDA Advisory Panel Approves Moderna “Booster” for Seniors, At-Risk People

The FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted on Thursday to recommend that the agency authorize a “booster” dose of Moderna’s COVID-19 vaccine for all individuals over 65 and younger people who have chronic medical conditions and/or are essential workers.  The Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to vote on the Moderna booster doses on October 21, and a final FDA decision could follow within days. Recap: three weeks ago, the FDA amended the emergency use authorization (EUA) of Pfizer’s COVID-19 vaccine to make it the first vaccine available as a booster dose. 

Authorization of COVID-19 Antiviral Pill Anticipated in December

In their October 14 public meeting, the FDA VRBPAC announced that it will meet on November 30 to review data on Merck’s experimental oral antiviral COVID-19 treatment, which potentially means that FDA could issue an EUA for the antiviral drug sometime in December.  On Monday, Merck submitted an EUA for the drug, known as molnupiravir, which contained data showing that the antiviral treatment reduced hospitalization and death by 50%.  While the FDA does have the option to bypass review by VRBPAC, the agency communicated in a press release that it believes a “public discussion” will help “ensure clear understanding of the scientific data” necessary to decide whether it’s worth approving the antiviral for emergency use.

House Dems Clear Short-Term Debt Ceiling Bill, but Divisions on Reconciliation Bill Remain

On October 12, the House voted 219-206 to increase the debt ceiling by $480 billion, staving off default through at least early December. But despite unanimous support among House Democrats to address the debt ceiling, which they will have to address again in two short months, members of the caucus have yet to come to an agreement on a $3.5 trillion budget reconciliation package. Democrats can only afford to lose three votes in the House and no votes in the Senate. Therefore, achieving unanimous or near-unanimous support in both chambers has been an enormous challenge for the White House and Democratic leadership, who are eager to pass a measure in the upcoming weeks.  On Tuesday, Speaker Nancy Pelosi (D-CA) acknowledged that the bill’s final price tag is likely to be lower than $3.5 trillion as lawmakers within the party continue to negotiate on the  final package. 

ICYMI: Zebras Are on the Loose outside Washington, DC

Three zebras who escaped from a farm in Upper Marlboro, MD in August have been spotted roaming the wooded areas and green spaces of the Maryland suburbs of Washington, DC for the past several weeks.  While wildlife experts say the zebras appear to be safe due to a lack of predators like lions and hyenas, one of the zebras unfortunately died last month after it was caught in an illegal snare trap in Prince George’s County, MD.  Although local animal control officials are on the case, experts say catching the zebras will be difficult due to their intelligence and strong fight-or-flight response. 

What Happened, What You Missed: October 4-8

Pfizer Asks FDA to Authorize Vaccine for Kids

On October 7, Pfizer formally asked the Food and Drug Administration (FDA) to authorize its COVID-19 vaccine for emergency use in children aged 5-11.  When approved, an estimated 28 million children in the US will be eligible for vaccines.  The FDA Vaccines and Related Biological Products Advisory Committee is scheduled to meet on October 26 to discuss use of the Pfizer vaccine in kids, and federal health officials have said emergency use authorization (EUA) could come between late October and late November. 

Senate Clears Short-Term Debt Ceiling Increase

Late Thursday, the Senate voted 50-48, a party line vote, to increase the debt ceiling by $480 billion, which the Treasury Department estimates will enable the federal government to continue to borrow money through December 3.  The current debt limit expired on August 1, and the Treasury Department has been using extraordinary measures to ensure the federal government can meet its debt obligations since then.  However, Thursday’s vote doesn’t change the underlying standoff that caused gridlock over the debt ceiling in the first place.  Since extraordinary measures have been mostly exhausted, the Treasury Department will have little wiggle room to ensure the government can continue to pay its bills if Congress once again fails to address the debt ceiling by December 3.

White House Announces New $1B Investment in At-Home COVID-19 Tests

On October 6, the Biden administration announced plans to invest an additional $1 billion to boost the manufacturing capabilities for rapid, at-home COVID-19 tests.  According to the White House COVID-19 Response Coordinator Jeff Zients, the administration’s $1 billion investment along with the FDA’s recent approval of a rapid antigen test from ACON Laboratories could increase the number of at-home tests by 200 million per month by the year’s end.  As more Americans return to work and school, many public health experts have said more at-home tests could stop asymptomatic spread and control outbreaks.

Experimental Antiviral Shows Promise in Reducing Hospitalization, Death from COVID-19

On October 1, Merck reported that a phase 3 trial of its oral antibody treatment molnupravir reduced the risk of hospitalization or death by about 50% in COVID-19 patients.  The company also mentioned that it plans to seek an emergency use authorization from the FDA “as soon as possible.”  Public health experts see the arrival of an antiviral pill along with the availability of vaccines for children as a major step in transitioning out of the current public health emergency.

ICYMI: Filming Underway in DC for New HBO Series on Watergate

Over the past two weeks, Washington, DC residents have spotted Woody Harrelson and Justin Theroux, who are in town to film an upcoming HBO docuseries on the Watergate scandal called The White House Plumbers.  Filming of the five-part series has so far brought 1970s-era cars and a recreation of the Nixon campaign headquarters into downtown DC.  Fun fact, Justin Theroux is a Washington, DC native.