Direct Facts About A COVID Vaccine
July 14, 2020 8:38 PM   Subscribe

New England Journal Of Medicine article An mRNA Vaccine against SARS-CoV-2 — Preliminary Report gets detailed like you want it to be if you like reading this kind of thing. It's written in pretty understandable english with context clues to help the slightly stupid like me, but it's super interesting where they're at with this single (out of a zillion?) being developed.
posted by hippybear (44 comments total) 21 users marked this as a favorite
 
This is a big, fat nothingburger. They tested a possible vaccine on 45 subjects (actually 43, as they had to exclude 3 subjects because they didn't get the 2nd dose in time for them to be considered as following the same protocol...) in different combinations of 1st and 2nd dosages. Over 20% reported adverse reactions, and 50% showed signs of improved immune response to the virus.

No one died, and not enough people showed bad enough reactions to stop them from proceeding towards phase 2 trials, where hundreds of people will try out one of 3 dosage regimes. If none of them die, then we may be on our way to a vaccine with 50%-ish efficacy.

This is the threshold the FDA announced as acceptable recently, but because of the current epidemic of stupidity and anti-vax fear, I don't think it will be enough to actually contain the disease. If everyone in the country were vaccinated at 50% efficacy, we may - if we're really lucky - be able to achieve herd immunity. In 2020 or 2021, I don't see that happening.
posted by Anoplura at 8:58 PM on July 14, 2020 [8 favorites]


So this is the Moderna vaccine candidate. (The company that has never produced a successful vaccine in the past but nonetheless received enormous amounts of Trump administration funding.)

They put out a press release in mid-May saying they were going to be publishing results Real Soon Now. It's kind of impressive that they finally have; I guess they weren't just BSing. They had become a bit of a punch line.

Also on Monday, Pfizer/BioNTech announced they have FDA fast-track approval for development of 2 of their 4 vaccine candidates which have passed Phase 1, and will be progressing to Phase 2 of testing.

ATM everyone is waiting on results from Oxford/AstraZenica's Phase 3 tests in Brazil and South Africa. That's the big one. If they have good results, it's on to mass manufacturing!
posted by Harvey Kilobit at 9:08 PM on July 14, 2020 [19 favorites]


In addition to the many vaccines being developed--not only many in the US, but in several other countries (for example, England, China, Russia, Taiwan, South Korea all have vaccines in development) --at least 17 that I can find in a quick search.

I'm no expert on vaccines, but you'd think that at least some of these people know what they are doing and have a chance at making a successful vaccine.

I'm hopeful.
posted by eye of newt at 9:19 PM on July 14, 2020 [4 favorites]


Maybe this will work and maybe it won't but for me Moderna has a whiff of Theranos grifter about it. I'm not sure I'm going to trust any vaccine that comes out this quickly from the Trump administration.
posted by JackFlash at 9:22 PM on July 14, 2020 [9 favorites]


There are now 150 different COVID-19 vaccine candidates in development. (Link goes to a World Health Organization webpage, click on the button on the left to download a PDF of the list.)
posted by Harvey Kilobit at 9:28 PM on July 14, 2020 [6 favorites]


Here's a pretty nifty Vaccine tracker, via this comment posted by chortly at 9:42 PM on June 6
posted by ecco at 9:37 PM on July 14, 2020 [11 favorites]


Anoplura, unless I’m misreading the article, I don’t see where they had 50% with increased immune responses. What I read said that all participants had a good antibody response after vaccination. Also, where does it say that participants in the next phase will get one of three dosing regimens? What I read is that they’re most likely going to conduct larger trials using the 100 microgram dose. You say hundreds, but the reports (not in this article) are that phase 3 trials are starting in two weeks and they’re recruiting 30,000 participants. Can you point me to what I missed after reading this?
posted by azpenguin at 9:50 PM on July 14, 2020 [15 favorites]


Anoplura, I don't think you are reading this with a practiced eye.

The adverse results are nothing more than seen with a variety of proven vaccines and appear to be limited to slight fever, body aches and pain at the injection site, all indicative of a good immune system. response.

This is actually a pretty good phase 2 result.
posted by mygoditsbob at 10:23 PM on July 14, 2020 [21 favorites]


I'm an RNA biologist, and I've followed Moderna and other companies' work in RNA therapeutics space casually over the past two years. To the extent that that makes me biased, it's that I really want RNA vaccines to work. In principle, injecting RNA and getting a person's cells to make viral protein for you is substantially more straightforward than producing and purifying viral protein aand making a vaccine from that. But the latter approach is, as noted, much more validated, and when it comes to vaccine testing and manufacture, that's not something to be discounted lightly.

Derek Lowe had a very nice layperson rundown of all the different technologies we use to make vaccines back in April on his blog, and what some of the tradeoffs are that come with each approach. If effective, the mRNA vaccine will likely be the easiest to scale up manufacturing for, just because making literal kilograms of purified RNA, while it will undoubtedly set world records, is a lot easier and faster (it can be done in vitro) than making the equivalent dose-amount of protein (which you'd need to do in cells, in a bioreactor).

Anyway, phase 3 registration for this particular vaccine candidate happened today (clinicaltrials.gov). The National Institute of Allergy and Infectious Diseases is creating a registry of potential volunteers for this and many other vaccine trials that you can sign up for over here. I'm not an immunologist, but my take on the adverse events out of phase 2 is basically the same as mygoditsbob above. I signed up as a volunteer hoping I might get picked as one of the 30,000 people who'll be randomized to this vaccine or placebo. My expectations are that all of these first round of vaccines (pre-2022) will be only partially protective, and I'm unconcerned about fever or other adverse events for myself, although I wouldn't be surprised if we find out there are subpopulations of individuals (for ex, folks with immune conditions) where the AEs for this vaccine candidate or others are a bigger deal.
posted by deludingmyself at 10:37 PM on July 14, 2020 [48 favorites]


So this is the Moderna vaccine candidate. (The company that has never produced a successful vaccine in the past but nonetheless received enormous amounts of Trump administration funding.)

Moderna executives dumped stock after the Trump administration made its announcement two months ago. The press tried to qualify that stock sales were timed before the announcement, except that Trump hired a Moderna exec to time and make the announcement, so it would have been trivially possible for the Trump hire to coordinate scheduling with his former colleagues at the company.

We never heard any follow up on this from the press, and the SEC is unlikely to look at this under the current regime.

This wouldn't be the first time the Trump administration has been more than tangentially involved in pump-and-dump schemes. This one just happens to coincide with 130k+ mostly-avoidable deaths, and counting.
posted by They sucked his brains out! at 10:50 PM on July 14, 2020 [9 favorites]


Sorry, 140k and counting. It's been a long few days.
posted by They sucked his brains out! at 11:23 PM on July 14, 2020


This looks promising. The speed at which they've been able to move is impressive, and even if this doesn't end up being the most effective vaccine, if it works well enough and it is able to enter distribution quickly, it's going to make a real difference while research continues on subsequent, improved vaccines. Even if it's only moderately effective and only a fraction of the population receive the vaccine, that may be enough to slow or stop the spread in some communities. More so when vaccinations are accompanied by well-coordinated public health campaigns to reduce viral spread in other ways, less so in the U.S. where that doesn't seem to be politically possible, but it will certainly save lives if it works. Of course we could get lucky and this (or another one of the first round of vaccine candidates) will turn out to be highly protective with few side effects, but even if not, the rate at which research is progressing here is really unprecedented. It's incredible that we're already at Phase III trials being launched.

I'm not expert enough to comment on the paper in any great detail, but I thought it was worth calling attention to this bit:
We found strong correlations between the binding and neutralization assays and between the live virus and pseudovirus neutralization assays. The latter finding suggests that the pseudovirus neutralization assay, performed under biosafety level 2 containment, may, when validated, serve as a relevant surrogate for live virus neutralization, which requires biosafety level 3 containment.
This is potentially quite a big deal from a research perspective, not limited to just this particular vaccine candidate. Biosafety level 2 (BSL-2) facilities are common at research universities throughout the U.S., but BSL-3 facilities are rarer and more expensive to run and maintain. (I'm not familiar with whether other countries use the same BSL categorization system as the U.S., but the equivalent statement will be true in any country with a significant biomedical research program.) What they're saying is that if this result holds generally, a lot more researchers will be able to participate in vaccine research. Although I'm not an expert, it seems likely to me that live virus neutralization assays (which require BSL-3) will still be necessary, but if more labs are able to help identify promising candidates using the pseudovirus neutralization technique (which requires only BSL-2), that might speed research even further.
posted by biogeo at 12:45 AM on July 15, 2020 [11 favorites]


Did Moderna do a challenge study in primates with this?
posted by benzenedream at 1:18 AM on July 15, 2020 [2 favorites]


I've mostly been avoiding all writing about SARS-CoV-2 vaccines. There's a lot of science to be done before we have a real vaccine, much of it boring and slow. And every company is in a hurry to give the best possible spin and get all the press they possibly can. It doesn't lead to very good journalism.

One exception, I really liked the Economist's article last week: Oxford University is leading in the vaccine race. It's unusually jingoistic for the Economist, but it's a very optimistic take on the development of one of the furthest along in the pipeline vaccine candidates. The article does a good job explaining the business of vaccine development and production.
posted by Nelson at 6:48 AM on July 15, 2020 [8 favorites]


Derek Lowe has posted his analysis of the Moderna Phase I data. A really important practical point:
Moderna’s candidate is absolutely going to need two injections (as did the Pfizer/BioNTech vaccine candidate)
This is very important not only for the obvious reason that it more than doubles the logistical problems (because you now also have to have a followup system to make sure people come back for round 2 at the appropriate time) but also because we literally do not have the manufacturing capacity to make enough sterile containers for a vaccine as fast as we would like. Doubling the number of vials, syringes, etc that have to be made is a major consideration. It's also a potential bottleneck in the plan to pre-make hundreds of millions of doses of the major vaccine candidates while we wait for approval.

For a good overview of where the most promising candidates stand, his most recent vaccine news roundup was posted on July 7th (I think it might technically be an update of a June 29th post).
posted by jedicus at 7:35 AM on July 15, 2020 [11 favorites]


Please, please, please. But don't let the promise and hope deter us from doing what we need to do and know how to do now. Merck CEO says raising COVID-19 vaccine hopes 'a grave disservice'
posted by Mr.Know-it-some at 8:06 AM on July 15, 2020 [2 favorites]


Did Moderna do a challenge study in primates with this?

good to see benzenedream in this thread. I made a point of bookmarking this comment a while back ...

It is important to remember that in a novel scientific crisis or discovery, the worst experiments are done the fastest by the least careful experimenters and are usually the least trustable (see Pons and Fleischman's cold fusion furor for a good example of this -- it was "replicated" early on by others who made the same mistakes before being debunked by actual experts in measuring energy output carefully).
posted by philip-random at 8:36 AM on July 15, 2020


Did Moderna do a challenge study in primates with this?

No. Their other vaccine candidates (e.g., the one for respiratory syncytial virus, which I believe was in Phase 2 pre-COVID) have been tested in small animal models of upper respiratory infection. The DNA vaccine being developed by Sinovac Biotech has been tested for efficacy in a macaque challenge study and showed protective benefit. Both of these use nucleic acid to encode a stabilized form of the gene/mRNA for the nCoV2 spike protein (an otherwise very flexible piece of viral machinery the virus uses to attach to and enter cells, and that immune cells can recognize because it's located on the exterior surface of the virus), and both are roughly equivalent levels of new technology. In a DNA vaccine you need to deliver this payload efficiently enough for it to enter the nucleus of human cells so that it can get treated like other DNA, get transcribed into RNA, exported back to the cytoplasm, and then make viral protein. An RNA vaccine payload has slightly less of a delivery challenge because you only need to deliver the RNA to the cytoplasm to get the same result.

I realize there's a lot of negativity about this topic, and I understand it. Societally we're trying to speed up vaccine development as fast as possible because we've got a raging pandemic from a disease none of our immune systems have ever encountered before, and even a set of kind of crappy vaccines are likely to save lives. Thinking about the tradeoffs that come with that - probably fewer phase 2 trials looking at safety for specific risk groups, probably we roll out the first few semi-effective vaccines that are the product of weeks/months of preclinical optimization instead of years - doesn't make me comfortable, but neither does anything about our current situation. I still get a flu shot every year even when the best guess at what the circulating flu strains will be several months earlier was wrong and that year's shot offers limited protection, and I expect the first round of COVID vaccines will be much the same.
posted by deludingmyself at 9:35 AM on July 15, 2020 [10 favorites]


My concern is that a rushed vaccine might have serious adverse effects (or even makes the disease worse, do people still think that's possible?) and then nobody will want to get the good vaccines when they come out.
posted by atoxyl at 10:29 AM on July 15, 2020


I think we need to be negative about this topic, because there are no shortage of vaccine candidates and getting our hopes up about Moderna without challenge studies is a bad bet. There may be shortages of sterile vials, needles, and other supplies that preclude doing multiple doses of the entire population. Non-crazy leaders would help, but even with wartime level production efforts producing 1B doses of any biologic is troublesome.

There have been many vaccine failures which produced great titers of neutralizing antibodies (the one I'm most familiar with is an HSV surface protein vaccine effort) and didn't do anything in patients due to cryptic defenses of the virus that may not have been known at the time.

The troubling part of this vaccine development is that nobody really knows how the endemic coronaviruses reinfect so quickly in the same individuals year after year despite having almost no genetic variability (at least compared to something like influenza A). If this feature was known we could try to engineer it out and disable it. I think this may cause the most problems with attentuated vaccines (since we don't really know what we're attenuating) but hopefully it is not a purely peptide effect and requires replication of the virus to achieve, in which case the inactivated viruses and component vaccines may overcome this "feature" for naive individuals.
posted by benzenedream at 11:01 AM on July 15, 2020 [6 favorites]


For those who don't know what a challenge study is : it's taking unexposed animals, vaccinating them, then deliberately infecting animals with the live virus and seeing how the infection progresses. A positive challenge study would be one that completely prevents replication of the virus post-vaccination. These are subject to the caveat that immune systems are the parts of mammals that vary the most from each other, but primate studies are as good as you can get independent of a human study.
posted by benzenedream at 11:28 AM on July 15, 2020 [7 favorites]


Again, while I love the idea of mRNA vaccines scaling, I do think that getting that mRNA into the cells is going to remain tricky- while it sounds like they've had some success in their early trials, my (albeit limited) experience with lipid nanoparticles is that they're very fussy. You're basically trying to encapsulate the mRNA into a little sac of lipids with a just the right match to the membrane of the cells so that they can fuse and dump their contents in. While it can lead to great results, it seems to take a lot of practice, the nanoparticles aren't particularly shelf stable, and are really fussy about how they're handled, so unlike a traditional vaccine, one major issue with rolling them out in large numbers is not the manufacturing, but the fact that mistakes by whoever is injecting the vaccines could really decrease how effective they might be.
posted by whm at 11:31 AM on July 15, 2020 [2 favorites]


I wonder how effective a first vaccine needs to be to avoid a stink when the people it's inneffective in protecting get covid. Which seems like it would really boost antivaxxing even when a better vaccine comes along.

I mean, if I'm told the vaccine is 50% effective, I'll take it and proceed under the assumption I'm still not safe, and be glad for the chance, but I doubt everyone would react like that. (And I also somewhat doubt my own subconcious reactions in that situation.)
posted by joeyh at 11:53 AM on July 15, 2020 [3 favorites]


I think we need to be negative about this topic, because there are no shortage of vaccine candidates and getting our hopes up about Moderna without challenge studies is a bad bet.

The decision seems to have been to use humans as the challenge studies, because tons of us are actively getting exposed on a routine basis, and waiting to see if a vaccine is effective in challenged animals in a pandemic, for a newly emerging disease that lacked a validated animal models until May, has its own costs. There are reasonable arguments to be made both for and against this approach, imo.

From a science communication perspective the whole situation makes me despair whenever I think about it much. Like, leaving aside mRNA vaccines specifically, is there a good way to communicate to the public that we're full steam ahead on developing a first wave of vaccines that may only be partially protective unless we get really lucky, but will hopefully be better than not having a vaccine? Because that's absolutely where we're headed.
posted by deludingmyself at 12:13 PM on July 15, 2020 [4 favorites]


Non-crazy leaders would help, but even with wartime level production efforts producing 1B doses of any biologic is troublesome.

There's a complicated and related side-story about horseshoe crab blood, which is used to test vaccines and other therapeutics for bacterial contamination. Crabs are collected, some blood is removed and processed, and the crabs are returned to sea.

Because the crabs are endangered, some drug companies are researching using an engineered source for the factor in this blood, but a safe and effective product is still out of reach. On the other hand, ceasing crab collection and return also causes the loss of many existing jobs, which causes its own problems in an economic depression.

Some reading, for those interested:

https://www.smithsonianmag.com/smart-news/race-coronavirus-vaccine-runs-horseshoe-crab-blood-180975048/
https://www.nytimes.com/2020/06/03/science/coronavirus-vaccine-horseshoe-crabs.html
https://www.theatlantic.com/science/archive/2018/05/blood-in-the-water/559229/
posted by They sucked his brains out! at 12:22 PM on July 15, 2020 [3 favorites]


My concern is that a rushed vaccine might have serious adverse effects (or even makes the disease worse, do people still think that's possible?) and then nobody will want to get the good vaccines when they come out.

Even if the vaccine is as close to 100% harmless as anything can ever be a significant proportion of the population will refuse to vaccinate. I just hope it is not so many that we get a low simmer situation with occasional big outbreaks.

I'm also very curious if their will be legal requirements for vaccination for schools in the U.S. and whether they will be as loophole ridden as current requirements. I fully expect it for school in Canada where it is already the case for other vaccinations.
posted by srboisvert at 12:37 PM on July 15, 2020 [1 favorite]


Wait until the public finds out the government is planning to inject nanobots that hijack cellular machinery to replicate themselves by the billions.
posted by JackFlash at 1:03 PM on July 15, 2020 [2 favorites]


From a science communication perspective the whole situation makes me despair whenever I think about it much.

Agreed, and having a for-profit motive merged with the communication is a terrible idea. There should have been some sort of nationalization of the efforts that would exempt public companies from normal disclosure requirements. Normally nobody would pay much attention to early stage data that doesn't have much predictive power for efficacy, but in this case everything is being scrutinized and publicized to a much wider audience that would need a lot of expectations management to avoid weird backlash (and there are so many bad actors lurking waiting to confuse the population).
posted by benzenedream at 1:26 PM on July 15, 2020 [2 favorites]


Toxicologist/epidemiologist working in vaccines and immunotherapeutics chiming in to say, this is far from "a big, fat nothingburger." Anoplura, I'm not sure where your position is coming from with that comment, but it's not coming from any of these fields.

May day started at 3 am with conference calls on this, and I'm just now taking a lunch break almost 12 hours later. I don't work for Moderna or have a stake in the success of this vaccine (other than the obvious desire to have a functional vaccine ASAP), but I wanted to point out just how much of a paradigm shift the Moderna approach is: for the first time since vaccines have been regulated, Moderna's candidate used an argument for safety that came from an impressive accumulation of modern human-biology based science rather than years or decades of preclinical optimization in nonhuman animal models. Companies have been trying to do this for decades, but regulators have been very reticent to allow it. So, along comes a pandemic and sudden regulatory will to shift the paradigm of drug development even a tiny bit to allow for expediency, and badda boom, we're all watching with bated breath. Caution is a virtue, but I disagree almost totally with every rebuttal Anoplura has listed. These published results are exceedingly good, interesting, promising, etc. A vaccine with 50% efficacy would be smashing. New companies with no marketed products develop new drugs all the time--then they sell their IP to major companies that take the steps to being a drug to market. I could go on, but I need to get back to work.

In parting, feel free to look at the sites (scroll down and expand the list of 87 participating sites) for the next phase of clinical trials in case they're coming to your region and you're interested in participating. I'll sure as hell be signing up.
posted by late afternoon dreaming hotel at 2:37 PM on July 15, 2020 [11 favorites]


Yikes. Just getting computer time now.

First, I apologize for my comment. My intent in the first 2 paragraphs was to say that it's way too early to get excited about this vaccine, and that this isn't even "news", yet. The third paragraph was a loosely connected musing about how difficult any kind of vaccine roll-out will be in the US at this time.

Re-reading it now, I can see that it reads more like a snarky dismissal of the vaccine, where I intended a criticism of the over-hyping of preliminary results we so often see in the popular media. I also realize that "nothingburger" was a very poor choice of words for what I was trying to imply. I'll try to make better contributions to the discussion.

Regarding the vaccine efficacy, I was under the impression that the seasonal flu vaccine was typically high 60% to 70%, and that that was lower than other vaccines such as polio and mmr. A quick web search seems to back that up.

I understand that SARS-CoV-2 has some novel features that complicate vaccine development, but given how widespread it is, and how difficult the vaccination campaign is likely to be, isn't 50% efficacy kind of low? Not trying to make an argument, I'm genuinely curious. I'd appreciate an explainer from someone with an infectious disease background about what we can expect in the hypothetical situation where we end up with a 50% effective vaccine, but only the current treatment options/knowledge.
posted by Anoplura at 7:11 PM on July 15, 2020


If R0 is >1 and R0 × 50% is <1, then that factor of 50% is enough to make the difference between a growing pandemic and a subsiding one.
posted by flabdablet at 7:16 PM on July 15, 2020 [3 favorites]


If R0 is >1 and R0 × 50% is less than 1, then that factor of 50% is enough to make the difference between a growing pandemic and a subsiding one.

That's assuming 100% vaccination rate, which is likely impossible. But the more important question is behavioral. Will people feel safe enough to fly on airplanes, go to restaurants, go to schools, go to work if they still have a 50% chance of getting sick if exposed, even if the exposure rate is reduced.
posted by JackFlash at 7:54 PM on July 15, 2020 [1 favorite]


Caveat vaccine: "Quality, on-time, cost" Pick 2. The really big worry is we'll get the last 2 but not the first.
posted by storybored at 9:02 PM on July 15, 2020 [1 favorite]


We may end up getting a fast vaccine and then maybe some kind of Vaccine 2.0 (even 3.0?) later. The idea to get some immunity started but continue to develop until something much better has come along.

Or maybe not. Depends on how the funding goes, after all.
posted by hippybear at 9:15 PM on July 15, 2020 [1 favorite]


Anoplura:

I’m still not sure where “50%” is coming from. Can you help point that out?
posted by argybarg at 11:41 PM on July 15, 2020 [1 favorite]


argybarg, I don't know if I'm the first one in this thread to say 50%, but it's a semi-arbitrary number in line with seasonal flu vaccine effectiveness. Seasonal flu vaccines have a similarly tight development timeline, although the underlying technology, adjuvant, and regulatory path are all worked out. On the virus side of things flu probably isn't the best comparison though, since influenza mutates and recombines at a far higher rate than coronaviruses, necessitating a constantly changing annual vaccine.
posted by deludingmyself at 8:56 AM on July 16, 2020


I was thinking more of Anoplura’s statement that “50% showed signs of improved immune response to the virus.” I don’t see that in the paper.
posted by argybarg at 12:57 PM on July 16, 2020 [1 favorite]


Yeah, it was actually 100%:
The mRNA-1273 vaccine induced anti–SARS-CoV-2 immune responses in all participants,
posted by mmoncur at 9:10 PM on July 16, 2020 [1 favorite]


Yes, 100% was my understanding from the paper as well; see also for example Figure 2. I don't see where a 50% figure for improved immune response is mentioned, and I think this might just be a mistaken reading. Though it is worth noting that these are biochemical assay results, and not necessarily proof that the body would actually mount a full immune response. (Not that the paper is claiming this, I just wanted to be clear for anyone following along.)
posted by biogeo at 9:40 PM on July 16, 2020


I’m still not sure where “50%” is coming from. Can you help point that out?

Oh, boy... I re-read the abstract a few times, and looked at all the accompanying images, and have no idea where I got that number from. I remember it as being a rounding of a real figure that nicely corresponded with the FDA's 50% efficacy threshold, but now it seems like I was misreading.

Ugh. I apologize again. I genuinely thought I had something to contribute at the time, but now it's clear that it was a noisy derail. Sorry fam. *slinks away*
posted by Anoplura at 9:53 PM on July 16, 2020 [8 favorites]


Hey, we all make mistakes. Not all of us own up to them. Personally I admire that more than getting things perfect all the time.
posted by biogeo at 9:58 PM on July 16, 2020 [8 favorites]


Can I ask about the Oxford-AstroZeneca results here too? I don’t know if their method is very different and also don’t know how (if?) one can compare results across studies like these.
posted by nat at 12:36 PM on July 20, 2020


Not a virologist or anything, but I’m watching these with interest (in part because there’s not much else to do these days...) The Oxford vaccine takes a different approach than Moderna. Moderna’s vaccine uses mRNA to trick cells into expressing the spike protein, so the body sees it and mounts a response. Oxford, on the other hand, uses a chimpanzee adenovirus (a type of common cold virus) that’s been rendered harmless and then put the spike protein on it, so again, the body sees the spike protein. Block the spike and the virus can’t get into cells. The Oxford vaccine seems to induce not just antibodies but a T-cell response. There’s others in development with varying degrees of promise. These two vaccines are the furthest along and Oxford has actually already started Phase 3 trials in Brazil. Oxford researchers had a head start because they had been working on vaccines for the original SARS virus as well as MERS, both of which are coronavirii. There’s a fair amount of similarity with SARS-CoV-2, and that gave them a bit of a jumpstart.

Early results show both vaccines are apparently safe and they work as expected. The big question now is, are they actually effective? Will the body’s response to the vaccine actually stop infection? That’s the answer we need, and Oxford is actually discussing doing challenge trials, although that’s ethically tricky with a virus that’s killed several hundred thousand people. We need a way to stop the pandemic, so tine is essential, however, we’re rushing a trial process that normally takes years, so we’re going to have to hope that there’s no unpleasant surprises down the road if one of these vaccines gets authorized in the near future.
posted by azpenguin at 8:35 PM on July 20, 2020 [4 favorites]


One can't easily separate ethics from how biology is done, as much as some people have tried. (Though I suppose some have made bioethics into a separate and successful media career, so it can be done in that way.)

Not too long ago in Nature, there is an article in which author and bioethicist Nir Eyal is interviewed about his recent preprint.

In this interview and in the preprint, issues of consent, ethics, and safety of doing accelerated biological research about this virus in a time of emergency are discussed. Dr. Eyal notes:
Are there any precedents for infecting healthy people with a pathogen?
We do human-challenge studies for less deadly diseases quite frequently. For example, for influenza, typhoid, cholera and malaria. There are some historical precedents for exposure to very deadly viruses. The thing that demarcates the design that we propose from some of these historical instances is that we feel there is a way to make these trials surprisingly safe.
As an example, there was a challenge trial for malaria performed in 2012. Healthy individuals were bitten by mosquitoes carrying the malaria parasite and then treated with antimalarial therapies.

Clinical trials are done under the aegis of government agencies with review and approval processes, some of which are described on the FDA web site. IRBs or Institutional Review Boards provide oversight:
Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor biomedical research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
There are definitely ethical issues surrounding medical trials, especially under exploitative regimes that leave people to fend for themselves during a time of global crisis. Dr. Eyal continues:
Do you worry that countries with authoritarian governments could conduct such studies on vulnerable groups, such as prisoners or members of persecuted minorities?
We would only recommend conducting the studies in an ethical fashion, with fully informed consent. Vaccine makers want to sell their product to other countries. They want to publish their scientific articles in prestigious journals and there would be many obstacles if their trial doesn’t adhere to widely accepted standards.
Science does aim, for the most part, to do the right thing (if, at the very least, to maintain reputation, which is a more powerful currency than money in our community), and there are methods and regulatory mechanisms in place to try to enforce better and kinder societal standards.
posted by They sucked his brains out! at 1:44 PM on July 21, 2020 [1 favorite]


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