Safety and Immunogenicity of mRNA-1273 in Older Adults. The paper is out!!! nejm.org/doi/full/10.10…
Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)
Salute to the REAL MVPs (30,000+ people) who gave their time and trust to the science of it all. You are more than data points... You are a heroes!!! 🦠💚
Hopefully, you all will be tuning into the FDA Vaccines and Related Biological Products Advisory Committee Meeting on December 17, 2020 to hear all about the Moderna COVID-19 Vaccine.
The juxtaposition of the EUA announcement in a text with my boss #drbarney with the MERS coronavirus stabilized spike protein bound to antibodies as his phone background is HISTORIC!
*anticlimax drumroll* if you read the FDA EUA package...
“94.1% efficacy at preventing Covid-19 illness, including severe disease. Aside from transient local & systemic reactions, no safety concerns were identified” nejm.org/doi/10.1056/NE…
Good morning esp. to @moderna_tx scientists who woke up a year ago to begin manufacturing clinical-grade mRNA-1273. The beauty of their platform and manufacturing expertise is that it only took 41 days to ship pure "ready-for-muscle" vaccine product. 💉❤️nature.com/articles/s4158…
Most notable about this is that the company "at financial risk" decided to make the product. There wasn't even a confirmed COVID-19 case in the US yet, but PREPAREDNESS.
"Give me six hours to chop down a tree and I will spend the first four sharpening the axe.” x Lincoln
Sharpening the axe, we worked together for several years on MERS vaccines. We even knew based on my lab notebooks what doses would work in animals, what exact construct to design, vaccine schedule, etc. etc. It was a data-driven financial risk. Thoughtful.
Today, also marks the anniversary of when we got on the phone with @Baric_Lab to plan challenge experiments. There are 3 mouse strains in that Nature paper b/c we knew @SarahRLeist would make a challenge model in @ least 1 of them, & we wanted to be prepared to challenge asap.
We even knew what the subprotective dose would be (based on MERS work) and used it b/c we also knew the FDA and manuscript reviewers would be concerned about enhancement so we set to prove against the nay-sayers/skeptics. Thoughtful.
... @DenisonLab was also on that call... viral infectivity/neutralization assay development was discussed in detail. We made sure live virus assays could be run, outside of contracting organizations that the whole world would use.... through our friends and colleagues.
... @McLellan_Lab was also on that call... @LabWrapp was going to solve the high definition structure of the spike protein that we were expressing in the vaccine. We needed to know our sequence choice was right. science.sciencemag.org/content/367/64…
I should be a collaboration consultant. Booking info in bio hahaha.
Anyways that's what I was doing a year ago.
Andddddddd...it re-begins >>> Moderna Announces it has Shipped Variant-Specific Vaccine Candidate, mRNA-1273.351, to NIH for Clinical Study
Today, my dad and my PhD dad get to witness me getting an honorary degree from UNC. I didn’t “walk” after defending my dissertation. So today... I walk.
So many full circle moments this year.
Honored.
1/n: I hope that no one to which I owe manuscript edits is reading this, but I felt a thread on my spirit as I listened to my UNC commencement address entitled "Home". instagram.com/tv/CPEMTyPHthd…
2/n: I just got an honorary doctorate from the institution (@unc) that I also received my PhD in Microbiology and Immunology in 2014. I cried during my "thank you", and I cried when I defended my dissertation, and I cried when @HarvardChanSPH announced my faculty appt last wk.
“She was also involved in several extracurricular activities, including serving as a representative on Student Congress, a delegate to the Association of Student Governments, a staff member in the Attorney General’s office and as a member of the science policy advisory group.”
This quote is a reminder to all students far and wide to not allow anyone to put you in a box. You are not “just” a PhD student. You are a citizen first. Do you, Boo.
1/n: I had to forego the only midday nap I’ve had in over a yr yesterday to address my @instagram DMs b/c so many are hurriedly writing about vaccine dosing, w/o remembering the current dosing is great, safe, effective AND (surprise) public trust matters. instagram.com/stories/kizzyp…
2/n: We understand things can change for science-driven efficiency. Would delaying a second dose be “ok”, probs; but ppl know about efficacy data from the current schedule. I'm often scrambling to find solid data to match X scientist's op ed so of course lay ppl are confused af.
3/n: Remember how confused ppl were when masks were first deemed not needed then suddenly science suggested that in fact they are?! That was us (scientists) on our high horses, not waiting for the data to policy circle to be completed. Just stop!
1/n: Good morning esp. to our animal techs, who bled ~200 mice last yr on this day. It was the 2-wk post-prime timepoint, & we just had to peek at the antibody responses.
Do you think they knew those mice had gotten the vaccine they would themselves get only a year later? 💉 ❤️
2/n: We’d immunized 3 mouse strains, w/ multiple doses of mRNA-1273 to not just be prepared to show protection (ala @Baric_Lab@SarahRLeist), but also to be prepared to show that sub-protection was not a cause for vaccine-induced enhancement.
3/n: These figs never make it into my talks cause who care about mice when u have 94.1% human efficacy?
So fig. 2 (nature.com/articles/s4158…) shows IgG antibodies that bind the SARS-CoV-2 spike protein 2 wks after the 1st dose, particularly in the modestly-high dose (1 ug) groups.
1/n: I’m about to use this morning’s “woke up in a panic ‘cause my ‘to do’ list is longer than my day” rant to address this consistent and *flawed* argument
2/n: Because I work at the center that the Clinton Administration erected in with the purpose of developing a HIV vaccine, I’m privileged to have watched HIV vaccine development from “point A” to ummmm let’s say ‘bout “point M” over the years.
3/n: Which is darn good, considering HIV is so genetically diverse, a retrovirus, decorated in glycans, hides from immunity, probs needs a little more than “just” antibodies, etc etc etc
1/n: People are asking me for comments, and I'll tell you how my ex project manager used to tell me re: me overachieving & striving for "perfection" in some things...
"Don't let the perfect get in the way of the good enough."
This is darn good for 1-dose ... "in a pandemic".
2/n: I feared that actually... that ppl would be spoiled by mRNA and any vaccine to come after would be looked at as "lesser than". Vaccines are being transformed in front of all of our eyes, but science is going to science...
3/n: ...and the fact that science is producing multiple good-enough candidates with utilities in various niches of global acceptance/distribution/pricing/etc in only a year is...