A Phase 3 clinical trial of investigational vaccine mRNA-1273 to prevent #COVID19, co-developed by #NIH @NIAIDNews and @Moderna, has begun. The multisite trial will assess preventive power, enrolling 30k+ volunteers. Learn more: https://t.co/r1Li3GhSw3 pic.twitter.com/sRWyXCiDjo
— NIH (@NIH) July 27, 2020
This is one of the vaccines that have made it out of Phase 1 and 2 clinical trials with indications of safety and effectiveness. Phase 3 will be primarily assessing effectiveness.
The protocol is for two shots. The first will be on the first day of the observational period and the second is on Day 29. Initial effectiveness and safety results will start coming in after two months from the first day of the observational period. This trial is recruiting across the country including in numerous current hotspots. We should start to get solid hints from the data in October.
Even as the trials for this and other vaccine candidates start, the next big challenge will be logistics. Hundreds of millions of doses will be needed in the United States. Billions will be needed globally. Some of the candidates require complex cold-chain storage/distribution networks. All require some type of administration mechanism. Most of the typical global supply had already been spoken for with regular vaccines including the flu. We need to surge capacity and quality control to get a one-off huge bump in production.
Ceci n est pas mon nym
It irritates the heck out of me that many articles will add the words “President Trump’s Operation Warp Speed” to discussion of vaccines as if he had something to do with it.
WereBear
@Ceci n est pas mon nym: Especially since that’s a negative. Because he always IS.
rikyrah
Don’t trust anything under this Administration
Spanky
Does this mean I need to start hoarding syringes for nymsake Spanky’s insulin shots?
germy
Oh, it’s affecting “our people” ??
Nina
They also need volunteers, including people who are not in perfect health. https://www.coronaviruspreventionnetwork.org/
DavidC
@rikyrah: I trust the scientists and am hopeful about the FDA’s review process. There’s a lot at stake in making sure that safety is not compromised. The fact that the FDA has already laid out guidelines is good.
TImeline: Start end of July, earliest 2nd dose would be end of August. How long will enrollment take? Two months? So maybe data in December? We have to get enough patients exposed to Covid to know if the vaccine is efficacious, and it will take some time to know how long the efficacy lasts
I think we will have some safety and antibody data in October, but whether it prevents disease could take longer. JMHO.
DavidC
@Nina: Also extremely important to get enough subjects from minority groups where past public health efforts have led to distrust.
JAFD
Good morning, Mr. Anderson, and all you other jackals
To change subject; trust you’ve seen the ‘hospital reviews’ at the Washington Monthly – washingtonmonthly.com
Wondering what’s your take thereon ?
And another medical story, some of you might find interesting:
https://www.patheos.com/blogs/slacktivist/2020/06/16/51892/
Stay well, keep cool, and
Have great week, everyone !
Ohio Mom
I believe in vaccines, everyone in Ohio Family gets an annual flu shot and I joke that Ohio Son has been inoculated against diseases I’d never heard of.
I am old enough to remember suffering through the measles (I was too young when I had the other childhood diseases to have memories of them), and I also remember my mother’s excitement about getting us that sweet sugar cube of polio vaccine.
And of course I am terrified of catching Covid, and tired of/furious about this never-ending quarantine.
But — I also remember a couple of vaccine snafus: the swine flu vaccine that had a risk of leading to Guillian-barre syndrome, and the infant rotovirus vaccine that had to be recalled.
I particularly remember the rotovirus vaccine being recalled because Ohio Son just missed the age cutoff for the first round — he was already a toddler and too old.
I admire and am grateful to those volunteering to test any Covid vaccine because I don’t want to go first. I am suspicious that because there is so much pressure to get a vaccine out, that short cuts will be taken and horrible results will follow.
I am willing to be told why my fears are unfounded, I’d like to have more confidence.
EmbraceYourInnerCrone
@Spanky: yes
Ceci n est pas mon nym
@Ohio Mom: Your fears are not unfounded. That’s why this is a cautious process with the number of doses increased in steps. You may see side effects in 1 million doses that didn’t show up in a trial of 1000.
Also at least one of the vaccines in development had side effects (headache and fevers) in the smaller scale trials. I don’t remember which one or whether it’s one of the ones going to Phase 3.
But I’m not an anti-vaxxer. I will take a vaccine at some point. My risk tolerance is such that I wouldn’t sign up for the Phase 3 trials right now, but I will be carefully watching all the data on risk and efficacy and there will come a point where I feel I should take it.
Ohio Mom
Embrace your crone and Spanky: Seconding the Yes.
Probably prudent for all of us to stockpile all sorts of things to some degree. What to stockpile and how much to amass — that’s the tricky part. Medicines and medical supplies are obvious places to start though.
Ohio Mom
Ceci n est pas mon nym: An old friend who is a pharmacist works for a multi-national drug company. Her first position was tracking side effects from a newish drug.
She explained to me that the studies before a drug is released may only have a few hundred subjects and may miss the side effects that occur say, in one in a thousand patients. But once the drug is being taken by millions, all of a sudden a lot of people are having that side effect.
This simplified explanation made me gulp hard. I thought the vetting process was more robust.
PsiFighter37
Really disappointed that Moderna is quite explicit about selling this to make money, and there’s not a peep about it. I feel like vaccines in the past were done by the government and not outsourced to private companies who were out to make a buck.
Chris Johnson
I think it’s safe to assume that, whether or not any vaccine is a horrible disaster, we’ll get Russian-backed trolls claiming it is a horrible disaster to make sure people don’t take it. Hoping there’s some kind of authoritative source that I can weigh against the inevitable shenanigans.
Another Scott
Thanks for this.
I’ve found it interesting that China is doing their vaccine trials in places like India – because there are too few cases in their own country to know if their vaccine candidates are effective or not.
Donnie’s minions are apparently thinking that it’s some sooper-genius 11-dimensional chess move to let the virus run rampant here, that way companies can do their own testing on Americans. So much winning!!
:-/
Seriously, giving the misinformation and xenophobia everywhere, I wonder how companies are going to deal with the “OMG! Foreigners are trying to kill us off with this GMO poison!!11 If it were safe, they would have tested it on their own people!!11ONE” stuff that you know is coming. :-(
It’s so sad and infuriating that our world has come to this.
Fingers crossed that there are several vaccines that are safe and effective. We need a distributed attack.
Cheers,
Scott.
Matt McIrvin
@Ceci n est pas mon nym:
From what I’ve heard, most or all of the vaccine candidates do. Even if the early vaccines are safe, they’re likely to be a rough ride for many people who get them, which is a problem for public acceptance (this so easily gets distorted into “the vaccine gave me the disease”). But this certainly isn’t unheard of with vaccines.
Nina
@Ceci n est pas mon nym: The Oxford vaccine had the headaches and fevers, particularly in high doses (which were discontinued in phase 3 since medium doses were shown to have effective antibody production).
Kirk Spencer
Re ramping up the logistics chain, expect resistance.
It costs capital to ramp up. A use-once solution is a bankruptcy waiting to happen.
Matt McIrvin
@Another Scott: It’s a double-edged sword–while rampant spread gives you a bigger population to test vaccines and treatments on, it also gives doctors and patients stronger incentives to bypass or defeat effectively controlled double-blind trials. I’ve heard that people elsewhere are complaining about this happening with experimental COVID drugs in the US–doctors prioritizing “treat ’em and maybe it works” over systematic investigation to see what really works, because we’re pretty desperate. There’s also a certain amount of privilege-filtered “kitchen-sink treatment for me, placebo-controlled trials for thee”.
Jamey
“All require some type of administration mechanism. ”
Welp, we in the USA are fucked…
evodevo
@Ohio Mom: Uh, no…it’s never been that robust…and BigPharma also tries to slide stuff by the FDA even in good times, when the FDA was staffed and run by competent medical people…nowadays? Who knows…
evodevo
@Matt McIrvin: Yes, I still hear this crap out of co-workers…”I didn’t get the flu till I had a flu shot!!11!!!” They don’t seem to comprehend that the reaction of your immune system is what gives you symptoms – and I have tried to explain that to them over and over. And when you challenge your immune system with a vaccine, you may get feverish, feel like crap and your arm will hurt. THAT’S your immune system gearing up. It’s NOT the flu….On the other hand, if you get a fever, and cough for a week, THAT’S the flu, and you probably already had it when you got the shot. (Or picked it up in the Dr’s office while waiting to get the shot lol)
Matt McIrvin
@evodevo: Yeah, there’s that too. With those yearly flu shots they always tell you it’ll be, what, a couple of weeks before you really have immunity–and in a raging flu season, it’s not at all implausible that you’ll catch the flu during that interval, or that the virus was already lurking in you when you got the shot. But “post hoc ergo propter hoc” is an easy mistake to make.
The Moar You Know
They do need to start coming clean about the side effects now. The worst that Moderna reported was only a bit worse than my reaction to the second shot (it’s always the second shot that gets ya) to the shingles vaccine. First shot I had about 4-5 hours of just feeling vile. And how I would have appreciated it if the doc had just said “yeah, for the second one you’re gonna need to clear about three or four days off your calendar” because that’s exactly what I had to do. Damn.
Beats the shit out of getting shingles, though.
Ken
@PsiFighter37: Moderna just lost a patent case that involves some of the techniques they were using with this vaccine. No idea how that might impact their profit, but it probably prevents them from blocking other companies that develop similar mRNA vaccines.
BTW, the mRNA vaccines are a different approach to triggering the immune system. Instead of using killed virus or viral fragments, it uses an mRNA strand that enters your cells and caises them to express the viral proteins. The immune system says “now THAT doesn’t look right” and ramps up to recognize it faster next time.
DavidC
@evodevo: The FDA reviewers are the same people who have been there over the years. They are not political appointees.
KayInMD (formerly Kay (not the front-pager))
@Ohio Mom: This is what happened with the swine flu vaccine & Gillian Barre in the ’70s if I recall correctly. The side effect didn’t show up right away, and didn’t show up until many thousands- perhaps it was millions, I don’t remember exactly – were inoculated. That’s one of the reasons why this super-rushed vaccine development process is so concerning, at least to me.
DavidC
@PsiFighter37: No, pharma companies have been the ones who have done the latest vaccines.- including Hep B, shingles, HPV. They don’t make a ton of money on these, which is why the US government has been so involved in teh Covid vaccines.
Disclosure: I spent 16 years in immunology and vaccine (HIV and Lyme) research.
KayInMD (formerly Kay (not the front-pager))
@Matt McIrvin: This is why my doc always has me get my flu shot in September, or as early as she has the vaccine. Her office gives me a call to remind me to come in. She’s a GP, but specializes in gerontology ( turned 70 yesterday!) so she does this with all her older patients. She wants us to get the shot & develop immunity before the flu is rampant in the community.
JPL
@KayInMD (formerly Kay (not the front-pager)): It was several months later. I held off because I was pregnant. It was Ford’s operation warp speed.
Roger Moore
@Ohio Mom:
OTOH, it’s hard to see how they can do things any differently. No matter what you call it, you have to start administering a drug at first to a few people and later to more people. If you’re going to start giving a hundred times more people a drug, you’ll find some more effects. That’s true whether you call that expansion a clinical trial or commercial release.
Dorothy A. Winsor
@JPL: I need more coffee. I looked at this and wondered why a car company was involved in a vaccine.
KayInMD (formerly Kay (not the front-pager))
@JPL: Lol I held off because I had a newborn and could barely get it together to get dressed before my husband got home from work, much less go to the doctor for a flu shot. So babies saved us both.
Roger Moore
@Matt McIrvin:
It shouldn’t be surprising that they do. The purpose of a vaccine is to activate the immune system, and fever and headaches are results of that immune response.
Matt McIrvin
@KayInMD (formerly Kay (not the front-pager)): IIRC, Guillain-Barré is one of the many, many things that COVID-19 itself can cause, so it’s probably something to look out for from the vaccines as well–and then you get into the awful calculations like whether it’s actually worth putting up with a certain amount of this to smash the virus.
Matt McIrvin
@Roger Moore: True, though the magnitude varies–with seasonal flu shots, I usually just get a mild headache and a sore arm that I can manage with a couple of ibuprofen.
raven
Interesting take on the loss of smell
The article says it’s solved.
Uncle Cosmo
@The Moar You Know: First or second version of the vaccine? I was about to sign up for the first one when I found out that (1) it was pricey, (2) side effects could be pretty awful, and (3) – the kicker – the seroconversion rate was barely north of 50%. Which AFAICT is why the developers of the second version kept working on it, and (again IIUC) that one has a much higher chance of protecting you from the shingles.
Sab
@JPL: And Donald Rumsfeld, Ford’s chief of staff at the time, got a very high level job at Searle right afterwards without any pharmaceutical experience.
Roger Moore
@Matt McIrvin:
I think most of the people who complain about the flu shot are getting mild symptoms from the shot and think it’s the flu. The flu has really bad symptoms- body aches, high fever, etc.- and will incapacitate the patient for a week or more. If the people complaining about getting their flu shot were only mildly inconvenienced, they didn’t get the flu.
raven
@The Moar You Know: We both got sicker from the second one but I had shingles in my eye 20 years ago and it will be worth it if I never see that again.
DavidC
@Uncle Cosmo: @Uncle Cosmo: I’ve had both after I already got shingles. The older vaccine had few side effects. For the second one, I was done for a day after each shot – chills, aches. It’s more effective, especially for us olds, because it is also adjuvanted. Still better than shingles.
Kelly
I was nervous about Trump slipping something shoddy past the FDA. The pharma corps must have notice my feeling was widespread. There where several items in the news noting vaccines will meet standards in many countries before mass distribution. I’m less worried now.
ballerat
@germy: I’ve commented this before: it’s a genocide.
Now that the wrong people are getting hurt the problem they are struggling with is how save “their” people without saving most of Those People.
I am also certain a lot more evidence will come out in the years ahead. This will go in the history books next to small pox blankets.
Mousebumples
Re: immunizations and pregnancy, I got my flu shot super early last year (August) since I wanted to develop antibodies that I could pass to my daughter before she was born a few weeks late. Babies can’t get the flu shot until 6mo of age, and it was important to me to be able to try to protect her as best I could.
Re covid immunizations – i want to see the data. They aren’t recruiting for phase 3 near me, but if they were, I would think about participating. But as others have said above, vaccines can cause light side effects – fever, malaise, headaches, and injection site pain are all common and should not be a reason to not get a vaccine. They are all short term and better than getting the virus itself.
ballerat
Absolutely. Worse, if it actually does have side effects.
Trump will put enormous pressure to get a vaccine released a week or so before the election. We won’t find out the effects until after, but so what? Having it be safe is not the point. Getting something out there to win the election is. And that rush means side-effects are much more likely.
We won’t hear about the side-effects until after the election but it will play right into the Russian trolls’ narrative.
We could get the worst of all possible outcomes: Another 4 years of Trump, a failed vaccine, a re-energized and seemingly vindicated anti-vaxxer movement and a nation growing suspicious of vaccines.
I really hope they won’t release the vaccine until it is ready, which means well after November. We also need a national response to these Russian anti-vaxxer attacks, and a national program of vaccine education, neither of which we’ll get until after Jan 20.
We can’t fail in this. It has to work the first time. It has to be successful. And we have to have some national leadership to counter the Russian-concocted anti-vaxxer poison.
DavidC
@ballerat: I don’t see a vaccine being approved before the safety data are widely known. I assume that there would be a public Advisory Committee meeting after FDA review and before approval.
yellowdog
@Ohio Mom: I believe I was one of the children the original Salk vaccine was tested on. I remember when I was in kindergarten being lined up in the hall and given an injection. The timing is right for the vaccine trial, and I don’t think there were any other common vaccines at the time, except for smallpox and I doubt if they’d be giving that to a bunch of Long Island five year olds.
PAM Dirac
@DavidC:
I just don’t see what in it for the particular company to cooperate with a rigged approval process. First, as DavidC noted, there are processes in place and if they are skipped, it will be obvious. Second, any company wants to sell the vaccine world wide and other regulatory bodies aren’t going to just go along with the US idiots. Lastly there are a pretty large number of competing companies and I certainly don’t see any possibility that the “losing” companies will just shut up about any nonsense. The magnitude of the crisis means that even the most well meaning regulators are going to feel pressure to act, but I just don’t see how an almost complete fabrication of an effective vaccine is going to go unnoticed and unchallenged.
Roger Moore
@ballerat:
I don’t think a vaccine coming out in October is going to do much to help Trump. It’s not enough to announce that help is at hand; most people will need to see some tangible results to be convinced. Even assuming we could get enough doses to treat the population at large- and I sincerely doubt we’ll get there in 90 days- it would still take a couple of months before we start seeing tangible results. I’m sure Trump is convinced a vaccine is all he needs, but he’s just fooling himself.
NeenerNeener
I’ve got MS and have had exacerbations from flu shots, so as much as I’d like to have immunity to COVID19 I would be risking my health more than most if the vaccine has fever side effects.
And I know it’s purely anecdotal, but my father was talked into having a pneumonia vaccine with his flu shot one year, and 3 days later had full on pneumonia. He lost 20 lbs in about 10 days and hacked all day and night. It took 2 months and lots of prescriptions before he got over it. He was so pissed off at his GP after that that he switched doctors.
Fair Economist
@Ken: I really like the mRNA approach because it should generate a much stronger T cell response, which produces much broader immunity than B cell (antibody) responses. There’s a plausible hypothesis that one of the main drivers to COVID severity is whether your T cell response to common cold coronavirus caries over. No B cell response would.
Fair Economist
@Roger Moore: An early vaccine is bad politically for “let grandma die (and everybody get lung damage)” proponents like Trump. An early vaccine means we should definitely have waited. If no vaccine were ever going to be available, “let infections happen” would have been necessary although of course it should still have been managed.
Roger Moore
@Fair Economist:
Question for someone who knows more immunology than me: is an mRNA vaccine going to work primarily through MHC class I rather than class II? That’s what I’d naively expect- the idea is to get the cells to express viral proteins- but I want to make sure I understand how it’s supposed to work.
Comrade Misfit
I routinely get immunized. But I have some qualms with taking this vaccine, given the flat-out rush to develop it. Speed, effectiveness, quality– pick two.
I keep thinking about how NASA cut corners on testing the Hubble telescope, in order to stay on schedule and to save money. That didn’t work out so well.
We have to hope that the scientists at the FDA can resist the pressure to speed up the approval pricess that will be brought by the President and the political appointees running things.
If not, we can have a result somewhere between the swine flu and I Am Legend.
Fair Economist
@Roger Moore: Yeah, (oversimplifying) Type I displays peptides from the cell while Type II displays digested external peptides so I would think Type I would be more important for viruses. Type I displays shorter peptides so it would be more relevant for crossimmunity too, FWIW.
namekarB
I Hate to rain on the parade but I don’t foresee any vaccine before mid 2021. Even then 20% of the population won’t get vaccinated. The vaccine will have no immunizing affect on another portion (Seen estimates in 20% range). And finally how do we get vaccine mass produced, distributed and available?
So, best case scenario, mid 2021 they start rolling out vaccinations, 1 out 5 people refuse and another percentage will fail to develop immunity after vaccination so we’ll still have Covid popping up all over the place.
Please, no more posts on how close we are to a vaccine, it only gets people’s hopes up when reality is that it will be a long haul