Skip to main content

FDA advisers tackle the first RSV vaccines

Delivered every Tuesday and Friday by 12 p.m., Prescription Pulse examines the latest pharmaceutical news and policy.
Feb 28, 2023 View in browser
 
POLITICO's Prescription Pulse newsletter logo

By Katherine Ellen Foley and David Lim

Driving the Day

An electron micrograph of Respiratory Syncytial Virus, also known as RSV, is pictured.

FDA advisers could recommend that the agency approve two first-time vaccines for respiratory syncytial virus, shown in the image above. | CDC via AP

FDA ADVISERS TO VOTE ON RSV VACCINES — The FDA’s Vaccine and Related Biological Products Advisory Committee convenes a two-day meeting today to consider recommending two new respiratory syncytial virus vaccinations for adults 60 years and older. If recommended and the FDA then approves them, the candidates from Pfizer and GSK would be the first vaccines against RSV for any age group.

The RSV vaccine pipeline came into the spotlight this past holiday season when a trifecta of respiratory viruses — the flu, Covid-19 and RSV — put health officials nationwide on high alert for an overwhelming number of hospitalizations.

Typically, RSV produces a mild, coldlike illness in healthy adults but can be dangerous for young children, older adults and those with compromised immune systems. Federal researchers started working on a vaccine in the 1960s but abruptly halted when a candidate made some pediatric trial participants susceptible to more severe illness from RSV, leading to two deaths. It wasn’t until a decade ago that researchers made the breakthrough to develop a safer effective candidate.

FDA advisers will discuss and vote on whether to recommend Pfizer’s RSV candidate today. The company, which asked the FDA in December to approve its vaccine candidate, reported Phase III trial results demonstrating the vaccine was 66.7 percent effective at protecting against RSV with two or more symptoms and 85.7 percent effective at preventing RSV with three or more symptoms.

However, the FDA raised concerns that Pfizer couldn’t provide data on the duration of immunity or protection for those who are 80 years and older or have compromised immune systems. It also raised concerns that two in nearly 20,000 people who received the vaccine developed Guillain-BarrÊ syndrome, a dangerous autoimmune condition that damages the body’s nervous system. Guillain-BarrÊ cases for adults 60 and older in trials are typically no more than three per 100,000 adults.

On Wednesday, the expert panel will consider GSK’s vaccine, which in late-stage clinical trials was more than 82 percent effective at preventing lab-confirmed RSV among adults 60 and older. One case of Guillain-BarrÊ was reported among the roughly 15,000 participants that received the vaccine.

The FDA’s advisers will consider the benefits of those vaccines — plus the fact that the risk of severe autoimmune reactions like Guillain-BarrÊ syndrome due to viral infections increases with age, regardless of a person’s vaccination status. At the end of both days, they’ll vote on whether they’ll recommend the agency approve these candidates.

The FDA isn’t obligated to follow its expert advice, though it often does. Either way, the agency is slated to make a final approval decision in May.

IT'S TUESDAY. WELCOME TO PRESCRIPTION PULSE. Rep. Alexandria Ocasio-Cortez (D-N.Y.) is talking with Energy and Commerce ranking member Frank Pallone (D-N.J.) about the FDA’s regulation of sunscreen — which she described Monday on Instagram as “woefully behind.”

Send news and tips to David Lim (dlim@politico.com or @davidalim) or Katherine Ellen Foley (kfoley@politico.com or @katherineefoley).


TODAY ON OUR PULSE CHECK PODCAST, Megan Messerly talks with host Alice Miranda Ollstein about the yearlong deadline for states to assess whether their residents on Medicaid are still eligible for the program — and Arkansas' plans to finish its assessment in half the time. Megan previews what could be in store for Medicaid there and in other states.

 

DOWNLOAD THE POLITICO MOBILE APP: Stay up to speed with the newly updated POLITICO mobile app, featuring timely political news, insights and analysis from the best journalists in the business. The sleek and navigable design offers a convenient way to access POLITICO's scoops and groundbreaking reporting. Don’t miss out on the app you can rely on for the news you need, reimagined. DOWNLOAD FOR iOSDOWNLOAD FOR ANDROID.

 
 
Play audio

Listen to today’s Pulse Check podcast

Tobacco

Tobacco is pictured.

The Society for Research on Nicotine and Tobacco holds its annual meeting this week. | Patrick Sison/AP Photo


SRNT GATHERING TO FOCUS ON TOBACCO REGULATION — This week, the Society for Research on Nicotine and Tobacco will convene in San Antonio for its annual meeting. SRNT doesn’t allow members affiliated with the tobacco industry to attend — a policy that organizers instated in 2021.

Brian King, the director of the FDA’s Center for Tobacco Products, will kick off the three-day event with opening remarks about the agency’s progress on tobacco regulation at 1:30 p.m. CST.

Eyes emoji: King’s update on CTP will come after the center responded to the Reagan-Udall’s review of the FDA’s tobacco regulatory operations. King pledged to create an Office of Policy to clearly outline CTP’s priorities, call on its advisory committee for help at least annually and pursue user fees for the products it regulates, including e-cigarettes.

Are you attending SRNT? Reach out to Katherine to say hi at kfoley@politico.com

SUPREME COURT DECLINES TO HEAR RJR CASE — The Supreme Court said Monday it would not hear the case tobacco giant R.J. Reynolds filed against Los Angeles County in California. The company escalated the 2020 case to the Supreme Court following a California statewide ban on most flavored tobacco products, including menthol cigarettes. In November, California voters chose to uphold the flavor ban, which went into effect in December. The Los Angeles case could have overturned the statewide ban, but now it will not.

Eye on the FDA

DUNN DEPARTS — Top FDA regulator Billy Dunn, who led the review of Biogen’s controversial Alzheimer’s drug Aduhelm, has left the agency, according to an internal email sent Monday by the agency’s Office of New Drugs Director Peter Stein.

“Billy has decided to retire from FDA and explore other opportunities while continuing his focus on improving the lives of patients with neurological diseases,” Stein wrote.

Teresa Buracchio, who has served as acting deputy director of the FDA’s Office of Neuroscience since November, is stepping in as acting director. In addition, she has been appointed permanently to the deputy director role.

MEDICAL DEVICES

FIRST OTC FLU/COVID TEST AUTHORIZED — On Friday, the FDA authorized emergency use of the first over-the-counter test that can detect both Covid-19 and the flu. But the test maker — Lucira Health — is in the midst of a Chapter 11 bankruptcy filing and trying to find a buyer.

“The Company anticipated an EUA for an OTC indication on the COVID-19 and Flu test in August 2022, though the FDA’s approval process became protracted, resulting in high expenditures without new revenue from the combined test kit during the 2022-2023 flu season,” Lucira Health said in a press release Wednesday.

The company said it intends to continue normal operations while pursuing a sale.

Around the Agencies


DEA FLOATS REVOKING PANDEMIC TELEHEALTH RULES — The Drug Enforcement Administration proposed Friday to reinstate requirements that patients have in-person visits with doctors to get prescriptions for certain medications that the agency had waived during the Covid pandemic, POLITICO’s Ben Leonard reports.

If the rule is finalized as proposed, patients seeking drugs like Adderall to treat attention-deficit/hyperactivity disorder or Oxycontin for pain must go to a doctor’s office before they can start taking the drug.

The proposed rule would give patients who started those drugs during the pandemic a 180-day grace period to comply with the in-person visit requirement.

Quick Hits

The CDC is tracking a rise in the prevalence of Shigella bacteria cases resistant to antibiotics it describes as a serious public health threat, CBS News’ Alexander Tin reports.

The CDC found evidence of the SARS-CoV-2 virus in more than 80 percent of wastewater from some international flights landing in New York from Aug. 1 to Sept. 9, POLITICO’s Krista Mahr reports.

DOCUMENT DRAWER

The Universities Allied for Essential Medicines North America filed a citizen petition Monday asking the FDA to boost its enforcement of clinical trial reporting requirements.

The FDA cautioned health care providers Monday that Abbott Trifecta heart valves have a potential risk of early structural deterioration.

The FDA issued draft guidance Friday for drugmakers developing neovascular, or wet, age-related macular degeneration.

 

STEP INSIDE THE WEST WING: What's really happening in West Wing offices? Find out who's up, who's down, and who really has the president’s ear in our West Wing Playbook newsletter, the insider's guide to the Biden White House and Cabinet. For buzzy nuggets and details that you won't find anywhere else, subscribe today.

 
 
 

Follow us on Twitter

David Lim @davidalim

Lauren Gardner @Gardner_LM

Katherine Ellen Foley @katherineefoley

 

Follow us

Follow us on Facebook Follow us on Twitter Follow us on Instagram Listen on Apple Podcast
 

To change your alert settings, please log in at https://www.politico.com/_login?base=https%3A%2F%2Fwww.politico.com/settings

This email was sent to rouf@idiot.cloudns.cc by: POLITICO, LLC 1000 Wilson Blvd. Arlington, VA, 22209, USA

Please click here and follow the steps to unsubscribe.

Comments

Popular Posts

💡The most innovative iPhone trick of the year.

Watch the performance: The ULTIMATE every-day carry. Make the physical light on the back of your iPhone come to life and move around. Then hand everything out for examination. This is a wildly innovative idea you have to see to believe.   ...

"Ingenious. Spectators can't reverse engineer it" -Doug Henderson

"I'm doing this first thing in the morning at work, they'll be spitting coffee through their noses, how freaking simply and clever...." - Jeff Thornley https://www.penguinmagic.com/p/7311 Dan Harlan fooled Penn & Teller on national TV recently, and we're proud to present his reputation making mind-reading effect "All Seeing Eye". A masterpiece that will fool everyone you show. Rave reviews have been pouring in since it came out. It's one of the most highly rated tricks on the site.. ...

AI is raising stakes for plastic surgery

The ideas and innovators shaping health care Jan 30, 2024 View in browser   By Daniel Payne , Ruth Reader and Erin Schumaker OPERATING ROOM For plastic surgeons, AI could mean more patients with higher expectations. | Getty ...

Playbook PM: Biden gets an eerie welcome to Pittsburgh

Presented by The American Beverage Association: POLITICO's must-read briefing on what's driving the afternoon in Washington. Jan 28, 2022 View in browser   By Garrett Ross and Eli Okun Presented by A two-lane bridge collapsed in Pittsburgh early Friday, prompting rescuers to rappel nearly 150 feet while others formed a human chain to help rescue multiple people from a dang...

HHS to doctors: Share patient info or else

Presented by Optum Rx: Delivered daily by 10 a.m., Pulse examines the latest news in health care politics and policy. Oct 31, 2023 View in browser   By Chelsea Cirruzzo and Ben Leonard Presented by ...

U.S. court pauses Apple Watch ban / New York Times sues Microsoft and OpenAI / Japan preparing antitrust legislation

Plus: Prime Video will start showing ads on Jan. 29. Inside Tech For December 27, 2023 Here's a glance at today's top tech stories: A court has temporarily paused a U.S. ban on Apple Watches. The New York Times has sued Microsoft and OpenAI over copyright claims. Japan is preparing antitrust legislation targeting Google and Apple. Prime Video will show ads starting on Jan. 29.  Beth p/beth-duckett 1 A federal appeals court has paused a U.S. import ban on Apple's latest smartwatches as a patent dispute continues.  Apple can now resume Apple Watch sales on its website and in its retail stores across the U.S. More: The International Trade Commission (ITC), a federal agency, recently found that Apple had infringed on tech company Masimo's patents for technology that reads blood oxygen levels. The ITC ordered Apple to pause all sales of its Watch models - specifically, the Apple Watch Series 9 and Ultra 2 - containing...

"A mind-reading MASTERPIECE."

Watch a full performance here: https://www.penguinmagic.com/p/4760 This is the kind of trick you end your show with. It's that good. Two spectators each think of a name, or a place.   They don't even tell each other what they're thinking!   And yet you are able to read their thoughts through sheer mind-power. "One of my strongest effects of the last 30 years" - Bob Cassidy This was the great Bob Cassidy's signature effect.  A flash of brilliance so inspired, that it can turn anyone into a master...

Less members, less problems

Presented by Heat Pump Nation Inc.: Inside the Golden State political arena Aug 29, 2023 View in browser   By Lara Korte , Dustin Gardiner and Sejal Govindarao Presented by Heat Pump Nation Inc. California state Sen. Mike McGuire (D-Healdsburg) right, talks to reporters after he was named to succeed President Pro Tem Toni Atkins, left, as the new Senate leader at the Capitol ...

Breaking News: Top lawmakers strike funding deal, potentially averting weekend shutdown

Breaking News Alert Top lawmakers strike funding deal, potentially averting week...

"The best piece of magic I have ever purchased." -Ray Espinal

Watch the performance: Watch the performance here: https://www.penguinmagic.com/p/12801 "AMAZING! I can see so many possibilities with this!" -Shin Lim "The challenge is how to make it feel LESS perfect." - Javier Bonilla "I'm an absolute zero-prop guy especially when it comes to electronics in mentalism, yet, here I am. I am deeply impressed. A must-buy for the working pro. " - Phedon Bilek 3 totally ordinary looking dice -- you know in real-time what they ro...