Reviewing Moderna's briefing document, which was made public this morning. The vaccine is clearly effective at preventing severe disease and will receive emergency authorization in the next week.
My focus is on side effects and adverse events. 1/ fda.gov/media/144434/d…
You're going to hear that many of the side effects are actually a sign that the vaccine is working. Here's what that means. After an mRNA vaccine (Pfizer, Moderna) is injected into your arm, muscle cells will take up the material and make coronavirus spike protein. 2/
The material is also taken up by something called a dendritic cell. This cell will also make spike protein, and will then travel to the local lymph nodes (in the armpit) to stimulate more immune cells (helper T cells and cytotoxic T cells) to spring into action. 3/
Signaling molecules (cytokines) will then prompt the immune system to produce fever, chills, & a vague sense of discomfort. This response is so robust, 21% of Moderna volunteers under age 65 felt armpit swelling in the inoculation arm compared to just 7% in the placebo group. 4/
That's an amazing (albeit uncomfortable) sign that the vaccine is working. These effects can be even more pronounced after the second shot because your immune system is primed to respond. The sensation has been compared to receiving a tetanus shot.
It's important to: 1) prepare people for these sensations 2) have a plan in place to manage symptoms and 3) stagger the vaccine rollout so essential workers have time to recover.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
Antibody treatments from Lilly and Regeneron have become a standard of care for U.S. politicians, many of whom tout them as a “miracle cure” for #COVID19. They’re not. I don’t know a single doctor who routinely prescribes them. 1/
It’s created a disconnect where patients and their families are understandably frustrated that they don’t have access to the “best” #COVID treatments. I hear from them all the time. 2/ google.com/amp/s/www.nyti…
Antibody treatments are not FDA approved. They have an emergency authorization for high-risk outpatients and can actually be harmful for some hospitalized patients. 3/ google.com/amp/s/www.nyti…
UPDATE: After an initial dip reported in late November👇, #coronavirus infections actually increased in London during the final weeks of a nationwide lockdown. 1/
New results from the REACT-1 study found that infections grew from 0.98% in mid-November to 1.21% in early December while a nationwide lockdown was still in place. 2/ imperial.ac.uk/news/210873/co…
Important implications as other countries consider lockdowns. Is transmission more likely to occur at home? Is a new viral mutation to blame (one that makes the virus more contagious but not more lethal)?
Perhaps lockdowns only work in short bursts. 3/ timesofmalta.com/articles/view/…
1. mRNA vaccines (Pfizer, Moderna) appear to be incredibly effective at preventing symptomatic disease. Better than we'd ever dreamed. 2. The side effect profile after two months is similar to other vaccines that protect against viruses. 2/
3. These vaccines are not FDA approved; rather, companies have permission to vaccinate people under an emergency authorization. Approval won't happen until spring because we don't know the rare and/or long-term side effects. 3/
Here are the most challenging #COVID19 questions I got this week: 1/
1. When will life return to normal? Some answer this by looking at when we'll hit herd immunity. That's not how I think about it. I don't believe we'll reach herd immunity in the US in 2021 (vaccine hesitancy & escape mutations), but I do think we'll get normalcy by the fall. 2/
Coronavirus will eventually mirror influenza: The goal isn't to make it go away; the goal is give people the opportunity to get vaccinated. We've just accepted that there will be millions of influenza cases and tens of thousands of deaths every single year. At some point...3/
UPDATE: Pfizer's data demonstrates its vaccine is safe & effective (at least in the short term). But the trial wasn't designed to detect a reduction in several meaningful outcomes, including: 1) hospitalizations, 2) use of intensive care, or 3) deaths.
This isn't surprising. 1/
These trials often lack statistical power to assess severe outcomes. (Moderna won't answer the questions either). Example: we still don't know if influenza vaccination in the elderly improves mortality. Randomized trials measuring this haven't been done. thelancet.com/journals/lanin…
Pfizer acknowledged this in its data release yesterday: "higher attack rates would be needed to confirm efficacy of the vaccine against mortality." (page 48). Large observational studies will be needed, presumably after authorization.
UPDATE: I've been digging through Pfizer's vaccine data. It's incredibly encouraging and frankly, I'm stunned that this was all done in one year.
The FDA's advisory panel will review this data publicly on Thursday. You can check it out here: 1/ fda.gov/media/144245/d…
mRNA vaccines are described as new (there aren't any on the market) but they've been studied for decades. Pfizer has overcome the challenges limiting their use, including: 1) instability of free RNA in the body, 2) unintended inflammatory outcomes, & 3) mild immune responses. 2/
It's also reassuring that Moderna had such similar topline results using the same mRNA platform. This doesn't appear to be an aberrant outcome.
If there's one thing I'd like to know more about from Pfizer's data, it's at the bottom of page 43: 3/