Good morning! It has been 393 days since the first documented human case of COVID-19.
Light headlines section today, but some good news. Keep in mind, though: the virus is still out there.
I read through the Pfizer vaccine publication in The New England Journal of Medicine today, and while it’s mostly redundant with the FDA submission, I may do an in-depth on it later this week that walks through some of the finer points.
Also, some reader comments and questions.
As usual, bolded terms are linked to the running newsletter glossary.
Keep the newsletter growing by sharing it! I love talking about science and explaining important concepts in human health, but I rely on all of you to grow the audience for this:
Now, let’s talk COVID.
The first doses of Pfizer’s vaccine are shipping
What a day! Check out this from Pfizer:
Don’t think I’ve ever been so relieved to see FedEx and UPS trucks.
Deaths in the US exceed 300,000
This is the sad part of the news. The number of dead from COVID-19 in the US is now approximately the same as the population of the city of Tampa, FL. The toll is as if a city of that size disappeared in the course of a year.
That said, death is a lagging indicator. Deaths follow the identification of cases and the passage of the clinical course of disease. It takes weeks for deaths to appear after spikes in case counts. In other words, as long as daily new cases in the US are not stabilized, this number won’t stabilize either.
By comparison, New Zealand has had 25 deaths. The US isn’t New Zealand, but it didn’t need to be this way.
I look forward to when this is a thing of the past, and I hope we learn something from all this death.
What am I doing to cope with the pandemic? This:
Preparing for a snowstorm
It’s supposed to snow in New York City this week!
Normally, I’d be thinking about how to manage working from home, making sure that I have everything I need to do so, and looking to hunker down for a couple of days.
Well, not this time. This whole year has been a snow day. I’m working from home, and I’m hunkered down. So I’m just going to enjoy the pretty white stuff falling from the sky, when it comes.
We got some comments and questions on vaccines from yesterday. Reader Greg H asked:
What are your thoughts on the Novavax COVID19 vaccine? How does it compare with the mRNA vaccines, specifically around safety profiles. The data from the UK has been very good, no?
Here’s what I answered:
I've followed Novavax for a very long time. When I first entered the industry, I heard about them because they were working on vaccines for a number of pathogens that were of interest from a global health perspective. In the time I've followed them, they've had major failures in more vaccine areas than I can really count here. They're a small, scrappy biotech that has tilted at some major windmills, and lost every time.
Their technology in COVID-19 is a recombinant protein vaccine--something that I would have bet on over the mRNA vaccines before trial results were released, because the mRNA technology was unproven. I think the scientific argument for Novavax's design is still strong, but I think they are now playing catchup. It will be harder for them to conduct their clinical trials with other vaccines in the field, but they do have a brief period of opportunity now--while the other vaccines are still restricted in terms of the types of patients who might receive them.
The Novavax candidate is a recombinant spike protein, and that's similar to the antigens expressed in the mRNA vaccines. It may have some variations relative to those vaccines, but I can't offhand think of any reason it shouldn't work given the success of those other candidates. The big question is whether it is able to get its clinical trials completed before the wide availability of other COVID-19 vaccines makes that very difficult.
In terms of safety profile, we really do need to wait for the Phase 3 trial to be more certain about this, but so far it looks like the safety profile is nothing to be particularly worried about.
On the other hand, this kind of thing is always full of surprises. Maybe their design has some quirk that means it doesn't do the job. This is why we do trials; if we could predict what would happen, we wouldn't need to test vaccines.
Something I didn’t highlight here is that the Novavax candidate is designed to ship at warmer temperatures than the Moderna and Pfizer vaccines, though still requiring refrigeration. This should make it a more deployable vaccine, but it really needs to pass clinical trials first. I’m optimistic about it—if it can finish those trials before the other vaccines are too widely available.
Also interesting about their trials is that in one of them, they are looking at the safety of the vaccine if it is given along with a simultaneous influenza virus vaccination—this sort of combined safety study is important, because without it, the vaccines have to be given individually. That means more visits to the doctor for vaccinations, which is inefficient and unpleasant for everyone involved. But, it all has to work. Just remember that—I’ll stop repeating it now.
Meanwhile, Carl Fink asked:
Why couldn't Sanofi apply for use of their vaccine specifically for you young people (I'm 59), with the idea that giving it to 30-year-olds would leave more doses of the Moderna vaccine for people my age and older?
Here’s my answer:
Well, Carl, I never would have been able to guess your age, for what it's worth.
Regardless, I think the issue is that the trial is very carefully balanced in terms of how it enrolls patients. If a substantial enough proportion of patients were inadequately vaccinated, that's going to mess up the results. I imagine that Sanofi's researchers did everything they could to try and salvage the trial before admitting defeat.
If, perhaps, they had tried to enrich their trial with younger people, maybe they would have been able to keep going. It appears that's not what happened. It's really just a shame.
You might have some questions or comments! Send them in. As several folks have figured out, you can also email me if you have a comment that you don’t want to share with the whole group.
I’ve been contemplating changing the schedule of this newsletter a little bit; perhaps reducing it from daily to 3 times a week. I’m interested in your thoughts; feel free to comment publicly or send them my way privately.
Thank you to those who answered me about this already; I’m taking all of the feedback under consideration.
Join the conversation, and what you say will impact what I talk about in the next issue.
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This newsletter will contain mistakes. When you find them, tell me about them so that I can fix them. I would rather this newsletter be correct than protect my ego.
Though I can’t correct the emailed version after it has been sent, I do update the online post of the newsletter every time a mistake is brought to my attention.
No corrections since last issue.
See you all next time.
Always,
JS