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

OK so this is what the doc from @oldmom4896’s link says to the doctor taking over for him when he signs out: All the patients are getting worse except one. Oh and maybe another one might be getting better but maybe their liver is failing.

Just like the flu? No it is not just like the flu. People who get hospitalized for the flu get better, mostly.

Research Determines Protests Did Not Cause Spike In Coronavirus Cases
https://www.forbes.com/sites/tommybeer/2020/07/01/research-determines-protests-did-not-cause-spike-in-coronavirus-cases/NA#3c63942f7dac

Your link didn’t work for me – here’s what did:
https://www.forbes.com/sites/tommybeer/2020/07/01/research-determines-protests-did-not-cause-spike-in-coronavirus-cases/

"For most viruses, not having a spleen does not seem to be a major risk factor for illness.

So far this seems to be true for COVID-19 as well. New studies are being published constantly, but lack of a spleen has not been identified as a risk factor for acquiring COVID-19 or having worse outcomes. This is likely because the other lymphoid tissues in the body are able to produce an adequate response. However, it is likely that a person’s ability to fight any infection is at least a little diminished compared to what it would be if they did have a spleen. So with an infection like COVID-19 that can be severe and deadly even in healthy individuals, anyone without a spleen should be extra vigilant in following CDC recommendations to protect themselves and others."

I’m good with that. I’m not going to worry about DH as I was. Of course, he’s 66 so he needs to be careful. But he runs three miles, seven days a week, and lifts weights most days. He’s in good shape.

My mother had her spleen removed when she was 65 and lived to be over 80. In the end it was Parkinson’s that did her in.

@“Cardinal Fang” — don’t know how quickly they can resolve, because we don’t do frequent scans. Each regular chest CT has the same amount of radiation as about 300 chest x-rays, from what I was taught. (There are lower-dose scans now in use for lung cancer screening and I don’t know what the radiation dose is for those.) So usually 3 months would be the earliest to repeat a acan for follow-up purposes.

After 3 months, you could see improvement in, or you could see resolution of inflammatory changes.

https://www.cnn.com/2020/07/06/health/regeneron-coronavirus-antibody-drug-bn/index.html

How many phases are there? I thought they were on trial phase a few months ago.

There are 3 main phases. Phases 1/2 are dose selection, metabolism, and safety studies (with some drugs, efficacy can also be derived from that data). Phase 3 is the final efficacy phase.

https://www.drugwatch.com/fda/clinical-trials/

What happens after phase 3? Is the vaccine ready to general use?

After Phase 3 trial are complete, the vaccine goes to the FDA for approval.

If approved by the committee, then things like labeling, manufacturing and distribution processes are vetted and approved. And a process for continuing monitoring is developed. The vaccine will likely be required to conduct a Stage 4 trial–which is post-market surveillance for adverse events.

For a fuller explanation of the vaccine approval process–read the explanation at the FDA.

https://www.fda.gov/vaccines-blood-biologics/development-approval-process-cber/vaccine-product-approval-process

FDA has issued specific guidance for covid-19 vaccine development, and an accelerated approval pathway option if a vaccine shows an immune response or other measure that is reasonably likely to predict clinical benefit.

Access this guidance here:

https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-takes-action-help-facilitate-timely-development-safe-effective-covid

@Iglooo - if you are talking about the Regeneron trial in the link I posted, is not a preventative vaccine. It is a therapeutic antibody “cocktail” administered to a person who just got infected with the virus or has been in close contact with someone who has been infected. Not something that would be used to vaccinate the masses against future potential exposures to generate herd immunity.

Right, my bad. Does the treatment drug follow similar procedure as vaccine?

The Regeneron drug is being tested both as a treatment and as a preventive. Trials for both pathways were announced yesterday.

https://investor.regeneron.com/news-releases/news-release-details/regeneron-announces-start-regn-cov2-phase-3-covid-19-prevention.

^Thanks. Good info.

Is this valid?

https://www.yahoo.com/news/dr-marc-siegel-results-groundbreaking-011150250.html

@Mwfan1921 – I have not been following this closely enough, but is Regeneron the drug that the US purchased the full supply of and is distributing to hospitals? I thought I read that the full inventory will be exhausted by Sept nationwide, but that some hospitals in TX already need more than their allocation. I am sketchy on the details, so asking in case some of the informed people here know.

If this is true, can production be ramped up, assuming the phase 3 trial is successful?

@Mwfan1921 - it is a biological drug. A “therapeutic vaccine” as some people may call it, but it is not a preventative vaccine that is intended to create longer term immunity. The active ingredient here is a cocktail of antibodies; the intended recipients are those with known exposure to the virus. Vaccines intended to protect the herd contain pieces of the pathogen (or something that mimics or leads to generation of them) so that the body’s own immune system learns to recognize the pathogen and neutralize it, typically, by producing its own antibodies.

All new therapeutics go through the three-phase approval at the FDA. Sometimes, this process is somewhat accelerated.

I never said the Regeneron drug was a vaccine, just that it is being tested as a preventive (for those who have been in close contact with an infected person)…in addition to the treatment trials for those with covid-19, (whether hospitalized or not) per the press release (and clinical trials.gov)

Just clarifying this further for folks who don’t click on links.