FDA's advisers worry about trust in Covid-19 vaccine

FDA’s advisers worry about trust in Covid-19 vaccine

Vaccine advisers to the US Food and Drug Administration said Thursday they are worried about public trust in any coronavirus vaccine.

The first Covid-19-focused meeting of the Vaccines and Related Biological Products Advisory Committee – a standing committee that advises the FDA on vaccine approval – skewed heavily toward worries that people will see emergency use authorization (EUA) of a Covid-19 vaccine as too rushed.

“There’s only one chance to do this right. If we do it wrong, then we are done for,” said Sheldon Toubman, staff attorney for the New Haven Legal Assistance Association who is the consumer representative on the committee.
“We won’t be able to dig out of it.”

The FDA has said it would consider an EUA for any of the several vaccines now in advanced clinical trials – a process faster than full licensure – but has also promised it will have stricter requirements for a vaccine EUA than it would for an EUA for a drug to treat coronavirus.

But the term implies corners are being cut – and perceptions matter, Toubman argued.

“So anything that sounds like emergency use authorization, it sounds like it’s being done in a rush and it’s not full review,” he said.
“I recommend that we not do an EUA here.”

Some vaccine experts agreed. “I wish we could get rid of the word EUA,” said Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia and a committee member.

“It’s very clear that the public has significant concerns about safety,” added Dr. Archana Chatterjee, Vice President for Medical Affairs at Rosalind Franklin University and a committee member.

New model predicts more than 385,000 US Covid-19 deaths by February 1

An influential model of the coronavirus pandemic predicts 385,611 coronavirus deaths in the United States by February 1.

The US has reported at least 223,000 Covid-19 deaths over the past eight months, according to Johns Hopkins University. The model estimates that the country could see more than 100,000 additional deaths over the next three months.

The new model is slightly fewer than last week’s forecast for the same time frame – but the Institute for Health Metrics and Evaluation at the University of Washington School of Medicine says case counts and deaths are up across the US.

I remember back in the days when people thought 156K was thought to be an exaggerated number. Remember those days?

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Aye mate…

It almost appears as though you are gleeful about this prognostication.:face_with_raised_eyebrow:

Due to Trump’s failure to jump on this and hit it head on, we have this problem now.

The pandemic is causing “unacceptable” shortages in US drug supplies, report says

The coronavirus pandemic is causing “unacceptable” shortages of US drug supplies in the United States, according to a report from the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota.

The report says shortages have limited 29 of 40 drugs critical for treating Covid-19 patients, including propofol, albuterol, midazolam, hydroxychloroquine, fentanyl, azithromycin and morphine, according to the American Society of Health-System Pharmacists. The FDA, which has more stringent criteria for shortages, show 18 of 40 are on the Drug Shortage list.

Another 67 out of 156 critical acute drugs – including diazepam, phenobarbital, lidocaine and acetaminophen – are in short supply, the report said.

“Drug shortages can be a matter of life and death, and some shortages mean that a life-saving drug is not available to U.S. patients at any price,” the authors wrote.

“The urgency with the drug shortage supply issue is related directly to the major increase in COVID-19 cases that we will experience in the coming months,” Michael Osterholm, the director of CIDRAP, said in a news release.

“This, in turn, will dramatically increase the need for specific COVID-19 treatment drugs, while at the same, COVID-19 is having a major impact on two of the three key drug manufacturing areas of the world, India and Italy,” Osterholm added.

Task force warns several US regions show signs of “deterioration” amid Covid-19 surges

With more than two dozen states reporting rising Covid-19 infections, new reports from leading health officials show a worsening of the pandemic across several US regions.

In White House coronavirus task force reports obtained by CNN this week, officials say there are “early signs of deterioration in the Sun Belt and continued deterioration in the Midwest and across the Northern States.”
The data comes as more state leaders have sounded the alarm on increasing infections, hospitalizations and deaths. The national average of new daily cases has climbed to just under 60,000 – a level that hasn’t been seen since the first week of August.

On Wednesday, at least 14 states saw their highest seven-day average of new daily cases, according to Johns Hopkins University: Alaska, Colorado, Idaho, Illinois, Indiana, Kansas, Kentucky, Michigan, Montana, New Mexico, Ohio, Utah, Wisconsin and Wyoming. And at least five states – Illinois, Montana, Ohio, Oklahoma and Utah – reported their highest daily case counts Thursday.

Meanwhile, more than 41,000 people are hospitalized with Covid-19 across the country, according to the COVID Tracking Project. Hospitals in states like Missouri and Idaho say they’ll soon be facing a crisis if hospitalizations continue to surge.

Deaths are also creeping upward. On Wednesday, the US reported the highest daily death toll in more than a month, with more than 1,100 new deaths. And an updated model from the University of Washington’s Institute for Health Metrics and Evaluation projects more than 140,000 Americans will likely die from the virus in the next three months.

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