Public Health News | Measles outbreak, RFK Etc

  • Thread starter Thread starter nycfan
  • Start date Start date
  • Replies: 498
  • Views: 13K
  • Politics 
Sorry, wrote that between meetings fully in my regulator affairs mode. When a company gets a medication or vaccine approved, there are usually further studies planned throughout the life cycle. For example, company A has a chemotherapy that gets approved for use in patients with stage 4 disease, then wants to show that it I improves outcomes in patients with stage 3, or company B has a flu vaccine that is effective in adults and wants to use it in pediatric patients. Each expansion of the indication or population will require an additional study evaluating safety and efficacy for that specific case. Once the study is conducted, companies have to organize the data and submit everything to FDA for their evaluation. Companies can submit as many changes as they like- they’re charged a fee with each one, which is part of how FDA is funded.

For the product in question (you’ve almost certainly seen a commercial for it), we had four planned submissions over the second half of the year. FDA has asked us to limit it to two, which apparently is pretty unprecedented.
Great info, thanks. So the FDA is turning down more frequent data and associated fees they’d be owed.

Can you think of any efficiencies this new approach creates for them? For instance, maybe the cost and resources of the data ingest process become relatively inefficient the more often they have to run it. And maybe the fees as currently structured aren’t compensating for that.

Or something?
 

This has kind of flown under the radar. FDA hasn’t given a decision for Novavax’s COVID vaccine and the deadline has now passed. The published data looked good.

“In an interview with CBS News’ Jon Lapook, RFK Jr. attributed the delay to the vaccine’s single-antigen composition, which he said has never worked against respiratory diseases. “We’re looking at that vaccine, and it is a single-antigen vaccine. And, for respiratory illnesses, the single-antigen vaccines have never worked,” RFK Jr. said, adding that “we are actually shifting our priorities to multiple-antigen vaccines. And NIH is already working on a number of those.”

Single antigen vaccines have been proven to work in the context of the H1N1 pandemic, so he’s talking out of his ass per usual. And it’s interesting (concerning) that Novavax is the first target of the anti-vaccine efforts because it’s a traditional vaccine which has historically been what the MAGA crowd has pointed to as an alternative to the mRNA vaccines.
 
Great info, thanks. So the FDA is turning down more frequent data and associated fees they’d be owed.

Can you think of any efficiencies this new approach creates for them? For instance, maybe the cost and resources of the data ingest process become relatively inefficient the more often they have to run it. And maybe the fees as currently structured aren’t compensating for that.

Or something?

I don’t have much insight into the internal workings of FDA but my suspicion given recent experience with previous submissions is that this is directly related to staffing. Typically when we submit the data package and related documents, FDA will conduct a preliminary review and then give us general timelines of when we can expect to receive questions from them, and then a deadline by which they need to approve or reject the changes. They normally start sending questions about a month in advance. With all the changes and chaos, we’ve been getting questions from them as late as just a week prior to the deadline, often very late in the evenings or over the weekends.
 
Last edited:
I don’t have much insight into the internal workings of FDA but my suspicion given recent experience with previous submissions is that this is directly related to staffing. Typically when we submit the data package and related documents, FDA will conduct a preliminary review and then give us general timelines of when we can expect to receive questions from them, and then a deadline by which they need to approve or reject the changes. They normally start sending questions about a month in advance. With all the changes and chaos, we’ve been getting questions from them as late as just a week prior to the deadline, often very late in the evenings or over the weekends.
That’s what I was hoping wasn’t the case, even though all indications pointed that way.

Great info, thanks.
 
My law partner (who lived in Chapel Hill) was diagnosed with this last November. He died 16 days after diagnosis. His death occurred just a matter of weeks after the first symptom appeared. To make matters even worse (as if they could be worse), all this happened right after his 23-year-old daughter was diagnosed with thyroid cancer. It was absolutely devastating.
 
Last edited:
This is actually quite concerning if they can’t pin it on BSE tainted meat. Prion diseases are known in a variety of mammals, but evidence of zoonotic transmission of humans is limited to cows. The big worry is that cervids (deer and their relatives can get chronic wasting disease - a prion disease that leads to ataxia, myoclonus and rapid loss of skeletal muscle and is 100% fatal) may pose a threat - cell culture results suggest transmission from deer to people is possible. We can monitor domestic livestock. Keeping track of the health of deer herds is damn near impossible.

Oh, and prion protein is found in antler velvet so think twice about those supplements.
 
This is actually quite concerning if they can’t pin it on BSE tainted meat. Prion diseases are known in a variety of mammals, but evidence of zoonotic transmission of humans is limited to cows. The big worry is that cervids (deer and their relatives can get chronic wasting disease - a prion disease that leads to ataxia, myoclonus and rapid loss of skeletal muscle and is 100% fatal) may pose a threat - cell culture results suggest transmission from deer to people is possible. We can monitor domestic livestock. Keeping track of the health of deer herds is damn near impossible.

Oh, and prion protein is found in antler velvet so think twice about those supplements.
I had thought that some years ago they found a link to humans getting some form of prion disease from eating squirrel head stew. Maybe it didn't prove out. Not a large target group to follow, I'd guess.
 
This is actually quite concerning if they can’t pin it on BSE tainted meat. Prion diseases are known in a variety of mammals, but evidence of zoonotic transmission of humans is limited to cows. The big worry is that cervids (deer and their relatives can get chronic wasting disease - a prion disease that leads to ataxia, myoclonus and rapid loss of skeletal muscle and is 100% fatal) may pose a threat - cell culture results suggest transmission from deer to people is possible. We can monitor domestic livestock. Keeping track of the health of deer herds is damn near impossible.

Oh, and prion protein is found in antler velvet so think twice about those supplements.
Reminds me of this prion like disease where the researchers were shut down by a conservative government. (In this article the newly elected left-wing provincial premier is trying to restart the research.



Health officials first warned in 2012 that more than 40 residents of the province were suffering from a possible unknown neurological syndrome, with symptoms similar to those of the degenerative brain disorder Creutzfeldt-Jakob disease. A year later, however, an independent oversight committee created by the province determined that the group of patients had most likely been misdiagnosed and were suffering from known illnesses such as cancer and dementia. A final report from the committee, which concluded there was no “cluster” of people suffering from an unknown brain syndrome, signalled the end of the province’s investigation.

But earlier that year, the Guardian reported that a top federal scientist worried there was “something real going on” in New Brunswick. Another said the investigation “was shut down” and that caseloads were higher than officially acknowledged. “I don’t think it is helpful to suggest or point to who or why – suffice to say that we were prepared to marshal both financial and human scientific resources to tackle the mystery, but they were declined,” the scientist wrote.

More than 450 people in the province – many living on the Acadian peninsula – are believed to be suffering from the illness, including several under the age of 45. At least 40 people have died, according to the premier.
 
My law partner (who lived in Chapel Hill) was diagnosed with his last November. He died 16 days after diagnosis. His death occurred just a matter of weeks after the the first symptom appeared. To make matters even worse (as if they could be worse), all this happened right after his 23-year-old daughter was diagnosed with thyroid cancer. It was absolutely devastating.
Ugh. that's awful.
 
I had thought that some years ago they found a link to humans getting some form of prion disease from eating squirrel head stew. Maybe it didn't prove out. Not a large target group to follow, I'd guess.
Yeah, so that’s an interesting one. There are quite a few stories about “prion-like” illnesses in people who had eaten squirrel meat. Enough in fact that it used to be mentioned as a likely case of zoonotic transmission, but cell culture studies have failed to demonstrate that it’s possible.
 
Yeah, so that’s an interesting one. There are quite a few stories about “prion-like” illnesses in people who had eaten squirrel meat. Enough in fact that it used to be mentioned as a likely case of zoonotic transmission, but cell culture studies have failed to demonstrate that it’s possible.
Does one grow squirrel culture lines with or without serum :).

"Bullwinkle, do you know what an A-Bomb is?"
 
Does one grow squirrel culture lines with or without serum :).

"Bullwinkle, do you know what an A-Bomb is?"
You know, I have no idea if there are commercially available, immortalized squirrel cell lines, but it would probably be a lot easier for technicians to warm to the idea of handling live squirrels than rats.
On the other hand, I shudder to think what IACUC and veterinarians would require as enrichment for research squirrels.
 
You know, I have no idea if there are commercially available, immortalized squirrel cell lines, but it would probably be a lot easier for technicians to warm to the idea of handling live squirrels than rats.
On the other hand, I shudder to think what IACUC and veterinarians would require as enrichment for research squirrels.
Recognizing this is not at all what this thread is about.... So anyway I looked:

Cellosaurus cell line GS-iPSC1 (CVCL_A2WQ)

Who knew
 
Back
Top