“Be Ready to Distribute Vaccines on Nov. 1”
CDC tells states: Be ready to distribute vaccines on Nov. 1, Modern Healthcare, September 2, 2020
The federal government told states to prepare for a coronavirus vaccine to be ready to distribute by Nov. 1; from which the declaration of the early timeline raised concern among public health experts about the “October surprise” of a vaccine approval and use being driven by political considerations ahead of a presidential election, rather than science.
The planning documents here and here sent to governors Aug. 27 by CDC Director Robert Redfield advises states they will receive permit applications “in the near future” from the authorized distributor, McKesson Corporation, to distribute vaccines to places which include state and local health departments and hospitals. Dr Redfield wrote in an accompanying letter,
“CDC urgently requests your assistance in expediting applications for these distribution facilities and, if necessary, asks that you consider waiving requirements that would prevent these facilities from becoming fully operational by November 1, 2020,”
There is not even a hint or a suggestion of partial Phase 3 testing being given beforehand which causes me to wonder if the extent of this is allowed under the 21st Century Cures Act passed in 2018. The act allowed for the skirting of some testing and the use actual data outside of the normal testing protocol to show a drug works? I believe the Cures Act only allowed a partial go-live on new drugs during a phrase 3. We must be following Putin lead. He gave the vaccine to his daughter. Perhaps, Trump will have Ivanka inoculated ?
Any volunteers at AB?
C.D.C. Tells States How to Prepare for Covid-19 Vaccine by Early November, New York Times, September 2, 2020
There never has been a successful vaccine against a Coronavirus
While it is true that there has never been a successful vaccine against Coronavirus *in humans,” it is false that there never has been a successful vaccine against a Coronavirus. Vaccines have been produced against several animal diseases caused by coronaviruses, including as of 2003 infectious bronchitis virus in birds, canine coronavirus, and feline coronavirus. There is no logical reason to believe that success cannot be achieved in humans. How durable the immunity will prove is a separate, albeit critical, question.
Thank you for your input. I agree with your points. The point I was attempting to make is their bypassing clinical trial or a partial trial and going straight to inoculation and measuring the impact then. Part of the Cures Act was allowing some real life testing to push new drugs along. I think this is because Putin claimed his daughter was inoculated.
I just happened to look below and saw who you were answering.
My post was directed at the resident troll, not at you.
I know, thank you though for commenting.
The people who got their first dose of the Moderna vaccine on July 27th would have had their second dose a week and a half ago.
How can anyone possibly think that we can determine now whether or not it should be mass produced for release two months from now? None of the vaccinated coming down with Covid-19 in the last week doesn’t mean 100% effectiveness.
Just what type of waivers do they think they will need to start production? Like Azar said, it might not be safe or effective, but we will have a vaccine.
I’m in the Moderna trial, and I don’t get my second dose until the end of next week. And they still haven’t met their projected 30K enrollment goal.
“How can anyone possibly think that we can determine now whether or not it should be mass produced for release two months from now? ”
Nobody “thinks” that. Mostly, it’s just propaganda for the Trumpenproletariat and something to grab the news cycle.
Best of luck. I assume it is investigational program mRNA-1273 vaccine?
To answer Run’s question, I will not consider being vaccinated until the moron in chief is no longer in office. His greatest accomplishment is that I no longer trust any part of the federal government. For the record I am not and never have been an antivaxer but when the CDC comes out in favor of less testing and the FDA over hypes the “ possible” benefits of plasma therapy, not to mention DHS burying intelligence the moron in chief does not like, I will not put something in my body that any part of this government promotes. I am thinking that the equity markets figured that out too after yesterday’s unfathomable rally. I think the moron in chief’s desperation is showing.😊
Whether you know it or not, you got an endorsement of someone I trust. Take a moment and look p the 21st Century Cures Act as sponsored by Fred Upton. It is from there from which I believe thy draw their power.
“There is no logical reason to believe that success cannot be achieved in humans.”
Joel – I agree that Bert is a troll but wait a second here. Something that works in lab rats is not necessarily an indication it will work in humans. There have been tons of situation where a treatment or a vaccine passed early trials on animals but failed miserably in trials on people. Of course we do have several potential vaccines that have gotten through phase II trials. But getting through phase II trials is also no guarantee that it will pass phase III trials. Don’t make the Trump mistake of getting ahead of the science.
Joel is in science. We had talked about his role weeks ago. As mentioned in this thread, he is in a Moderna trial participant for (I believe) It appears he mRNA-1273.
To no one in particular and just some information. I get multiples of medical information. Much of it I understand and alot flies over my head too. Not a doctor; but, I did work in manufacturing healthcare supplies and pharma at a manufacturing level. This article to me today from Medscape, What Do You Think of the FDA’s COVID-19 Decisions? I usually read the article and then go on to read the comments by the medical people. You probably get what your own personal doctor will nor tell you. The comments are useful and inciteful. This article has a questionnaire which I skipped by and went to the results. Again some interesting information.
The second article I am linking too is about the current FDA director: Dear Commissioner Hahn: Tell the Truth or Resign A Dr.Eric Topol has written a letter to Dr. Stephen Hahn who replaced Dr. Scott Gottlieb as Director. Here again, I would ask you to read the article and then go to the comments (~450). There is a lot of good information there which you not get during your 30 minute visit with your physician. These comments are informative on the trials being held without complete Phase 3 trials and some decisions being made which are erroneous as pointed out in the letter.
Another good read.
Yes, the mRNA trial.
Yes, I’m well aware that many treatments that work in rodents don’t work in humans. We have cured cancer thousands of times over in mice, for example. If you read my post, you’ll see that it falsifies the assertion that no coronavirus vaccines have worked, while acknowledging explicitly that none have worked in humans, yet. There are a variety of different vaccine strategies that have made it through phase II with promising results. Of course, no thoughtful person would forego the much larger phase III trials that I’m participating in. Odds are, with so many shots on goal and favorable antecedents in animal models, a vaccine that produces antibodies that work in vitro will emerge. Whether that vaccine is protective against disease and is durable over years is not explicitly tested by the Moderna protocol.
But while the Moderna trial isn’t a challenge trial sensu stricto, with 30,000 participants, a signifiant number are bound to become infected, and they will be tracked.
Potemkin vaccine. Remember the hoards of caravans that were approaching our southern border that vanished into thin air the day after the 2028 election. They will claim that the vaccine is or will work right up to Nov 4.
(too-good-to-be-true — don’t show the pres — FWIW)
Inspired by llamas’ unique antibodies, scientists create a potent anti-coronavirus molecule — Usha Lee McFarling — August 11, 2020
“The lab-made one created by the UCSF team is so stable it can be converted into a dry powder and aerosolized … ”
“ ‘We’d like as soon and as fast as possible to find a partner to make this,’ said Peter Walter, a veteran biochemist who permanently resides on many short lists of those expected to win a Nobel Prize and who co-led the project with structural biologist Aashish Manglik.”
“Their compound, they say, could be cheaply made in enormous quantities using bacteria or yeast, and would require low doses because it is so potent against the virus and can be administered directly to the lungs and or nasal passages.”
Remember Gerald Ford and the swine flu vaccine? What could go wrong?
Under the National Swine Flu Immunization Program that received bipartisan approval from Congress, the federal government planned to buy 200 million doses of vaccines developed by drug companies and distribute them for free to state health agencies. It would have been the largest immunization campaign in American history, even more ambitious than prior polio vaccination drives. Problems plagued the program from the start, however. One drug company produced 2 million vaccine doses with the wrong viral strain. Tests could not achieve suitable antibody levels in children. And with the compressed timeframe precluding the typical years of experimentation and clinical trials, insurance companies refused coverage for vaccine makers in the case of inevitable adverse reactions….Although photographs of Ford receiving a vaccination were distributed in hopes of rallying support, public confidence was further shaken when dozens of vaccine recipients were diagnosed with Guillain-Barré syndrome, a rare neurological disorder causing muscle weakness, tingling in the extremities and paralysis.
My mom got Guillain-Barré syndrome. She survived somehow.
Immunology and vaccine design/testing have come a long way in 45 years. Just like we learned the lessons from thalidomide. Now, politicians are flogging the FDA for being too cautious and want to go back to the Wild West.
What Terry said. They’ve reversed the usual approach to inquiry. Whatever they say is assumed to be a lie until proven otherwise.
Trump contradicts coronavirus project chief on when vaccine could be ready
Washington Post – September 4
President Trump on Friday asserted that a coronavirus vaccine would probably be available for distribution next month, contradicting his administration’s chief scientific adviser responsible for accelerating vaccine production. The discussion comes after the Centers for Disease Control and Prevention told all states and U.S. territories to be ready to provide a vaccine to health-care workers and other high-priority groups as early as Nov. 1, which prompted concern that the Food and Drug Administration was rushing to approve a vaccine before Election Day, Nov. 3, for political reasons.
Health and Human Services Secretary Alex Azar denied that the federal government’s Nov. 1 timeline for vaccine distribution is related to the presidential election two days later.
No shortcuts on COVID-19 vaccine
via @BostonGlobe – editorial – September 3
Another day, another horrifying COVID-19 milestone: This week the number of US cases topped 6 million. The death toll now exceeds 180,000.
An equally undeniable truth is that life as we know it, as we once lived it — complete with in-person sporting events and theater and concerts — will not return until there is a safe and effective vaccine, widely trusted and administered.
And there’s certainly no shortage of effort. At least a dozen US firms are working on a COVID-19 vaccine. Two are in Phase 3 clinical trials already (one made by Moderna and the other by Pfizer/BioNTech). The so-called Oxford vaccine by AstraZeneca begins trials in the US this week, and Johnson & Johnson’s entry into the Phase 3 field is expected later this month. It is widely anticipated that a vaccine could be available by the end of this year or early 2021.
But President Trump has made it clear, in speeches and on Twitter, that his target date is some time ahead of the Nov. 3 election — an “October surprise” that would somehow make the voting public forget how his ineptitude has contributed to the spread of this dreaded virus. And now the Trump appointee at the head of the Centers for Disease Control and Prevention has alerted governors to get ready to distribute a COVID-19 vaccine by Nov. 1. …
(Not exactly new news.)
2nd US virus surge hits plateau, but few experts celebrate
AP – July 30
NEW YORK — While deaths from the coronavirus in the U.S. are mounting rapidly, public health experts are seeing a flicker of good news: The second surge of confirmed cases appears to be leveling off.
Scientists aren’t celebrating by any means, warning that the trend is driven by four big, hard-hit places — Arizona, California, Florida and Texas — and that cases are rising in close to 30 states in all, with the outbreak’s center of gravity seemingly shifting from the Sun Belt toward the Midwest.
Some experts wonder whether the apparent caseload improvements will endure. It’s also not clear when deaths will start coming down. COVID-19 deaths do not move in perfect lockstep with the infection curve, for the simple reason that it can take weeks to get sick and die from the virus.
The future? “I think it’s very difficult to predict,” said Dr. Anthony Fauci, the government’s foremost infectious-disease expert.
The virus has claimed over 150,000 lives in the U.S., by far the highest death toll in the world, plus more than a half-million others around the globe. …
(About 5 weeks later, the toll is over 188,000. But I noticed
that today’s Doonesbury shows a chart which suggests a
plateau in 7-day average total new cases with the US
about 13x times higher than Europe.)