Who will get the new mRNA shots this fall?

From: POLITICO's Prescription Pulse - Tuesday Sep 12,2023 04:03 pm

Sep 12, 2023

By Katherine Ellen Foley, David Lim and Lauren Gardner

Presented by Pharmaceutical Care Management Association

Driving the Day

A doctor extracts the Pfizer COVID-19 Vaccine out of a vial.

If the CDC approves updated Covid vaccines today, the shots could be available later this month. | Mary Altaffer/AP Photo

CDC DECISIONS ON NEW COVID SHOTS CRUCIAL — The FDA greenlit updated Covid-19 shots Monday, which generate immunity against the XBB.1.5 subvariant of Omicron, paving the way for individuals to receive shots later this month.

What matters now is today’s debate and votes by the CDC’s expert vaccine advisers on who should get the updated vaccines. Their recommendations and the CDC director’s expected approval will affect who’s eligible for free shots, what the Biden administration’s messaging will be as the number of new Covid cases continues to rise and whether the rollout of the new shots will be a success.

The last time the government recommended that everyone get updated boosters, the uptake rate was low — somewhere below 20 percent. Some experts said the most effective approach would be to recommend certain groups get the shot, such as older adults and adults and children with compromised immune systems, who are more vulnerable to severe disease from the virus.

“The CDC needs to make the case for [everyone getting the shots],” Dr. Paul Offit, a Children's Hospital of Philadelphia infectious disease expert, told Prescription Pulse.

The FDA cleared the new vaccines for everyone, including children as young as 6 months. Manufacturers report that their shots generate immunity against the XBB subvariants of the virus, per the FDA’s June recommendation, as well as the newer EG.5 and FL.1.5.1 subvariants, which currently account for more than 30 percent of cases in the U.S. The vaccine makers also said their shots generate immunity against BA.2.86, a strain circulating globally that appears to have a higher number of mutations and is being monitored by the World Health Organization.

The agency’s announcement didn’t include Novavax’s vaccine, still pending FDA authorization. If authorized, the company’s updated shot would be the only non-mRNA vaccine available. Novavax reported it had begun the application process in August during its second-quarter earnings call with investors. Pfizer-BioNTech and Moderna asked the agency to review their updated shots in June.

Today, before the CDC vaccine advisory panel votes on its recommendations, it will hear from all three manufacturers about the effectiveness of the updated vaccines as well as get the latest data on Covid’s spread in the U.S. After the panel votes, CDC Director Mandy Cohen is expected to endorse its recommendations. And the shots will be available in a matter of days at pharmacy chains, health clinics and doctors’ offices.

IT’S TUESDAY. WELCOME BACK TO PRESCRIPTION PULSE. Good news for Beltway commuters: Starting this week, D.C.’s Metrorail is increasing the number of trains it runs, which will lead to shorter wait times.

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

TODAY ON OUR PULSE CHECK PODCAST, host Kelly Hooper talks with POLITICO health care reporter Ben Leonard, who breaks down what's in House GOP leaders' newly unveiled health care package that's focused on boosting transparency and addressing high drug costs.

Listen to today’s Pulse Check podcast

A message from Pharmaceutical Care Management Association:

Why is Congress making it easier for Big Pharma to raise drug prices and boost profits at the expense of patients and taxpayers? Misguided proposals want to restrict PBM tools but would actually INCREASE drug costs and invite Big Pharma to collude on drug prices under the guise of “transparency” – rigging the system against patients yet again. Reject anti-PBM reforms that will keep drug prices high and offer a massive windfall to Big Pharma.

In Congress

U.S. Capitol.

Appropriations bills and drug shortages hearings are just two of the items on Congress' agenda this week. | Patrick Semansky/Associated Press

MINIBUS WATCH — The Senate is expected to take an initial procedural vote on a package of appropriations bills today, setting up a legislative pathway for the upper chamber to pass the three-bill package that includes Agriculture-FDA, Military Construction-VA and Transportation-HUD.

ANOTHER DRUG SHORTAGES HEARING — The House Energy and Commerce Health Subcommittee is slated to convene Thursday at 10 a.m. to discuss five bills aimed at preventing drug shortages.

Notably, the list includes bills from Republican and Democrat lawmakers, such as legislation penned by subcommittee ranking member Anna Eshoo (D-Calif.) that would empower HHS to require drugmakers to report data on the suppliers of active pharmaceutical ingredients, quantities of drugs being manufactured and other information.

Another bill set to be discussed, sponsored by E&C Chair Cathy McMorris Rodgers (R-Wash.), incorporates a laundry list of proposals from her drug shortage discussion draft unveiled in July, such as exempting certain generic injectable drugs from the 340B drug discount program.

DOWNLOAD THE POLITICO APP: Stay in the know with the 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. DOWNLOAD FOR iOS – DOWNLOAD FOR ANDROID.

Eye on the FDA

INDUSTRY DEFENDS COMMON COLD DRUG — FDA’s advisers on nonprescription drugs will vote Tuesday on whether current science on the approved dosage of a key ingredient in common, over-the-counter cold medicines supports its FDA-approved efficacy as a nasal decongestant.

The Consumer Healthcare Products Association warned Monday that any change to phenylephrine’s status as “generally recognized as safe and effective” could negatively impact consumers who want to self-treat their cold symptoms.

A 2005 law required drugs containing pseudoephedrine, which studies suggest is more effective at relieving nasal congestion, to be moved behind the counter due to the substances’ use in methamphetamine production. Compelling customers to seek out those products, CHPA’s Marcia Howard argued, means they would need the assistance of a pharmacist since those products are kept behind the counter — a change that could hamper the ability of rural consumers and people who can’t access pharmacies during regular business hours to get the medications they want.

FDA weighs in: FDA officials said the science on how cold medicines work in the body has changed since the agency last considered phenylephrine’s efficacy in 2007.

“Anytime a product’s been on the market for that long, it’s human nature to make assumptions about what we think we know about the product,” Dr. Theresa Michele, director of the FDA’s Office of Nonprescription Drugs, said to advisory committee members Monday. “We’re asking you to put aside those assumptions and help us think critically about the data at hand and, in particular, what the data may or may not show.”

A message from Pharmaceutical Care Management Association:

Around the Agencies

FTC TO CONSIDER IMPROPER PATENTS IN ORANGE BOOK — On Thursday, the Federal Trade Commission will consider weighing in on whether the improper listing of patents in the FDA’s Orange Book could be “an unfair method of competition.”

Lawmakers, including Rep. Pramila Jayapal (D-Wash.) and Sen. Elizabeth Warren (D-Mass.), have expressed concern to FDA Commissioner Robert Califf that improperly listed patents in the agency’s list of approved drug products increase drug costs.

The lawmakers argued that pharmaceutical companies improperly keep patents in the Orange Book — which contains patent and exclusivity data — to prevent generic drug manufacturers from competing with them.

JOIN 9/19 FOR A TALK ON BUILDING THE NEW AMERICAN ECONOMY: The United States is undergoing a generational economic transformation, with a renewed bipartisan emphasis on manufacturing. Join POLITICO on Sept. 19th for high-level conversations that examine the progress and chart the next steps in preserving America’s economic preeminence, driving innovation and protecting jobs. REGISTER HERE.

Pharma Moves

Haider Warraich is joining the FDA as a senior clinical adviser for chronic disease, reporting to FDA Commissioner Robert Califf.

Quick Hits

Moderna has struck a $1.8 billion deal with oncology drugmaker Immatics to develop mRNA-based cancer treatments, Nicole DeFeudis reports for EndPoints News.

For STAT, Helen Branswell writes that the recent surge in Covid infections and hospitalizations is part of our new normal.

Document Drawer

The FDA released its over-the-counter monograph order request fee rates for fiscal 2024.

A message from Pharmaceutical Care Management Association:

Big Pharma is the link between patients and high drug prices. And now, Congress is considering several misguided proposals that could put $10 billion a year back in Big Pharma's pocket while also giving them even greater power to keep drug prices high by inviting anti-competitive collusion on price.

Why does Congress want to let Big Pharma boost their own profits at the expense of patients and taxpayers?

Restricting PBM tools will increase – not decrease – drug costs. And now there’s data to prove it. PBM reforms will cost taxpayers, keep drug prices high and offer a massive giveaway to Big Pharma. It's time to reject proposals that mean big profit windfalls for Big Pharma and higher drug costs for hard-working Americans.

Get the facts.