This week, the country's attention was focused clearly on the election, but Covid didn't slow down. Many states hit all-time highs for new infections and hospitalizations. Sometime this week, there will be over 60,000 people hospitalized with Covid, breaking our previous record.
The midwest is suffering from the most dramatic increase in cases, but the spike is hardly limited to there. Some states and counties are starting to hit capacity at their hospitals, increasing the fatality rate. Worse yet, that percentage of tests that come back positive is off the charts. This matters because the higher the percent positive rate, the more cases you're likely missing by not testing enough.
Today it was reported that President-elect Biden will announce a Covid task force tomorrow. He is putting the pieces together to have a national-level plan when he is inaugurated. It will be great to have a president that gives ending the epidemic the attention and priority it should have. However, we can't wait for January to start to tamp the virus back down.
In Canada, they do Thanksgiving in early October. We've now seen a spike in cases related to family gatherings that occurred. We have only weeks before our holiday season starts in earnest. If cases continue to rise as they have in the last few weeks, December and January will be truly awful. I hope we see Governors and mayors implement restrictions to get the spread under control.
Yesterday there were lots of marches and people partying outside when the election was called. The data from this summer and The BLM protests didn't show large outdoor events to be effective at spreading Covid, so I wouldn't expect to see a spike from these marches either.
There was no news on the vaccine front this week, which was unsurprising. The four leading candidates [Pfizer, Moderna, AstraZeneca, and J&J] have all publicly signaled they expect to have results in late November / early December. The only reason we would hear news is if there was another pause due to an adverse event. The rise in cases will ensure enough Covid in the control group to fully understand how effective the vaccine is.
Once the first vaccine is approved, we'll enter a contentious period. Up till now, the various pharma companies have been aligned on process and science. After the first approval, that alignment will go away.
One aspect that hasn't been settled is what to do about the control group. For context, the approval that will be given is an Emergency Use Authorization. Usually, the FDA would require more data to approve the vaccine, and the goal would be to continue to run the trial to the standard endpoints. This allows the FDA to gauge longer-term effectiveness and see if other side effects develop.
That explicitly requires the control group to continue not to get the vaccine and be at risk of catching Covid. Is it ethical to not tell the volunteers who are in control vs. the test group? Is it ethical to not run the study to the standard endpoints? What happens if someone in the control group thinks they are in the control group and goes out and gets the shot from a regular clinic?
If you vaccinate the control group, you're essentially ending the study. Even if there were adverse effects that developed later without the control group, you can't be sure it was the vaccine.
Beyond ethical considerations, there will be posturing between the companies to get market share and money. The fact of the matter is that the mRNA vaccines [Pfizer and Moderna] aren't great for distribution. If you are a government and have a choice, you'll prefer the AstraZeneca one and the J&J even more, purely from a logistics perspective. I worry that Pfizer and Moderna will move to block out the later vaccines.
This week we saw the first detailed readout of pharma companies up to some dirty practices. The drug remdesivir made by Gilead has gotten a lot of attention in the last few months. A few weeks ago, it was given a EUA by the FDA, and before that, they signed a $1 billion+ deal with the EU. The issue is that Gilead knew in late September that the extensive study done by WHO was about to report that remdesivir wasn't effective. Gilead has some internal studies that claim the drugs' utility, but the outside studies don't support that conclusion.
As always, where there's money getting spent quickly, there is an opportunity for fraud and deceit. Under a lame-duck administration, I worry the FDA will not be able to vet the data and make the right decisions.
We continue to find new potential treatments. The LA Times had an article on an effort to use a snakebite anti-venom to treat Covid. It's early, but I suspect we'll see many more of these types of discoveries over the coming months. Rockefeller University released a study showing robust long term immunity in recovered Covid patients. They studied people who had Covid more than six months ago. They found stable B cell production, which you would expect if the patients had long term immunity.
There are early reports of an outbreak of Covid in minks in Denmark, causing the Dans to cull all minks in the country. The virus has mutated in the minks and reinfected humans. The reports have many scary words, but it's too early to tell if this is a real concern as not much data has been released. Overall, Covid hasn't been mutating in ways that would prevent the vaccines from working.
Take care out there. It'll be a long few weeks.
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