I wanted to separate the discussion about the process of developing the vaccine from the other thread about delivering the vaccine.
I have heard opinions ranging from “we’ve never developed a vaccine for a coronavirus, so don’t get your hopes up” to “12-18 months best case” (Fauci) to “we’re going to do it by October” (Trump, with oddly suspicious timing.) The Moderna vaccine seems to have some good news lately, in terms of both safety and efficacy. Not the end of their road, by any stretch, but the news I’ve seen has been quite optimistic, perhaps overly so.
I’m completely outside of any areas of expertise here, but a number of smart folks here did a great job throwing cold water on the hydroxychloroquine bullshit. So is the Moderna news as good as they’re saying? Is there any reasonable hope of a vaccine being approved (not manufactured at scale, necessarily, but approved) by fall/winter? What about the other vaccines under development?
I’m certainly no expert but one thing should be clear: some parts of testing require the specific application of time. You aren’t going to know all the side effects from a vaccine the day after testing. You don’t know it’s total effect or duration of effect on the immune system the day after you test. These are obvious truths that people tend to forget completely because, hey, let’s skip all the waiting because we are in a rush.
Some Moderna execs and investors appear to be dumping stock at it surged to its new high of around $87. It’s not a good look, some say, for those with inside information to be dumping stock when Moderna appears to be leading the field in development of the Covid-19 vaccine. It may just be some profit taking. But it may also speak to the level of confidence in their anticipated results. A Harvard Medical School professor (whose name I don’t recall) said that Moderna has not released sufficient data to the scientific community that fully substantiate the claims of success made about their Phase I results. So there may be further reason to be cautious about an imminent vaccine from them.
I had seen news of the stock dumps after the press release previously, and see two potential hypotheses: one is that they intentionally pumped their stock with a misleading press release, and sold stock to take advantage. The other is that the press release is correct, but they still see a reasonable probability that the vaccine won’t be highly profitable or there is significant risk that their vaccine won’t be first to market.
I saw this mentioned as well, and I would assume the reaction may be due to the dosage of the vaccine rather than an inherent issue with the vaccine itself. It’s common for flu vaccines to cause flu-like symptoms in some people since the body is reacting as if it is the real flu. I would guess part of vaccine testing is to find the dosage which is strong enough to be effective without causing severe flu-like symptoms. So Haydon’s reaction may have been somewhat expected based on the dosage.
Right, the article talks about that. It’s something a lot of people might not consider; it’s not just about hitting on the magic formula, it’s also about getting the dose right. But also, even the optimal dose might have some negative effects, at least on some people. Maybe that’s outweighed by the benefit. A lot goes into this process.
Totally get the qualitative principle here, but what does this mean in practice? Would a company like Moderna (for example) have several cohorts of test subjects each getting a different dose? Are they expected to have that sewn up before moving to Phase III? Are they likely to have some sort of coarse answer by some date, but then 6-18 months later we’ll know much better what the right dosage is (like your AZT example)?
As I understand it, right now they’re looking at how people react (if test subjects react badly, the dose needs to be lowered) and antibodies (if test subjects don’t produce antibodies at levels similar to those who’ve recovered from the disease, the dose needs to be raised.) It sounds like there are 3 different doses currently being tested; this guy got the highest dose, and that may be too high. OTOH, he was only sick for a day; if the lower doses turn out to be ineffective, his dose may be the one we need. Of course, the idea that the antibodies confer immunity is still just a working hypothesis that will need to be tested, either over a long period of time, or with human challenge trials to deliberately try to infect the people who have been vaccinated. I’m not a medical professional, though, so I may have it wrong.
First, it is true, we have never developed a vaccine for a corona virus. As most of the other corona virus infections are minor, cold-like illnesses they has not been much incentive to develop a vaccine. They were attempting to make one for SARS, but SARS became a non-issue before they could do that. With the disappearance of SARS as a threat we have not had the incentive to pursue one, but now we most definitely do have incentive to make a vaccine and to do so rapidly. Hence, people saying “12-18 months best case” even as others say “we’ve never done this”. In their own way, they are both correct and true, but context helps.
Of course, it may take longer than 18 months. And there may be other issues, like dosage problems or side effects. It will be a rocky road ahead.
12-18 months is just a super best case scenario, if everything goes well. As I said above, some things need time if you are trying to do it remotely correctly.
Vaccines function by provoking a response from the immune system. Some of the symptoms of many illnesses, fever for example, are a result of the immune system, not to action of the actual pathogen. For this reason it is not uncommon to have some symtoms after being vaccinated. For well crafted vaccines these tend to be rare, mild and short lived…but this is why people will claim they “got sick” after a flu shot, for example.
Of course many pathogens DO directly damage the body, but these wouldn’t be described as the flu-like or cold-like symptoms that are mostly artifacts of immunoresponse.
There in fact was a good amount of work that continued on trying to develop a SARS vaccine for years after the 2002 outbreak. And several candidates emerged that provided decent protection from infection. Testing progressed into 2012 at least. Problem was that in animal models while they protected against infection, and good titers, they also provoked T cell responses on challenge to the virus that got out of control and led to serious pathology.
We know that infection with SARS-CoV-2 can cause T cell mediated over-reaction harms. The presumption is that Pediatric Multisystem Inflammatory Syndrome (that Kawasaki like entity) is one portion of that spectrum, as are many of the adults who get very ill.
IF a SARS-CoV-2 vaccine does infrequently trigger such a “vaccine enhancement” response from the immune system, like how the ones for SARS-CoV sets up the immune system to dysfunctionally respond when exposed, a rushed process will not reveal it.
Minimally the rushed process would result in its showing it not in animal studies but in large human trials. And that happening with one rushed to large human trial product will push the others all back.
There really aren’t too many shortcuts that don’t risk making things take longer.
Yes. I don’t know what they mean, but I’m seeing numbers like “25%”, “50%” etc, along with the possibility that there might nor be any overlap between the “not dangerous” and the “effective” doses.
Does anyone have any information on vaccines other than the (to me, not very credible) announcement from Moderna? I gather there are a bunch of them, in a bunch of countries, moving forward, and some building on foundations laid during SARS, but I don’t understand it. Is anyone keeping track of the various vaccine projects in one nice central place? (This thread would be convenient.) It seems we can at least save the ferrets.