Prepare for Flu, Monkeypox Drug Warning, New Cancer Blood Test, More

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US warned to brace for a difficult flu season  

© AP

Health experts are warning the nation to brace for what could be an exceptionally severe flu season this fall and winter, as more people who have not built up immunity over the last few years mix and mingle. There are two big reasons why more people could be vulnerable to the flu this year.

  • The first is that with coronavirus restrictions such as the wearing of masks all but forgotten, people are more likely to come into contact with the flu virus this year than over the last two years.
  • The second reason is that fewer people are likely to be immune from the flu virus this year because fewer people have been getting the flu over the last two years — as the pandemic locked people down and as people worried more about getting COVID-19.

Richard Webby, a virologist at St. Jude Children’s Research Hospital’s infectious diseases department, said the past two flu seasons simply have not seen the same levels of exposure to the flu.

“As a population, our immunity to the flu is down a bit,” Webby said. “When the virus comes back, it’s probably going to have a little bit more room to spread, a little bit more room to potentially cause disease.”

Amesh Adalja, senior scholar at the Johns Hopkins Center for Health Security at the Bloomberg School of Public Health, said the flu season for the past two years has essentially been “nonexistent” and added that this trend was always bound to end once social distancing became less practiced.

According to Adalja, evidence of the flu picking back up is a sign that people are returning to “some semblance of their life pre-COVID.”

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FDA: TPOXX USE SHOULD BE RESTRICTED TO ENSURE EFFICACY  

The Food and Drug Administration (FDA) is warning there is potential for the monkeypox virus to change significantly enough that the treatments currently being used to fight the outbreak could be rendered ineffective.

TPOXX, the smallpox antiviral that has been authorized to treat cases of monkeypox, works through the inhibition of the VP37 protein found in orthopoxviruses, the family of viruses that both smallpox and monkeypox belong to.

“However, as noted in the drug label, TPOXX has a low barrier to viral resistance. This means small changes to the VP37 protein could have a large impact on the antiviral activity of TPOXX,” the FDA said.

Effectiveness TBD: The efficacy of TPOXX against monkeypox infections is still not known, with little to no human data available. The drug was approved to treat smallpox by the FDA based on data from animal studies and there is currently no safety or efficacy data for monkeypox treatment.

Stingy guidance: The CDC is monitoring for changes to the monkeypox virus that could make it better at evading potential protection from TPOXX. The FDA advised that “the drug be used in a judicious manner,” due to the potential of monkeypox becoming resistant.

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White House launches monkeypox research agenda  

© The Hill, Peter Afriyie

The White House on Thursday announced a round of new research commitments aimed at better understanding how to diagnose, treat and prevent monkeypox, with new clinical trials being done both in the U.S. and in countries where the virus is endemic.

During a press briefing, chief White House medical adviser Anthony Fauci acknowledged there are “a number of unanswered questions” when it comes to the monkeypox response.

  • There are currently no treatments approved by the Food and Drug Administration (FDA) specifically meant to treat and prevent monkeypox.
  • The treatments that have been utilized throughout the outbreak — mainly the Jynneos vaccine and the antiviral tecovirimat, or TPOXX — are both approved to treat and prevent smallpox infections.

Funding still unclear: Funding for the responses to the ongoing monkeypox outbreak as well as the COVID-19 pandemic has been stretched thin in recent months, as Congress has yet to approve any more money despite the White House’s request for nearly $4 billion for the monkeypox response. Fauci said the money for the current clinical trials came was pulled from several different sources.

“The money that we’re using on the clinical trials is money that we’ve taken from our poxvirus portfolio as well as others. So we hope that we get supplemental funding to be able to do the things that I’m talking about,” he said.

NEW CLINICAL TRIALS PLANNED FOR BLOOD TESTS TO DETECT CANCERS 

President Biden is set to sign an order to boost biotechnology as part of promoting a “Cancer Moonshot.” The cancer-focused initiative was launched in 2016 and restarted earlier this year.

On the horizon, the National Cancer Institute (NCI) is planning a large-scale clinical trial for cancer detection tests that can detect multiple types of cancer from blood samples.

If any of these types of screening tests gets approval from the Food and Drug Administration (FDA), cancer diagnosis may become much more accessible for millions of people.

Out-of-reach: There is one multi-cancer early detection test currently available in the U.S. called Galleri, which can be used to detect more than 50 types of cancer.

It is not currently FDA approved, so it’s not covered by insurance, costing $949 out-of-pocket. It isn’t meant to be a stand-alone diagnostic but a supplement to existing cancer screenings like mammograms, low-dose CT scans or colonoscopies. The upcoming clinical trial spearheaded by the NCI could help bring these tests to a wider number of patients. The agency is planning to enroll 24,000 healthy people ages 45 to 70 in 2024, a total of 225,000 people overall.

 

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