I'm watching the FDA's Vaccines and Related Biological Products Advisory Committee discuss Moderna's data. The vaccine is clearly effective at preventing severe disease and may also limit transmission. As with all #COVID vaccine candidates, long-term side effects are unknown. 1/
Here's a topic of debate: As the pandemic expands, vaccine recipients may be continually exposed to coronavirus. How will the vaccinated immune system respond? Here's why this matters: We've seen that side effects are more pronounced after Moderna's second inoculation. 2/
This is, in part, because the immune system is now primed to respond to the second dose. How will the primed human immune system react to repeated viral exposure? And what will Moderna do to monitor this? 3/
Will a subset of vaccine recipients have more pronounced symptoms after repeated exposure? (This seems unlikely, but remains unknown).
It's incredibly reassuring to see these nuances debated in an open forum and to see the study sponsor so prepared to track this phenomenon.
• • •
Missing some Tweet in this thread? You can try to
force a refresh
UPDATE: Here’s one way #COVID medicine has changed since the spring: We now know how #coronavirus can invade and destroy muscle. This has relevance for patients who have profound fatigue, difficulty walking, or weakness that just won’t go away. 1/
The new insights may also help us unravel Long COVID, to understand why some people have such a hard time recovering. It all began several months ago, when a link was established between the virus and muscle injury: 2/ wwwnc.cdc.gov/eid/article/26…
We now know that in a subset of people, #coronavirus can manipulate a signaling molecule, interferon, to trick the human body into making proteins that are toxic to muscle tissue. 3/ nejm.org/doi/full/10.10…
UPDATE: There are now 2 #COVID19 vaccines authorized for emergency use in the United States. Although both use an mRNA platform and have similar safety and efficacy profiles, they are not interchangeable. 1/
You can't get one dose of Pfizer and then, several weeks later, take a shot of Moderna. The vaccines use different nucleic acid constructs, dosages, dosing intervals, storage & handling requirements, & lipid formulations. You want to boost the immune system with the same vaccine.
Some vaccines are interchangeable. You can start the Hepatitis B series with a vaccine made by one manufacturer and, in some cases, complete it with another. Not so with COVID. We don't have experience combining Pfizer with Moderna, and it is not recommended to switch.
UPDATE: New guidelines were published today to help clinicians identify cases of Long #COVID (symptoms lasting 4 weeks or more) to ensure proper diagnosis, treatment, & rehabilitation. It's an important step forward, but it's not without controversy: 1/ nice.org.uk/guidance/ng188
The new guidelines include a name change from Long COVID to post-COVID-19 syndrome. Some are not happy about the switch, which implies a degree of recovery from the virus. Given the relatively poor understanding of Long COVID, the switch may be premature. marlin-prod.literatumonline.com/pb-assets/Lanc…
The condition potentially impacts millions of people worldwide. It's been estimated that one in five people have symptoms that persist after 5 weeks, and one in ten have symptoms for 12 weeks or longer. We still don't know if this condition is a group of several unique syndromes.
NEW: Study finds death rate for patients hospitalized with #COVID19 is nearly 3x higher than death rate for patients hospitalized with influenza. This is one of the many ways coronavirus differs from the flu: 1/ thelancet.com/journals/lanre…
In this French study of more than 100k people, #COVID19 patients more frequently developed respiratory failure, blood clots in the lungs, or brain bleed than patients with influenza, but less frequently developed a heart attack (myocardial infarction) or abnormal heartbeat. 2/
COVID patients were more likely to need intensive care and spent nearly twice as much time in the ICU as influenza patients (15 days vs. 8 days). 3/
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…
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/