And as of an hour ago, that would be today:
That was fast!
I think it will be a little longer before the CDC officially authorizes it. No?
I thought the FDA was the authorizing authority.
The FDA’s committee of independent advisors have made the recommendation, which the FDA is expected to approve.
The recommendation will then go to the CDC Immunization Advisory Committee, which will decide which groups they recommend getting boosters. (I’m assuming the same groups the FDA’s committee has recommended.) That committee is already scheduled to meet on 10/21.
Then the CDC director will sign off on it, after which the shots can be given.
So probably next week. Works for me.
I’m anxious to hear what they decide about boosters for j&j. I have a lot of friends who got that.
I think the FDA Advisory Panel will say something tomorrow.
Is the half dose of Moderna 1 of their 2 shots or is it half of 1 of their 2 shots?
I’m guessing that J&J has a higher percentage of younger people (than the first two) since it came out later. Would that affect the approval process since the booster is aimed at older people first?
If what I’ve read holds, it will be one half of the standard Moderna dose, which is 100 micrograms, so the third Moderna will be 50 micrograms, unless the FDA in its wisdom approves otherwise. Until now they have approved what the advisory group recommended.
I believe 50 micrograms is .5 of a milliliter in volume.
The Pfizer dose is .3 milliliters for the 3rd, for comparison. This is the same dose as Pfizer 1 & 2.
I’m pretty sure the Pfizer vaccine is stored at one concentration, but needs to be diluted to a lower concentration before being injected. So how many milliliters is ambiguous.
But the Pfizer booster is 30 micrograms, just like the first two shots, and the recommended Moderna booster is 50 micrograms, less than the 100 micrograms of each of the first two shots.
If, instead of a booster, you get a third dose for the immune compromised, it will be 100 micrograms.
Pfizer dose is .3 milliliters by volume, which is pretty small. Moderna is 1 milliliter, still pretty small as injections go.
Pfizer is stored frozen. Just before reconstituting with a sterile diluent the vaccine is thawed, then 1.8 milliliters of the diluent is added to the vial. 6 doses of .3 milliliters can then be withdrawn from the vial with low head volume syringes. So basically 1.8 milliliters of fluid volume in, then 1.8 milliliters of fluid vaccine back out, so the milliliters aren’t ambiguous. [from the CDC professional website]
So you know how they will handle the smaller doses for kids? (If those get approved.)
From the article I linked :
“I think we heard pretty loud and clearly that there was not much appetite for moving down the age range very significantly, if at all,” said Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research.
I doubt very much that a SpikeVax booster will be approved for people under 18, at least not in the foreseeable future.
Immunocompromised individuals who’ve already received a third Spikevax injection may have gotten a full dose, but Moderna is currently recommending the 50-microgram booster dose for the immunocompromised.
Oh, interesting.
The primary dose was only approved in September, wasn’t it? So it will be a while before anyone is even looking for a booster. And i expect we’ll see data at least in how well Pfizer immunity hold up in that age group from Israeli data well before American SpikeVax kids come close to 6 months out from their primary immunization.
Where did you see that? I hadn’t heard.
My booster reaction ended up being slightly more severe and persistent than I thought at first. Got the shot Wednesday afternoon, arm got sore about 3 hours later, NBD. But arm remained sore all day Thursday, and pain spread to armpit/lymph node area by evening. I also felt some all-over body aches, particularly in my lower back. I took 3 doses of Advil; one in the morning, afternoon, and evening, and went to bed with a heating pad. This morning, I woke up still achy, but 2 more Advil and a hot shower fixed me right up. I think this is the end of it.
“I don’t agree with doing this down to 18 years of age at all,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrics professor at Children’s Hospital of Philadelphia.
“I think we heard pretty loud and clearly that there was not much appetite for moving down the age range very significantly, if at all,” said Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research.
Thanks for questioning! I need to retract my earlier statement. I was basing it on patient portal communication with my rheumatologist. I’d asked if I needed to get a third injection of Moderna because I’m immunocompromised (due to lupus). She replied that she expected the Moderna lower-dose booster would likely get approved, and I should get that. HOWEVER, I’m not in the severely immunocompromised groups (solid organ transplant, AIDS) who were advised to get the full-dose third injection. My assumption that this was the blanket recommendation for all immunocompromised people was WRONG. I apologize.
I researched to make sure I was incorrect and found this article tracking the FDA advisory panel meeting yesterday [Bolding in the 2nd-4th paragraphs is mine.]:
This could get confusing
9:40 a.m.: Kurilla has asked a question that immediately made clear that there is plenty of room for confusion about who should get boosted, when, and with which dose of Moderna’s vaccine.
Kurilla, who is director of the National Institutes of Health’s division of clinical innovation in the National Center for Advancing Translational Sciences, asked whether, if the Moderna booster is authorized, it will supplant an earlier emergency use authorization allowing people who are severely immunocompromised to get a third dose of the Moderna vaccine. (A third dose for severely immunocompromised people who got the Pfizer vaccine is also allowed.)
This question is important because the third dose previously authorized is a full dose of the Moderna vaccine, the 100-microgram shot, one month after someone’s second dose. The booster VRBPAC is being asked to advise on today is the 50-microgram booster Moderna has proposed for the general population, given six months or later after the last dose in the series.
It appeared from the answers of FDA staff that the answer to Kurilla’s question is “No.” Sudhakar Agnihothram, from FDA’s Division of Vaccines and Related Product Applications, said that people who are severely immunocompromised may opt to get a fourth dose, the half-dose booster shot, when the appropriate time has elapsed after their third shot.
But then Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, jumped in. Marks seemed to suggest it wasn’t clear if people who are severely immunocompromised will be eligible to get a fourth shot. “This is far enough in the future that I don’t want to make a definitive statement,” he said, adding he’d welcome it if the panel discussed this issue later in the meeting.