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FDA pushes back on Trump administration attempt to rebrand ‘emergency authorization’

While Congress mandated earlier this year that Medicare cover the cost of administering a licensed vaccine, the requirement did not include drugs authorized under emergency-use designations. That’s raised the prospect that millions of people could be forced to pay out of pocket unless Congress were to adopt a quick fix.

HHS officials over the past month thought they found a solution, with Charrow arguing that the FDA should make clear that emergency authorization of a Covid-19 vaccine is equal to a “pre-licensure,” and should be covered by Medicare as a result, the officials said.

But Hahn firmly opposed the idea, amid concerns that failing to stick to the FDA’s technical language would erode the agency’s credibility and open it up to accusations that it’s allowing politics to influence its role in the Trump administration’s vaccine hunt.

“Hahn is hell bent against any modification of definitions, because it would be viewed as a politicization of science,” one senior administration official said, adding that while Hahn has so far rebuffed the proposal, some believe the White House could still get involved and demand changes.

Of particular concern, the official said, is that referring to a Covid-19 vaccine as having won a “pre-licensure” would be conflated with the shot being fully licensed by the FDA – a level of regulatory approval that signals the vaccine has met significantly higher standards for safety and effectiveness, and one the agency does not expect to grant to any vaccine candidates any time soon.

President Donald Trump has already spent months contradicting his own health officials involved in the complicated vaccine development process, claiming repeatedly that a viable vaccine is just around the corner and could be delivered faster than the end-of-year target agreed upon by the officials.

Suddenly changing how the FDA labels an eventual coronavirus vaccine could further muddle the situation, FDA officials worried, sparking confusion and deepening distrust of its work toward authorizing a vaccine.

In a statement, an FDA spokesperson pointed to “important substantive differences” between an emergency use authorization and the more stringent process required to seek full licensure of a vaccine.

“There is no such thing as ‘pre-licensure’ or ‘pre-approval’ under the laws FDA administers,” the spokesperson said.

An HHS spokesperson said that its Centers for Medicare and Medicaid Services is still exploring coverage options for vaccines authorized under an emergency use designation. And two administration officials downplayed the “pre-licensure” concept as an “academic discussion” about safety and effectiveness that never rose to the level of HHS Secretary Alex Azar.

But in talks with Hahn over the past several weeks, HHS officials presented the “pre-licensure” relabeling as the simplest and quickest way to close the Medicare coverage loophole, officials familiar with the conversations said.

The move would also prevent the Trump administration from having to rely on Congress to pass a legislative fix – a path that could get bogged down in gridlock on Capitol Hill.

“They’re trying to get creative – Congress is in disarray and they want a solution

HHS pushes back against Nevada’s rapid test pause for Covid-19

The federal government is pushing back on an order from Nevada’s department of health to suspend rapid Covid-19 tests in nursing homes — suggesting the decision “can only be based on a lack of knowledge or bias,” according to a letter signed by Dr. Brett Giroir, assistant secretary for the U.S. Department of Health and Human Services.

The move comes one week after the Nevada Department of Health and Human Services mandated that long-term care facilities in the state stop using two Covid-19 antigen tests that had been supplied by the federal government.

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State health officials in Nevada said the antigen tests, which can deliver results within 15 minutes, had an unusually high number of false positives. That indicates a person is infected when in fact he or she is not.

Covid-19 antigen tests are designed to detect certain proteins on the surface of the coronavirus. More sophisticated tests — called PCR tests — look for the virus’s genetic material in a sample. These are more accurate, but can take up to three days to get a result.

The federal government began rolling out the antigen tests, made by Quidel and Becton, Dickinson and Company, to nursing homes nationwide in August.

Quick results are important, because “nursing homes have accounted for as much as 40 percent” of the overall Covid-19 deaths in the U.S., Giroir said Friday on a call with reporters.

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But within a month of that test rollout, the Nevada department of health said it began to receive “anecdotal reports” of false positives. By October, health officials in the state determined the rate of false positives was 60 percent.

That’s a major problem, said Dr. Michael Wasserman, president of the California Association of Long Term Care Medicine. “If you have a large number of false positives, it will throw your facility into complete chaos and panic.”

“We’re already in a pandemic,” Wasserman said. “We don’t need more chaos.”

On Oct. 2, health officials in Nevada sent a letter to its nursing home facilities advising them “to immediately discontinue the use of all Covid-19 point of care (POC) antigen tests until the accuracy of the tests can be better evaluated.”

Part of the issue relates to staffing, which is already a stretched resource at many nursing facilities.

Indeed, the tests were meant for workers inside nursing homes, including possible asymptomatic staffers.

“This is obviously necessary to keep an unaware infected individual from coming into a nursing home, and starting a potentially devastating outbreak,” Giroir said. He added that if an individual does have a false positive, it would be detected by a PCR test within 48 hours, and the person could return to work. (The Centers for Disease Control and Prevention recommends that positive antigen tests are confirmed with a PCR test.)

But Wasserman said the false positives can decimate a nursing home’s staff.

“You already have people who

Fitness instructor, 41, pushes for mammogram, discovers breast cancer

Turning 40 meant getting a first mammogram for Heather Harrington, so she was surprised when her doctor told her not to worry about it until a few years down the road.

Harrington decided to follow the advice and wait. But when her 41st birthday approached this year, she felt uneasy. Her grandmother was 42 when her breast cancer was discovered so late in the course of the disease that it had spread all over her body.

Harrington kept thinking about that mammogram.

“For some odd reason this year, I was like man, I just feel like I want to go get one,” Harrington, who lives in Denver, Colorado, told TODAY.

“Honestly, I feel like maybe it was like a tap on my shoulder from (my grandmother).”

The diagnosis: stage 3 breast cancer that will require a bilateral mastectomy.

Harrington had no symptoms and felt nothing out of the ordinary in her body. She leads a healthy lifestyle that includes plenty of exercise as a fitness instructor and gym owner.

Sitting in shock after hearing the news at her doctor’s office in August, she was convinced the clinic must have had the wrong person’s chart, she recalled thinking.

“I’ve always done the right thing. I work out every day, I eat right, I try to take as good care of my body as I can, and cancer just doesn’t care,” she said. “It just doesn’t discriminate.”

Harrington owns two gyms in Denver and teaches classes. (Courtesy Teddy Sitorek)
Harrington owns two gyms in Denver and teaches classes. (Courtesy Teddy Sitorek)

She urged other women to get checked out even as the guidance on mammograms can be confusing, with different guidelines from different agencies.

The screening can find breast cancer early, but it can also show a spot that looks like cancer but is not, leading to unnecessary anxiety and invasive tests, the Centers for Disease Control and Prevention noted.

Another worry is overdiagnosis, or finding cancer that wouldn’t have gone on to cause any symptoms or problems.

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The American Cancer Society recommends women with average breast cancer risk have an annual mammogram starting at 45; while the U.S. Preventive Services Task Force advises they can wait until 50 and have the test every other year.

Both agencies say women can choose to start annual breast cancer screening at 40 if they wish to do so.

Something about waiting until 45 “just sat with me wrong,” Harrington said, noting she had no pushback when she requested her first mammogram at 41. The clinic had minimal scheduling options because of the epidemic and she almost cancelled amid the busyness of her life, but decided to just check it off the list.

After getting the screening at the beginning of August, she was asked to come back for a second look. Her family and friends reassured her it was normal for the radiologist to want to get a different picture, but she knew it was serious when it turned out she’d also been scheduled for a breast ultrasound and a biopsy.

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After

FDA issues new vaccine guidance that pushes approval past election

The Food and Drug Administration has released its long-awaited guidance on how it will issue Emergency Use Authorizations (EUAs) for COVID-19 vaccines. The FDA says safety data on any vaccine will need to be monitored for at least two months after Phase 3 clinical trials are completed, likely closing the door on the possibility of approving a vaccine before Election Day.

“Data from Phase 3 studies should include a median follow-up duration of at least two months after completion of the full vaccination regimen to help provide adequate information to assess a vaccine’s benefit-risk profile,” the agency wrote in a briefing document for an upcoming vaccine advisory committee meeting. 

An EUA does not require as much proof as the more exhaustive, standard FDA approval process, but can expedite treatments deemed beneficial in an emergency.

The FDA’s Center for Biologics Evaluation and Research oversees the vaccine approval process and often consults with an outside advisory committee. The expert committee, set to meet on October 22, is made up of scientists, physicians, biostatisticians, and a consumer representative who are tasked with advising the FDA on the safety and efficacy of the vaccine. According to the FDA, the purpose of the meeting is not to “discuss any particular vaccine candidate.”

By providing the committee with two months of data on risks and benefits after the Phase 3 trial is completed, the panel of experts will have more time to screen for severe COVID-19 disease and adverse events among study participants, according to the guidance. 

FDA Commissioner Stephen Hahn said in a statement that he hoped the guidelines would help “the public understand our science-based decision-making process that assures vaccine quality, safety and efficacy.”

Time is essential in vaccine trials. Most adverse effects from a vaccine occur within the first month or two, but issues can also crop up long after they are administered, which is why companies continue to follow participants for at least two years, according to William Moss, executive director of Johns Hopkins’ International Vaccine Access Center. 

Approval of any EUA will require a “trade-off decision” between a vaccine’s societal value and “potential, rare, delayed side effects,” Moss told CBS News. 

President Trump has repeatedly asserted that a vaccine is imminent. On Labor Day, he said it could be ready “during the month of October.” On Monday, upon returning to the White House after a four-day stint in the hospital for his own coronavirus diagnosis, the president said that a vaccine is coming “momentarily.” 

“We have the best medicines in the world. And they all happened very shortly, and they’re all getting approved, and the vaccines are coming momentarily,” he said.


COVID-19, Trump and the race to a vaccine: Vo…

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The FDA noted in its briefing document that the guidance is not legally enforceable. “Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited,” it said. 

The agency almost always follows the panel’s advice,

Pfizer CEO pushes back against Trump claim on vaccine timing

The head of Pfizer, one of the drugmakers racing to develop a coronavirus vaccine, told employees he was disappointed that its work was politicized during this week’s presidential debate and tried to reassure U.S. staff that the company won’t bend to pressure to move more quickly.

Chief Executive Officer Albert Bourla told the employees Thursday that the company is “moving at the speed of science,” rather than under any political timing, according to a staff letter obtained by The Associated Press.

“The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us,” Bourla wrote.


Despite top U.S. federal health officials repeatedly stating that a vaccine is unlikely to be available widely until 2021, President Donald Trump has insisted that a vaccine will be ready before Election Day.

During Tuesday’s debate with former Vice President Joe Biden, Trump said he had talked with the companies whose experimental vaccines are furthest along in testing.

“I’ve spoken to Pfizer, I’ve spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. They can go faster than that by a lot,” Trump claimed. “It’s become very political.”

Pfizer has said that it expects to have data from its ongoing late-stage test by October that could show whether the vaccine is safe and effective. In his letter to employees, Bourla wrote that the company hopes to have “a hundred million doses delivered by the end of the year.”

Those doses could not be distributed until the Food and Drug Administration reviews Pfizer’s data and decides whether to issue what’s called an emergency use authorization. That would allow distribution of the vaccine on a limited basis, with initial shots expected to go to medical and other frontline workers, nursing homes and people most at risk of catching or becoming seriously ill from the virus.

Moderna’s chief executive, Stéphane Bancel, told the UK’s Financial Times on Wednesday that Moderna would not be ready to seek emergency use authorization from the FDA for its vaccine candidate before Nov. 25 at the earliest.

Johnson & Johnson just started the late-stage and final patient study of its vaccine last week.

And AstraZeneca, which has a candidate in late-stage trials around the world, has its U.S. study on hold while the FDA reviews a possible safety problem.

Bourla and top executives of eight other companies developing COVID-19 vaccines and treatments pledged in early September not to seek even emergency use authorization, let alone a full approval of their products, until they were proven safe and effective.

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Johnson reported from Fairless Hills, Pennsylvania. Lemire reported from Washington.

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Follow Linda A. Johnson at https://twitter.com/LindaJ_onPharma

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