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What Happened, What You Missed: October 11-15

  • Posted In FDA

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.

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What Happened, What You Missed: October 4-8

  • Posted In FDA

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.

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

  • Posted In FDA

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.

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When Are Kids Going to Get Vaccinated?

  • Posted In FDA

Parents are mad.  While grown-ups have been eligible for COVID-19 vaccines for almost a year, there currently aren’t any options for children under 12.  This is especially concerning for many parents as the kids return to school amid a nationwide surge in cases.

A Different Process

On September 20, Pfizer/BioNTech released data showing its mRNA vaccine is safe and effective in children aged 5-11.  As the Food and Drug Administration (FDA) has fully approved the vaccine for individuals aged 16 and older and Pfizer/BioNTech vaccine is still available to individuals aged 12 to 15 through emergency authorization, why is the approval process taking so long for children?

  • More data.  Earlier this year, FDA asked Pfizer/BioNTech and the other vaccine developers to provide six months of follow-up data for all clinical trial participants.  In comparison, the approval process for adults only required two months of follow-up data.
  • More scrutiny.  Unlike the emergency use authorization (EUA) for adults, FDA doesn’t just rely on a company’s summary of the clinical trial data for children’s vaccines.  The agency looks at individual reports from every child, including data on side effects and blood tests.
  • Biological differences.  Kids aren’t simply smaller adults.  Children have more active immune systems than grown-ups, which means scientists need to ensure they’re providing the right dosage.  Pfizer/BioNTech has specifically been testing children aged 5-11 with a two-dose regimen administered three weeks apart.  Each dose contains 10 micrograms, which is about a third of the dosage used for individuals aged 12 and up.

Pressure Grows for FDA to Speed Up Timeline

Earlier this year, it appeared that FDA would be able to approve vaccines for children aged 5-11 by early fall, just in time for the start of school.  However, signs that the approval timeline would extend first appeared in July when 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.  These changes caused many health experts to revise their predictions on a timeline for approval for EUA, with some saying that the FDA would not make a decision until winter 2021 or early 2022.

The prospects of a longer timeline combined with a nationwide surge in cases sparked panic among many parents of younger children.  While COVID-19 poses a low risk for healthy kids, there is a justifiable concern about immunocompromised children as well as the ability for kids to pass the virus onto vulnerable adults.  As a result, some parents are even looking for doctors to skirt the rules and vaccinate their children, while others are signing their kids up for clinical trials, even though it’s unknown whether their child will be receiving the vaccine or a placebo.

Pressure from Pediatricians: The American Academy of Pediatrics (AAP) urged the FDA in an August 5  letter to “continue working aggressively towards authorizing safe and effective COVID-19 vaccines for children under age 12 as soon as possible” due to the threat posed by the Delta variant.  Specifically, AAP indicated that a two-month follow-up period to collect safety data is sufficient, as opposed to the six-month period FDA initially requested.  AAP also noted that reported cases of myocarditis in children who are receive mRNA vaccines like Pfizer/BioNtech’s are “extremely rare.”

The FDA is listening and took the rare step of publicly responding to the concerns around approving a COVID-19 vaccine for children on September 10. .  In addition to vowing to adhere to strict safety standards, FDA stated clinical trials are required to have a “follow-up period for safety data of at least about two months,” indicating a change from the previously requested six-month follow-up period.

The Timeline, Revised

With the FDA apparently open to a shorter follow-up period for safety data, what does the approval timeline look like now?  At the the Morgan Stanley Global Healthcare Conference 2021 on September 14, Pfizer CEO Albert Bourla laid out a new estimated approval timeline for children aged 5-11.

  • Pfizer to have all safety and immunogenicity date in late September (topline results were released on September 20).
  • Pfizer to file for EUA in early October.
  • FDA to approve EUA within 3-6 weeks, meaning children aged 5-11 could get their shots as soon as late October or early November. 

Bourla also said Pfizer will likely have enough data on how well its vaccine works on children under 5 years of age as early as the end of October, putting that vaccine on the path for EUA by the FDA by the end of the year.

This is reassuring news for parents of kids aged 5-11, to potentially have a vaccine available by Halloween than, say, early 2022.  But let’s not get our hopes up as COVID-19 has proven itself to be an incredibly unpredictable virus, and changing conditions could cause scientists and regulators to shift their approval considerations once again.

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What Happened, What You Missed: September 13-17

  • Posted In FDA

Ahead of a September 17 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), Food and Drug Administration (FDA) staff declined to take a position on whether to back third-dose “booster” shots of the Pfizer COVID-19 vaccine in a meeting briefing document.  While FDA staff acknowledged that some observational studies have pointed to declining efficacy of the Pfizer vaccine over time, much of the data presented in these studies has yet to be verified independently.  FDA staff also wrote that overall data indicates all currently authorized COVID-19 vaccines still offer protection against hospitalization and death.  Alongside the briefing document, FDA released data from Pfizer’s application for booster shots on September 15 that offers the company’s case for a third, immunity-restoring dose that VRBPAC will consider during its Friday meeting.  Separately, Moderna announced on Wednesday new data that points to benefits of a third “booster” dose of its vaccine.

House Dems’ Drug Pricing Plans on Thin Ice after E&C Markup

On September 15, three moderate House Democrats – Reps. Scott Peters (D-CA), Kathleen Rice (D-NY), and Kurt Schrader (D-OR) – blocked passage of a measure to allow the government to directly negotiate on drug prices during the third day of the Energy and Commerce (E&C) Committee markup.  Even though the drug pricing measure passed the Ways and Means Committee later that day, the push-back from the three moderate House Democrats signifies the challenges Speaker Nancy Pelosi (D-CA) faces in securing near-unanimous support among House Democrats to advance the $3.5 trillion “human” infrastructure plan. Reps. Peters, Rice, and Schrader believe the sweeping price negotiation plan would hurt drug innovation and has no chances of passing the Senate.  Instead, they are pushing for a more modest proposal that would subject price negotiations to a limited number of drugs, which progressive Democrats consider to be a non-starter.

CMS Proposes to Repeal Medicare Breakthrough Device Coverage Rule

On September 13, the Centers for Medicare and Medicaid Services (CMS) issued a proposed rule to repeal a Medicare breakthrough device coverage rule that was finalized in the waning days of the Trump administration in January 14, 2021.  Under the initially established pathway,  Medicare would cover a breakthrough medical device for four years beginning on the date of FDA authorization.  However, under the Biden Administration, CMS feels the rule needs to be withdrawn because FDA’s approval standards do not necessarily mean a product is safe for Medicare’s patient population.  The proposed rule is considered a win for the insurance industry, which felt the coverage pathway would result in “premature coverage of unproven devices for the Medicare population.”  And, if CMS finalizes the rule, it  would be bad news for medical device manufacturers, which saw Medicare coverage as payoff for taking the risk to develop breakthrough devices.

Pompeo, Christie Named Co-Chairs of Republican Redistricting Group

Former Secretary of State Mike Pompeo and former New Jersey Governor Chris Christie were named national co-chairs of the National Republican Redistricting Trust (NRRT), an organization aimed at providing resources to support Republicans in the post-2020 census redistricting process.  NRRT was launched in 2017 as a counterweight to the National Democratic Redistricting Committee, which is being led by former Attorney General Eric Holder during the Obama administration.  The announcement comes as both parties prepare for a redistricting process that is likely to face numerous legal challenges.  As discussed in an August 10 blog post, Democrats’ razor-thin majority in the House means redistricting could have an outsize effect on which party controls the lower chamber after the 2022 midterm elections.

ICYMI: Congressman Gets Mistaken for an Intern

Overheard DC, a Twitter account that shares interesting exchanges heard around the nation’s capital, posted an exchange  on Tuesday of a congressional intern asking an individual at the Subway in the Rayburn House Office Building who he worked for.  The individual replied, “I’m a member,” meaning he’s a member of Congress. The member in question turned out to be Rep. Gregory Meeks (D-NY), who currently chairs the House Foreign Affairs Committee.  Meeks later commented “glad I still blend in with the cool kids” when resharing the Overheard DC tweet.  The tweet also saw engagement from Rep. Abigail Spanberger (D-VA), who said she had previously experienced a similar case of mistaken identity.

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