Analysis | Federal officials urge mpox vaccinations to blunt a summer surge – The Washington Post

Good morning, and happy Monday! Special shout-out to my colleague Fenit Nirappil for his help with todays newsletter top. Send tips to McKenzie.Beard@washpost.com.

Todays edition: A growing trend of at-home medical testing is booming, but medical providers worry about the tests accuracy and reliability. Federal health officials released data showing gains in health-care coverage among minority communities. But first

How the CDC is taking on mpox this summer

With summer travel picking up and Pride festivities underway, public health experts are bracing for a return of mpox, the infectious disease formerly known as monkeypox.

The virus fueled a peak of up to 3,000 weekly cases in the United States between mid-July and late August 2022, predominantly spreading among men who have sex with men and killing at least 58 people. Vaccination efforts and behavioral changes quelled the outbreak, but the virus has continued to circulate at low levels throughout the country ever since.

On the ground, providers like Joseph Cherabie, medical director of the St. Louis STI/ HIV Prevention Training Center, says the mpox cases he has treated recently are largely in younger Black people and patients with uncontrolled HIV who are unvaccinated. He told my colleague Fenit Nirappil in a recent interview that more cases may be going undetected as mpox falls off the radar of patients and health providers, and noted that shots have become a harder sell as people have developed vaccine fatigue.

This comes as the Centers for Disease Control and Prevention is paying close attention to a version of the virus in the Democratic Republic of Congo linked to more fatalities.

I recently caught up with Christina L. Hutson, chief of the CDCs Poxvirus and Rabies Branch, about how the agency is working to raise awareness about mpox in hope of averting a summer surge. This conversation has been edited for clarity and brevity.

Health Brief: How are you approaching your outreach efforts this year?

Hutson: Our goal right now is creating awareness about the continued circulation of the virus in the U.S. and encouraging those who are unvaccinated or received only one dose to complete the two-dose vaccination series.

For the second year, were again working closely with the HHS Office of the Assistant Secretary of Health on a summer Pride initiative. This effort is really focusing on improving vaccine equity by partnering with health departments and community-based organizations to provide comprehensive sexual health services, including mpox vaccines, at local pride and LGBTQIA+ events.

Were also leaning on some of our existing partnerships with LGBTQIA+ organizations, and we have social media influencers we work with to make sure were getting that communication out there.

Finally, weve been funding the creation of materials that help address questions that men who have sex with men have raised about mpox and its vaccine. We now have social media tool kits, an mpox vaccine locator, and digital and print materials that have all been developed to help both clinicians and those at risk.

Health Brief: A recent report from the CDC indicates that there is long-term protection from the mpox vaccine, but Ive heard questions swirling about whether those at risk need a third dose. Can you explain why that isnt necessary?

Hutson: The paper looked at a total of 32,819 probable or confirmed mpox cases from the start of the outbreak up until May 2024, and we saw that less than 1 percent occurred in people who were fully vaccinated. This really illustrates that the vaccine is effective, and when we do see breakthrough infections, they are generally more mild.

The data set doesnt indicate that a booster is necessary, but it does illustrate that only 1 in 4 people who are eligible are fully vaccinated.

More patients are turning to a shadow system of DIY medical tests

A growing trend of at-home medical testing enabled by Silicon Valley start-ups and independent labs has boomed in recent years, The Posts Elizabeth Dwoskin, Daniel Gilbert and Tatum Hunter report. But medical providers worry this convenience comes with a slew of concerns, including the accuracy and reliability of these tests.

Venture capitalists and entrepreneurs told The Post they envision a world where frequent at-home testing is a routine part of life, enabling everyone to become the CEO of their own health, said Luca Springer, who co-founded a Silicon Valley start-up that aims to make cancer testing as simple as a home-pregnancy test.

But the boom angers some doctors, who argue that circumventing their offices can lead to questionable remedies, misdiagnosis or delayed medical care.

While the FDA generally reviews all but the lowest-risk medical tests, it doesnt supervise wellness tests marketed directly to consumers. Other start-ups avoid stringent FDA review by having physicians oversee some part of the testing process creating what experts call a two-track system of standards.

Its likely that some companies break the rules entirely, evading the agency and betting it wont police a fast-growing market, said Alberto Gutierrez, a former senior FDA official.

The FDA is starting to pay attention: Regulators finalized a contentious rule in April to begin holding lab-made tests to the same standards as conventional ones, phasing out a historically hands-off position in response to the ballooning industry. Still, businesses are charging ahead.

In other industry news, GlaxoSmithKline announced Friday that the FDA has approved its vaccine Arexvy for preventing respiratory syncytial virus (RSV) in adults ages 50 to 59 at increased risk.

The move to include those younger than 60 is aimed at addressing hospitalization rates among adults ages 50 to 64 with conditions such as COPD, asthma, heart failure and diabetes. The company said more than 13 million people have medical conditions that increase their risk of developing severe RSV outcomes.

Democrats ramp up patent battle with drug industry

Our colleague Dan Diamond sends us this dispatch.

Sen. Elizabeth Warren (D-Mass.) and Rep. Pramila Jayapal (D-Wash.) last week sent letters to eight pharmaceutical company CEOs, urging them to take down 130 patents listed in an FDA registry, I scooped on Friday.

Its the latest skirmish in a bigger fight over whether pharma companies are taking advantage of the FDAs Orange Book to box out generic competitors by making tiny tweaks to their products, like changing the design of an inhaler cap. If a patent is listed in the registry, it can effectively delay generic competition for another 2.5 years.

The Federal Trade Commission has twice warned pharmaceutical companies that hundreds of their patents are improperly listed in the Orange Book and must be taken down. The pharma industry has complied in some cases, but industry officials and some companies have pushed back, saying the Orange Book rules are unclear, and insisting theyre not trying to game patent rules.

The latest flash point: The FTC in April flagged more than 300 patents, including the 130 that Warren and Jayapal are focusing on.

Today is the deadline for pharma companies to either take down that batch of patents or reaffirm that they belong in the registry, a source familiar told me. Democrats say theyll continue to target more patents and push the industry, too.

Theyre making too damn much money off these inaccurate listings, Warren told me. And theyre not about to delist, unless they get a good hard shove from someone.

HHS sees improvements in health-care coverage for minorities

The Department of Health and Human Services released data Friday showing gains in health-care coverage among minority communities. The administration said the five reports highlight the progress made to increase affordable and quality health care.

From 2010 to 2020, there were significant declines in the percentages of uninsured people, with the highest decrease among Latinos. Black Americans saw their rate drop from 20.9 to 10.8 percent, Latinos from 32.7 to 18 percent, Asian American and Native Hawaiian/Pacific Islander from 16.6 to 6.2 percent and American Indians and Alaska Natives from 32.4 to 19.9 percent.

Today, external FDA advisers are set to convene to discuss the safety and efficacy of Eli Lillys experimental Alzheimers drug donanemab.

On Tuesday: A House appropriations subcommittee meets at 6 p.m. to discuss appropriations for fiscal 2025, including for the FDA.

On Wednesday: The Senate Finance Committee has scheduled a 10 a.m. hearing on youth residential treatment facilities.

From Wednesday to Friday, the Childrens Hospital Association will host its family advocacy days in D.C. Pediatric patients and their families will visit Capitol Hill to share their stories and advocate for policies that ensure childrens access to high-quality medical care.

Email fenit.nirappil@washpost.com and lena.sun@washpost.com with your questions or any suggestions for what youd like to see in future coverage of an outbreak of a highly virulent bird flu in dairy cattle that also infected at least three dairy workers.

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Analysis | Federal officials urge mpox vaccinations to blunt a summer surge - The Washington Post