Monitoring vaccines

[hedrick]

It looks like the lack of a plan to deal with Covid is matched by lack of a plan to monitor the effects of vaccines. The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?

This has to be high on the priority list for a new president.

 

[hedrick]

The other gap is that there isn’t much work yet on vaccines for children. Testing always starts with adults, moves to teens, and then down in age. The first test for teens just started, with a 12 year old getting the first shot. This will have to happen very rapidly if we’re going to fully open schools for Fall 2021.

 

[JohnDB]

This is a closing of redundant beurocracy .

You already have two other government agencies that take care of this...a third isn't needed.

Epidemiology and calculus and statistical analysis don't take very long once you have access to de-idendtifyng data.
Your drugmakers already, by law, have to look for this stuff. And then it's followed up by other epidemiologists looking independently for this, (third party monitoring of drugmakers) then on top of this the NIH will contract other scientists to look again.

Another governmental department was really unhelpful with doing anything that was already being done. Nobody knew they existed to begin with.

 

[hedrick]

This is a closing of redundant beurocracy .

You already have two other government agencies that take care of this...a third isn't needed.

Epidemiology and calculus and statistical analysis don't take very long once you have access to de-idendtifyng data.
Your drugmakers already, by law, have to look for this stuff. And then it's followed up by other epidemiologists looking independently for this, (third party monitoring of drugmakers) then on top of this the NIH will contract other scientists to look again.

Another governmental department was really unhelpful with doing anything that was already being done. Nobody knew they existed to begin with.

You've paraphrased the press release. But the article suggests that having lots of agencies looking at pieces of the puzzle doesn't replace having one team providing leadership and coordination.

To quote: "An F.D.A. official who declined to be identified said that in the absence of the National Vaccine Program Office, F.D.A. and C.D.C. staff members were relying on relationships they had built across the agencies, meeting regularly to discuss their separate projects. That leaderless effort concerns Dr. Lurie. “There’s no sort of active coordination to bring all the information together,” she said."

This sounds exactly like accounts of early efforts to respond to signs of pandemic. It's not that no one was looking at it, but that there was no leadership, and no path to the president or top advisors.

 

[MIDutch]

This is a closing of redundant beurocracy .

You already have two other government agencies that take care of this...a third isn't needed.

Epidemiology and calculus and statistical analysis don't take very long once you have access to de-idendtifyng data.
Your drugmakers already, by law, have to look for this stuff. And then it's followed up by other epidemiologists looking independently for this, (third party monitoring of drugmakers) then on top of this the NIH will contract other scientists to look again.

Another governmental department was really unhelpful with doing anything that was already being done. Nobody knew they existed to begin with.

As if anyone (outside of trump supporters) actually trusts the trump administration to do the right thing ("I don't take any responsibility at all", "so I told my people, please, stop the testing", "we'll have a vaccine before the election").

 

[JohnDB]

What's really going to be the biggest issue soon is
"Which Vaccine?"
Who is first?
Why can't I have that vaccine?

There are over 200 Emergency Use Approved vaccines coming soon.

Many are very similar to each other. (There's only so many ways to crack an egg successfully)

And the data is becoming available for the various 30,000 patients in each of the studies. Some are going to have 85%-95% effective rates. 50% probably isn't going to happen.

But someone's vaccine will be first...who gets it? What if a better one is second or 54th?
Military has a plan to deliver the vaccines under armed escort everywhere. I highly recommend not acting in a threatening manner towards military convoys.
The vaccines must be kept super cold frozen until they are injected. (Thawed for 30 minutes first)

But does grandma get one first or the first responders?
What about essential workers?
How about those who are incarcerated?
From nursing homes to prisons.
Hotels?
Airports and public transportation?
Kids and teachers?

A fight is coming...
I know some people are saying that they don't want to be first...
And to them I say "THANK YOU" suckers....
The first ones have already been vaccinated and the controlling protocols will become lax for second or third shipments. Confusion will abound by the time there are a hundred vaccines available. Between the fights in lines for the vaccine and the choices of which one to get...it's going to be yet another mess.

Overall...
The vaccine patterns from successful MERS and SARS vaccines seems to be working for this virus.
I look forward to seeing the data coming out.

 

[JohnDB]

You've paraphrased the press release. But the article suggests that having lots of agencies looking at pieces of the puzzle doesn't replace having one team providing leadership and coordination.

To quote: "An F.D.A. official who declined to be identified said that in the absence of the National Vaccine Program Office, F.D.A. and C.D.C. staff members were relying on relationships they had built across the agencies, meeting regularly to discuss their separate projects. That leaderless effort concerns Dr. Lurie. “There’s no sort of active coordination to bring all the information together,” she said."

This sounds exactly like accounts of early efforts to respond to signs of pandemic. It's not that no one was looking at it, but that there was no leadership, and no path to the president or top advisors.

It's a matter of appointments and assignments. Appoint a project manager and assigning the duties. This is "One Minute Manager" stuff that may confuse the press and lifetime govt workers...but it's not difficult.

 

[sesquiterpene]

It looks like the lack of a plan to deal with Covid is matched by lack of a plan to monitor the effects of vaccines. The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?
This has to be high on the priority list for a new president.

From the article:

We’re behind the eight ball,” said Daniel Salmon, who served as the director of vaccine safety in that office from 2007 to 2012, overseeing coordination during the H1N1 flu pandemic in 2009. ”We don’t even know who’s in charge.”

and

Dr. Lurie, now an adviser at the Coalition for Epidemic Preparedness Innovation, has been waiting along with other researchers, month after month, for coordinated leadership to emerge from the federal government on long-term vaccine safety. “There are a whole bunch of people who were really concerned about this,” she said.

Sheesh.

 

[hedrick]

It's unclear how real Trump's claims are that he has a plan to distribute vaccines. If he does, presumably he'll control the priorities. Otherwise, many states are developing priorities. Here's an article on the effort in NJ: NJ aims to get 70% vaccinated | NJ Spotlight News. It's clearly not finished. NJ is saying the early priorities are health-care workers, elderly, and those with medical conditions putting them at risk. Nursing homes would be an obvious target, both because they match the profile, and because it's relatively easy to do. Lots of people in one place, with nurses to do it. Beyond that it doesn't sound like the plans had gotten into details of delivery as of Oct 5 (when the article was written).

I get flu shots from CVS. But the number of shots that need to be done may not be supported by that approach. When we had a measles epidemic at my university, we had nurses in the student centers, and people lined up. We've done the same thing for flu shots. That sounds like the kind of effort that will happen. Trump is suggesting using the military. Presumably he's envisioning that kind of mass vaccination.

 

[JohnDB]

It's unclear how real Trump's claims are that he has a plan to distribute vaccines. If he does, presumably he'll control the priorities. Otherwise, many states are developing priorities. Here's an article on the effort in NJ: NJ aims to get 70% vaccinated | NJ Spotlight News. It's clearly not finished. NJ is saying the early priorities are health-care workers, elderly, and those with medical conditions putting them at risk. Nursing homes would be an obvious target, both because they match the profile, and because it's relatively easy to do. Lots of people in one place, with nurses to do it.

He has claimed for months that he has tasked the military with distribution.

Military loves orders...they follow ones like that. They also Excell in logistics. Moving equipment and supplies is what they do best. They also shoot back.

 

[sesquiterpene]

Your drugmakers already, by law, have to look for this stuff. And then it's followed up by other epidemiologists looking independently for this, (third party monitoring of drugmakers) then on top of this the NIH will contract other scientists to look again.

The drugmakers have to report any adverse events that they learn about - which is far different from actively monitoring for them. One of the activities of the now shuttered office was actively monitoring PRISM, a database comprising real-time medical events from over 60 million people. In our current administration, this monitoring of vaccine safety has ceased.

 

[JohnDB]

Just as an FYI...
They are still monitoring the effectiveness of the SARS and MERS vaccines...these 17 years later.

And another question is when do we allow those who have received placebo vaccines to get the real vaccines? They are at risk and may wish for a vaccine for themselves.

 

[Andrewn]

Singapore halts use of flu vaccines after 48 die in South Korea

 

[JohnDB]

Singapore halts use of flu vaccines after 48 die in South Korea

No deaths associated with influenza vaccination have been reported in Singapore to date, but the decision to halt the use of SKYCellflu Quadrivalent and VaxigripTetra was precautionary, the health ministry and the Health Sciences Authority (HAS) said in a statement late on Sunday.


Apparently it's not related.

 

[sesquiterpene]

There are over 200 Emergency Use Approved vaccines coming soon.
Many are very similar to each other. (There's only so many ways to crack an egg successfully)

Well, no.
There are only ~6 that will have some data by the end of the year. How many of the latecomers will be able to recruit people into clinical trials? And remember, the EAU for remdesivir didn't pan out.
Here's a medicinal chemist [edit:also read the comments] pondering what might happen once an EUA is issued :
https://blogs.sciencemag.org/pipeline/archives/2020/10/21/the-vaccine-tightrope

 

[NerdGirl]

It looks like the lack of a plan to deal with Covid is matched by lack of a plan to monitor the effects of vaccines. The Trump Administration Shut a Vaccine Safety Office Last Year. What’s the Plan Now?

This has to be high on the priority list for a new president.

From the article:
"An H.H.S. spokesperson said that the vaccine office was not shuttered. “The office was not ‘closed,’ but was merged with the Office of Infectious Disease and HIV/AIDS Policy and was strengthened,” the spokesperson said in a statement. “All the functions continue in this new organizational structure.”

In a brief statement, a different spokesperson said that Operation Warp Speed was working closely with the Centers for Disease Control and Prevention “to synchronize the IT systems” involved in monitoring vaccine safety data."

 

[sesquiterpene]

One of the activities of the now shuttered office was actively monitoring PRISM, a database comprising real-time medical events from over 60 million people. In our current administration, this monitoring of vaccine safety has ceased.

I was touting the use of PRISM here within the past couple months, in response to some antivaxxers. I guess I didn't figure in the Trump administrations commitment to public health...

 

[NerdGirl]

The vast majority of "incidents" following vaccines are completely unrelated to the vaccine itself. It's a bloated mess of unnecessary information that is largely irrelevant.

Every person who is given a vaccine is also given a VIS, a Vaccine Information Statement. This paper explains all of the common and uncommon possible side effects and reactions from the vaccine, including a number to call to report any adverse effects.

Chill, people.

 

[Mayzoo]

Just as an FYI...
They are still monitoring the effectiveness of the SARS and MERS vaccines...these 17 years later.

And another question is when do we allow those who have received placebo vaccines to get the real vaccines? They are at risk and may wish for a vaccine for themselves.

Frequently at the end of a clinical trial, those who received the placebo are the first to receive the "real thing" if they wish to.

 

[sesquiterpene]

The vast majority of "incidents" following vaccines are completely unrelated to the vaccine itself. It's a bloated mess of unnecessary information that is largely irrelevant.
Chill, people.

The only way to find what's necessary is to actually collect and analyze the data. Remember, the initial Phase III trials on 30-40,000 people won't find the type of rare side effects such as GBS and Intussusception that have led to withdrawal of some previous vaccines. Large-scale, real time monitoring is a necessity for public health.

I am a very avid promoter of vaccines - but I didn't realize that some of our safety programs had ceased.