Pfizer and BioNTech launch trial of Omicron-targeted Covid vaccine

https://www.reuters.com/business/healthcare-pharmaceuticals/pfizer-biontech-launch-trial-omicron-targeted-covid-vaccine-2022-01-25/

by caaqil • 4 years ago

66 141 4 years ago

reuters.com

peteradio2• 4 years ago

Who is in the control group now? You can't exactly exclude people who have prior contact with older variants or that would mislead populations with high prior exposure. Also how do they factor in prior vaccination? Are they going to have high powered arms for all these different subtypes of immune response?

IgorPartola• 4 years ago

If you read the article, that is addressed there.

peteradio2• 4 years ago

I'm sorry I don't see it. I only see mention of dividing groups by unvaccinated/vaccinated. That doesn't give indication to prior exposure at all.

zaroth• 4 years ago

Seems to me that Omicron is essentially a vaccine in its own right. Highly attenuated and extremely mild to non-existent symptoms.

The best part is even the anti-vax crowd will be innoculated!

rgrieselhuber5• 4 years ago

Natural immunity, what a concept!

NikolaeVarius2• 4 years ago

As opposed to artificial immunity?

r00fus5• 4 years ago

Don't worry BA.2 is right around the corner and it's not clear if the BA.1 variant (Omicron) gives you immunity to BA.2. Lots of people infected with Delta, also caught Omicron.

So yeah, you're immune but possibly not for the next variant, and that variant may be more severe.

fpgaminer5• 4 years ago

Highly attenuated and extremely mild to non-existent symptoms.

Hospitals are getting overloaded due to Omicron. People are dying in droves. Omicron is by no means mild.

"Omicron may be milder compared to Delta, but it’s not mild. " Source: https://yourlocalepidemiologist.substack.com/p/state-of-affa...

native_samples3• 4 years ago

Where? In the UK hospitals are quiet for this time of year (less than 80% loaded which for the UK is quiet), and deaths are below the 5 year running average.

prvc• 4 years ago

I don't see what the supporting evidence for that conclusion is in the article.

nicoburns• 4 years ago

I think Omicron is almost universally mild for those who have had the existing vaccines. And as most people have (here in the UK anyway), I can understand why people are seeing it as mild.

ripper1138• 4 years ago

The data in the article makes a pretty compelling argument that Omicron is extremely mild.

cma• 4 years ago

Even if it was as mild as flu, with its much higher rate of spread hospitals would probably still be seeing a big surge.

nradov5• 4 years ago

A lot of the deaths occurring right now are still from patients that were infected by the Delta variant weeks ago.

Preliminary research indicates that Omicron has an 87% lower fatality rate. Of course that number is a little fuzzy because it's impossible to perform a real controlled experiment.

https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4010080

PragmaticPulp• 4 years ago

and extremely mild to non-existent symptoms

For some, but hardly guaranteed. Still a lot of hospitalizations happening and the extreme treatments have to be rationed because we’re running out so fast.

The thing is: You don’t get to choose or predict if you’ll get the mild case or the severe case. You can’t ignore the serious cases and make your decisions on the assumption that you’ll be in the “no long term effects” group. The vaccine is a much more predictable and tested response. I’d much rather have the vaccine.

ethbr04• 4 years ago

Once the lethality data started to accumulate, I had the same thought. Even though it's still definitely not something you want to get, especially if you have comorbidities.

It's insane to think about, but as our biological engineering skills mature, it's worth having a discussion about whether (1) mass vaccination + (2) release of highly-contagious, low-lethality strain should be in the pandemic playbook.

There are no sure things in biology, but a hypothetical reality where Delta (or god forbid something like MERS-CoV) is circulating with Omicron-rates of transmissibility... start to beg questions about what the least bad approach is.

chasd002• 4 years ago

(2) release of highly-contagious, low-lethality strain should be in the pandemic playbook.

political and ethical suicide

jaywalk3• 4 years ago

There are theories floating around that omicron is actually what you're describing. The number and types of mutations it has versus other variants definitely stands out.

Of course, nobody would ever admit it if that's true. So it's just a curious thing to think about.

yucky2• 4 years ago

release of highly-contagious, low-lethality strain should be in the pandemic playbook.

We could even blame it on wet markets ;)

samwillis• 4 years ago

I don’t think that is fully confirmed as so many people who are getting it are double or triple vaccinated already.

(I currently have Covid, probably Omicron, triple vaxed, and would describe it as a rotten cold)

qbasic_forever5• 4 years ago

Wait, didn't people make this exact same argument about the alpha variant (B.1.1.7) that had a massive worldwide surge around this time a year ago?

What happened--why did we go on to have delta, omicron, etc. surges?

Or put more bluntly--why should anyone believe that *this time* omicron will be any different than the past variants which were touted as finally bringing herd immunity, but failed to do so?

Why is it that every surge seems to bring the exact same arguments and people saying "don't worry this one will stop the pandemic"? I've been reading it for two years and still haven't seen it happen anywhere in the world.

mercy_dude2• 4 years ago

I don’t buy Omicron will be the one ending this. There will be more variants. Midterm variant will be a very good one to watch out for. Our political class have figured it’s much easier to defer judgements or lack thereof to scientists and thus take no responsibility for failed policy measures or debates.

groby_b2• 4 years ago

Just one country as an example: The US lost 15K people last week to Omicron. 150K people hospitalized, 25K in the ICU. That's nowhere close to "mild to non-existent" compared to a vaccine.

qbasic_forever5• 4 years ago

As a point of comparison too about 690k Americans die of heart disease a year, or a rate of about 13k deaths from heart disease a week.

Currently the 'mild' omicron strain of the virus is killing more people per week than the number one killer of Americans (heart disease).

https://www.cdc.gov/nchs/fastats/leading-causes-of-death.htm

Usurping the top spot for causes of death in a week is not mild by any means.

jaywalk3• 4 years ago

The US lost 15K people last week to Omicron.

Bullshit. There is no data to suggest all of those deaths were from omicron, and no reason to believe that's the case either. Don't spread misinformation.

nradov5• 4 years ago

Your numbers are way off. Many of the deaths last week weren't necessarily from Omicron. Some were patients infected by the Delta variant in previous weeks before Omicron became completely dominant.

yucky2• 4 years ago

The US lost 15K people last week to Omicron.

Not true. You're referring to all Covid deaths, not Omicron. We are still seeing the Delta strain lethality in the numbers.

guelo• 4 years ago

The biggest logical fallacy I've noticed during the pandemic is people making definitive statements like yours while the science remains uncertain and changing.

I don't know how much weight to put on this news snippet from yesterday from a Dutch scientist saying they're seeing people that got infected with Omicron getting reinfected with new Omicron subvariant BA.2: https://nyheder.tv2.dk/2022-01-21-ny-omikron-variant-spreder...

Gibbon1• 4 years ago

I always ask myself when someone makes a definitive statement if they actually have a way of knowing that. That detector has been off the charts this whole pandemic. The usual suspects proclaimed Omicron was 'mild' whatever that actually means well before any data was available to show either way.

It's looking more and more like Omicron isn't mild. In particular it's producing worse infections in children. Not to mention it's immune escape means it's infecting vaccinated people. Mild infection in vaccinated people vs no infection in vaccinated people as you had with other variants.

tablespoon5• 4 years ago

Seems to me that Omicron is essentially a vaccine in its own right. Highly attenuated and extremely mild to non-existent symptoms.
The best part is even the anti-vax crowd will be innoculated!

I don't think it's anything close to "highly attenuated":

https://www.nytimes.com/live/2022/01/25/world/omicron-covid-...

The C.D.C. attributed the tendency of Omicron cases to cause less severe illness to the virus itself, as well as growing levels of immunity from prior infections and from the rollout of vaccinations. It said that roughly 30 million more people were fully vaccinated during the Omicron surge than during the Delta wave in the fall.
As a result, a smaller proportion of coronavirus cases are ending in hospitalizations: The C.D.C. said there had been a peak of 27 hospital admissions for every 1,000 cases in January, compared with 78 admissions per 1,000 cases in the fall.

If it were "highly attenuated," I'd expect close to 0 hospital admissions for every 1,000 cases, not 27.

Exaggerating "less severe" to "near harmless" is one of those errors anti-vax people and other denialists commonly make in their arguments.

fivea3• 4 years ago

Seems to me that Omicron is essentially a vaccine in its own right. Highly attenuated and extremely mild to non-existent symptoms.

No, not really. Fully vaccinated individuals in highly vaccinated populations who contract covid tend to experience mild to non-existent symptoms.

Omicron is not a vaccine. The vaccine is the vaccine.

https://www.euro.who.int/en/health-topics/health-emergencies...

adolph• 4 years ago

No Studies found for: covid-19 | pfizer BioNTech | Start date on or after 01/01/2022

Maybe it is part of an existing study?

https://clinicaltrials.gov/ct2/results?cond=covid-19&spons=p...

smallerfish• 4 years ago

Reuters crashes if the browser has a cookie blocker active - its js expects a certain cookie to be there.

noahmbarr• 4 years ago

Seems like a day late and a dollar short on this effort.

thehappypm• 4 years ago

Um, Omicron was discovered 2 months ago.

fpgaminer5• 4 years ago

It's not about Omicron today, it's about Omicron's descendants.

Before Omicron, two doses provided >90% protection, and held up well against Delta. Now, two doses provides only 40% protection against Omicron. Whereas three doses bumps that back up to 80%.

Given these trends it's clear that we need a plan forward, just in case, for whatever comes on the menu next year. It's likely to be an Omicron descendant, since Omicron is dominating the gene pool. It's a reasonable assumption that an Omicron derived vaccine would have provided >90% protection against Omicron. And so, reasonably, being Omicron-boosted in the future should provide something like 80% protection against whatever the next dominate strain will be, whereas the existing boosters might not fare as well.

That's the hope anyway.

EricE2• 4 years ago

Omnicron is so mild for the VAST majority of people that frankly the best thing that can happen is for it to just spread and we all get to heard immunity that much faster.

Thankfully it's so much more virulent that this is going to happen whether we like it or not. Makes me think of the old chicken pox parties when I was a kid.

The virus is carried by animals and it's not going away. So we had better start figuring out how to more reasonably live with it, stop with the asinine one size fits all solutions; many of them (like cloth masks) that are actually anti-science based and stop destroying so many people's lives - especially children - I can't imagine being a child in todays idiotic overreactive and politically energized environments, especially since children had the least to fear even from the original, pretty nasty virus. Yes, there are even kids that are more at risk - but you don't screw everyone - you protect the vulnerable. Common sense seems to be utterly out the window as everyone is running around panicking; it's beyond nuts.

nradov5• 4 years ago

If you're going to state vaccine effectiveness percentages then you need to define the endpoint. Stating that it provides 40% protection against Omicron is meaningless. Is that against PCR confirmed infection, symptomatic infection, hospitalization, death, or something else? And over what time period?

The reality is that two doses of the existing mRNA vaccines still provide very good protection against severe disease for the vast majority of patients.

https://peterattiamd.com/covid-part2/

r00fus5• 4 years ago

Omicron BA.2 is already here [1]. In Denmark, it's already >50% of the cases.

[1] https://deadline.com/2022/01/omicron-offshoot-ba2-in-us-1234...

fpgaminer5• 4 years ago

Whether this pans out into an approved vaccine or not, I'm terribly curious about the results of the study comparing Omicron booster versus existing booster.

Apparently the existing booster shot elicited a more diverse set of antibodies compared to the ones from just a two shot regimen. Which is kinda interesting. I forget what it's called, but there's this phenomenon in immunology where the immune system can get "stuck" with whatever initial antibodies it comes up with and doesn't adapt well. Seems that wasn't the case with the COVID boosters, thankfully. And that explains why the boosters have been so dramatically more effective against Omicron (80% versus <40% for those with just two shots, natural immunity, etc; IIRC).

But would an Omicron booster have elicited an even "better" set of antibodies? Would we get back to 90% protection like the good ole days?

And of course the big question; is an Omicron booster going to provide better forward protection?

The results of this study are going to be deliciously intriguing.

flatiron2• 4 years ago

I feel like we are going to have to get a yearly booster and they will be guessing the strains every year just like the flu.

Note: 100% a gut feeling

ethbr04• 4 years ago

That was pretty obvious since March 2020. Highly contagious respiratory viruses with non-human reservoirs don't go back into the bottle, once they're circulating.

walterbell4• 4 years ago

Jan 23rd, https://www.rt.com/news/546859-pfizer-ceo-future-vaccines/

In a series of interviews with Israeli TV channels, Albert Bourla said it would “not be a good scenario” if people were to get boosters every four to five months. “What I'm hoping [is] that we will have a vaccine that you will have to do once a year,” ... Bourla argued that it is both easier to sell the idea and “easier for people to remember” if a vaccine is required only once per year, calling it “an ideal situation” from “a public health perspective.”

fpgaminer5• 4 years ago

There's some distant hope for a "super" vaccine against the entire coronavirus (sub)family: https://yourlocalepidemiologist.substack.com/p/pan-coronavir...

loceng4• 4 years ago

Will there be confirmed better oversight than with Pfizer's 12-15 year old clinical trial, re: Maddie De Garay's story?

https://youtu.be/L2GKPYzL_JQ - "How many more adverse effects have been covered up during the trials? - Maddie de Garay's story."

cguess• 4 years ago

FYI this guy is extremely anti-vax and what he was saying was roundly condemned. https://www.theguardian.com/australia-news/2021/dec/07/liber...

walterbell4• 4 years ago

The Maddie de Garay story is tragic and history will not look kindly on the unnecessary censorship of an injured child in Pfizer's original clinical trial. They could have used that incident as an opportunity to demonstrate the protocols for investigation and prevent of similar injuries.

It's promising that there will be slightly higher regulatory standards for the Omicron vaccine: clinical trial in humans must be completed before approval and clinical trial data must be submitted at the same time, i.e. no 75-year delays.

the debate appears to have shifted with the European Medicines Agency (EMA) saying on Friday that international regulators now preferred clinical studies to be carried out before approval of a new vaccine ... Inclusion of clinical trial data in the regulatory filings may have an impact on the delivery of initial batches.

ralph84• 4 years ago

I forget what it's called, but there's this phenomenon in immunology where the immune system can get "stuck" with whatever initial antibodies it comes up with and doesn't adapt well.

It's called original antigenic sin[0]. It's one of the reasons that mass vaccination against a variant that is no longer circulating may not be the wisest strategy. But anyone who dares mention it is shouted down as anti-vaxx.

[0]https://en.wikipedia.org/wiki/Original_antigenic_sin

xadhominemx6• 4 years ago

I guess that’s a theoretical possibility for a different virus, but in truth the mRNA vaccines provide robust protection from serious illness from omicron: https://ourworldindata.org/covid-deaths-by-vaccination

macilacilove2• 4 years ago

the immune system can get "stuck" with whatever initial antibodies it comes up with and doesn't adapt well

Original antigenic sin. However I don't think it predicts that the alpha-based boosters we have will be any more effective, and I don't think that we are observing particularly impressive effectiveness either.

b0sk• 4 years ago

Omicron is not mild to the unvaccinated.. and as a result, to the hospital infrastructure.

qbasic_forever5• 4 years ago

50% of people recently hospitalized in King county, Washington, (where Seattle is located) are vaccinated: https://kingcounty.gov/depts/health/covid-19/data/vaccinatio...

It appears for some vaccinated people Omicron is not mild either.

foxyv2• 4 years ago

Keep in mind that 69% of the population in Washington is vaccinated. This will skew the proportion of hospitalized towards the vaccinated. Vaccination seems to be about 70% effective at preventing serious disease requiring hospitalization. So yeah, not mild in vaccinated people either, just less horrifyingly bad.

https://www.nejm.org/doi/full/10.1056/NEJMc2119270

Pfizer and BioNTech launch trial of Omicron-targeted Covid vaccine

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