So two weeks ago it seems like the administrations plan was to give pre-election approval to the Oxford/AZ vaccine. It seems like a reasonable contender for safety, since it's using a well proven approach (not to mention the Russians stole it and are dosing lots of people with it).

The problem is they didn't even register a P3 trial in the US until late August.

So now the administration is looking at two other vaccines for pre-election approval. Moderna and Pfizer. Both are messenger RNA vaccines, a technology that's never been used before.

Note that a pre-election approval date seems to be the constant here, only the vaccines they're looking at have changed.

There's a committee that approves vaccines, called the Vaccines and Related Biological Products Advisory Committee, or VRBPAC. They have a meeting scheduled for the 22nd of October, but no applications for approval are on the agenda.

I looked at the membership of that committee, the newest members all started 2/1/20, so we can assume they're actual scientists, not political sycophants. I doubt they share the Whitehouse's imperative of late October approval when safety considerations would demand another month or two of time.

Dr Peter Marks runs the Biologics division of the FDA, which is where vaccines are approved (a different division than the 'drug' approval side of the FDA). He has said he'll resign if the politics trumps the science in this. (He's a serious guy, my foundation has dealt with him directly since our main treatment is a plasma based product.)

Nevertheless, Trump's appointee at the FDA can overrule him and the committee, and the political head of HHS can overrule the FDA completely.


Its worth noting that literally everybody is in favor of early approval. The actual P3 trials for Moderna don't conclude until late 2022. Not a typo. The study protocol continues for 2 years.

But earlier in the summer, or maybe late spring, the FDA came out with minimum guidelines for covid vaccine approval. They defined a relatively low bar on efficacy (50%, with lower bound on the confidence interval being 30%) in order to speed up the trial. (it takes time for the control group to get enough infections to establish robust efficacy statistics).

On the safety side, there was less of a compromise. I think none at all. They require the companies to monitor 'serious and medically attended adverse effects' for 6 months past dosing. Potentially more if it's a novel vaccine platform, say messenger RNA which has never been tried before.


It is on this basis that Fauci and others have said early 2021 for emergency approval. The P3 trials of the major contenders got up and running in July or so.


Note that you can speed up efficacy testing by increasing the number of people dosed. If you dosed enough people, you could have efficacy results in a month.

But you can't throw bodies at safety results, any more than 3 pregnant women can produce a baby in 3 months. It might simply take time for adverse reactions to appear.


So, will Trump force a pre-election approval before the safety data are in?


And what if he does? We've already seen polling data about wariness towards the vaccine. How would this effect it?

In previous surveys, people on the left were more open to the vaccine than people on the right. Surely Trump overruling scientists who then resign would cause a rethink on the left. Would people on the right who are more skeptical become less so?


If you zoom out far enough, true vaccine efficacy - creating herd immunity - is really the product of two numbers: the technical efficacy of the vaccine and people's confidence in it - i.e. the percentage of people who are willing to take it.

How much damage is he willing to do to that confidence number for a pre-election 'victory'? Will he even take the time to understand the tradeoff?

quote:

So, will Trump force a pre-election approval before the safety data are in?


And what if he does? We've already seen polling data about wariness towards the vaccine. How would this effect it?

A. You betcha...

...If he thinks this might net him a few thousand votes in battleground states. The people who think this would be a cynical ploy have already made up their minds. The few thousand "conversions" are probably people who would react positively to "leadership" and "doing something."

B. Probably not good, unless Trump gets lucky and the first approved vaccines exceed expectations for safety and effectiveness.

The downside risk, however, is huge. If one of those vaccines proves to be a dud, or even worse, gives people Guillain-Barre syndrome (remember that one?), the damage done could last a generation.

"take the time" assumes he'd understand if he did.

He has one and only one filter ... what's good for him.

Shades of Thalidomide.

Shouldn't we elect a WTFer to get the first vaccine for the group?

I nominate you.

quote:

Originally posted by CHAS:
Shouldn't we elect a WTFer to get the first vaccine for the group?

I nominate you.

Thanks, but if elected, I will not serve.

In a rational world, with a rational vaccine program, I wouldn't be first in line anyway. Medical professionals and first responders first (NOT politicians); teachers and essential personnel second (NOT politicians); people who are in the highest risk categories, because they are elderly or have pre-existing conditions (OK, maybe some politicians); then people who realistically cannot work from home and have to incur the risk of interaction, and may have family members who are high risk; then people in higher risk but not highest risk categories (that's where I fit); then the general population.

That's my order of priority, anyway.

From a reliable Facebook source who didn't provide a link:

quote:

Moncef Slaoui, the chief adviser for the White House vaccine program, said on Thursday that it was “extremely unlikely but not impossible” that a vaccine could be available by the end of October.
In an interview with National Public Radio, Slaoui, explained that the CDC guidance to states to prepare for a vaccine as early as late October — a notification Slaoui said he had learned of through the media — was “the right thing to do” in case a vaccine was ready by that time. “It would be irresponsible not to be ready if that was the case,” he said.
However, he described that as a “very, very low chance.”
That message was in conflict with the optimistic assertions from the White House that a vaccine could be ready before Election Day in November.
Slaoui confirmed that the two main candidates, Vaccine A and Vaccine B, were being developed by Pfizer and Moderna. He said that there was “no intent” to introduce a vaccine before clinical trials were completed, and that trials would only be completed when an independent safety monitoring board, separate from the government, affirmed the effectiveness of the vaccine.
The interviewer, Mary Louise Kelly, raised the timing of a possible vaccine given in the documents the C.D.C. recently sent to public health officials, and asked directly whether the delivery of the vaccine was being motivated by political concerns.
“For us there is absolutely nothing to do with politics,” Slaoui responded, saying that those involved were working as hard as they could because so many people were dying every day.
“Many of us may or may not be supportive of this administration.”
Though he continued to express doubt that a vaccine would be ready by the end of October, Slaoui said, “I firmly believe that we will have a vaccine available before the end of the year and it will be available in quantities that can immunize patients, subjects at the highest risk,” including the elderly and those who are working in jobs with high exposure to the virus.
He estimated that there would be enough vaccine by the end of the year to immunize “probably between 20 and 25 million people.” He said that manufacturing would be ramped up so that there would be enough vaccine doses to immunize the U.S. population “by the middle of 2021.”

As I mentioned above, that’s the near universal view of the professionals. Let us hope they don’t get overruled.

If a vaccine is rammed through that

a) doesn't meet the minimalist 50% threshold, or

b) hasn't passed the safety threshold (i.e. there is still uncertainty, or worse, some initial worries), ...

... I would hope that someone on the inside would quit and walk into a TV station immediately.

They can give all the directives they want that states should be ready by November 1. If the states don't have the resources to do it, it ain't gonna happen...

quote:

The CDC’s director, Dr. Robert Redfield, also wrote to governors last week about the urgent need to have vaccine distribution sites up and running by Nov. 1, McClatchy first reported. Redfield asked governors to expedite the process for setting up these facilities.

SPECIAL REPORTS

Underfunded And Under Threat

A series examining how the U.S. public health front lines have been left understaffed and ill-prepared to save us from the coronavirus pandemic. The project is a collaboration between KHN and the AP.

But health departments that have been underfunded for decades say they currently lack the staff, money and tools to educate people about vaccines and then to distribute, administer and track doses to some 330 million people. Nor do they know when, or if, they’ll get federal aid to do that.

“There is a tremendous amount of work to be done to be prepared for this vaccination program and it will not be complete by Nov. 1,” said Dr. Kelly Moore, associate director of immunization education at the Immunization Action Coalition, a national vaccine education and advocacy organization based in St. Paul, Minnesota. “States will need more financial resources than they have now.”

Dozens of doctors, nurses and health officials interviewed by KHN and The Associated Press expressed concern about the country’s readiness to conduct mass vaccinations, as well as frustration with months of inconsistent information from the federal government.

The gaps include figuring out how officials will keep track of who has gotten which doses and how they’ll keep the workers who give the shots safe, with enough protective gear and syringes to do their jobs.

With only about half of Americans saying they would get vaccinated, according to a poll from AP-NORC Center for Public Affairs Research, it also will be crucial to educate people about the benefits of vaccination, said Molly Howell, who manages the North Dakota Department of Health’s immunization program.

The unprecedented pace of vaccine development has left many Americans skeptical about the safety of COVID-19 immunizations; others simply don’t trust the federal government.

“We’re in a very deep-red state,” said Ann Lewis, CEO of CareSouth Carolina, a group of community health centers that serve mostly low-income people in five rural counties in South Carolina. “The message that is coming out is not a message of trust and confidence in medical or scientific evidence.”

https://khn.org/news/health-of...or-covid-19-vaccine/

quote:

Originally posted by QuirtEvans:
https://blogs.sciencemag.org/p...1Pv3Gb6kqk3BdgjMfa24

I doubt that many people have any understanding how complex the whole vaccine development process is.

Really interesting article; thanks for posting it.