The Biden Administration is expected to push for vaccinated folks to get boosters in an effort to deal with surging Covid-19 numbers.
The Biden administration is planning to announce that most Americans who have received the coronavirus vaccine will need booster shots to combat waning immunity and the highly transmissible delta variant that is sparking a surge in covid-19 cases, according to four people familiar with the decision.
The administration’s health and science experts are coalescing around the view that people will need the boosters eight months after being fully vaccinated, according to the people, who spoke on the condition of anonymity to discuss a decision not yet public. The move is likely to be announced as soon as this week.
Administration of boosters would not occur until mid- or late September, after an application from Pfizer-BioNTech for the additional shots is cleared by the Food and Drug Administration, the individuals said.
The conclusion that boosters will be broadly needed was reached after intense discussions last weekend involving high-ranking officials who scrutinized the latest data from the United States and other countries on the effectiveness of the shots.
It is a striking change from public statements by senior officials in recent months who had said it was far too soon to conclude that Americans would need booster shots. In July, the Centers for Disease Control and Prevention and the FDA put out an unusual statement that said, “Americans who have been fully vaccinated do not need a booster shot at this time.” Officials have repeatedly said it was not clear whether boosters would be needed.
But in recent days, the messaging has started to change. As data from other countries and the United States showed waning immunity, health officials moderated their language, hinting that booster shots would be likely. Last week, Anthony S. Fauci, the White House chief medical adviser, said it was “likely” everyone will need a coronavirus booster at some point.
The White House on Monday night declined to comment.
The timing of the announcement remains in flux. It had been tentatively planned for Wednesday, but it was not clear whether the schedule would change. The individuals said the statement was likely to provide additional details on who would get the extra shots and when.
Ordinary Times intrepid Editor-in-Chief Will Truman recently wrote about the crossed streams of the FDA pushing a vaccine that its own process is yet to fully approve:
I have a tendency to make simple things complicated, but to me this is whole complicated situation has one very simple component: FDA approval should reflect what the FDA knows about the safety and efficacy of a drug. If it knows a drug is safe and effective, it should be approved. If it is not approved, it should be because we don’t know enough to know its safety or efficacy (or both). And if only fools and knaves believe what the FDA officially says about a drug (or requires drug manufacturers to say), that reflects poorly on the FDA. It is untenable to argue that the system must be ignored to be preserved. That “approved by the FDA” is a statement that simultaneously means everything and nothing. At once a gold standard and a technicality for pedants.
Whether it’s a small tweak that allows an alternative path towards full approval, or an overhaul of the system wherein we tier ongoing approval, or somewhere in between, this is a problem that needs to be addressed.
So, to all of you: Please get vaccinated, if you are not already. Outside of rare circumstances, you’re safer for having done so and it will help prevent severe infection and it will help reduce transmission. Please ignore the regulators’ failure to declare this drug safe and approved.
And to the FDA: I shouldn’t need to say that.
I guess it’s better than nothing, but at this point, shouldn’t we be looking at intranasal and/or delta- or multivariant-targeted boosters, rather than just going for a third round with the original vaccine?Report
I hope we get there, but I don’t know if the m-RNA backbone this is built on would facilitate that.Report
I suspect the administration has some internal indication of when the BioNTech and Moderna vaccines will be fully licensed. At that point, a couple of things happen. (1) A booster dose of a licensed vaccine falls within the usual “off label” laws, and administering such w/o further FDA licensing doesn’t threaten providers’ medical licenses. (2) It makes approval of alternative vaccine tech more difficult. At least as I understand it, getting an EUA for such would require initial clinical testing that showed some significant improvement vs the fully-licensed mRNA vaccines: more effective, safer, less expensive, something.
Right now, the administration “will announce” the desirability of boosters. Watch for it to happen right after the full licensing.Report
Someone within the CDC releases their internal data (power-point presentation) in support of their claim that “the war has changed,” and it seems everyone just selects the bits that support their pre-existing position. Here is the entireity of what the CDC said about waning immunity:
“Preliminary VE estimates assessing duration of protection for 2 doses of mRNA vaccines
▪ VISION (test negative design across 8 integrated healthcare systems), data through June 22, 2021
– VE against hospitalization 88% (CI 86-90)
– No evidence of waning immunity to 16 weeks post-2nd dose
▪ IVY3 (test negative design across 21 hospitals), data through June 2021
– VE against hospitalization 87% (CI 85-97)
– No evidence of waning immunity through 20 weeks post-2nd dose
▪ Healthcare personnel (test negative design across 33 sites), data to May 31, 2021
– VE against symptomatic infection 90%
– No evidence of waning immunity through 14 weeks post-2nd dose
(CONFIDENTIAL – preliminary data, subject to change)”Report
“The Biden administration is planning to announce that most Americans who have received the coronavirus vaccine will need booster shots to combat waning immunity and the highly transmissible delta variant that is sparking a surge in covid-19 cases, according to four people familiar with the decision.”
Is anyone claiming that the surge in cases is due to declining immunity? I mean, if immunity will fall and we need boosters, that’s one thing, but this opening paragraph indicates something different.Report
You may be parsing the sentence incorrectly. Try “to combat (waning immunity) and (the highly transmissible delta variant that is sparking a surge in covid-19 cases).”Report
Yeah, I guess the “is” rather than “are” indicates that. But still, why would boosters combat the surge?Report
The other issue is the surge already peaked in the initial round of states and the Rt has dropped below 1. (Florida, Texas, Louisiana, Arkansas, and Missouri for example) Other states are surging (D.C., Dakotas, Indiana, Iowa, Maine, New Mexico, North Carolina, Ohio, Oregon, and Washington), with Rt 1.3 or more.
Seems like we’ve seen this movie before. Cases go up, people pull back, cases peak and then government announces a policy change.Report
Texas has peaked? News to me.
I mean GOOD news, as our ICU’s are packed full and I know several people waiting on urgent surgeries.
Oh, and we just re-ordered some mortuary trucks.Report