Inside Medicine. What Are You Seeing? [COVID-19 medical news]

Exists, but not FDA approved. https://news.harvard.edu/gazette/story/2020/08/cheap-daily-covid-tests-could-be-akin-to-vaccine/

Basically, these tests could show if an asymptomatic person is contagious enough that they should avoid contact with others and contact their physician if concerned, even though they may not catch all asymptomatic (but not (yet) contagious) cases. I.e. they would be highly useful for public health purposes, even though they may not be accurate enough for individual diagnosis.

Existing tests that are expensive and/or inconvenient and which have a delay in returning results are less effective for public health purposes, even though they are more accurate for making individual medical diagnoses (although if the results are delayed, they may not even be that useful for that purpose).

There’s a simple (and, one has to admit, good) reason why the vaccine makers are evaluating their vaccines on whether they prevent any disease, rather than serious disease: speed. If a vaccine maker wants to evaluate their vaccine on whether it prevents a condition, they have to wait until enough people in their study population experience that condition.

They have to wait until N people experience the condition. If they look for N people in the study to get any symptomatic covid, that’s going to be a whole lot sooner than for N people to get serious covid illness. Changing the condition, for example from any illness to serious illness, doesn’t change the N.

Pfizer hopes to show efficacy with 32 people getting sick, and they think that will happen toward the end of October. If they were looking for 32 people to get serious illness, they’d have to wait until well into 2021. And the 32 people is only a very early stopping point; very possibly the vaccine won’t be good enough/lucky enough to prove effective with that small number. The other vaccine makers’ interim numbers are higher.

I also wanted to shout out to the Mean Green! My nephew is there!

I think I view this as a sprint AND a marathon. I think there is a hurry–loads of people have their lives completely on hold, their businesses shriveling and dying, and are catching the virus and in some cases getting very sick and dying. If we could have a very helpful but not perfect vaccine 4 months earlier than a better vaccine, that might still be preferable. I haven’t read that we cannot ever take a second different vaccine. So if we get a helpful vaccine, and down the road an even better vaccine comes out, we might be able to eventually get that one, too. In the meantime, the partially effective vaccine can do wonders for our world (say in the example it prevents 60% of potential cases.). But maybe we can’t ultimately double up? Does anyone have information on that?

I agree with this completely, but we need to really know if the first vaccine is, indeed, helpful. If it ends up being a placebo far more harm than good could come from it - not just in illnesses with their effects, but also in trust for vaccines in general.

Once the masses start getting the vaccine they are going to assume all is well and act accordingly. Is it?

I don’t have any personal contacts with this vaccine’s development, but I have had plenty of stories told to me describing the money/jobs/pressure/etc at stake with research of all sorts (medical included) to get desired answers. I’d heard tales of falsified data that is sometimes caught before it goes too far and sometimes not. When I’ve asked what happens to the person falsifying the data invariably it’s just “they moved on to another lab.”

I’d love to think everything works right within research - that there are enough checks and balances and people are solely looking for human “good.” But I’ve heard too many stories from those who are involved - pharmaceutical included - to have rose colored glasses - esp if it’s in house.

For some $19/dose might not appear to be much. Multiply that by hundreds of millions and compare it to the negative $$ amount spent if they get nothing.

There’s a lot at stake. I prefer to be cautious.

Whatever comes out people will take and it won’t be too long before I have data from real life.

It’s a study of one, so it means only one thing-it needs more study. But perhaps this drug will add to the arsenal of other therapies that might indeed prevent critical illness or death.

https://■■■■■■■■■■/beingwell/is-silmitasertib-the-covid-19-treatment-breakthrough-weve-been-waiting-for-263cf9c696d5

They’re not going to give even Emergency Use Authorization for a placebo. Any vaccine that is approved will be somewhat effective.

It’s reasonable to be concerned that the vaccine might have undetected side effects that arise after half a year or more, that it might have rare but serious side effects, that the vaccine might not work at all for some populations or people with some health conditions.

It might be just me due to my internet access, but I can’t get this link to work (other links do). Any chance you can copy part of it or give me something to search for to find it?

This depends if the data is valid. There’s no virus challenge. There are no similar experiences (like the German theater experiment). This (to me) allows for a lot of confounding variables. Who gets a chance to be infected is going to be luck of the draw. Will the results be sound? Maybe. Maybe not. We won’t know.

The odds of catching it for everyone is 0% if they don’t come into contact with the virus. Super spreaders make it high in their realm, but even wind can change who gets exposed and who doesn’t.

To believe the data is not valid is to believe that that the vaccine makers failed to randomize their participants. Yes, someone who doesn’t wear a mask is more likely to get infected. Someone who is unlucky enough to encounter a superspreader is more likely to get infected. But these events are just as likely to happen to the placebo participants as to the vaccine participants.

Yes, we are looking at one random test hoping it has typical results.

Out of curiosity, is there any other vaccine that has gotten approval without virus challenges among tested subjects assuring a more level playing field?

I don’t know. That’s why I’m asking.

I don’t know, but we do know that the Russians and Chinese have approved vaccines, what we don’t know is if they work. Since the Russians announcement a month ago there hasn’t been any information on mass inoculatons in Russia. I for one hope that they start doing mass inoculations with the Russian and Chinese vaccines so we can see if they are effective. I believe that India purchased the Chinese vaccine, but not sure where they are with that. Since the virus is spreading like crazy in India that could be a great place to test vaccines right now.

What vaccines have used challenge trials? The first two vaccines I looked up, polio and measles, didn’t use challenge trials. The conventional view is that deliberately exposing a person to a disease that you can’t cure is unethical.

There is historical precedent for multiple vaccines being made for other infections:

  • Shingles: first vaccine was Zostavax, a live virus vaccine. Years later (recently), Shingrix, a recombinant adjuvanted vaccine became available, and is considered much more effective.
  • Polio: for many years, it was available as both an oral live virus vaccine and an injected inactivated virus vaccine. The latter is now the only one used in the US because it does not have the back-mutation risk of the live virus, but the oral live virus vaccine is still used where polio is endemic and facilities/equipment for injection are less available.
  • Influenza: while the vaccines are commonly produced in eggs, there are now vaccines produced without eggs. There have also been nasal spray versions, although these have recently been found to be less effective.
  • COVID-19: a vaccine called Sputnik-V was approved in Russia. But, for various reasons, there does not seem to be much interest in the US for getting it.

I’m positive that either no vaccine will be approved (because something goes very wrong) or that several will be approved. A lot of pharma companies are spending many billions of dollars to develop vaccines, and they will want those vaccines approved.

A possible outcome: several vaccines may be approved, but any differences in effectiveness between them may not be fully known for some time longer (after millions of people get each of the various vaccines and had time to be exposed to infection). If there are any significant differences in effectiveness, expect the more effective ones to gain market share if they do not have significant drawbacks.

Hmm, sorry.

Let me try again with a different source/article:

https://www.medicircle.in/usfda-approved-silmitasertib-showed-remarkable-result-covid-patient

That sounds awesome. It’s things like these I’m hoping work and give me more hope than a vaccine (considering the flu vax isn’t that effective - worth getting, but not super effective).

If there’s a way to treat those who draw the short straws ending up with bad cases, it’s a massive leap forward in turning this mountain into a molehill.

Medical advances have already lowered the death rates (or so it seems to me looking at numbers hospitalized vs died). May they keep up the good work!

Medical advances yes, plus the fact that many (I don’t know what proportion) of the infections in the last month have been in younger aged adults. So that’s also driving down percentages in many key indicators such as IFR, hospitalizations/severe cases, and need for ventilators.

I haven’t seen any data from theirs either, nor would I jump in line to get them without significant data from sources I’d trust.