Patterico's Pontifications

11/16/2020

Prioritizing A Potential COVID-19 Vaccine

Filed under: General — Dana @ 12:17 pm



[guest post by Dana]

Terrific news:

It feels like it’s been a long time since Anthony Fauci has delivered good news—but here it is. U.S. biotech firm Moderna announced Monday that preliminary analysis shows that its COVID-19 vaccine is nearly 95 percent effective at preventing the disease. It appears to be particularly effective at stopping people from falling severely ill, according to The Washington Post. “It’s extremely good news. If you look at the data, the numbers speak for themselves,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases. Moderna’s vaccine was co-developed with Fauci’s institute and is being tested in 30,000 people. While Pfizer’s recently announced vaccine needs ultra-cold storage at around minus 75C, Moderna said its vaccine would be easier to store as it remains stable at minus 20 degrees Celsius for up to six months, and can be kept in a standard fridge for up to 30 days.

Now that we have a glimpse of an eventual end to the pandemic in our near future, Dr. Fauci cautioned this weekend that getting back to normal “won’t be like the flick of a switch.”

“If we get the overwhelming majority of people taking the vaccine and you have on the one hand, an effective vaccine, on the other hand, a high degree of uptake of the vaccine, we could start getting things back to relative normal as we get into the second and third quarter of the year”—meaning 2021—”where people can start thinking about doing things that were too dangerous just months ago, but we’ve got to put all those things together—we can’t just wish it happening. We’ve got to get the vaccine, it’s gotta be deployed and we can’t abandon fundamental public health measures. You can approach a degree of normality while still doing some fundamental public health things that synergize with the vaccine to get us back to normal.”

Fauci reiterated that normality wouldn’t come at the flick of a switch. “If we get most of the country vaccinated in the second, third quarter of the year and the vaccine continues to prove its efficacy and people adhere to those fundamental measures, I think we can start approaching the degree—[but it] is not going to be a light switch, we’re not going to turn it on and off going from where we are to completely normal. It’s going to be a gradual accrual of more normality as the weeks and the months go by as we get well into 2021.”

Of course, not everyone will want to take the vaccine: anti-vaxxers, young people who don’t see the need for it, the elderly who figure there is little reason for it at their advanced age, etc. And certainly, questions about any potential side effects (of both Moderna and Pfizer’s vaccines) will give Americans pause. Here is look at what scientists have seen thus far:

So far, both vaccines appear to be generally tolerable — but by no means painless. In its announcement Monday, Moderna said it observed a few short-lived severe side effects in volunteers, including fatigue, muscle pain, and headache. None required hospitalization. For its part, Pfizer said last week that its independent data monitors reported no serious safety concerns. In an earlier update from its Phase 1 clinical trial, Pfizer’s vaccine led to mild or moderate fever and pain at the site of injection, side effects that resolved over time, the company said.

But the most important safety data won’t come until patients have been followed for months and even years. Pfizer and Moderna have promised to collect and disclose that information in time.

I’m also interested in learning how the distribution of the vaccines will be prioritized. Clearly, frontline workers receiving the vaccines first makes sense. But what about after that?

Both Moderna and Pfizer have promised to file for emergency use authorizations in the coming weeks. If the FDA grants them, as it’s widely expected to do before the end of the year, the companies will ship doses to the federal government, which is in charge of allocating the limited supply to front-line workers and people at an elevated risk of severe Covid-19.

For everyone else, neither vaccine is likely to be available until spring at the earliest, in large part because of logistics. (By that time, Pfizer and Moderna are also likely to have generated enough supporting data to justify full FDA approvals.) Pfizer and Moderna expect to produce just 70 million doses of their vaccines by the end of 2020, enough for only 35 million people around the globe. In 2021, the companies could have as many as 2.3 billion doses between them, but in a pandemic-ravaged world of 7.5 billion people, that’s not going to be enough to satisfy demand. Unless more Covid-19 vaccines prove to work in the coming months, the world will be rationing doses well into next year.

One of President-elect Joe Biden’s coronavirus task force health advisors, Dr. Zeke Emanuel, has previously written about the path he would like to see taken with regard to vaccine distribution:

The model allows the country that produces the vaccine to hold onto enough of a supply to reach a threshold for herd immunity (“Rt below 1″). Beyond that, the model supports distributing the vaccine internationally, which means giving away or selling doses of the vaccine before it’s available to every citizen in that country, Emanuel explained to Scientific American.

“Reasonable national partiality does not permit retaining more vaccine than the amount needed to keep the rate of transmission (Rt) below 1, when that vaccine could instead mitigate substantial COVID-19–related harms in other countries that have been unable to keep Rt below 1 through ongoing public-health efforts,” the Science magazine article titled “An ethical framework for global vaccine allocation” argues.

“Associative ties only justify a government’s giving some priority to its own citizens, not absolute priority,” Emanuel wrote with his co-authors.

Contra to Emanuel’s ideas, the Trump administration’s stated plan differed considerably:

The Trump administration had said that the U.S. will share any coronavirus vaccine it develops with other countries after American needs are met and that the U.S. will not coordinate with the World Health Organization (WHO) on distribution.

“Our first priority of course is to develop and produce enough quantity of safe and effective FDA-approved vaccines and therapeutics for use in the United States,” Health and Human Services Secretary Alex Azar said during an August visit to Taiwan.

“But we anticipate having capacity that, once those needs are satisfied, those products would be available in the world community according to fair and equitable distributions that we would consult in the international community on,” Azar said.

Here is the Mayo Clinic’s estimate for herd immunity in the U.S.:

Even if infection with the COVID-19 virus creates long-lasting immunity, a large number of people would have to become infected to reach the herd immunity threshold. Experts estimate that in the U.S., 70% of the population — more than 200 million people — would have to recover from COVID-19 to halt the epidemic.

As the vaccines get ready for mass production, the debate about distribution and prioritizing who gets it first is bound to increase.

Here is how the President and the President-elect reacted to today’s great news about the vaccine:

–Dana

67 Responses to “Prioritizing A Potential COVID-19 Vaccine”

  1. It will be interesting to see whether the distribution will be ready during Trump’s tenure and thus he will direct it (or rather, someone in his administration since he doesn’t appear too interested in Covid these days), or if it will happen after Biden takes the helm. There’s a lot at stake and we have two very different scenarios.

    Dana (6995e0)

  2. Two viable vaccines now.

    ‘Once again, I congratulate the brilliant women and men who produced this breakthrough and have brought us one step closer to beating this virus. I am also thankful for the frontline workers who are still confronting the virus around the clock.’- Idiot Elect

    Really Joe? “No miracle is coming.” – Joe Biden.

    You’ve been Trumped.

    DCSCA (797bc0)

  3. It’s wonderful to see a Democrat like Joe Biden congratulate Big Pharma at a time when most Democrats hate Big Pharma. It’s almost like Biden gets lots of money from Big Pharma, hence the nice tweet.

    https://www.newsweek.com/big-pharma-joe-biden-fix-drug-pricing-1534809

    Hoi Polloi (7cefeb)

  4. @3. It’s ‘a miracle.’ 😉

    DCSCA (797bc0)

  5. I Was a Military COVID Planner. The Vaccine Rollout Is Going to Be a Nightmare
    ….
    The incoming administration will inherit one of the most daunting challenges any president has ever faced: planning and executing a national mass-vaccination campaign in the middle of a global pandemic.

    Before I retired from the Army, I served as a COVID crisis planner at NORTHCOM, where we were terrified of a potential “COVICANE.” Luckily, a major hurricane did not deliver a Katrina- or Harvey-like hit to a big city facing a coronavirus outbreak this year, at least on the scale we feared.

    But our next biggest concern was what the virus might do to rural America. And it’s playing out in harrowing fashion right now.
    …..
    With cases spiking to over 10 million, the virus is everywhere, and spreading deeply into every corner of the country. This is where the Biden administration will face its biggest challenge, especially as it pertains to rolling out a potential vaccine.
    …….
    ….[T]he vaccines themselves present a logistical challenge alone that borders on the impossible for rural America. The Pfizer vaccine, now the leading contender, will require ultra-cold storage of at least -94 degrees Fahrenheit and two rounds of shots. Another leading vaccine candidate from Moderna also requires cold storage, albeit not to the same extent, according to the company. Typically, hospitals and large clinics have this capability. Small towns lacking even the most basic health clinics do not.

    To deploy the Pfizer vaccine or any other one, health planners will have to figure out a way to deliver it to rural areas while maintaining its required temperature long enough to ensure that the population receives both doses. This scene will be repeated all across small-town America. This presents a big risk: An uncoordinated federal roll out of vaccines requiring ultra-cold storage could leave state and local governments competing for resources much like they were competing for PPE earlier in the pandemic.
    …….
    At NORTHCOM, we were the military’s lead for the Defense Support to Civil Authorities (DSCA) mission, and we had only one dedicated pandemic expert on the staff at the start of the crisis. Afterwards, we surged a lot of resources at the problem, but it just isn’t realistic to think the military can replicate the hard work of state and local health-care planners.

    Instead of a military miracle, it will take nearly flawless coordination between local, state, and the federal government to execute the plan. Our long winter with COVID could turn into a slog through the spring and summer even with an effective vaccine. Pockets of the virus could linger with us for months as we try to reach Americans in every isolated place….

    Getting this right is going to be hard, and given the our climate of disinformation and vaccine scepticism, we may never get to the point where we are completely free from COVID. ……
    …….

    Rip Murdock (d2a2a8)

  6. @5 Properly incentivized, the private sector will distribute the vaccine much more quickly than the government. The free market is always more efficient than central planning. It’s like a law of economics or something.

    norcal (a5428a)

  7. Regarding government distribution, Hayek would like a word:

    The curious task of economics is to demonstrate to men how little they really know about what they imagine they can design.

    F.A. Hayek

    norcal (a5428a)

  8. 1) Anyone who refuses a vaccine when offered is not offered it again until everyone else has been served.

    2) After hospital workers, EMTs, police, and other emergency personnel who cannot avoid exposure:
    a) assisted living facility occupants and staff.
    b) other elderly
    c) Other people with compromised immune systems (e.g. transplant patients, chemo/radiation patients, HIV+, and similar)
    d) Persons with chronic pulmonary illness or conditions (COPD, asthma, emphysema, cystic fibrosis, etc).
    e) Persons with other chronic conditions known to create risk.

    Not sure what the statistics are about race, but if as it seems, that blacks are more susceptible, maybe they go up on the list. If Asians are less susceptible, maybe they go to the bottom. Data seems confused though, and other factors may apply.

    Kevin M (ab1c11)

  9. Properly incentivized, the private sector will distribute the vaccine much more quickly than the government.

    There is no benefit to distributing it faster than it can be manufactured. I think that is the place to focus efforts.

    Kevin M (ab1c11)

  10. Trump always claimed that the favorable vaccine news was being suppressed until after the election. Just because he’s paranoid does not mean that people were not out to screw him.

    Kevin M (ab1c11)

  11. Unless I missed it, the post didn’t mention Moderna’s connection with Operation Warp Speed.

    beer ‘n pretzels (042d67)

  12. @11: True. Which is why their vaccine production is owned by the US government.

    Kevin M (ab1c11)

  13. As for immunizing people outside the USA, it would make sense to share some with Canada and northern Mexico. It would also make sense to close our borders entirely to the unvaccinated. Probably schools, too.

    Kevin M (ab1c11)

  14. It would also make sense to close our borders entirely to the unvaccinated.

    Great idea. I’m sure Biden will follow the science on this. LOL

    beer ‘n pretzels (042d67)

  15. Great idea. I’m sure Biden will follow the science on this. LOL

    beer ‘n pretzels (042d67) — 11/16/2020 @ 3:17 pm

    All that screaming, four miles of new wall, total failure on immigration, and you’re still convinced Biden was the problem.

    Give the guy a chance. Don’t be a sore loser.

    Dustin (4237e0)

  16. The model allows the country that produces the vaccine to hold onto enough of a supply to reach a threshold for herd immunity (“Rt below 1″). Beyond that, the model supports distributing the vaccine internationally, which means giving away or selling doses of the vaccine before it’s available to every citizen in that country, Emanuel explained to Scientific American.

    I just love it when scientists start making ethical pronouncements. Sorry, Charlie, but I’m just as qualified to make value judgements as you are. Screw you and your model, Zeke Emanuel. Another of your models suggests that Joe Biden should not take significant medical measures to extend his life, because he’s over 75.

    Here’s a value judgement for you, Dr. Emanuel. Country A doesn’t have a claim on a vaccine developed by Country B. It’s okay for Country B to close its borders to Country A until each and every citizen of Country B has a chance to be vaccinated. To argue the contrary is akin to supporting Communism, e.g., “From each according to his ability. To each according to his need.”

    Now, there may be a geopolitical calculation where it is in the national interest of the U.S. to provide a vaccine to some countries sooner rather than later, but that is a different argument.

    norcal (a5428a)

  17. As for immunizing people outside the USA, it would make sense to share some with Canada and northern Mexico. It would also make sense to close our borders entirely to the unvaccinated. Probably schools, too.

    Kevin M (ab1c11) — 11/16/2020 @ 3:14 pm

    Agree with sharing with Canada and northern Mexico, as well as the borders. Not so sure about the schools though.

    HCI (92ea66)

  18. It will be interesting to see whether the distribution will be ready during Trump’s tenure and thus he will direct it (or rather, someone in his administration since he doesn’t appear too interested in Covid these days), or if it will happen after Biden takes the helm. There’s a lot at stake and we have two very different scenarios.

    Dana (6995e0) — 11/16/2020 @ 12:19 pm

    I’m guessing the latter, unfortunately. Given that Trump is choosing to be a hyper lame duck President for the remainder of his term. His administration is practically inert, other than his usual rage tweeting.

    HCI (92ea66)

  19. DCSCA:

    #2

    Did Biden steal your girlfriend? Push your sister off the Acela? Rip off your best speech?

    Appalled (1a17de)

  20. @19. No. He did nothing. For 47 years.

    You bought him; you own him.

    DCSCA (797bc0)

  21. The orange buffoon with the unsuccessful hair transplants wants credit for the vaccine that other people invented, while “it is what it is” and he “takes no responsibility” for the hundreds of thousands of dead Americans and the millions of sick ones.

    On the other side, the public servant of 47 years with the successful hair transplants congratulates the people who actually invented the vaccine and thanks the ones who have been fighting the coronavirus without it for most of the past year.

    There’s something to see there for people who want to see it.

    nk (1d9030)

  22. @21. Congratulations: “No miracle coming.”

    DCSCA (797bc0)

  23. The orange buffoon with the unsuccessful hair transplants wants credit for the vaccine that other people invented

    The Orange buffoon had heard “on his watch” for the past nine months and fittingly threw that dookie back in your face. There is certainly now something to see there.

    beer ‘n pretzels (042d67)

  24. The Orange buffoon had heard “on his watch” for the past nine months

    So you’re blaming Trump for 250,000-300,000 dead Americans?

    You want to have it both ways right? Trump is both innocent of all that’s wrong and responsible for all that’s good?

    Why? He already lost. What’s it to you that people adore this guy?

    Dustin (4237e0)

  25. “No miracle coming.”

    Nope. Just hard work. Science. Vaccines and sacrifice.

    If Trump had believed in hard work we’d be doing a lot better, he would be too, and we could mock Biden for losing the election he had no chance at. But Trump took the lazy path of pretend and fantasy.

    Dustin (4237e0)

  26. Oh, no, no, no, Mr. beer ‘n pretzels! Do not put words in my mouth praising the corrupt criminal traitor with faint damns.

    The coronavirus did not merely happen on Trump’s watch. The decimation and desolation it has caused America is due to Trump’s malignant indifference and hopeless incompetence.

    nk (1d9030)

  27. It appears to be particularly effective at stopping people from falling severely ill, according to The Washington Post.

    If the first shot is given at least something like six weeks in advance of infection.

    Like the Pfizer vaccine, it is two step vaccine. Unlike the Pfizer vaccine, (rated 90% effective) the Moderna vacciine (rated 94.5% effective) it only has to be stored at below 25 degrees Fahrenheit. (I also read minus 4 degrees F) The Pfizer vaccine has to be stored at minus 80 degrees Fahrenheit but comes packed in dry ice, creating a hazardous transportation problem, and can keep that way for maybe 10 days but can last a bit longer in an ordinary freezer.

    The Pfizer vaccine’s two doses come 21 days apart; the Moderna vaccine 28 days apart.

    Patients given one dose will get a slip with an appointment for the booster shot – they recommend that people take a picture of the piece of paper – so many people have cameras or cell phone cameras nowadays and can upload them. They could also mark it on a calendar or appointment book but might lose it before they get home. So they say take a picture if you can.

    The vaccine (I’m not sure which one) can give people what feels like a mild case of Covid. A fever of 100.3 and tiredness for about one day.

    Joe Bideb: What was true with the first vaccine remains true with the second: we are still months away. Until then, Americans need to continue to practice social-distancing and mask-wearing to get the virus under control.

    Note that Dr. Anthony Fauci did not say “until then” but well past that time. Especially if Joe Biden decides that all he needs to do is get R0 below 1.0 and then ship it off to other countries that have an R0 above 1.0.

    Sammy Finkelman (f6c6ee)

  28. DCSCA (797bc0) — 11/16/2020 @ 1:05 pm

    Two viable vaccines now.

    The UK also has one six in the pipeline.

    https://pressofatlanticcity.com/news/world/uk-to-run-final-stage-trials-of-janssen-covid-vaccine/article_42b504db-6adc-5843-9866-8be5efff32b8.html

    I think they tested it out by deliberately infecting people who agreed.

    China also has a vaccine which they have used on the military, for important people, and for people traveling outside of China.

    https://www.npr.org/sections/goatsandsoda/2020/11/12/933956247/china-is-inoculating-thousands-with-unapproved-covid-19-vaccines-why

    “There is no problem at all. Lots of our colleagues had the shot very early, as early as July,” says Guo Peiyu, a construction worker for state behemoth China Railway Group. He is one of hundreds of workers being sent to the Democratic Republic of the Congo this month, where China Railway is building billions of dollars worth of roads in exchange for mineral mining rights.

    China has four vaccines in development by three companies (one has two)

    More:

    …Antibodies from new vaccines in rare cases can be found to make things worse.

    [I think this is a general possibility with vaccines for some diseases. New vaccines only because such vaccines are generally taken off the market.]

    “I think the second question will be around something called enhanced respiratory disease,” says Kim, referring to a form of lung disease that some animals developed after getting experimental vaccines for SARS, another coronavirus that infected 8,098 people from 2002 to 2004.

    Sammy Finkelman (f6c6ee)

  29. China has four vaccines in development by three companies (one has two)

    I know this is more for the Trump fans to say, but if I learned China had a vaccine for COVID 19 two years ago I wouldn’t be that surprised.

    Dustin (4237e0)

  30. 8.

    c) Other people with compromised immune systems (e.g. transplant patients, chemo/radiation patients, HIV+, and similar)

    These people can’t be vaccinated. Not only will it not tend to work, it can cause disease.

    They need antibodies, not vaccines.

    Not sure what the statistics are about race, but if as it seems, that blacks are more susceptible, maybe they go up on the list.

    They might actually be, apart from sociological causes, because of lower Vitamin D levels in the blood. Of course, that can be cured with a pill. The CDC probably won’t recommend anything like that for a long, long time

    R0 <1.0 is not the metric to use for when you can slow down and distribute some of it abroad. It's when the level of weekly infections per thousand has dropped.

    But again, this is not a cure. It's preventative. The Regeneron and Eli Lilly antibodies are a cure. Vaccines are for when there is no epidemic.

    Sammy Finkelman (f6c6ee)

  31. 29. Dustin (4237e0) — 11/16/2020 @ 6:23 pm

    but if I learned China had a vaccine for COVID 19 two years ago I wouldn’t be that surprised.

    No, I think they’ve just been studying coronaviruses for longer. They developed a vaccine against SARS which turned out to be no good.

    Now I think the virus probably escaped from the Wuhan Center for Disease Control and Prevention, located about 300 yards from the seafood/eyeglasses market that was scapegoated as the source (not to be confused with the Wuhan Institute of Virology, eight miles away.)

    The Wuhan Institute of Virology had links with the outside world. The Wuhan Center for Disease Control and Prevention, not so much.

    Sammy Finkelman (f6c6ee)

  32. The orange buffoon with the unsuccessful hair transplants wants credit for the vaccine that other people invented, while “it is what it is” and he “takes no responsibility” for the hundreds of thousands of dead Americans and the millions of sick ones.

    On the other side, the public servant of 47 years with the successful hair transplants congratulates the people who actually invented the vaccine and thanks the ones who have been fighting the coronavirus without it for most of the past year.

    There’s something to see there for people who want to see it.

    That’s what struck me when I read the post. Biden’s tweets are not remarkable or especially profound, but my God do they look like the words of an adult when placed next to the mewling of the self-obsessed infant.

    Patterico (115b1f)

  33. ‘Just hard work. Science. Vaccines and sacrifice.’

    On Donald’s watch.

    ‘There’s a dark winter ahead.’ – Idiot-elect.

    Because, you know, if you ain’t for him then you ain’t black.

    DCSCA (797bc0)

  34. This:

    Biden’s tweets are not remarkable or especially profound, but my God do they look like the words of an adult when placed next to the mewling of the self-obsessed infant.

    Half of America just want a normal adult in office. Let him be old and boring and not particularly bright. Just normal. Trump’s hissy fits, erratic behavior and irrational thinking have successfully exhausted America. We just want normal. That’s how low the bar is now.

    Dana (6995e0)

  35. 34. Are you saying that a man displaying signs of dementia occupying the highest office in the land and possessing the ability to order a nuclear strike is what passes for “normal?” I wholly reject your premise that is somehow “better” than Trump.

    Gryph (f63000)

  36. Normal…

    https://www.youtube.com/watch?v=fNQAbF33gFM

    You bought him; you own him.

    DCSCA (797bc0)

  37. The Regeneron antibodies look better than the Eli Lilly antibodies, so naturally, the FDA approved the li Lilly antibodies first.

    https://blogs.sciencemag.org/pipeline/archives/2020/10/29/the-latest-antibody-data-from-lilly-and-from-regeneron

    They may not have made enough of it.

    As Matthew Herper details in this column at Stat, we have not prioritized production of these antibodies the way that we have vaccines, so there are (at the moment) only about 50,000 doses of the Regeneron cocktail available. A look at the map will suggest that the entire stockpile, even if given immediate authorization and Star Trek transporter-style distribution, would vanish into the national epidemic like a rock thrown into a pond. You’d have to look very hard to see its effects at all. We had around 80,000 new cases yesterday, and that number is going up. 50,000 doses of an antibody that seems to help cut down on hospital visits is not going to make much of a dent in that situation.

    the discussion, some sayit does amount to something.

    One problem is that this duplicates only one element of the body’s immune response. The discussion also goes into vaccines.

    Sammy Finkelman (f6c6ee)

  38. OT- CSPAN-1 carrying live coverage now of Dragon approach and docking w/t ISS.

    Truly wonderous and majestic imagery of our Earth, our ISS and humans at work in space.

    It never grows old.

    DCSCA (797bc0)

  39. Postscript. Science fiction becomes reality; what a waltz: this television imagery is incredible- from the space station to Dragon to the astronauts working their controls and displays- it looks exactly like a segment from ‘2001: A Space Odyssey.’ All that’s missing is a little classical music.

    DCSCA (797bc0)

  40. YouTube, too.

    262 miles above Idaho gives new meaning to “flyover country”.

    nk (1d9030)

  41. In a 1959 “Peanuts” comic strip*, the kids wonder whether a light in the sky is “a sputnik”, lowercase, common noun, connoting more than one up there. When did they become “satellites”?

    *(Yes, a 1959 “Peanuts” comic strip, who are you to judge me?)

    nk (1d9030)

  42. 37.

    SF: The Regeneron antibodies look better than the Eli Lilly antibodies, so naturally, the FDA approved the Eli Lilly antibodies first.

    The situation is even worse:

    https://blogs.sciencemag.org/pipeline/archives/2020/11/13/lillys-monoclonal-eua

    I’ve been meaning to write about what has to be called a regulatory mystery. Eli Lilly obtained an Emergency Use Authorization for its monoclonal antibody (bamlanivimab) against SARS-Cov-2, but (as detailed in this post) the dosage that they applied for was 700mg. Which is one-quarter of the dose that showed any efficacy against the primary endpoint in the actual clinical trial…has to be the only EUA ever granted for a dose that failed in the clinic. To be sure, the company has said that there was no difference between the three doses on various secondary endpoints, and in fact says that they’re not sure that they’ve found the lowest effective dose yet…

    One person says they used the wrong endpoint (nasopharyngeal loa, or day 11 viral load – and after all neutralizing antibodies don’t clear viral particles from the system but rather block the binding of the virus to the receptor.)

    But Eli Lilly may have a marketing strategy to be very careful not to compete with a vaccine, and have only a high cost treatment with marginal utility, since that is what will most easily get approved.

    Sammy Finkelman (f6c6ee)

  43. Half forgotten:

    https://www.biocentury.com/article/631024

    Operation Warp Speed officials who briefed reporters Friday expressed enthusiasm about the potential of mAbs to help symptomatic patients who have not been hospitalized, discussed plans for deploying the products if and when FDA issues EUAs, and tried to distance themselves from the political controversies swirling around every aspect of COVID-19 in the U.S.

    They said the administration is putting the finishing touches on plans to meet the president’s promise to provide mAbs at no cost to American patients, and noted the need to find safe ways to infuse infectious patients.

    https://www.biocentury.com/article/631812

    Supply constraints have shadowed the anticipated EUA for bamlanivimab, as well as for the two-mAb cocktail REGN-COV2 from Regeneron Pharmaceuticals Inc

    Sammy Finkelman (f6c6ee)

  44. @41. Snoopy and Charlie Brown are very NASA, nk. For starters, see Apollo 10 for details. 😉

    DCSCA (797bc0)

  45. @32: Biden’s tweets are not remarkable or especially profound, but my God do they look like the words of an adult when placed next to the mewling of the self-obsessed infant.

    An adult doesn’t require others to write tweets for him.

    beer ‘n pretzels (042d67)

  46. An adult doesn’t require others to write tweets for him.

    I can think of one putative “adult” who would benefit very strongly — so strongly! — from such a service.

    Patterico (115b1f)

  47. Perhaps you prefer your tweets written in crayon. To each his own.

    Patterico (115b1f)

  48. I’m trying to imagine what it’s like to be impressed by tweets. Failing at it, but I’ll try harder tomorrow.

    beer ‘n pretzels (042d67)

  49. @ 48 — Is it too hard to imagine that a regular tweeting pattern might actually tell us something important about the person who chooses to express his thoughts in that medium?

    Radegunda (20775b)

  50. Trump’s superfans have said that Twitter is his very important way of reaching the American people directly.
    But sometimes they find it more useful to scoff at anyone so naive as to think his tweets have any importance whatsoever.

    Radegunda (20775b)

  51. I’m trying to imagine what it’s like to be impressed by tweets. Failing at it, but I’ll try harder tomorrow.

    Radegunda beat me to it, but this is exactly what so many of us have been saying for the past four years.

    JVW (ee64e4)

  52. Dana,
    I’m not sure i see much difference between the proposal outlined by Biden’s team and the one outlined by Trump’s. Azar said “After American needs are met.” I didn’t see where they defined what that was. It’s very possible that other then the chest puffing Trump and Biden want to do very similar things.

    It is funny, in a sad way, that Trump prioritized that he get credit for the good thing that happened, and Biden’s statement focused on praising the people more directly responsible for the work.

    Time123 (441f53)

  53. but mr time only a super genius like president donald who really gets this stuff and was totally joking about the whole bleach thing could have come up with the idea of developing a vaccine in response to a raging pandemic

    its obvious to anyone willing to do the analysis

    Dave (1bb933)

  54. He did call it the Wuhan Flu.
    And then the China Virus.
    And now he administered the coup de grace with the China Plague.
    And the sad thing is that to him and his followers that’s not a joke. To them, that’s fighting and winning.

    nk (1d9030)

  55. @49: Absolutely! It tells us that Joe needs a ghost writer for his own thoughts.

    beer ‘n pretzels (042d67)

  56. I’m trying to imagine what it’s like to be impressed by tweets. Failing at it, but I’ll try harder tomorrow.

    Radegunda beat me to it, but this is exactly what so many of us have been saying for the past four years.

    JVW (ee64e4) — 11/16/2020 @ 11:53 pm

    Trump superfans feel powerless, picked on and disrespected. When trump says dumb Sh*t on twitter they feel better because someone is giving voice to their sense of persecution in a way that demands the attention they don’t think their issues usually get.

    When someone else says something on twitter they don’t understand why anyone would pat attention to such a silly platform.

    Time123 (b4d075)

  57. @55, you mean he took the time to put out a thoughtful statement instead of what the guy at the end of the bar would say after his 4th beer?

    Time123 (b4d075)

  58. Some people are trying to tell Governors not to promote distrust of a vaccine:

    https://www.nytimes.com/2020/11/16/us/coronavirus-vaccine-states-trump.html

    They talk as if the only problem could be that approvals are too fast, and they say it wasn’t.

    I guess these people are trying to enhance the authority of the FDA. When they say yes, it should be a yes. hey are focusing on salesmanship.

    The Governors of California, Oregon. Washington, Nevada, Connecticut, West Virginia and New York, plus the local D.C. government want to uphold their suspicions of Trump. They, or others, got Trump not to interfere, and they delayed approval of the vaccine past Election Day. (the interference was insidious, done by setting conditions and warning of possible interference to go too fast – they had no evidence of Trump doing anything wrong – the Senate should hold hearings on political pressure from all sides.)

    State officials said they did not believe they would slow any vaccinations. They hoped to examine clinical trial data once it became available, conducting their reviews alongside the federal government.

    It may not even be possible for states to hold up a vaccine. While they have some authority to control how drugs are dispensed within their borders, three former F.D.A. lawyers said that states would not be able to thwart distribution during a pandemic.

    Besides New York, officials in California, Connecticut, West Virginia and the District of Columbia have appointed committees to review coronavirus vaccines offered for F.D.A. approval. Governors in Nevada, Oregon and Washington have joined California’s effort, with each state adding a representative to the panel.

    Safety and efficacy data will also be examined by two independent federal advisory committees of medical experts. One panel counsels the F.D.A.; the other offers recommendations to the Centers for Disease Control and Prevention, which sets guidelines and priorities on who should get a vaccine.

    “It’s an incredibly rigorous and intense process that is evidence- and science-based,” said Dr. Julie Morita, who has served on the C.D.C.’s advisory committee and is an executive vice president at the Robert Wood Johnson Foundation, a public health philanthropy.

    Dr. Morita said she thought the state committees would ultimately come to the same conclusions as the federal government, but worried about a lack of consistent messaging. “The last thing we need right now is any kind of miscommunication about what the recommendations are,” she said. “The more aligned everybody is, the better for the public.” Dr. Morita is now serving on President-elect Joseph R. Biden Jr.’s Covid-19 task force.

    They want blind faith – both ways. Particularly, now that we have Biden’s hand selected experts.

    In an effort to address state officials’ concerns, the F.D.A. said last week that it would offer briefings on its vetting process and the basis for any decision to authorize a vaccine.

    Dr. Peter Marks, director of the F.D.A.’s Center for Biologics Evaluation and Research, which reviews vaccines, said he wanted the process to be transparent and welcomed questions from state officials. He also said he had felt “buffered” by the F.D.A. commissioner, Dr. Stephen Hahn, from any White House interference. He added that F.D.A. physicians and researchers who assessed vaccines were “civil servants” and “not political appointees.”

    Throughout the pandemic, Mr. Trump and his administration have been criticized for putting pressure on federal health agencies — including the F.D.A. and the C.D.C. — to ease restrictions and speed approvals for vaccines and unproven treatments, such as hydroxychloroquine.

    The White House initially opposed F.D.A. guidelines that called for gathering comprehensive safety data before the agency would issue an emergency authorization for a vaccine. (The guidelines would have made it nearly impossible to have one approved before the election.) Then, in early October, the administration relented.

    Dr. Michael Osterholm, director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the F.D.A.’s transparency and guidelines helped assuage the fears of many public health experts who felt “the White House was putting their thumb on the scale in a very big way.”

    Now, he said, he was “absolutely confident in the F.D.A. process” and thought the state review committees were “absolutely unnecessary.” This past week, he was named to Mr. Biden’s coronavirus task force.

    State officials have said Mr. Trump’s loss in the election will not alter their plans for reviews….

    “This has become a somewhat political conversation,” Dr. Mark Ghaly, California’s health secretary, acknowledged in an interview. He said the state’s review was intended “to give Californians additional confidence and trust in the system.”

    The state committee, named in October, is still deciding on a process, but it plans to assess some of the same data used by the federal advisory committees, according to Dr. Arthur Reingold, the group’s chairman….

    ….Mr. Cuomo, speaking with CNN on Friday, said the goal was “to give people confidence,” adding, “As soon as the F.D.A. approves it, we will have our panel approve it.”

    In an interview with The New York Times, Mr. Cuomo said if his state panel expressed confidence in the vaccine, he would be the first New York resident to receive it and his adult children would be vaccinated on television to reassure the public it was safe.

    Earlier that day, Mr. Trump attacked New York’s planned review, claiming that the state would not receive vaccines when they are first rolled out across the country.

    Health experts who had been involved in recommending other vaccines said there was little reason for the public to doubt the approval process, which takes into account comprehensive clinical trials conducted by universities and other independent bodies.

    Pfizer has said it plans to ask the F.D.A. for emergency authorization this month….

    ….In interviews, members of several states acknowledged the committees’ expertise, insisting that their own assessments would not be duplicative.

    Officials in West Virginia and the District of Columbia said their aim was to communicate the safety and effectiveness of a vaccine to the public, not necessarily to approve or deny its use.

    One of the main goals is to “reassure the public and the governor that it was free of political interference,” she said.

    I think the main goal is to assure the public (falsely) that Democrats were not guilty of political interference and that the concerns were justified.

    Sammy Finkelman (f6c6ee)

  59. For alll that, it’s possible for bad, or dangerous for certain people, vaccine to be approved:

    https://www.npr.org/sections/goatsandsoda/2019/05/03/719037789/botched-vaccine-launch-has-deadly-repercussions This was eventually approved in the USA with warnings.

    You can get the science wrong and a set of rules will not avoid it.

    Sammy Finkelman (f6c6ee)

  60. Back to today’s New York Times story:

    Dr. Ezekiel Emanuel, a professor of medical ethics and health policy at the University of Pennsylvania and a member of Mr. Biden’s coronavirus team, described the state reviews as “a symbol of the utter breakdown in trust in the process,” and said he did not think they would reveal anything the federal reviews did not.

    Trust just happened to break down? Sure. [NOT!]

    These reviews are designed to justify the distrust.

    Sammy Finkelman (f6c6ee)

  61. The more common problem is too slow approval, or even the company giving up

    https://www.wsj.com/articles/trump-biden-and-covid-vaccines-11605568709

    Credit here goes to private drug investment and innovation, but also to the Trump Administration for speeding up government approvals. The Administration pushed reforms in the Food and Drug Administration’s bureaucratic and risk-averse culture, even if it didn’t always succeed. Former FDA Commissioner Scott Gottlieb put a particular priority on speeding up drug approvals. New generic approvals increased to 107 last year from 73 in 2016.

    The FDA has also fast-tracked reviews of breakthrough medicines such as gene therapies and let drug makers use creative and adaptive trial designs that aren’t the double-blind randomized control placebo “gold standard.” From 2017 to 2019, an average of 51 novel therapies were approved compared to 32 on average from 2010 to 2016. All of this has been especially helpful on Covid….

    This summer the FDA was criticized for granting an emergency use authorization (EUA) for convalescent plasma to treat Covid. More than a dozen non-gold standard studies showed benefits. A Mayo Clinic trial that enrolled some 35,000 patients found seven-day mortality was 44% lower among non-intubated patients under the age of 80 who were treated within 72 hours of diagnosis with plasma containing high levels of antibodies versus lower levels.

    The study didn’t find a [probably should be “statistically significant = irrefutable difference] difference in survival among all patients [when combined] and didn’t include a placebo group….

    Yet now some critics claim that the FDA jumped the gun by approving remdesivir and should have waited for supposedly more robust evidence like the WHO trial. Some also say the FDA should have consulted outside experts before granting emergency authorization. These panels are notorious for nitpicking trial designs and shooting down promising therapies that only benefit a subgroup of patients. They allow the FDA to disperse accountability for decision-making. Pressure is now building on the FDA to revoke the remdesivir approval and, barring that, for the feds to cut reimbursement for the drug.

    Some critics of the Trump FDA’s accelerated approvals are on Mr. Biden’s Covid task force. Take Ezekiel Emanuel, who helped inspire ObamaCare’s bureaucratic panel for cutting Medicare spending, which Congress has since repealed. He believes government needs to clamp down on doctors who prescribe treatments that incrementally help patients, especially the elderly with fewer years to live.

    Then there’s David Kessler, the FDA commissioner in the George H.W. Bush and Clinton Administrations. Mr. Kessler let the agency be hijacked by trial lawyers and banned most silicone breast implants because of unascertainable risks, which many women said they were willing to bear. During his tenure, approvals of new medical devices ground to a halt.

    One of the big jobs of “the FDA commissioner is to put their body on the line in between all the forces that want to influence the agency,” Mr. Kessler told Politico in August. What he meant is the agency should ignore doctors and patients who want access to therapies that don’t pass this “expert” bureaucratic obstacle course.

    The Trump FDA’s Covid innovation has been providing real-time feedback and clear guidance to drug and vaccine makers about its expectations. This has helped therapies and vaccines advance and cut Phase 3 trials from three years to a few months. These reforms are one of the success stories of the federal Covid response. But there’s a serious risk that the Biden team will default to their instincts and reimpose a culture of bureaucratic control that restricts new medical advances.

    Sammy Finkelman (f6c6ee)

  62. Sammy —

    Trump fostered the mistrust by his behavior throughout the pandemic. No amount of closely reasoned paragraphs can conceal that basic and profound failure of leadership.

    Appalled (1a17de)

  63. I thought Obama’s head of the FDA, Scott Gottlieb, was a goniff, too. But nobody trusts any part of Trump’s health care alphabet soup now.

    nk (1d9030)

  64. 62. Appalled (1a17de) — 11/17/2020 @ 7:43 am

    Trump fostered the mistrust by his behavior throughout the pandemic.

    In general, yes. He was constantly predicting it would all be over soon, that we would open up soon/

    On closer inspection, no. There was pushback, so that Trump knew that if something was done wrong it would become known, and there was knowledge of what was actually happening. Trump argued, but he didn’t order anything approved.. And they knew it.

    Trump did not attempt to tell the pharmaceutical companies what to do. He talked to them and maybe asked what help they needed. (and the pharmaceutical companies weren’t about to put out a disaster.)

    And Trump tended to cave when the accusations got too strong.

    Hee evn gave in whe

    No amount of closely reasoned paragraphs can conceal that basic and profound failure of leadership.

    Sammy Finkelman (f6c6ee)

  65. Trump even gave in when the pressure got too much, or when the pharmaceutical companies gave in (mostly the latter, which they did even when the medical science didn’t require them too.)

    When the pharmaceutical companies surrendered on something that was it. He couldnn;t be more Catholic than the Pope.

    https://www.nytimes.com/2020/10/20/health/covid-vaccines-fda-trump.html

    The F.D.A.
    wanted to require two months of follow-up data to make sure a vaccine was safe and effective, all but ensuring one would not be ready by Election Day as President Trump had promised.

    Mr. Meadows told the commissioner the White House would not sign off on the guidance because it was unnecessary and would delay vaccine approval, so he should drop it, the officials said…

    ….Mr. Meadows, Jared Kushner, the president’s son-in-law and senior adviser, and the president himself have called Dr. Hahn directly to urge him to speed up emergency authorization of vaccines and treatments, according to the two senior administration officials.

    But despite the White House refusal to approve the new vaccine guidance document, the F.D.A. published the guidelines in briefing materials to an advisory committee that will discuss them on Thursday, effectively making them official. And nearly two weeks after Mr. Trump called the antibody treatment he received when sick with Covid-19 a miraculous “cure” and said that he had authorized it, the F.D.A. has not yet approved it….

    The antibodies probably matter most when someone’s condition is rapidly or semi-rapidly deteriorating relatively early in the course of the disease, indicating that body’s immune response isn’t ramping up fast enough or they just got exposed to too much virus. Late in the disease, either there already is a strong, maybe too strong immune response, or it’s too little to help. Before the disease gets going it would probably confer temporary immunity but that might be difficult to prove, especially if you are looking for the lowest effective dose first.

    Sammy Finkelman (f6c6ee)

  66. No amount of closely reasoned paragraphs can conceal that basic and profound failure of leadership

    There was a lack of intelligent understanding. So even when he was onto something, and, of course, looking at all sorts of things, he sometimes was, he gave up.

    The distrust was promoted, or reacted to, by people within the FDA

    https://www.usatoday.com/story/opinion/2020/09/10/sound-science-to-meet-covid-challenges-fda-career-officials-column/5756948002

    Trump also did not know how to answer his critics. But he was still better than someone who would just go along with the bad status quo.

    Sammy Finkelman (f6c6ee)

  67. With the antibodies, there is also an issue of quality manufacturing standards, but if watched, that should be no problem. That’s an issue with any drug.

    About Dr. Gottlieb: What I have noticed that he seems to be careful, like Pfizer, not to challenge the FDA and he says some things only when questioned. He also is kind to Donald Trump, and interprets what he does as most favorably as he legitimately can (it helps that Trump does usually base what he says on something – except Trump’s judgement is probably better than he makes it appear.)

    Dr. Scott Gottlieb always talks about the antibodies as a bridge to vaccine, (like he’s afraid someone might say they would supersede a vaccine, and that’s a no-no with the FDA or maybe Pfizer)

    He’s lately not volunteered a mention of it, only referring to that sort of thing when prompted.

    And of course, manufacturing was not ramped up, as he wanted it to be, so that’s a reason.

    The antibodies are better, more immediate and more universal, than a vaccine. It should be possible to prove it, but they may have to be careful in selecting a metric because some won’t get to the heart of it. It’s been proven for Vitamin D, so it should be for the neutralizing antibodies as well.

    https://www.hackensackmeridianhealth.org/HealthU/2020/11/03/should-you-take-vitamin-d-for-covid-prevention

    Of course, there, with Vitamin D, you know who’s deficient. How do you determine who’s deficient in antibody response? Well, for someone already testing positive, two blood tests for immune response, a specific number of hours apart, maybe could do it. A clinician, of course, could just watch how the patient is doing over 8 to 12 hours. And maybe judge by age and other things who is likely to be deficient.

    Pharmacuetical companies will pick the mot rovable indication when asking for approval, nit the most useful one, though. By now, they’ve become experts at gaming the system (while usually avoiding fraudulant claims. Oxycontin did not, because its big claim was that it was non-addictive.)

    Sammy Finkelman (f6c6ee)


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