"I'm not concerned about variants like I was a few months ago," he said. "Every single variant has been looked at with a vaccine and has been found to be effective...If the variants do start to become problematic, the vaccines can be adjusted. On the fly, they can change the genetic code that's in an mRNA vaccine."(emphasis added)
Now wait just a moment. Changing the secret sauce in a vaccine requires a retest of the new recipe. The FDA has a whole stack of rules about such a thing - I believe it would fall under the Abbreviated New Drug Approaval (ANDA) process. Even under this EUA, there was a test and placebo group (the observation period was 2 weeks vs 2-3 years, but there WAS a test).
It is entirely possible the quoted doctor is a dope and doesn't understand the FDA approval process or even the EUA. Or...maybe...Moderna et al have been granted approval in the EUA to change the genetic code "on the fly" without any testing.
logi_cal869's unreported but observed vaccine adverse event has raised my concern to just about sloppy data collection and record keeping on such matters, but combined with this comment I now wonder if there IS the possibility of Moderna et al "tweaking" the secret sauce "on the fly" and never hearing about it.
"With RNA, however, vaccine makers could more quickly pivot to an effective selection of antigens. “You could theoretically move very fast to adjust sequence and address that — almost on the fly,” says Ron Renaud, chief executive of Translate Bio, an RNA-focused company in Lexington, Massachusetts, that is working with Sanofi Pasteur on RNA-based vaccines for influenza, COVID-19 and several other viral and bacterial pathogens.Thanks to their plug-and-play functionality, RNA vaccines could aid basic research. Justin Richner, a vaccinologist at the University of Illinois College of Medicine in Chicago, is developing a RNA-based dengue vaccine in his own laboratory. Richner and his colleagues routinely chop and change the gene sequence encoding the envelope protein that the dengue virus uses to launch its attack on human cells. By iterating their design, the researchers have tested around 15 vaccine candidates in mice.
How COVID unlocked the power of RNA vaccines (Nature.com)
"If the variants do start to become problematic, the vaccines can be adjusted. On the fly, they can change the genetic code that's in an mRNA vaccine."
What Experts Predict From COVID This Fall and Winter (WebMD.com)
"Unlike traditional whole virus vaccines, mRNA vaccines can be quickly and relatively easily adjusted to target new variants."
Coronavirus Variants—Will New mRNA Vaccines Meet the Challenge? (NIH)
"One possibility is to swap vaccines’ old versions of the spike protein — based largely on the virus that was first identified in Wuhan, China — for an updated molecule that has the specific amino-acid changes that hinder antibody responses. But researchers will first need to determine whether any such changes have knock-on effects that alter how the immune system reacts to the vaccine. Another possibility is to include both new and old forms of the spike protein in a single jab — scientists call this a multivalent vaccine.Moderna has started work on updating its mRNA vaccine to match spike mutations in 501Y.V2. The biotech company, based in Cambridge, Massachusetts, says it also intends to test the effectiveness of a third dose of its original coronavirus vaccine, and is looking into the possibility of a multivalent vaccine, said Tal Zaks, Moderna’s chief scientific officer, in a 25 January call with investors. But before deciding on any path, researchers will need to study how animals, and probably humans, respond to any potential vaccine update, says Subbarao.“It’s not going to be as simple as [altering] an amino acid site and saying ‘okay we got it’.”
How to redesign COVID vaccines so they protect against variants (Nature.com)