Coronavirus

[Dan]

Aren't you in the general Philadelphia area? I thought Pennsyltucky refers to southwest Pennsylvania.

Maybe Pennsyltucky is more a state-of-mind than a geographic location .

Well I'm about 300,000 from the front of the line in Maryland. I always thought Pennsylvania was Philadelphia and Pittsburgh with Alabama in between.

 

[TLS Guy]

The great stable genius, passed on locking in millions of doses of Pfizer vaccine doses. So we will go to the back if the queue until June.

Meanwhile the UK starts vaccinations. Giving priority to care homes there makes sense, as most of them are old Georgian and Victorian houses that are impossible to provide infection control in. The sort of building in use here would never be allowed anywhere in the US. A lot of these are very nice old buildings, but not for care homes.

This was the nursing home my mother spent the last five weeks of her life in.

I'm sure medical staff and first responders will come next. I think the Moderna vaccine will be approved there soon, and I expect them to allow the Oxford vaccine to roll out as further studies continue. This crisis is far too severe and deadly for normal procedures to apply. I'm sure a sensible risk benefit analysis has been done.
This winter is already turning out to be a total catastrophe, and normal procedures have to be suspended. This pandemic needs ending ASAP by any reasonable means. We need all vaccines that are reasonable means rolled out now. Allowing these enormous numbers of preventable deaths to continue when they can be prevented is now obscene. Any vaccine shown to save significantly more lives than otherwise needs approval.

 

[Mr._Clark]

I read another report that the UK should use it's 800,000 vaccine doses to vaccinate 800,000 people with a single injection, instead of vaccinating 400,000 people with the proper two doses. Again, what a genuinely bad idea. (We really need a good face-palm emoji).

The headlines today say Pfizer's vaccine is "safe and effective after one dose." I have not yet read the entire FDA briefing document (link in article below), but the headlines appear to contradict the following statement at pages 32-33 of the FDA report:

"The efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks. The trial did not have a single-dose arm to make an adequate comparison."

Pfizer's Covid-19 vaccine is safe and effective, even after one dose, FDA says

Experts are happy about the early protection, but still stress the importance of getting both doses.

www.nbcnews.com

 

[Swerd]

The headlines today say Pfizer's vaccine is "safe and effective after one dose." I have not yet read the entire FDA briefing document (link in article below), but the headlines appear to contradict the following statement at pages 32-33 of the FDA report:

"The efficacy observed after Dose 1 and before Dose 2, from a post-hoc analysis, cannot support a conclusion on the efficacy of a single dose of the vaccine, because the time of observation is limited by the fact that most of the participants received a second dose after three weeks. The trial did not have a single-dose arm to make an adequate comparison."

Pfizer's Covid-19 vaccine is safe and effective, even after one dose, FDA says

Experts are happy about the early protection, but still stress the importance of getting both doses.

www.nbcnews.com

I agree. The Advisory Committee cannot act on something that was not included in the clinical trial. The clinical trial compared 2 arms: two doses of vaccine vs. placebo. There was no 3rd arm in that trial with one dose of vaccine, and therefore, efficacy after a single dose cannot be evaluated.

That NBC News article said this:

The new information shows it has benefits even after the first dose, with an effectiveness of more than 50 percent about a week later. What's more, the effectiveness seems to be the same across all age groups, racial and ethnic minorities, and people with underlying conditions, such as obesity, diabetes and high blood pressure.​

It is possible that the FDA can decide – on it's own – that for the time being, one dose is better than none. But the Advisory Committee is unlikely to suggest that, considering the absence of any clinical data. If the FDA decides to allow one dose now, it would also have to require the second dose at a later time when more vaccine becomes available. They would have to weigh whether one dose now with the 2nd dose later is worth the delay by estimating how many people might fail to get their second dose because of the delay.

And we have the Orange Peril & his minions to thank for the failure to order more vaccine when there was an opportunity.

 

[Swerd]

Philadeplhpihi

WTF?

A comment on atrocious spelling – or – a comment on WTF beating Pittsburgh the other night.

 

[Swerd]

NPR had a better written report about the 1 dose vs. 2 dose question for the Pfizer vaccine.

FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe

The Food and Drug Administration finds "no specific safety concerns" that would stand in the way of authorization of the vaccine for emergency use. Effectiveness is 95% after two doses.

www.npr.org

The FDA released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech. The analysis finds "no specific safety concerns identified that would preclude issuance of an Emergency Use Authorization (EUA)." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue.

The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart. The clinical data also suggest that the vaccine may be able to prevent COVID-19 after the first dose — 82% effective — though the FDA analysis says the available information doesn't allow for a firm conclusion on that potential effect.

All this is good news. Let's see what the Advisory Committee says on Thursday, and what the FDA does afterwards. It's possible that the FDA might act as soon as Friday, 11 December.

I have read that this same Vaccine Advisory Committee will review and vote on the Moderna vaccine as soon as it has finished with Pfizer's. Next week?

 

[TLS Guy]

NPR had a better written report about the 1 dose vs. 2 dose question for the Pfizer vaccine.

FDA Analysis Of Pfizer COVID-19 Vaccine Finds It Effective And Safe

The Food and Drug Administration finds "no specific safety concerns" that would stand in the way of authorization of the vaccine for emergency use. Effectiveness is 95% after two doses.

www.npr.org

The FDA released a detailed analysis Tuesday morning of the COVID-19 vaccine from Pfizer and its partner BioNTech. The analysis finds "no specific safety concerns identified that would preclude issuance of an Emergency Use Authorization (EUA)." Serious reactions were rare. Side effects are common, however, with a majority of study volunteers experiencing reactions at the site of injection, headaches and fatigue.

The analysis also affirms the previously stated vaccine effectiveness of 95%, assessed a week after two doses of vaccine. The vaccine doses are given 21 days apart. The clinical data also suggest that the vaccine may be able to prevent COVID-19 after the first dose — 82% effective — though the FDA analysis says the available information doesn't allow for a firm conclusion on that potential effect.

All this is good news. Let's see what the Advisory Committee says on Thursday, and what the FDA does afterwards. It's possible that the FDA might act as soon as Friday, 11 December.

I have read that this same Vaccine Advisory Committee will review and vote on the Moderna vaccine as soon as it has finished with Pfizer's. Next week?

The FDA needs to change policy and do what the UK regulator did. They have been looking at trial data as the trials proceeded and not wait for a huge dump of data at completion of phase 3. That seems to me a much better way to go about it.

I suspect that the UK have made the decision, but not announced it publicly, that using a single dose in as many people as possible will get to herd immunity quicker than waiting for everyone to get two doses. That is my strong hunch. They probably have enough data already to make that projection.

In the UK they are distributing all doses immediately. In the US they are holding back half their doses so everyone gets the second dose on time. I think this issue needs constant review, and we should be able to determine soon the quickest route to herd immunity. That is the goal line that ends this pandemic. This is a call with huge public health and economic consequences.

The Johnson and Johnson results will be interesting as that is a single dose vaccine.

 

[GO-NAD!]

The FDA needs to change policy and do what the UK regulator did. They have been looking at trial data as the trials proceeded and not wait for a huge dump of data at completion of phase 3. That seems to me a much better way to go about it.

I suspect that the UK have made the decision, but not announced it publicly, that using a single dose in as many people as possible will get to herd immunity quicker than waiting for everyone to get two doses. That is my strong hunch. They probably have enough data already to make that projection.

In the UK they are distributing all doses immediately. In the US they are holding back half their doses so everyone gets the second dose on time. I think this issue needs constant review, and we should be able to determine soon the quickest route to herd immunity. That is the goal line that ends this pandemic. This is a call with huge public health and economic consequences.

The Johnson and Johnson results will be interesting as that is a single dose vaccine.

Are you suggesting that they administer single doses to maximize coverage and when sufficient vaccine stocks are accumulated, go back and give everyone their second dose? Or, would they be then spaced too far apart to be effective?

 

[TLS Guy]

Are you suggesting that they administer single doses to maximize coverage and when sufficient vaccine stocks are accumulated, go back and give everyone their second dose? Or, would they be then spaced too far apart to be effective?

I have no idea if that question can be answered specifically as there is no published data. However on general principles if these vaccines are inducing immune memory, then delaying the second shot may not matter a lot. However if the immune memory is short lived' then three shots might be required' and that would not be a good thing. However it might not be a bad as delay in achieving herd immunity. As these vaccines roll out I think a lot of data points need to be collected. I think we may be have to look at this as the largest trial in the history of medicine and continue to study dosing and spacing issues over time. So the public need to prepare for alterations in advice over time. If this was not a hyper emergency, these issues would be studied over years before roll out. In this case we do not have that luxury of time. We are punching the clock hard.

 

[GO-NAD!]

I have no idea if that question can be answered specifically as there is no published data. However on general principles if these vaccines are inducing immune memory, then delaying the second shot may not matter a lot. However if the immune memory is short lived' then three shots might be required' and that would not be a good thing. However it might not be a bad as delay in achieving herd immunity. As these vaccines roll out I think a lot of data points need to be collected. I think we may be have to look at this as the largest trial in the history of medicine and continue to study dosing and spacing issues over time. So the public need to prepare for alterations in advice over time. If this was not a hyper emergency, these issues would be studied over years before roll out. In this case we do not have that luxury of time. We are punching the clock hard.

While I understand the motivation to maximize the benefit of any vaccine on hand, I wonder if any inconsistencies might play into the hands of the anti-vaccers and the vaccine-hesitant/Nervous Nelly's. "See!? They have no idea what they're doing! They're going to kill us all!

I, for one, will take the vaccine whenever it's made available to me.

 

[Alex2507]

I, for one, will take the vaccine whenever it's made available to me.

Go for the Russian one. It gave the women erections!

 

[Swerd]

The FDA needs to change policy and do what the UK regulator did. They have been looking at trial data as the trials proceeded and not wait for a huge dump of data at completion of phase 3. That seems to me a much better way to go about it.

You've misinterpreted what I previously said. Today, the FDA released to the public a detailed analysis of the Pfizer trial. They had been continuously monitoring the trial data as it was reported by trial sites, via a networked database. There were weekly summaries, however, that data was only made public today.

The FDA or it's Advisory Committee will have to make an educated guess to decide whether to go with one dose followed by a second dose 3 weeks later, or a second dose after some longer time, such as 6 or 12 months later. The trial collected blood samples from each person 1 week after the first dose, and again 1 week after the second dose. Some type of laboratory assay (such as an ELLISPOT assay) to quantify T-cells capable of secreting IFN-λ after stimulation with corona virus Spike protein was done for each person's samples. Based on that, Pfizer was able to measure an 82% response after dose 1, and a 95% response after dose 2. The 3 weeks between doses was not long enough to adequately determine clinical immunity and instead made use of the lab test to measure successful immunizations.

The educated guess to answer that question must be balanced by their guess to another question. How many people will fail to get the second dose after 3 weeks vs. how many will fail to get the second dose after a longer time?

 

[John Parks]

 

[Trell]

Go for the Russian one. It gave the women erections!

I'm surprised that you knew about that, the blood-filled clitoris, that is I thought that kind of practical information was banned in USA.

 

[Dude#1279435]

"...it would take 5, 6, 7 years"

No, they predicted 12-18 months. I couldn't take it anymore after 5 minutes. I stopped.

February golf trips
"It's a democratic hoax"
"It will magically disappear"
Enough already.

 

[Mr._Clark]

This article seems to explain the Moderna vaccine quite well. I say "seems to" because I do not know enough about the vaccine to spot errors in the article.

How Moderna’s Vaccine Works (Published 2022)

Two shots can prime the immune system to fight the coronavirus.

www.nytimes.com

 

[TLS Guy]

I have spent a good deal of the day reviewing the massive data dumps from the Pfizer trials and an event bigger dump in Lancet today from the Oxford group.

The Pfizer data is well presented and is clear. It is a highly effective vaccine. The length of the immunity is unknown. We know nothing of its ability to prevent asymptomatic spread. It is safe, although I think in press reports of the significant and unpleasant local effects and the transient systemic effects have been minimized. However, they were all in the nuisance category with no long term harm. This is clean data and comparatively easy to discern. As above, there are issues that the study did not address. The local reactions were anticipated prior to the study by the way, so they are no surprise.

The Moderna vaccine is similar, and I expect data to be similar and the side effects. The cold chain is much less arduous.
So we await the publication of their results.

The Oxford group published their results in The Lancet today. There is a lot of data here, and picking out the details takes time and some discernment.
The whole study is somewhat disorganized in many ways. However it does contain a lot of useful information.

The vaccine has been studied in the UK, Brazil and South Africa. However the South African data is incomplete.
It seems originally this vaccine was designed to be single dose. But early phase data showed a less then hoped for immune response. So the booster dose at a month was added. Now for various reasons early dosing was at half the dose it ended up being. So some early enrollees had a low first dose and a full second dose. Now the trial was designed to have the doses given 28 days apart. However because of early difficulties in manufacture, some enrollees got their second doses at 6 and 8 weeks after the first. This actually in the end produced some intriguing data. In addition the subjects in the Oxford study were more ethnically diverse than in the Pfizer study. The age ranges are similar in both studies. However the half first dose subjects were a significantly lower age group. However in the two full dose studies there really was no significant difference in effectiveness between age groups. So I tend to agree with professor Pollard that the increased effectiveness of the LD/SD regime is almost certainly real. So the vaccine was 60% effective in the SD/SD group and 90% effective in the LD/SD group. If you combine the groups then you get a 70% effective result.

Now because of the 6 to 8 week delay between doses you can infer that one dose is 50% effective. That would make it questionable to advise a single dose regimen. However there was no significant change in effectiveness when the second dose was delayed.

In addition this group did study asymptomatic and symptomatic PCR testing. Even one dose drastically reduced asymptomatic PCR positivity. This has enormous public health implications and is very positive news.

The other really encouraging thing is that as far as I can tell no subject who had at least one dose of either of these vaccines became seriously ill. All the serious illness and deaths were in the placebo arm.

In addition in both studies great care was taken to discern any evidence of vaccine acceleration. There was no evidence of vaccine acceleration even in those vaccinated who had previously had conformed Covid-19 infection. I think this vaccination of previously infected subjects was only addressed by the Oxford group.

There seems a bit of a dispute developing I think between Pfizer and the regulator. As far as I can discern, the FDA want the control group to remain unvaccinated to better understand the long term side effects. Pfizer feel, and I agree, that this is unethical and they plan to vaccinate subjects in the placebo arm.

So there is a lot of information to digest and I'm sure with experience, clinical practice and recommendations will evolve.

 

[Dude#1279435]

The right information will help change their mind!

Yes, COVID-19 Can Cause Erectile Dysfunction

A urologist discusses the findings of a study that links COVID-19 to erectile dysfunction.

health.clevelandclinic.org

I think it's because a lot of them are young and want to let others get it first. That was my original position too, but if I'm ever asymptomatic than I think I'd take it.

 

[Dude#1279435]

WH Task Force are not expecting a reduction in fatalities/cases till spring according to CNN.

 

[TLS Guy]

WH Task Force are not expecting a reduction in fatalities/cases till spring according to CNN.

I think that may even be optimistic. I think we should see the start of decline by April/May, but the real impact likely will be June/July time frame. Bank in at least 6 more months of serious disruption. If you are a business that is what I would plan for and hope it might be a bit less.