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Don't misunderstand, I'm lining up asap. But I do have concerns about the speed at which it was developed and approved. I'm not finding anything alarming in the list of side effects, but I don't know if I completely trust that.

Any thoughts from those smarter than I?

I doubt very seriously that I would fit into a category of “people smarter than you”, but I am an alternative medicine freak by nature, who feels there is great good in some conventional medicine. I am always attracted to facilities that incorporate all types of intervention. And I will admit that there were certain vaccinations that I did not give to my children.

I am one of the individuals in the US who has “comorbidities“. I have a auto immune issues, I’m over 65, and I am obese. And of course, my husband is at the top end of who needs to be protected.

But both of us are very tentative about the vaccine. I am torn between the miraculous speed at which it was developed, and the possible steps that were shortened or omitted to do so.

Putting faith in these huge medical corporations is going to be a real struggle for me. And at the same time, I wouldn’t want to do anything to discourage anyone from getting the vaccine.

Very scary times.

Which vaccine are you getting? Do you have any allergies? The NHS (England) stopped giving the vax to people with allergies because there were a few bad reactions.

Some vaccines are more effective than others, so you should know which one you are getting so that you aren't overly confident.

As for the speed - this was a whole-out worldwide race for the holy grail, with a great deal of resources devoted to it. Like during the HIV/Aids era for drug development. There were several players who were able to get up to speed very quickly (phase I, II, III trials). The results were able to be reviewed very quickly, basically being put to the front of the line. This does not typically happen, but this vax was a very high priority situation.

Is it impossible that corners were cut? No, not impossible. But overall, I think that the process was respected. There could be side effects that did not come out in the trials - but that happens all the time even in the regular process. Drugs get pulled from the market due to side effects that did not show up in the clinical trials. Once the drug/vax is on the market there is a much greater opportunity to find those side effects because many more people are using the drug.

I believe it's the same here. We will see more people with more side effects because many more people will be using the vaccine than did during the trials. But it is still likely that the benefits are much greater than the risks.

You should not take a vaccine that contains as any component something to which you are allergic. Like when you get a flu vaccine, they ask if you are allergic to eggs. That's because the vaccine is incubated in eggs. I don't know what these vaccines are made up of, but if you have any allergies you should make sure.

Also, try to get a high efficiency vax, they don't all have the same efficiency. Best bang for your buck!!

So in my professional scientific opinion, I would not be worried about the speed per se, more about the problems that always come up, even in the slow and bogged down fda bureaucracy.

possible steps that were shortened or omitted

I hope I am not sounding naïve, but I have worked on data analysis for drugs for fda approval. Even in the days of HIV/Aids, when sick people were BEGGING for early drug approval, without full analysis, the fda did not do it.

I was personally against that because these were people who were LITERALLY DYING and wanted to try ANYTHING. fda didn't want to set a precedent. They did instate an accelerated procedure, but this was basically the bare minimum for acceptability. There wasn't anything 'cut out', instead a more speeded up procedure for approval.

There is a lot of fda bureaucracy, some of which is not really necessary but more of a cya type. There is a balance of speed vs cya, and in a high-priority world-wide epidemic the tendency goes more to speed than cya. But the speed does not remove the scientifically necessary steps, it just devotes more resources to them.

Thanks for This Zen.

I’m certainly not saying I’m not going to get the vaccine. And I am certainly not suggesting or wanting to influence anyone else not to get it. For sure.

I have some issues with the FDA and their recommendations.

But I am in no way a scientist as are you - so I have some thinking to do. OTOH, my H has decided not to receive the vaccine. Not sure if he will have a change of heart.

Thanks, Zen, it all makes sense. I also read an article that said the groundwork for this type of vaccine had been laid years ago for other coronaviruses.

I am a firm believer in vaccines.

As to which one I'll get, I don't believe I'll have a choice, I think the allocation and distribution is up to our state.

Years ago, I tested positive for an egg allergy. I wanted to challenge that, and did, in a different allergist's office. I get the flu shot every year and have had no problems other than the normal sore arm and mild flu symptoms. I also had(ve) asthma but it's been mostly quiescent for many years.

Whats...please consider it all carefully. Your family is so vulnerable.

But the speed does not remove the scientifically necessary steps, it just devotes more resources to them.

Thank you for this statement Zen.

I see my Rheum on Monday and find out if I can have it or not too. If they say I'm good, I will be getting it sooner than later if at all possible, since I am in a high risk group, and may not be able to WFH for much longer.

Please talk to your Dr if you have other reservations.

One last thing to keep in mind is that there are 2 shots that you have to have to be fully vaccinated.

The 2 NHS workers had the Pfizer vaccine, and they had epi-pens so they had a defense. Not sure why they were given the vax in the first place, since if they had epi-pens that would indicate to me that they had some kind of allergies.

Pfizer says that in the 44k phase III there was 0.6% allergic reaction in the vaxed and 0.5% of the placebo. Not 0 but pretty small. They say that anyone with an allergy to any of the ingredients should not get their vax, but I haven't seen any list of ingredients.

WR - Think carefully about getting/not getting it. I think that since your H stays home most of the time, he should be low risk (but ianad). But you go out, right? Make sure to mask up, social distance, wash/sanitize hand (and wash face more than usual). Ask for a (knowledgeable!!) physician's advice about getting vaxed, because of your autoimmune. That might make you more likely to have an adverse reaction.

There ARE valid reasons not to be vaxed (not all that many though), but the scientific process is not one of them. The valid reasons don't apply to a large amount of the population. But you know your individual body best of all.

Yes, I do go out. I ALWAYS have a mask on, and I avoid a whole isle in the grocery store if someone is coming down toward me. I am extra careful because of my H. But I know that all the care in the world is no guarantee.

It’s odd that although I am a news junkie, this is the first I’m hearing about the egg allergy warning. I don’t have allergies, but I do wonder why I have missed any news about that.

You smart scientists and medical people are such a blessing! It’s like I have my own personal advisory cabinet to help me with things!!!

The other thing to keep in mind - most phase 3 trials are a few hundred participants, so extrapolating data for larger populations takes longer, more likely to have inaccuracies, etc.

Per the paperwork I saw of someone I know in the Pfizer trial, they're over 43 *thousand* in their trial. The sheer volume allows them to project out numbers much more easily and with more accuracy than is possible in normal vaccine creation.

I'm relatively low-risk, but I'll be getting it whenever it's available for me to do so.

yes, there were *44,000*, half got the vaccine, and 42,000 went to the second shot (vaccine or placebo). There are never this many patients in phase III drug trials.

I am torn between the miraculous speed at which it was developed, and the possible steps that were shortened or omitted to do so.

It is my understanding that they didn't omit any steps, but that they went on simultaneously. So while they were doing in vivo and animal trials, they were also doing human trials. I'm sure the people who signed up for this, were fully schooled on the risks of enrolling in this kind of study. And I'd guess that some of those phase 1 and phase 2 steps are still being studied.

Remember, by the time someone like me becomes qualified to receive the vaccine, there will be data of people getting it going back to last summer when the first enrollees got their shots. So probably close to a year of studying those first enrollees before I am able to get it.

It’s odd that although I am a news junkie, this is the first I’m hearing about the egg allergy warning.

When you get the annual flu shot, asking you about egg allergies is part of the process. If you get it at your physician's office, then they will know from your records if you have an egg allergy or not, and are trained to look for that. If you get the flu shot at a pharmacy or some other place, since they don't have all of your medical records in front of them, they ask you if you have an allergy to eggs. It's nothing new, so no reason to be making the news, so you didn't miss anything.

There is a balance of speed vs cya, and in a high-priority world-wide epidemic the tendency goes more to speed than cya.

Exactly. These pharmaceutical companies are not going to put their entire futures at risk to get a vaccine to market earlier than another company. And with the worldwide notoriety of this pandemic, you can bet, if any of these vaccines is found to be harmful and it was missed by cutting corners in the scientific process, that company will be ruined forever. The CEOs and board members of these companies know this. The scientists at reputable companies will not risk their reputations to make a few bucks.

@number4 "Why Can't Drug Companies Be Sued for Vaccine Injuries?

When most drugs cause harm, the pharmaceutical companies that make them can be sued in product liability lawsuits. But that isn't the case with vaccines. In 1986, Congress passed a law that protects vaccine manufacturers from being sued in civil personal injury and wrongful death lawsuits resulting from vaccine injuries.

Both drugmakers and federal government officials admit that although vaccines are created with the purpose of keeping the public safe, they can cause rare but serious, and sometimes fatal, side effects.

In the 1970s and 80s, drugmakers paid out millions to plaintiffs in hundreds of vaccine-related injury lawsuits. The litigation was complex and expensive because of how difficult it is to show epidemiological cause and effect in these cases.

Eventually, some drugmakers decided to stop making vaccines altogether. This drew alarm from public health officials, who worried about sustaining existing vaccines and also the development of new vaccines."

Well that explains it, because I don’t actually get a flu shot.

So I would’ve never have been in a position to be asked about allergies.

The science for these vaccines is pretty damn solid based on everything that I have read (and I have read a lot). I'll provide only limited credentials to protect my identity, but I inarguably qualify as someone smart enough about viruses, microorganisms, and public health to have an informed opinion.

The biggest issues, based on my reading, would be extremely rare side effects and common side effects of vaccines that in my opinion are exceptionally minor.

Starting with the minor but common side effects. These are: (1) shots hurt, and (2) you feel sick for a period after the shot. These are implicitly part of the vaccination process. The illness after the shot is literally your immune system responding to the vaccine, which is intended. It's uncomfortable but minor and to be expected.

As far as rare side effects, these are super-duper hard to parse out statistically. The example that I remember is from a vaccine that has been around for a long, long time. They have determined that this particular vaccine doubles the rate of Guillain-Barre syndrome from 1 in 100,000 to 2 in 100,000.

Anyway, everything in life is a risk... in my opinion, the risk of serious complications from NOT getting the vaccine is far greater than the risk of getting the vaccine.

in my opinion, the risk of serious complications from NOT getting the vaccine is far greater than the risk of getting the vaccine.

I would amend this to say that the current evidence shows that the risk of serious complications from NOT getting vaxed is (far) greater than the risk of getting vaxed EXCEPT FOR those with known or predictable conditions, especially those who have allergies. These people should only receive the vax under their (knowledgeable) physician's supervision.

The Pfizer vax seems pretty solid and is being rolled out in most of Western Europe and, most recently, Canada. The Moderna also has a lot of support. The Oxford/AstraZeneca is not so good and the trial is much smaller and incomplete. The efficacy is only around 70%, much smaller than 90-95% for the other two. It also looks like it will not be approved by the fda any time soon due to a number of problems with their trials.

Not everyone CAN be vaxed - like those with allergies or people with autoimmune or rheum (like tn). But if you can be, you should be (imho).

[This message edited by ZenMumWalking at 2:44 PM, December 9th (Wednesday)]

@TruthisPower -

Bad PR from omitting or rushing steps is enough to ruin a company's image forever. Look at what pharma bro, Martin Shkreli, did to Retrophin, and it wasn't even science-related. They had to change their brand name to escape from that nightmare.

Will rare side effects occur? Probably, but gross negligence? No. Things are different for pharmaceutical companies now than they were in the 70s and 80s. Almost every medication out there has the potential for side effects. But the side effects risk is so minimal that I'm willing to risk it, just like I risk other medications that could possibly cause me harm, including something as mundane as acetaminophen or ibuprofen.

In 1986, Congress passed a law that protects vaccine manufacturers from being sued in civil personal injury and wrongful death lawsuits resulting from vaccine injuries.

Instead, there is a government fund for severe harmful effects of vaccines, because it is in the public interest to have a high percentage uptake.