The Vaccine(s)

[T Bredehoft]

so Pfizer may have simply defaulted to the worst case storage requirement

A good possibility, we probably will never know.

 

[mksj]

A good possibility, we probably will never know.

It is actually known, one of the areas I work in on advising companies. It is a matter of stability over time and expiration time under various scenarios. Long term storage in distribution centers will most likely require ultra-low refrigeration. These centers are required to have 24/7 monitoring, inclusive of transport there are various temperature monitoring equipment when this occurs depending on the fragility of the drug. Most of this is worked out in advance, I often advise/design/review these studies at different points in the drug development process, as well as administration and marketing. I also do medical safety review for ongoing trials. The nature of these types of vaccines is they do degrade faster with warmer storage temperatures. So you may see months at -20C and weeks or days at 4C. If there is a high turnover of vaccine, then not a problem. It is a concern if one does not track these temperature changes then the vaccine could degrade and become ineffective. There are other limiting factors as well with packaging the product and dosing/administration. It is a bit more of a complex process that each company needs to sort out, provide a safety margin and also comply with country specific medical requirements. At this point it is a bit of a horse race between the different COVID vaccines in the pipeline, and part of the PR campaign.

As far as individuals having flu like symptoms from vaccinations, to some degree this is expected as you are generating an immune response to a vaccine protein/antigen. It is also much more complicated as to the type of vaccine. In some people this may be mild in others more significant, but these typically last a few days at most. In rare case there may be long term reactions as I experienced (guillain barre syndrome) which didn't show up for months after the vaccination. The estimated risk is around 10-40 per 1 million vaccinations, but highly variable on the vaccine and other factors. Often initial vaccinations are given in a series of 2 or 3 injections/administrations, typically with 1-2 months between the 1st and 2nd. A single injection you might have 60-70% of individuals being effectively vaccinated and the second dose boosting that to 90-95% effective. Shingrix the Herpes Zoster Vaccine is a good example, a single vaccination is about 90% effective in individuals in the 50-70 Y/O, but above 70 only 70%. A second vaccinations brings this up to ~95% for all groups. Well worth the short term discomfort vs. the getting Herpes Zoster which increases with age.

 

[rwm]

MSKJ-That's good info thanks!
I am due to get either shingles or the vaccine! I think I am going to hold off until I see how the Covid vaccine plays out. I don't want 3 different vaccines in a short period of time no matter what the safety profile. (Influenza, Herpes Zoster and SARS cov 2)
Robert

 

[MontanaLon]

We are currently having a severe outbreak in my area. The hospital is full and then some. Then there is the fact that many of the staff of the hospital have been infected with the virus. This is no longer April in New York where the hospitals were jammed and there was not enough PPE for proper use. Today, there is no recycling of PPE on multiple patients. All of the staff that has been infected were adhering to all of the precautions. All of the precautions were ineffective.

For the last week we have had about .15% of the population of the county testing positive for the virus. A significant number of the positive cases have been asymptomatic but so far those reporting the test results have not been forthcoming with the actual numbers of asymptomatic cases. That number is extremely important in order to judge how widespread the actual infection is in the county. The majority of the asymptomatic positives seem to be coming from people who are having elective surgery or being cleared for visiting the doctor's office for other procedures.

What we can assume is that the actual number of cases is some multiple of the actual positive tests but there doesn't seem to be any interest in doing any randomized testing of the population in general to discover what that number actually is. The rate it is spreading now is beyond being able to stop and will result in the virus burning itself out in a relatively short period of time. Currently about 1% of the population of the county is testing positive in a week. That is about 3 times higher than the national numbers which suggests the virus has already infected more people in more densely populated areas and is no longer spreading as fast in areas that had higher numbers in the spring. That indicates herd immunity is suppressing cases in at least some areas of the country.

It is very likely that before the vaccine is widely available the virus will have burned itself out in most areas.

 

[rwm]

I would be careful about waiting on herd immunity. I have seen estimates that it would take 70% of the population to be infected for that to occur.
I agree it would be really nice if we had random community samples to see where we are. In Gaston County NC right now we have a 6.8% positive rate out of 32000 tests. The problem with that number is it is not random and likely skewed up by symptomatic cases who went to get tested.
Robert

 

[MontanaLon]

I would be careful about waiting on herd immunity. I have seen estimates that it would take 70% of the population to be infected for that to occur.
I agree it would be really nice if we had random community samples to see where we are. In Gaston County NC right now we have a 6.8% positive rate out of 32000 tests. The problem with that number is it is not random and likely skewed up by symptomatic cases who went to get tested.
Robert

That is the problem with the lack of transparency on the numbers. We are getting positive cases only and to find any other information we have to go looking. Our positivity rate is 14% right now. The lack of any numbers of symptomatic vs asymptomatic among those tested is very troubling. If they were only testing symptomatic people now like they did at the start of the testing and finding 14% of those with symptoms were positive it paints a very different picture than if all the tests were on asymptomatic people and the positivity rate was 14%.

I guess my problem with it is we are being told the results of testing and they are treating it like a peer reviewed double blind study and people are buying it. If the virus is as easily spread as they say and clearly it is given the fact that health care providers are contracting the virus even with all of the recommended precautions then it is likely that the virus has in fact infected far more people than the testing has caught up to this point.

There is a lot of smoke and mirrors going on surrounding the virus. Things that should be looked at are not being addressed and things that are unimportant are being treated as the holy grail of information.

Nothing is as it seems.

 

[mksj]

It is true that "Nothing is as it seems", but there is extensive data available in different areas with this regard, it is a matter of extracting valid information and presenting it in a meaningful manner. In many case people want to believe what they want, and there is also a lot of smoke a mirrors. The main focus has been to try to contain the rate of spread so that hospitals are not overwhelmed, and we are back at the breaking point with this aspect. Many countries are now in lock-down mode because of the recent increase. PPE's are not 100% effective, part of this is training and part is people are not 100% compliant. There are numerous peer review publications to show that the transmission of COVID relates to compliance with use of PPE's, as to infectivity with healthcare workers, we are looking are extremely high risk factors for transmission and in many cases lack of adequate PPE's. Looking at it as a whole "The prevalence of COVID-19 was 2,747 cases per 100,000 among frontline health care personnel compared with 242 cases per 100,000 in the general community", and the those workers in nursing homes and assisted living are 2-3X higher risk than compared to hospital settings often due to poor training and lack of PPE's. PPE's help, they are not 100%, I personally find it a joke they way people wear masks with their noses exposed or otherwise and that one can think that some piece of fabric is going to provide proper protection. Proper PPE's have a rating for particle size, require proper fitment and training. None of which has been provided to the public, let alone people even using masks. So it is all a matter of degrees, but if you think that PPE's don't work, then ask your doctor not to wear one when he does a surgical procedure on you.

Infection Prevention

www.idsociety.org

I am very doubtful that heard immunity will occur in the near future, the whole concept is a bit abstract and is a bit simplistic, this is not going to go away at that point. I started in medicine before we knew what HIV was, so similar statistics and statements of outcomes, all to the point of moderating the severity of the epidemic that was occurring. I ran the HIV clinic, participated in many of the HIV trials that brought drugs to market and the eventual ability to treat the disease. I also had 2 crews of my staff pass in the process and countless other friends/associates, after the original premise that only 10% of HIV infected will go on to develop AIDS. We all new at the time it was going to be 100%, and each year they revised the percentage. They have been trying to develop a vaccine for HIV for decades with little results. So we tell little white lies to diminish the impact. Yes, nothing is as it seems, but to have a vaccine that can provide neutralizing antibodies in 90-95% of vaccinated individuals is going to have very tangible and meaningful impact long before we see heard immunity from direct exposure and millions more people dying. We know vaccines can/do work, the preliminary findings on the ongoing COVID trials supports that in a significant manor which has been unprecedented in modern times. If you question vaccines, I though Ebola if it broke out would disseminate populations in the most horrific manor. A vaccine was developed and release in 2019 that has demonstrated 100% effectiveness vs. a mortality rate of ~90% if contracted. A matter of choice and risk.

First FDA-approved vaccine for the prevention of Ebola virus disease, marking a critical milestone in public health preparedness and response

FDA announced today the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in indivi

www.fda.gov

 

[graham-xrf]

@mksj :
Hi Mark. I wonder you can help on whether folk who have "recovered", maybe having a period of relative immunity, can encounter, and pick up a replicating viral load that they can be spreading?

They may be without symptoms, and the virus in them may be doomed (herd immunity?), but are they still a public health hazard, because having "had it", they think measures to halt a runaway spread of the virus no longer applies to them?

 

[Cooter Brown]

 

[GunsOfNavarone]

I'm sure someone has already said this, but I picture I AM LEDGEND and the cancer vaccine...