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.

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

Pfizer Submits Initial Data on COVID-19 Vaccine in Kids

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

CDC: Side Effects from Booster Shots Are Mild

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

Gallup: Delta Variant Likely Prompted More Americans to Get Vaccinated

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

Congress Averts Shutdown, but Leaves Debt Limit Unresolved

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

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

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

When Are Kids Going to Get Vaccinated?

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.

What Happened, What You Missed: September 13-17

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.

What’s Taking FDA So Long to Fully Approve Pfizer’s COVID-19 Vaccine?

It took the Food and Drug Administration (FDA) just three weeks to issue an emergency use authorization (EUA) for Pfizer’s COVID-19 vaccine in December 2020 when Pfizer submitted the request.  In contrast, it’s been over two months since Pfizer initiated a “rolling submission” of its biologics license application (BLA) for its vaccine on May 7, and FDA has yet to comment on its timeline for approval.  Amid growing calls for FDA to fully approve Pfizer’s vaccine, what’s making the review process take so long?

Why the Push for Full Approval?

Many people believe full approval of Pfizer’s COVID-19 vaccine will help get more shots into arms, which is seen as vital to protecting Americans from the rapidly spreading Delta variant.  According to data from the Centers for Disease Control and Prevention posted on July 6, the Delta variant makes up 51% of new COVID-19 cases in the US.  Additionally, studies show the Delta variant is at least 40% more transmissible than the Alpha variant, which was previously the country’s dominant variant.  The surge in the Delta strain comes as many Americans remain vulnerable to COVID-19, as only 67% of Americans have received at least one COVID-19 shot, and the pace of vaccinations has dropped off considerably in recent weeks. 

Full approval of the COVID-19 vaccine is one way public health experts believe could convince more Americans to roll up their sleeves, which addresses vaccine hesitancy, a sentiment echoed by several major elected officials.   In June, President Joe Biden said going from “temporary approval to full approval” would “increase the number of people” willing to get vaccinated.  Similarly, Arkansas Governor Asa Hutchinson, whose state has some of the nation’s lowest vaccination rates, remarked in June that full approval is needed to combat vaccine hesitancy.  According to a Kaiser Family Foundation poll from May 2021, 32% of unvaccinated adults said full approval of one of the currently authorized vaccines would make them more likely to get vaccinated.

Furthermore, fully approving the vaccine will allow for more businesses and organizations to mandate the COVID-19 vaccine, which could help increase vaccination rates.  While several hospitals and health systems such as Houston Methodist and Trinity Health have mandated the vaccine for their employees, some health systems like Beth Israel Leahy Health in Boston are holding off until a vaccine is fully FDA-approved.  Even though lawsuits against vaccine mandates have so far held up in court, many employers and organizations seem to be holding off on mandating  employees to get the vaccine out of fear of litigation.   Even the US Army has communicated to servicemembers that vaccination won’t be mandated until “full FDA licensure.”

What’s the Hold Up?

The reason for FDA’s longer process for fully-approving Pfizer’s COVID-19 vaccine is due to the fact that the business of issuing a BLA is more intensive than an EUA.   For an EUA to be issued, companies need to provide the FDA data that demonstrates efficacy and safety from a Phase 3 trial with a median follow-up period of at least two months.  In contrast, a BLA requires FDA to look through at least six months of clinical trial data as well as a close examination of the company’s manufacturing process, both of which take additional time.  Dr. Paul Offitt, a member of FDA’s Vaccines and Related Biological Products Advisory Committee,  commented in December 2020 that Merck’s BLA submission for its 70,000-person rotavirus vaccine trial contained enough pages to exceed the height of the Sears Tower, a 1,450-foot skyscraper in Chicago currently known as the Willis Tower.

There are benefits for drug manufacturers in getting their products fully approved.  According to former FDA Commissioner Dr. Robert Califf, a BLA would allow Pfizer to being marketing its vaccine directly to consumers.  Additionally, full approval would open the door to Pfizer increasing the price of its vaccine post-pandemic, potentially generally billions of dollars for the company.

When Will the Vaccine Be Fully Approved?

Unfortunately, FDA has yet to shed any light on its timeline for fully approving the Pfizer vaccine.  In late June, an FDA spokesperson  told The Hill that the agency “cannot comment on individual applications before it.”  More recently, the FDA told Army Times on July 2 that timelines for approval “may vary depending on a number of factors.” 

While fully approving a vaccine normally takes between 8-12 months, there is reason to believe Pfizer will receive a decision from the FDA soon. Former FDA scientist Jesse Goodman said in June that the FDA might not complete its review process for another 3-4 months, meaning a BLA might not come until  September or October.  Notably, Goodman cautions against fully approving the vaccine too quickly, as it could “undermine confidence” in the vaccine. 

Ultimately, FDA is in a tough position.  As a full review of the Pfizer vaccine continues, the agency must strike a balance between ensuring the American people can benefit from a fully approved vaccine in a timely manner without giving off the sense that the BLA was issued too quickly.  Absent any communication from FDA, however, vaccine observers have no choice but to sit and wait.

What Happened, What You Missed: July 5-9

CDC, FDA Counter Pfizer on Need for Booster Shot

On July 8, the Centers for Disease Control and Prevention, and the Food and Drug Administration issued a joint statement saying that vaccinated Americans “do not need a booster shot at this time.”  The agencies also affirmed that currently approved vaccines are still effective against variants such as Delta.  The statement was issued hours after Pfizer announced it will soon seek authorization for a COVID-19 booster to provide added protection against COVID-19 variants.  New research out of Israel suggest Pfizer’s vaccine is less effective against the Delta variant, which is prompting greater interest in booster shots. CDC and FDA have vowed to continue to review new data on vaccine efficacy as it becomes available.

Biden Outlines “Door-to-Door” Vaccination Push

On July 6, President Joe Biden announced a new community-focused effort to get more Americans vaccinated though door-to-door outreach, mobile clinics, and directing  more vaccine doses to workplaces, pharmacies, and doctor’s offices.  The President’s announcement comes as parts of the country with lower vaccination rates have seen an increase in new cases due to the Delta variant.  According to the CDC, the Delta variant comprises 51% of new COVID-19 cases in the US.  Biden also announced a goal to get as many adolescents aged 12 to 18 vaccinated as soon as possible before the school year begins as well as the mobilization of new “COVID-19 Surge Response teams” to aid communities with higher numbers of unvaccinated people. 

New Study: Vaccines Prevented 279K Deaths

According to a study released on July 7 by the Commonwealth Fund, the US vaccination campaign against COVID-19 prevented about 279,000 deaths and 1.25 million hospitalizations between December 12, 2020 and July 1, 2021.  The study also found that vaccines blunted the spread of the Alpha variant in the spring, preventing nearly 4,500 deaths per day.  However, the report warned that the Delta variant will continue to pose a “special threat” to unvaccinated populations in the coming months, requiring renewed commitment to vaccinations.

FDA Limits Use of New Alzheimer’s Drug to Early-Stage Patients

On July 8, Biogen announced that the FDA had updated the labeling for its recently approved Alzheimer’s drug so that it can only be usedfor patients with mild Alzheimer’s disease.  This change in labeling comes after the drug, known as Aduhelm, attracted criticism for being approved for all patients with all stages of Alzheimer’s when its clinical trials only included people in the earliest stages of Alzheimer’s.  The decision to narrow the number of people who can be treated with the drug could address the criticism of Aduhelm’s financial impact, which has a list price of $56,000.

Fencing Around Capitol to Come Down Soon

According to a memo from the House Sergeant at Arms to all members of Congress and staff, the remaining fencing surrounding the US Capitol Building will start being removed as early as July 9.  The black perimeter fencing was initially put up to bolster security at the Capitol in the wake of the January 6 riot.  The memo states that the Architect of the Capitol has the ability to “expeditiously reinstall” the fencing, if it is needed.  An outer perimeter fence that closed off several blocks around the Capitol was already removed in March.  Despite pending removal of the remaining fence, which is expected to take about three days, the Capitol still remains closed to visitors. 

ICYMI: New Book Looks at the Role of Presidents’ Friends

A new book by journalist and former political operative Gary Ginsburg was published on July 6, tells the story of nine friends to  US presidents and the impact of their relationships.  For example, Eddie Johnson, a longtime Jewish friend of President Harry Truman, may have played a pivotal role in lobbying the 33rd president to make the US the first nation to recognize the statehood of Israel.  Other friendships profiled include President Franklin Pierce and Nathaniel Hawthorne, author of The Scarlet Letter, and President Bill Clinton and Vernon Jones, his golfing partner.

Everything You Need to Know about COVID-19 Booster Shots

Every year, you get your flu shot.  Will the same be said for COVID-19 shots?  No one knows for sure, but federal officials and public health experts are weighing in on whether certain people might need COVID-19 booster shots as soon as this fall.  With questions about the longevity of vaccine-induced immunity and the potential for vaccine-eluding variants still unanswered, it certainly does not hurt to prepare.

What Is the Administration Planning?

On May 11, David Kessler, MD, Chief Science Officer of the White House COVID-19 Response Team, told a Senate panel that the Biden Administration is preparing for the possibility of booster shots for people who do not have a robust or long-lasting immunity, or if new variants evade protection from previously-administered vaccines.  Kessler said the booster shots would likely be a third shot of Pfizer or Modern’s mRNA vaccine rather than a new shot tailored to emerging variants.  He also confirmed that the booster shots would be free to Americans and funded by congressional appropriations through the end of Fiscal Year (FY) 2021.  Since Kessler’s testimony, the Administration purchased 200 million additional doses of Moderna’s COVID-19 vaccine in June to vaccinate children or to serve as a booster shot for adults.  Any decision to use booster shots would be up to the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC).

Kessler’s testimony was not the first time someone raised the possibility that people vaccinated against COVID-19 could need booster shots in the future.  In February, Johnson & Johnson CEO Alex Gorsky said COVID-19 booster shots may be needed annually, like flu shots.  Similarly, Pfizer CEO Albert Bourla said in April that people will likely need a third dose of a COVID-19 vaccine within 12 months of being fully vaccinated. 

How Long Does Immunity from Vaccines Last?

Since the vaccines were just developed in 2020, experts say only time will tell how long protection from the vaccines will last.  Of the few studies conducted so far, research from the New England Journal of Medicine published in April 2021 found Moderna’s COVID-19 vaccine can produce strong antibody protection for at least six months following the second dose.  Pfizer also announced research findings in April confirming its vaccine’s efficacy six months after the second dose.  

However, new research suggests it could be for a year or longer.  A pair of studies published in May 2021 found that the B-cells of people infected with COVID-19 still continued to mature and strengthen one year after infection, suggesting some type of immune response.  More recently, a study published in the journal Nature in June suggested immunity from mRNA vaccines could last for years.

What about the Variants?

However, many of these studies were conducted before the Delta variant became more prevalent.  Public health experts say the Delta variant, which was first discovered in India in October 2020, is 43-90% more transmissible than previous COVID-19 variants, leading some to believe that currently-approved vaccine are less efficacious against the  Delta variant.  A recent study said the Delta variant could become dominant in the US by mid-July.

Fortunately, the vaccines still offer strong protection.  According to a study by Oxford University researchers, two doses of the Pfizer vaccine appears to provide 79% protection against the Delta variant, compared to 92% against the Alpha variant, which is currently the dominant variant in the US, and was first discovered in the United Kingdom in September 2020.  Since the Moderna vaccine uses the same mRNA technology as Pfizer’s, it can be inferred that two Moderna doses offer the same levels of protection as the Pfizer vaccine provides against the Delta variant. 

But what about the Johnson & Johnson vaccine?  Compared to its Moderna and Pfizer counterparts, the single-dose vaccine has been administered far less, meaning public health officials have little data regarding its effectiveness against the Delta variant.  However, experts say a Johnson & Johnson vaccine is better than no vaccine at all, and that one dose is likely effective at protecting a recipient against serious illness or death.  Additionally, former Senior Advisor to the COVID-19 Response Coordinator Andy Slavitt has said that recipients of the Johnson & Johnson could take a single mRNA booster shot now for added protection.

Nonetheless, just because the current vaccines remain effective against the Delta variant does not  mean they are  necessarily guaranteed to be effective against future variants.  As explained by CDC Director Rochelle Walensky on June 22, the Delta variant represents a “set of mutations” of COVID-19, and future mutations could produce a variant that evades protection from vaccines.  However, scientists say it’s unlikely a variant will arise that will make COVID-19 vaccines totally unless.  While vaccines appear to offer diminishing protection from being infected from newer COVID-19 variants, they still appear effective at preventing hospitalization and death.    

The Jury Is Still Out

The point of vaccines is to protect people from serious illness and death, and until fully vaccinated individuals are finding themselves with infections severe enough to require hospitalization, is it difficult to predict when booster shots will be needed and how often.  In an interview on May 21, National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said the need for booster shots is still unclear.  The CDC Advisory Committee on Immunization Practices reached a similar conclusion on June 24, saying there currently is not enough data to determine booster shots are needed, although the panel did not rule out the possibility of requiring booster shots if immunity wanes or new variants render existing vaccines less effective.  Considering this risk, the evolving nature of the virus, and the pain the world has already experienced at the hand of COVID-19, the US government has every reason to prepare for the worst and continue this conversation around COVID-19 booster shots.

Is an Effective Alzheimer’s Treatment Around the Corner?

More than 6.2 million Americans currently have Alzheimer’s disease, a number that is projected to double by 2050.  Despite a growing need to treat Alzheimer’s, some four decades of research have yet to yield any effective therapeutics.  This could change as soon as June 7, 2021, which is the date the Food and Drug Administration (FDA) may decide to approve a new Alzheimer’s treatment from Biogen.  Why has it been so hard to develop an effective Alzheimer’s treatment, and does Biogen’s drug mark a breakthrough?

Failed Research Efforts So Far

Since the National Institute on Aging first began studying ways to treat Alzheimer’s disease in earnest in 1978, progress on effective therapeutics has been extremely limited.  A major reason for the lack of progress is the newness of the field of neurobiology, especially as it applies to Alzheimer’s, dementia, and other complex brain disorders.  Most of the knowledge on the human brain has only been acquired within the last 40 years, while a better understanding of genetic and biologic pathways has only occurred within the last 30 years.  Additionally, brain lesions and biomarkers associated with Alzheimer’s could not be visualized until 2004.  As a result, meaningful research and development of  Alzheimer’s treatments could not accelerate until a quarter-century worth of understanding could be attained.

Since the 1990s, research pertaining to  Alzheimer’s treatments has focused on how the disease develops and progresses.  Alzheimer’s develops when toxic plaques clump together between neurons in the brain, resulting in inflammation and cell death in the brain.  Many potential drug treatments have failed while under development and at a higher rate than other drugs —  99.6% for Alzheimer’s drugs in development have failed, compared to an 80% failure rate for cancer drugs.  Among those failed potential therapies were a a pair of therapeutics from Eli Lilly and Roche, which saw their clinical trials end in February 2020.  Researchers point to the complexity of Alzheimer’s as one of the reasons why so many promising treatments have gone to the wayside.  The last Alzheimer’s therapeutic to receive FDA approval was Forest Labs’ Namenda in 2003, which along with the handful of other Alzheimer’s drugs, only alleviates symptoms temporarily

Enter Stage-Right: Aducanumab

Like other recent drug development programs, Biogen’s aducanumab is an injectable, monoclonal antibody treatment that targets plaque build-ups between neurons.  If approved, aducanumab would be the first disease-modifying drug for Alzheimer’s, meaning it is effective in slowing cognitive decline.  This could open the door to Alzheimer’s becoming a chronic disease that people live with for many years, similar to diabetes and cancer

According to data discussed during an FDA advisory committee meeting in November 2020, aducanumab proved effective in a small phase 2 clinical trial and one of two large phase 3 clinical trials. 

Will FDA Give Aducanumab the Nod?

Mr. Barker, the answer is “not sure.”  While the experimental drug was shown effective in the small phase 2 and large phase 3 trials, a second phase 3 trial failed to yield positive results.  As a result, some members of the panel have expressed a desire to see more data from an additional phase 3 trial, although such an undertaking would require another three to five years of research.  Additionally, there is some concern about the actual benefits of aducanumab, which showed only modest changes on two objective measures used in the clinical trials: the Mini-Mental State Examination and the Alzheimer’s Disease Assessment Scale. 

Also, there are concerns about side effects which may not only impact patients but also  the health care system as a whole.  30% of clinical trial participants who took the drug were found to have a reversible swelling of the brain, while over 10% had small brain bleeds.  These side effects were detected using amyloid positron emission tomography (PET) scans, and given the millions of Alzheimer’s patients, the large number of PET scans necessary to monitor for side effects would test the limits of neurologists, radiologists, and other clinicians.

What’s the Cost?

Aducanumab will be sure to have a high price tag if approved.  One year’s worth of aducanumab treatment could be priced as high as $50,000 per year, and if only a third of the 6 million Americans with Alzheimer’s were to take the drug, sales could reach $36 billion a year.  Since most people with Alzheimer’s begin noticing symptoms in their mid-60s, Medicare is likely to pick up the tab for most aducanumab treatments, not to mention the PET scans and other health care services required to monitor for side effects.

What Could Happen?

FDA is not in an enviable position on aducanumab.  The agency may determine that it cannot sign off on the safety and efficacy of the drug, or at least request more data before making a decision, despite the clear and significant need such a drug for those currently affected by Alzheimer’s and their loved ones.  As such,the projected growth in the number of Alzheimer’s patients and a lack of existing therapeutics mean any decision on June is sure to impact millions of people.