Vaccine news: Johnson and Johnson, roll out failures, and multiple sclerosis
Tons of news on multiple vaccine fronts.
The biggest news here is from the media reports about a new COVID vaccine from Johnson and Johnson that only requires one dose.
But I also wanted to spend some time on other vaccine news. I think it’s worth a look into the issues with roll out of approved COVID vaccines as well as a report that I was sent by a handful of different people about a possible vaccine for multiple sclerosis.
Let’s get to it.
What’s up with the Johnson and Johnson vaccine?
News reports have been really encouraging about this vaccine.
Johnson and Johnson just released the initial data for their COVID vaccine that looked at the immune response generated in different age ranges with a couple of different vaccine regimens, including a regimen that only requires 1 dose.
It makes sense that people would be excited - a 1 dose vaccine simplifies everything here. Fewer shots, less missed doses, less confusion about timing, quicker societal vaccination.
While there’s certainly reason to feel optimism after this data, I’m not ready to proclaim this as anything other than some preliminary news.
What’s different about this vaccine?
The J&J vaccine is an adenovirus vector, which is the same mechanism of vaccination as the AstraZeneca vaccine. It’s different than the Pfizer and Moderna vaccine, which are mRNA vaccines.
What did this study test?
In this Phase 1/2 trial, they tested 2 groups of patient. One group between ages 18-55 and another group over 65. More than 90% of participants in each group were white.
The protocol is a bit confusing. They tested 5 different protocols here:
“We randomly assigned the participants in a 1:1:1:1:1 ratio to one of five vaccination groups: low dose followed by low dose, low dose followed by placebo, high dose followed by high dose, high dose followed by placebo, and placebo followed by placebo “
So basically, they tested two different dosing regimens (low dose and high dose) and two different vaccination regimens (one dose vs two doses). And compared each of them to a placebo.
What did they evaluate for effectiveness?
They didn’t test effectiveness of any of these vaccine regimens.
They measured antibody responses - not COVID infections. This is the important caveat.
The J&J vaccine elicited an immune response that appears that it will be effective with all of the vaccination regimens - even the low dose/placebo group seemed to develop signs that immunity would develop.
The figure below is a bit confusing, but I’ll walk you through it.
The top and bottom panels are looking at different lab markers of immunity. Each color represents a different dosing regimen. The bold columns of “HCS” represent human convalescent serum, meaning they compared these levels to people who have recovered from COVID.
Ok, this is confusing, can you just sum it up?
Yes, let’s do that.
Even a single shot of the low dose J&J vaccine elicited an immune response that lasted for more than 2 months.
Lower doses and a single regimen produced a less impressive immune response than higher doses and a two dose regimen.
So there’s certainly promise but unanswered questions remain.
What are these unanswered questions?
I’ll list a few that I have:
Does the vaccine truly prevent COVID? Ultimately, I don’t care what my antibodies look like, I care whether I get infected and whether I get sick
Does the difference in immune response that we see between the dosing regimens have any clinical significance? It certainly might
How long does this immune response persist for? We only have data out to a little over 2 months here
Ultimately, this is just a preliminary report that you would never hear about if it were for a viral illness other than COVID. The vaccine does appear safe, although mild vaccine side effects appear more common in this vaccine than in the Pfizer/Moderna options (which you would expect from an adenovirus vector compared to an mRNA vector anyway).
While an immune response makes us optimistic (and based on other vaccines portends clinical efficacy), I’m waiting to see Phase 3 trial results before drawing any conclusions.
It’s just too soon to tell.
Switching gears, let’s get into vaccine rollout
Simply put, this has been a total mess. Too many rules, too many regulations, too confusing for too many people.
Look at the New York State Website for Phased distribution. There are 11 categories of people in the Phase 1a and 1b vaccine roll out.
You can go through the eligibility screening questionnaire on their website to see if you’re eligible and to make an appointment, but you need to answer a lot of questions about your medical conditions that might impact your ability to make an appointment.
I’ve had quite a few patients tell me that when they list their medical problems in the NY State app they get a message telling them that they aren’t eligible for vaccination and they need to contact their physician - but I have no ability to input information to bypass these hurdles.
And even though there aren’t really any medical conditions that should preclude vaccination, the checklists and questions are confusing people.I’ve had literally dozens of patients calling my office and asking about whether they can be vaccinated due to their medical problems or what medications they should adjust around the time of vaccination.
And how come we’re only vaccinating people Monday-Friday during normal business hours?
I recognize that this is a huge administrative challenge
I certainly don’t mean to dismiss what an enormous project this is.
But the hurdles to jump through make this impossible for even the most educated participant to fully understand.
Too many steps, too many checklists, too many screening questions.
It’s simply too confusing.
I started out thinking that the vaccine distribution needed to be targeted to those at highest risk - essential workers, the elderly, those who work in nursing homes, people in prisons, etc - to optimize our limited vaccine doses.
This would certainly be the best plan in a perfect world. Unfortunately, we don’t live in a world where a confusing roll out can be managed well.
I’ve come around to a different idea - let’s just vaccinate people.
Our policy makers need to make this simple:
Vaccination locations open 24/7
Simplify the eligibility criteria. Either make an age cutoff or just use first-come, first-served
Vaccinate as many people as quickly as we can
No additional steps or hurdles
We don’t have time to waste.
One last vaccine snippet - what about the multiple sclerosis vaccine?
A few friends sent me news reports on a new mRNA vaccine being developed to treat multiple sclerosis.
Here’s the paper those reports come from.
I’m not even ready to get excited about this. The study was done in mice looking at an experimentally induced disease similar to multiple sclerosis. It’s a preliminary study in a non-human animal.
This is certainly an important first step, but think of it as a first step that might not even be on the right path rather than a sign that an MS vaccine is just on the horizon.
There’s a long history of promising studies in mice not amounting to much in humans.
Don’t spend any more timing thinking about this one.
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