Omicron is here is it time to get boosted?

[TallGuyJohninBKK]

Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

 

First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose

 

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. 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.

 

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts to towards this goal.”

 

(more)

 

https://www.businesswire.com/news/home/20220124005896/en/

 

[ozimoron]

I can see anti Fauci heads exploding now. "He wasn't supposed to say this!"

 

"A COVID-19 vaccine specifically targeting the Omicron variant would be "prudent", even if it ultimately may not be needed, the top US infectious disease official said, as Pfizer announced trials for such a vaccine."

 

https://www.abc.net.au/news/2022-01-26/pfizer-biontech-omicron-specific-covid19-vaccine-clinical-trials/100781920

[ozimoron]

“The vaccines are still providing good defense against severe disease, hospitalization and death,” Long said. “Even if you’ve had COVID 19 before — you’ve had a natural infection — the protection from the vaccine is still stronger, longer lasting and actually ... does well for people who’ve been previously infected.”

The latest version is another reminder that the pandemic hasn’t ended.

 

https://apnews.com/article/coronavirus-pandemic-science-health-united-states-d09b3c6cc8b047c41d6cbf74043d0713

[thaibeachlovers]

14 hours ago, TallGuyJohninBKK said:

Pfizer and BioNTech Initiate Study to Evaluate Omicron-Based COVID-19 Vaccine in Adults 18 to 55 Years of Age

 

First participants enrolled in clinical trial received Omicron-based vaccine candidate as a two-dose primary series and as a booster dose

 

NEW YORK & MAINZ, Germany--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced the initiation of a clinical study to evaluate the safety, tolerability and immunogenicity of an Omicron-based vaccine candidate in healthy adults 18 through 55 years of age. 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.

 

“While current research and real-world data show that boosters continue to provide a high level of protection against severe disease and hospitalization with Omicron, we recognize the need to be prepared in the event this protection wanes over time and to potentially help address Omicron and new variants in the future,” said Kathrin U. Jansen, Ph.D., Senior Vice President and Head of Vaccine Research & Development at Pfizer. “Staying vigilant against the virus requires us to identify new approaches for people to maintain a high level of protection, and we believe developing and investigating variant-based vaccines, like this one, are essential in our efforts to towards this goal.”

 

(more)

 

https://www.businesswire.com/news/home/20220124005896/en/

 

Why stop at 55? That's not old in this age.

 

That alone makes me suspicious.

[ozimoron]

"Calling the Omicron variant “mild” was an unforced error that an understanding of lagged time series would have prevented.

 

Omicron is not mild. Viruses do not need to evolve to be less deadly. And endemicity has nothing to do with mildness."

 

https://dglassman.medium.com/omicron-was-never-mild-2b130568d7fa

 

[Credo]

10 hours ago, thaibeachlovers said:

Why stop at 55? That's not old in this age.

 

That alone makes me suspicious.

It makes you suspicious or it simply supports your narrative and gives you an excuse to dismiss the outcome?

Pretty much everybody who follows studies knows that they will target a group that is younger and healthier in the initial trials.  It will then be expanded to include other groups.  Do you think they should start with infants, as well?

You can be assured that were many other criteria beside age, such as general health, absence of specific diseases, smoking, drug use, etc..   Take a look at the occasional ads for participants in a study on any medication.   

 

I suspect no matter what they do, you will be suspicious.

 

[thaibeachlovers]

4 hours ago, Credo said:

I suspect no matter what they do, you will be suspicious.

On that at least, you are correct.

[thaibeachlovers]

4 hours ago, Credo said:

Pretty much everybody who follows studies knows that they will target a group that is younger and healthier in the initial trials.  It will then be expanded to include other groups.  Do you think they should start with infants, as well?

As I remarked initially, 55 is not old, and IMO is not markedly less healthy than those of a younger age. If that were the criteria I'd be making it 60 at least. I know 70 + year olds that are still fit and healthy, and work outdoors every day farming.

[thaibeachlovers]

On 1/21/2022 at 8:14 PM, ozimoron said:

Yes he is. He at least posts links to evidence. You hardly ever do. I see lots of anecdotes.

You are wrong on that. I always post links WHERE THEY ARE REQUIRED to back up my post. When I'm giving something that is MY OPINION, I don't give links because it's MY OPINION and I add that's it's IMO.

 

Have a nice day.

[Virt]

15 hours ago, thaibeachlovers said:

Why stop at 55? That's not old in this age.

 

That alone makes me suspicious.

Maybe they are doing a phase 1 and 2 first, and then in phase 3 letting in some elderly?

 

https://www.healthline.com/health-news/older-adults-are-more-at-risk-for-covid-19-so-why-dont-vaccine-trials-include-them#The-state-of-COVID-19-vaccine-trials

[thaibeachlovers]

18 minutes ago, Virt said:

Maybe they are doing a phase 1 and 2 first, and then in phase 3 letting in some elderly?

 

https://www.healthline.com/health-news/older-adults-are-more-at-risk-for-covid-19-so-why-dont-vaccine-trials-include-them#The-state-of-COVID-19-vaccine-trials

I don't consider 56 to 60 to be "elderly" We don't even get the pension till 65.

[Virt]

14 minutes ago, thaibeachlovers said:

I don't consider 56 to 60 to be "elderly" We don't even get the pension till 65.

Just saying it's not unusual to use young and healthy individuals in phase 1 and 2.

[Credo]

1 hour ago, thaibeachlovers said:

As I remarked initially, 55 is not old, and IMO is not markedly less healthy than those of a younger age. If that were the criteria I'd be making it 60 at least. I know 70 + year olds that are still fit and healthy, and work outdoors every day farming.

When testing a drug/vaccine, there is more than one phase.   As a we age, the immune system becomes less responsive.  The immune system reacts differently at different ages.  When we are an infant, it basically lacks any knowledge of what to target, although it has all the tools necessary, it simply lacks exposure.   At the other end of the spectrum, it begins to slow in the mid-fifties.  By the 70's the slowing is significant (much of that has to do with the Thymus).   

The immune response is most likely still strong enough to include the entire 50's, but that is also the age, especially for men, that deaths from other causes start to increase which can skew the results of any testing.

 

If it works on the age range they have selected, they will have a clear view of how effective it is, whether there are any side effects -- without running a risk of increased deaths, which starts happening with the older group -- and it will lay the groundwork for further exploring it's effectiveness on older adults as well as on children and adolescents.

[ozimoron]

12 hours ago, thaibeachlovers said:

You are wrong on that. I always post links WHERE THEY ARE REQUIRED to back up my post. When I'm giving something that is MY OPINION, I don't give links because it's MY OPINION and I add that's it's IMO.

 

Have a nice day.

When anyone asserts a fact it is not just their opinion.

[thaibeachlovers]

4 hours ago, ozimoron said:

When anyone asserts a fact it is not just their opinion.

LOL. How could I claim a "fact" was an "opinion"? One can not be the other, IMO.

Edited January 27, 2022 by thaibeachlovers

[Chomper Higgot]

10 hours ago, thaibeachlovers said:

As I remarked initially, 55 is not old, and IMO is not markedly less healthy than those of a younger age. If that were the criteria I'd be making it 60 at least. I know 70 + year olds that are still fit and healthy, and work outdoors every day farming.

If the age limit was 60 you’d be moaning it’s not 70.

[TallGuyJohninBKK]

2 hours ago, Chomper Higgot said:

If the age limit was 60 you’d be moaning it’s not 70.

 

The exclusion, or underrepresentation, of senior citizens from COVID vaccine trials seems to have been the subject of a lot of discussion and debate in scientific circles. Not to mention also underrepresentation of minority groups. Considering that both are more highly impacted by COVID illness.

 

September 28, 2020

The Exclusion of Older Persons From Vaccine and Treatment Trials for Coronavirus Disease 2019—Missing the Target

 

Older adults are at greatest risk of severe disease and death due to coronavirus disease 2019 (COVID-19). Globally, persons older than 65 years comprise 9% of the population,1 yet account for 30% to 40% of cases and more than 80% of deaths.2

 

Unfortunately, there is a long history of exclusion of older adults from clinical trials. In response, the National Institutes of Health instituted the Inclusion Across the Lifespan policy, requiring the inclusion of older adults in clinical trials.3 Thus, we reviewed all COVID-19 treatment and vaccine trials on http://www.clinicaltrials.gov to evaluate their risk for exclusion of older adults (≥65 years).

...

Our findings indicate that older adults are likely to be excluded from more than 50% of COVID-19 clinical trials and 100% of vaccine trials. Such exclusion will limit the ability to evaluate the efficacy, dosage, and adverse effects of the intended treatments. We acknowledge that some exclusions for severe or uncontrolled comorbidities will be essential to protect the health and safety of older adults."

 

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2771091

 

 

Older Adults, Minorities Underrepresented in COVID-19 Vaccine Trials

 

"Sharon K Inouye, M.D., a geriatrician at Boston's Hebrew Senior Life and professor of medicine at Harvard Medical School, wants a similar goal set for older adult enrollment. People ages 65-plus account for about 16 percent of the U.S. population, according to the latest census estimates. But given the devastating and disproportionate toll the virus has had on older adults, Inyoue says around 40 percent of clinical trial participants should represent this group.

"What are you seeing in the trials today? Nowhere near 40 percent,” Inyoue says. “And so that is extremely worrying to me."

 

"Efforts to increase participation among older adults and minorities in the current vaccine trials are not unique to the coronavirus pandemic. Both populations have long been underrepresented in trials across a range of treatments. And “the entire vaccine community has been grumpy about that for some time,” says William Schaffner, professor of medicine and an infectious disease expert at Vanderbilt University."

 

https://www.aarp.org/health/conditions-treatments/info-2020/range-of-subjects-in-vaccine-trials.html

 

South Florida Sun Sentinel |

Jan 22, 2021 at 11:04 AM

 

"Until now, research about the vaccine’s effect on older people has been minimal and short term. Of the 21,720 people who received the Pfizer-BioNTech vaccine rather than the placebo in its phase 3 trial, 7,971 or 37% were over age 55. Pfizer’s study did not include a breakout for those 65 and older. In the Moderna phase 3 trial, of the 15,181 volunteers given the vaccine rather than the placebo, 3,763 or 25 percent were older than 65."

 

Weblink to source

 

 

[TallGuyJohninBKK]

In reading thru the various citations above, it was a bit hard to find a clear explanation of why... though reasons were kind of hinted at at various points:

 

--not wanting "comorbitities" in older people to bias the outcomes

--not enough older people in the interest pools for trials participation

--concern by older people about vaccine reactions, or the vaccine manufacturers concerned that non-vaccine related reactions might harm their results?.

 

But all in all, I had a hard time finding a cogent explanation of WHY. COVID is clearly disproportionately impactful toward the elderly. So why wouldn't you want them as a sizable component of any clinical trials?

[TallGuyJohninBKK]

Meanwhile, Moderna has launched their clinical trial for their Omicron flavored booster vaccine:

 

"Moderna said it expects to enroll about 600 people in the study, which will take place at up to 24 sites in the US. Some participants will have already received two doses of Moderna's vaccine, and some will have received a booster shot."

 

https://www.cnn.com/2022/01/26/health/moderna-omicron-antibodies-booster/index.html

 

"Moderna said it would study its Omicron-specific booster in adults aged 18 years and older."

 

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-starts-trial-testing-omicron-specific-booster-shot-2022-01-26/

 

I looked at Moderna's corporate announcement, and it also appears to say only adults age 18 and above, but no specifics beyond that.

 

https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participant-Dosed-in-Phase-2-Study-of-Omicron-Specific-Booster-Candidate-and-Publication-of-Data-on-Booster-Durability-Against-Omicron-Variant/default.aspx

 

 

 

 

[Scott]

7 hours ago, TallGuyJohninBKK said:

Meanwhile, Moderna has launched their clinical trial for their Omicron flavored booster vaccine:

 

"Moderna said it expects to enroll about 600 people in the study, which will take place at up to 24 sites in the US. Some participants will have already received two doses of Moderna's vaccine, and some will have received a booster shot."

 

https://www.cnn.com/2022/01/26/health/moderna-omicron-antibodies-booster/index.html

 

"Moderna said it would study its Omicron-specific booster in adults aged 18 years and older."

 

https://www.reuters.com/business/healthcare-pharmaceuticals/moderna-starts-trial-testing-omicron-specific-booster-shot-2022-01-26/

 

I looked at Moderna's corporate announcement, and it also appears to say only adults age 18 and above, but no specifics beyond that.

 

https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-First-Participant-Dosed-in-Phase-2-Study-of-Omicron-Specific-Booster-Candidate-and-Publication-of-Data-on-Booster-Durability-Against-Omicron-Variant/default.aspx

 

I am slightly skeptical of a variant-specific vaccine, at least at this point in time.  But, that said, it is very good to know that they are able to produce one quickly.   

 

As time goes by, we will probably be looking at variant-specific vaccines, much like we have for influenza.   

[thaibeachlovers]

12 hours ago, TallGuyJohninBKK said:

In reading thru the various citations above, it was a bit hard to find a clear explanation of why... though reasons were kind of hinted at at various points:

 

--not wanting "comorbitities" in older people to bias the outcomes

--not enough older people in the interest pools for trials participation

--concern by older people about vaccine reactions, or the vaccine manufacturers concerned that non-vaccine related reactions might harm their results?.

 

But all in all, I had a hard time finding a cogent explanation of WHY. COVID is clearly disproportionately impactful toward the elderly. So why wouldn't you want them as a sizable component of any clinical trials?

Obviously I don't KNOW, but I agree it's a possibility that the drug developers fear that older people may be more likely to suffer adverse effects during a trial, and wish to avoid such, as it might affect the likelihood of marketing the drug.

Follow the money.

[Scott]

2 hours ago, thaibeachlovers said:

Obviously I don't KNOW, but I agree it's a possibility that the drug developers fear that older people may be more likely to suffer adverse effects during a trial, and wish to avoid such, as it might affect the likelihood of marketing the drug.

Follow the money.

Older people are simply at greater risk of dying during the study period and this can skew the results.   When large scale trials are done that mitigate for the likelihood of people dying from other causes, then older people are usually a part of those trials.   At both ends of the spectrum, the young and the old, the immune system reacts a little differently.  In very young people, it simply is immature and not fully operational.  In older people, it has begun the phase of slowing and may not have a robust immune response -- that is true regardless of this vaccine or any other well-known and tested vaccine.  As an example, most older people are given a much more potent dose of the Influenza vaccine than younger people.  The same with those who are immunocompromised.   

 

The move from Emergency Use to full authorization of the vaccines was not done until sufficient data has been accumulated.   

 

As far as following the money, well, I am not sure that would work particularly well, but it is for certain that any drug developed would first have trials designed to show it in the best possible light.   Real-world conditions will usually show a decrease in the efficacy of any drug, but it should not be a significant drop.

[Chomper Higgot]

2 hours ago, Scott said:

Older people are simply at greater risk of dying during the study period and this can skew the results.   When large scale trials are done that mitigate for the likelihood of people dying from other causes, then older people are usually a part of those trials.   At both ends of the spectrum, the young and the old, the immune system reacts a little differently.  In very young people, it simply is immature and not fully operational.  In older people, it has begun the phase of slowing and may not have a robust immune response -- that is true regardless of this vaccine or any other well-known and tested vaccine.  As an example, most older people are given a much more potent dose of the Influenza vaccine than younger people.  The same with those who are immunocompromised.   

 

The move from Emergency Use to full authorization of the vaccines was not done until sufficient data has been accumulated.   

 

As far as following the money, well, I am not sure that would work particularly well, but it is for certain that any drug developed would first have trials designed to show it in the best possible light.   Real-world conditions will usually show a decrease in the efficacy of any drug, but it should not be a significant drop.

Added to which the conduct of drug trials and the selection of trial candidates is very highly regulated.

 

Follow the regulation.

 

The vaccines are safe and effective, who they were not tested on is a red herring.

 

 

[Scott]

1 hour ago, Chomper Higgot said:

Added to which the conduct of drug trials and the selection of trial candidates is very highly regulated.

 

Follow the regulation.

 

The vaccines are safe and effective, who they were not tested on is a red hearing.

 

 

I would have to agree that it is a red herring. 

 

Drug and vaccine trials are very highly regulated and that goes back to the TGN1412 trials.   Theralizumab, also known as TGN1412,  is an immunomodulatory drug designed to increase the CD28 cells that fight cancer.  It was first tried successfully on Macaques Monkeys.  It was then moved to human trials but they had missed one important thing.  Macaques have a much lower number of CD28 immune cells, so when the trials were done with 6 young, healthy adult males the results were disastrous.  Even though the dose given to the participants was 500 times lower the participants ended up with an immune response that was positively nuclear.   

Within minutes the participants experienced a massive cytokine storm, inflammation throughout their body and multi-organ failure.  They were able to keep them alive but at least one lost fingertips and toes.  The result was the development of much more controlled protocols involving drug trials.   

[TallGuyJohninBKK]

Boosters increase protection against death from Omicron in over-50s to 95% - UKHSA

 

"LONDON, Jan 27 (Reuters) - COVID-19 boosters increase protection against death from the Omicron variant to 95% in people aged 50 or over, the UK Health Security Agency said on Thursday.

 

The UKHSA said that around six months after a second dose of any of the COVID-19 vaccines, protection against death with Omicron was around 60% in those aged 50 and over. However, this increased to around 95% two weeks after receiving a booster vaccine dose.

 

UKHSA added that data continued to show high levels of protection against hospitalisation from the booster. Effectiveness against hospitalisation was around 90% for the Pfizer-BioNTech shot (PFE.N), , dropping to 75% 10-14 weeks after the booster. For Moderna (MRNA.O), effectiveness against hospitalisation was 90-95% up to 9 weeks after the booster.

 

(more)

 

https://www.reuters.com/world/uk/boosters-increase-protection-against-death-omicron-over-50s-95-ukhsa-2022-01-27/

[rott]

On 1/25/2022 at 6:08 PM, Tony125 said:

 

Immunity against variants found in Sinovac recipients who got mixed vaccine booster

https://www.yahoo.com/news/immunity-against-variants-found-sinovac-040526117.html

 

 

 

Land of Smiles? Thailand may have more face masks laws than anywhere on the planet

https://www.yahoo.com/lifestyle/land-smiles-thailand-may-more-114353086.html

 

 

Why are children who have had Covid at risk of becoming diabetic?

https://www.yahoo.com/news/why-children-had-covid-risk-155236434.html

I had 2 Moderna jabs, what is recommended for the booster.? 

[Tony125]

Moderna vaccine gets full US approval

https://www.msn.com/en-us/news/us/moderna-vaccine-gets-full-us-approval-canadian-prime-minister-justin-trudeau-tests-positive/ar-AATk6td

 

Pfizer was the first but now Moderna  is the second Covid vaccine given full US FDA approval and no longer just for emergency use. That because of testing and the results of millions of dosages given in real world situation. FDA has also announced that vaccine for under 5 year olds may be ready by the end of February. 

Edited February 1, 2022 by Tony125
spelling

[ozimoron]

Omicron subvariant BA.2 more infectious than 'original', Danish study finds

 

https://www.reuters.com/business/healthcare-pharmaceuticals/omicron-subvariant-ba2-more-infectious-than-original-danish-study-finds-2022-01-31/

[ozimoron]

Omicron amps up concerns about long COVID and its causes

 

https://apnews.com/article/long-covid-omicron-research-45986f5b42e47e656d5b385bd51b2bb2

[Rimmer]

A troll post has been removed