Early data suggests monkeypox vaccine may be working, CDC says

Sep 29, 2022

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By David Lim, Krista Mahr and Daniel Payne

Presented by

With Alice Miranda Ollstein and Marcia Brown

CDC Director Rochelle Walensky

CDC Director Rochelle Walensky is optimistic that the monkeypox vaccine is doing its job. | Drew Angerer/Getty Images

WALENSKY: CAUTIOUS OPTIMISM MONKEYPOX VACCINE WORKS — Early data analyzed by the CDC shows that unvaccinated people at risk for monkeypox were 14 times more likely to be infected than individuals who received a first dose of Jynneos' vaccine designed to prevent smallpox, Krista reports.

"There have been limited data on how well the Jynneos vaccine performs against monkeypox in real-world conditions," CDC Director Rochelle Walensky said during a briefing on Wednesday. "These new data provide us with a level of cautious optimism that the vaccine is working as intended."

But the early data has limitations. While it shows that people with one vaccine dose were infected at a lower rate than unvaccinated people, it doesn't reflect how individuals' behavioral changes — or other factors like testing, age or underlying health conditions — might have played into that outcome.

Multiple clinical trials and studies are underway to better understand the effectiveness of various vaccine administration routes, as well as antiviral Tpoxx against monkeypox. It's unclear whether those efforts will be impacted by Congress' refusal so far to provide the $4.5 billion the White House says it needs to fund its monkeypox response.

Despite their new optimism about the protection one dose offers, officials emphasized on Wednesday that laboratory evidence still suggests people are best protected from the virus after a second vaccine dose and encouraged all eligible people to complete the full regimen.

"This just tells us to keep on trucking forward because we need that second dose in arms," said Demetre Daskalakis, deputy coordinator of the White House monkeypox response.

It's Thursday. Welcome back to Pulse — Our thoughts are with those impacted by Hurricane Ian. Send tips and feedback to dlim@politico.com, kmahr@politico.com and dpayne@politico.com.

Want more Pulse? Today in our Pulse Check podcast, Ruth Reader talks with Alice Miranda Ollstein about how abortion bans can complicate your prescriptions. Plus, Ruth discusses the White House's ambitious plan to end hunger in the country by 2030. Listen to today's Pulse Check podcast.

A message from PhRMA:

Did you know: 39% of insured Americans say they don't understand what's covered by their insurance. Health insurance coverage should be predictable and transparent, and insured Americans agree. Learn more from our latest Patient Experience Survey report.

In Congress

Samples at a lab

GOP lawmakers want to know more about the FDA's and the CDC's biosafety practices. | Karen Ducey/Getty Images

HOUSE E&C GOP PRESS CDC, NIH FOR BIOSAFETY BRIEFING — Top House Republicans asked the CDC and NIH on Wednesday to brief their staff on biosafety practices by researchers studying viruses that could pose a threat to humans and animals. The letter, addressed to Walensky and acting NIH Director Lawrence Tabak, is the latest preview of the oversight priorities for the GOP if they retake the House.

"Even if it is not connected to the origins of the pandemic, the risks are apparent and biosafety practices need to be strengthened as our oversight examines the risks and benefits of virus-hunting research to prevent pandemics," House Energy and Commerce ranking member Cathy McMorris Rodgers (R-Wash.), health subcommittee ranking member Brett Guthrie (R-Ky.) and oversight subcommittee ranking member Morgan Griffith (R-Va.).

FIRST IN PULSE: DEMS WARN OF POTENTIAL BRAIDWOOD IMPACTS — A new report from House Education and Labor Committee Democrats released this morning highlights the potential impact of the Braidwood v. Becerra federal district court decision that could restrict insurance coverage of preventive health services like HIV prevention drugs and STD screenings.

The ruling's impact and scope won't be evident for weeks, if not longer, as the case winds through the courts. But the report underlines Democrats' embrace of the ACA's popular coverage requirements ahead of the midterm elections.

JEC: OPIOID EPIDEMIC COST U.S. ALMOST $1.5T IN 2020 — A new analysis from the Joint Economic Committee released Wednesday estimates the opioid epidemic cost the U.S. nearly $1.5 trillion in 2020, an increase of $487 billion from 2019.

"Opioid use increased during the pandemic, leading to the highest number of opioid-related deaths on record in the United States," the new analysis states. "The data show 2020 and 2021 saw the highest numbers of fatal opioid overdoses ever reported, with 69,061 and 80,926 fatalities, respectively."

NALOXONE TRAINING ON THE HILL — Reps. David Trone (D-Md.) and Ann McLane Kuster (D-N.H.), co-chairs of the Bipartisan Addiction and Mental Health Task Force, co-hosted a training session on the opioid antagonist, naloxone, for a few dozen congressional staffers on Wednesday, marking the end of National Recovery Month.

Trone and Kuster, citing family members' battles with opioid addiction, spoke about the importance of making naloxone widely available at low or no cost. They also touted bipartisan mental health legislation, which contains several substance use–related measures, that the House overwhelmingly passed in June, which House members hope the Senate will take up after the midterms.

"This is the single most important thing that we can do right now to save American lives," Rahul Gupta, director of the White House Office of National Drug Control Policy, told POLITICO on the event's sidelines, adding it's critical that naloxone is accessible and affordable. "Too often when you are suffering from an overdose, your ZIP code gets to define whether you live or die, and that should not be the case."

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Around the Agencies

CMS GREENLIGHTS MASSACHUSETTS, OREGON MEDICAID WAIVERS — The federal health department announced Wednesday it approved demonstration projects to "test coverage for evidenced-based nutritional assistance and medically tailored meals" in the Medicaid program, POLITICO's Ruth Reader reports.

The programs — announced alongside a slate of other policy initiatives at a White House conference on hunger, nutrition and health — are part of the government's effort to end hunger in the U.S. by 2030.

FDA WEIGHS UPDATING 'HEALTHY' LABEL FOR FOOD — The FDA unveiled a new proposed rule on Wednesday that will update the criteria for which foods can be labeled as "healthy," Marcia reports.

The move to encourage greater consumption of vegetables, fruit and dairy is part of the FDA's collaboration with the administration as policymakers work to implement the strategy laid out in yesterday's White House conference. The agency also has plans to implement a new nutrition labeling system, ease access to nutrition information in online shopping and lower sodium content in the food supply.

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IN THE STATES

PHARMACISTS TORN BETWEEN FEDERAL AND STATE ABORTION DRUG LAWS — Pharmacist and physician groups say that since the fall of Roe v. Wade this June, they've been trapped between state laws threatening prosecution if they dispense certain medications and federal warnings of legal consequences if they don't.

So far, they're following the states, Alice and Daniel report, and that's leading to widespread delays in patients accessing drugs to treat everything from lupus to acne to a miscarriage.

What's happening: Pharmacists in the roughly dozen states that have implemented abortion bans this year are taking extra steps to verify a patient's diagnosis before filling a prescription for a drug that could be used to end a pregnancy or for another purpose. If they can't, the patient is sometimes turned away.

The federal response: The Biden administration put out guidance in July warning pharmacists not to deny patients medications for abortion, birth control or other drugs they suspect could be used off-label to end a pregnancy — warning them that refusing to serve patients could put them in legal jeopardy and cost them their participation in Medicare, Medicaid and other federal programs.

Is it working? Depends who you ask.

The onus is on individuals to file an online report if they've been refused prescribed medication, and HHS declined to tell POLITICO whether they've received any reports and, if so, whether they investigated or took action.

While groups like the American Medical Association say the instances of patient denials would be far more rampant if the Biden guidance hadn't been released, they acknowledge it hasn't stopped them from proliferating.

In the Courts

HOSPITALS PRAISE 340B RULING — A federal judge ruled Wednesday that HHS must immediately cease reimbursement cuts for hospitals partaking in the 340B drug pricing program instead of waiting until 2023.

"[CMS] has the clear responsibility to restore the appropriate payments for 340B drugs immediately, and now a federal court has ordered it to do so without delay," Maureen Testoni, CEO of trade group 340B Health, said in a statement. Wednesday's ruling comes after a unanimous Supreme Court decision earlier this year that found the agency's cut in reimbursement rates was unlawful.

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What We're Reading

British health experts warn that influenza could pose a serious public health threat this winter due to lower population immunity and fear that fewer people will seek out flu shots, POLITICO Europe's Helen Collis reports.

A message from PhRMA:

According to new data, insured Americans are struggling to navigate their health care coverage, particularly the insurer- and PBM-imposed barriers and cost sharing practices that stand between them and their medicines:

· 39% of insured Americans say they don't understand what's covered by their insurance.
· Even with insurance, 15% report they would be unable to afford health care if they were to become seriously ill because of high out-of-pocket costs.

Americans want policy reforms that improve their insurance by providing more predictability and transparency in what is covered and lowering what they pay out of pocket. Read more in PhRMA's latest Patient Experience Survey.