Patterico's Pontifications

9/25/2020

Trump And A Covid Vaccine

Filed under: General — Dana @ 1:36 pm



[guest post by Dana]

During a campaign rally in Jacksonville, Florida, President Trump suggested that the Covid-19 vaccine was being intentionally delayed for political reasons (2nd video, unable to separate the two):

“We will have a vaccine so soon, you won’t even believe it, although they are trying to do a little bit of a political hit. ‘Let’s delay the vaccine just a little bit.’ Did you notice that?”

As you recall, Trump promised that there would be a vaccine before the end of the year.

So, what might have prompted Trump’s accusation of an intentional delay of the vaccine? How about safety reasons to help ensure that the vaccine is safe and allay the fears Americans have about taking a fast-tracked vaccine:

On Wednesday afternoon, Moncef Slaoui, head of Operation Warp Speed, the $10 billion public-private partnership to fast-track a coronavirus vaccine, confirmed a proposed FDA measure that could slow down its pace, requiring pharmaceutical companies to provide two months of safety results before candidate vaccines can be authorized for emergency use by the public.

Additionally:

Earlier Wednesday, the commissioner of the FDA, Dr. Stephen Hahn, made a commitment to America that the “FDA will not authorize or approve a vaccine that we would not feel comfortable giving to our families.”

“FDA will not authorize or approve any Covid-19 vaccine before it has met the agency’s rigorous expectations for safety and effectiveness. Decisions to authorize or approve any such vaccine or therapeutic will be made by the dedicated career staff at FDA, through our thorough review processes, and science will guide our decisions,” Hahn specifically promised the Senate Health Committee.
“FDA will not permit any pressure from anyone to change that,” he added.

According to a recent YouGov poll, Americans are indeed cautious about taking a Covid vaccine. Only one-third are planning on taking the vaccine when it becomes available. It then makes sense that the FDA take extra steps to, not only ensure the efficacy of the vaccine but to also reassure Americans of its safety:

32 percent of Americans say they would not get a coronavirus vaccine, if and when one becomes available. Another 32 percent of Americans haven’t made their decision, saying they are unsure if they would get vaccinated. In contrast, only two in five (36%) Americans say they would get a coronavirus vaccine.

Trump reacted to news of the proposed FDA measure exactly how you might guess he would react:

President Donald Trump said Wednesday that the White House may not approve tougher FDA guidelines for authorizing the emergency use of any coronavirus vaccines.

“That has to be approved by the White House,” Trump said. “We may or may not approve it.”

Trump also suggested that the FDA’s decision to revise the standards, first issued in June, “was a political move more than anything else.”

According to former FDA heads, it’s possible that “Trump could pressure scientists into authorizing or approving a Covid-19 vaccine.”

While Covid has been politicized by both sides of the aisle, Trump has repeatedly insisted that a vaccine will be available before the end of the year, preferably before the election. But by labeling cautionary moves as little more than political is to ignore the very real concerns about safety that American have:

Trump’s repeated promises that a vaccine is imminent contradict top government health officials who say that a shot won’t be ready until late 2020 at the earliest, and that it will take months longer to get it to all Americans. The president’s hard charge for a vaccine has prompted fears that his administration will rubber-stamp a shot based on political calculations rather than scientific data.

Even the White House scientific community is pushing back on Trump:

On Wednesday, top health officials in the Trump administration, led by chief US infectious disease scientist Anthony Fauci and the heads of the CDC and FDA, took the unusual step of pledging to the public that coronavirus vaccines will be vetted without political interference and promising to get the shots themselves.

And on Thursday, the heads of the National Academy of Sciences and National Academy of Medicine took the rare step of denouncing the politicization of science, particularly regarding vaccines. “Any efforts to discredit the best science and scientists threaten the health and welfare of us all,” they said in their statement.

In yet another major sign of the scientific community’s discomfort with Trump’s push for a speedy vaccine, an HHS advisory panel voted unanimously this week to recommend COVID-19 vaccines be approved for the public through the FDA’s “gold standard” licensing process, rather than the emergency avenues now being contemplated.

“Great caution should be exercised,” the panel’s statement read. Any expedited decisions from the FDA should only come with the recommendation of outside expert panels at both that agency and the CDC, the statement added. Those panels typically advise the heads of HHS agencies, though their votes on vaccines are not legally binding.

While politics has always been a part of scientific development, Trump has taken it to a whole new level:

“Political interference in scientific issues is not new,” science policy expert Albert Teich of George Washington University told BuzzFeed News. “But the willingness of the Trump administration to twist science to serve what the president regards as his interests, and the impact on matters of life and death to the nation and its citizens, is unprecedented.”

For his part, Trump is giving developers the benefit of the doubt, rather than considering the concerns of the American people:

“I have tremendous trust in these massive companies that are so brilliantly organized in terms of what they’ve been doing with the tests,” he said. “I don’t see any reason why [a vaccine] should be delayed further because if they delay it a week or two weeks or three weeks, you know, that’s a lot of lives you’re talking about.”

–Dana

25 Responses to “Trump And A Covid Vaccine”

  1. Hello.

    Dana (292df6)

  2. Had to chuckle, Dana- read the cadence of your header ‘[Donald] Trump And A Covid Vaccine’ and instantly though of ‘Indiana Jones And The Last Crusade.’ 😉

    DCSCA (797bc0)

  3. Aaron Rupar’s take is always spot on, especially about internet tractors.

    We know politics aren’t involved in any of this. Just follow the science, which says biker festivals spread the virus and BLM protests don’t.

    beer ‘n pretzels (c1bc39)

  4. Trump’s gonna Trump. But I’d still encourage the Trump haters out there to consider that your only alternative at this point is a man in his late seventies who may be suffering from Lewy-body Dementia or Alzheimer’s.

    Gryph (f63000)

  5. beer ‘n pretzels,

    Aaron Rupar is not the issue here. I just happened to find the clip at his Twitter feed. Ignore him, and judge what Trump himself says. If you can find a video clip sans Rupar’s commentary, link here, and if I can, I will put that up instead if it will re-direct your focus to the actual subject of the post.

    Dana (292df6)

  6. Trump’s gonna Trump.

    Yeah, excusing this as just Trump doesn’t wash in my book. Not when we’re talking life and death issues. And if this is the best anyone can do to defend Trump, well, then I think that it’s highly likely that even a man in his late seventies who may be suffering from Lewy-body Dementia or Alzheimer’s would be doing a better job with this than the current guy. That’s how low he has set the bar.

    Dana (292df6)

  7. 6. Given that CoViD-19 is in fact NOT a life-or-death issue any more than any seasonal flu, and even if it were, there is no way to lay all 200,000+ deaths definitively at Trump’s feet, just no.

    Gryph (f63000)

  8. And might I remind you, Dana, I did not vote for Trump in 2016. I don’t like the guy.

    Gryph (f63000)

  9. I’m not keen on this unproven and fast tracked virus, but since people have been terrified into giving up all their rights, maybe this might calm things down, right,

    bolivar de gris (7404b5)

  10. Baby Donnie wants his lolly.
    When does he want it?
    Now!

    nk (1d9030)

  11. How about safety reasons to help ensure that the vaccine is safe

    Phase I and Phase II trials determine that. Phase III continues that, but mostly test efficacy. After that it’s mostly bureaucratic box checking and ass-covering. Everyone still remembers thalidomide.

    There are people who would take it now, and there are those who will not take it so long as Trump is President. There are those who will never take a vaccine, and would tell you they are all unsafe.

    I have no doubt that, were Biden to be elected that the vaccine would come out shortly thereafter, and Biden would take the credit. His campaign has already announced their strategy for dealing with Covid-19: A massive national effort to vaccinate everyone.

    It is not hard to believe that there are partisans in the FDA and CDC who will do whatever is necessary to delay a vaccine past the election. Just as there are partisans within the administration that would rush it to market.

    Why is the one believable and the other not?

    Kevin M (ab1c11)

  12. Only one-third are planning on taking the vaccine when it becomes available.

    If I were 20, I’d sure as heck wait. Not worth the risk. But if I was 75 and overweight, I’d want it right the F now as the risk of NOT taking it is too great. People’s needs vary.

    Kevin M (ab1c11)

  13. Then again the cross-tabs in that Youtube poll are strange. Most likely not to get vaccinated? Blacks and Hispanics (>40% no). All age groups except 45-64 are more likely yes than no.

    Trump voters are less likely than Biden voters to take the vaccine, and half of Trump voters would distrust a vaccine that came before the election (only 14% would “trust completely”

    Kevin M (ab1c11)

  14. I think it is possible to believe both that a vaccine is being delayed AND that nobody trusts one that Trump pushed out.

    Meanwhile, I am glad I’ve been taking statins.

    Kevin M (ab1c11)

  15. I think that it’s highly likely that even a different man in his late seventies who may be suffering from Lewy-body Dementia or Alzheimer’s would be doing a better job with this than the current guy.

    FIFY.

    Kevin M (ab1c11)

  16. For Phase III to finish by the end of the year would result in the fastest development of a vaccine for a novel infectious agent in the history of vaccines and would represent a massive triumph of science and engineering.

    The idea that waiting for Phase III to finish is a conspiracy to hurt Trump is absurd — until Phase III has finished *we don’t know if the vaccine actually works*.

    aphrael (4c4719)

  17. There’s intentions and then there are intentions:

    Sean Davis
    @seanmdav

    BREAKING: Explosive new FBI texts uncovered by DOJ show that FBI agents were so horrified by the bureau’s actions to take down Trump that they purchased liability insurance to protect themselves after they got sued.
    _ _

    Webb
    @DCWebb93
    ·
    The tragedy in all this is even though everyone involved took an oath to support & defend the constitution, not one of them seems to have had the courage to challenge Comey & senior leadership with their concerns or just blow a loud whistle.

    Any of them could have shut it down.
    _

    40-some days to put these people back in power folks!
    _

    harkin (8295ed)

  18. FBI agents (and all other kinds of federal employees) have been buying Bivens insurance since 1971. They can’t all count on Bill Barr to defend them and indemnify them for free if they’re sued for calling a lady a liar in the performance of their duties.

    nk (1d9030)

  19. They not only had no case, they were committing a fraud on the court by using this witness, deja vu all over again

    Alex berenson is very skeptical of these rushed procedures but aaron ‘tractor’ rupar?

    Bolivar di griz (7404b5)

  20. Clinical trial phases (this information repeats numerous places, not just at this link

    Phase I

    Phase I trials aim to find the best dose of a new drug with the fewest side effects. The drug will be tested in a small group of 15 to 30 patients. Doctors start by giving very low doses of the drug to a few patients. Higher doses are given to other patients until side effects become too severe or the desired effect is seen. The drug may help patients, but Phase I trials are to test a drug’s safety. If a drug is found to be safe enough, it can be tested in a phase II clinical trial.
    Phase II

    Phase II trials further assess safety as well as if a drug works. The drug is often tested among patients with a specific type of cancer. Phase II trials are done in larger groups of patients compared to Phase I trials. Often, new combinations of drugs are tested. Patients are closely watched to see if the drug works. However, the new drug is rarely compared to the current (standard-of-care) drug that is used. If a drug is found to work, it can be tested in a phase III clinical trial.
    Phase III

    Phase III trials compare a new drug to the standard-of-care drug. These trials assess the side effects of each drug and which drug works better. Phase III trials enroll 100 or more patients.

    Often, these trials are randomized. This means that patients are put into a treatment group, called trial arms, by chance. Randomization is needed to make sure that the people in all trial arms are alike. This lets scientists know that the results of the clinical trial are due to the treatment and not differences between the groups. A computer program is often used to randomly assign people to the trial arms.

    There can be more than two treatment groups in phase III trials. The control group gets the standard-of-care treatment. The other groups get a new treatment. Neither you nor your doctor can choose your group. You will also not know which group you’re in until the trial is over.

    Every patient in a phase III study is watched closely. The study will be stopped early if the side effects of the new drug are too severe or if one group has much better results. Phase III clinical trials are often needed before the FDA will approve the use of a new drug for the general public.

    Two vaccines entered phase III trials around the first of August. That means they have already been judged safe and shown to have therapeutic effect. Now they are to be tested on large groups (in this case about 30K each) to compare them against each other and “the current standard of care” which in this case is respirators and other Hail Marys.

    Some drugs, if they show strong results early on are released for emergency use. Both of these drugs are being produced in quantity on a speculative bases. The real problem in getting these trials done is that they take quite a while to ramp up, signing up patients, getting them to sign forms, be tested for current conditions, etc. This takes time, especially when supervised by a bureaucracy.

    Unless the trial is ended early — with one of both vaccines having a reasonable effect and not expose any safety concerns — there won’t be anything available until January at the earliest.

    Now, that question: “Do we have enough information?” is where the real problems lie. One man’s caution is another man’s ass-covering. I do think there should be some effort to get this done earlier as we are entering prime virus season, and you can be SO safe that people die needlessly.

    Doing nothing is always the default position, but withholding a vaccine that can save thousands because you are worried about killing tens seems wrong-headed.

    Kevin M (ab1c11)

  21. For people who are fearful of a rushed vaccine, because they don’t trust Trump: suppose a vaccine is announced on November 15th, never mind what happens to Trump. Would that seem like it was rushed to help TRUMP, or rushed to help PEOPLE?

    Kevin M (ab1c11)

  22. Why is the one believable and the other not?

    Because anything Donald Trump says should be presumed false until proven otherwise.

    Dave (1bb933)

  23. Would that seem like it was rushed to help TRUMP, or rushed to help PEOPLE?

    Whether it was rushed to help Trump or rushed to help people is question of fact, not a matter of opinion. We won’t have to guess.

    Dave (1bb933)

  24. Because anything Donald Trump says should be presumed false until proven otherwise.

    I bet you cashed that check straight-away.

    Kevin M (ab1c11)

  25. No weekend thread?

    harkin (5c8ee7)


Powered by WordPress.

Page loaded in: 0.2780 secs.