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

I don’t see how we could have decent safety or efficacy data for vaccines by November. They just started Phase 3 trials. It will take time to give thousands of research subjects the first dose, and then a month later, the second dose. Then, wait about another month for the vaccine to be fully effective.

Now, it’s November and you can start gathering data about whether the vaccine works and whether it has side effects, unless levels of the virus have fallen very low in the areas where you are running your trial. If you guessed right and chose an area where levels of the virus are high, it still takes time for people to be exposed and for the results to shake out. What about the post-Covid clotting and inflammatory syndromes? What if they still happen despite the vaccine, or if vaccine enhancement makes them worse? Those problems take 3-5 weeks to develop after infection with Covid. Assuming your subject got infected in mid-November, you still wouldn’t know much about the result until early 2021.

I just don’t see how it’s possible to rush this science. I don’t like the idea of encouraging/coercing healthcare workers and other essential workers to basically be research subjects by giving them vaccines in November before we have data.

Personally, I’ve taken to getting most of my Covid news from the New York Times. I know they used to allow all Covid articles to be read for free - you only needed to create an account. I’m not sure if that’s still the case or not, because I was so impressed by their daily email and reporting that I went ahead and subscribed when they ran a special for $1/week for a year for basic online access. That’s cheaper than my local newspaper with far more coverage of multiple stories. I still keep my local paper too. The NYT doesn’t give me the local news like obituaries, police reports, school achievements, and what’s going on. There’s room in my life for both.

I like cc for it’s “close to home” Covid news - the community we have here and what’s going on. I also like when those in the medical field report on what they’re seeing.

You’ve summed up my thoughts about a rushed vaccine far better than I ever could have. I am most definitely NOT anti-Vax, but I’m also not a believer in pushing things beyond their limits hoping for the best, esp with a virus that has proven to be evil when it’s bad. There are many ways more harm than good could be done. I think those doing the pushing don’t care. They just want to give people hope to restore the economy (or similar). It’s ok if it’s a placebo to them. It’s not to me. Even placebos are supposed to be proven to be safe - just ineffective. This is not yet proven to be safe. It could give people false confidence and be really dangerous as they let their guard down.

Since my son is in health care, I really don’t want him to have to be a guinea pig either. If all of our health care workers get this shot and it turns out to be bad (similar to the pulled Dengue Fever one), it could be horrid for health care.

I don’t disagree with any of that. Adding in that both the Pfizer and Moderna products are novel vaccine technologies, and I would sure like to see at least a year of safety data. Looks like that’s not going to happen though…and you are exactly right, the people who are the first to get the vaccine are basically enrolling in a clinical trial.

If I have to make a choice, I want rapid (instant) strip tests before a vaccine…those tests will likely let our lives get back to normal faster than a vaccine will.

@Creekland sorry to hear that your area is seeing a surge.

I personally think that one of the worst things to happen is distrust and rushing a vaccine at this point

My understanding about the vaccine trials is they give half the participants the vaccine, half not, and then wait to see what happens.

Suppose the vaccine were fantastic, and protected every single person who got it, and the early results were no side effects (or no side effects except a sore arm, who cares about a sore arm).

This success would become obvious quickly. People who didn’t have the vaccine would be getting infected, and people who did wouldn’t be getting infected. This would become statistically significant quickly.

If this rosy scenario came to pass, it would be right for the FDA to give an Emergency Use Authorization. But this is not what scientists are expecting. If the vaccine is good, but not fantastic, it will take longer to evaluate.

I’m not totally opposed to an early release, but I’d want to feel that people I trust had made the decision.

Unless they are challenging all volunteers with the virus, they won’t know for quite some time if the vax worked or not. With this virus they also need to wait beyond the typical time to see if there are issues.

I wish they were looking more at random samples of survivors to see if the German study showing over 3/4ths had cardiac abnormalities even if they were asymptomatic was the norm or an anomaly - or anything in between.

These studies are happening, it will be awhile to get all the data in. One thing that is different in the US is lack of testing which may hamper getting a sample of people. Imo

My husband is listening to a report from Albert Einstein Medical School right now. So far what I am hearing is plasma works best if you get it early in your hospital stay and if you are young. In fact if you are over 65 it’s not clear it helps at all. But this is from analyzing what’s been done not blind trials.

But we also need people to refrain from going to where they can expose others (e.g. work, school classroom, restaurant, party, etc.) if they lick the strip before they go and it shows positive. Basically, we will be depending on people to do what is needed to protect others (similar to wearing masks when in proximity to others, especially indoors).

If not, then it will come down to workplaces, schools, restaurants, parties, etc. gating entrances with lick-the-strip testing before allowing entry.

The decision will be made by an independent safety board. I am guessing safety measures are in place against political pressure.

Only the decision to stop the trial early is made by an independent safety board, afaik. The FDA is in charge for EUA.

This is the same concept as vaccines. We rely on people to take them to protect others, and polls show that might not work out well for a covid vaccine.

Regarding the strip, it would be licked on site…at the entrance to school, work, a sporting event. So yes, some positive people would be out and about but it would represent a significant advance in testing nonetheless.

Can you link an article showing where they are happening? I haven’t had any luck finding anything about it in the US.

ETA: The articles I have read have all been referencing foreign studies and have shown similar after effects affecting a lot more than just those who were hospitalized, but there haven’t been many studies as far as I can tell. A lot of anecdotes.

This isn’t a study but at least someone looking at it in the US? In a particular demographic. https://www.centredaily.com/sports/college/penn-state-university/psu-football/article245448050.html

Thanks - I’m glad they’re repeating that info. I heard about it back when they decided to cancel and was glad then that they were putting athlete lives above money and prestige. What I don’t get is why many athletes and their parents don’t give a hoot. I guess they just assume they will be in the percentage without issues? Everyone assumes they will be the hero - not the red shirt on Star Trek (possibly dating myself).

Fans don’t really care. Break one and replace it with another as long as the game goes on. That’s what happens with other injuries. But one would think parents would care. Are they just not understanding what is going on or that it has the possibility of being permanent?

However, getting a (safe, effective) vaccine is also protection for oneself, so people also have selfish motivations to get vaccines, whether or not other people get them. Remember the rush for Shingrix when it first came out?

Perhaps the message that athletes and parents may understand better is that the longer term after-effects could end the athlete’s playing career, or reduce the athlete’s capabilities on the field (i.e. instead of being a good player, maybe the athlete after COVID-19 after-effects is only good enough to be a third string scrub).

There is going to be a vaccine trail site in Minneapolis and they are hoping to enroll 1500 people. They are particularly anxious to enroll people of color, those over 65, and those with conditions such as asthma and high blood pressure. The vaccine is the one developed by Oxford.

I (asthmatic) started down the route of signing up. I was almost done when I realized I shouldn’t do it. I just started a new migraine injection medication (Emgality) and the waters could be muddied by dueling situations should I have side effects. I was pretty bummed.

Apparently, the Army has stepped up to offering the military as research subjects, too. Our son has informed us that he will be getting the vaccine in November. He’s not happy about it for all the reasons listed above, but he has no choice.

We will wait and “let Mikey try it” first.