Project WARP SPEED is a federal effort to get a vaccine approved and distributed as quickly as possible for COVID-19. We are moving a system that is designed for sequential, incremental analysis to rapid parallel development along with risk tolerance that we have never taken before on a society wide scale. One of the biggest short-cuts that is likely to be taken is Emergency Use Approvals (EUA) off of incomplete trials.
I am looking at the Moderna ClinicalTrials.Gov application for their Phase 3 trial as an example of where risk is likely to be taken.
Study Type : Interventional (Clinical Trial)
Estimated Enrollment : 30000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older
Estimated Study Start Date : July 27, 2020
Estimated Primary Completion Date : October 27, 2022
Estimated Study Completion Date : October 27, 2022
The trial is estimated to last for 27 months. The trial is big enough that we should be fairly confident that any statistically significant results are actually happening instead of merely a function of luck. Recruiting for this trial will be starting next week. One of the major concerns in April is no longer in play; people were worried that effective suppression of community spread would make any trial underpowered as the two arms (vaccine and placebo) would be compared for a very rare event. Our need to go to bars obliberated that worry.
The trial is looking at several pre-specified primary endpoints.
Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273 [ Time Frame: Day 29 (second dose) up to Day 759 (2 years after second dose) ] Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal [ Time Frame: Up to Day 759 (2 years after second dose) ] Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) [ Time Frame: Up to Day 8 (7 days after first dose) and up to Day 36 (7 days after second dose) ] Number of Participants with Unsolicited AEs [ Time Frame: Up to Day 57 (28 days after each dose) ]
The first person who is dosed on July 27 will enter the first end point (no COVID infection at any point after the 2nd injection) on September 8. The first safety primary endpoint that can be met is on September 1st while the unsolicited adverse event endpoint is September 22. The study intends to track new COVID infections and adverse events for two years, but the first burst of data will be showing up in the analysts hands by late September or early October.
If the placebo arm of the study is located in regions with massive community spread and the placebo arm volunteers engage in high risk behaviors, there could be sufficient effectiveness data even before recruitment for the study closes. The short cut would be to wait for the first cohort’s earliest safety outcomes and then accelerate emergency approval of the vaccine fundamentally on the basis that any adverse events short of playing Russian roulette with an single shot flintlock is acceptable for any protective gains.
Other vaccines are on similar trial time frames. The United States is likely to approve at least vaccine with only short term knowledge of efficacy and no knowledge about medium or long term trade-offs.
That is the trade-off we’re making. This could likely buy a year or two with far less knowledge of consequences for a set of injections that billions of people will take than we normally tolerate.
debbie
Is there an upper age limit on these trials?
CarolDuhart2
All I can say is these are brave people who are risking their lives for this. Please, pay the whole freight for either way for these people. And I wouldn’t mind a big cash payment regardless so no matter what happens, their families are taken care of.
lee
My oldest is a pretty good candidate for the placebo. Where she lives is seeing a high rate of infection and she is less than careful about her behavior.
Any idea on how she might volunteer?
rikyrah
Hmmph ???
Ken
Have any overseas companies approached the US about running vaccine trials here? I vaguely recall that China had to drop some sort of trial – might have been for a treatment rather than a vaccine – because they ran out of domestic cases.
Cameron
@Ken:Â I read something this morning that the Oxford U group is seeking to conduct trials in USA and Brazil as well as UK.
PAM Dirac
EUAs can and should come with plans for monitoring and adverse event reporting. There aren’t going to be a billion doses administered within weeks of issuing an EUA, so the situation won’t be completely blind. There also will likely be multiple EUAs, so it should be possible to modify the vaccination plan on the fly plan well before a billion doses is reached. Effective use of these data does depend on the FDA willing to enforce the EUA conditions and decision making based on good public heath criteria rather than who gives the biggest kickbacks. Yet another reason why the Nov election is so critical.
J.
Question: Are we potentially trading one problem for another by rushing a vaccine?
I ask because every time I see a drug ad, it seems the potential risks or side effects are worse, often much worse, than the problem the drug is supposedly curing or ameliorating.
WereBear
@J.: I am not a professional, but there are three main ways a vaccine goes wrong.
This last is why the testing is supposed to be extensive and diverse. Like the COVID-19 itself, which creates the cytokine storm that does the most damage, a vaccine which creates the very damage it’s supposed to be preventing is a real possibility.
Cheryl Rofer
This is my own, IANAdoctor, personal take:
I totally want to be able to go back to “normal.” I don’t intend to even consider taking a vaccine until mid-2021 at the earliest. The trials need time. Potential delayed effects need time. By mid-2021, we should have a functional FDA and a functional CDC again, with the toadies purged.
In practical terms, I doubt that mass doses of any vaccine can be produced before the beginning of 2021. There will be prioritization to medical workers (at least after January 20). So it’s entirely likely that vaccines won’t even be available to most of us until mid-2021.
There are a great many fundamentally different approaches to vaccines. I’ve been learning stuff about immunity that I never knew before. The fact that no reinfections have been reported (except for Jair Bolsonaro, who reports he tests positive every few months) suggests that some sort of immunity is possible. So I think there’ll be a vaccine.
But we have no way of being assured of safety or effectiveness under the Trump administration.
DavidC
I am not sure that companies would want to pursue an EUA for a vaccine. They know that a lot is at stake giving stuff to healthy people (including children and people with other medical conditions). As noted in yesterday’s testimonies, companies are working to get approvals in multiple countries so there would be less incentive to short-circuit an approval. The review for an EUA should be as rigorous as a full review for licensure – especially for the safety part. Vaccine AEs tend to happen rather quickly, and the big risk is whether the vaccine makes the disease worse.
Disclosure: in a prior life I worked in the vaccine field (HIV, Lyme disease), and in a more recent life was involved in putting together an EUA package – not for a vaccine, though.
trnc
@lee: Wait a minute, you want your somewhat high-risk daughter to get the placebo?
DavidC
@Cheryl Rofer: People clear the disease, so a productive immune response to a vaccine is likely. Although antibodies may decline, there could still be memory T and B cells – a challenge could result in a rapid ramp-up and T cell immunity could be important in directly fighting the infection. There have been some good articles on this recently.
trnc
Not only that, but rushing this vaccine will become the pharmaceuticals’ excuse to cut regulations for trial time on everything going forward
Ladyraxterinok
Thalidomide tragedy!!
Does anyone in this admin remember? If they do, I suspect no one cares.
I
David Anderson
@Ken: There are pre-exisiting large scale, multi-site trial networks that are being re-purposed for COVID trials. Some of these networks are international with plenty of non-US manufacturers and developers involved.
patrick II
About a week ago the White House asked hospitals to bypass the CDC and forward it straight to the White House, because the CDC did not have the capability to show as complete of a picture. So, is that data available from a different government site now, or did it disappear? (leaving private sites to fill the gap).
Anonymous At Work
@Cheryl Rofer: Oddly, and I can’t believe I am typing this, the FDA under Trump hasn’t been that bad. Standard Republican in charge. Gottlieb even went after vaping properly. And all decisions are vetted by large and diverse enough committees that anything being railroaded would be obvious and leaked to the press within minutes.
lee
Yes. That pretty much is her. If it helps, why not? Someone has to do it.
trnc
@lee: Ah, got it. Although the subject isn’t supposed to know whether they’ve gotten the placebo or the real vaccine, right?
DavidC
@Anonymous At Work: A big question is whether the FDA would convene an advisory committee. That takes time – materials go to the AdComm 30 days before the meeting. Review of one or more products would probably be an all-hands-on-deck affair.
joel hanes
Never purchase a tech product in the first month after introduction.
Never install beta software on your work computer.
I think I’ll be waiting at least two months after the first vaccine is widely available.
And maybe I’ll be waiting for the second vaccine.
joel hanes
@DavidC:
Although antibodies may decline, there could still be memory T and B cells â a challenge could result in a rapid ramp-up and T cell immunity could be important in directly fighting the infection. There have been some good articles
Here’s one.
ixnay
Veterinary take here: check out the FIP vaccine from more than a few years ago. FIP is a mutated feline coronavirus. Just saying.
Constance Reader
@debbie: If there were, ClinicalTrials.gov would say so. I’ve been in the pharmaceutical research industry for more than 20 years and I’d bet that age will be one of the stratification factors in the data analysis, so they would want older subjects if they can recruit them.
Matt McIrvin
@Cheryl Rofer:
I keep seeing sporadic news stories reporting that one person got infected twice, with consequent handwringing about how it means that a vaccine is impossible or that getting COVID confers no immunity. There was a rash of those back in the spring that seem to have been false alarms, but another one popped up recently. The coverage always seems to have little regard for what a single anecdote means in this context.
J.
@WereBear: Thank you. It’s your #3 that worries me the most, having experienced a cytokine storm after getting a flu shot years ago.
Matt McIrvin
@WereBear: I can only imagine the disaster for public health that an unsafe COVID vaccine would be–antivaxxers are already a huge problem, and the remaining public goodwill is bound up in the expectation that vaccines will be extremely safe. That’s something you can’t half-ass, especially when the vaccine is the highest-profile vaccine since polio. The problem with the swine flu vaccine in 1976 still casts a long shadow.
Roger Moore
@Cheryl Rofer:
As I understand it, part of Project Warpspeed is to pay the vaccine companies to start production before approval so we have lots of doses available as soon as we find a vaccine that works. Normally this would be seen as wasteful, but given how expensive the pandemic is, it makes sense to pay for failed vaccines to get the successful ones earlier.
Cheryl Rofer
@Matt McIrvin: Yes, it’s the single anecdote problem. Most of those stories seem to have been resolved by recognizing that a positive analysis for SARS-CoV-2 in those people turned out to be a positive for the virus’s RNA, not the virus itself. The dregs that haven’t been eliminated from people’s bodies yet, noninfective. As practitioners learn more about what they’re testing for, we are seeing fewer of these anecdotes.
Cheryl Rofer
@Roger Moore: That’s reasonable. But Project WarpSpeed (horrible name) is headed up by Jared, so the awards will probably go to grifters and there won’t be vaccine anyway. I’ll be happy to be wrong.
WereBear
@Matt McIrvin: I agree. Current anti-vaxxers have their latest resurgence thanks to a thoroughly debunked study by a UK doctor. Who had his license yanked because he stood to benefit financially from scaring people away from the standard MMR vaccine.
In other words, the starkest possible refutation of their claims. But it has no effect on them.
Mary G
I am not an early adopter unless I have to be, and I don’t have to be, so I expect to wait. On the other hand, I was in a clinical trial of one biologic drug for RA and started another the instant it got FDA approval, with exceptional results both times, so I have some faith in Big Pharma’s ability to bring results.
joel hanes
Here’s another article about early vaccines, from a respected source.
DavidC
@Cheryl Rofer: I thought OWS was headed up by Azar and Espar. From what I’ve gleaned, they have technical reviews by SMEs within the government
ETA: That’s normally what BARDA does.
DavidC
@joel hanes: Exactly. This piece from The Atlantic was also good.
https://www.theatlantic.com/ideas/archive/2020/07/could-covid-19-immunity-really-disappear-months/614377/
Roger Moore
@joel hanes:
I have some experience dealing with the FDA*, and an approved drug is nothing like a beta or early release tech product. The whole point of clinical trials is that they aren’t going to let something go into production until it’s been vetted and shown to be safe and effective. The FDA is not perfect, but there’s a huge difference between products the manufacturer can release whenever they feel like it and ones that have to undergo an independent review before they can be released.
*My lab is FDA registered as a contract testing lab. We have been inspected by the FDA 3 times, and I have been personally involved in all aspects of our response, including being personally questioned by the FDA inspector, each time. The FDA does not come to play.
Amir Khalid
@WereBear:
It’s appalling that even after his exposure as a fraud, Andrew Wakefield is a heroic martyr to anti-vaxxers. And they still call him Doctor.
Cheryl Rofer
@DavidC and others on FDA: I agree that FDA seems less damaged than other government agencies. Likewise, the problems at CDC seem largely at the top. But I don’t have a granular look inside them, so I’m wary with something that could damage my health. Waiting for the Biden admin to clean out the rot.
Yes, Azar and Esper are in there somewhere. But, like all Trump initiatives, he’s appointed multiple people with overlapping “responsibilities” and will ultimately stick his nose in to mess things up. And Secretary of Defense? for vaccines? really?
DavidC
@Cheryl Rofer: DoD has a medical research presence (I live 2 blocks from one such facility) and lots of experience with procurement and distribution – maybe those experiences would be helpful? I am guessing that they wanted to bring together the major medical research players.
Jinchi
My biggest concern is the grifters, especially during the Trump administration. We’ve already seen some pretty disturbing trends with him harping snake oil cures, buying up and hording medical supplies, allowing price gouging, encouraging self medication (“What do you have to lose?”), and pseudo-science nonsense (Mark Grenon wrote to Trump saying chlorine dioxide âcan rid the body of Covid-19â days before the president promoted disinfectant as treatment). Combine that with the constant stream of evidence that the Republican party has become a death cult, and I won’t trust a vaccine until it’s gotten a green light from more than just the current US government.
CaseyL
@Cheryl Rofer:
That isn’t as preposterous as it sounds: the US Armed Forces would be a huge customer for the vaccine, and the effects of a pandemic definitely have a “national defense interest” element.
Mind you, I don’t trust Esper to do the right thing, or to even know what’s going on, but that’s true of everyone in the GOP Crime Syndicate Masquerading as a Government.
But on the face of it, involving DOD isn’t outrageious.
DavidC
@Jinchi: I would trust the FDA reviewers enough to enroll in a clinical trial – but it looks I am too isolated for the researchers’ tastes. LOL.
DavidC
@CaseyL: “Like”
Omnes Omnibus
@CaseyL: Oh sure, let’s experiment on the military. After all, they already volunteered, amirite?
Jinchi
@DavidC: Trump’s management of BARDA is one of the reasons I’ll be very cautious before taking a US vaccine.
chopper
@Cheryl Rofer:
i’m just wondering how all the anti-vax and Q-types (‘it’s all a hoax!’) who have been egged on by trump for years are going to factor in when a viable vaccine is announced. never mind the fundagelicals who will point to proof of covid vaccination being needed to return to school or work or whatever as ‘the mark of the beast’.
i assume, even if we have paid manufacturers to start production before their vaccine passes 3rd round, that we’ll have the logistical abilities to get this widely distributed quickly. just look at how this administration has been with regards to getting PPE and testing out.
CaseyL
@Omnes Omnibus: No, not experiment on them – at least, that wasn’t what I meant – just that once a vaccine is approved, the military is a huge customer for it.
Yutsano
@CaseyL: DoD would work on distribution to armed services members, families, and possibly even further down the family tree but that’s unusual. There’s a large number of hospitals and clinics on bases that could head distribution in a rapid amount of time. I have a few friends working on Covid cases in military hospitals and distribution of an effective vaccine is a priority here. So I can see DoD having a role here.
ColoradoGuy
Iâm wondering about joining the Moderna Phase 3 trials, here in Colorado. On one hand, Iâm nearly 71, so definitely in the high-risk group, but on the other hand, extremely cautious in terms of exposure. So is there any benefit in joining, or is it all downside?
Jinchi
I know of a few in my family. They won’t take any vaccine, or give it to their children. They believe the solution is for everyone to get it already so that we can reopen the country. And they won’t blame Trump, because it’s clear he thinks the same way they do.
Ken
So… if we classify the vaccine as an herbal supplement, we could
be making moneystart saving lives faster?debbie
@Constance Reader:
Thanks. I was only half-listening to NPR yesterday, but I thought I heard they would only trial up through age 55.
Yutsano
@Jinchi: I’m guessing they already home school their kids, because I can guarantee you this will be a requirement for public schools as soon as a vaccine is available.
CaseyL
@Jinchi:
A year or so ago, there was a woman who refused to get her children vaccinated against the usual childhood illnesses. Two of them got whooping cough; one had to be intubated. She still insists she did the right thing, and would do it all over again.
These people are completely braindead.
Jinchi
You’d think so, but no.
Mary G
?
Anonymous At Work
On the Can-We-Trust-the-FDA thread, this isn’t just a US-only affair. Trust in Trump overseas is non-existent. Dictators play him for a fool and democracies view him as their literal worst nightmare. If the FDA doesn’t convene an advisory committee and handle this all above-board, the truth will come out when these companies move beyond the USA’s 350 million people and move to the world’s other 7000 million people.
The principle worry with the original timeline is an EUA for frontline medical personnel for a vaccine that either overprovokes an immune response (cytokine storms are scary as EFF) or underprovokes an effective response, leading to mass infection of doctors and nurses.
And the final reason that the FDA should, and probably will, handle this very transparently is that COVID-19 is so effective at transmission that the vaccine(s) approved will be mandated and giving anti-vaxxers any avenue of refusal would be stupid. Given Republicans’ hatred of expertise and science, and given the DFH’s distrust of profit and actual medical knowledge, you’ll want to shut them down hard and fast.
Chris T.
“Obliberated”: is that what you get when you combine “obliterated” with “imbibed”? Or is it “liberty”?
Amir Khalid
@Chris T.:
“Obliberated” is how you say it after you’ve had a few.
DavidC
@Jinchi: Gary Disbrow has been there for a while and I’m sure that he knows that BARDA is under intense scrutiny.
Jinchi
@DavidC: It’s not that I distrust BARDA, the FDA or the CDC. But Trump has no problem sidelining people and organizations who are push back on his political agenda.
DavidC
@Jinchi: The push for hydroxychloroquine was (IMHO) because it was seen as a quick fix – the game changer that would cure the pandemic. I don’t see any reason for Trump to favor one vaccine over another.
VeniceRiley
I’ve signed up at the clinical trials volunteers site, even though I expect, being in a healthcare setting but not front line, to be among the first cohorts to get a jab. I need to get on with my life. it’s a critical time for me, and I’m beyond done with groundhog day. My future wife needs me, and she’s 8 hours away.
The Moar You Know
The sooner the better. Â Pretty sure Iâve got the virus. Â Will get tested today. Â Feel horrific.
I am a fanatic masker, work remotely and have no social life. Â If Iâve got it, I got it when I had to go to the ER a couple weeks ago for diverticulitis. Â Yay. Â Wish me luck.
VeniceRiley
@The Moar You Know: I’m sorry TMYK.
Jinchi
@The Moar You Know: Sorry to hear it. Wish for the best.
billcinsd
@DavidC: I donât see any reason for Trump to favor one vaccine over another.
You mean as long as he, a family member, or a crony has no financial interest. That was one reason he was pushing hydroxychlorquinone
Kent
I’m no expert in the science behind vaccines. But I do know something about risk assessment and I have been following this topic with some interest.
Every time the topic of vaccine development is discussed on NPR or some other news source it seems we always hear from some medical ‘ethicist’ who does a lot of pro-forma hand-wringing about the ethics involved with asking volunteers to participate in VOLUNTARY vaccine trials where they may be infected with Covid.
At the same exact time, we have tens of thousand of medical workers across the country who are being asked to INVOLUNTARILY expose themselves to Covid infections on penalty of losing their job by being forced to use inadequate and recycled PPE.  Many are even dying. And the medical “ethicists” are nowhere to be found.
I find the cognitive dissonance stunning.
Kent
He will favor whatever American vaccine gets developed over any foreign one no matter how much it might be safer, more effective, or more cost effective. Because he can bully and extract concessions from domestic companies much easier than one from say Germany, the UK, or China.
If it is an American company he can make them kiss his ring and he can crash their rolling out party with great fanfare and adulation. He can’t do that with a vaccine developed in Germany or China.
DavidC
@The Moar You Know: Best wishes to a speedy recovery.
Ben Vernia
I may be too late to this discussion to get attention, but here’s my question: I was looking over the Moderna Phase I article in NEJM, and noticed that despite the small sample size, they did not screen participants for prior SARS-CoV-2 exposure using either antibody or PCR tests. That struck me as odd. Granted, recipients of any approved vaccine won’t be tested, either, but for purposes of safety and dosing, I would think that they would want to know that the subjects had no prior virus exposure before administering the vaccine candidate.
chopper
@Ben Vernia:
jesus chicken-fried christ, you’d think the first thing they’d do is check people for pre-existing immunity, otherwise it could confound the whole study.
chopper
@chopper:
i mean, i guess for phase I it isn’t as important, but still
Seanly
@lee: In a double-blind study, you don’t get to pick if you’re in the control group (placebo) or the group with the trial medicine. You don’t even know which one you got as the ‘double’ means the researchers are also unaware.
My wife was in a double-blind study of post-coma recovery of mental acuity for heavy sedation. She was in a medically-induced coma and they wanted to test propofol vs something else while in the coma and then test her mentally upon waking and at 1 month & 6 months later. So the bottle for the IV drip came up from the pharmacy & was wrapped for the study. However, propofol is white so the nurse laughed and said “well, I guess we know which she’s getting in the study”.
Ascap_scab
If chosen for this study, would the vaccinated (or placeboed) be told to not protect themselves with masks or distancing? Told to resume normal interactions? And what of those they interact with? If they are masked, or would that change the dynamic? Will the participants (and placeboed) be deliberately dosed with Covid19 at some point to see if the vaccine works?
hitchhiker
I’ve been writing professionally about science and research (specifically neuroscience and spinal cord injury) for the last ten years.
Describing something as complex as these trials to a general public that has been conditioned to reject data and words of more than 3 syllables is going to be very, very challenging. It will help that we have a president, cabinet, and (hopefully) senate leadership that can get on board with full-throated, constant, and clear messaging.
But damn.
I mean, I understand very well how trials work and how to read data, and I have to go slowly through that post. When I think of what it would take to untangle the meaning for a willing audience, it takes my breath away. And when I think of how ridiculously simple it will be for idiots to miscommunicate about it … ugh.
Next year is going to be very strange.
Robert Sneddon
@Seanly: Properly constituted double-blind tests take note of things like visible differences between active materials and placebos — pills are made identical, any liquids are made to look and taste the same (if ingested). For vaccination double-blind protocols it’s quite often the case that the “placebo” injection is an active vaccination for something like chickenpox or TB which will produce a reaction in the subject (swelling in the injection site, some discomfort etc.)
Robert Sneddon
@Ascap_scab: No, anyone volunteering for these trials will be expected to go about their lives as they had before. The results are measured statistically — did the placebo cohort do better, worse or the same as the cohort that received the vaccination? Did the vaccinated cohort suffer any ill-effects in noticeably greater numbers? That’s the sort of statistics that will determine whether a given vaccine candidate is worth producing and administering to the general population.
As for being deliberately exposed to COVID-19, this is a vexed question. It’s called a “challenge” trial and has been discussed and will continue to be discussed for COVID-19. Ethically it’s very much a dark area, even for folks who would volunteer knowing the risks. If a really effective treatment for sufferers can be found, something that raises the survival rate way above what it is now with possible pre-screening for susceptibility and a lot of other factors then, maybe. Right now it’s not going to happen though.
JaySinWA
@Constance Reader:
@debbie:
This trial is actively soliciting applications for adults over 65. They filter applications out for people with uncontrolled existing conditions.
LongHairedWeirdo
That’s actually one thing that concerns me. You’re right, if a bloc of placebo subjects are risky, or if a bloc of experimental subjects are cautious, we could see a huge amount of skew in the data. And it seems like you’d want each collection of subjects who live in the same general area to get vaccinated at roughly the same time, so you don’t combine control groups living in Florida with a vaccine group in Hawaii.
And the other thing that concerns me, of course, is that we just can’t trust the federal government to have dug into the data that well. I could imagine them finding that the vaccine provides 50% protection *if* you juggle the numbers *just right*, and using that as proof of efficacy. However, I am *mostly* calm because there should be enough MDs in the chain of command that they can’t cover up piss-poor research. (Ref: Armageddon, “you said we did a bad job…” “NO, *I* said you did a piss-poor job.”)
But I’d feel a lot better with Biden in charge. I’m more confident he’d have someone doing such a thorough debriefing on the data collection and methods that several of the men on the vaccine team would check to make sure they weren’t *literally* de-briefed.
(See what I did there? BWAHAHAHA! BwahahaOkay, it wasn’t that funny.)
Ben Vernia
@chopper: Yeah, I’d like to know the rationale for that. By comparison, in the Oxford study (a modified adenovirus vaccine), they excluded volunteers with prior COVID-19 history, as well as those at high risk, and those with recent COVID-compatible symptoms. They only screened some of them for antibodies because the tests came online only after the study had begun. Even so, they noted that some subjects had Spike protein antibodies in the pre-vaccine blood sample.
ballerat
@Cheryl Rofer: Nothing exists beyond that psychopathâs immediate gratification, especially when someone else pays. Heâll take the mess of pottage every time.
Trump will push for this vaccine to be âreadyâ in October so he can announce he has found the cure.
It wonât matter if it turns out to have severe effects or is deadly. He has no qualms about how many deaths it takes to get him re-elected. Heâs already proved that.
Also, Trump will not prioritize healthcare workers. Jared will be in charge of it. Distribution will be corrupt and based on politics just like PPE supplies were.
This trial should run at least a year before jumping the gun, for all kinds of sane reasons.
ballerat
That corrupt stupid motherfucker. In charge of the whole project. Of course.
Jared will cherry-pick a few seemingly positive numbers, call it a scientific consensus, then hold a big presser 10 days before the election where they will announce the miracle vaccine will be available âfor anyone who wants oneâ and it will be ready âin 2 weeksâ.
Lies again of course, but after the election thereâs no backsies.
joel hanes
@Roger Moore:
Trump successfully fucked with the emergency authorization for hydroxychloroquine for political reasons.
I assume there is enormous pressure on the FDA to approve emergency access to a coronavirus vaccine before late October, also for political reasons.