Pfizer Launches Clinical Trial for Omicron Booster Awfully Late….What Gives?


As much fun as it is to lift up rocks and examine creepy crawlies, even then, sometimes less is more. So we’ll stick to the high points of the latest Pfizer vaccine anomaly, this one on the stop and go Omicron booster, and let readers, particularly readers with intel or at least knowledge of clinical trials and “normal” FDA approval processes, opine further.

Recall that one of the widely-touted reasons for being excited about the brave new world of mRNA vaccines was that new versions designed to target mutations could ostensively be developed in a week or two. Mind you, it was understood that it would still take time for them to be properly tested for efficacy and then subject to regulatory review/approval.

Recall further that despite the supposed miraculous tunabilty of mRNA vaccines, no one launched a Delta booster. We discussed this lapse in a December post:

One reason was that Delta overlapped with the older variants a bit before becoming dominant. Second is that the performance of the original vaccines didn’t fall as much in reducing risk of hospitalizations and death as it appears to when boosted for Omicron. Sadly the vaccines did do more to reduce contagion of the wild type virus than Delta, but that change doesn’t get much mention.

But as far as I can tell, the idea of ??developing a new vaccine targeting Delta wasn’t even seriously entertained. Our GM described an additional issue which I never saw mentioned in the press: the Delta variations were orthogonal to some other variants. So while the original vaccine was pretty effective against wild type and Delta and the “orthogonal” variants, one aimed at Delta would not do much to combat the orthogonal variants. So it made sense to stick with the original vaccine as a reasonable “good enough for all current seasons” compromise.

Recall additionally that when the obviously fast-moving and super-different Omicron burst onto the scene, experts who weren’t cognitively or financially captured were warning it would significantly or entirely evade the current vaccines. That concern was quickly confirmed by who fell to early outbreaks in Norway and Denmark. And then at the end of November, the great unwashed public was subjected to narrative conflict. As we wrote then:

After repeatedly claiming that a Biden Administration would “follow the science” on Covid, it now appears to be hoist on its petard of instead relying on least effort approaches combined with better propaganda, aka placing all its bets on vaccines.

These headlines illustrate the problem. The first is the lead in the Wall Street Journal; the second is from the Financial Times:

Recall finally that early in the Omicron march across the globe, Pfizer said it would have an Omicron booster read to roll by early March. But the Biden administration bizarrely went to war with that idea. Hoisting again from our late December post, Maybe No Omicron Boosters?:

Even though Pfizer and then other vaccine-makers said they could have a booster targeting Omicron out in three months or so, the Administration is talking down the possibility of one. That seems odd in that:

2 vaccine doses barely create a dent against Omicron, and previous infection, according to initial Imperial College data didn’t either (although some other studies suggest prior infection could blunt severity; the jury is still out on many important Omicron questions)

There is good evidence that a booster of the current vaccines reduces the odds of severe outcomes, but not to the same degree as against earlier variants. However, it’s not as clear even against the original variants whether a booster produces as long-lived immunity as the first shots did; it may be shorter, even before you get to how it behaves against Omicron. Israel is launching its fourth round of booster shots only five months after offering boosters to the highest-risk populations. In other words, given that some , perhaps many, members of the public won’t be happy about a more than twice a year vaccination regime, if one is to stay current, another reason to back an Omicron-specific booster is it might last longer against Omicron than the current vaccines , which were developed against the wild type virus….

it’s disconcerting to see what sure looks like official reducing of expectations regarding getting an Omicron booster around March, as Pfizer and now others have indicated. From Top regulator says need for Omicron vaccine depends on staying power of variant in STAT:

Whether Americans will need additional vaccines specifically tailored to the rapidly spreading Omicron variant of the coronavirus may depend on how long it circulates in the United States, a top regulator told STAT in an interview Wednesday.

“If it turns out that Omicron is the new variant that actually things settle into, well then of course we will probably need an Omicron-specific vaccine,” said Peter Marks, the Food and Drug Administration’s top vaccine regulator. “On the other hand , if this is just a variant that’s passing through and we get [a new variant] in a month or two, we won’t need that.”

Marks added that Omicron is “a very, very fast-moving virus” that “could pass across this country within a matter of a few weeks,” and that he does not know for sure whether Omicron-specific jabs will be needed….

All three manufacturers with vaccines authorized in the United States — Pfizer, Moderna, and Johnson & Johnson — are currently readying Omicron-specific vaccines. Pfizer has said it could begin delivering its Omicron-specific vaccine by March, pending FDA approval.

Huh? Unless you assume Omicron will be displaced by yet another variant, even those who were boosted will need a new shot in 5-6 months. And even assuming perfect compliance, 75% odds of not getting a serious infection falls to 42% if you play that game three times, as in go 15-18 months under an Omicron regime. While if an Omicron booster lowers the odds of serious infection by 90%, the risk of getting a bod case over the same time period with perfect compliance is 73%. And to the degree the risk reduction is higher than 90%, the better the long-term odds.

And you don’t have to go far into the article to see that our suspicion, that this messaging reflects an Administration preference, looks correct, particularly when contrasted with the fact that the vaccine-makers are moving ahead with Omicron products:

The Biden administration has signaled that it plans to fight the spread of Omicron through existing booster shots, which were not formulated specifically for Omicron. Early data suggest that the booster shots from Moderna and Pfizer significantly enhance protection against the Omicron variant…

Anthony Fauci, the head of the National Institute of Allergy and Infectious Diseases and the chief medical adviser of the Biden Covid-19 response, has expressed doubts about the need for Omicron-specific shots.

Even if you wonder about the wisdom of having to get repeatedly jabbed with Covid vaccines, the risk/return tradeoff is clearly better, all other things being equal, with a more effective vaccine. So if you are going to use mRNA vaccines to combat Omicron , that argues for a sure-to-be-more-potent Omicron booster against Omicron rather than a less ooomphy one designed to beat the wild type variant.

Back to the current post. The latest development is that Pfizer announced that it was starting clinical trials for its Omicron booster yesterday:

From the press release:

The study will have three cohorts examining different regimens of the current Pfizer-BioNTech COVID-19 vaccine or an Omicron-based vaccine. The study will draw upon some participants from the companies’ Phase 3 COVID-19 booster study and is part of their ongoing efforts to address Omicron and determine the potential need for variant-based vaccines….

The study will evaluate up to 1,420 participants across the three cohorts:

  • Cohort #1 (n = 615): Received two doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one or two doses of the Omicron-based vaccine
  • Cohort #2 (n = 600): Received three doses of the current Pfizer-BioNTech COVID-19 vaccine 90-180 days prior to enrollment; in the study, participants will receive one dose of the current Pfizer-BioNTech COVID-19 vaccine or the Omicron-based vaccine
  • Cohort #3 (n=205): Vaccine-naïve participants will receive three doses of the Omicron-based vaccine

1420 participants? Across three cohorts? This is a joke, not a serious study. And the age group is 18 to 55, so it excludes those most in need of protection, the elderly

IM Doc commented:

Am I reading this correctly? The Omicron shot will actually be a brand new series of three more shots? They must be smoking something.

And GM:

This is bonkers. They are only now starting the trial.

We are indeed likely not getting an updated vaccine…

Bizarrely, Pfizer is still messaging that it will have a vaccine ready to go by March, when starting now with recruiting, getting participants jabbed, and compiling the data and writing up the results for an FDA submission for a mere single Omicron booster would take until the start of March at the very earliest. The FDA has to take at least a smidge of time for review.

And given the three cohorts, Pfizer presumably ought to wait for at least the results of one Omicron booster v. two, and better yet, a three shot regime. I’m not even guesstimating a timeline beyond pointing out the obvious “No way by early March.”

Oh, and let us not forget the other really big fly in the ointment: BA.2 is on the move, and it looks to be considerably more infectious than Omicron.

Yet Pfizer is clearly messaging its early March fantasy hard. The subhead of an Associated Press story, Pfizer opens study of COVID shots updated to match omicron, published yesterday: “The highly contagious omicron variant has darkened the world’s outlook on beating the virus, but new boosters could be ready by as early as March.”

I supposed one could surmise that Pfizer has shifted the goalposts on what “ready” means.

Our GM added:

This is all a charade.

If they had any real intention of stopping Omicron with vaccines, production would have been running 24/7 on November 30th the latest.

After all it’s a copy-paste operation for the RNA and then you need to make new labels for the tubes.

With no testing — you don’t have time for that, nor has it been done historically for flu pandemics.

So if you believe in the vaccines, as the Administration clearly does, what gives? Had they bought a ton of mRNA vaccine inventory, say for the VA, and didn’t want to toss it? Or were they so wedded to their storyline that they’d rather urge Americans to keep taking a highly-certain-to-be-only-marginally-effective booster than tell them they’d have to wait for better?

This is shaping up to be a case study of short seller David Einhorn’s favorite saying, “No matter how bad you think it is, it’s worse.” And here, we are looking at putting more nails in the coffin of our fading empire, just as the Spanish flu was arguably the death knell for the Ottoman Empire. Or you could just measure the damage in deaths, shortened lifespans, and impaired health for many.

Print Friendly, PDF & Email





Source link